UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
Washington, D.C. 20549
FORM 40-F
x | Registration statement pursuant to Section 12 of the Securities Exchange Act of 1934 |
or
¨ | Annual report pursuant to Section 13(a) or 15(d) of the Securities Exchange Act of 1934 |
For the fiscal year ended
Commission File Number
Concordia Healthcare Corp.
(Exact name of registrant as specified in its charter)
Ontario, Canada | 2834 | N/A | ||
(Province or Other Jurisdiction of Incorporation or Organization) |
(Primary Standard Industrial Classification Code) |
(I.R.S. Employer Identification No.) |
277 Lakeshore Road East, Suite 302
Oakville, Ontario L6J 1H9
(905) 842-5154
(Address and telephone number of registrants principal executive offices)
CT Corporation
111 Eighth Avenue
New York, New York 10011
(212) 590-9070
(Name, address (including zip code) and telephone number (including area code)
of agent for service in the United States)
Securities to be registered pursuant to Section 12(b) of the Act:
Title of Each Class: |
Name of Each Exchange On Which Registered: |
|
Common Shares, no par value | NASDAQ Global Select Market |
Securities registered pursuant to Section 12(g) of the Act: None
Securities for which there is a reporting obligation pursuant to Section 15(d) of the Act: None
For annual reports, indicate by check mark the information filed with this form:
¨ Annual Information Form | ¨ Audited Annual Financial Statements |
Indicate the number of outstanding shares of each of the registrants classes of capital or common stock as of the close of the period covered by the annual report: N/A
Indicate by check mark whether the Registrant: (1) has filed all reports required to be filed by Section 13 or 15(d) of the Exchange Act 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 x No
Indicate by check mark whether the registrant has submitted electronically and posted on its corporate Web site, if any, every Interactive Data File required to be submitted and posted pursuant to Rule 405 of Regulation S-T (§232.405 of this chapter) during the preceding 12 months (or for such shorter period that the registrant was required to submit and post such files).
¨ Yes x No
FORWARD LOOKING STATEMENTS
The Exhibits incorporated by reference into this Registration Statement contain forward-looking statements within the meaning of applicable securities laws, which are based upon the Registrants current internal expectations, estimates, projections, assumptions and beliefs. Statements concerning the Registrants objectives, goals, strategies, intentions, plans, beliefs, expectations and estimates, and the business, operations, future financial performance and condition of the Registrant are forward-looking statements. The words believe, expect, anticipate, estimate, intend, may, will, would and similar expressions and the negative and grammatical variations of such expressions are intended to identify forward-looking statements, although not all forward-looking statements contain these identifying words. These statements are not guarantees of future performance and involve known and unknown risks, uncertainties and other factors that may cause actual results or events to differ materially from those anticipated in the forward-looking statements. In addition, the Exhibits incorporated by reference into this Registration Statement may contain forward-looking statements attributed to third-party industry sources.
By their nature, forward-looking statements involve numerous assumptions, known and unknown risks and uncertainties, both general and specific, that contribute to the possibility that the predictions, forecasts and projections that constitute forward-looking statements will not occur. In preparing this Registration Statement, the Registrant has not updated such forward-looking statements to reflect any change in circumstances or in managements beliefs, expectations or opinions that may have occurred prior to the date hereof. Nor does the Registrant assume any obligation to update such forward-looking statements in the future.
Some of the risks and other factors which could cause actual results to differ materially from those expressed in the forward-looking statements contained in the Exhibits incorporated by reference into this Registration Statement include, but are not limited to, the risk factors included under the heading Risk Factors in Exhibit 99.3 attached hereto.
DIFFERENCES IN UNITED STATES AND CANADIAN REPORTING PRACTICES
The Registrant is permitted, under a multijurisdictional disclosure system adopted by the United States, to prepare this report in accordance with Canadian disclosure requirements, which are different from those of the United States. The Registrant prepares its financial statements, which are filed with this report on Form 40-F in accordance with International Financial Reporting Standards as issued by the International Accounting Standards Board, and the audit is subject to Canadian auditing and auditor independence standards.
DOCUMENTS FILED PURSUANT TO GENERAL INSTRUCTIONS
In accordance with General Instruction B.(l) of Form 40-F, the Registrant hereby incorporates by reference Exhibit 99.1 through Exhibit 99.35, as set forth in the Exhibit Index attached hereto.
-1-
OFF-BALANCE SHEET TRANSACTIONS
The Registrant does not have any off-balance sheet transactions that have or are reasonably likely to have a current or future effect on the Registrants financial condition, changes in financial condition, revenues or expenses, results of operations, liquidity, capital expenditures or capital resources that are material to investors.
TABULAR DISCLOSURE OF CONTRACTUAL OBLIGATIONS
The disclosure provided under Contractual Obligations on page 23 of Exhibit 99.5, Managements Discussion & Analysis for the Year Ended December 31, 2014, is incorporated by reference herein.
UNDERTAKINGS
The Registrant undertakes to make available, in person or by telephone, representatives to respond to inquiries made by the Commission staff, and to furnish promptly, when requested to do so by the Commission staff, information relating to: the securities registered pursuant to Form 40-F; the securities in relation to which the obligation to file an annual report on Form 40-F arises; or transactions in said securities.
CONSENT TO SERVICE OF PROCESS
Concurrently with the filing of the Registration Statement on Form 40-F, the Registrant will file with the Commission a written irrevocable consent and power of attorney on Form F-X. Any change to the name or address of the Registrants agent for service shall be communicated promptly to the Commission by amendment to the Form F-X referencing the file number of the Registrant.
-2-
SIGNATURES
Pursuant to the requirements of the Exchange Act, the Registrant certifies that it meets all of the requirements for filing on Form 40-F and has duly caused this Registration Statement to be signed on its behalf by the undersigned, thereunto duly authorized.
CONCORDIA HEALTHCARE CORP. | ||
/s/ Mark Thompson |
||
Name: | Mark Thompson | |
Title: | Chief Executive Officer |
Date: June 1, 2015
EXHIBIT INDEX
The following documents are being filed with the Commission as exhibits to this registration statement on Form 40-F.
Exhibit |
Description |
|
99.1 | Unaudited Condensed Interim Consolidated Financial Statements dated March 31, 2015 | |
99.2 | Managements Discussion and Analysis for the three months ended March 31, 2015 | |
99.3 | Annual Information Form for the year ended December 31, 2014 | |
99.4 | Consolidated Financial Statements for the years ended December 31, 2014 and 2013 | |
99.5 | Managements Discussion and Analysis for the year ended December 31, 2014 | |
99.6 | Annual Information Form for the year ended December 31, 2013 | |
99.7 | Material Change Report dated May 1, 2015 | |
99.8 | Material Change Report dated April 14, 2015 | |
99.9 | Material Change Report dated March 17, 2015 | |
99.10 | Material Change Report dated March 16, 2015 | |
99.11 | Code of Conduct effective July 7, 2014 | |
99.12 | Asset Purchase and Sale Agreement between PBM Pharmaceuticals, Inc. and Concordia Pharmaceuticals Inc. dated as of March 19, 2014 | |
99.13 | Guarantee dated September 3, 2014 | |
99.14 | Asset Purchase Agreement by and between Eisai Inc. and Concordia Pharmaceuticals Inc. dated as of September 3, 2014 | |
99.15 | Supply Agreement dated September 30, 2014 | |
99.16 | License Agreement dated September 30, 2014 | |
99.17 | Sumitomo Assignment and Assumption Agreement dated September 17, 2014 | |
99.18 | Asset Purchase Agreement between Covis Pharma S.à.r.l., Covis Injectables S.à.r.l., Covis Pharma Holdings S.à.r.l., Concordia Pharmaceuticals Inc. and Concordia Healthcare Corp. dated as of March 9, 2015 | |
99.19 | Purchase Agreement between Concordia Healthcare Corp., Concordia Healthcare Inc., Concordia Healthcare (USA) Inc., Complete Medical Homecare, Inc., Concordia Labs Inc., Pinnacle Biologics, Inc., Concordia Pharmaceuticals Inc., Concordia Laboratories Inc., and RBC Capital Markets, LLC dated April 13, 2015 | |
99.20 | Assignment and Assumption Agreement between Covis Pharma S.à.r.l., Covis Injectables S.à.r.l., and Concordia Pharmaceuticals Inc. dated as of April 21, 2015 | |
99.21 | Bill of Sale between Covis Pharma S.à.r.l., Covis Injectables S.à.r.l., and Concordia Pharmaceuticals Inc. dated as of April 21, 2015 | |
99.22 | Escrow Agreement between Covis Pharma S.à.r.l., Covis Injectables S.à.r.l., Concordia Pharmaceuticals Inc., and U.S. Bank National Association dated as of April 21, 2015 | |
99.23 | Intellectual Property Assignment Agreement between Covis Pharma S.à.r.l., Covis Injectables S.à.r.l., Covis Pharma Holdings S.à.r.l., and Concordia Pharmaceuticals Inc. dated as of April 21, 2015 | |
99.24 | Transition Services Agreement between Covis Pharma S.à.r.l., Covis Injectables S.à.r.l., and Concordia Pharmaceuticals Inc. dated as of April 21, 2015 | |
99.25 | Credit and Guaranty Agreement between Concordia Healthcare Corp., Concordia Healthcare Inc., Concordia Healthcare USA Inc., Complete Medical Homecare, Inc., Concordia Labs Inc., Pinnacle Biologics, Inc., Concordia Pharmaceuticals Inc., Concordia Laboratories Inc., RBC Capital Markets, LLC, Morgan Stanley Senior Funding, Inc., GE Capital Markets, Inc., TD Securities (USA) LLC, General Electric Capital Corporation, Export Development Canada, The Toronto-Dominion Bank, Fifth Third Bank and Royal Bank of Canada dated as of April 21, 2015 | |
99.26 | Business Acquisition Report dated February 10, 2014 | |
99.27 | Business Acquisition Report dated June 9, 2014 | |
99.28 | Business Acquisition Report dated December 12, 2014 | |
99.29 | News release dated May 25, 2015 | |
99.30 | News release dated May 7, 2015 | |
99.31 | News release dated April 21, 2015 |
99.32 | News release dated February 12, 2015 | |
99.33 | News release dated December 22, 2014 | |
99.34 | Letter from Former Auditor dated May 20, 2015 | |
99.35 | Letter from Successor Auditor dated May 20, 2015 |
Exhibit 99.1
Unaudited Condensed Interim Consolidated Financial Statements of
Concordia Healthcare Corp.
March 31, 2015
[1]
Table of Contents
Condensed Interim Consolidated Balance Sheets |
3 | |||
Condensed Interim Consolidated Statements of Income and Comprehensive Income |
4 | |||
Condensed Interim Consolidated Statements of Changes in Equity |
5 | |||
Condensed Interim Consolidated Statements of Cash Flows |
6 | |||
Notes to Condensed Interim Consolidated Financial Statements |
7-33 |
[2]
Concordia Healthcare Corp.
Condensed Interim Consolidated Balance Sheets
As at March 31, 2015 and December 31, 2014
(Stated in thousands of U.S. Dollars, except per share amounts)
(Unaudited)
March 31,
2015 |
December 31,
2014(Audited) |
|||||||
Assets |
||||||||
Current |
||||||||
Cash |
$ | 35,363 | $ | 42,770 | ||||
Accounts receivable (Note 4) |
20,065 | 29,371 | ||||||
Inventory (Note 5) |
7,662 | 6,718 | ||||||
Prepaid expenses and other current assets (Note 6) |
15,961 | 5,793 | ||||||
|
|
|
|
|||||
79,051 | 84,652 | |||||||
Fixed assets (Note 7) |
1,562 | 760 | ||||||
Deferred taxes |
1,046 | 861 | ||||||
Intangible assets (Note 8) |
465,009 | 470,168 | ||||||
Goodwill (Note 9) |
36,259 | 36,259 | ||||||
|
|
|
|
|||||
Total Assets |
$ | 582,927 | $ | 592,700 | ||||
|
|
|
|
|||||
Liabilities |
||||||||
Current |
||||||||
Accounts payable |
$ | 9,049 | $ | 6,773 | ||||
Accrued liabilities |
6,844 | 3,849 | ||||||
Provisions (Note 10) |
18,820 | 21,799 | ||||||
Royalties payable |
1,316 | 3,141 | ||||||
Dividends payable |
2,166 | 2,165 | ||||||
Taxes payable |
48 | 13,309 | ||||||
Current portion of notes payable (Note 12) |
572 | 1,372 | ||||||
Current portion of long-term debt (Note 11) |
253,347 | 27,336 | ||||||
Current portion of purchase consideration payable (Note 13) |
2,240 | 2,065 | ||||||
|
|
|
|
|||||
$ | 294,402 | $ | 81,809 | |||||
Long-term debt (Note 11) |
| 226,145 | ||||||
Notes payable (Note 12) |
4,053 | 3,890 | ||||||
Purchase consideration payable (Note 13) |
22,417 | 23,043 | ||||||
Deferred taxes |
120 | 17 | ||||||
Other liabilities |
240 | 246 | ||||||
|
|
|
|
|||||
Total Liabilities |
321,232 | 335,150 | ||||||
|
|
|
|
|||||
Shareholders Equity |
||||||||
Share capital (Note 14) |
247,087 | 247,035 | ||||||
Reserve for share based compensation (Note 16) |
5,912 | 5,028 | ||||||
Accumulated other comprehensive income (loss) |
(567 | ) | (274 | ) | ||||
Retained earnings |
9,263 | 5,761 | ||||||
|
|
|
|
|||||
Total Shareholders Equity |
261,695 | 257,550 | ||||||
|
|
|
|
|||||
Total Liabilities and Shareholders Equity |
$ | 582,927 | $ | 592,700 | ||||
|
|
|
|
|||||
Commitments and contingencies (Note 18) |
||||||||
Subsequent events (Note 23) |
Approved and authorized for issue by the Board of Directors on May 14, 2015. | ||
Jordan Kupinsky | Mark Thompson | |
Director (Signed) | Director (Signed) | |
The accompanying notes are an integral part of these consolidated financial statements. |
[3]
Concordia Healthcare Corp.
Condensed Interim Consolidated Statements of Income and Comprehensive Income
For the three months ended March 31, 2015 and 2014
(Stated in thousands of U.S. Dollars, except per share amounts)
(Unaudited)
Three Months ended March 31, | ||||||||
2015 | 2014 | |||||||
Revenue |
$ | 36,435 | $ | 16,810 | ||||
Cost of sales |
4,345 | 3,854 | ||||||
|
|
|
|
|||||
Gross profit |
32,090 | 12,956 | ||||||
|
|
|
|
|||||
Operating expenses |
||||||||
General and administrative |
6,317 | 4,691 | ||||||
Business acquisition related costs |
2,438 | 174 | ||||||
Selling and marketing |
3,105 | 944 | ||||||
Research and development |
3,088 | 1,418 | ||||||
Share-based compensation |
897 | 756 | ||||||
Depreciation expense |
56 | 34 | ||||||
|
|
|
|
|||||
Total operating expenses |
15,901 | 8,017 | ||||||
|
|
|
|
|||||
|
||||||||
|
|
|
|
|||||
Operating income |
16,189 | 4,939 | ||||||
|
|
|
|
|||||
Other income and expenses |
||||||||
Interest and accretion expense |
8,641 | 4,705 | ||||||
Amortization of intangible assets |
5,205 | 580 | ||||||
Change in fair value of contingent consideration |
(1,282 | ) | 567 | |||||
Foreign exchange (gain) loss |
(409 | ) | 865 | |||||
Fair value (gain) loss on foreign exchange forward contract |
(2,549 | ) | | |||||
Other (income) expense |
416 | (5 | ) | |||||
|
|
|
|
|||||
Income (loss) before tax |
6,167 | (1,773 | ) | |||||
|
|
|
|
|||||
Income taxes |
||||||||
Current |
535 | 185 | ||||||
Deferred |
(36 | ) | (122 | ) | ||||
|
|
|
|
|||||
Net Income (loss) |
5,668 | (1,836 | ) | |||||
|
|
|
|
|||||
Other comprehensive income (loss) |
||||||||
Exchange differences on translation of foreign operations |
(293 | ) | (13 | ) | ||||
|
|
|
|
|||||
Total comprehensive income (loss) for the period |
$ | 5,375 | $ | (1,849 | ) | |||
|
|
|
|
|||||
Earnings per share (Note 15) |
||||||||
Basic earnings per share |
$ | 0.20 | $ | (0.09 | ) | |||
Diluted earnings per share |
$ | 0.19 | $ | (0.09 | ) |
The accompanying notes are an integral part of these consolidated financial statements.
[4]
Concordia Healthcare Corp.
Condensed Interim Consolidated Statements of Changes in Equity
For the three months ended March 31, 2015 and 2014
(Stated in thousands of U.S. Dollars, except per share amounts)
(Unaudited)
Share Capital | ||||||||||||||||||||||||
Number of
Shares |
Amount |
Reserve for
Share Based Compensation |
Accumulated
Other Comprehensive Income (Loss) |
Retained
Earnings |
Total
Shareholders Equity |
|||||||||||||||||||
Balances, January 1, 2014 |
17,985,889 | $ | 57,521 | $ | 1,555 | $ | 15 | $ | 2,431 | $ | 61,522 | |||||||||||||
Issuance of Common Stock during the period |
5,750,000 | 56,998 | | | | 56,998 | ||||||||||||||||||
Exercise of options |
125,357 | 992 | (318 | ) | | | 674 | |||||||||||||||||
Share based compensation expense |
| | 756 | | | 756 | ||||||||||||||||||
Net loss |
| | | | (1,836 | ) | (1,836 | ) | ||||||||||||||||
Foreign currency translation adjustment |
| | | (13 | ) | | (13 | ) | ||||||||||||||||
|
|
|
|
|
|
|
|
|
|
|
|
|||||||||||||
Balances, March 31, 2014 |
23,861,246 | $ | 115,511 | $ | 1,993 | $ | 2 | $ | 595 | $ | 118,101 | |||||||||||||
|
|
|
|
|
|
|
|
|
|
|
|
|||||||||||||
Balances, January 1, 2015 |
28,861,239 | $ | 247,035 | $ | 5,028 | $ | (274 | ) | $ | 5,761 | $ | 257,550 | ||||||||||||
Issuance of Common Stock during the period |
| | | | | | ||||||||||||||||||
Dividends |
| | | | (2,166 | ) | (2,166 | ) | ||||||||||||||||
Exercise of options |
12,500 | 52 | (13 | ) | | | 39 | |||||||||||||||||
Share based compensation expense |
| | 897 | | | 897 | ||||||||||||||||||
Net income |
| | | | 5,668 | 5,668 | ||||||||||||||||||
Foreign currency translation adjustment |
| | | (293 | ) | | (293 | ) | ||||||||||||||||
|
|
|
|
|
|
|
|
|
|
|
|
|||||||||||||
Balances, March 31, 2015 |
28,873,739 | $ | 247,087 | $ | 5,912 | $ | (567 | ) | $ | 9,263 | $ | 261,695 | ||||||||||||
|
|
|
|
|
|
|
|
|
|
|
|
The accompanying notes are an integral part of these consolidated financial statements.
[5]
Concordia Healthcare Corp.
Condensed Interim Consolidated Statements of Cash Flows
For the three months ended March 31, 2015 and 2014
(Stated in thousands of U.S. Dollars, except per share amounts)
(Unaudited)
Three Months Ended
March 31, |
||||||||
2015 | 2014 | |||||||
Cash flows from operating activities |
||||||||
Net income (loss) after tax |
$ | 5,668 | $ | (1,836 | ) | |||
Adjustments to reconcile net income to net cash flows from operating activities: |
||||||||
Accretion and interest expense |
8,641 | 4,705 | ||||||
Depreciation and amortization expense |
5,261 | 617 | ||||||
Share based compensation expense |
897 | 756 | ||||||
Change in fair value of contingent consideration |
(1,282 | ) | 567 | |||||
Fair value (gain) loss on foreign exchange forward contract |
(2,549 | ) | | |||||
Other (income) expense |
416 | | ||||||
Income tax provision |
499 | 63 | ||||||
Cash income taxes paid |
(14,176 | ) | | |||||
|
|
|
|
|||||
3,375 | 4,872 | |||||||
Changes in operating assets and liabilities, excluding effect of acquisitions |
||||||||
Accounts receivable |
9,306 | 12,949 | ||||||
Inventory |
(943 | ) | 311 | |||||
Prepaid expenses and other current assets |
(7,619 | ) | (1,910 | ) | ||||
Accounts payable |
2,300 | (18,259 | ) | |||||
Accrued liabilities |
2,537 | (4,377 | ) | |||||
Provisions |
(2,979 | ) | 2,710 | |||||
Royalties payable |
(1,825 | ) | 662 | |||||
Other liabilities |
(6 | ) | | |||||
|
|
|
|
|||||
Net cash provided by (used in) operating activities |
4,146 | (3,042 | ) | |||||
|
|
|
|
|||||
Cash flows from investing activities |
||||||||
Purchase consideration paid |
| (109 | ) | |||||
Purchase of fixed assets and software |
(904 | ) | (171 | ) | ||||
|
|
|
|
|||||
Net cash used in investing activities |
(904 | ) | (280 | ) | ||||
|
|
|
|
|||||
Cash flows from financing activities |
||||||||
Payment of credit facility |
(5,950 | ) | | |||||
Interest paid |
(2,142 | ) | (3,534 | ) | ||||
Dividends paid |
(2,165 | ) | | |||||
Proceeds from exercise of options |
38 | 674 | ||||||
Net proceeds from issuance of common stock |
| 56,998 | ||||||
Payment of senior and subordinated debt |
| (15,742 | ) | |||||
|
|
|
|
|||||
Net cash (used in) provided by financing activities |
(10,219 | ) | 38,396 | |||||
|
|
|
|
|||||
Net change in cash |
(6,977 | ) | 35,074 | |||||
Unrealised foreign exchange (gain) loss in cash and cash equivalents |
(430 | ) | | |||||
Cash at beginning of period |
42,770 | 42,899 | ||||||
|
|
|
|
|||||
Cash at end of period |
$ | 35,363 | $ | 77,973 | ||||
|
|
|
|
The accompanying notes are an integral part of these consolidated financial statements.
[6]
Concordia Healthcare Corp.
Notes to Condensed Interim Consolidated Financial Statements
For the three months ended March 31, 2015 and 2014
(Stated in thousands of U.S. Dollars, except per share amounts)
(Unaudited)
1. | Description of Business and General Information |
Concordia Healthcare Corp. (the Company, Concordia or the Group) is an integrated healthcare company that targets three areas: (a) legacy pharmaceutical products; (b) specialized healthcare distribution that services the growing diabetic market; and (c) the acquisition and/or development of orphan drugs.
These three business units are run as separate divisions but are inter-related. The cash-flow from legacy pharmaceutical products is used to fund operations and is also intended to fund the expansion of indications for potential orphan drugs. The specialized healthcare distribution division provides additional growth and cash-flow generation. Additionally, through its registered pharmacy operation, this business is intended to provide a specialty distribution capability for orphan drugs once acquired and/or developed. The three business units were acquired during 2013 and are expected to provide the Company with an increased market share of the related products, as well as savings in costs through economies of scale. During 2014, the Company has grown the Legacy Pharmaceuticals Division through the acquisition of Donnatal ® and Zonegran ® .
Concordia Healthcare Corp.s shares were listed for trading on the TSX under the symbol CXR on December 24, 2013.
The registered and head office of the Company is located at 277 Lakeshore Rd. East, Suite 302, Oakville, Ontario, L6J 1H9.
[7]
Concordia Healthcare Corp.
Notes to Condensed Interim Consolidated Financial Statements
For the three months ended March 31, 2015 and 2014
(Stated in thousands of U.S. Dollars, except per share amounts)
(Unaudited)
2. | Significant Accounting Policies |
(a) | Basis of Presentation |
These condensed interim consolidated financial statements for the three months ended March 31, 2015 have been prepared in accordance with IAS 34, Interim Financial Reporting. These condensed interim consolidated financial statements do not include all the information and disclosures required in the annual financial statements, and should be read in conjunction with Concordias annual financial statements as at December 31, 2014.
(b) | Business Combinations |
Acquisitions during the year ended December 31, 2014 and three months ended March 31, 2015 have been accounted for as business combinations using the acquisition method. The consideration transferred in a business combination is measured at fair value at the date of acquisition. Acquisition-related transaction costs are recognized in income and comprehensive income as incurred.
At the acquisition date, the identifiable assets acquired and the liabilities assumed are recognized at their fair value, except that:
| deferred tax assets or liabilities, and assets or liabilities related to employee benefit arrangements are recognized and measured in accordance with IAS 12 and IAS 19 respectively; and |
| liabilities or equity instruments related to share-based payment arrangements of the acquiree or share-based payment arrangements of the Group entered into to replace share-based payment arrangements of the acquiree are measured in accordance with IFRS 2 Share-based Payment at the acquisition date. |
Goodwill is measured as the excess of the sum of the consideration transferred, the amount of any non-controlling interests in the acquiree, and the fair value of the acquirers previously held equity interest in the acquiree (if any) over the net of the acquisition-date amounts of the identifiable assets acquired and liabilities assumed exceeds the sum of the consideration transferred, the amount of any non-controlling interests in the acquiree and the fair value of the acquirers previously held interest in the acquiree (if any), the excess is recognized immediately in profit or loss as a bargain purchase gain.
[8]
Concordia Healthcare Corp.
Notes to Condensed Interim Consolidated Financial Statements
For the three months ended March 31, 2015 and 2014
(Stated in thousands of U.S. Dollars, except per share amounts)
(Unaudited)
2. | Significant Accounting Policies (continued) |
(b) | Business Combinations (continued) |
When the consideration transferred by the Group in a business combination includes assets or liabilities resulting from a contingent consideration arrangement, the contingent consideration is measured at its acquisition-date fair value and included as part of the consideration transferred in a business combination. Changes in the fair value of the contingent consideration that qualify as measurement period adjustments are adjusted retrospectively, with corresponding adjustments against goodwill. Measurement period adjustments are adjustments that arise from additional information obtained during the measurement period (which cannot exceed one year from the acquisition date) about facts and circumstances that existed at the acquisition date.
The subsequent accounting for changes in the fair value of the contingent consideration that do not qualify as measurement period adjustments depends on how the contingent consideration is classified. Contingent consideration that is classified as equity is not remeasured at subsequent reporting dates and its subsequent settlement is accounted for within equity. Contingent consideration that is classified as an asset or a liability is remeasured at subsequent reporting dates in accordance with IAS 39, or IAS 37 Provisions, Contingent Liabilities and Contingent Assets, as appropriate, with the corresponding gain or loss being recognized in profit or loss.
(c) | New standards, interpretations, policies and amendments adopted |
The accounting policies adopted in the preparation of the condensed interim consolidated financial statements are consistent with those followed in the preparation of the Companys annual consolidated financial statements for the year ended December 31, 2014, except as described below:
Restricted and Deferred Share Unit Plans
The expenses related to the Restricted Share Units (RSUs) and Deferred Share Units (DSUs) are accrued based on fair value, determined as of the date of grant. This expense is recognized as compensation expense over the vesting period. Until the liability is settled, the fair value of the RSUs and DSUs is remeasured at the end of each reporting period and at the date of settlement, with changes in fair value recognized as share-based compensation expense or recovery over the vesting period.
[9]
Concordia Healthcare Corp.
Notes to Condensed Interim Consolidated Financial Statements
For the three months ended March 31, 2015 and 2014
(Stated in thousands of U.S. Dollars, except per share amounts)
(Unaudited)
3. | Acquisitions |
The Donnatal Transaction
On May 15, 2014, Concordia, through its subsidiary, Concordia Pharmaceuticals Inc. (CPI), completed the purchase of Donnatal ® , pursuant to the terms and conditions of a definitive agreement, from a privately held specialty pharmaceutical company carrying on business as Revive Pharmaceuticals. Donnatal ® is an adjunctive therapy in the treatment of irritable bowel syndrome (IBS) and acute enterocolitis.
The purchase price paid to Revive Pharmaceuticals was $329,151 comprised of $200,000 in cash and an aggregate of 4,605,833 common shares of the Company valued at $129,151 based on the closing price of the Companys stock on May 15, 2014 of CAD$30.50 per share converted to USD using the May 15, 2014 Bank of Canada closing USD: CAD exchange rate of 1:1.0877.
The Company paid for the cash component of the acquisition through a combination of available cash and debt financing. Accordingly, the Company entered into a secured credit facility having a principal amount of up to $195,000, consisting of a $170,000 term loan and a $25,000 operating line (the Credit Facility) (Note 11). The obligations of the Company under the Credit Facility are secured by the assets of the Company and the assets of its material subsidiaries. The Company expensed $8,314 of transaction costs in relation to the acquisition.
The purchase price has been allocated as follows:
Total | ||||
Inventory |
$ | 1,339 | ||
Prepaid expenses and deposits net of accrued liabilities |
279 | |||
Acquired product rights |
327,523 | |||
Goodwill |
10 | |||
|
|
|||
$ | 329,151 | |||
|
|
|||
Consideration Comprised of: |
||||
Cash |
$ | 200,000 | ||
Equity issued |
129,151 | |||
|
|
|||
$ | 329,151 | |||
|
|
The goodwill arising on acquisition is deductible for tax purposes.
[10]
Concordia Healthcare Corp.
Notes to Condensed Interim Consolidated Financial Statements
For the three months ended March 31, 2015 and 2014
(Stated in thousands of U.S. Dollars, except per share amounts)
(Unaudited)
3. | Acquisitions (continued) |
The Zonegran Transaction
On September 30, 2014, Concordia, through its subsidiary CPI, completed the purchase of Zonegran ® for commercialization and sale in the United States, including Puerto Rico, from Eisai Inc. (Eisai), pursuant to the terms and conditions of a definitive agreement. Zonegran ® is an adjunctive therapy in the treatment of partial seizures in adults with epilepsy.
The purchase price paid to Eisai was $91,402 in cash, which included approximately $1,402 for purchased inventory.
The Company paid for the acquisition through debt financing. Accordingly, the Company entered into an incremental senior credit facility of $95,000 (the Incremental Term Loan) (Note 14) by way of an amendment and restatement of the Credit Facility. All obligations of the Company under the Incremental Term Loan and the amended and restated Credit Facility are secured by the assets of the Company and the assets of its material subsidiaries. The Company expensed $3,849 of transaction costs in relation to the acquisition.
The purchase price has been allocated as follows:
Net Assets Acquired |
||||
Inventory |
$ | 1,402 | ||
Accrued liabilities |
(2,040 | ) | ||
Acquired product rights |
92,040 | |||
|
|
|||
Total net assets acquired |
$ | 91,402 | ||
|
|
|||
Consideration Comprised of: |
||||
Cash |
$ | 91,402 | ||
|
|
|||
Total Consideration |
$ | 91,402 | ||
|
|
4. | Accounts Receivable |
Accounts receivable, as at March 31, consist of the following:
As at
March 31, 2015 |
As at
December 31, 2014 |
|||||||
Accounts Receivable |
$ | 20,328 | $ | 29,668 | ||||
Allowance for Doubtful Accounts |
(263 | ) | (297 | ) | ||||
|
|
|
|
|||||
Net Accounts Receivable |
$ | 20,065 | $ | 29,371 | ||||
|
|
|
|
There were $118 of write-offs recorded during the three months ended March 31, 2015 (2014 - $53).
[11]
Concordia Healthcare Corp.
Notes to Condensed Interim Consolidated Financial Statements
For the three months ended March 31, 2015 and 2014
(Stated in thousands of U.S. Dollars, except per share amounts)
(Unaudited)
5. | Inventory |
Inventory, as at March 31, consists of the following:
As at
March 31, 2015 |
As at
December 31, 2014 |
|||||||
Finished goods |
$ | 5,809 | $ | 4,863 | ||||
Raw materials and work in process |
2,665 | 2,660 | ||||||
Obsolescence provision |
(812 | ) | (805 | ) | ||||
|
|
|
|
|||||
Inventory (net of obsolescence reserve) |
$ | 7,662 | $ | 6,718 | ||||
|
|
|
|
Inventory amounts charged to cost of sales during the three months ended March 31, 2015 is $2,685 (2014 $1,444). The Company increased its reserve for obsolete inventory by $7 during the quarter.
6. | Prepaid Expenses and Other Current Assets |
Prepaid expenses and other current assets, as at March 31, consist of the following:
As at
March 31, 2015 |
As at
Decebmer 31, 2014 |
|||||||
Manufacturing deposits |
$ | 6,002 | $ | 1,294 | ||||
Foreign exchange forward contract |
2,549 | | ||||||
Other assets |
2,022 | 800 | ||||||
Deferred debt and equity issuance costs |
1,833 | | ||||||
Prepaid clinical trial costs |
1,749 | 2,313 | ||||||
Taxes receivable |
1,424 | 760 | ||||||
Prepaid insurance |
259 | 422 | ||||||
Prepaid license fees |
102 | 154 | ||||||
Prepaid rent |
21 | 50 | ||||||
|
|
|
|
|||||
Total prepaids and other current assets |
$ | 15,961 | $ | 5,793 | ||||
|
|
|
|
[12]
Concordia Healthcare Corp.
Notes to Condensed Interim Consolidated Financial Statements
For the three months ended March 31, 2015 and 2014
(Stated in thousands of U.S. Dollars, except per share amounts)
(Unaudited)
7. | Fixed Assets |
[13]
Concordia Healthcare Corp.
Notes to Condensed Interim Consolidated Financial Statements
For the three months ended March 31, 2015 and 2014
(Stated in thousands of U.S. Dollars, except per share amounts)
(Unaudited)
8. | Intangible Assets |
Acquired
Product Rights |
Customer
List |
Intellectual
Property |
Total | |||||||||||||
Balance, January 1, 2014 |
$ | 26,020 | $ | 2,880 | $ | 32,800 | $ | 61,700 | ||||||||
Additions |
419,563 | | | 419,563 | ||||||||||||
Impact of foreign exchange |
| | (55 | ) | (55 | ) | ||||||||||
Amortization |
(8,720 | ) | (680 | ) | (1,640 | ) | (11,040 | ) | ||||||||
|
|
|
|
|
|
|
|
|||||||||
Balance, December 31, 2014 |
$ | 436,863 | $ | 2,200 | $ | 31,105 | $ | 470,168 | ||||||||
|
|
|
|
|
|
|
|
|||||||||
Additions |
46 | | | 46 | ||||||||||||
Impact of foreign exchange |
| | | | ||||||||||||
Amortization |
(4,625 | ) | (170 | ) | (410 | ) | (5,205 | ) | ||||||||
|
|
|
|
|
|
|
|
|||||||||
Balance, March 31, 2015 |
$ | 432,284 | $ | 2,030 | $ | 30,695 | $ | 465,009 | ||||||||
|
|
|
|
|
|
|
|
Acquired product rights include brands, trademarks and patents that were acquired as part of the transactions described in Note 3. In 2014 the Company reassessed the useful lives of its intangible assets and changed the estimate for certain acquired product rights from an indefinite life to useful lives ranging from 15 to 30 years.
The customer list was acquired as part of the acquisition of assets from Global Medical Direct LLC and affiliated entities (collectively Global). The transaction was completed on October 25, 2013 and had an effective date of August 1, 2013.
The intellectual property was acquired on December 20, 2013 as part of the acquisition of Pinnacle Biologics, Inc. and its subsidiaries.
[14]
Concordia Healthcare Corp.
Notes to Condensed Interim Consolidated Financial Statements
For the three months ended March 31, 2015 and 2014
(Stated in thousands of U.S. Dollars, except per share amounts)
(Unaudited)
9. | Goodwill |
Goodwill, as at March 31, consists of:
As at
March 31, 2015 |
As at
December 31, 2014 |
|||||||
Opening balance |
$ | 36,259 | $ | 36,249 | ||||
Additions |
10 | |||||||
|
|
|
|
|||||
Total |
$ | 36,259 | $ | 36,259 | ||||
|
|
|
|
The carrying value of goodwill is reviewed at each reporting date to determine whether there exist any indications of impairment. As at March 31, 2015, there was no indication of impairment and no impairment loss has been recognized.
10. | Provisions |
The following table describes movements in the Companys provisions balance:
As at
March 31, 2015 |
As at
December 31, 2014 |
|||||||
Opening Balance |
$ | 21,799 | $ | 24,208 | ||||
Additions |
10,484 | 33,820 | ||||||
Utilization |
(13,463 | ) | (36,229 | ) | ||||
|
|
|
|
|||||
Closing Balance |
$ | 18,820 | $ | 21,799 | ||||
|
|
|
|
The closing balance relates to provisions made to estimate the liabilities arising from chargebacks, returns, rebates and other price adjustments. Although these estimates and provisions relate to revenue recognition transactions, namely the sales of products, the payments made for the underlying transactions are made directly to the claimants concerned and not to the original customer. Payments are expected within 12 months from the balance sheet date. Invoices received for such charges and estimates are shown in the Accounts Payable when received. The provision is for the uninvoiced portion of the charges and estimates.
11. | Debt Financing and Warrants |
Credit Facility
On May 14, 2014, the Company entered into the Credit Facility of $170,000 with GE Capital Canada Finance, Inc. and a syndicate of lenders. The obligations of the Company under the Credit Facility are secured by the assets of the Company and the assets of its material subsidiaries. The Credit Facility bears a variable interest rate and matures on May 14, 2019 with fixed repayments required over the term to maturity, as well as mandatory repayments based on excess cash flow generated by the Company as defined in the Credit Facility agreement, calculated annually.
On September 30, 2014, the Company amended the Credit Facility to facilitate the acquisition of Zonegran ® . An Incremental Term Loan of $95,000 was added to the Credit Facility solely for the acquisition of Zonegran ® and related expenses. This amended and restated Credit Facility matures on October 1, 2020. All obligations of the Company under the amended and restated Credit Facility are secured by assets of the Company and the assets of its material subsidiaries.
[15]
Concordia Healthcare Corp.
Notes to Condensed Interim Consolidated Financial Statements
For the three months ended March 31, 2015 and 2014
(Stated in thousands of U.S. Dollars, except per share amounts)
(Unaudited)
11. | Debt Financing and Warrants (continued) |
Credit Facility (continued)
Interest rates are calculated at the U.S. Prime Rate or LIBOR plus applicable margins based on a leverage table. The amended and restated Credit Facility contains standard events of default which if not remedied within a cure period would trigger the repayment of any outstanding balance. As at March 31, 2015, no such events of default have occurred.
Under the terms of the amended and restated Credit Facility, the Company is required to comply with certain financial covenants, as defined under the amended and restated Credit Facility, under which the Companys total leverage ratio cannot exceed 4.25:1.00, the senior leverage ratio cannot exceed a certain cap ranging from 3.25:1.00 to 2.25:1.00, and the fixed charge ratio cannot be less than 1.11:1. Throughout the year ended December 31, 2014 and as at March 31, 2015, the Company was in compliance with all of the financial covenants. Transaction costs associated with the amended and restated Credit Facility have been included as a reduction to the carrying amount of the liability and are amortized through interest and accretion expense using the effective interest rate method.
On April 21, 2015 the Company completed the acquisition of 18 products, comprised of 12 branded products, 5 authorized generic contracts and a product distributed by a third party in Australia pursuant to the terms of a distribution agreement, from Covis Pharma S.à.r.l and Covis Injectables, S.à.r.l (collectively, Covis) for $1.2 billion in cash (the Covis Acquisition). As part of the financing related to the Covis Acquisition the Company decided that it would retire the amended and restated Credit Facility. As a result of this planned early repayment of the amended and restated Credit Facility, during the quarter ended March 31, 2015, the Company recognized $5,815 in accretion interest using an effective interest rate of 12.915% for the original term loan and 13.690% for the Incremental Term Loans. Interest expense on the amended and restated Credit Facility was $2,456 for the three months ended March 31, 2015. On April 21, 2015, the Company retired the amended and restated Credit Facility, and paid the remaining balances in full. See Note 23, Subsequent events.
As at
March 31, 2015 |
As at
December 31, 2014 |
|||||||
Face value of the loans on issuance |
$ | 265,000 | $ | 265,000 | ||||
Less: Transaction costs |
(8,561 | ) | (8,561 | ) | ||||
|
|
|
|
|||||
Book value upon issuance |
256,439 | 256,439 | ||||||
Repayment of principal |
(10,200 | ) | (4,250 | ) | ||||
Accretion interest |
7,108 | 1,292 | ||||||
|
|
|
|
|||||
Carrying value |
$ | 253,347 | $ | 253,481 | ||||
Less: current portion |
(253,347 | ) | (27,336 | ) | ||||
|
|
|
|
|||||
Long-term portion |
$ | | $ | 226,145 | ||||
|
|
|
|
Revolving Credit Facility
On May 14, 2014, the Company entered into a senior secured revolving credit facility (the Revolving Facility) in the principal amount of $25,000 with GE Capital Canada Finance, Inc. and a syndicate of lenders. The Revolving Facility is for working capital requirements and is repayable on demand. Loans under the Revolving Facility are repayable without any prepayment penalties, and bear interest at U.S. Prime Rate or LIBOR plus applicable margins based on a leverage table. The Company has not borrowed against the Revolving Facility and there is no balance outstanding against this facility as at March 31, 2015.
[16]
Concordia Healthcare Corp.
Notes to Condensed Interim Consolidated Financial Statements
For the three months ended March 31, 2015 and 2014
(Stated in thousands of U.S. Dollars, except per share amounts)
(Unaudited)
12. | Notes Payable |
Notes payable, as at March 31, consist of the following:
As at
March 31, 2015 |
As at
December 31, 2014 |
|||||||
Notes payable issued related to acquisition of Global assets |
$ | 4,625 | $ | 5,262 | ||||
Less: Current portion |
(572 | ) | (1,372 | ) | ||||
|
|
|
|
|||||
Long-term portion of Notes payable |
$ | 4,053 | $ | 3,890 | ||||
|
|
|
|
The notes payable of $4,625 as at March 31, 2015 represents the value of the notes issued by the Company related to the acquisition of assets from Global. The notes are unsecured, have a total face value of $7,000 and a coupon interest rate of 6%. The notes have been recorded at the present value of expected payments with a market representative interest rate of 12%. Interest expense and accretion expense amount to $158 and $5 respectively for the three months ended March 31, 2015 ($169 and $32 respectively for the three months ended March 31, 2014). The effective interest rate has been determined to be 12.38%. Principal repayments are due subject to the achievement of certain EBITDA thresholds over the 7 year term of the note. Based on the most recent forecast of EBITDA for Complete Medical Homecare Inc. (CMH), a subsidiary of the Company, the Company reduced the notes payable liability by $800 in the first quarter of 2015 and recorded an associated gain in the fair value of contingent consideration in the statement of income and comprehensive income.
13. | Purchase Consideration Payable |
As at
March 31, 2015 |
As at
December 31, 2014 |
|||||||
Contingent purchase consideration |
||||||||
Due to Shionogi Inc. (1) |
$ | 410 | $ | 410 | ||||
Due to former owner of Global (2) |
1,336 | 2,452 | ||||||
Due to former owners of Pinnacle (3) |
17,758 | 17,124 | ||||||
|
|
|
|
|||||
Total contingent purchase consideration |
$ | 19,504 | $ | 19,986 | ||||
|
|
|
|
|||||
Non-contingent purchase consideration |
||||||||
Fair value of annual payments due to former owners of Pinnacle (4) |
4,772 | 4,772 | ||||||
Consideration assumed on acquisition of Pinnacle |
381 | 350 | ||||||
|
|
|
|
|||||
Total non-contingent purchase consideration |
5,153 | 5,122 | ||||||
|
|
|
|
|||||
Total purchase consideration payable |
24,657 | 25,108 | ||||||
Less: Current portion |
(2,240 | ) | (2,065 | ) | ||||
|
|
|
|
|||||
Purchase consideration payable |
$ | 22,417 | $ | 23,043 | ||||
|
|
|
|
[17]
Concordia Healthcare Corp.
Notes to Condensed Interim Consolidated Financial Statements
For the three months ended March 31, 2015 and 2014
(Stated in thousands of U.S. Dollars, except per share amounts)
(Unaudited)
13. | Purchase Consideration Payable (continued) |
(1) | Following the closing of acquisition of certain pharmaceutical assets from Shionogi Inc. on May 6, 2013, as additional consideration for the sale, transfer, conveyance and assignment of the assets and the grant of the Ulesfia ® license, the Company is required to pay Shionogi thirty percent (30%) of worldwide net sales of Kapvay ® that exceeds $1,500 (in the aggregate) during each calendar quarter commencing with the calendar quarter beginning October 1, 2013 until such payments equal $6,000 in the aggregate. |
(2) | As part of the consideration for the acquisition of assets from Global on October 25, 2013, the Company is obligated to pay an additional earn-out payment of up to $4,000 payable in common shares of the Company subject to meeting certain performance metrics. The earn-out payment provisions provide that on each earn-out calculation date, if the aggregate adjusted EBITDA of CMH exceeds $7,000 for the preceding year then an earn-out payment of common shares will be made which is equal in value to the aggregate adjusted EBITDA of CMH for the preceding year multiplied by 14.285714%. The number of common shares of the Company to be paid is calculated by dividing the dollar value of the earn-out payment by the dollar volume weighted average trading price of the common shares of the Company on the TSX. The aggregate earn-out payments are subject to a $4,000 cap. Based on the most recent forecast of EBITDA for CMH, the Company reduced the earn-out liability by $1,115 in the first quarter of 2015 and recorded an associated gain in the fair value contingent consideration in the statement of income and comprehensive income. |
(3) | As part of the consideration for the acquisition of Pinnacle in 2013, the Company is obligated to pay additional payments of up to $5,000 based on the achievement of certain milestones related to clinical trials. The Company is also obligated to pay additional earn-out payments equal to 15% of worldwide sales of Photofrin ® in excess of $25,000 over the 10 calendar years following the Companys acquisition of Pinnacle. The fair value of these obligations as at March 31, 2015 and December 31, 2014 is $17,758 and $17,124, respectively. The change in fair value from December 31, 2014 of $634 has been recorded as an expense in the current period. |
(4) | As part of the consideration for the acquisition of Pinnacle in 2013, the Company is obligated to make 10 annual payments of $1,000, with the first payment made on December 31, 2014. The obligation is subordinated and is not subject to interest. The obligation has been recorded at the present value of required payments with a market representative interest rate of 15%. Interest expense amounted to $176 for the three months ended March 31, 2015. |
An estimate of the range of outcomes for the contingent purchase consideration is as follows:
Contingent Purchase Consideration Payable | Lower range | Upper range | ||||||
Due to Shionogi |
$ | 410 | $ | 6,000 | ||||
Due to former owner of Global Medical Direct LLC |
$ | Nil | $ | 3,000 | ||||
Due to former owners of Pinnacle Biologics Inc. |
$ | 5,000 | $ | 42,500 |
14. | Share Capital |
The Company is authorized to issue an unlimited number of common shares.
On March 11, 2014 the Company announced the completion of a short-form prospectus offering, on a bought deal basis, of 5,750,000 common shares of Concordia, which included an exercise by the underwriters of an over-allotment option of 15% (the Offering). Aggregate gross proceeds of the Offering were CAD $67,563. Net proceeds to the Company, after the deduction of underwriters fees and transaction expenses of CAD $4,469, were CAD $63,094.
[18]
Concordia Healthcare Corp.
Notes to Condensed Interim Consolidated Financial Statements
For the three months ended March 31, 2015 and 2014
(Stated in thousands of U.S. Dollars, except per share amounts)
(Unaudited)
14. | Share Capital (continued) |
The Offering was completed at a price per common share of CAD $11.75.
The Company recorded net proceeds of $56,999.
On May 15, 2014, the Company issued an aggregate of 4,605,833 common shares to PBM Pharmaceuticals Inc. (carrying on business as Revive Pharmaceuticals) for the purchase of Donnatal ® , valued at $129,151 based on the closing price of the Companys stock on the TSX on May 15, 2014 of CAD$30.50 per share converted to USD using the May 15, 2014 Bank of Canada closing USD: CAD exchange rate of 1:1.0877.
The Companys board of directors approved a $0.30 per common share annualized eligible dividend with $0.075 per common share being paid to shareholders on a quarterly basis.
The below table sets forth changes in issued and outstanding common shares and warrants for the period from January 1, 2014 to March 31, 2015.
Number of | Amount | |||||||
Common
Shares |
Common
Shares |
|||||||
Balances as at January 1, 2014 |
17,985,889 | $ | 57,521 | |||||
March Private Placement |
5,750,000 | 56,999 | ||||||
Acquisition of Donnatal |
4,605,833 | 129,151 | ||||||
Exercise of stock options |
519,517 | 3,364 | ||||||
|
|
|
|
|||||
Balances as at December 31, 2014 |
28,861,239 | $ | 247,035 | |||||
|
|
|
|
|||||
Exercise of stock options |
12,500 | 52 | ||||||
|
|
|
|
|||||
Balances as at March 31, 2015 |
28,873,739 | $ | 247,087 | |||||
|
|
|
|
15. | Earnings Per Share |
For the three months ended
March 31, |
||||||||
2015 | 2014 | |||||||
Net Income (loss) for the period attributable to shareholders |
$ | 5,668 | $ | (1,836 | ) | |||
|
|
|
|
|||||
Weighted average number of ordinary shares in issue |
28,871,869 | 19,327,195 | ||||||
Adjustments for: |
||||||||
Dilutive Stock Options and agent warrants |
1,713,082 | 2,261,440 | ||||||
|
|
|
|
|||||
Weighted average number of fully diluted shares |
30,584,951 | 21,588,635 | ||||||
|
|
|
|
|||||
Earnings per share: |
||||||||
Basic |
$ | 0.20 | $ | (0.09 | ) | |||
Diluted |
$ | 0.19 | $ | (0.09 | ) | |||
|
|
|
|
[19]
Concordia Healthcare Corp.
Notes to Condensed Interim Consolidated Financial Statements
For the three months ended March 31, 2015 and 2014
(Stated in thousands of U.S. Dollars, except per share amounts)
(Unaudited)
16. | Share Based Compensation |
Employee Stock Option Plan
The Company has an incentive stock option plan that permits it to grant options to acquire common shares to its directors, officers, employees, and others. The maximum number of common shares which may be reserved for issue under the stock option plan cannot exceed up to ten percent (10%) of the common shares of the Company, issued and outstanding from time to time, on a non-diluted basis (which maximum number is inclusive of any common shares reserved for issuance pursuant to the Companys long-term incentive plan), as determined by the Board of Directors. The exercise price at which any option may be exercised to acquire a common share of the Company must be not less than the lesser of (i) the closing trading price of the common shares on the TSX on the date of grant and (ii) the volume-weighted average price of the common shares on the TSX for the five trading days immediately preceding the date of grant. As at March 31, 2015, the company had issued a total of 2,325,000 options to executive officers, employees and non-management members of the Board of Directors (December 31, 2014 2,275,000).
During the three months ended March 31, 2015, 50,000 employee stock options were issued, 12,500 options were exercised, and 7,500 options were cancelled, leaving a balance of 1,955,000 unexercised options outstanding as at March 31, 2015.
As at March 31, 2015, 380,383 stock options (December 31, 2014 422,883) were available for grant under the stock option plan.
The Black-Scholes model was used to compute option values. Key assumptions used to value each grant are set forth in the table below:
Date of Grant |
January 1,
2014 |
January 29,
2014 |
March 14,
2014 |
April 17,
2014 |
June 2,
2014 |
August 15,
2014 |
February 11,
2015 |
|||||||||||||||||||||
Number of options granted |
100,000 | 330,000 | 335,000 | 50,000 | 5,000 | 95,000 | 50,000 | |||||||||||||||||||||
Market price |
$ | 5.88 | $ | 10.32 | $ | 13.46 | $ | 19.52 | $ | 29.82 | $ | 31.50 | $ | 46.18 | ||||||||||||||
Fair value of each option granted |
$ | 4.53 | $ | 5.37 | $ | 6.86 | $ | 10.07 | $ | 15.39 | $ | 16.48 | $ | 23.05 | ||||||||||||||
Assumptions: |
||||||||||||||||||||||||||||
Risk-Free Interest Rate |
1.63 | % | 1.63 | % | 1.63 | % | 1.63 | % | 1.63 | % | 1.63 | % | 1.63 | % | ||||||||||||||
Expected Life |
3 | 3 | 3 | 3 | 3 | 3 | 3 | |||||||||||||||||||||
Volatility |
84.22 | % | 79.48 | % | 77.36 | % | 78.55 | % | 78.61 | % | 80.10 | % | 75.46 | % | ||||||||||||||
Expected Forfeitures |
NIL | NIL | NIL | NIL | NIL | NIL | NIL |
Exercise price for each of the stock options issued agreed to the market prices at the date of issue.
As historical volatility of the Companys common shares is not available, expected volatility is based on the historical performance of the common shares of other corporations with similar operations.
All the options issued have different vesting terms ranging from immediate vesting to vesting over a period of 3 years. All options issued have a life of 10 years.
For the three months ended March 31, 2015, the total compensation charged against income with respect to all stock options granted was $897 (2014 $756). An amount of $897 (2014 $756) has been recognized in shareholders equity related to these options for the three months ended March 31, 2015.
[20]
Concordia Healthcare Corp.
Notes to Condensed Interim Consolidated Financial Statements
For the three months ended March 31, 2015 and 2014
(Stated in thousands of U.S. Dollars, except per share amounts)
(Unaudited)
16. | Share Based Compensation (continued) |
Long-Term Incentive Plan
The Company has a Long-Term Incentive Plan (LTIP). Under the terms of the LTIP, the Board of Directors may grant units (Units), which may be either restricted share units (Restricted Share Units or RSUs) or deferred share units (Deferred Share Units or DSUs) to officers, directors, employees or consultants of the Company. Each Unit represents the right to receive one common share in accordance with the terms of the LTIP.
The maximum number of common shares of the Company which may be reserved and set aside for issue under the LTIP in respect of awards of DSUs to DSU Participants, and for payments in respect of awards of RSUs to RSU Participants, shall not exceed 10% of the common shares issued and outstanding from time to time on a non-diluted basis (for purposes of clarity, the maximum number of common shares reserved and set aside for issue under the LTIP shall be inclusive of any common shares reserved for issuance pursuant to any other security based compensation arrangement of the Company, including the stock option plan of the Company).
On each vesting date, the Company will decide, in its sole discretion, whether to make all payments in respect of vested RSUs to the RSU Participant or vested DSUs to the DSU participants in cash, common shares issued from treasury or a combination thereof based on the fair market value of the common shares as at such date.
During the three months ended March 31, 2015, the Company issued 1,000 RSUs to a director which vested within ten (10) business days of the date of issuance. The $56 payment in respect of the vested RSUs was settled in cash and recorded in general and administrative expense.
Mercari Options
In connection with the completion of Companys qualifying transaction, the Company issued 25,998 options to the former directors of the Company (the Mercari Options). Each one of the Mercari Options is exchangeable for one common share of the Company at an exercise price of CAD $4.81 for a period of ten years. The Mercari Options were valued using a Black-Scholes option-pricing model at $63.
A pricing model with observable market based inputs was used to estimate the fair value of the Mercari Options. The variables used to compute the values were as follows: an expected life of two years; a risk free rate of 1.2%; a volatility rate of 100%; and an exercise price and market price of CAD $4.81. All of the Mercari Options were exercised in the first quarter of 2014.
Agent Options
In connection with the private placement (the Private Placement) completed by Concordia Healthcare Inc., a subsidiary of the Company, and the closing of the Companys qualifying transaction in December 2013, the Company issued 220,800 options (the Agents Options) to the syndicate of agents that conducted the Private Placement. The Agents Options have been valued using a Black-Scholes option-pricing model at $422 and this amount has been offset against the net proceeds from the Private Placement.
The fair value of Agents Options cannot be measured reliably by the Company, thus the equity instrument has been measured based on the amount recognized for goods received or services rendered during the vesting period based on the number of options expected to vest. The Company measures the fair value of the Agents Options using the Black-Scholes option-pricing model.
Each Agents Option is exchangeable for one common share of the Company at an exercise price of CAD $6.25 for a period of two years. During the three months ended March 31, 2015, nil options were exercised. The outstanding balance of unexercised options outstanding is 77,280 as at March 31, 2015.
[21]
Concordia Healthcare Corp.
Notes to Condensed Interim Consolidated Financial Statements
For the three months ended March 31, 2015 and 2014
(Stated in thousands of U.S. Dollars, except per share amounts)
(Unaudited)
16. | Share Based Compensation (continued) |
Information with respect to stock option transactions for the three months ended March 31, 2015 and December 31, 2014 is as follows:
Number of
Stock Options |
Weighted
Average Exercise Price |
|||||||
Balance, January 1, 2014 |
1,621,798 | $ | 3.86 | |||||
Granted during the year |
915,000 | 13.80 | ||||||
Cancelled during the year |
(15,001 | ) | 10.52 | |||||
Exercised during the year |
(519,517 | ) | 2.45 | |||||
|
|
|
|
|||||
Balance, December 31, 2014 |
2,002,280 | $ | 8.72 | |||||
|
|
|
|
|||||
Weighted-average exercise price of options exerciseable as at December 31, 2014 |
$ | 4.25 | ||||||
Granted during the period |
50,000 | | ||||||
Cancelled during the period |
(7,500 | ) | 10.32 | |||||
Exercised during the period |
(12,500 | ) | 3.00 | |||||
|
|
|
|
|||||
Balance, March 31, 2015 |
2,032,280 | $ | 8.66 | |||||
|
|
|
|
|||||
Weighted-average exercise price of options exerciseable as at March 31, 2015 |
$ | 11.55 |
For the options exercised during the three months ended March 31, 2015, the weighted average market price on the date of exercise was $49.54.
As at March 31, 2015 outstanding stock options were as follows:
Year of Expiry |
Exercise Price |
Number of
Stock Options |
Exercisable | |||||||||
2015 |
$ | 5.87 | 77,280 | 77,280 | ||||||||
2023 |
$ | 3.00 | 812,500 | 600,000 | ||||||||
2023 |
$ | 5.87 | 250,000 | 125,000 | ||||||||
2024 |
$ | 5.88 | 100,000 | 50,000 | ||||||||
2024 |
$ | 10.32 | 257,500 | 107,500 | ||||||||
2024 |
$ | 13.46 | 335,000 | 167,500 | ||||||||
2024 |
$ | 19.52 | 50,000 | 12,500 | ||||||||
2024 |
$ | 29.82 | 5,000 | 1,250 | ||||||||
2024 |
$ | 31.50 | 95,000 | 23,750 | ||||||||
2025 |
$ | 46.18 | 50,000 | | ||||||||
|
|
|
|
|
|
|||||||
2,032,280 | 1,164,780 | |||||||||||
|
|
|
|
|
|
[22]
Concordia Healthcare Corp.
Notes to Condensed Interim Consolidated Financial Statements
For the three months ended March 31, 2015 and 2014
(Stated in thousands of U.S. Dollars, except per share amounts)
(Unaudited)
17. | Related Party Transactions |
The Company had the following related party transactions during the three months ended March 31, 2015 and 2014:
Three Months Ended
March 31, |
||||||||
2015 | 2014 | |||||||
Legal fees paid or payable to firms affiliated with directors (a) |
4 | 42 | ||||||
|
|
|
|
|||||
$ | 4 | $ | 42 | |||||
|
|
|
|
(a) | Legal fees include professional services for advice relating to intellectual property matters. |
18. | Commitments and Contingencies |
Lease Commitments
The Company leases facilities under operating leases in Canada, Barbados and the United States. The leases typically run for a period of months up to five years.
The below table sets forth the Companys obligations under operating leases:
Minimum
Lease Payments |
||||
2015 |
$ | 1,939 | ||
2016 |
1,731 | |||
2017 |
1,658 | |||
2018 |
1,528 | |||
2019 |
1,405 | |||
Thereafter |
780 | |||
|
|
|||
$ | 9,041 | |||
|
|
The Canadian facility lease expires on June 30, 2018 with an option to renew the lease for an additional 5 years after that date. The Barbados office lease expires in October of 2016. The facility leases in the United States expire during 2014, 2015 and 2020.
On February 19, 2015, the Company entered into an aircraft lease agreement to use and operate an aircraft for business travel purposes. The term of the lease is 5 years and the annual lease payment is $1,020. In addition, on the same day, the Company entered into an aircraft management and operating agreement for a term of one year (with the term being extended automatically for additional one-year periods in the event neither party gives the other party notice of termination at any point 60 days prior to the expiry of the current term), which includes fixed and variable payments. The fixed portion of the aircraft management and operating agreement is $620 per annum.
[23]
Concordia Healthcare Corp.
Notes to Condensed Interim Consolidated Financial Statements
For the three months ended March 31, 2015 and 2014
(Stated in thousands of U.S. Dollars, except per share amounts)
(Unaudited)
18. | Commitments and Contingencies (continued) |
Royalties
The Company has a commitment to pay royalties on sales of each of the drugs acquired as part of the Shionogi transaction at certain prescribed rates. These royalties are payable on a quarterly basis.
Guarantees
All directors and officers of the Company, and each of the Companys various subsidiaries, are indemnified by the Company for various items including, but not limited to, all costs to settle lawsuits or actions due to their association with the Company, subject to certain restrictions. The Company has purchased directors and officers liability insurance to mitigate the cost of any potential future lawsuits or actions.
In the normal course of business, the Company has entered into agreements that include indemnities in favour of third parties, such as purchase and sale agreements, confidentiality agreements, engagement letters with advisors and consultants, leasing contracts, license agreements, information technology agreements and various product, service, data hosting and network access agreements. These indemnification arrangements may require the applicable Concordia entity to compensate counterparties for losses incurred by the counterparties as a result of breaches in representations, covenants and warranties provided by the particular Concordia entity or as a result of litigation or other third party claims or statutory sanctions that may be suffered by the counterparties as a consequence of the relevant transaction.
In connection with the acquisition of Zonegran ® , the Company guaranteed the payment, performance and discharge of CPIs payment and indemnification obligations under the asset purchase agreement and each ancillary agreement entered into by CPI in connection therewith that contained payment or indemnification obligations. Pursuant to the asset purchase agreement dated March 9, 2015 between CPI, the Company, Covis and Covis Pharma S.à.r.l (the Covis Purchase Agreement) (see Note 23) the Company guaranteed the payments due by CPI of CPIs obligations under the Covis Purchase Agreement.
Litigation and Arbitration
In the normal course of business the Company may be the subject of litigation claims. As at March 31, 2015, there are no material claims against the Company. On February 12, 2015, Concordia announced that it received a civil investigative demand (CID) from the United States Federal Trade Commission regarding its attention deficit hyperactivity disorder product Kapvay ® and a competitive supply agreement entered into with a generic drug manufacturer (the Competitive Supply Agreement). The CID is a request for documentation and information to determine whether CPI, the counterparty to the Competitive Supply Agreement or their affiliates or any other person engaged in unfair methods of competition in or affecting commerce by entering into agreements relating to Kapvay ® . CPI and Concordia are cooperating with the information requests.
[24]
Concordia Healthcare Corp.
Notes to Condensed Interim Consolidated Financial Statements
For the three months ended March 31, 2015 and 2014
(Stated in thousands of U.S. Dollars, except per share amounts)
(Unaudited)
19. | Financial Instruments and Management of Risk |
The Companys financial instruments are exposed to certain financial risks, including currency risk, interest rate risk, credit risk and liquidity risk.
Currency Risk
The Company is exposed to currency risk related to the fluctuation of foreign exchange rates. The Company operates primarily in United States dollars. The Companys Barbados office incurs a small number of transactions in Barbados dollars and has a small bank balance, the totals of which are considered to have an insignificant effect on financial reporting.
The Company may enter into foreign exchange forward contracts to minimize transaction exposures and the resulting volatility in earnings. To mitigate exchange-rate risk, the Company may utilize foreign exchange forward contracts. During the quarter ended March 31, 2015, the Company entered into a foreign exchange forward contract to purchase $244,935 USD to mitigate the foreign currency risk associated with the Canadian dollar proceeds from the offering of subscription receipts on April 8, 2015 as described in Note 23, Subsequent Events. The contract matures on May 20, 2015 at an exchange rate of $1.2542 against the US dollar. The foreign exchange forward contract has been marked-to-market as at March 31, 2015, resulting in a foreign exchange gain of $2,549.
The Company does not believe it is exposed to currency risk on its net assets denominated in Barbados dollars as the currency is fixed to the U.S. dollar. The Company, however, is exposed to currency risk though its net assets denominated in Canadian dollars.
As at March 31,
2015 |
As at December 31,
2014 |
|||||||
CAD$ | CAD$ | |||||||
Cash |
$ | 756 | $ | 520 | ||||
Accounts payable and accrued liabilities (Net of accounts receivable) |
914 | (352 | ) | |||||
|
|
|
|
|||||
$ | 1,670 | $ | 168 | |||||
|
|
|
|
Interest Rate Risk
Interest rate risk is the risk that the fair value or future cash flows of a financial instrument will fluctuate because of changes in market interest rates. The long term debt bears interest at floating rates and as such is subject to interest rate cash flow risk resulting from market fluctuations in interest rates. Contingent consideration payable and notes payable bear interest at a fixed rate of interest, and as such are subject to interest rate price risk resulting from changes in fair value from market fluctuations in interest rates. A 1% appreciation (depreciation) in the interest rate would result in the following:
[25]
Concordia Healthcare Corp.
Notes to Condensed Interim Consolidated Financial Statements
For the three months ended March 31, 2015 and 2014
(Stated in thousands of U.S. Dollars, except per share amounts)
(Unaudited)
19. | Financial Instruments and Management of Risk (continued) |
Three Months Ended
March 31, |
||||||||
2015 | 2014 | |||||||
Impact of a 1% increase in interest rates for contingent purchase consideration payable on net income |
$ | (180 | ) | $ | (216 | ) | ||
Impact of a 1% decrease in interest rates for contingent purchase consideration payable on net income |
170 | 205 | ||||||
Impact of a 1% increase in interest rates for long-term debt on net income |
(877 | ) | n/a | |||||
Impact of a 1% decrease in interest rates for long-term debt on net income |
$ | 877 | n/a |
Credit Risk
Credit risk is the risk of a financial loss to the Company if a customer or counterparty to a financial instrument fails to meet its contractual obligation. Financial instruments that potentially expose the Company to significant concentrations of credit risk consist of cash, accounts receivables and other receivables. The Companys investment policies are designed to mitigate the possibility of deterioration of principal, enhance the Companys ability to meet its liquidity needs and provide high returns within those parameters. Cash is on deposit with a Canadian chartered bank located in Canada and Barbados. Management monitors the collectability of accounts receivable and estimates an allowance for doubtful accounts. As at March 31, 2015, the allowance for doubtful accounts was $263 (December 31, 2014 $297).
The Company has concentration risk, as approximately 69% of total sales came from four customers (e.g. wholesalers) and 56% of total accounts receivable came from four customers (e.g. wholesalers).
Liquidity Risk
Liquidity risk is the risk that the Company will encounter difficulties in meeting its financial liability obligations as they become due. The Company has a planning and budgeting process in place to help determine the funds required to support the Companys normal operating requirements on an ongoing basis. Since inception, the Company has financed its cash requirements primarily through issuances of securities, short-term borrowings and issuances of long-term debt. The Company controls liquidity risk through management of working capital, cash flows and the availability and sourcing of financing.
[26]
Concordia Healthcare Corp.
Notes to Condensed Interim Consolidated Financial Statements
For the three months ended March 31, 2015 and 2014
(Stated in thousands of U.S. Dollars, except per share amounts)
(Unaudited)
19. | Financial Instruments and Management of Risk (continued) |
Liquidity Risk (continued)
The following tables summarize the Companys significant contractual undiscounted cash flows as at March 31, 2015 and December 31, 2014:
March 31, 2015 |
||||||||||||||||||||||||||||
3 to 6 | 6 months to | |||||||||||||||||||||||||||
Financial Instruments |
< 3 months | months | 1 year | 1 to 2 years | 2 to 5 years | Thereafter | Total | |||||||||||||||||||||
Accounts payable and accrued liabilities |
$ | 15,893 | $ | | $ | | $ | | $ | | $ | | $ | 15,893 | ||||||||||||||
Provisions |
| 18,820 | | | | | 18,820 | |||||||||||||||||||||
Royalties payable |
| 1,316 | | | | | 1,316 | |||||||||||||||||||||
Taxes payable |
48 | | | | | | 48 | |||||||||||||||||||||
Current portion of long-term debt |
| 253,347 | | | | | 253,347 | |||||||||||||||||||||
Long-term debt |
| | | | | | | |||||||||||||||||||||
Current portion of purchase consideration payable |
888 | | | | | | 888 | |||||||||||||||||||||
Purchase consideration payable |
1,500 | 2,072 | 8,743 | 38,744 | 51,059 | |||||||||||||||||||||||
Current portion of note payable |
| | | | | | | |||||||||||||||||||||
Notes payable |
| | 200 | 1,800 | 3,400 | | 5,400 | |||||||||||||||||||||
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|||||||||||||||
$ | 16,829 | $ | 273,483 | $ | 1,700 | $ | 3,872 | $ | 12,143 | $ | 38,744 | $ | 346,771 | |||||||||||||||
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|||||||||||||||
December 31, 2014 |
||||||||||||||||||||||||||||
3 to 6 | 6 months to | |||||||||||||||||||||||||||
Financial Instruments |
< 3 months | months | 1 year | 1 to 2 years | 2 to 5 years | Thereafter | Total | |||||||||||||||||||||
Accounts payable and accrued liabilities |
$ | 10,622 | $ | | $ | | $ | | $ | | $ | | $ | 10,622 | ||||||||||||||
Provisions |
| 21,799 | | | | | 21,799 | |||||||||||||||||||||
Royalties payable |
| 3,141 | | | | | 3,141 | |||||||||||||||||||||
Taxes payable |
13,309 | | | | | | 13,309 | |||||||||||||||||||||
Current portion of long-term debt |
| 5,950 | 21,386 | | | | 27,336 | |||||||||||||||||||||
Long-term debt |
| | | 109,280 | 110,407 | 13,727 | 233,414 | |||||||||||||||||||||
Current portion of purchase consideration payable |
855 | 33 | | | | | 888 | |||||||||||||||||||||
Purchase consideration payable |
1,500 | 2,072 | 8,743 | 38,744 | 51,059 | |||||||||||||||||||||||
Current portion of note payable |
| | | | | | | |||||||||||||||||||||
Notes payable |
| | 1,000 | 1,200 | 4,000 | | 6,200 | |||||||||||||||||||||
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|||||||||||||||
$ | 24,786 | $ | 30,923 | $ | 23,886 | $ | 112,552 | $ | 123,150 | $ | 52,471 | $ | 367,768 | |||||||||||||||
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Fair Value
The fair value of the purchase consideration payable and notes payable was determined using a Level III valuation technique by using discounted cash flow models that use discount rates that reflect the Companys borrowing rate as at March 31, 2015. The fair value gain on foreign exchange forward contract has been marked-to-market based on Level II information provided by the counterparty. The Companys own non-performance risk was assessed to be insignificant as at March 31, 2015.
[27]
Concordia Healthcare Corp.
Notes to Condensed Interim Consolidated Financial Statements
For the three months ended March 31, 2015 and 2014
(Stated in thousands of U.S. Dollars, except per share amounts)
(Unaudited)
20. | Capital Management |
The Companys capital management objectives are to safeguard its ability to provide returns for shareholders and benefits for other stakeholders, by ensuring it has sufficient cash resources to fund its activities, to pursue its commercialization efforts and to maintain its ongoing operations. The Company includes long-term debt and shareholders equity in the definition of capital.
The below table sets forth the Companys capital structure:
As at March 31,
2015 |
As at December 31,
2014 |
|||||||
Long-term debt |
$ | 253,347 | $ | 253,481 | ||||
Notes payable |
4,625 | 5,262 | ||||||
Shareholders Equity |
261,695 | 257,550 | ||||||
|
|
|
|
|||||
$ | 519,667 | $ | 516,293 | |||||
|
|
|
|
21. | Segmented Reporting |
Operating Segments
The Company has three reportable operating segments: The Legacy Pharmaceuticals Division, The Orphan Drugs Division and The Specialty Healthcare Distribution Division. A brief description of each segment follows below.
The Legacy Pharmaceuticals Division
The Legacy Pharmaceuticals Division focuses on the management and acquisition of legacy pharmaceutical products, both with patent life and exclusivity remaining (pre-legacy) and products that have reached full maturity but continue on a predictable revenue generation path, collectively referred to as legacy products.
The Orphan Drugs Division
The Orphan Drugs Division is intended to provide growth opportunities through the expansion into new indications for existing orphan products or the acquisition of approved orphan drugs and further expansion within their identified markets.
The Specialty Healthcare Distribution Division
The Speciality Healthcare Distribution Division is a nation-wide provider of diabetes testing supplies and other healthcare products in the United States.
[28]
Concordia Healthcare Corp.
Notes to Condensed Interim Consolidated Financial Statements
For the three months ended March 31, 2015 and 2014
(Stated in thousands of U.S. Dollars, except per share amounts)
(Unaudited)
21. | Segmented Reporting (continued) |
Operating Segments (continued)
The below table sets forth operating income, interest and accretion expense, change in fair value of contingent consideration, income taxes, total assets and total liabilities by reportable operating segment for the three months ended March 31, 2015 and 2014:
[29]
Concordia Healthcare Corp.
Notes to Condensed Interim Consolidated Financial Statements
For the three months ended March 31, 2015 and 2014
(Stated in thousands of U.S. Dollars, except per share amounts)
(Unaudited)
21. | Segmented Reporting (continued) |
Operating Segments (continued)
Legacy
Pharmaceuticals |
Orphan
Drugs |
Specialty
Healthcare Distribution |
Corporate | Eliminations |
Three Months
Ended March 31, 2014 |
|||||||||||||||||||
Revenue |
$ | 9,309 | $ | 3,570 | $ | 3,931 | $ | | $ | | $ | 16,810 | ||||||||||||
Cost of sales |
2,210 | 700 | 944 | | | 3,854 | ||||||||||||||||||
|
|
|
|
|
|
|
|
|
|
|
|
|||||||||||||
Gross profit |
7,099 | 2,870 | 2,987 | | | 12,956 | ||||||||||||||||||
|
|
|
|
|
|
|
|
|
|
|
|
|||||||||||||
Operating expenses |
||||||||||||||||||||||||
General and administrative |
383 | 760 | 2,091 | 1,457 | | 4,691 | ||||||||||||||||||
Selling and marketing |
(4 | ) | 573 | 375 | | | 944 | |||||||||||||||||
Research and development |
350 | 1,068 | | | | 1,418 | ||||||||||||||||||
Share based compensation |
| | | 756 | | 756 | ||||||||||||||||||
Business acquisition related costs |
13 | | | 161 | | 174 | ||||||||||||||||||
Depreciation expense |
6 | | 24 | 4 | | 34 | ||||||||||||||||||
|
|
|
|
|
|
|
|
|
|
|
|
|||||||||||||
Total operating expenses |
$ | 748 | $ | 2,401 | $ | 2,490 | $ | 2,378 | $ | | $ | 8,017 | ||||||||||||
|
|
|
|
|
|
|
|
|
|
|
|
|||||||||||||
|
||||||||||||||||||||||||
|
|
|
|
|
|
|
|
|
|
|
|
|||||||||||||
Operating income |
$ | 6,351 | $ | 469 | $ | 497 | $ | (2,378 | ) | $ | | $ | 4,939 | |||||||||||
|
|
|
|
|
|
|
|
|
|
|
|
|||||||||||||
|
||||||||||||||||||||||||
|
|
|
|
|
|
|
|
|
|
|
|
|||||||||||||
Interest and accretion expense |
| 201 | 194 | 4,310 | | 4,705 | ||||||||||||||||||
Change in fair value of contingent consideration |
| 567 | | | | 567 | ||||||||||||||||||
Amortization of Intangible Assets |
| 410 | 170 | | | 580 | ||||||||||||||||||
Foreign Exchange (Gain) Loss |
(16 | ) | 5 | | 876 | | 865 | |||||||||||||||||
Other (Income) Expense |
(5 | ) | | | | | (5 | ) | ||||||||||||||||
|
|
|
|
|
|
|
|
|
|
|
|
|||||||||||||
Income (Loss) Before Tax |
$ | 6,372 | $ | (714 | ) | $ | 133 | $ | (7,564 | ) | $ | | $ | (1,773 | ) | |||||||||
|
|
|
|
|
|
|
|
|
|
|
|
|||||||||||||
Income taxes (Recovery) |
130 | (55 | ) | (12 | ) | | | 63 | ||||||||||||||||
|
|
|
|
|
|
|
|
|
|
|
|
|||||||||||||
Net income (loss) |
$ | 6,242 | $ | (659 | ) | $ | 145 | $ | (7,564 | ) | $ | | $ | (1,836 | ) | |||||||||
|
|
|
|
|
|
|
|
|
|
|
|
|||||||||||||
|
||||||||||||||||||||||||
|
|
|
|
|
|
|
|
|
|
|
|
|||||||||||||
Total Assets |
$ | 88,401 | $ | 66,909 | $ | 11,943 | $ | 97,479 | $ | (70,586 | ) | $ | 194,146 | |||||||||||
|
|
|
|
|
|
|
|
|
|
|
|
|||||||||||||
|
||||||||||||||||||||||||
|
|
|
|
|
|
|
|
|
|
|
|
|||||||||||||
Total Liabilities |
$ | 34,024 | $ | 30,455 | $ | 9,929 | $ | 1,637 | $ | | $ | 76,045 | ||||||||||||
|
|
|
|
|
|
|
|
|
|
|
|
Geographic Segments
The Companys revenue by country of origin of external customer is all in the United States, with the exception of $333 of revenue in the Orphan Drugs segment that originates from customers outside of the United States.
The Company has operations in Barbados, Canada, the United States and the Netherlands. The below table sets forth assets and liabilities by geographic location (excluding inter-company balances and investments in subsidiaries):
[30]
Concordia Healthcare Corp.
Notes to Condensed Interim Consolidated Financial Statements
For the three months ended March 31, 2015 and 2014
(Stated in thousands of U.S. Dollars, except per share amounts)
(Unaudited)
21. | Segmented Reporting (continued) |
Geographic Segments (continued)
Barbados | Canada | United States | Netherlands |
As at
March 31, 2015 |
||||||||||||||||
Current assets |
$ | 50,150 | $ | 14,234 | $ | 13,742 | $ | 925 | $ | 79,051 | ||||||||||
Non-current assets |
432,762 | 328 | 70,786 | | 503,876 | |||||||||||||||
|
|
|
|
|
|
|
|
|
|
|||||||||||
Total Assets |
482,912 | 14,562 | 84,528 | 925 | 582,927 | |||||||||||||||
|
|
|
|
|
|
|
|
|
|
|||||||||||
Current liabilities |
28,748 | 260,933 | 4,203 | 518 | 294,402 | |||||||||||||||
Non-current liabilities |
21 | | 26,809 | | 26,830 | |||||||||||||||
|
|
|
|
|
|
|
|
|
|
|||||||||||
Total Liabilities |
$ | 28,769 | $ | 260,933 | $ | 31,012 | $ | 518 | $ | 321,232 | ||||||||||
|
|
|
|
|
|
|
|
|
|
|||||||||||
Barbados | Canada | United States | Netherlands |
As at
December 31, 2014 |
||||||||||||||||
Current assets |
$ | 61,544 | $ | 12,532 | $ | 9,566 | $ | 1,010 | $ | 84,652 | ||||||||||
Non-current assets |
481,752 | 274 | 26,022 | | 508,048 | |||||||||||||||
|
|
|
|
|
|
|
|
|
|
|||||||||||
Total Assets |
543,296 | 12,806 | 35,588 | 1,010 | 592,700 | |||||||||||||||
|
|
|
|
|
|
|
|
|
|
|||||||||||
Current liabilities |
34,194 | 32,081 | 15,000 | 534 | 81,809 | |||||||||||||||
Non-current liabilities |
20,418 | 226,145 | 6,778 | | 253,341 | |||||||||||||||
|
|
|
|
|
|
|
|
|
|
|||||||||||
Total Liabilities |
$ | 54,612 | $ | 258,226 | $ | 21,778 | $ | 534 | $ | 335,150 | ||||||||||
|
|
|
|
|
|
|
|
|
|
22. | Directors and key management compensation |
Compensation, consisting of salaries, bonuses and director fees to key management personnel and directors for the three months ended March 31, 2015 amounted to $871 (2014 $399).
[31]
Concordia Healthcare Corp.
Notes to Condensed Interim Consolidated Financial Statements
For the three months ended March 31, 2015 and 2014
(Stated in thousands of U.S. Dollars, except per share amounts)
(Unaudited)
23. | Subsequent events |
Acquisition
On April 21, 2015 the Company completed the previously announced acquisition to acquire substantially all of the commercial assets from Covis for $1.2 billion in cash. The Covis drug portfolio acquired (the Portfolio) consists of 18 branded and authorized generic products. The Portfolio includes branded pharmaceuticals, injectables and authorized generics that address medical conditions in various therapeutic areas including cardiovascular, central nervous system, oncology and acute care markets.
The acquisition was structured as an all-cash transaction with a purchase price of $1.2 billion for the Portfolio. The Company paid for the acquisition through a mix of term loans, bonds and equity as further described below.
Bank Facilities
Concurrent with the closing of the Covis Acquisition, the Company entered into a credit agreement (Credit Agreement) dated April 21, 2015, by and among the Company, certain of the Companys subsidiaries, the Royal Bank of Canada, Morgan Stanley Senior Funding, Inc., TD Securities (USA) LLC, GE Capital Markets, Inc., Fifth Third Bank and certain lenders party thereto (collectively, the Lenders). Pursuant to the terms of the Credit Agreement, the Lenders agreed to provide senior secured credit facilities in an aggregate principal amount of up to $700 million comprising: (i) a senior secured revolving credit facility (the Revolving Facility) in an aggregate principal amount of up to $125 million; and (ii) a senior secured term loan facility (the Term Facility) in an aggregate principal amount of $575 million (together, the Bank Facilities). The Bank Facilities are secured by the assets of the Company and the assets of the Companys material subsidiaries.
The Term Facility will mature on the seventh anniversary of the Covis Acquisition date (unless extended by the lenders under the Term Facility) and the Revolving Facility will mature on the fifth anniversary of the Covis Acquisition date (unless extended by the lenders under the Revolving Facility). The Term Facility bears a variable interest rate with fixed repayments required over the term to maturity, as well as mandatory repayments based on excess cash flow generated by the Company as defined in the Credit Agreement, calculated annually. Interest rates are calculated at the U.S. Prime Rate or LIBOR plus applicable margins based on a leverage table.
The funds made available to the Company under the Term Facility were used to partially fund (i) the purchase price for the Covis Acquisition; (ii) the fees and expenses incurred in connection with the Covis Acquisition; and (iii) the repayment and retirement of the Companys outstanding debt issued pursuant to the terms and provisions of the amended and restated Credit Facility with GE Capital Canada Finance Inc. and a syndicate of lenders. The Company has not drawn on the Revolving Facility.
Senior Notes due 2023
In connection with the Covis Acquisition, Concordia also closed its previously announced private offering of $735 million of its 7.00% Senior Notes due 2023 (the Notes). The Notes were priced at an issue price of 100.00% of their face amount to yield 7.00%. Interest on the Notes is payable semi-annually on April 15th and October 15th of each year. The Company is not required to make mandatory redemption or sinking fund payments with respect to the Notes.
[32]
Concordia Healthcare Corp.
Notes to Condensed Interim Consolidated Financial Statements
For the three months ended March 31, 2015 and 2014
(Stated in thousands of U.S. Dollars, except per share amounts)
(Unaudited)
23. | Subsequent events (continued) |
The net proceeds of the offering of the Notes were used to partially fund (i) the purchase price for the Covis Acquisition; and (ii) the fees and expenses incurred in connection with the Covis Acquisition.
Equity Offering
On April 8, 2015, Concordia announced the closing of its short form prospectus offering, on a bought deal basis, of 4,329,428 subscription receipts (Subscription Receipts) of the Company, which included the exercise by the Underwriters (as defined below) of an over-allotment option of 15%, for aggregate gross proceeds of CAD $368,001,380 (the 2015 Offering).
The 2015 Offering was completed at a price per Subscription Receipt of CAD $85.00 by a syndicate of underwriters led by RBC Capital Markets, as sole bookrunner and co-lead manager, and including GMP Securities L.P., as co-lead manager, and TD Securities Inc. (collectively, the Underwriters). Upon closing of the 2015 Offering, the Underwriters received payment for their expenses and 50% of their commission under the 2015 Offering.
Upon closing of the Covis Acquisition each holder of Subscription Receipts automatically received, without payment of additional consideration or further action, one Concordia common share in exchange for each Subscription Receipt held.
Pursuant to the agreement governing the Subscription Receipts, certain proceeds from the Offering, which had been held in escrow, were released from escrow on behalf of Concordia to fund a portion of the purchase price for the Covis Acquisition and to pay for the balance of the Underwriters commission under the Offering. Sufficient funds to pay a dividend equivalent amount equal to $0.075 per Subscription Receipt (less applicable withholding taxes, if any), as a result of the dividends declared on each common share by Concordia with a record date of April 15, 2015, were held in escrow and released from escrow and paid concurrent with the payment of the Companys dividend to all holders of Common Shares on April 30, 2015. The funds in excess of the amount required to satisfy the dividend equivalent amount were remitted to the Company.
[33]
Exhibit 99.2
Managements Discussion and Analysis
For the three months ended March 31, 2015
Dated: May 14, 2015
Table of Contents
FORWARD-LOOKING STATEMENTS |
3 | |||
CRITICAL ACCOUNTING ESTIMATES |
4 | |||
NEW ACCOUNTING POLICIES ADOPTED IN THE PERIOD |
6 | |||
COMPANY OVERVIEW |
7 | |||
HISTORY AND KEY DEVELOPMENTS |
7 | |||
Q UALIFYING T RANSACTION |
7 | |||
F INANCINGS AND A CQUISITIONS |
8 | |||
RECENT EVENTS |
10 | |||
SELECTED QUARTERLY FINANCIAL INFORMATION |
11 | |||
RESULTS OF OPERATIONS |
13 | |||
FINANCIAL POSITION |
17 | |||
LIQUIDITY AND CAPITAL RESOURCES |
19 | |||
C ASH F LOWS |
19 | |||
INDEBTEDNESS |
21 | |||
T ERM AND C REDIT F ACILITIES |
21 | |||
N OTES P AYABLE |
21 | |||
N ON -C ONTINGENT P URCHASE C ONSIDERATION |
21 | |||
CONTRACTUAL OBLIGATIONS |
21 | |||
RELATED PARTY TRANSACTIONS |
22 | |||
CONTINGENCIES |
22 | |||
OFF BALANCE SHEET ARRANGEMENTS |
23 | |||
NON IFRS FINANCIAL MEASURES |
23 | |||
EBITDA |
23 | |||
A DJUSTED EBITDA |
24 | |||
A DJUSTED EPS |
24 | |||
OUTSTANDING SHARE DATA |
25 | |||
DISCLOSURE CONTROLS AND PROCEDURES AND INTERNAL CONTROL OVER FINANCIAL REPORTING |
25 | |||
D ISCLOSURE C ONTROLS AND P ROCEDURES |
25 | |||
I NTERNAL C ONTROLS OVER F INANCIAL R EPORTING |
26 | |||
A SSESSMENT OF DC&P AND ICFR |
26 |
[2]
The following Managements Discussion and Analysis ( MD&A ) was prepared as of May 14, 2015 and should be read in conjunction with the unaudited condensed interim consolidated financial statements and related notes for the three months ended March 31, 2015 and the audited consolidated financial statements and related notes for the year ended December 31, 2014 of Concordia Healthcare Corp. ( Concordia or the Company ), which were prepared in accordance with International Financial Reporting Standards ( IFRS ). Amounts are stated in thousands of U.S. Dollars, which is the functional currency of the Company, unless otherwise noted.
Some of the statements contained in this MD&A constitute forward-looking statements within the meaning of applicable Canadian securities legislation. See Forward-Looking Statements for a discussion of risks, uncertainties, and assumptions relating to these statements. Additional information relating to the Company, including the Companys Annual Information Form, is available on SEDAR at www.sedar.com . The results of operations, business prospects and financial condition of Concordia will be affected by, among other things, the Risk factors set out in Concordias Annual Information Form dated March 19, 2015 available on SEDAR at www.sedar.com .
Certain measures used in this MD&A do not have any standardized meaning under IFRS. When used, these measures are defined in such terms as to allow the reconciliation to the closest IFRS measure. See Selected Financial Information, Results of Operations and Non-IFRS Financial Measures.
Forward-looking Statements
This MD&A may contain forward-looking information and forward-looking statements (collectively, forward-looking information) regarding Concordia and its business. This forward-looking information is not based on historical facts but rather on the expectations of Concordias management ( Management ) regarding the future growth of the Company, its results of operations, performance and business prospects and opportunities. Forward-looking information may include financial and other projections, as well as statements regarding future plans, objectives or economic performance, or the assumptions underlying any of the foregoing. This MD&A uses words such as will, expects, anticipates, intends, estimates, or similar expressions to identify forward-looking information. Such forward-looking information reflects the current beliefs of Management based on information currently available to them, and are based on assumptions and subject to risks and uncertainties.
Forward-looking information included in this MD&A is based in part, on assumptions that may change, thus causing actual future results or anticipated events to differ materially from those expressed or implied in any forward-looking information. Such assumptions include that:
| Concordia will sustain or increase profitability, and will be able to fund its operations with existing capital, and/or it will be able to raise additional capital to fund future acquisitions; |
| Concordia will be able to attract and retain qualified staff, equipment and services in a timely and efficient manner; |
| Concordia will be able to acquire any necessary technology, products or businesses and effectively integrate such acquisitions; |
| Concordia will be successful in developing and clinically testing products under development; |
| Concordia will be successful in obtaining all necessary approvals for commercialization of its products from the U.S. Food and Drug Administration, or other regulatory authorities; |
| The results of continuing and future safety and efficacy studies by industry and government agencies relating to Concordias products will be favorable; |
| Concordias products will not be adversely impacted by competitive products and pricing; |
| Raw materials and finished products necessary for Concordias products will continue to be available; |
| Concordias ability to generate sufficient cash flow from operations and to access existing and proposed credit facilities and the capital markets to meet its future obligations on acceptable terms; |
[3]
| Concordia will be able to continue to rely on third party contract manufacturers to manufacture the Companys products on favorable terms; |
| Concordia will be able to maintain and enforce the protection afforded by any patents or other intellectual property rights; |
| Concordias products will be successfully licensed to third parties to market and distribute such products on favorable terms; |
| Concordias key strategic alliances, out licensing and partnering arrangements, now and in the future, will remain in place and in force; |
| The general regulatory environment will not change in a manner adverse to the business of Concordia, including the areas of taxation, environmental protection, consumer safety and health regulation; |
| The tax treatment of Concordia and its subsidiaries will remain constant and the Company will not become subject to any material legal proceedings; |
| Concordia will be able to comply with its contractual obligations, including, without limitation, its obligations under debt arrangements; |
| Future currency exchange and interest rates; |
| General economic, financial, market and political conditions impacting the industry in which the Company operates; |
| Timely receipt of any required regulatory approvals; |
| The ability of Concordia to conduct operations in a safe, efficient and effective manner; and |
| The ability of Concordia to successfully market its products and services. |
Management cautions that the foregoing list of assumptions is not exhaustive. Forward-looking information involves known and unknown risks, uncertainties and other factors that may cause the actual results, performance or achievements of the Company to differ materially from any future results, performance or achievements expressed or implied by the forward-looking information. Risks related to forward-looking information include those risks referenced to in the Companys filings with the Canadian Securities Regulators, including risks described in the Companys Annual Information Form dated March 19, 2015 under the heading Risk Factors. Actual results, performance or achievement could differ materially from that expressed in, or implied by, any forward-looking information in this MD&A, and, accordingly, investors should not place undue reliance on any such forward-looking information. Further, any forward-looking information speaks only as of the date on which such forward-looking information is made and the Company undertakes no obligation to update any forward-looking information to reflect the occurrence of unanticipated events, except as required by law, including applicable securities laws. New factors emerge from time to time and the importance of current factors may change from time to time and it is not possible for Management to predict all of such factors, changes in such factors and to assess in advance the impact of each such factors on the business of Concordia or the extent to which any factor, or combination of factors, may cause actual results to differ materially from those contained in any forward-looking information contained in this MD&A.
Trademarks
This MD&A includes trademarks which are protected under applicable intellectual property laws and are the property of Concordia or its affiliates. Solely for convenience, the trademarks of Concordia referred to in this MD&A may appear with or without the ® or TM symbol, but such references or the absence thereof are not intended to indicate, in any way, that the Company or its affiliates will not assert, to the fullest extent under applicable law, the respective rights or the rights of the applicable licensor to these trademarks. Any other trademarks used in the MD&A are the property of their respective owners.
Critical Accounting Estimates
In preparing the Companys consolidated financial statements, Management is required to make estimates and assumptions that affect the reported amounts of assets and liabilities, the disclosure of contingent liabilities at the date of the consolidated financial statements and the reported amounts of expenses during the reporting periods.
[4]
Significant estimates made by Management include: gross to net deductions; allowance for doubtful accounts; inventory reserves; useful lives of amortizable tangible and intangible assets; fair value of contingent consideration; weighted average cost of capital; determining the fair value of share-based payments and the provision for income taxes and the ability to realize deferred tax assets. On an ongoing basis, Management reviews its estimates to ensure that these estimates appropriately reflect changes in the Companys business and new information as it becomes available. If historical experience and other factors used by Management to make these estimates do not reasonably reflect future activity, the Companys consolidated financial statements could be materially impacted.
Chargebacks
The provision for chargebacks is an estimate used in the recognition of revenue. In the United States, Concordia sells its products directly to wholesale distributors. The wholesale distributors sell directly to independent pharmacies, managed care organizations, hospitals and group purchasing organizations (indirect customers). The difference between the price that Concordia sells to wholesalers and the price the wholesaler sells to indirect customers is referred to as a chargeback. The provision for chargebacks is calculated based upon historical experience. As sales are made to large wholesale customers, Concordia continually monitors the provision for chargebacks and makes adjustments when it believes that actual chargebacks may differ from estimated provisions.
Returns
The provision for returns is an estimate used in the recognition of revenue. Concordia has a returns policy that allows wholesalers to return the product within a specified period prior to and subsequent to the expiration date. Provisions for returns are recognized in the period in which the underlying sales are recognized, as a reduction of sales revenue. Concordia estimates provisions for returns based upon historical experience, which represents Managements best estimate. Concordia continually monitors provisions for returns and makes adjustments when it believes that actual product returns may differ from established reserves.
Rebates
The provision for rebates is an estimate used in the recognition of revenue. Rebates are granted to healthcare authorities and under contractual arrangements with certain customers. Products sold in the United States are covered by various programs (such as Medicaid and Medicare) under which products are sold at a discount. Concordia estimates its provisions for rebates based on current contractual terms and conditions as well as the historical experience, changes to business practices and credit terms. Concordia continually monitors the provision for rebates and makes adjustments when it believes that actual rebates may differ from established provisions. All rebates are recognized in the period in which the underlying sales are recognized as a reduction of sales revenue.
Other price adjustments
The provision for other price adjustments is a significant and complex estimate used in the recognition of revenue. Other price adjustments are credits issued by the wholesaler to reflect various decreases in the selling price. The price that Concordia sells to the Wholesaler is known as the Wholesale Acquisition Cost ( WAC ). Decreases to WAC are discretionary decisions made by the wholesalers to reflect competitive market conditions. Amounts recorded for other price adjustments are based upon estimated declines in market prices. Concordia regularly monitors these and other factors and re-evaluates the provision as additional information becomes available.
Share-based compensation
IFRS 2 requires that each installment of options be treated as a separate share option grant with graded-vesting features. Forfeitures are estimated at the time of grant and revised if actual forfeitures are likely to differ from previous estimates. Options granted to parties other than employees are measured at their fair values. Share-based compensation is recognized as compensation in the statement of comprehensive earnings based on the fair values of the underlying options at the time of the grant, with the compensation expense amortized over the vesting period for the grantee. Concordia uses the Black-Scholes option pricing model to price its options in computing share based compensation, which requires certain
[5]
assumptions on numerous variables including the stock price volatility rate for a publicly held corporation. Due to the absence of a company specific volatility rate given the limited trading history of the Companys stock, Concordia uses comparable rates to other companies in the pharmaceutical industry. The selection of a different option pricing model (binomial model) and a different volatility rate could produce a different value for share based compensation, which could impact results.
Impairment of non-financial assets
The Company reviews amortized non-financial assets for impairment whenever events or changes in circumstances indicate that the carrying amount of the assets may be impaired. The Company also reviews, on an annual basis, non-financial assets with indefinite life for impairment. If the recoverable amount of the respective non-financial assets is less than its carrying amount, it is considered to be impaired. In the process of measuring the recoverable amount, Management makes assumptions about future events and circumstances. The actual results may vary and may cause significant adjustments.
Income taxes
Concordia is subject to income taxes in different jurisdictions and therefore uses judgment to determine the provision for income taxes. There are transactions and calculations for which the ultimate tax determination is uncertain. Provisions for uncertain tax positions are recorded based on Managements estimate of the most likely outcome. Where the final tax outcome of these matters is different from the amounts that were initially recorded, such differences will impact the current and deferred income tax assets and liabilities in the period that such determination is made.
Acquisition-Related Contingent Purchase Consideration
Some of the acquisitions Concordia has completed include contingent consideration to be potentially paid based upon the occurrence of future events, such as sales performance and the achievement of certain future development, regulatory and sales milestones.
Acquisition-related contingent consideration associated with an acquisition is initially recognized at fair value and then re-measured each reporting period, with changes in fair value recorded in the consolidated statements of income (loss). The estimates of fair value contain uncertainties as they involve assumptions about the likelihood of achieving specified milestone criteria, projections of future financial performance, and assumed discount rates. Changes in the fair value of the acquisition-related contingent consideration obligations result from several factors including changes in discount periods and rates, changes in the timing and amount of revenue estimates and changes in probability assumptions with respect to the likelihood of achieving specified milestone criteria. A change in any of these assumptions could produce a different fair value, which could impact results.
New Accounting Policies adopted in the period
The accounting policies adopted in the preparation of the condensed interim consolidated financial statements are consistent with those followed in the preparation of the Companys annual consolidated financial statements for the year ended December 31, 2014, except as described below:
Restricted and Deferred Share Unit Plans
The expenses related to the Restricted Share Units (RSUs) and Deferred Share Units (DSUs) are accrued based on fair value, determined as of the date of grant. This expense is recognized as compensation expense over the vesting period. Until the liability is settled, the fair value of the RSUs and DSUs is remeasured at the end of each reporting period and at the date of settlement, with changes in fair value recognized as share-based compensation expense or recovery over the vesting period.
[6]
Company Overview
Concordia is an integrated healthcare company with three operating segments:
1. | The Legacy Pharmaceuticals Division |
The Legacy Pharmaceuticals Division focuses on the management and acquisition of legacy pharmaceutical products, both with patent life and exclusivity remaining (pre-legacy) and products that have reached full maturity but continue on a predictable revenue path, collectively referred to as legacy pharmaceutical products. Regardless of stage of the life cycle the targeted products have a well-established record of safety and efficacy and a history of stable, predictable prescription demand.
2. | The Orphan Drugs Division |
The Orphan Drugs Division is intended to provide growth opportunities through the expansion into new indications for existing products or the acquisition of approved orphan drugs and further expansion within their identified markets and new indications.
3. | The Specialty Healthcare Distribution Division |
The Speciality Healthcare Distribution ( SHD ) Division is a nation-wide provider of diabetes testing supplies, and other healthcare products in the United States.
These three business units are run as separate divisions but are inter-related. The cash-flow from legacy pharmaceutical products is used to fund operations, provide capital for future acquisitions and is also intended to fund the development of new indications for orphan drugs.
These three divisions are identified as reportable segments under IFRS for the purposes of disclosure in the Companys consolidated financial statements.
History and Key Developments
Qualifying Transaction
On December 20, 2013 the Company entered into an amalgamation agreement (the Amalgamation Agreement ) and completed its qualifying transaction pursuant to the policies of the TSX Venture Exchange (the Qualifying Transaction ). The Qualifying Transaction proceeded by way of a three-cornered amalgamation among Mercari Acquisition Corp. ( Mercari ), a capital pool company listed on the NEX board of the TSX Venture Exchange, Mercari Subco Inc., a wholly-owned subsidiary of Mercari, and Concordia Healthcare Inc. ( CHI ), a private Ontario corporation incorporated on December 5, 2012. On December 18, 2013, and prior to the completion of the Qualifying Transaction, Mercari changed its name to Concordia Healthcare Corp. and completed a consolidation of its share capital on a basis of one post-consolidation common share for every 48.08 common shares existing immediately before the consolidation. The Qualifying Transaction resulted in a reverse takeover of Mercari by the shareholders of CHI.
Immediately upon completion of the Qualifying Transaction, the shareholders of CHI held 98.5% of the shares of the amalgamated corporation, and for accounting purposes CHI was deemed the acquirer. The Qualifying Transaction constituted a reverse takeover but did not meet the definition of a business combination under IFRS 3; accordingly the Company has accounted for the transaction in accordance with IFRS 2. The assets and liabilities of Mercari have been included in the Companys consolidated balance sheet at fair value, which approximate their pre-combination carrying values.
Mercaris shares were delisted from the NEX board of the TSX Venture Exchange. Concordias shares
[7]
were listed for trading on the Toronto Stock Exchange (the TSX ) under the symbol CXR on December 24, 2013.
Financings and Acquisitions
Term and Credit Facilities
On May 6, 2013, CHI entered into two loan and security agreements: (i) a loan under a senior loan agreement (the Senior Loan Agreement ) in the principal amount of $19.0 million bearing interest at 12% per annum, calculated daily, maturing on October 30, 2015 with interest paid monthly in arrears, and (ii) two loans under a subordinate loan agreement (the Subordinate Loan Agreement ) in the aggregate principal amount of $5.15 million bearing interest at 18% per annum, calculated daily, maturing on October 30, 2015 with interest paid monthly in arrears only if the loan under the Senior Loan Agreement was repaid. The Senior Loan Agreement included a working capital loan of $3.0 million where the interest rate was 12% per annum. The working capital loan was repaid and cancelled on August 7, 2013. On March 28, 2014 the Company repaid in full the amounts owing under the Senior Loan Agreement and the Subordinate Loan Agreement.
On September 19, 2013, the Company entered into a senior secured revolving credit facility in the principal amount of $3.0 million. The Company did not draw on the revolving credit facility and cancelled it on May 13, 2014.
On May 14, 2014, the Company entered into a secured credit facility with GE Capital Canada Finance, Inc. ( GE Capital ) and a syndicate of lenders having a principal amount of up to $195 million, consisting of a $170 million term loan and a $25 million revolving credit facility (the May Credit Facility ). On September 30, 2014, the Company amended and restated the May Credit Facility whereby incremental term loans of $95 million were added to the May Credit Facility (together with the May Credit Facility, the Credit Facility ). The Credit Facility bore a variable interest rate and was to mature on October 1, 2020 with fixed repayments required over the term to maturity, as well as mandatory repayments based on excess cash flow generated by the Company as defined in the Credit Facility, calculated annually. Interest rates were calculated at the U.S. Prime Rate or LIBOR plus applicable margins based on a leverage table. The Credit Facility was secured by the assets of the Company and the assets of the Companys material subsidiaries. On April 21, 2015 the Company repaid the Credit Facility in full. For additional information regarding the repayment please see Recent Events below.
Private Placements
On May 5, 2013, CHI completed a private placement of 6,000,000 common shares at a price of $1.00 per share. Total proceeds from the transaction were $6 million.
On various dates in August of 2013, CHI completed private placements of a total of 1,166,666 shares at a price of $3.00 per share. Total proceeds from the transactions were $3.5 million.
On December 19, 2013, CHI completed a private placement (the Private Placement ) of subscription receipts conducted by a syndicate of agents. Pursuant to the Private Placement, CHI issued 5,520,000 Subscription Receipts at a price of $6.25 Canadian Dollars ( CAD ) per Subscription Receipt for total gross proceeds to CHI of CAD $34.5 million. Each Subscription Receipt was exchanged for one common share of CHI, which common shares were then exchanged for common shares of the Company on a one-for-one basis pursuant to the Qualifying Transaction.
Public Offerings
On March 11, 2014, the Company announced the completion of a short-form prospectus offering, on a bought deal basis, of 5,750,000 common shares of Concordia, which included the exercise by the underwriters of an over-allotment option of 15%, for aggregate gross proceeds of CAD $67,562,500. Net proceeds to the Company, after the deduction of underwriters fees, were CAD $63,508,750.
[8]
This offering was completed at a price per common share of CAD $11.75 by a syndicate of underwriters co-led by GMP Securities L.P. and Canaccord Genuity Corp. and including Barclays Capital Canada Inc., Beacon Securities Limited and Cormark Securities Inc.
Acquisitions
Concordia Pharmaceuticals Inc. ( CPI ), a subsidiary of the Company, acquired certain legacy pharmaceutical business assets from Shionogi Inc. ( Shionogi ) on May 6, 2013 (the Shionogi Transaction ). These legacy pharmaceutical assets are comprised of three FDA approved drugs: Kapvay ® , which is used to treat Attention Deficit Hyperactivity Disorder, Ulesfia ® , which is a topical treatment for pediculosis (head lice), and Orapred ODT ® , an anti-inflammatory used in the treatment of certain pulmonary diseases such as asthma. The purchase price paid to Shionogi was $28.7 million and included $25.6 million paid for the products, $2.3 million paid for inventory including raw material, work in process and finished goods and $0.8 million in contingent consideration, subject to meeting certain performance metrics.
Concordia Healthcare USA Inc. ( CHUSA ), a subsidiary of the Company, acquired its specialty healthcare distribution business assets from Global Medical Direct LLC and affiliated entities (collectively, Global ) on October 25, 2013 with an effective date of August 1, 2013 (the Global Transaction ). The Companys specialty healthcare distribution business is a United States national Internet and mail-order provider of diabetes testing supplies, and other healthcare products. This business also includes a full-service pharmacy with full fulfillment capacity and can ship medications across the United States. CHI, through CHUSA acquired the specialty healthcare distribution business for total consideration of $13.2 million comprised of $5.0 million in cash, a vendor note with a fair value on the date of acquisition of $5.6 million and an additional earn-out payment with an estimated present value on the date of acquisition of $2.6 million payable in common shares of the Company subject to meeting certain performance metrics. In addition, 1 million common shares of the Company at US$3.00 per share were issued as finders fees in connection with the acquisition of the SHD Division.
On November 8, 2013, CHI and certain of its affiliates entered into an agreement to acquire 100% of the shares of Pinnacle Biologics Inc. ( Pinnacle ) for total consideration of $58.0 million (the Pinnacle Transaction ) comprised of $32.7 million of cash consideration, $5.0 million of CHIs common shares issued at a price of $5.63 per common share (being a 10% discount to the CAD $6.25 price per Subscription Receipt issued as part of the Private Placement, 10 annual cash payments with an estimated present value of $5.0 million and milestone and other contingency payments with an estimated value of $15.3 million. The acquisition of Pinnacle closed on December 20, 2013. The acquisition of Pinnacle was financed through available cash, which included net proceeds of CAD $34.5 million received by the Company through the Private Placement of Subscription Receipts of CHI, which closed on December 19, 2013. Pinnacles Photofrin ® , now owned by CLI, a subsidiary of the Company, is FDA approved for the treatment of three rare forms of cancer.
On March 19, 2014, the Company, through its subsidiary CPI, entered into a definitive agreement to acquire Donnatal ® , an adjunctive therapy in the treatment of irritable bowel syndrome ( IBS ) and acute enterocolitis, from a privately held specialty pharmaceutical company carrying on business as Revive Pharmaceuticals ( Revive Pharmaceuticals ). The acquisition of Donnatal ® closed on May 15, 2014.
CPI acquired Donnatal ® for $200 million in cash and an aggregate of 4,605,833 common shares of Concordia, representing approximately 16.17% of the Companys outstanding common shares on a non-diluted basis (approximately 14.96% on a fully-diluted basis) as at the date of acquisition and after giving effect to the acquisition.
The Company paid for the cash component of the acquisition through a combination of available cash and debt financing from the May Credit Facility.
[9]
On September 30, 2014, the Company, through its subsidiary CPI, completed the purchase of Zonegran ® for commercialization and sale in the United States, including Puerto Rico, from Eisai Inc., pursuant to the terms and conditions of a definitive agreement entered into as of September 3, 2014. Zonegran ® is an adjunctive therapy in the treatment of partial seizures in adults with epilepsy.
CPI acquired Zonegran ® for $91.4 million in cash, which included approximately $1.4 million for purchased inventory. CPI paid for the acquisition through debt financing from the Credit Facility.
On October 1, 2014 Concordia Laboratories Inc.( CLI ), a subsidiary of the Company incorporated in Barbados, acquired certain intellectual property from Pinnacle, a subsidiary of the Company incorporated in the United States. The inter-company sale of the intellectual property triggered a cash tax liability of $13.5 million, which was paid by the Company in the first quarter of 2015.
Recent Events
Acquisition
On April 21, 2015 the Company completed the previously announced acquisition to acquire substantially all of the commercial assets of privately held Covis Pharma S.à.r.l and Covis Injectables, S.à.r.l (together Covis ) for $1.2 billion in cash (the Covis Acquisition ). The Covis drug portfolio acquired (the Portfolio ) consists of 18 branded and authorized generic products. The Portfolio includes branded pharmaceuticals, injectables and authorized generics that address medical conditions in various therapeutic areas including cardiovascular, central nervous system, oncology and acute care markets.
The Covis Acquisition was structured as an all-cash transaction with a purchase price of $1.2 billion for the Portfolio. The Company paid for the acquisition through a mix of term loans, bonds and equity as further described below.
Bank Facilities
Concurrent with the closing of the Covis Acquisition, the Company entered into a credit agreement ( Credit Agreement ) dated April 21, 2015, by and among the Company, certain of the Companys subsidiaries, the Royal Bank of Canada, Morgan Stanley Senior Funding, Inc., TD Securities (USA) LLC, GE Capital Markets, Inc., Fifth Third Bank and certain lenders party thereto (collectively, the Lenders ). Pursuant to the terms of the Credit Agreement, the Lenders agreed to provide senior secured credit facilities in an aggregate principal amount of up to $700 million comprising: (i) a senior secured revolving credit facility (the Revolving Facility ) in an aggregate principal amount of up to $125 million; and (ii) a senior secured term loan facility (the Term Facility ) in an aggregate principal amount of $575 million (together, the Bank Facilities ). The Bank Facilities are secured by the assets of the Company and the assets of the Companys material subsidiaries.
The Term Facility will mature on the seventh anniversary of the Covis Acquisition date (unless extended by the lenders under the Term Facility) and the Revolving Facility will mature on the fifth anniversary of the Covis Acquisition date (unless extended by the lenders under the Revolving Facility). The Term Facility bears a variable interest rate with fixed repayments required over the term to maturity, as well as mandatory repayments based on excess cash flow generated by the Company as defined in the Credit Agreement, calculated annually. Interest rates are calculated at the U.S. Prime Rate or LIBOR plus applicable margins based on a leverage table.
The funds made available to the Company under the Term Facility were used to partially fund (i) the purchase price for the Covis Acquisition; (ii) the fees and expenses incurred in connection with the Covis Acquisition; and (iii) the repayment and retirement of the Companys outstanding debt issued pursuant to the terms and provisions of the Credit Facility with GE Capital and a syndicate of lenders. The Company has not drawn on the Revolving Facility.
[10]
Senior Notes due 2023
In connection with the Covis Acquisition, Concordia also closed its previously announced private offering of $735 million of its 7.00% Senior Notes due 2023 (the Notes). The Notes were priced at an issue price of 100.00% of their face amount to yield 7.00%. Interest on the Notes is payable semi-annually on April 15 th and October 15 th of each year. The Company is not required to make mandatory redemption or sinking fund payments with respect to the Notes.
The net proceeds of the offering of the Notes were used to partially fund (i) the purchase price for the Covis Acquisition; and (ii) the fees and expenses incurred in connection with the Covis Acquisition.
Equity Offering
On April 8, 2015, Concordia announced the closing of its short form prospectus offering, on a bought deal basis, of 4,329,428 subscription receipts ( 2015 Subscription Receipts ) of the Company, which included the exercise by the Underwriters (as defined below) of an over-allotment option of 15%, for aggregate gross proceeds of CAD $368,001,380 (the 2015 Offering ).
The 2015 Offering was completed at a price per 2015 Subscription Receipt of CAD $85.00 by a syndicate of underwriters led by RBC Capital Markets, as sole bookrunner and co-lead manager, and including GMP Securities L.P., as co-lead manager, and TD Securities Inc. (collectively, the Underwriters ). Upon closing of the 2015 Offering, the Underwriters received payment for their expenses and 50% of their commission under the 2015 Offering.
Upon closing of the Covis Acquisition each holder of 2015 Subscription Receipts automatically received, without payment of additional consideration or further action, one Concordia common share in exchange for each 2015 Subscription Receipt held.
Pursuant to the agreement governing the 2015 Subscription Receipts, certain proceeds from the 2015 Offering, which had been held in escrow, were released from escrow on behalf of Concordia to fund a portion of the purchase price for the Covis Acquisition and to pay for the balance of the Underwriters commission under the 2015 Offering. Sufficient funds to pay a dividend equivalent amount equal to $0.075 per 2015 Subscription Receipt (less applicable withholding taxes, if any), as a result of the dividends declared on each common share by Concordia with a record date of April 15, 2015, were held in escrow and released from escrow and paid concurrent with the payment of the Companys dividend to all holders of common shares on April 30, 2015. The funds in excess of the amount required to satisfy the dividend equivalent amount were remitted to the Company.
Selected Quarterly Financial Information
The following table sets forth selected unaudited financial information for Concordia as at March 31, 2015 and for the previous seven quarters:
[11]
Q1-2015 | Q4-2014 | Q3-2014 | Q2-2014 | Q1-2014 | Q4-2013 | Q3-2013 | Q2-2013 | |||||||||||||||||||||||||
Revenue |
36,435 | 42,896 | 36,432 | 26,053 | 16,810 | 16,684 | 14,725 | 9,038 | ||||||||||||||||||||||||
Gross profit |
32,090 | 37,811 | 31,936 | 21,499 | 12,956 | 12,628 | 12,147 | 7,334 | ||||||||||||||||||||||||
Operating income |
16,189 | 23,335 | 14,868 | 2,731 | 4,939 | 292 | 7,897 | 5,796 | ||||||||||||||||||||||||
Net income (Loss) |
5,668 | 3,718 | 10,535 | (827 | ) | (1,836 | ) | (7,083 | ) | 5,364 | 4,150 | |||||||||||||||||||||
Cash |
35,363 | 42,770 | 30,945 | 32,708 | 77,973 | 42,899 | 23,426 | 14,100 | ||||||||||||||||||||||||
Total assets |
582,927 | 592,700 | 587,323 | 490,135 | 194,146 | 170,765 | 79,370 | 50,171 | ||||||||||||||||||||||||
Total liabilities |
321,232 | 335,150 | 332,314 | 246,010 | 76,045 | 109,243 | 59,727 | 40,021 | ||||||||||||||||||||||||
EBITDA (1) |
20,069 | 23,007 | 14,272 | 1,651 | 3,546 | (4,320 | ) | 7,908 | 5,788 | |||||||||||||||||||||||
Adjusted EBITDA (1) |
19,580 | 25,406 | 20,259 | 12,441 | 5,903 | 6,818 | 8,555 | 5,796 | ||||||||||||||||||||||||
Earnings (Loss) per share |
||||||||||||||||||||||||||||||||
Basic |
$ | 0.20 | $ | 0.13 | $ | 0.37 | $ | (0.03 | ) | $ | (0.09 | ) | $ | (1.12 | ) | $ | 0.66 | $ | 2.52 | |||||||||||||
Diluted |
$ | 0.19 | $ | 0.12 | $ | 0.35 | $ | (0.03 | ) | $ | (0.09 | ) | $ | (1.12 | ) | $ | 0.61 | $ | 1.18 | |||||||||||||
Adjusted (1) |
$ | 0.53 | $ | 0.74 | $ | 0.57 | $ | 0.38 | $ | 0.05 | $ | 0.40 | $ | 0.69 | $ | 1.18 |
Notes:
(1) | Represents a non-IFRS measure. For the relevant definitions and reconciliation to reported results see Non-IFRS Financial Measures. |
The sequential decline in revenue, gross profit and operating income from the fourth quarter of 2014 to the first quarter of 2015 was primarily driven by:
| A sequential decline in Legacy Pharmaceuticals Division revenue and gross profit of $5.1 million and $4.9 million, respectively; |
| A sequential decline in SHD Division revenue and gross profit of $1.1 million and $0.9 million, respectively; and |
| Increased business acquisition related costs of $1.5 million. |
The decline in the Legacy Pharmaceuticals Divisions revenue and gross profit is primarily attributable to two, one-time, unfavorable impacts. One impact resulted from a reduction in inventory of all products, but primarily Donnatal ® , held by one of the Companys primary wholesalers. In the first quarter of 2015, one wholesaler reduced the level of Donnatal ® inventory it has historically carried from approximately 8 weeks of sales to approximately 4 weeks of sales, resulting in a one-time reduction of revenue. This brings the inventory to levels consistent with that of Concordias products held by all wholesalers. A second impact resulted from a second large wholesaler delaying Donnatal ® inventory purchases during its fiscal year-end period, which had the effect of deferring product sales into April. These inventory adjustments in the period affected EBITDA by approximately $3.5 million. Meanwhile, the underlying demand for Donnatal ® was unaffected by the inventory changes in the period, and weekly total prescriptions ( TRX) and new prescriptions ( NRX ) demand throughout the period trended upward as improvements to physician targeting and promotional strategy made through the fourth quarter of 2014 and the first quarter of 2015 began to take effect. Specifically, comparing the first and second eight-week period in 2015, TRX and NRX counts increased 3.6% and 6.8% respectively.
The decline in SHD Division revenue and gross profit is primarily attributable to changes by two of the pharmacy benefit managers ( PBMs ) that Complete Medical Homecare, Inc. ( CMH ), a subsidiary of the Company, contracts with whereby the PBMs removed certain generic diabetic testing products from their formularies that had been supplied by CMH to its patient base. The resulting loss in revenue negatively impacted the performance of the SHD Division in the first quarter of 2015. The SHD Division has instituted a number of initiatives to recover the loss of revenue from the formulary changes initiated by the PBMs, which include expanded product offerings, increasing the portfolio of products offered to CMHs existing patient base, and increasing relationships with PBMs to gain access to more patients.
[12]
Results of Operations
The following table sets forth the unaudited consolidated results of operations of the Company for the three months ended March 31, 2015 and 2014:
Q1-2015 | Q1-2014 | |||||||
Revenue |
$ | 36,435 | $ | 16,810 | ||||
Cost of sales |
4,345 | 3,854 | ||||||
|
|
|
|
|||||
Gross profit |
32,090 | 12,956 | ||||||
|
|
|
|
|||||
Operating expenses |
||||||||
General and administrative |
6,317 | 4,691 | ||||||
Business acquisition related costs |
2,438 | 174 | ||||||
Selling and marketing |
3,105 | 944 | ||||||
Research and development |
3,088 | 1,418 | ||||||
Share based compensation |
897 | 756 | ||||||
Depreciation expense |
56 | 34 | ||||||
|
|
|
|
|||||
Total operating expenses |
15,901 | 8,017 | ||||||
|
|
|
|
|||||
|
|
|
|
|||||
Operating income |
16,189 | 4,939 | ||||||
|
|
|
|
|||||
Other income and expense |
||||||||
Interest expense |
8,641 | 4,705 | ||||||
Amortization of intangible assets |
5,205 | 580 | ||||||
Change in fair value of contingent consideration |
(1,282 | ) | 567 | |||||
Foreign exchange loss |
(409 | ) | 865 | |||||
Fair value gain on foreign exchange forward contract |
(2,549 | ) | | |||||
Other (income) expense |
416 | (5 | ) | |||||
|
|
|
|
|||||
Profit before tax |
6,167 | (1,773 | ) | |||||
|
|
|
|
|||||
Income taxes |
||||||||
Current |
535 | 185 | ||||||
Deferred |
(36 | ) | (122 | ) | ||||
|
|
|
|
|||||
Net income |
$ | 5,668 | $ | (1,836 | ) | |||
|
|
|
|
|||||
EBITDA (1) |
$ | 20,069 | $ | 3,546 | ||||
Adjusted EBITDA (1) |
$ | 19,580 | $ | 5,903 |
Notes:
(1) | Represents a non-IFRS measure. For the relevant definitions and reconciliation to reported results, see Non-IFRS Financial Measures. |
[13]
Revenue and Gross Profit
The following table sets forth unaudited revenue and gross profit by operating segment for the three months ended March 31, 2015 and 2014:
Legacy
Pharmaceuticals |
Orphan
Drugs |
Specialty
Healthcare Distribution |
Total | |||||||||||||
Three months ended March 31, 2015 |
||||||||||||||||
Revenue |
$ | 31,072 | $ | 3,080 | $ | 2,283 | $ | 36,435 | ||||||||
Cost of sales (including royalties) |
3,380 | 483 | 482 | 4,345 | ||||||||||||
|
|
|
|
|
|
|
|
|||||||||
Gross profit |
$ | 27,692 | $ | 2,597 | $ | 1,801 | $ | 32,090 | ||||||||
|
|
|
|
|
|
|
|
|||||||||
Three months ended March 31, 2014 |
||||||||||||||||
Revenue |
$ | 9,309 | $ | 3,570 | $ | 3,931 | $ | 16,810 | ||||||||
Cost of sales (including royalties) |
2,210 | 700 | 944 | 3,854 | ||||||||||||
|
|
|
|
|
|
|
|
|||||||||
Gross profit |
$ | 7,099 | 2,870 | $ | 2,987 | $ | 12,956 | |||||||||
|
|
|
|
|
|
|
|
Legacy Pharmaceuticals Division
Legacy Pharmaceuticals Division revenue for the three months ended March 31, 2015 was $31.1 million, compared to $9.3 million in the same quarter of the prior year. The additions of Donnatal ® and Zonegran ® in the second and third quarters of 2014, respectively, drove an increase in revenue of approximately $24.0 million, which was partially offset by a combined decline in revenue from Kapvay ® , Orapred ® and Ulesfia ® of approximately $2.2 million.
Gross profit for the Legacy Pharmaceuticals Division for the three months ended March 31, 2015 was $27.7 million compared to $7.1 million in the prior year. The increase of $20.6 million was primarily due to sales growth in the division, with the acquisition of Donnatal ® and Zonegran ® accounting for the majority of the increase.
Cost of sales for the three months ended March 31, 2015 and 2014 were $3.4 million and $2.2 million, respectively, and reflect the costs of active pharmaceutical ingredients, excipients, packaging, freight costs and royalties. Legacy Pharmaceuticals Division gross margin in the first quarter of 2015 was 89.1% compared with 76.3% in the same quarter of 2014. The increase in gross margin percentage is primarily driven by the inclusion of Donnatal ® .
Orphan Drugs Division
Net revenues for the Orphan Drugs Division were $3.1 million and $3.6 million for the three months ended March 31, 2015 and 2014, respectively. Revenue for the Orphan Drugs Division represents the sales of Photofrin ® , Ethyol ® , lasers and fibers. The decrease of $0.5 million in Orphan Drugs revenue was primarily driven by a slight decline in volume of sales of Photofrin ® in the United States as compared to the same quarter in the prior year.
Cost of sales for the three months ended March 31, 2015 was $0.5 million, compared to $0.7 million in the same period of the prior year.
Gross profits were $2.6 million and $2.9 million for the three months ended March 31, 2015 and 2014, respectively. Gross margin was 84.3% in the first quarter of 2015, compared to 80.4% in the same quarter of the prior year. The gross margin for Orphan Drugs in the first quarter of 2014 was negatively impacted by provisions taken for obsolete inventory, which were not repeated in the first quarter of 2015.
[14]
Specialty Healthcare Distribution Division
Net revenues for the SHD Division declined by $1.6 million from $3.9 million in the first quarter of 2014 to $2.3 million in the first quarter of 2015. The decline in SHD Division revenue and gross profit is primarily attributable to changes by two of the PBMs that CMH contracts with whereby the PBMs removed certain generic diabetic testing products from their formularies that had been supplied by CMH to its patient base. The resulting loss in revenue negatively impacted the performance of the SHD Division in the first quarter of 2015.
Costs of sales for the three months ended March 31, 2015 and 2014 were $0.5 million and $1.0 million, respectively, and related to the cost of products, warehousing and freight.
Gross profits were $1.8 million and $3.0 million for first quarter of 2015 and 2014, respectively. Gross margin improved from 76.0% in the first quarter of 2014 to 78.9% in the current quarter primarily due to product mix.
General and Administrative Expenses
General and administrative expenses reflect the costs related to salaries and benefits, professional and consulting fees, public company costs, transition services agreement expenses, travel, facility leases and other administrative expenditures.
General and administrative expenses increased from $4.7 million in the first quarter of 2014 to $6.3 million in the first quarter of 2015. The increase of $1.6 million was driven by increased spending in the Legacy Pharmaceuticals Division of $1.1 million and increased spending at corporate of $1.3 million, partially offset by a decline in spending in the SHD Division. The overall increase in general and administrative expenses was expected as the Company has grown significantly from the first quarter of 2014.
Selling and Marketing Expenses
Selling and marketing expenses reflect costs incurred by the Company for the marketing, promotion and selling of the Companys portfolio of products across the Legacy Pharmaceuticals, Specialty Healthcare Distribution and Orphan Drugs divisions.
Selling and marketing expenses increased from $1.0 million in the three months ended March 31, 2014 to $3.1 million during the same period in 2015. The increase of $2.1 million was primarily driven by the cost of the sales and marketing field force related to Donnatal ® .
Research and Development Expenses
Research and development expenses reflect costs for clinical trial activities, product development, professional and consulting fees and services associated with the activities of the medical, clinical and scientific affairs in addition to quality assurance costs and regulatory compliance and drug safety costs (Pharmacovigilence) of the Company.
Research and development expenses increased from $1.4 million in the three months ended March 31, 2014 to $3.1 million in the same period of 2015. The increase of $1.7 million was partially driven by costs related to the Phase 3 clinical trial to expand the indication of Photodynamic therapy with Photofrin ® for the treatment of cholangiocarcinoma. The increase is also partially attributable to the costs of research studies related to Kapvay ® incurred in the first quarter of 2015.
[15]
Share Based Compensation
The share based compensation expense for the three months ended March 31, 2015 was $0.9 million, which was consistent with the same period in the prior year. The share based compensation expense relates to the fair value of share based option awards to employees, management and directors of the Company.
The fair value is calculated using the Black-Scholes option-pricing model. Assumptions that affect the application of the fair value model include the determination of volatility of the Companys common shares, risk-free interest rate and the life of the options issued.
Business Acquisition Related Costs
Business acquisition related costs for the three months ended March 31, 2015 were $2.4 million compared to $0.2 million during the same period in the prior year. Business acquisition related costs include legal, accounting, advisory and professional fees directly incurred by the Company. In the current quarter, these costs were primarily driven by the costs related to the Covis acquisition.
Interest Expense
Interest expense for the three months ended March 31, 2015 and 2014 was $8.6 million and $4.7 million, respectively, and related primarily to interest of $2.5 million and accretion interest expense of $5.8 million incurred on the Companys Credit Facility with GE Capital Finance, Inc. In the first quarter of 2015 as part of the financing related to the Covis Acquisition the Company decided that it would retire the Credit Facility with GE Capital Finance, Inc. upon closing of the Notes and Bank Facilities. As a result of the early repayment of the Credit Facility the Company incurred $5.8 million in accretion expense in the first quarter of 2015.
In the first quarter of 2014, the Company incurred interest and accretion expense of $4.7 million, which included minimum interest payments related to the early retirement of the Companys Senior Loan Agreement and Subordinate Loan Agreement.
Change in Fair Value of Contingent Consideration
The change in the fair value of contingent consideration recorded during the three months ended March 31, 2015 was a gain of $1.3 million, which included $1.1 million in reduction of an earn-out payable and $0.8 million in reduction of a note payable to the former owner of Global, based on the most recent forecast of EBITDA for CMH. The remaining expense of $0.7 million is primarily driven by the change in the present value of contingent consideration due to the previous owners of Pinnacle for milestone and earn-out payments related to the clinical trial and worldwide sales of Photofrin ® .
Amortization of Intangible Assets
Amortization of intangible assets during the three months ended March 31, 2015 was $5.2 million and related to the amortization of acquired product rights, a customer list and intellectual property.
Amortization related to acquired product rights was $4.6 million for the three months ended March 31, 2015. The Company amortizes acquired product rights on a straight-line basis over their estimated useful lives.
Amortization related to the customer list acquired as part of the acquisition of CMH and related assets in October of 2013 was $0.2 million in first quarter of 2015. The customer list is amortized on a straight-line basis over an estimated useful life of 4 years and 5 months.
Amortization related to the intellectual property acquired as part of the acquisition of Pinnacle in December of 2013 was $0.4 million in first quarter of 2015. The intellectual property is amortized on a straight-line basis over an estimated useful life of 20 years.
[16]
Foreign Exchange (Gain) Loss
The foreign exchange gain for three months ended March 31, 2015 was $0.4 million, compared to a $0.9 million loss during the same period in the prior year. The loss of $0.9 million in the first quarter of 2014 was primarily due to a loss incurred on the translation of Canadian dollar proceeds from the equity offering completed on March 11, 2014.
Fair value gain on foreign exchange forward contract
Other income in the first quarter of 2015 was $2.5 million and was primarily driven by a mark to market gain on a foreign exchange forward contract. The Company entered into the contract during the quarter to hedge the Canadian dollar net proceeds from the 2015 Offering.
Financial Position
The following table presents a summary of Companys financial position as at March 31, 2015 and December 31, 2014:
As at | As at | Change | ||||||||||||||
March 31,
2015 |
December 31,
2014 |
$ | % | |||||||||||||
Working capital |
$ | 43,022 | $ | 49,090 | $ | (6,068 | ) | -12.4 | % | |||||||
Long-lived assets |
503,876 | 508,048 | (4,172 | ) | -0.8 | % | ||||||||||
Other current liabilities |
258,373 | 46,247 | 212,126 | 458.7 | % | |||||||||||
Long-term liabilities |
26,830 | 253,341 | (226,511 | ) | -89.4 | % | ||||||||||
Shareholders equity |
261,695 | 257,550 | 4,145 | 1.6 | % |
Working capital
Concordia defines working capital as current assets less accounts payable, accrued liabilities, provisions and royalties payable. The $6.1 million decrease in working capital from December 31, 2014 to March 31, 2015 is primarily due to the following:
| $9.3 million decrease in accounts receivable primarily driven by collections in the Legacy Pharmaceuticals Division and a sequential decline in revenue; |
| $7.4 million decrease in cash primarily driven by cash used in financing activities; and |
| $5.3 million increase in accounts payable and accrued liabilities due to timing of payments to vendors and service providers for the three months ended December 31, 2014. |
Offset by:
| $10.2 million increase in prepaid expenses and other current assets primarily driven by manufacturing deposits, deferred debt and equity issuance costs associated with Covis Acquisition and advanced funding of clinical trial costs; |
| $1.0 million increase in inventory; |
| $3.0 million decrease in provision due to payments made in 2015 that related to sales provisions recorded in 2014; and |
| $1.8 million decrease in royalty payable in the first of quarter of 2015, due to timing of payments to vendors for product sales. |
[17]
Long-lived assets
Long-lived assets consist of fixed assets, intangible assets, goodwill and deferred taxes.
Fixed assets consist of computers, leasehold improvements and equipment. The net book value of fixed assets increased from $0.8 million as at December 31, 2014 to $1.6 million as at March 31, 2015. The increase of $0.8 million was primarily driven by leasehold improvements.
Intangible assets consist of acquired product rights, customer lists, intellectual property and goodwill. Intangible assets decreased from $470.2 million as at December 31, 2014 to $465.0 million as at March 31, 2015. The decrease was driven by $5.2 million in amortization in the current quarter.
Goodwill remained unchanged at $36.3 million at March 31, 2015. The carrying value of goodwill is reviewed at year end to determine if any indications of impairment exist. As at March 31, 2015, there was no impairment loss recognized.
Other current liabilities
Other current liabilities consist of dividends payable, taxes payable and the current portions of notes payable, long-term debt and purchase consideration payable.
Taxes payable decreased from $13.3 million at December 31, 2014 to $0.05 million at March 31, 2015. The decrease of $13.3 million was primarily driven by the payment made in the current quarter for a tax liability of $13.5 million on the sale of certain intellectual property from Pinnacle to CLI.
Long-term obligations
Long-term obligations consist of long-term debt, notes payable and purchase consideration payable, other liabilities and deferred taxes.
On May 14, 2014, the Company entered into the May Credit Facility with GE Capital and a syndicate of lenders having a principal amount of up to US$195 million, consisting of a $170 million term loan and a $25 million revolving credit facility. On September 30, 2014, the Company amended and restated the May Credit Facility whereby incremental term loans of $95 million were added to the May Credit Facility. The Credit Facility bore a variable interest rate and was to mature on October 1, 2020 with fixed repayments required over the term to maturity, as well as mandatory repayments based on excess cash flow generated by the Company as defined in the Credit Facility, calculated annually. Interest rates were calculated at the U.S. Prime Rate or LIBOR plus applicable margins based on a leverage table. The obligations of the Company under the Credit Facility were secured by the assets of the Company and the assets of the Companys material subsidiaries. The carrying value of the Credit Facility as at March 31, 2015 was $255.3 million. On April 21, 2015 the Company repaid the Credit Facility in full. For additional information regarding the repayment please see Recent Events. Given the early retirement of the Credit Facility the entire carrying value of $255.3 million has been included in current liabilities as at March 31, 2015.
The change in fair value of contingent consideration recorded during the three months ended March 31, 2015 was an overall gain of $1.3 million. The gain is attributable to:
| a $1.3 million reduction in contingent consideration related to an earn-out payable to a former owner of Global. The earn-out is based on the achievement of certain EBITDA thresholds for CMH. Based on the most recent forecast of EBITDA for CMH the earn out liability was reduced in the first quarter of 2015; and |
|
a $0.8 million reduction in the principal balance of notes payable. The notes payable form part of the consideration for the acquisition of CMH from Global and repayment is based on the |
[18]
achievement of certain EBITDA thresholds for CMH. Based on the most recent forecast of CMH the principal balance was reduced in the first quarter of 2015. |
The gains described above were partially offset by an expense of $0.7 million driven by the change in the present value of contingent consideration due to the previous owners of Pinnacle for milestone and earn-out payments related to the clinical trial and worldwide sales of Photofrin ® .
Shareholders equity
Shareholders equity increased from $257.5 million as at December 31, 2014 to $261.7 million as at March 31, 2015. The increase of $4.2 million primarily relates to:
| $5.7 million in net income for the three months ended March 31, 2015. |
| Share based compensation of $0.9 million. |
Offset by:
| $2.2 million in dividends. |
| Exchange differences on translation of foreign operations of $0.3 million. |
Liquidity and Capital Resources
Cash Flows
Management believes that ongoing operations and associated cash flow provide sufficient liquidity to support Concordias business operations for at least the next 12 months.
As at March 31, 2015, the Company held cash and cash equivalents of $35.4 million and had an additional $25.0 million available from the Credit Facility, which provides further flexibility to meet any unanticipated cash requirements.
Liquidity risk is the risk that the Company will encounter difficulty in meeting obligations associated with financial liabilities. The Company manages liquidity risk through the management of its capital structure. Accounts payable are all due within the current operating period.
In managing the Companys capital, Management estimates future cash requirements by preparing a budget and a multi-year plan for review and approval by the Companys board of directors (the Board of Directors ). The budget establishes the approved activities for the upcoming year and estimates the costs associated with those activities. The multi-year plan estimates future activity along with the potential cash requirements and is based upon Managements assessment of current progress along with the expected results from the coming years activity. Budget to actual variances are prepared and reviewed by Management and are presented quarterly to the Board of Directors.
The purpose of liquidity management is to ensure that there is sufficient cash to meet all the financial commitments and obligations of Concordia as they come due. Since inception Concordia has financed its cash requirements primarily through the issuances of securities, short-term borrowings, long-term debt as well as income from operations.
The below table sets forth the Companys net cash flows provided by and used in operating, investing and financing activities:
[19]
For the three months
ended March 31, |
||||||||
2015 | 2014 | |||||||
Net cash provided by (used in) operating activities |
4,146 | (3,042 | ) | |||||
Net cash used in investing activities |
(904 | ) | (280 | ) | ||||
Net cash provided by (used in) financing activities |
(10,219 | ) | 38,396 | |||||
|
|
|
|
|||||
Increase (decrease) in Cash |
(6,977 | ) | 35,074 | |||||
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Unrealised foreign exchange gain in cash and cash equivalents |
(430 | ) | | |||||
Beginning Cash |
42,770 | 42,899 | ||||||
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Ending Cash |
35,363 | 77,973 | ||||||
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Net Cash Provided by Operating Activities
Net cash provided by operating activities was $4.1 million for the three months ended March 31, 2015. Adjustments to reconcile net income of $5.7 million to net cash flow from operating activities include:
| $5.3 million in depreciation and amortization expense; |
| $0.9 million in share based compensation expense; |
| $1.3 million of gain on change in fair value of contingent consideration; |
| $14.2 million related to income taxes paid in cash during the year; |
| $0.5 million in income tax provision; |
| $0.4 million in other (income) expense; |
| $2.5 million in fair value gain on foreign exchange forward contract; and |
| $8.6 million related to interest and accretion expense. |
The above adjustments are offset by increases in operating assets of $0.8 million.
Net cash used in operating activities was $3.0 million for the three months ended March 31, 2014 and was driven by the operations of the Legacy Pharmaceuticals Division.
Net Cash Used in Investing Activities
Net cash used in investing activities was $0.9 million for the three months ended March 31, 2015, and was primarily due to additions in fixed assets.
Net cash used in investing activities was $0.3 million for the three months ended March 31, 2014 and was primarily due to cash payments for fixed assets of $0.2 million and contingent consideration of $0.1 million.
Net Cash Used In / Provided by Financing Activities
Net cash used in financing activities was $10.2 million for the three months ended March 31, 2015 and was primarily used for:
| $5.95 million in principal repayments related to the Credit Facility; |
| $2.1 million in cash interest paid; and |
| $2.2 million in dividends paid. |
Net cash provided by financing activities was $38.4 million for the three months ended March 31, 2014 and was primarily driven by net proceeds from issuance of common stock of $57.0 million and $0.7 million in proceeds from the exercise of options. Proceeds from the equity issuance were used to repay the amounts owing under the Senior Loan Agreement and the Subordinate Loan Agreement plus accrued interest amounting to a combined $19.3 million.
[20]
Indebtedness
Term and Credit Facilities
On May 14, 2014, the Company entered the May Credit Facility with GE Capital and a syndicate of lenders having a principal amount of up to $195 million, consisting of a $170 million term loan and a $25 million revolving credit facility. On September 30, 2014, the Company amended and restated the May Credit Facility whereby incremental term loans of $95 million were added to the May Credit Facility. The Credit Facility bore a variable interest rate and was to mature on October 1, 2020 with fixed repayments required over the term to maturity, as well as mandatory repayments based on excess cash flow generated by the Company as defined in the Credit Facility, calculated annually. Interest rates were calculated at the U.S. Prime Rate or LIBOR plus applicable margins based on a leverage table. The Credit Facility was secured by the assets of the Company and the assets of the Companys material subsidiaries. The carrying value of the Credit Facility as at March 31, 2015 was $253.3 million. On April 21, 2015 the Company repaid the Credit Facility in full. For additional information regarding the repayment please see Recent Events. Given the early retirement of the Credit Facility the entire carrying value of $253.3 million has been included in current liabilities as at March 31, 2015.
Notes Payable
As part of the consideration for the acquisition of the Global assets on October 25, 2013, the Company issued notes payable that have a fair value of $4.6 million as at March 31, 2015. The notes are unsecured, have a total face value of $7,000 and a coupon interest rate of 6%. The notes have been recorded at the present value of expected payments using a market representative interest rate at the time of issuance of 12% per annum. Principal repayments are due subject to the achievement of certain EBITDA thresholds by CMH, a subsidiary of the Company. Based on most recent forecast of EBITDA for CMH, the Company reduced the note payable liability by $0.8 million in the first quarter of 2015 and recorded an associated gain in the fair value of contingent consideration in the statement of income and comprehensive income.
Non-Contingent Purchase Consideration
As part of the consideration for the acquisition of Pinnacle the Company is obligated to make 10 annual payments of $1 million, with the first payment due and paid on December 31, 2014. The obligation is subordinated and is not subject to interest. The Company has recorded an obligation of $4.8 million as at March 31, 2015, which represents the present value of required payments using a market representative interest rate of 15% at the time of the Pinnacle Transaction. Upon the acquisition of Pinnacle the Company also assumed a liability related to purchase consideration, which had a value of $0.4 million as at March 31, 2015.
Contractual Obligations
The following table summarizes Concordias material contractual obligations as at March 31, 2015:
As at March 31, 2015 |
Total | 2015 | 2016 | 2017 | 2018 | 2019 | Thereafter | |||||||||||||||||||||
Finance lease obligation |
71 | 33 | 31 | 7 | | | | |||||||||||||||||||||
Operating leases |
9,041 | 1,939 | 1,731 | 1,658 | 1,528 | 1,405 | 780 | |||||||||||||||||||||
Notes payable |
5,400 | 200 | 800 | 1,000 | 1,000 | 1,200 | 1,200 | |||||||||||||||||||||
Non-contingent purchase consideration |
9,000 | 1,000 | 1,000 | 1,000 | 1,000 | 1,000 | 4,000 | |||||||||||||||||||||
Long-term debt (a) |
254,800 | 254,800 | | | | | | |||||||||||||||||||||
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Total contractual obligations |
$ | 278,312 | $ | 257,972 | $ | 3,562 | $ | 3,665 | $ | 3,528 | $ | 3,605 | $ | 5,980 | ||||||||||||||
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Notes:
(a) | On April 21, 2015, the Company retired the Credit Facility and paid the remaining balances in full. |
[21]
Related Party Transactions
The Company paid legal fees, including professional services for advice relating to intellectual property matters, to a firm affiliated with a director of the Company was in the amount of $0.004 for the three months ended March 31, 2015 and $0.042 for the three months ended March 31, 2014.
Contingencies
Following the closing of the Shionogi Transaction as additional consideration for the sale, transfer, conveyance and assignment of the assets and the grant of the Ulesfia ® license, the Company is required to pay Shionogi thirty percent (30%) of worldwide net sales of Kapvay ® that exceeds $1.5 million (in the aggregate) during each calendar quarter commencing with the calendar quarter beginning October 1, 2013 until such payments equal $6.0 million in the aggregate.
As part of the consideration for the Global Transaction, the Company is obligated to pay an additional earn-out payment of up to $4.0 million payable in common shares of the Company subject to meeting certain performance metrics. The earn-out payment provisions provide that on each earn-out calculation date, if the aggregate adjusted EBITDA of CMH, exceeds $7.0 million for the preceding year then an earn-out payment of common shares will be made which is equal in value to the aggregate adjusted EBITDA of CMH for the preceding year multiplied by 14.285714%. The number of common shares to be paid is calculated by dividing the dollar value of the earn-out payment by the dollar volume weighted average trading price of the Companys common shares on the TSX. The aggregate earn-out payments are subject to a $4.0 million cap.
As part of the consideration for the Pinnacle Transaction, the Company is obligated to pay additional payments of up to $5.0 million based on the achievement of certain milestones related to clinical trials. The Company made a payment in the fourth quarter of 2014 of $0.5 million related to this contingent obligation. The Company is also obligated to pay additional earn-out payments equal to 15% of worldwide sales of Photofrin ® in excess of $25.0 million over the 10 calendar years following the Companys acquisition of Pinnacle.
Royalties
The Company has a commitment to pay royalties on sales of each of the drugs acquired as part of the Shionogi Transaction at certain prescribed rates. These royalties are payable on a quarterly basis.
Guarantees
All directors and officers of the Company, and each of the Companys various subsidiaries, are indemnified by the Company for various items including, but not limited to, all costs to settle lawsuits or actions due to their association with the Company, subject to certain restrictions. The Company has purchased directors and officers liability insurance to mitigate the cost of any potential future lawsuits or actions.
In the normal course of business, the Company has entered into agreements that include indemnities in favor of third parties, such as purchase and sale agreements, confidentiality agreements, engagement letters with advisors and consultants, leasing contracts, license agreements, information technology agreements and various product, service, data hosting and network access agreements. These indemnification arrangements may require the applicable Concordia entity to compensate counterparties for losses incurred by the counterparties as a result of breaches in representations, covenants and warranties provided by the particular Concordia entity or as a result of litigation or other third party claims or statutory sanctions that may be suffered by the counterparties as a consequence of the relevant transaction.
In connection with the acquisition of Zonegran ® , the Company guaranteed the payment, performance and discharge of CPIs payment and indemnification obligations under the asset purchase agreement and each ancillary agreement entered into by CPI in connection therewith that contained payment or indemnification
[22]
obligations. Pursuant to the asset purchase agreement between CPI, Concordia, Covis and Covis Pharma Holdings S.à.r.l dated March 9, 2015 (the Covis Purchase Agreement ), Concordia guaranteed the due and punctual payment by CPI of CPIs obligations under the Covis Purchase Agreement.
Litigation and Arbitration
In the normal course of business the Company may be the subject of litigation claims. As at March 31, 2015, there are no material claims against the Company. On February 12, 2015, Concordia announced that it received a civil investigative demand from the United States Federal Trade Commission regarding its attention deficit hyperactivity disorder product Kapvay ® . See the disclosure under the heading Legacy Pharmaceuticals Division Legacy Products Kapvay ® - Genericization of Kapvay ® and Legal Proceedings, and Regulatory Matters in the Companys Annual Information Form.
Off Balance Sheet Arrangements
The Company leases facilities under operating leases in Canada, Barbados and the United States. The leases typically run for a period of months up to five years. The Company also has operating leases for office equipment. On February 19, 2015, the Company entered into an aircraft lease agreement to use and operate an aircraft for business travel purposes. The term of the lease is 5 years and the annual lease payment is $1.02 million. In addition, on the same day, the Company entered into an aircraft management and operating agreement for a term of one year (with the term being extended automatically for additional one-year periods in the event neither party gives the other party notice of termination at any point 60 days prior to the expiry of the current term), which includes fixed and variable payments. The fixed portion of the aircraft management and operating agreement is $0.62 million per annum. There are no other off balance sheet arrangements as at March 31, 2015.
Non IFRS Financial Measures
This MD&A makes reference to certain non-IFRS measures. These non-IFRS measures are not recognized measures under IFRS and do not have a standardized meaning prescribed by IFRS, and are therefore unlikely to be comparable to similar measures presented by other companies. When used, these measures are defined in such terms as to allow the reconciliation to the closest IFRS measure. These measures are provided as additional information to complement those IFRS measures by providing further understanding of the Companys results of operations from Managements perspective. Accordingly, they should not be considered in isolation nor as a substitute for analyses of the Companys financial information reported under IFRS. Management uses non-IFRS measures such as EBITDA, Adjusted EBITDA and Adjusted EPS to provide investors with a supplemental measure of the Companys operating performance and thus highlight trends in the Companys core business that may not otherwise be apparent when relying solely on IFRS financial measures. Management also believes that securities analysts, investors and other interested parties frequently use non-IFRS measures in the evaluation of issuers. Management also uses non-IFRS measures in order to facilitate operating performance comparisons from period to period, prepare annual operating budgets, and to assess its ability to meet future debt service, capital expenditure, and working capital requirements.
The definition and reconciliation of EBITDA, Adjusted EBITDA and Adjusted EPS used and presented by the Company to the most directly comparable IFRS measures follows below.
EBITDA
EBITDA is defined as net income adjusted for net interest expense, income tax expense, depreciation and amortization. Management uses EBITDA to assess the Companys operating performance. A reconciliation of net income to EBITDA is provided below.
[23]
Adjusted EBITDA
Adjusted EBITDA is defined as EBITDA adjusted for one-time charges including costs associated with acquisitions, and the Companys listing on the TSX, non-recurring gains, non-cash items such as unrealized gains / losses on derivative instruments, share based compensation, change in fair value of contingent consideration, and realized / unrealized gains / losses related to foreign exchange revaluation. Management uses Adjusted EBITDA as the key metric in assessing business performance when comparing actual results to budgets and forecasts. Management believes adjusted EBITDA is an important measure of operating performance and cash flow, and provides useful information to investors because it highlights trends in the underlying business that may not otherwise be apparent when relying solely on IFRS measures.
The table below sets forth the reconciliation of net income to EBITDA and to Adjusted EBITDA for the three months ended March 31, 2015 and 2014:
Q1-2015 | Q1-2014 | |||||||
Net Income |
$ | 5,668 | $ | (1,836 | ) | |||
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Interest and accretion expense |
8,641 | 4,705 | ||||||
Income Taxes |
499 | 63 | ||||||
Depreciation expense |
56 | 34 | ||||||
Amortization of intangible assets |
5,205 | 580 | ||||||
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EBITDA |
$ | 20,069 | $ | 3,546 | ||||
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Business acquisition related costs |
2,438 | 174 | ||||||
Share based compensation |
897 | 756 | ||||||
Change in fair value of contingent consideration |
(1,282 | ) | 567 | |||||
Foreign exchange loss |
(409 | ) | 865 | |||||
Fair value gain on foreign exchange forward contract |
(2,549 | ) | | |||||
Other (income) expense |
416 | (5 | ) | |||||
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Adjusted EBITDA |
$ | 19,580 | $ | 5,903 | ||||
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Adjusted EPS
Adjusted EPS is defined as adjusted net income divided by the weighted average number of fully diluted shares outstanding. Adjusted net income is defined as net income (loss) adjusted for one-time charges including costs associated with acquisitions, the Companys listing on the TSX, non-recurring gains, non-cash items such as unrealized gains / losses on derivative instruments, share based compensation, change in fair value of contingent consideration, realized / unrealized gains / losses related to foreign exchange revaluation, accelerated accretion interest expense, the tax impact of the above items and one-time tax expenses associated with one-time gains. Management believes Adjusted EPS is an important measure of operating performance and cash flow, and provides useful information to investors.
[24]
Q1-2015 | Q4-2014 | Q3-2014 | Q2-2014 | Q1-2014 | Q4-2013 | Q3-2013 | Q2-2013 | |||||||||||||||||||||||||
Weighted average number of fully diluted shares |
30,584,951 | 30,439,316 | 30,127,443 | 27,826,313 | 21,588,635 | 10,389,617 | 8,792,924 | 3,522,945 | ||||||||||||||||||||||||
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Net income (loss) |
5,668 | 3,718 | 10,535 | (827 | ) | (1,836 | ) | (7,083 | ) | 5,364 | 4,150 | |||||||||||||||||||||
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Adjustments: |
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Share-based compensation |
897 | 1,090 | 1,258 | 1,380 | 756 | 426 | 644 | | ||||||||||||||||||||||||
Exchange listing expenses |
| | | | | 2,404 | | | ||||||||||||||||||||||||
Business acquisition related costs |
2,438 | 940 | 4,093 | 8,314 | 174 | 3,692 | | | ||||||||||||||||||||||||
Depreciation |
56 | 41 | 40 | 16 | 34 | 4 | 14 | | ||||||||||||||||||||||||
Amortization |
5,205 | 9,299 | 580 | 580 | 580 | 120 | | | ||||||||||||||||||||||||
Change in fair value of contingent consideration |
(1,282 | ) | 500 | 579 | 983 | 567 | | | | |||||||||||||||||||||||
Change in fair value of derivative warrants |
| | | | | 4,648 | | | ||||||||||||||||||||||||
Foreign exchange loss (gain) |
(409 | ) | (242 | ) | 73 | | 865 | 116 | 5 | 8 | ||||||||||||||||||||||
Fair value gain on foreign exchange forward contract |
(2,549 | ) | 111 | (16 | ) | 113 | (5 | ) | (148 | ) | (2 | ) | | |||||||||||||||||||
Interest accretion expense |
5,815 | | | | | | | | ||||||||||||||||||||||||
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Tax adjustments |
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Tax effect |
(17 | ) | (14 | ) | (48 | ) | (66 | ) | (8 | ) | | | | |||||||||||||||||||
Transfer of IP |
477 | 7,012 | | | | | | | ||||||||||||||||||||||||
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Adjusted net income |
16,299 | 22,455 | 17,094 | 10,493 | 1,127 | 4,179 | 6,025 | 4,158 | ||||||||||||||||||||||||
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Adjusted EPS - diluted |
$ | 0.53 | $ | 0.74 | $ | 0.57 | $ | 0.38 | $ | 0.05 | $ | 0.40 | $ | 0.69 | $ | 1.18 | ||||||||||||||||
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Outstanding Share Data
The authorized capital of the Company consists of an unlimited number of common shares. As at March 31, 2015 and May 14, 2015, the Company had, respectively, 28,873,739 and 33,304,040 common shares issued and outstanding. As at March 31, 2015 and May 14, 2015, there were, respectively, 2,032,280 and 1,931,500 options outstanding that entitle the holders thereof to purchase one common share per option of the Company.
As at March 31, 2015 and May 14, 2015, the Company had, respectively, nil and 916 unvested restricted stock units ( RSU s) outstanding. Each RSU can be settled either in cash or shares issued from treasury or a combination of cash and shares issued from treasury at the sole discretion of the Company.
Disclosure Controls and Procedures and Internal Control over Financial Reporting
Disclosure Controls and Procedures
The Company is required to review and report on the effectiveness of its disclosure controls and procedures ( DC&P ) in accordance with National Instrument 52-109, Certification of Disclosure in Issuers Annual and Interim Filings ( NI 52-109 ), issued by the Canadian Securities Administrators. NI 52-109 requires a Chief Executive Officer ( CEO ) and Chief Financial Officer ( CFO ) to certify that they are responsible for establishing and maintaining DC&P for the Company, that DC&P have been designed and are effective in providing reasonable assurance that material information relating to the Company is made known to them, that they have evaluated the effectiveness of the Companys DC&P and that their conclusions about the effectiveness of those DC&P at the end of the period covered by the relevant annual filings have been disclosed by the Company.
A control system, no matter how well conceived and operated, can provide only reasonable, not absolute, assurance that its objectives are met. Due to inherent limitations in all such systems, no evaluations of controls can provide absolute assurance that all control issues within a company have been detected. In addition, the design of any system of control is based upon certain assumptions about the likelihood of future events and there can be no assurance that any design will succeed in achieving its stated goals under
[25]
all future events, no matter how remote, or that the degree of compliance with the policies or procedures may not deteriorate. Accordingly, the Companys DC&P are effective in providing reasonable, not absolute, assurance that the objectives of its disclosure control system have been met.
Internal Controls over Financial Reporting
NI 52-109 also requires CEOs and CFOs to certify that they are responsible for establishing and maintaining internal controls over financial reporting ( ICFR ) for the Company, that the ICFR have been designed and are effective in providing reasonable assurance regarding the reliability of financial reporting and the preparation of financial statements in accordance with IFRS, and that the Company has disclosed any change in its internal controls during its most recent interim period that has materially affected, or is reasonably likely to materially affect, its ICFR.
The design and operating effectiveness of the Companys ICFR were evaluated by Management in accordance with Internal Controls over Financial Reporting Guidance for Smaller Public Companies, as published by the Committee of Sponsoring Organizations of the Treadway Commission ( COSO ), and NI 52-109, as at March 31, 2015.
Assessment of DC&P and ICFR
Based on the evaluation of the Companys DC&P and ICFR as at March 31, 2015, the CEO and CFO concluded that the Companys DC&P and ICFR were effective.
[26]
Exhibit 99.3
ANNUAL INFORMATION FORM
CONCORDIA HEALTHCARE CORP.
For the year ended December 31, 2014
March 19, 2015
TABLE OF CONTENTS
GLOSSARY OF TERMS |
1 | |||
EXPLANATORY NOTES |
9 | |||
Trademarks |
9 | |||
Currency |
9 | |||
Market Data |
9 | |||
CAUTIONARY NOTE REGARDING FORWARD-LOOKING INFORMATION |
10 | |||
BACKGROUND AND CORPORATE STRUCTURE |
12 | |||
Name, Address and Incorporation |
12 | |||
Intercorporate Relationships |
13 | |||
GENERAL DEVELOPMENT AND DESCRIPTION OF THE BUSINESS |
13 | |||
Development of the Business |
13 | |||
Growth Strategy |
18 | |||
Competitive Strengths |
20 | |||
Corporate Operations |
21 | |||
Employees |
22 | |||
The Pharmaceutical Market |
22 | |||
Customers |
25 | |||
Distribution Outsourcing |
25 | |||
Competitive Conditions |
25 | |||
Government Regulation |
26 | |||
Proprietary Protection |
26 | |||
Revenue By Division |
26 | |||
LEGACY PHARMACEUTICALS DIVISION |
27 | |||
Industry Overview |
27 | |||
Legacy Pharmaceuticals Division Overview |
30 | |||
Legacy Products - Kapvay ® |
30 | |||
Legacy Products - Orapred ODT ® |
32 | |||
Legacy Products - Ulesfia ® |
33 | |||
Legacy Products - Donnatal ® |
35 | |||
Legacy Products - Zonegran ® |
36 | |||
SPECIALTY HEALTHCARE DISTRIBUTION DIVISION |
38 | |||
Specialty Healthcare Distribution Division Overview |
38 | |||
Industry Overview |
38 | |||
SHD Division Operations |
39 | |||
SHD Division Products |
40 | |||
SHD Division Marketing |
40 | |||
SHD Division Suppliers |
41 | |||
SHD Division Competition |
41 | |||
Corporate Compliance |
41 | |||
Medicare Competitive Bidding |
42 | |||
ORPHAN DRUGS DIVISION |
42 | |||
Orphan Drugs Division Overview |
42 | |||
Industry Overview |
42 |
PDT with Photofrin ® |
43 | |||
Existing Indications |
44 | |||
New Indications |
45 | |||
Special Protocol Assessment |
45 | |||
Other Developments |
45 | |||
RISK FACTORS |
46 | |||
Risk Factors Related to the Business |
46 | |||
Risk Factors Related to the Common Shares |
64 | |||
DIVIDEND POLICY |
68 | |||
DESCRIPTION OF CAPITAL STRUCTURE |
68 | |||
Common Shares |
68 | |||
Stock Option Plan |
68 | |||
Long Term Incentive Plan |
70 | |||
DEBT FINANCING |
73 | |||
GE Amended Credit Agreement |
73 | |||
MARKET FOR SECURITIES |
74 | |||
Trading Price and Volume |
74 | |||
Prior Sales |
74 | |||
DIRECTORS AND EXECUTIVE OFFICERS OF THE CORPORATION |
76 | |||
Directors and Executive Officers, Positions and Security Holdings |
76 | |||
Biographies |
77 | |||
Corporate Cease Trade Orders or Bankruptcies |
80 | |||
Penalties or Sanctions |
80 | |||
Individual Bankruptcies |
80 | |||
Conflicts of Interest |
81 | |||
PROMOTER |
81 | |||
LEGAL PROCEEDINGS AND REGULATORY MATTERS |
81 | |||
INTEREST OF MANAGEMENT AND OTHERS IN MATERIAL TRANSACTIONS |
81 | |||
AUDIT COMMITTEE |
81 | |||
Reliance on Certain Exemptions |
82 | |||
Audit Committee Oversight |
82 | |||
Pre-Approval Policies and Procedures |
82 | |||
External Auditor Service Fees |
82 | |||
TRANSFER AGENT AND REGISTRAR |
83 | |||
MATERIAL CONTRACTS |
83 | |||
INTEREST OF EXPERTS |
83 | |||
ADDITIONAL INFORMATION |
84 | |||
SCHEDULE A CHARTER OF THE AUDIT COMMITTEE |
GLOSSARY OF TERMS
In addition to terms defined elsewhere, the following are defined terms used in this Annual Information Form:
2013 Subscription Receipts | has the meaning ascribed to that term under the heading General Development and Description of the Business - Development of the Business - 2013 Private Placement in this Annual Information Form. | |
2014 Offering | has the meaning ascribed to that term under the heading General Development and Description of the Business - Development of the Business - 2014 Public Offering in this Annual Information Form. | |
2015 Offering | has the meaning ascribed to that term under the heading General Development and Description of the Business - Development of the Business - Proposed 2015 Public Offering in this Annual Information Form. | |
2014 Underwriters | has the meaning ascribed to that term under the heading General Development and Description of the Business - Development of the Business - 2014 Public Offering in this Annual Information Form. | |
2015 Subscription Receipts | has the meaning ascribed to that term under the heading General Development and Description of the Business - Development of the Business - Proposed 2015 Public Offering in this Annual Information Form. | |
2015 Underwriters | has the meaning ascribed to that term under the heading General Development and Description of the Business - Development of the Business - Proposed 2015 Public Offering in this Annual Information Form. | |
Acquisition Closing Date | has the meaning ascribed to that term under the heading General Development and Description of the Business - Development of the Business - Covis Portfolio Acquisition in this Annual Information Form. | |
ADHD | means Attention Deficit Hyperactivity Disorder. | |
AED | means antiepileptic drug. | |
AG | means an authorized generic. | |
Agency Agreement | has the meaning ascribed to that term under the heading General Development and Description of the Business - Development of the Business - 2013 Private Placement in this Annual Information Form. | |
Agents | has the meaning ascribed to that term under the heading General Development and Description of the Business - Development of the Business - 2013 Private Placement in this Annual Information Form. | |
Agents Options | has the meaning ascribed to that term under the heading General Development and Description of the Business - Development of the Business - 2013 Private Placement in this Annual Information Form. |
ANDA | means the Abbreviated New Drug Application. | |
Annual Information Form | means this annual information form. | |
Anti-Kickback Statutes | means the United States federal Foreign Corrupt Practices Act and the United States federal Anti-Kickback Statute. | |
Audit Committee | has the meaning ascribed to that term under the heading Audit Committee in this Annual Information Form. | |
Big Pharma | means large branded pharmaceutical companies. | |
Board | means the board of directors of the Corporation. | |
Bond Bridge Facility | has the meaning ascribed to that term under the heading General Development and Description of the Business - Development of the Business - Covis Portfolio Acquisition in this Annual Information Form. | |
CAGR | means compound annual growth rate. | |
CDC | means the Centers for Disease Control and Prevention. | |
cGMP | has the meaning ascribed to that term under the heading Risk Factors - Risk Factors Related to the Business in this Annual Information Form. | |
CHIP | means the Childrens Health Insurance Program which provides free or low-cost health coverage for children up to age 19. CHIP covers United States citizens and eligible immigrants. | |
CHUSA | means Concordia Healthcare (USA) Inc., a Delaware corporation, incorporated on April 16, 2013 and a subsidiary of the Corporation. | |
CID | means an FTC civil investigative demand. | |
CLI | means Concordia Laboratories Inc., a Barbados corporation, incorporated on October 29, 2013 and a subsidiary of the Corporation. | |
CMS | means the Centers for Medicare and Medicaid Services. | |
CNS | means central nervous system. | |
Commitment Letter | has the meaning ascribed to that term under the heading General Development and Description of the Business - Development of the Business - Covis Portfolio Acquisition in this Annual Information Form. | |
Common Shares | means the common shares in the capital of the Corporation. | |
Competitive Supply Agreement | has the meaning ascribed to that term under the heading Legacy Pharmaceuticals Division - Legacy Products - Kapvay ® - Genericization of Kapvay ® in this Annual Information Form. |
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Complete Medical Homecare Share Purchase Agreement | means the Share Purchase Agreement dated August 30, 2013 among CHUSA, and Complete Medical Homecare, Inc., Robert Shea, Joseph Corso and Mark Franz for the purchase by CHUSA of the issued and outstanding shares of Complete Medical Homecare Inc. | |
Concordia Private Co. | has the meaning ascribed to that term under the heading General Development and Description of the Business - Development of the Business - 2013 Debt Financings in this Annual Information Form. | |
Consolidation | has the meaning ascribed to that term under the heading Background and Corporate Structure - Name, Address and Incorporation in this Annual Information Form. | |
Corporation or Concordia | means Concordia Healthcare Corp., a corporation incorporated pursuant to the OBCA on January 20, 2010, and unless the context otherwise requires, includes each of the subsidiaries of Concordia Healthcare Corp. | |
Covis Injectables | means Covis Injectables S.à.r.l., Zug Branch. | |
Covis Pharma | means Covis Pharma S.à.r.l., Zug Branch. | |
Covis Portfolio | has the meaning ascribed to that term under the heading General Development and Description of the Business - Development of the Business - Covis Portfolio Acquisition in this Annual Information Form. | |
Covis Purchase Agreement | has the meaning ascribed to that term under the heading General Development and Description of the Business - Development of the Business - Covis Portfolio Acquisition in this Annual Information Form. | |
CPAP | means continuous positive airway pressure. | |
CPI | means Concordia Pharmaceuticals, Inc., a Barbados corporation, incorporated on December 19, 2012 and a subsidiary of the Corporation. | |
DESI | means Drug Efficacy Study Implementation. | |
DSUs or Deferred Share Units | has the meaning ascribed to that term under the heading Description of Capital Structure - Long Term Incentive Plan in this Annual Information Form. | |
DSU Participant | has the meaning ascribed to that term under the heading Description of Capital Structure - Long Term Incentive Plan in this Annual Information Form. | |
DSU Termination Date | has the meaning ascribed to that term under the heading Description of Capital Structure - Long Term Incentive Plan in this Annual Information Form. | |
DME | means durable medical equipment. |
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Donnatal Purchase Agreement | has the meaning ascribed to that term under the heading General Development and Description of the Business - Development of the Business - Donnatal ® Acquisition in this Annual Information Form. | |
Earnout Calculation Date | means the date which is the anniversary date of the closing of the purchase of assets from Global for each of the five years following the date of the closing of the Global asset purchase. | |
Earnout Payment | means the payment which is equal in value to the aggregate adjusted EBITDA of Global for the preceding year multiplied by 14.285714%. | |
EBITDA | means earnings before interest, taxes, depreciation and amortization. | |
Eisai | means Eisai, Inc. | |
Equity Bridge Facility | has the meaning ascribed to that term under the heading General Development and Description of the Business - Development of the Business - Covis Portfolio Acquisition in this Annual Information Form. | |
EU | means the European Union. | |
Extension Period | has the meaning ascribed to that term under the heading Description of Capital Structure - Long Term Incentive Plan in this Annual Information Form. | |
FDA | means the United States Food and Drug Administration. | |
Final Vesting Date | has the meaning ascribed to that term under the heading Description of Capital Structure - Long Term Incentive Plan in this Annual Information Form. | |
forward-looking statements | has the meaning ascribed to that term under the heading Forward- Looking Information in this Annual Information Form. | |
FTC | means the United States Federal Trade Commission. | |
GE Amended Credit Agreement | has the meaning ascribed to that term under the heading General Development and Description of the Business - Development of the Business - Zonegran ® Acquisition in this Annual Information Form. | |
GE Capital | means General Electric Capital Corporation. | |
Global | means Global Medical Direct, LLC and its affiliated entities. | |
Global Medical Direct Asset Purchase Agreement | means the Asset Purchase Agreement dated August 30, 2013 among CHUSA and Global Medical, Inc., Global, Joseph Corso, Mark Franz and Robert Shea for the purchase of assets relating to the development, manufacturing, marketing, claims processing, distribution and selling of durable medical equipment products of Global Medical, Inc. and Global. | |
Global Purchase Agreement | means, collectively, the Midwest Asset Purchase Agreement, the Global Medical Direct Asset Purchase Agreement and the Complete Medical Homecare Share Purchase Agreement. |
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Health Care Reform Act | has the meaning ascribed to that term under the heading Legacy Pharmaceuticals Division - Industry Overview - Healthcare Reform - The Patient Protection and Affordable Care Act . | |
HIPAA | has the meaning ascribed to that term under the heading Specialty Healthcare Distribution Division - SHD Division Operations . | |
HME | means home medical equipment. | |
HMO | means health maintenance organizations. | |
IBS | means irritable bowel syndrome. | |
IFRS | means International Financial Reporting Standards. | |
IMS Health | means IMS Institute for Global Health Informatics. | |
ITA | means the Income Tax Act (Canada). | |
Knight | has the meaning ascribed to that term under the heading Orphan Drugs Division - Other Developments in this Annual Information Form. | |
Lachlan | has the meaning ascribed to that term under the heading Legacy Pharmaceuticals Division - Legacy Products - Ulesfia ® - Distribution Agreement with Lachlan Pharmaceuticals in this Annual Information Form. | |
Legacy Pharmaceuticals Division | means the Corporations healthcare business carried on by the Corporations subsidiary, CPI, which includes the acquisition and management of legacy pharmaceutical products. | |
Legacy Products | means all or any one of the Corporations following legacy pharmaceutical products, as the context may require: Kapvay ® (clonidine extended release tablets), Orapred ODT ® (prednisolone sodium phosphate orally disintegrating tablets), Ulesfia ® (benzyl alcohol) Lotion, Donnatal ® (belladonna alkaloids, phenobarbital) and Zonegran ® (zonisamide). | |
LIBOR | means the London Interbank Offered Rate. | |
LTIP or Long Term Incentive Plan | has the meaning ascribed to that term under the heading Description of Capital Structure - Long Term Incentive Plan in this Annual Information Form. | |
Mapi | has the meaning ascribed to that term under the heading General Development and Description of the Business - Competitive Strengths - Partnership with Leading Service Providers . | |
MCO | means managed care organization. | |
May 2014 Credit Facility | has the meaning ascribed to that term under the heading General Development and Description of the Business - Development of the Business - Donnatal ® Acquisition in this Annual Information Form. |
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Medicare Bidding Program | means the Centers for Medicare and Medicaid national mail-order competitive bidding program. | |
Midwest Asset Purchase Agreement | means the Asset Purchase Agreement dated August 30, 2013, among CHUSA and Midwest Medical Services, Joseph Corso, Mark Franz, and Robert Shea for the purchase of assets relating to the development, manufacturing, marketing, claims processing, distribution and selling of DME products of Midwest Medical Services. | |
Midwest Medical Services | means Midwest Medical Services, Inc. | |
Mylan | means Mylan Inc. | |
NASDAQ | means the NASDAQ Stock Market. | |
NEX | means the NEX board of the TSX-V. | |
NDA | means new drug application, being a formal proposal to the FDA to approve a new pharmaceutical for sale and marketing in the United States. | |
NOOH | means Notice of Opportunity Hearing. | |
NSCLC | means non-small cell lung cancer. | |
OBCA | means the Business Corporations Act (Ontario). | |
ODA | means the United States federal Orphan Drug Act of 1983. | |
ODT | means orally disintegrating tablet. | |
Offering Price | has the meaning ascribed to that term under the heading General Development and Description of the Business - Development of the Business - Proposed 2015 Public Offering in this Annual Information Form. | |
OOPD | means the FDA Office of Orphan Products Development. | |
Orphan Drugs Division | means the Corporations orphan drugs division. | |
OS | means oral suspension. | |
OTC | means over-the-counter. | |
OTCQX | means the International tier of the OTCQX over-the-counter market. | |
PDT | has the meaning ascribed to that term under the heading Orphan Drugs Division - PDT with Photofrin ® - Photodynamic Therapy with Photofrin ® in this Annual Information Form. | |
Pinnacle | means Pinnacle Biologics, Inc. and its affiliated entities, Pinnacle Oncology LLC, Pinnacle Biologics B.V. and Compagnie Biologiques Pinnacle, which were acquired by a subsidiary of Concordia Private Co. on December 20, 2013, and which are subsidiaries of the Corporation. |
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Pinnacle Purchase Agreement | means the Agreement and Plan of Merger of November 8, 2013 among Pinnacle Biologies, Inc., Guillermo Herrera (as the stockholders representative), Concordia Private Co., Concordia Labs Inc., and Concordia Healthcare USA (Midwest Medical) Inc., pursuant to which Concordia Private Co. indirectly acquired Photofrin ® . | |
Private Placement | has the meaning ascribed to that term under the heading General Development and Description of the Business - Development of the Business - 2013 Private Placement in this Annual Information Form. | |
Qualifying Transaction | has the meaning ascribed to that term under the heading Background and Corporate Structure - Name, Address and Incorporation in this Annual Information Form. | |
RBC | has the meaning ascribed to that term under the heading General Development and Description of the Business - Development of the Business - Covis Portfolio Acquisition in this Annual Information Form . | |
RBC Credit Facilities | has the meaning ascribed to that term under the heading General Development and Description of the Business - Development of the Business - Covis Portfolio Acquisition in this Annual Information Form . | |
RBC Facilities | has the meaning ascribed to that term under the heading General Development and Description of the Business - Development of the Business - Covis Portfolio Acquisition in this Annual Information Form . | |
Robins | has the meaning ascribed to that term under the heading Risk Factors - Risk Factors Related to the Business in this Annual Information Form. | |
RSUs or Restricted Share Units | has the meaning ascribed to that term under the heading Description of Capital Structure - Long Term Incentive Plan in this Annual Information Form. | |
RSU Participant | has the meaning ascribed to that term under the heading Description of Capital Structure - Long Term Incentive Plan in this Annual Information Form. | |
SEC | means the United States Securities and Exchange Commission. | |
SEDAR | means the System for Electronic Document Analysis and Retrieval. | |
Senior Loan Agreement | means the Loan Agreement made May 6, 2013, among Concordia Private Co., CPI, CHUSA, Fulcrum Capital Partners Inc. and Windsor Private Capital Limited Partnership in respect of the provision to Concordia Private Co. of term loan facilities in the aggregate amount of $19 million. | |
Shionogi | means Shionogi Inc. |
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Shionogi Purchase Agreement | means the Asset Purchase Agreement dated May 6, 2013, between CPI and Shionogi for the purchase by CPI of the Kapvay ® , Orapred ODT ® and Ulesfia ® Legacy Products from Shionogi. | |
Specialty Healthcare Distribution Division or SHD Division | means the Corporations Specialty Healthcare Distribution Division. | |
Specialty Pharma | means smaller specialty and niche-market pharmaceutical companies. | |
Stock Option Plan | has the meaning ascribed to that term under the heading Description of Capital Structure - Stock Option Plan in this Annual Information Form. | |
Subordinate Loan Agreement | means the Loan Agreement made May 6, 2013, among Concordia Private Co., CPI, CHUSA, BG Capital Group Limited and Universal Casualty Company in respect of the provision to Concordia Private Co. of term loan facilities in the aggregate amount of $5.15 million. | |
TSX | means the Toronto Stock Exchange. | |
TSX-V | means the TSX Venture Exchange. | |
Underwriting Agreement | means the underwriting agreement by and among GMP Securities L.P., Canaccord Genuity Corp., Barclays Capital Canada Inc., Beacon Securities Limited, Cormark Securities Inc. and the Corporation dated February 24, 2014, which was entered into in connection with the 2014 Offering. | |
Units | has the meaning ascribed to that term under the heading Description of Capital Structure - Long Term Incentive Plan in this Annual Information Form. | |
VWAP | means the dollar volume weighted average trading price of the Common Shares for the 10 days preceding the Earnout Calculation Date. | |
Zonegran Purchase Agreement | has the meaning ascribed to that term under the heading General Development and Description of the Business - Development of the Business - Zonegran ® Acquisition in this Annual Information Form. | |
Zylera | has the meaning ascribed to that term under the heading Legacy Pharmaceuticals Division - Legacy Products - Ulesfia ® - Distribution Agreement with Lachlan Pharmaceuticals in this Annual Information Form. |
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EXPLANATORY NOTES
Unless otherwise stated, the information in this Annual Information Form is stated as of December 31, 2014, and all references to the Corporations fiscal year are to the year ended December 31, 2014. In this Annual Information Form, the Corporation and its subsidiaries are collectively referred to as the Corporation or Concordia, unless the context otherwise requires.
Information contained on, or otherwise accessed through, the website of the Corporation, www.concordiarx.com, shall not be deemed to be a part of this Annual Information Form and such information is not incorporated by reference herein and should not be relied upon by readers for the purpose of determining whether to invest in the Common Shares or any other securities of the Corporation.
Unless otherwise indicated, all charts, graphs, tables and figures are prepared by the Corporations management.
Trademarks
This Annual Information Form includes trademarks which are protected under applicable intellectual property laws and are the property of the Corporation or its affiliates. Solely for convenience, the trademarks of the Corporation referred to in this Annual Information Form may appear with or without the ® or symbol, but such references or the absence thereof are not intended to indicate, in any way, that the Corporation or its affiliates will not assert, to the fullest extent under applicable law, their respective rights or the right of the applicable licensor to these trademarks. Any other trademarks used in this Annual Information Form are the property of their respective owners.
Currency
All references to C$ in this Annual Information Form refer to Canadian dollars and all references to $ are to United States dollars, unless otherwise indicated.
Market Data
This Annual Information Form contains statistical data, market research and industry forecasts that were obtained, unless otherwise indicated, from independent industry and government publications and reports or based on estimates derived from such publications and reports and managements knowledge of, and experience in, the markets in which the Corporation operates. Industry and government publications and reports generally indicate that they have obtained their information from sources believed to be reliable, but do not guarantee the accuracy and completeness of their information. While the Corporation believes this data to be reliable, market and industry data is subject to variation and cannot be verified due to limits on the availability and reliability of raw data, the voluntary nature of the data gathering process and other limitations and uncertainties inherent in any statistical survey. The Corporation has not independently verified the accuracy or completeness of such information contained herein. In addition, projections, assumptions and estimates of the Corporations future performance and the future performance of the industry in which the Corporation operates are necessarily subject to a high degree of uncertainty and risk due to a variety of factors, including those described under the heading Risk Factors in this Annual Information Form.
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CAUTIONARY NOTE REGARDING FORWARD-LOOKING INFORMATION
Certain statements contained in this Annual Information Form constitute forward-looking information within the meaning of applicable Canadian provincial securities laws (collectively, forward-looking statements ), which are based upon the Corporations current internal expectations, estimates, projections, assumptions and beliefs. Statements concerning the Corporations objectives, goals, strategies, intentions, plans, beliefs, expectations and estimates, and the business, operations, future financial performance and condition of the Corporation are forward-looking statements. The words believe, expect, anticipate, estimate, intend, may, will, would and similar expressions and the negative and grammatical variations of such expressions are intended to identify forward-looking statements, although not all forward-looking statements contain these identifying words. These statements are not guarantees of future performance and involve known and unknown risks, uncertainties and other factors that may cause actual results or events to differ materially from those anticipated in the forward-looking statements. In addition, this Annual Information Form may contain forward-looking statements attributed to third-party industry sources.
By their nature, forward-looking statements involve numerous assumptions, known and unknown risks and uncertainties, both general and specific, that contribute to the possibility that the predictions, forecasts, projections that constitute forward-looking statements will not occur. Such forward-looking statements in this Annual Information Form speak only as of the date of this Annual Information Form. Forward-looking statements in this Annual Information Form include, but are not limited to, statements with respect to:
| the performance of the Corporations business and operations; |
| the Corporations capital expenditure programs; |
| the future development of the Corporation, its growth strategy and the timing thereof; |
| the acquisition strategy of the Corporation; |
| the completion of the transactions under the Covis Purchase Agreement; |
| the completion and timing of the 2015 Offering and the entering into of documentation in respect thereof; |
| the estimated future contractual obligations of the Corporation; |
| the Corporations future liquidity and financial capacity; |
| the supply and demand for pharmaceutical products and services similar to the Corporations products and services; |
| cost and reimbursement of the Corporations products; |
| expectations regarding the Corporations ability to raise capital; |
| the Corporations treatment under government regulatory and taxation regimes; |
| the Corporations net sales of all or any one of the Corporations legacy pharmaceutical products, orphan drugs and other products; and |
| sales relating to the SHD Division. |
With respect to the forward-looking statements contained in this Annual Information Form, the Corporation has made assumptions regarding, among other things:
| the ability of the Corporation to comply with its contractual obligations, including, without limitation, its obligations under debt arrangements; |
| the ability of the Corporation to complete the transactions under the Covis Purchase Agreement and the 2015 Offering; |
| the successful licensing of products to third parties to market and distribute such products on favourable terms; |
| the ability of the Corporation to maintain key strategic alliances, out licensing and partnering arrangements, now and in the future; |
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| the general regulatory environment in which the Corporation operates, including the areas of taxation, environmental protection, consumer safety and health regulation; |
| the tax treatment of Concordia and its subsidiaries and the materiality of legal proceedings; |
| the timely receipt of any required regulatory approvals; |
| the general economic, financial, market and political conditions impacting the industry in which the Corporation operates; |
| the ability of the Corporation to sustain or increase profitability, fund its operations with existing capital, and/or raise additional capital to fund future acquisitions; |
| the ability of the Corporation to acquire any necessary technology, products or businesses and effectively integrate such acquisitions; |
| the development and clinical testing of products under development; |
| the ability of the Corporation to obtain necessary approvals for commercialization of the Corporations products from the FDA or other regulatory authorities; |
| future currency exchange and interest rates; |
| reliance on third party contract manufacturers to manufacture the Corporations products on favourable terms; |
| the ability of the Corporation to generate sufficient cash flow from operations and to access existing and proposed credit facilities and the capital markets to meet its future obligations on acceptable terms; |
| the availability of raw materials and finished products necessary for the Corporations products; |
| the impact of increasing competition; |
| the ability of the Corporation to obtain and retain qualified staff, equipment and services in a timely and efficient manner; |
| the ability of the Corporation to maintain and enforce the protection afforded by any patents or other intellectual property rights; |
| the ability of the Corporation to conduct operations in a safe, efficient and effective manner; |
| the results of continuing and future safety and efficacy studies by industry and government agencies related to the Corporations products; and |
| the ability of the Corporation to successfully market its products and services. |
Forward-looking statements contained in this Annual Information Form are based on the key assumptions described herein. The reader is cautioned that such information, although considered reasonable by the Corporation, may prove to be incorrect. Actual results achieved during the forecast period will vary from the information provided in this Annual Information Form as a result of numerous known and unknown risks and uncertainties and other factors.
Some of the risks and other factors which could cause actual results to differ materially from those expressed in the forward-looking statements contained in this Annual Information Form include, but are not limited to, the risk factors included under the heading Risk Factors in this Annual Information Form.
Management of the Corporation has included the above summary of assumptions and risks related to forward-looking statements included in this Annual Information Form in order to provide readers with a more complete perspective on the Corporations future operations and results. Readers are cautioned that this information may not be appropriate for other purposes. Readers are cautioned that the lists of assumptions and risk factors contained herein are not exhaustive.
Such forward-looking statements are made as of the date of this Annual Information Form and the Corporation disclaims any intention or obligation to update publicly any such forward-looking statements, whether as a result of new information, future events or results or otherwise, other than as required by applicable Canadian securities laws.
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All of the forward-looking statements made in this Annual Information Form are expressly qualified by these cautionary statements and other cautionary statements or factors contained herein, and there can be no assurance that the actual results or developments will be realized or, even if substantially realized, that they will have the expected consequences to, or effects on, the Corporation.
BACKGROUND AND CORPORATE STRUCTURE
Name, Address and Incorporation
Concordia Healthcare Corp. was incorporated pursuant to the provisions of the OBCA on January 20, 2010, under the name Mercari Acquisition Corp.. The Corporation completed its initial public offering on May 6, 2010, and was listed on the TSX-V as a capital pool company and subsequently on the NEX. On December 18, 2013, and prior to the completion of the Qualifying Transaction (as defined below), the Corporation changed its name to Concordia Healthcare Corp. and completed a consolidation of its share capital on a basis of one post-consolidation Common Share for every 48.08 common shares existing immediately before the consolidation (the Consolidation ). The Corporation completed its qualifying transaction pursuant to the policies of the TSX-V by way of a reverse takeover of the Corporation by the shareholders of Concordia Private Co. on December 20, 2013 (the Qualifying Transaction ). The Common Shares were delisted from the NEX and relisted for trading on the TSX under the symbol CXR on December 24, 2013. On January 30, 2014, the Common Shares were initially posted and quoted for trading on the OTCQX, under the trading symbol CHEHF.
The registered and head office of the Corporation is located at 277 Lakeshore Rd. East, Suite 302, Oakville, Ontario, L6J 1H9. The Corporations records office is located at 333 Bay St., Suite 2400, Toronto, Ontario M56 2T6.
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Intercorporate Relationships
The Corporations business is carried on through its various subsidiaries. The following chart illustrates, as at December 31, 2014, the Corporations subsidiaries, including their respective jurisdiction of incorporation and percentage of voting securities in each that are held by the Corporation either directly or indirectly:
Note :
(1) | Concordia Pharmaceuticals Inc. is owned as to 50% by the Corporation and 50% by Concordia Healthcare Inc. |
GENERAL DEVELOPMENT AND DESCRIPTION OF THE BUSINESS
Development of the Business
Prior to the Qualifying Transaction, the Corporation did not own any assets other than cash and had not conducted any active business operations. Since its incorporation and prior to the Qualifying Transaction, the principal activities of the Corporation consisted of the financing through its initial public offering and a non-brokered private placement of 5,800,000 Common Shares at C$0.05 per Common Share for gross proceeds of C$290,000 completed on January 15, 2013.
As a result of the Qualifying Transaction, the Corporation is currently a diverse healthcare company that targets three areas through its various divisions: (a) legacy pharmaceutical products (Legacy Pharmaceuticals Division); (b) specialized healthcare distribution that services the growing diabetic market (Specialty Healthcare Distribution Division or SHD Division); and (c) the acquisition and/or development of orphan drugs (Orphan Drugs Division). These three business units are run as separate divisions but are inter-related. The cash-flow generated from the sale of the Legacy Products is used to fund operations and is also intended to fund the expansion of indications for potential orphan drugs. The
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Specialty Healthcare Distribution Division provides additional growth and cash-flow generation for the Corporation. Additionally, through its registered pharmacy operation, the SHD Division provides a specialty distribution capability for specialty pharmaceutical products and orphan drugs once acquired and/or developed. All three of these divisions are operated through a corporate organization that provides executive leadership, industry experience and financial and capital markets experience.
These three divisions are identified as reportable segments under IFRS for the purposes of disclosure in the Corporations audited consolidated financial statements.
2013 Debt Financings
On May 6, 2013, Concordia Healthcare Inc. ( Concordia Private Co. ) entered into two loan and security agreements: (i) a loan under the Senior Loan Agreement in the principal amount of $19 million bearing interest at 12% per annum, calculated daily, maturing on October 30, 2015, with interest paid monthly in arrears; and (ii) two loans under the Subordinate Loan Agreement in the aggregate principal amount of $5.15 million bearing interest at 18% per annum, calculated daily, maturing on October 30, 2015, with interest paid monthly in arrears only if the loan under the Senior Loan Agreement was repaid. The Senior Loan Agreement included a working capital loan of $3 million where the interest rate was 12%. The working capital loan was repaid and cancelled on August 7, 2013. On March 28, 2014, the Corporation repaid in full the Senior Loan Agreement and the Subordinate Loan Agreement.
On September 19, 2013, the Corporation entered into a senior secured revolving credit facility in the principal amount of $3 million. The Corporation did not draw on the revolving facility and cancelled it on May 13, 2014.
Acquisition of Kapvay ® , Orapred ODT ® and Ulesfia ®
CPI, a subsidiary of the Corporation, acquired certain of its Legacy Products from Shionogi on May 6, 2013, pursuant to the Shionogi Purchase Agreement. Such Legacy Products are comprised of three FDA approved drugs: (i) Kapvay ® , which is used to treat ADHD; (ii) Orapred ODT ® , an anti-inflammatory used in the treatment of certain pulmonary diseases such as asthma; and (iii) Ulesfia ® , which is a topical treatment for pediculosis (head lice). The purchase price paid to Shionogi was $28.7 million and included $25.6 million paid for the above mentioned Legacy Products, $2.3 million paid for the inventory including raw material, work in process and finished goods and $0.8 million in contingent consideration, subject to meeting certain performance metrics. Following the closing of this acquisition, as additional consideration for the sale, transfer, conveyance and assignment of the assets and the grant of the Ulesfia ® license, CPI is required to pay Shionogi 30% of worldwide net sales of Kapvay ® and royalty income relating to Kapvay ® that exceeds $1.5 million (in the aggregate) during each calendar quarter commencing with the calendar quarter beginning October 1, 2013 until such payments equal $6.0 million in the aggregate.
In September of 2013, the Corporation entered into the Competitive Supply Agreement with respect to Kapvay ® .
SHD Division Acquisition
CHUSA, a subsidiary of the Corporation, acquired its specialty healthcare distribution business assets from Global on October 25, 2013, with an effective date of August 1, 2013, pursuant to the Global Purchase Agreement. The Corporations specialty healthcare distribution business is a United States national internet, retail and mail-order provider of diabetes testing supplies and other healthcare products. This business also includes a full-service pharmacy with full fulfillment capacity and can ship
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medications across the United States. Concordia Private Co., through CHUSA, acquired the specialty healthcare distribution business for total consideration of $13.2 million comprised of $5 million in cash, a vendor note with a fair value on the date of acquisition of $5.6 million and an additional earn-out payment with an estimated present value on the date of acquisition of $2.6 million, payable in Common Shares subject to meeting certain performance metrics. The earn-out payment provisions provide that on each Earnout Calculation Date, if the aggregate adjusted EBITDA of Global exceeds $7 million for the preceding year then an Earnout Payment of Common Shares will be made which is equal in value to the aggregate adjusted EBITDA of Global for the preceding year multiplied by 14.285714%. The number of Common Shares to be paid is calculated by dividing the dollar value of the Earnout Payment by the VWAP. The aggregate Earnout Payments are subject to a $4 million cap, based on the VWAP of the Common Shares on the date of issuance of such shares. In addition, one million common shares of Concordia Private Co. at $3.00 per share were issued as finders fees in connection with the acquisition of the SHD Division, which common shares were exchanged for Common Shares in connection with the Qualifying Transaction.
Photofrin ® Acquisition
CLI, a subsidiary of the Corporation, holds certain legacy pharmaceutical products that have the potential, through further development, to be used to treat additional indications, specifically those indications that may qualify for orphan drug status. On November 8, 2013, Concordia Private Co. and certain of its subsidiaries, entered into the Pinnacle Purchase Agreement. Pursuant to the Pinnacle Purchase Agreement, on December 20, 2013, Concordia Private Co., through its subsidiaries, acquired 100% of the shares of Pinnacle for total consideration of $58 million comprised of $32.7 million of cash consideration, $5 million of Concordia Private Co.s common shares issued at a price of C$5.63 per common share (being a 10% discount to the price of the 2013 Subscription Receipts issued under the Private Placement), 10 annual cash payments with an estimated present value of $5 million and milestone and other contingency payments with an estimated value of $15.3 million. The acquisition of Pinnacle was financed with available cash, which included net proceeds of C$34.5 million received by Concordia Private Co. through the Private Placement of 2013 Subscription Receipts of Concordia Private Co., which closed on December 19, 2013. See General Development and Description of the Business - Development of the Business - 2013 Private Placement below. On October 1, 2014, CLI acquired certain intellectual property from Pinnacle.
2013 Private Placement
Prior to the Qualifying Transaction and pursuant to the terms and provisions of an agency agreement (the Agency Agreement ) dated December 19, 2013, between Concordia Private Co. and the Agents (as defined below), Concordia Private Co. completed a private placement (the Private Placement ) of subscription receipts (the 2013 Subscription Receipts ) through a syndicate of agents co-led by GMP Securities L.P. and Canaccord Genuity Corp., and including Beacon Securities Limited, Cormark Securities Inc. and National Bank Financial Inc. (collectively, the Agents ). Pursuant to the Private Placement, Concordia Private Co. issued 5,520,000 2013 Subscription Receipts at a price of C$6.25 per 2013 Subscription Receipt for total gross proceeds to the Corporation of C$34,500,000. Each 2013 Subscription Receipt was exchanged for one common share of Concordia Private Co., which common shares were then exchanged for Common Shares on a one-for-one basis pursuant to the Qualifying Transaction.
The Agents received options to purchase 220,800 common shares of Concordia Private Co. at an exercise price of C$6.25 (the Agents Options ). The Agents Options are exercisable until December 20, 2015. In connection with the Qualifying Transaction, the Agents Options were exchanged for compensation options of the Corporation on the same terms as those contained in the Agents Options.
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2014 Public Offering
On March 11, 2014, and pursuant to the Underwriting Agreement, the Corporation closed a short form prospectus offering, on a bought deal basis, of 5,750,000 Common Shares for aggregate gross proceeds of C$67,562,500 (the 2014 Offering ). The 2014 Offering was completed at a price per Common Share of C$11.75 by a syndicate of underwriters co-led by GMP Securities L.P. and Canaccord Genuity Corp. and included Barclays Capital Canada Inc., Beacon Securities Limited and Cormark Securities Inc. (collectively, the 2014 Underwriters ). The 2014 Underwriters received, as consideration for their services, a commission equal to 6% of the aggregate gross proceeds payable to the Corporation in respect of the 2014 Offering. Net proceeds to the Corporation after deduction of the 2014 Underwriters fees were C$63,508,750.
Donnatal ® Acquisition
Pursuant to the terms of an asset purchase agreement dated March 19, 2014, between CPI, Concordia and PBM Pharmaceuticals, Inc. (the Donnatal Purchase Agreement ), on May 15, 2014, CPI completed the acquisition of Donnatal ® , an adjunctive therapy in the treatment of IBS and acute enterocolitis. CPI acquired Donnatal ® for $200 million in cash and the issuance of an aggregate of 4,605,833 Common Shares, representing approximately 16.17% of the Corporations outstanding Common Shares on a non-diluted basis (approximately 14.96% on a fully-diluted basis) after giving effect to the acquisition, as of the acquisition date. The Corporation paid for the cash component of the acquisition through a combination of available cash and debt financing. In this respect, the Corporation entered into a secured credit facility having a principal amount of up to $195 million, consisting of a $170 million term loan and a $25 million operating line (the May 2014 Credit Facility ) with GE Capital, Healthcare Financial Services and a syndicate of lenders. The May 2014 Credit Facility was amended and restated by the GE Amended Credit Agreement. See General Development and Description of the Business - Development of the Business - Zonegran ® Acquisition below. The Corporation has filed a Form 51-102F4 - Business Acquisition Report in respect of the acquisition of Donnatal ® , a copy of which is available on SEDAR, online at www.sedar.com.
Zonegran ® Acquisition
Pursuant to the terms of an asset purchase agreement dated September 3, 2014, by and between CPI and Eisai (the Zonegran Purchase Agreement ), on September 30, 2014, CPI acquired Zonegran ® from Eisai for $90 million in cash, plus approximately $1.4 million for purchased inventory. Zonegran is an AED originally created by Dainippon Pharmaceutical Co., Ltd., (currently Dainippon Sumitomo Pharma Co., Ltd.). Zonegran ® was first approved by the FDA in March 2000 as an adjunctive therapy in the treatment of partial seizures in adults with epilepsy. The Corporation has filed a Form 51-102F4 - Business Acquisition Report in respect of the acquisition of Zonegran ® , a copy of which is available on SEDAR, online at www.sedar.com.
In connection with the closing of the acquisition, the Corporation provided a guarantee in favour of Eisai in respect of the punctual payment, performance and discharge of CPIs payment and indemnification obligations under the Zonegran Purchase Agreement and the ancillary agreements entered into in connection therewith.
The Corporation paid for the acquisition of Zonegran ® through debt financing. In this respect, GE Capital provided an incremental senior secured credit facility of up to $95 million by way of an amended and restated credit agreement dated September 30, 2014 (the GE Amended Credit Agreement ) to the May 2014 Credit Facility. All obligations of the Corporation under the GE Amended Credit Agreement are
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secured by existing first priority perfected security interests in the assets of the Corporation and the assets of its material subsidiaries.
Covis Portfolio Acquisition
Pursuant to the terms of an asset purchase agreement dated March 9, 2015, by and between the Corporation, CPI, Covis Pharma, Covis Injectables and Covis Pharma Holdings S.à.r.l. (the Covis Purchase Agreement ), the Corporation has agreed to acquire substantially all the assets of Covis Pharma and Covis Injectables for approximately $1.2 billion in cash.
The drug portfolio being acquired (the Covis Portfolio ) consists of 18 branded and authorized generic products. The distinctive product portfolio includes branded pharmaceuticals, injectables and authorized generics that address life threatening and other serious medical conditions in various therapeutic areas including cardiovascular, central nervous system, oncology and acute care markets. Key products are Nilandron ® , for the treatment of metastatic prostate cancer; Dibenzyline ® , for the treatment of pheochromocytoma (a type of tumor of the adrenal glands); Lanoxin ® , for the treatment of mild-to-moderate heart failure and atrial fibrillation; and, Plaquenil ® , for the treatment of lupus and rheumatoid arthritis.
The Corporation plans to finance the acquisition of the Covis Portfolio through the net proceeds of the 2015 Offering and debt financing. Accordingly, the Corporation has entered into a commitment letter (the Commitment Letter ) with Royal Bank of Canada ( RBC ), pursuant to which, RBC has agreed to provide senior secured credit facilities on the closing date of the acquisition of the Covis Portfolio (the Acquisition Closing Date ) in an aggregate principal amount of up to $750 million comprising: (i) a senior secured revolving credit facility in an aggregate principal amount of up to $100 million; and (ii) a senior secured term loan facility in an aggregate principal amount of up to $650 million (together, the RBC Facilities ). All obligations of the Corporation under the RBC Facilities will be guaranteed by all material subsidiaries of the Corporation and secured by first priority (subject to permitted liens) perfected security interests in the assets of the Corporation and the assets of and equity interests in its material subsidiaries.
In addition, RBC has agreed to provide the Corporation: (i) a senior unsecured bridge facility (the Bond Bridge Facility ) on the Acquisition Closing Date in an aggregate principal amount of up to $710 million less the aggregate gross proceeds provided by any senior unsecured notes and gross proceeds in excess of $150 million provided by any new equity issued by the Corporation, including the 2015 Subscription Receipts to be issued under the 2015 Offering, on or prior to the Acquisition Closing Date; and (ii) a senior unsecured equity bridge facility (the Equity Bridge Facility ) on the Acquisition Closing Date in an aggregate principal amount of up to $150 million less the aggregate amount of any new equity issued by the Corporation, including the 2015 Subscription Receipts to be issued under the 2015 Offering, on or prior to the Acquisition Closing Date (collectively with the RBC Facilities, the RBC Credit Facilities ). All obligations of the Corporation under the Bond Bridge Facility and the Equity Bridge Facility will be guaranteed by all material subsidiaries of the Corporation. The RBC Credit Facilities are subject to the completion of definitive documentation which will contain customary representations and warranties and restrictive covenants for facilities of this nature.
The acquisition of the Covis Portfolio, which is expected to close in the second quarter of 2015, is subject to satisfaction of customary closing conditions (including receipt of required regulatory approvals). The board of directors of all parties to the transaction have approved the acquisition.
Pursuant to the Covis Purchase Agreement, Concordia guaranteed the due and punctual performance by CPI of CPIs obligations under the Covis Purchase Agreement.
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Proposed 2015 Public Offering
On March 17, 2015, the Corporation announced that it had entered into a letter agreement with RBC Dominion Securities Inc., as sole bookrunner and co-lead manager, and GMP Securities L.P. as co-lead manager (and together with RBC Dominion Securities Inc. and other underwriters who may join the syndicate, the 2015 Underwriters ), pursuant to which the 2015 Underwriters agreed to purchase, on a bought deal basis, 3,764,720 subscription receipts of the Corporation (the 2015 Subscription Receipts ) at a price of C$85.00 per 2015 Subscription Receipt (the Offering Price ) for aggregate gross proceeds to the Corporation of C$320,001,200 (the 2015 Offering ). Each 2015 Subscription Receipt will entitle the holder thereof to receive, upon the closing of the acquisition of the Covis Portfolio, without payment of additional consideration or further action, one Common Share in exchange for each 2015 Subscription Receipt. In connection with the 2015 Offering, the Corporation agreed to grant the 2015 Underwriters an over-allotment option to purchase up to an additional 564,708 2015 Subscription Receipts at the Offering Price, exercisable in whole or in part, at any time up to 30 days following the closing of the 2015 Offering (so long as the Covis Purchase Agreement has not been terminated before or by such time or it has been announced that the acquisition of the Covis Portfolio will not be completed). If this option is exercised in full, an additional C$48,000,180 will be raised pursuant to the 2015 Offering and the aggregate gross proceeds will be C$368,001,380. The 2015 Underwriters will receive, as consideration for their services, a commission equal to 4% of the aggregate gross proceeds payable to the Corporation in respect of the 2015 Offering. Net proceeds are expected to be used, in part, to fund the acquisition of the Covis Portfolio.
Growth Strategy
The Corporation intends to grow its existing businesses by: (i) supplementing its Legacy Pharmaceuticals Division by acquiring or in-licensing additional legacy products; (ii) supplementing its Orphan Drug Division by acquiring additional orphan products; (iii) developing new indications for Photofrin ® and acquired orphan drugs that will qualify for Orphan Drug Status and create new marketing opportunities; and (iv) expanding the Specialty Healthcare Distribution Division by changing its product offerings and distributing additional products.
Legacy Product and Orphan Product Acquisitions
The Corporation focuses on acquiring legacy or orphan products that either enjoy market exclusivity through technical, manufacturing, regulatory or economic barriers to competition, or otherwise maintain stable and/or predictable demand and revenues. As the Corporations focus is not therapeutically driven, management of the Corporation believes that a broad selection of these products are available for potential product acquisitions.
The Corporation acquires legacy products that:
1. | Are known products, offering: |
a. | Proven efficacy and a well-understood position in therapy; |
b. | Proven safety profiles and therefore minimal safety risk for patients and physicians; |
c. | No costly launch promotion requirement; and |
d. | Limited or no ongoing sales and marketing investment; |
2. | Have minimal competitive threats due to: |
a. | Quantifiable generic penetration; and |
b. | Minimal pipeline (alternative product) risk; |
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3. | Have a predictable and reliable supply chain, including: |
a. | Readily available Active Pharmaceutical Ingredient (API); |
b. | Long-term supply chain in place; |
c. | Alternative manufacturing sources, if needed; and |
d. | Distribution by leading third-party logistics providers; |
4. | Have financial stability with upside potential, including: |
a. | An attractive cash flow profile; |
b. | Competitive value; and |
c. | Demonstrated responsiveness to limited promotion and investment. |
The Corporation also focuses on acquiring orphan products that provide opportunities to expand existing indications, specifically those qualifying for orphan drug status.
The Corporation believes it has developed a rigorous and comprehensive evaluation process to identify and review potential product acquisitions. This process includes in-depth due diligence reviews of all aspects of the business opportunity including legal, intellectual property and patent, medical and clinical, regulatory and quality assurance, manufacturing, financial (tax) and commercial reviews that are conducted by experts in their respective fields. At any given time, the Corporation may have numerous potential product acquisitions under evaluation.
Post-Acquisition Value Added by the Corporation
The Corporation has a focused post-acquisition program for legacy and orphan products that is designed to manage the performance of acquired drugs. Key components of this program include:
1. | Implementing cost adjustments based on market assessment; |
2. | Implementing authorized generic opportunities; |
3. | Exploring targeted promotion and co-promotion opportunities; |
4. | Effectively managing regulatory affairs and supply chain; and |
5. | Integrating acquisition and intellectual property into the Corporations tax efficient structure. |
The Corporation also has a focused post-acquisition program for orphan products. This program involves investing in further clinical development of the product for the purpose of demonstrating efficacy in additional indications, namely orphan indications that have been granted orphan drug status.
Cost Adjustments
Consistent with industry practice, the Corporation monitors the market for its products and implements cost adjustments based on this market assessment.
Authorized Generics
An authorized generic (AG) is a branded drug marketed as a generic drug under private label, typically that of a generic company. The goal of partnering with a generic company to introduce an AG is to maintain market share, thereby creating a revenue stream from the AG, while continuing to receive a revenue stream from brand sales. The Corporation intends to enter into AG partnerships whenever merited.
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Targeted Promotion and Co-Promotion
Where justified, the Corporation seeks to maintain and grow demand for, and revenues from, its legacy products via highly targeted promotional activities. The Corporations marketing strategies entail modest investment in direct detailing to carefully targeted physicians. Additionally, the Corporation offers couponing and co-pay assistance programs for its legacy brands, believing that this is a necessary measure to keep patients direct costs on par with competitors. These activities are aimed at increasing physician, pharmacy and consumer awareness and loyalty to the Corporations products.
The Corporation seeks to grow demand for its orphan products via more comprehensive, highly targeted promotional activities. The Corporation believes that because orphan products offer the potential for greater growth than do legacy products, a higher level of investment in promotional support of these products is warranted.
In addition, where justified, the Corporation will seek to partner with existing pharmaceutical companies that have sales forces with capacity to promote additional products. These potential co-promotion arrangements allow the Corporation to leverage an existing sales force without incurring additional fixed costs. The Corporation will also consider engaging a contract sales force where appropriate.
SHD Division Growth
Management of the Corporation plans to grow its SHD Division through four primary avenues: (a) expanding the existing patient base; (b) providing new product offerings to current and future patients; (c) developing a specialty distribution business within its full service pharmacy; and (d) through strategic partnerships. New patients are obtained by investing in new patient leads from lead generation companies and through additional contracts with medical and pharmacy providers. The Corporation intends to expand upon its existing product portfolio through the addition of new pharmaceutical offerings and new device offerings. Finally, the Corporation intends to create a specialty pharmaceutical distribution business within its SHD Division. The Corporation intends to offer through the SHD Division specialty distribution of pharmaceutical products to physicians who prescribe orphan and specialist medication to patients. These products are typically administered at the physicians office and require a much higher degree of control of the supply chain as many are just in time medications with limited shelf life. Accordingly, these distribution services generally have higher profit margins than traditional distribution services.
Competitive Strengths
Management of the Corporation believes that the Corporation possesses a number of attributes and competitive advantages that should enable it to maintain and grow revenues and operating cash flow.
Established Branded Legacy Products Portfolio
The Legacy Pharmaceuticals Division provides the Corporation with a portfolio of established, branded legacy products, all of which continue to generate income. The Corporations management believes that the Legacy Pharmaceuticals Division will continue to provide a predictable revenue base that may be grown via effective product management, and supplemented via acquisition of additional legacy products.
Superior Business Model for Acquisition of Legacy and Orphan Drug Products
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Specialty Pharma companies often focus on acquiring under-promoted or non-promoted products in specific therapeutic areas that can be grown through synergistic, targeted sales and marketing efforts. The Corporation believes it has a unique strategy in seeking to acquire legacy products primarily for the purpose of generating a stream of stable revenues and cash flow, which provides the Corporation with the flexibility to consider a broad range of acquisition targets from a variety of therapeutic areas. Therefore, the potential number of acquisition candidates is much larger for the Corporation than for most Specialty Pharma companies. Management of the Corporation believes that this approach provides the Corporation with a competitive advantage in acquiring products as it can often purchase diversified bundles of products from a single vendor, whereas Specialty Pharma companies are more likely to focus on individual product acquisitions. With this flexibility, certain vendors may view the Corporation as a preferred purchasing candidate.
Partnership with Leading Service Providers
The Corporation has entered into outsourcing relationships with leading providers of pharmaceutical contract services for many of the operational functions associated with its business and intends to pursue this strategy in the future. Manufacturing of Kapvay ® tablets is outsourced to UPM Pharmaceuticals, Inc. and packaged by Pharmaceutical Packaging Service. Orapred ODT ® is manufactured and packaged by CIMA Labs Inc. Ulesfia ® Lotion is manufactured by Contract Pharmaceuticals Limited and packaged by Pharmaceutical Packaging Service. Zonegran is manufactured by Eisai. Donnatal is manufactured by IriSys and packaged by Legacy Packaging. Warehousing, distribution, logistics, customer service and accounts receivable were transitioned to Cardinal Specialty Pharmaceutical Services in January 2014. All aspects of regulatory affairs and pharmacovigilance have been outsourced to the Mapi Group ( Mapi ). Other compliance-related matters are overseen by Compliance Implementation Services and Beckloff & Associates .
Aligned Management and Board with Product Acquisition Expertise
Certain members of the Corporations executive management team and Board have, on average, 15 years of pharmaceutical product acquisition and operational experience. The Corporations Chief Executive Officer, Mark Thompson, has spent his career in pharmaceutical M&A, having completed more than $2.5 billion of product transactions (not including the potential acquisition under the Covis Purchase Agreement). As a result, Mr. Thompson has a broad network within the industry. Certain members of the Corporations management team are also experienced in various aspects of pharmaceutical operations, including product development, clinical research, technology transfer, manufacturing, regulatory affairs, sales and marketing. The Corporations Barbados subsidiaries are also run by seasoned pharmaceutical executives. In addition, management of the Corporation and the Board maintain a material ownership interest in the business in order to further align interests.
Tax-Efficient Capital Structure
Active business income earned from the Legacy Pharmaceuticals Division and Orphan Drugs Division in the Barbadian subsidiaries will generally give rise to exempt surplus. Profits earned by the Barbadian subsidiaries are subject to a lower corporate tax rate than that of many other jurisdictions, and distributions by the Barbadian subsidiaries as exempt surplus dividends are not subject to further corporate tax in Canada.
Corporate Operations
The Corporation operates from five primary locations, including: (i) its Canadian head office located in Oakville, Ontario; (ii) the Legacy Pharmaceuticals and Orphan Drugs Divisions located in St. Michael,
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Barbados; (iii) the SHD Division located in North Kansas City, Missouri; (iv) Pinnacle located in Chicago, Illinois; and (v) CHUSA located in Charlottesville, Virginia. The Corporation leases all of its properties.
Employees
As at December 31, 2014, the Corporation had 214 full time employees and consultants, none of whom are unionized.
The Pharmaceutical Market
The global pharmaceutical industry is a highly diverse and complex industry comprised of a variety of sectors, including Big Pharma, Specialty Pharma, smaller, niche pharmaceutical manufacturers and marketers, biotechnology firms, large and small research and development organizations and generic drug manufacturers. These participants compete for market share based on drug advantages including clinical efficacy and safety, technological innovation or novelty, convenience or ease of administration and cost effectiveness.
According to IMS Health, the United States is the worlds largest pharmaceutical market with estimated sales of $377-$384 billion in 2014 and this market is expected to reach approximately $475 billion by 2020.
United States Pharmaceutical Product Lifecycle
Illustration of the United States Pharmaceutical Product Lifecycle
Most pharmaceutical products in the United States marketplace follow very similar paths of development from discovery through to loss of substantial market share to competing products. This lifecycle includes several key stages that each affect a products commercial viability. The key stages are described as follows:
Drug Discovery - In the drug discovery stage, researchers study the molecular mechanisms of a particular disease and attempt, through a variety of methods, to find or create a molecule that affects the way the disease functions. Typically, when a new molecule is identified that offers the potential to proceed further in development, a patent application is filed claiming the chemical formula that defines the new molecule and/or the process by which the new molecule is formulated or used. If issued, the patent carries a
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lifespan of 20 years from the date of filing. During this 20-year period, only the patent holder may use the discovery claimed in the patent.
Pre-clinical and Clinical Development - Following the drug discovery process, candidate molecules typically undergo one to three years of extensive pre-clinical laboratory and animal testing to assess safety and demonstrate biological activity against a disease. Prior to testing in humans, the drug developer must submit an investigational new drug application to the FDA (a request for permission to conduct further testing on humans). Once permission is granted, the molecule enters three phases of clinical (human) trials, which can take from two to ten years or more, during which safety and efficacy of the new molecule is determined.
FDA Approval, Product Launch and Growth - Once the drug developer submits all data and information generated during the discovery and development stages to the FDA, which constitutes an NDA, FDA scientists and advisory committees review it and decide whether the data justifies approval for widespread patient use and marketing. If approved, the new drug is introduced into the marketplace. Sales of a branded drug, often driven by sizeable promotional investment, may rise sharply after introduction as the drug gains popularity and becomes widely prescribed by physicians.
Maturity - After years of growth, sales of a new drug typically slow or reach a plateau, a stage of the products lifecycle referred to as maturity. The duration of the maturity stage is often dependent on the type of exclusivity the drug enjoys. These types include:
| Patent Exclusivity . If successfully patented during the drug discovery stage, the new drug will enjoy marketing exclusivity for the duration of the patent. After the patent expires, the discovery claimed in the patent can be used by anyone, and it is at this time that competition typically enters the market. Since the time required for a drug to advance through pre-clinical and clinical trials and to receive FDA approval is typically several years, drugs rarely enjoy the full 20 years of patent protected market exclusivity. |
| FDA Exclusivity . Regardless of patent status, the FDA, upon approving an NDA, grants marketing exclusivity to all newly discovered drugs, the term of the grant being dependent on a number of factors, including the use of the drug, whether the drug already exists in another formulation, and the total number of patients eligible to use the drug. FDA exclusivity can last from six months to seven years, and although this period runs concurrently with patent exclusivity, it is independent of any patent protection. |
| Other Barriers to Competition. In rare instances, a drug can maintain market exclusivity after both patent and FDA exclusivity expire due to technical, manufacturing and regulatory nuances that are very difficult or even impossible to overcome, and hence, competing products cannot be introduced. |
Loss of Market Exclusivity - When market exclusivity is lost and competing products enter the market, the brand loses market share very rapidly. Typically the brand will maintain approximately 10% of the market after only one year of losing market exclusivity. Competition comes principally from generic drugs, drugs that the FDA approves as equivalent to the brand based on abbreviated clinical development. Once approved, generic drugs, which are priced at substantial discounts to branded drugs, can be dispensed in place of the brand by a pharmacist, without consent from the prescribing physician.
|
Economic Barriers to Generic Competition - Sales of a branded drug are sometimes too small to warrant the investment necessary to develop and produce a competing generic formulation. As a result, a branded drug may not face generic competition, thereby maintaining market exclusivity. |
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While generic drug development is less rigorous and less costly than branded drug development (which is why generic drug prices are much lower than branded drug prices), filing costs, bioequivalence studies, manufacturing, packaging and ongoing regulatory requirements do create an economic barrier for generic entries. If sales of the branded product are relatively low, the expected economic return may not justify the investment required to develop and manufacture the generic drug. |
Legacy Stage - Once a drug loses market exclusivity and market share erodes, the drug enters the final stage of the product lifecycle, the legacy stage. Although market share falls dramatically in the legacy stage, it rarely erodes to zero. This is due to a number of reasons, the most common ones being physicians/patients insisting on prescribing/receiving branded drugs or top tier drug plans that continue to reimburse branded drugs regardless of the cost difference and availability of generics. Therefore, remaining demand for these drugs, while small, remains predictable and constant year after year, with little or no marketing investment. It is often at this stage when brand companies may think about divesting the drug. Reasons for divestiture are many and varied, including: (i) normal course divestiture of what is no longer a strategic asset (ii) a desire to immediately realize maximum value for the declining asset, possibly addressing near-term cash needs or funding long-term financial goals; (iii) a decision to direct attention and resources elsewhere, including the development, acquisition or licensing of early stage drugs (in the discovery, preclinical or clinical stages); (iv) a strategic change of focus, i.e. other therapeutic areas; (v) continued manufacturing and commercialization of low-volume products becomes economically unattractive to the brand company.
The Corporation intends to focus on acquiring legacy pharmaceutical products that have the following characteristics:
Legacy Product Characteristics | ||||||||||||||
Known products |
Minimal competitive threats |
Predictable and reliable supply chain |
Financial stability with upside potential |
|||||||||||
| Proven efficacy and a well-understood position in therapy | | Quantifiable generic penetration | | Readily available Active Pharmaceutical Ingredient (API) | | Attractive cash flow profile | |||||||
| Proven safety profiles and therefore minimal safety risk for patients and physicians | | Minimal pipeline (alternative product) risk | | Long-term supply chain in place | | Competitive value | |||||||
| No costly launch promotion requirement | | Alternative manufacturing sources, if needed | | Demonstrated responsiveness to limited promotion and investment | |||||||||
| Limited or no ongoing sales and marketing investment | | Distribution by leading third-party logistics providers |
Orphan Diseases and Orphan Drugs - Orphan drugs are developed specifically to treat rare medical conditions (such conditions being referred to as orphan diseases). The FDA grants orphan status to drugs which are defined as those intended for the safe and effective treatment, diagnosis or prevention of rare diseases/disorders that affect fewer than 200,000 people in the United States, or that affect more than 200,000 persons but are not expected to recover the costs of developing and marketing a treatment drug. Along with orphan status, the FDA also grants significant advantages to orphan drugs, including a more rapid development pathway as well as extended market exclusivity, regardless of patent status.
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Customers
The Corporation sells all of its pharmaceutical products directly to three major wholesalers in the United States, namely: AmerisourceBergen, McKesson and Cardinal Health, who combined account for approximately 95% of the Corporations total sales. Other direct buyers include additional smaller wholesalers and distributors, in addition to certain pharmacy chains and food stores that warehouse the products internally. Additional key customer groups include:
| Physicians and allied health professionals including nurses, physician assistants, and pharmacists. While physicians and allied health professionals are not themselves direct buyers of the Corporations products, they are important influencers in recommending or prescribing the Corporations products to patients. |
| Patients and their families/caregivers. In the United States, patients are faced with having to bear an increasing share of the cost of healthcare. For this reason, patients have become more educated regarding their medical needs and are playing an increasingly larger role in their healthcare decisions, including which medications they are taking. |
| Third-party payors such as Managed Care Organizations and group purchasing organizations. Third-party payors, like certain insurance companies and employers, make purchasing and reimbursement decisions based on a number of health outcomes and economic variables. |
| State and federal government health agencies. Certain United States federal government agencies like the Department of Veteran Affairs, the Department of Defence, prison systems and Indian Health Services may purchase pharmaceutical products directly from the Corporation or provide third-party reimbursement to those that do purchase the Corporations products. In addition, Medicaid programs at the state level may also reimburse patients in the purchase of the Corporations products. |
Distribution Outsourcing
Warehousing, distribution, logistics, customer service and accounts receivable were transitioned to Cardinal Specialty Pharmaceutical Services in January 2014. Management of the Corporation believes that such outsourcing relationships with leading providers of pharmaceutical contract services are an efficient means of pursuing the Corporations business plans and intends to pursue this strategy in the future.
Competitive Conditions
Competitors in the pharmaceutical market range from large multinational pharmaceutical development corporations to small, single product companies that may limit their activities to a particular therapeutic area, region or territory. Competition also comes from generic companies, which develop and commercialize formulations that are interchangeable with marketed brands. The Corporation competes with a variety of drug companies. At the present time there are generic products on the market that compete with Kapvay ® , Orapred ® and Zonegran ® . However, Ulesfia ® has patent protection until 2024. As a result of its highly complex manufacturing process, the Corporation believes that Photofrin ® is difficult to genericize. Finally, since Donnatal ® has a very unique regulatory history that predates the current FDA approval process, it is not a reference listed drug, and at this time there is no defined pathway for approval of a generic competitor to Donnatal ® .
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With respect to competition for its acquisition strategy, the Corporation competes principally with three types of companies: (a) other pharmaceutical companies seeking to acquire legacy drugs; (b) other pharmaceutical companies seeking to acquire orphan drugs and orphan drug candidates; and (c) companies developing drugs which could one day compete with the Corporations acquired drugs. With respect to (a), the Corporation believes that these companies typically focus on under-promoted products in specific therapeutic niches that offer growth potential through synergistic sales and marketing efforts. To the Corporations knowledge, there are few companies currently seeking to acquire legacy products solely for the purpose of generating a stream of consistent cash flow. In addition, since the Corporation is not focused on specific therapeutic classes, it has the ability to purchase diversified products and product bundles. With respect to other companies seeking orphan targets, the Corporation believes that it leverages its capital structure to provide it with a competitive advantage over its competitors.
Government Regulation
The FDA and comparable regulatory agencies in state and local jurisdictions and in foreign countries impose substantial requirements on the distribution and marketing of pharmaceutical and other healthcare products. These agencies and other federal, state and local entities regulate quality control, safety, effectiveness, labelling, packaging, storage, handling, distribution, record keeping, approval, advertising, and promotion of pharmaceutical products.
The Corporations operations are also subject to the Anti-Kickback Statutes. Such laws prohibit entities such as the Corporation from knowingly and willingly offering, paying, soliciting or receiving any form of remuneration (including any kickback, bribe or rebate) in return for the referral of items or services for which payment may be made under a federal health care program, or in return for the recommendation, arrangement, purchase, lease or order of items or services for which payment may be made under a federal health care program. Violation of the Anti-Kickback Statutes is a felony, punishable by criminal fines and imprisonment or both. In addition, the Department of Health and Human Services in the United States may impose civil penalties and exclude violators from participation in federal health care programs, such as Medicare and Medicaid. Many states have adopted similar prohibitions against payments intended to induce referrals of products or services paid by Medicaid or other third-party payors.
Proprietary Protection
The patents claiming Donnatal ® , Kapvay ® and Zonegran ® have all expired. Ulesfia ® s several patents expire in stages on August 11, 2017, July 11, 2022 and May 19, 2024. While patents claiming Orapred ® expire on April 9, 2018 and November 24, 2019, a generic competitor was legally introduced into the market in December 2014. PDT with Photofrin ® is a multi-faceted process (requiring the drug and two Class III devices) for which the Corporation maintains proprietorship at multiple levels. Further, the Corporation is developing the product for orphan indications that may receive FDA-granted orphan drug marketing exclusivity for extended periods.
Concordia also relies on trademarks, trade secrets and other proprietary information in connection with its business and such trademarks have been used, often for several years, to build brand equity and maintain physician and patient loyalty to branded drugs. As long as the trademarks continue to be used by the Corporation, registration of them can be renewed and the rights in them maintained.
Revenue By Division
As stated, the Corporation operates three different businesses or divisions: (i) the Legacy Pharmaceuticals Division; (ii) the Orphan Drugs Division; and (iii) the Specialty Healthcare Distribution Division.
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The following chart sets out, for each of the two most recently completed financial years, the revenue for each division of the Corporation derived from sales to customers outside of the Corporation:
Revenues (000,000) | ||||||||
Reportable Segment |
Year ended December 31,
2013 |
Year ended December 31,
2014 |
||||||
Legacy Pharmaceuticals Division |
$ | 36.9 | $ | 94.3 | ||||
SHD Division |
$ | 3.5 | $ | 17.2 | ||||
Orphan Drugs Division |
Nil | $ | 10.7 |
During each of the two most recently completed financial years, there were no sales or transfers to (i) joint ventures in which the Corporation is a participant or entities in which the Corporation has an investment accounted for using the equity method; or (ii) controlling shareholders.
LEGACY PHARMACEUTICALS DIVISION
Industry Overview
Management of the Corporation believes that a number of trends in the pharmaceutical industry create a favourable environment for the Legacy Pharmaceuticals Division.
United States Demographics
Demographic trends that are expected to maintain or increase the demand for all pharmaceutical products include longer life expectancies and a growth of older segments of the population. As demonstrated in the following chart, the life expectancy of a United States citizen has increased by approximately eight years from 1970 to 2010.
United States Life Expectancy
1970-2010
Source: US Department of Health and Human Services.
As a result of this increased life expectancy, the United States is expected to experience rapid growth of the older segments of its population. This effect will be further enhanced over the next decade as the largest segments of the baby boom generation reach 65 years of age. It is during these later years in life
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that pharmaceutical consumption increases. As illustrated in the chart below, approximately 10% of Americans use five or more prescription drugs, reflecting the need to treat the many diseases that commonly afflict an aging population.
Trends in the Percentage of Persons Using Prescription
Drugs in the United States
Source: CDC
Expanding Medicare Coverage
In the United States, Medicare, which provides health care coverage for citizens aged 65 and over and individuals with disabilities, until 2006 provided almost no coverage for prescription drugs other than drugs administered during a hospital stay or in physician offices. In 2006, Medicare Part D, the outpatient prescription drug benefit, commenced providing Medicare beneficiaries access to affordable prescription drug coverage by subsidizing the purchase of private drug plans. Medicare Part D allows beneficiaries to choose from a range of private drug plans that best meet their needs. This third-party reimbursement has enlarged the potential market of patients for prescription drugs, including certain legacy and orphan products.
Healthcare Reform - The Patient Protection and Affordable Care Act
The United States federal Patient Protection and Affordable Care Act, as amended by the United States federal Health Care and Education Reconciliation Act of 2010 (the Health Care Reform Act ) was signed into law in 2010 with the goal of increasing the quality, accessibility and affordability of health insurance in the United States. The law prevents patients from being denied insurance due to pre-existing conditions, prohibits insurance companies from dropping patients when they are sick, protects against gender discrimination, expands free preventative services and health benefits, expands Medicaid and CHIP, reforms Medicare payment and health care delivery policies, mandates larger employers to insure employees and creates a marketplace for subsidized health care insurance, the result of which provides tens of millions of individuals, families and small businesses with free or low-cost health insurance.
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As a result of the Health Care Reform Act, the pool of patients that previously did not have access to health insurance and drug reimbursement has been significantly expanded.
Government Regulation
The Corporation utilizes Mapi as its provider of regulatory affairs services, medical and drug information provision, and quality assurance services. These services include storage and maintenance of all regulatory dossiers, all routine and ad-hoc reporting and communications with the FDA and adverse drug reporting and provision of medical information relating to the products to physicians and patients. The Corporations outsource agreement with Mapi provides for a cost of service which is fixed for normal functions associated with the medical and regulatory maintenance of the products, with additional costs based on an hourly consulting rate for services as may be needed outside of normal maintenance. Mapi is owned by United Healthcare in the United States and currently services a large number of North American and European pharmaceutical and biotechnology companies in similar capacities.
In addition to providing regulatory, pharmacovigilance and medical information services, Mapi also provides expert market access strategies for the pharmaceutical, healthcare and biotech industry. Mapis senior consultants have extensive pharmaceutical regulatory consulting experience. As one of the largest regulatory affairs and market access consulting firms in North America, Mapis volume of product submissions is often larger than that of many biotechnology and pharmaceutical companies.
The Corporation also outsources to Mapi all activities that typically involve written responses to questions from patients or healthcare providers regarding the Corporations products. The Corporation, through Mapi, has established a dedicated toll-free phone number and mailing address for these drug information requests.
Product Divestitures
Management of the Corporation believes that pharmaceutical companies, particularly Big Pharma, are increasingly choosing to divest their legacy products for a number of reasons, including, but not limited to:
| Normal Course Divestiture of Non-Strategic Assets . Divesting products in the normal course of business in order to align product portfolios with overall business strategies; |
| Financially Motivated Divestitures . Divesting products to address specific near-term cash needs or to fund long-term financial goals; |
| Ongoing Industry Consolidation . Which is accelerating the trend toward portfolio rationalization as business combinations often result in overlapping, redundant and/or non-core drugs in the merged portfolio. In addition, business combinations may result in the divesture of certain products as required by antitrust or competition authorities; |
| Funding the Development, Acquisition or Licensing of Early Stage Drugs . Big Pharma seeking to expand internal product pipelines by: (i) increasing expenditures on internal discovery; and/or (ii) acquiring or licensing products from (typically) smaller, research-focused companies. Investing the proceeds of divestitures into development stage products, thereby expanding the number of promising new products in the pipeline; and |
|
Reallocation of Manufacturing Resources . Continued manufacturing of lower-volume products becomes economically unattractive to Big Pharma companies seeking to optimize manufacturing |
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resources by divesting lower-volume products when opportunities exist to reallocate manufacturing capacity to newer, more strategic or higher volume products. |
As a result, management of the Corporation believes that there is an active market for the acquisition and divestiture of legacy pharmaceutical products and that this market will continue to grow.
Legacy Pharmaceuticals Division Overview
The goal of the Legacy Pharmaceuticals Division is to acquire and manage drugs that are in the maturity or legacy stage of the pharmaceutical product lifecycle and continue on a predictable revenue generation path. These products have a well-established record of safety and efficacy and a history of stable, predictable demand.
The Legacy Pharmaceuticals Division consists of Kapvay ® (clonidine hydrochloride), Orapred ODT ® (prednisolone sodium phosphate), Ulesfia ® Lotion 5% (benzyl alcohol), Donnatal ® (belladonna alkaloids, phenobarbital) and Zonegran ® (zonisamide). Kapvay ® , Orapred ® and Ulesfia ® were acquired from Shionogi in May 2013 for total consideration of $28.7 million, excluding transaction costs. Donnatal ® was acquired from PBM Pharmaceuticals, Inc. in May 2014 for $200 million in cash and an aggregate of 4,605,833 Common Shares and Zonegran ® was acquired from Eisai in September 2014 for $90 million in cash, plus approximately $1.4 million for purchased inventory.
Legacy Products - Kapvay ®
Overview
A class of drugs called psychostimulants or stimulants has been used to treat ADHD for several decades. These medicines help those with ADHD to focus their thoughts and ignore distractions. According to WebMD, stimulant medications are effective in 70% to 80% of patients. This class of drug is used to treat both moderate and severe ADHD. Such drugs may be helpful in children, adolescents, and adults who are having difficulty with ADHD symptoms at school or at work, as well as at home. Some stimulants are approved for use in children over three, while others are approved for children over six.
In cases where stimulants do not work or cause unpleasant side effects, physicians may prescribe a non-stimulant drug, such as Kapvay ® . The first non-stimulant medication approved by the FDA was Strattera. It is now used in children, adolescents, and adults. The FDA subsequently approved a second non-stimulant drug, Intuniv, for children and teens between ages six and 17 and approved the non-stimulant Kapvay ® for use alone or in combination with a stimulant to enhance effectiveness. These medications can all improve concentration and impulse control.
Kapvay ® (clonidine), a non-stimulant treatment for ADHD, was approved on September 28, 2010. Kapvay ® is the only formulation of clonidine hydrochloride approved by the FDA for the treatment of ADHD, and is the first and only FDA-approved non-stimulant ADHD treatment indicated for use as add-on therapy to stimulant medication. Kapvay ® can also be used as monotherapy when treating ADHD. The underlying molecule, clonidine has other uses such as the treatment of high blood pressure. Kapvay ® is in the legacy stage of the product lifecycle, having lost market exclusivity in October 2013 and since that time has lost considerable market share due to generic competition.
Market
According to the American Psychiatric Association, 5% of children in the United States have ADHD; however, studies in the US have estimated higher rates in community samples. Results of recent surveys
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of parents published by the American Psychiatric Association show that approximately 11% of children between the ages of four and 17 (6.4 million children) have been diagnosed with ADHD as of 2011 and that the percentage and rates of ADHD diagnosis have increased from 2003 to 2011.
The following graph sets out the number of Kapvay ® prescriptions since the first quarter of 2011. The decline in branded prescriptions in the fourth quarter of 2013 is a result of the entry into the market of a generic alternative to Kapvay ® .
Source: Symphony Health
Marketing Strategy
At the time of the acquisition of Kapvay ® by CPI, the Corporation understood that loss of FDA exclusivity was imminent. For this reason, promotion for Kapvay ® was limited to direct mail and ongoing support for the Kapvay ® co-pay assistance card program for a brief period of time, until launch of the generic competitor. Following the acquisition of Kapvay ® , the Corporation implemented cost adjustments based on market assessments.
Competition
Existing as well as new generics are viewed by management of the Corporation as the main competitors to Kapvay ® .
Genericization of Kapvay ®
In September 2013, CPI entered into a competitive supply agreement (the Competitive Supply Agreement ) with a generic drug manufacturer. Pursuant to the Competitive Supply Agreement, CPI receives a supply price payment from the counter party.
On October 7, 2013, the generic drug manufacturer who was a party to the Competitive Supply Agreement entered the market with a generic competitor to Kapvay ® . In early December, 2014, CPI launched its own authorized generic of Kapvay ® . To date, such generic manufacturers product represents the only generic competitor to Kapvay ® , however, other generics may enter the market at any time.
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On February 12, 2015, Concordia received a CID from the FTC regarding Kapvay ® and the Competitive Supply Agreement. The CID is a request for documentation and information to determine whether CPI, the counterparty to the Competitive Supply Agreement or their affiliates or any other person has engaged in unfair methods of competition in or affecting commerce by entering into agreements relating to Kapvay ® . CPI and Concordia are cooperating with the information requests.
Legacy Products - Orapred ODT ®
Overview
Orapred ODT ® (prednisolone) is a corticosteroid used in the treatment of several severe allergic reactions in children. Orapred ODT ® was approved on June 1, 2006 for control of severe or incapacitating allergic conditions such as atopic dermatitis, and seasonal and perennial allergic rhinitis which are intractable to adequate trials of conventional treatment.
Many oral corticosteroids have a very bitter taste that discourages pediatric patients from correctly taking their medication for the full duration of their treatment plans. Orapred ODT ® was developed with a truly unique and effective taste masking technology, using a tri-layer process that encapsulates the active ingredient deep inside the tablet. Orapred ODT ® is in the legacy stage of the product lifecycle, having lost market exclusivity in December 2014 and since that time lost market share to a generic competitor.
Market
According to the American Lung Association, over 8.5 million children in the United States suffer from asthma, making it the leading chronic illness among children. More than 25% of children diagnosed with asthma reported an emergency room visit or urgent care visit due to their asthma in the past year and 9% reported an overnight stay. On average, children with uncontrolled asthma visit an emergency room three times a year.
The following graph sets out the number of prescriptions of Orapred ODT ® since the first quarter of 2011. The decline in volume in the fourth quarter of 2014 is a result of the entry into the market of a generic alternative to Orapred ODT ® .
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Orapred ODT
Source: Symphony Health
Marketing Strategy and Genericization of Orapred ODT ®
Shionogi entered into a Paragraph IV settlement with Mylan that allowed Mylan to launch a generic Orapred ODT ® on April 1, 2014. On December 8, 2014, Mylan launched its generic Orapred ODT ® . Management of the Corporation is currently reviewing opportunities with a generic drug manufacturer to produce an AG for Orapred ODT ® .
Competition
Other than new generics for Orapred ODT ® , management of the Corporation believes there are no new competitors to Orapred ODT ® in development.
Legacy Products - Ulesfia ®
Overview
Ulesfia ® is a topical treatment for head lice in patients six months of age and older and was approved by the FDA on April 9, 2009. It is the only prescription head lice product that is not an insecticide. Patents for Ulesfia ® expire on August 11, 2017, July 11, 2022 and May 19, 2024. Expiration of such patents may bring about additional competition. However, management of the Corporation believes that Ulesfia ® will be difficult to genericize because it is a topical treatment and there is no established pathway to develop a generic version of Ulesfia ® .
Ulesfia ® Lotion is a white topical lotion containing benzyl alcohol, 5% (50 mg/g of lotion) and is packaged in two individual eight fl. oz. polypropylene bottles with a nit (egg) comb. Ulesfia ® Lotion is non-neurotoxic and is used as part of an overall lice management program that includes the use of a fine-tooth comb or special nit comb to remove dead lice and nits. Ulesfia ® Lotion works by suffocating head lice. The active ingredient stuns the breathing holes, or lungs, of head lice. The other ingredients then clog the breathing holes, killing the lice. There is evidence that head lice are becoming resistant to some other treatments. Management of the Corporation believes that Ulesfia ® has a unique mode of action and is intended to work in such a way that resistance is reduced.
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Market
Reliable data on yearly head lice incidence in the United States is not available; however, the CDC estimates that six to 12 million infestations occur each year in the United States among children from 3 to 11 years of age.
The following chart illustrates the prescription volumes by quarter achieved by Ulesfia ® since 2011. The decline in share in the second quarter of 2014 is due to the loss of a preferred formulary position within a state Medicaid plan.
Pediculosis Treatments
Source: Symphony Health
Marketing Strategy
Management of the Corporation believes that Ulesfia ® will enjoy market exclusivity for the foreseeable future and that a generic entry for Ulesfia ® is not likely given that: (a) there are three listed patents; and (b) there is not a clear pathway at present for approval of a generic competitor.
Distribution Agreement with Lachlan Pharmaceuticals
On January 6, 2014, the Corporation announced that it entered into an Exclusive Distribution Agreement with Lachlan Pharma Holdings ( Lachlan ), a global pharmaceutical company, with a term of five years for the exclusive distribution of Ulesfia ® Lotion in the United States. Lachlan has an agreement with Zylera Pharmaceuticals, LLC ( Zylera ) to commercialize Ulesfia ® Lotion in the United States. The agreement provides Ulesfia ® with access to Zyleras sales force, as well as its wholesale and retail network. The Corporation believes that this partnership should help maintain the existing sales of Ulesfia ® Lotion across the United States.
Competition
There are several OTC and prescription drug treatments for head lice. OTC products currently constitute the majority of sales for treatment of this condition. Of the prescription drug treatments, Ulesfia ® is a market leader as the Corporation is able to leverage its brand and positioning as the only non-insecticide prescription treatment. Other prescription treatments include Stromectol which is marketed by Merck,
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Lindane which is marketed by Morton Grove Pharmaceuticals, and Ovide which is marketed by Medicis (Valeant).
Legacy Products - Donnatal ®
Overview
Donnatal ® is an adjunctive therapy for both IBS and acute enterocolitis. Currently, Donnatal ® is the only marketed phenobarbital and belladonna alkaloid combination product. Donnatal ® is available in two formulations, tablets and elixirs. Due to a unique regulatory history, management of the Corporation is not aware of any current competition from generics, despite the absence of patent or FDA-granted exclusivity. For this reason, while considered a legacy pharmaceutical product, Donnatal ® is in the Growth Stage of the product lifecycle.
Market
IBS is a chronic, life-long disease that requires long-term treatment. According to the CDC, the disease affects about 1 million to 1.3 million people in the United States with a higher incidence of Crohns disease in women and a slightly higher incidence of ulcerative colitis in men; however, as there are no standard criteria for diagnosing IBS, the precise rate of incidence is unknown. Safety of certain newer IBS therapies introduced during the last 15 years have demonstrated serious adverse events post-approval, leading in some cases to their withdrawal from the market; therefore, management of the Corporation believes physicians will tend to prefer older drugs like Donnatal ® .
Donnatal ® is the only phenobarbital and belladonna alkaloid product that has distinct legal rights to be actively marketed. Predecessor owners of Donnatal ® gained these rights by investing in clinical studies that promoted the efficacy of the drug and by complying with all FDA rulings and requests pertaining to the drugs DESI status since the 1970s. Donnatals ® competitors, both brands and generics, decided to forgo efficacy and clinical testing and therefore waived their right to legal entry into the marketplace.
Following its acquisition of Donnatal ® , the Corporation implemented cost adjustments based on market assessments. Management of the Corporation believes that, going forward, Donnatal ® has the opportunity to gain market share in the IBS sector.
Donnatal
Source: Symphony Health
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Marketing Strategy
A robust commercial infrastructure actively promoting Donnatal ® was acquired along with the product. Promotion for the drug is based on data analysis and various strategies to maximize profitability. The Corporation believes that its targeted representative coverage provides for successful, efficient sales management. Each week, Donnatals commercial team visits over 1,500 physicians by utilizing a broad array of sales and marketing tools.
Competition
In treating IBS, physicians often prescribe multiple medications in order to obtain adequate overall symptom relief. For this reason, management of the Corporation believes that the recent introduction and heavy promotion of new products to treat IBS that are specifically indicated for only certain types of IBS (i.e. constipation and diarrhea) may positively impact Donnatal ® volumes, as the Donnatal ® labelling states that Donnatal ® is indicated as adjunctive (additive) therapy in the treatment of irritable bowel syndrome.
Legacy Products - Zonegran ®
Overview
Zonegran ® (zonisamide) is a second generation adjunctive (additive) therapy for the treatment of partial seizures in adults with epilepsy. Zonegran ® was approved by the FDA in March 2000 and is a recognized prescribed drug for epilepsy. Zonegrans ® patent expired in March 2005 and there are currently nine approved generic competitors; however, management of the Corporation believes that Zonegran ® has a steady prescription base due to patient and physician loyalty to the brand. Management of the Corporation believes that doctors have long prescribed Zonegran ® due to its safe track record, it being a well-tolerated solution for patients, fewer side effects resulting from use of the drug, there being less of a need for monitoring, and the drug not being associated with unwanted weight gain as might be associated with other AED products.
Market
According to the CDC, epilepsy affects about 2.3 million adults and 467,711 children up to 17 years of age in the United States. Approximately one in 26 people will be diagnosed with epilepsy at some point in their lives and approximately 150,000 new cases of epilepsy will be diagnosed in the United States each year. Epilepsy results in an estimated $15.5 billion in annual medical costs and lost or reduced earnings and production.
This market is expected to grow as a result of the introduction of newer, third generation drugs; however, management of the Corporation believes that the second generation class of epilepsy drugs, to which Zonegran ® belongs, should maintain its market, sales-leader position, as all classes of these drugs experience a more gradual incorporation into the epilepsy treatment algorithm.
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Zonegran
Source: Symphony Health
Marketing Strategy
Zonegran ® has been off patent since 2005 and sales have remained relatively stable due to small volume declines offset by cost adjustments. The previous owner of the drug, Eisai, did not actively promote Zonegran ® primarily due to the drugs high degree of stability, which was owed largely to physicians reluctance to switch well-controlled epilepsy patients onto newer branded therapies or generic alternatives.
Genericization of Zonegran ®
Despite the expiration of Zonegran ® patents and loss of market exclusivity, and despite the availability of nine approved generic equivalents available, branded Zonegran ® has maintained, and the Corporation expects it to continue to maintain, an atypically large share of all zonisamide prescriptions due to:
| the long (4-6 weeks), carefully monitored titration schedule required to get patients to the efficacious (seizure free) dose; |
| the importance of maintaining both epilepsy and psychiatry patients at precisely their most efficacious dose; |
| epilepsy patients being treated, at least for the first year following diagnosis, by a specialty physician, typically a neurologist; and |
| management of the Corporations belief that specialty physicians are much more apt than general practitioners / family physicians to insist that branded medications, not generics, be dispensed for their patients. |
Competition
In the United States, Zonegran ® is currently off patent and although there are nine generic competitors, there is less switching between branded and generic combinations as epilepsy patients are unlikely to switch off of a combination that is controlling their seizures. It is more likely that generic products or other molecules will be targeted for new patients and for patients that are not adequately controlled by existing medications thus growing the overall market.
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SPECIALTY HEALTHCARE DISTRIBUTION DIVISION
Specialty Healthcare Distribution Division Overview
The SHD Division is a nation-wide provider of diabetes testing supplies and other healthcare products in the United States. The SHD Division operates primarily out of an office and warehouse facility in Kansas City, Missouri.
The SHD Division provides a reliable method for its patients to obtain medical supplies through the mail. It has created a seamless process for the customer by directly billing insurance companies, collecting and maintaining prescriptions, and ordering and delivering the goods to the customer, while keeping the customer informed throughout the process. The SHD Division has invested substantially in the area of diabetes education for its customers. Every product sent to customers includes valuable diabetes-related educational materials, an informative newsletter and recipes. More recently, the Corporation has decided to discontinue the distribution of its lower margin products leading to a product mix shift with more favourable margins.
Orphan and specialty products require a direct relationship with patients and doctors and require that the distributor of these products have the capacity to carry-out these functions. As many of these products are shipped just in time for administration, the distributor must have the pharmacist and distribution channel that will enable the doctors to liaise directly with the distributor. Moreover, after administration, the nursing staff within the distributor will have direct contact with the patients to monitor patient outcomes.
The Corporation intends to set up a specialty pharmacy channel within the SHD Division in the future to distribute orphan and specialty drugs. The Corporation intends that the specialty pharmacy distribution channel will have the capacity to carry out the direct to patient dialogue through its nursing staff to ensure the best possible patient outcome. By having the capacity to carry out these functions internally, the Corporation expects to retain control over the distribution of high value products.
Industry Overview
United States domestic healthcare spending is expected to increase by approximately $2.1 trillion from $2.7 trillion in 2011 to $4.8 trillion in 2021, according to CMS.
The SHD Division has historically targeted seniors and diabetics. As the baby boomer population ages, CMS estimates that the number of Americans over the age of 65 will increase from an estimated 42.1 million in 2012 to 55.9 million in 2021. According to research by the Robert Wood Johnson Foundation, over 90% of Americans over the age of 65 have at least one chronic condition, and over 70% of this population has multiple chronic conditions.
The products that the Corporation distributes are classified as DME. CMS estimates that the national expenditures within the DME market will increase by over $30 billion from $39.7 billion in 2011 to $70.7 billion in 2021. The number of DME companies with Medicare billings less than $300,000 has been declining, or consolidating, over the last few years according to HME News, primarily as a result of increased Medicare accreditation and bonding requirements implemented in 2009.
Diabetes Market
According to the CDC, 29.1 million people in the United States, or 9.3% of the population, have diabetes. Of these people, 21.0 million are diagnosed, while 8.1 million remain undiagnosed, meaning that 27.8% of Americans with diabetes remain undiagnosed. The total direct and indirect costs of diabetes to the
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United States are approximately $245 billion annually. Of these, direct medical costs account for approximately $176 billion and indirect costs (e.g. disability, work loss and premature death) account for approximately $69 billion. After adjusting for differences on account of age and sex, average medical expenditures among people with diagnosed diabetes were 2.3 times higher than people without diabetes.
SHD Division Operations
The SHD Division has streamlined its processes, beginning with the intake of the customer from the lead generation source, to shipment of the customers supplies from the warehouse, and through to the periodic reorder process. Management of the Corporation believes that the operations of the SHD Division is one of its key success factors, with a highly trained, professional staff of 77 employees (including the sales team) that services its customer base. The following operational functional descriptions apply to the majority of the SHD Divisions business.
Lead Generation - The SHD Division works with lead generation companies, who conduct marketing campaigns primarily through the internet, to gain new customers who have a need and inclination to receive their diabetes testing supplies through the mail.
Enrolment - Leads from the lead generation company are provided to the SHD Divisions Enrolment Department, which then contacts the customers and verifies information that the customer has provided to the lead generation company. An enrolment representative then proceeds to the sales process. The Enrolment Department handles each account according to the United States federal Health Insurance Portability and Accountability Act of 1996 ( HIPAA ) and applicable regulations and ensures that customer information is accurate.
Document Retrieval - The Document Retrieval Department is responsible for obtaining new prescriptions, refill prescriptions and medical documentation. The employees that review the prescriptions review approximately 150 prescriptions each day for accuracy and completeness. The prescription is verified for completeness and accuracy and then saved to the customers medical file.
Insurance Department - Once a valid prescription has been received, the Insurance Department is notified and then verifies the customers insurance coverage. This is where it is determined whether the supplies will go through the customers medical or pharmacy benefit. Once the customer has a valid prescription and their insurance benefits have been verified, the order is set up in the system, and is made ready for shipment.
Pharmacy - The SHD Division has a full-service pharmacy with accredited and licensed pharmacists on staff and with sufficient resources to nationally service a wide customer base with multiple products. This pharmacy has full fulfillment capacity and can ship medications across the United States.
The Corporation is developing the specialty pharmacy aspect of this pharmacy operation, and intends to flow additional pharmaceutical products through the SHD Divisions pharmacy.
Warehouse and Shipping Department - Once the pharmacy adjudication has been done or the medical order set, the packing slips are mass printed and sent to the warehouse to fulfill the orders.
Reorders Department - If a customer receives supplies through their health insurance, the Reorders Department is primarily responsible for processing those customers orders. Each time a reorder of supplies is due to be shipped, the reorder representative calls and confirms the order with the customer.
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Customer Service - The Customer Service Department is a key strength of the SHD Division, with employees handling upwards of 400 calls per day.
Billing Department - The Billing Department collects payments on an average of 1,700 claims billed per day. The average Days Sales Outstanding for the SHD Division is 50 days.
SHD Division Products
The following are some of the key products of the SHD Division.
Diabetes Testing Supplies and Pharmaceutical Products
The SHD Division provides a full range of diabetic testing supplies required to meet the needs of the Corporations customers, including: test strips, blood monitoring equipment/meters, lancets, lancing devices, control solutions and batteries. Diabetic testing supplies comprise the majority of the total revenue of the SHD Division. If a customer has an insurance provider other than Medicare, the SHD Division provides supplies for these customers and accepts assignment of insurance. Most of the diabetes supply business now runs through the pharmacy as most insurance plans consider these supplies to be part of the pharmacy benefit.
Wound Care Supplies
It is estimated by the CDC that each year there are approximately 82,000 diabetic amputations in the United States. This is because diabetes can cause complications (including nerve damage, a weakened immune system and the narrowing of arteries) that prevent wounds from healing properly, especially wounds on the lower legs and feet. These wounds may eventually become infected to a point where the entire lower extremity on which the wound resides needs to be removed. The SHD Division has teamed with DeRoyal wound care products to present the customer with an easy to use, seamless process for obtaining their wound care supplies. The SHD Division and DeRoyal work closely with the doctor to determine a treatment approach and stay in touch with the doctors office and the customer to ensure proper healing of the wound.
Urologicals - Catheters
There are many reasons that someone may require a urinary catheter. The SHD Divisions Catheter Supply Specialists are trained on products for both male and female catheterizing, and the Corporation supplies an extensive line of catheter supplies available to its customers. The catheter-related business of the SHD Division is not limited to diabetic customers.
Other Products
The SHD Division also sells orthotic braces, CPAP supplies and therapeutic products for the treatment of erectile dysfunction.
SHD Division Marketing
The SHD Division operates through the trade name Complete Medical Homecare. The SHD Division has historically undertaken a number of different approaches to marketing its products, including the following:
| inserting box stuffers with shipments to promote some of its other products (e.g., CPAP, wound care products, catheters); |
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| managing a reward program, whereby customers were rewarded with various gifts for their loyalty (e.g., diabetic cookbooks); |
| utilizing national online advertising techniques to promote diabetes testing supplies; |
| listing advertisements in local newspapers; and |
| distributing coupons within shipments, as well as posting coupons on the Corporations website. |
SHD Division Suppliers
The SHD Division sources its products from various manufacturers. As sales volumes have increased, partnerships have been developed with large manufacturers, enabling the Corporation to obtain preferred pricing and maintain a readily available supply of products for its customers medical necessities.
For the product areas of wound care supplies and urinary catheters, the SHD Division developed a relationship with Invacare Supply Group, now Independence Medical. With this relationship in place there is access to fifty or more manufacturers. For these product areas, the Corporation often utilizes Independence Medicals drop ship capabilities.
The SHD Divisions supplier/manufacturer base includes industry-recognized names such as: Diamond Diabetics Products (meters and supplies), Omnis, Biosense, Arkray and Medicine.
SHD Division Competition
The largest competitors to the SHD Division are CCS Medical, Arriva Medical, Walgreens, Target, Wal-Mart and CVS.
Management of the Corporation believes that the SHD Division sets itself apart from its competition through its customer service which includes: (a) a personal touch (live customer care coordinators versus an automated phone service that many of the competitors use), and (b) a seamless, efficient processing environment.
The subsector of specialty pharmaceutical distribution is dominated by AmerisourceBergen. Other distributors are McKesson Specialty, Curascript SD, Metro Medical and others.
Corporate Compliance
The SHD Division is nationally accredited to conduct Medicare-related business. Prior to Concordia Private Co.s acquisition of the business of the SHD Division, Global Medical Direct and Midwest Medical Services (the predecessor companies to the SHD Division) were investigated in February of 2012 by the United States Department of Justice and the United States Attorneys Offices for the Districts of Louisiana and Kansas. The investigation centered on the companies lead generation/marketing arrangements. The companies were accused of violating the Anti-Kickback Statutes and submitting false claims for diabetic supplies being provided to beneficiaries of federally funded healthcare programs. The companies owners have settled the case, and were mandated to sell the assets of the companies and pay restitution. Concordia Private Co. purchased the assets free and clear of any future claims from the government in relation to the investigations and resultant settlement.
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The SHD Division has strengthened its Corporate Compliance Program. It maintains an ongoing training program for its employees, which includes education on compliance with HIPAA and Medicare regulations, as well as industry and product training. The SHD Division has in place monitoring and auditing processes that allow the detection and prevention of compliance-related issues. The Corporation has implemented a thorough training program for the employees of the SHD Division, educating them on the rules surrounding the method with which customers can be solicited. Each employee is required to take a class and certify their understanding, compliance and adherence to the issue. Additionally, subsequent to the purchase by Concordia Private Co. of the business of the SHD Division, the Corporation engaged, on a term basis, an accredited Medicare Auditor to assist it with strengthening its internal compliance process.
Medicare Competitive Bidding
On July 1, 2013, CMS implemented the Medicare Bidding Program for diabetes testing supplies. Under this program, Medicare beneficiaries must obtain their diabetes testing supplies from one of the 20 companies that were awarded a contract, or obtain their supplies from their local pharmacy. The SHD Division did not apply for a contract under that competitive bidding program and elected to focus on private insurance.
ORPHAN DRUGS DIVISION
Orphan Drugs Division Overview
The Orphan Drugs Division is intended to provide growth opportunities through the expansion into new indications and new markets for existing or acquired orphan drugs. In the initial execution of its orphan drug strategy, Concordia Private Co., through its subsidiaries, acquired Pinnacle. Photofrin ® is owned by CLI, a subsidiary of the Corporation, and is FDA approved for the treatment of three rare forms of cancer.
Industry Overview
The ODA provides the framework for drug development to support the research of drugs for rare diseases. The ODA defines rare diseases as those with prevalence of disease in the population of less than 200,000 people. Alternatively, the ODA states that when the drug developer could have no reasonable expectation of profitability after developing a drug for a rare disease in the United States, the FDA may designate such a product as an orphan drug.
The OOPDs mission is to advance the evaluation and development of products that demonstrate promise for the diagnosis and/or treatment of rare diseases or conditions. In fulfilling that task, OOPD evaluates scientific and clinical data submissions from sponsors to identify and designate products as promising for rare diseases and to further advance scientific development of such promising medical products. The OOPD also provides incentives for sponsors to develop products for rare diseases. The program has successfully enabled the development and marketing of more than 400 drugs and biologic products for rare diseases since 1983. In contrast, fewer than 10 such products supported by industry came to market between 1973 and 1983. The Orphan Grants Program has been used to bring more than 45 products to marketing approval.
The National Institute of Health currently lists approximately 7,000 rare diseases, the majority of which are heritable or congenital and which affect approximately 25 million Americans. To receive orphan designation, a drug manufacturer must: (a) certify that the product is for a rare condition; (b) provide a scientific rationale for using the drug for that rare condition; and (c) provide supporting epidemiologic data.
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Once a disease has obtained the orphan designation, the ODA provides the manufacturer of a product that treats the orphan disease with the following benefits: (a) seven years of market exclusivity from the date of approval, meaning that no generic competitor can enter the market regardless of whether the innovator has a patent; (b) federal tax credits equal to 50% of clinical research expenditure to aid in the funding of development; (c) an exemption from the fee for FDA approval - which fee is in excess of $1.1 million; and (d) priority FDA review (accelerated approval process).
Management of the Corporation believes that orphan drugs are particularly attractive for two other reasons: (a) these products tend to have competitive value when compared to traditional pharmaceutical products; and (b) the selling and promotional expenses are substantially lower and offer greater returns than for traditional pharmaceutical products. As orphan drugs target very rare diseases, the physician community that treats patients with such diseases is typically very small. As a result, communication with this physician base requires a much smaller number of sales representatives. Additionally, the uptake of the drug by the physician base is typically much faster as the disease may have no alternate therapy and given the relatively small targeted population.
The following table sets out a sample of orphan drug treatments approved in the United States. Of significance are the accepted annual treatment costs which drive the relatively high revenues and margins in an otherwise small market (incidence of disease among total population).
Company |
Product |
Indication |
Incidence |
Annual Treatment Cost | ||||||
BioMarin |
Kuvan | Phenylkentonuria | 1-2/20,000 | $ | 80,000+ | |||||
Genzyme |
Cerezyme | Gaucher Disease | 1/20,000 | $ | 165,000+ | |||||
Genzyme |
Myozyme | Pompe Disease | 1/40,000 | $ | 300,000+ | |||||
Shire |
Elaprese | Hunter Syndrome | 1/81,000 males | $ | 300,000+ | |||||
Genzyme/BioMarin |
Aldurazyme | MPS I | 1/100,000-600,000 | $ | 175,000+ | |||||
BioMarin |
Naglazyme | MPS VI | 1/250,000-600,000 | $ | 300,000+ | |||||
Alexion |
Soliris | aHUS | ~2/1,000,000 | $ | 409,000+ | |||||
Alexion |
Soliris | PNH | 1-5/1,00,000 | $ | 409,000+ |
Source: Torreya Partners
In reviewing orphan drug opportunities, management of the Corporation seeks products that are already approved for one indication but can be developed to treat other indications. As the product is already approved, its safety and efficacy have been reviewed and accepted by the FDA, and therefore clinical development risk to the Corporation is reduced.
PDT with Photofrin ®
Pinnacle Biologics Inc.
The Corporations European subsidiary, Pinnacle Biologics B.V., is a Netherlands private limited liability entity, and is a wholly-owned subsidiary of Pinnacle. The entity was established in 2008 to commercialize pharmaceutical products outside of North America, consistent with the overall strategy of Pinnacle. Pinnacle Biologics B.V. has no employees. Dutch operations are managed through a service agreement with Trust Company Amsterdam. Compagnie Biologiques Pinnacle is a Quebec, Canada, entity incorporated to employ individuals residing in Canada, and is a wholly-owned subsidiary of Pinnacle. Pinnacle Oncology LLC is a partnership between Pinnacle, the University of Chicago and two individuals associated with the university. The purpose of this entity is to develop Pinnacle Oncology LLCs licensed patents to bring pharmaceutical products to the market in the field of protection against genotoxic mutagenesis.
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Photodynamic Therapy with Photofrin ®
The legacy pharmaceutical product owned by CLI, Photodynamic Therapy ( PDT ) with Photofrin ® , is a light-based (cancer) treatment that uses sodium porfimer (brand name Photofrin ® ), a photosensitizing drug derived from oxygen binding proteins found in blood. Photofrin ® is marketed by Pinnacle in the United States. Photofrin ® is intravenously administered and is differentially absorbed by tumorous cells. When activated by 630 nanometer lasers, Photofrin ® produces reactive singlet oxygen that attacks tumors through multiple tumoricidal cascades, including:
| direct cell attacks; |
| induction of apoptosis (programmed cell death); |
| destruction of malignant neovasculature; and |
| initiation of an immune response against the cancer. |
PDT with Photofrin ® has three oncology indications approved by the FDA; Esophageal Cancer, Barretts Esophagus and NSCLC. PDT with Photofrin ® is being further developed for the treatment of an additional rare form of cancer, cholangiocarcinoma.
Management of the Corporation believes that the patent portfolio that protects the product, in combination with certain manufacturing and regulatory hurdles, makes the product difficult to genericize.
Existing Indications
Esophageal Cancer
PDT with Photofrin ® is indicated to help lessen symptoms of esophageal (food pipe) cancer when the cancer blocks the esophagus or when the cancer cannot be treated with laser alone. The American Cancer Society estimates that there are approximately 16,000 new cases of esophageal cancer diagnosed annually in the United States. In general, the prognosis of esophageal cancer is quite poor, because most patients present with advanced disease.
Barretts Esophagus
PDT with Photofrin ® is indicated for the ablation of high-grade dysplasia in Barretts esophagus patients who do not have part or all of their esophagus removed with surgery. The American Cancer Society estimates that there are approximately 18,000 new cases of Barretts esophagus diagnosed annually in the United States. Barrett esophagus is a premalignant condition. Its malignant sequela, esophageal adenocarcinoma, has a mortality rate of over 85%.
Non-Small Cell Lung Cancer
Photofrin ® is indicated for the treatment of microinvasive endobronchial NSCLC in patients for who surgery and radiotherapy are not indicated. Photofrin ® is indicated for the reduction of blockage and symptom relief in patients with endobronchial NSCLC that partially or totally blocks the bronchi (airways entering the lungs). In these patients, PDT with Photofrin ® is used to relieve symptoms with endobronchial NSCLC when the cancer obstructs or blocks the airway. The American Cancer Society estimates that there are approximately 225,000 new cases of lung cancer diagnosed annually in the United
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States, of which a proportion are NSCLC and a proportion of those are candidates for treatment with Photofrin ® .
New Indications
Cholangiocarcinoma
Future growth is expected to come from clinically developing and marketing PDT with Photofrin ® for new indications, the first one being cholangiocarcinoma. Along with a marketable indication and corresponding product labeling, additional benefits of clinically developing PDT with Photofrin ® for cholangiocarcinoma include Orphan Drug Designation and subsequent market exclusivity benefits in the United States and the European Union.
Special Protocol Assessment
On November 12, 2013, Pinnacle reached an agreement with the FDA under a special protocol assessment to enroll patients with an advanced form of bile duct cancer in a pivotal Phase 3 clinical trial. There is currently no approved therapy for this cancer type. The special protocol assessment is a written agreement with the FDA regarding the design, endpoints and planned statistical analysis approach of the trial to be used in support of a potential NDA submission. The clinical trial will study the efficacy and safety of PDT with Photofrin ® as treatment for unresectable advanced perihilar cholangiocarcinoma Bismuth type III/IV.
Other Developments
On March 26, 2014, the Corporation was granted FDA premarket supplemental approval for its Optiguide ® DCYL700 Fiber Optic Diffuser Series flexible fiber. The Optiguide DCYL700 Fiber Optic Diffuser Series is a light delivery system used in PDT with Photofrin ® . The system features a more flexible, narrower cylindrical diffuser design that may assist physicians by providing greater access to tumors located in the right upper lobe of the lung and by improving maneuverability in other potentially challenging anatomic areas of the bronchus. The Optiguide ® DCYL700 Fiber Optic Diffuser Series is the latest addition to the Corporations portfolio of photodynamic products.
On July 23, 2014, Pinnacle entered into a collaboration agreement with Orphan Canada, a Toronto-based specialty pharmaceutical company that in-licenses therapies for rare disorders and specialty medicines within Canada. This agreement was later assigned to Knight Therapeutics Inc. ( Knight ) and CLI, respectively. Pursuant to the collaboration agreement, CLI and Knight will partner to support the continued supply of Photofrin ® in Canada, where it is approved for the treatment of certain forms of gastrointestinal, lung and bladder cancers.
On August 5, 2014, the Corporation announced that Thomas Jefferson University Hospital in Philadelphia, Pennsylvania was the first site approved to enroll patients in the Phase 3 multicenter clinical trial using Photofrin ® .
The Corporation enrolled the first patients in a randomized Phase 2 trial to evaluate PDT with Photofrin ® for patients with epithelioid malignant pleural mesothelioma. The study is expected to enroll over four years and is supported by a grant from the National Cancer Institute. The Corporation also initiated the Phase 3 bile duct cancer trial in Germany and the Phase 3 bile duct cancer trial in Korea.
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On November 28, 2014, the Corporation announced that Thomas Jefferson University Hospital had enrolled the first patient in the Phase 3 multicenter clinical trial. On February 12, 2015, the Corporation announced that it had enrolled its first patient in Phase 3 multicenter clinical trial in Korea.
RISK FACTORS
The following sets forth certain risks and uncertainties that could have a material adverse effect on the Corporations business, financial condition and results of operations and the trading price of the Common Shares, which could decline, and investors may lose all or part of their investment. Additional risks and uncertainties of which the Corporation currently is unaware or that are unknown or that it currently deems to be immaterial could have a material adverse effect on the Corporations business, financial condition and results of operations. The Corporation cannot assure you that it will successfully address any or all of these risks. The risks described below describe certain currently known material factors, any of which could have a material adverse effect on the Corporations business, financial condition and results of operations. There is no assurance that any risk management steps taken will avoid future loss due to the occurrence of the risks described below or other unforeseen risks.
Risk Factors Related to the Business
The Corporation has a limited operating history.
Concordia Private Co. was formed in December, 2012, and acquired (i) the SHD Division, (ii) Pinnacle; and (iii) many of the Corporations legacy pharmaceutical products (including Kapvay ® (clonidine extended release tablets), Ulesfia ® (benzyl alcohol) Lotion 5%, and Orapred ODT ® (prednisolone sodium phosphate orally disintegrating tablets)) in 2013. The Corporation also acquired its legacy pharmaceutical products, Donnatal ® (belladonna alkaloids, phenobarbital) and Zonegran ® (zonisamide) in 2014. The Corporation had no operations prior to acquiring Concordia Private Co. and Concordia Private Co. had no operations prior to acquiring its assets in 2013. The Corporations relatively brief operating history may make it difficult to evaluate the Corporations prospects for success and the ability of the Corporation to continue to declare and pay cash dividends to its shareholders. There is no assurance that the Corporation will continue to be successful and the Corporations operations and business may not be sustainable or may prove to be unsuccessful. The Corporation is in a relatively early stage of its operations and the likelihood of ongoing success of the Corporation must be considered in light of its stage of operations.
The Corporation has grown at a very rapid pace and the Corporation may be unable to successfully manage and/or support this growth.
The Corporations rapid growth has put significant demands on its processes, systems and personnel. The Corporation has made and expects to make further investments in additional personnel, systems and internal control processes to help manage its growth. If the Corporation is unable to successfully manage and/or support its rapid growth and the challenges and difficulties associated with managing larger, more complex operations and its business, this could have a material adverse effect on the Corporations business, financial condition and results of operations.
The Corporation may be unsuccessful in evaluating material risks involved in completed and future acquisitions.
The Corporation regularly reviews acquisition opportunities and as part of the review, conducts business, legal and financial due diligence with the goal of identifying and evaluating material risks involved in any particular acquisition. Despite the Corporations efforts, it may be unsuccessful in identifying and/or
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evaluating all such risks. As a result, the Corporation may not realize the expected benefits and synergies of any given acquisition. If the Corporation fails to realize the expected benefits and/or synergies from one or more acquisitions, or does not identify all of the risks associated with a particular acquisition, this could have a material adverse effect on the Corporations business, financial condition and results of operations.
In addition, while the Corporation has structured most of its recent acquisitions as asset purchases, it may fail to discover liabilities of any acquired companies for which it may be responsible as a successor owner or operator in spite of any investigation made prior to the acquisition. Such discoveries may divert significant financial, operational and managerial resources from existing operations, and could have a material adverse effect on the Corporations business, financial condition and results of operations.
The Corporation may be unable to identify, acquire or integrate acquisition targets successfully.
Part of the Corporations business strategy includes identifying, acquiring and integrating businesses, products, pharmaceuticals or other assets that the Corporation believes are complementary to its existing businesses, products, pharmaceuticals or other assets, and forming strategic alliances, joint ventures and other business combinations, to help drive future growth. The Corporation may also in-license new products or pharmaceuticals.
Acquisitions or similar arrangements may be complex, time consuming and expensive. The Corporation may enter into negotiations for an acquisition but determine not to, or be unable to, complete any particular acquisition or other arrangement, which could result in a significant diversion of management and other employee time, as well as substantial out-of-pocket fees and costs. In addition, in these circumstances, the Corporation could be subject to certain additional risks including that the market price of the Common Shares may reflect a market assumption that any such acquisition or other arrangement will occur, and a failure to complete such acquisition or other arrangement could result in a negative market perception regarding the Corporations ability to complete an acquisition and/or its business generally, resulting in a decline in the market price of the Common Shares and value of any other securities of the Corporation.
If an acquisition or other arrangement is completed, the integration into the Corporations business with the business, product or asset that is so acquired or subject to such other arrangement may also be complex and time-consuming and, if any such business, product and/or asset is not successfully integrated, the Corporation may not achieve the anticipated benefits, cost-savings or growth opportunities and may experience other opportunity costs. Potential difficulties that may be encountered during the integration process include, but are not limited to the following:
| integrating personnel, operations and systems, while maintaining a focus on selling and marketing existing and newly-acquired businesses, products and/or assets; |
| coordinating geographically dispersed organizations; |
| focusing management and employees on continued operations; |
| retaining existing customers and attracting new customers; |
| managing new products with which the Corporation has limited or no experience; and |
| identifying and managing inefficiencies associated with integrating the operations of the Corporations business. |
Furthermore, these acquisitions and other arrangements, even if successfully integrated, may not advance or enhance the Corporations business strategy as anticipated (or to an extent that the cost of such acquisitions and other arrangements would be justified), and they may expose the Corporation to increased competition or challenges with respect to the Corporations products or geographic markets and
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expose the Corporation to additional liabilities, including litigation, tax and successor liability risks, associated with any business, product or other asset that is acquired or subject to such other arrangement. Any one of these challenges or risks could impair the Corporations ability to realize any benefit from any such acquisition or other arrangement and this could have a material adverse effect on the Corporations business, financial condition and results of operations.
The Corporation relies on third parties to manufacture its products and its products could be subject to manufacturing or supply difficulties.
The Corporation does not have the internal capability to manufacture pharmaceutical products and relies on third parties to manufacture its products. The Corporation cannot be certain that manufacturing sources will continue to be available or that it can continue to out-source the manufacturing of its products on reasonable or acceptable terms or at all. Any loss of a manufacturer or any difficulties that could arise in the manufacturing process could significantly affect inventories and supply of products available for sale. If the Corporation is unable to supply sufficient amounts of its products to customers on a timely basis, its market share and/or revenues could decrease. If any of the Corporations third-party manufacturers are unable to manufacture its products or the manufacturing process is interrupted for any reason, it could have a material adverse effect on the Corporations business, financial condition and results of operations.
All of the Corporations contract manufacturers must comply with the applicable FDA regulations, which include quality control and quality assurance requirements, as well as the corresponding maintenance of records and documentation and manufacture of products according to the specifications contained in the applicable regulatory file. If any of the Corporations contract manufacturers do not or cannot comply with these requirements, the availability of marketed products for sale could be substantially reduced. In addition, the facilities of the Corporations contract manufacturers must be inspected and found to be in full compliance with current good manufacturing practices ( cGMP ) and quality system management requirements. The failure of any of the Corporations contract manufacturers to comply with cGMP regulations or quality system management requirements can result in enforcement action by the FDA, including, but not limited to, warning letters, fines, injunctions, civil or criminal penalties, recall or seizure of products, total or partial suspension of production or importation, suspension or withdrawal of regulatory approval for approved or in-market products, refusal of the government to renew marketing applications or approve pending applications or supplements, suspension of ongoing clinical trials, imposition of new manufacturing requirements, closure of facilities and criminal prosecution. If any of the Corporations contract manufacturers becomes subject to any enforcement action or proceeding, this could lead to a material delay or suspension in production of one or more of the Corporations products, which could have a material adverse effect on the Corporations business, financial condition and results of operations.
In addition, the Corporations business could suffer if certain manufacturing or other equipment of any of its contract manufacturers, or all or a portion of such contract manufacturers facilities, were to become inoperable for any period of time. This could occur for various reasons, including catastrophic events, such as hurricanes, earthquakes or other natural disasters, explosions, environmental accidents, pandemics, quarantine, equipment failures or delays in obtaining components or replacements, construction delays or defects, labour disturbances and other events, which are outside of the Corporations control. The Corporation could experience substantial production delays or inventory shortages in the event of any such occurrence until its applicable contract manufacturers repair such equipment or facility or build or locate replacement equipment or a replacement facility, as applicable, and seek to obtain necessary regulatory approvals for all of such replacements or otherwise resolve the issue. Any interruption in the manufacture of the Corporations products could affect the sales of the Corporations products and could have a material adverse effect on the Corporations business, financial condition and results of operations.
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If the Corporation encounters delays or difficulties with any of its contract manufacturers, packagers or distributors, sales of the Corporations products could be delayed or reduced and the Corporation may encounter difficulties in obtaining alternative contracts for such services. If the Corporation changes the source or location of supply or modifies the manufacturing process, regulatory authorities may require the Corporation to demonstrate that the product produced by the new source or from the modified process is equivalent to the product used in any clinical trials that were conducted. If the Corporation is unable to demonstrate this equivalence, the Corporation will be unable to have its products manufactured by such new source or from such location of supply, or use the modified process, and the Corporation may have incurred substantial expenses in seeking to ensure equivalence, which could have a material adverse effect on the Corporations business, financial condition and results of operations. The Corporation has and may in the future pursue strategic partnerships, including product supply arrangements with certain manufacturers and/or distributors which could be affected by any of the foregoing matters. To the extent that such arrangements are material to the Corporation, the aforementioned risks could have a material adverse effect on the Corporations business, financial condition and results of operations.
If the Corporations supply of finished products for any of its products is interrupted, the Corporations ability to maintain inventory levels could suffer and future revenues may be delayed and/or not realized.
Supply interruptions may occur and the Corporations inventory may not always be adequate. Numerous factors could cause interruptions in the supply of any of the Corporations products, including those listed in the risk factors above, failure to have a third-party supply chain validated in a timely manner, shortages in or the costs and availability of raw material required by the Corporations contract manufacturers, changes in the Corporations sources for manufacturing, and the Corporations failure to locate and obtain replacement manufacturers as needed and in a timely manner. Any of such supply interruptions or inventory shortages would affect the sales of the Corporations products, which could have a material adverse effect on the Corporations business, financial condition and results of operations.
The Corporation relies on third parties to perform distribution, logistics, invoicing, regulatory and sales services for its products.
The Corporation relies on third parties to provide distribution, logistics, invoicing, regulatory and sales services including warehousing of finished products, accounts receivable management, billing, collection, record keeping and processing of invoices (including with insurance companies). If the third parties cease to be able to provide the Corporation with these services or do not provide these services in a timely or professional manner, or if contracts with such third parties are terminated for any reason, the Corporation may not be able to successfully manage the logistics associated with distributing and selling its products which could result in a delay or interruption in delivering products to its customers and could impact product sales and revenues or the Corporations ability to integrate new products into its business, any of which could have a material adverse effect on the Corporations business, financial condition and results of operations.
In addition, the supply of the Corporations products to its customers (or, in some cases, supply from the Corporations contract manufacturers to the Corporation) is subject to and dependent upon the use of transportation services and third party distribution facilities. Such supply chain logistics result in the Corporation not being in control of its products at all times, while maintaining liability for such products. Moreover, transportation services or third party distribution facilities may be disrupted (including as a result of weather conditions or due to technical, labour or other difficulties or conditions), any of which could have a material adverse effect on the Corporations business, financial condition and results of operations.
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The Corporations effective tax rates may increase.
The Corporation has operations in various countries that have differing tax laws and rates. The Corporations tax reporting is supported by current domestic tax laws in the countries in which the Corporation operates and the application of tax treaties between the various countries in which the Corporation operates. The Corporations income tax reporting is and will continue to be subject to audit by domestic and foreign authorities. The Corporations effective tax rate may change from year to year based on changes in the mix of activities and income earned among the different jurisdictions in which the Corporation operates; changes in tax laws in these jurisdictions; changes in the tax treaties between various countries in which the Corporation operates; changes in the Corporations eligibility for benefits under those tax treaties; and changes in the estimated values of deferred tax assets and liabilities. Such changes could result in a substantial increase in the effective tax rate on all or a portion of the Corporations income.
The Corporations provision for income taxes is based on certain estimates and assumptions made by management of the Corporation. The Corporations consolidated income tax rate is affected by the amount of net income earned in its various operating jurisdictions, the availability of benefits under tax treaties, and the rates of taxes payable in respect of that income. The Corporation enters into many transactions and arrangements in the ordinary course of business in respect of which the tax treatment is not entirely certain. The Corporation therefore makes estimates and judgments based on the Corporations knowledge and understanding of applicable tax laws and tax treaties, and the application of those tax laws and tax treaties to the Corporations business, in determining its consolidated tax provision and accruals. For example, certain countries could seek to tax a greater share of income than may be provided for by the Corporation. The final outcome of any audits by taxation authorities may differ from the estimates and assumptions that the Corporation may use in determining its consolidated tax provisions and accruals. This could result in a material adverse effect on the Corporations consolidated income tax provision, financial condition and the net income for the period in which such determinations are made.
The expiration of core patent protection for Kapvay ® , Orapred ODT ® and Ulesfia ® could result in significant competition from generic products resulting in a significant reduction in sales.
The patent protecting the Corporations Kapvay ® product has expired and the Orapred ODT ® and Ulesfia ® patents will shortly expire, which could result in significant competition from generic products and could result in a significant reduction in sales. In order to continue to obtain commercial benefits from the Corporations Kapvay ® and Orapred ODT ® products, the Corporation will continue to rely on product manufacturing trade secrets, know-how and related non-patent intellectual property. The effect of these patent expirations on the Corporation and its financial results will depend, among other things, upon the nature of the market and the position of the Corporations products in the market from time to time, the growth of the market, the complexities and economics of manufacturing of a competitive product and regulatory approval requirements of generic drug laws. Accordingly, these patent expirations could have a material adverse effect on the Corporations business, financial condition and results of operations.
The Corporation is subject to risks related to the regulatory environment in respect of Donnatal ® .
Currently, the Corporation markets its Donnatal ® products as the owner of the conditionally approved ANDA for Donnatal ® and as a party to the unresolved Notice of Opportunity Hearing for anticholinergic and barbiturate combination drug products. The Corporation makes no assurances that the FDA will not seek to begin a hearing process to remove these products from the market. If this were to happen it could have a material adverse effect on the Corporations business, financial condition and results of operations.
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A.H. Robins Company, Inc. ( Robins ) began marketing Donnatal ® , an anticholinergic and barbiturate combination drug used to treat gastrointestinal problems, in the 1940s. Because certain anticholinergic and barbiturate combination drug products were on the market with safety-only NDAs or were identical, related, or similar to products on the market with safety-only NDAs, the FDA included these products in the DESI review program. On June 20, 1978, the FDA issued a Federal Register notice requiring manufacturers of anticholinergic/barbiturate combinations involved in this DESI hearing to obtain an approved NDA or ANDA, and conduct clinical trials to support the efficacy of these products. On December 30, 1980, Robins, after already conducting clinical trials, obtained conditionally approved ANDAs for Donnatal ® Tablets, Donnatal ® Elixir, and Donnatal ® Capsules from the FDA. On May 6, 1983, the FDA published a Federal Register notice revoking the exemption for continued marketing for anticholinergic/barbiturate combination products based on its review of the submitted studies and proposed to, but did not, withdraw approval of the ANDAs for these products including for Donnatal ® Tablets, Donnatal ® Elixir, and Donnatal ® Capsules. In response to this 1983 notice, Robins requested a hearing regarding its Donnatal ® Tablets, Donnatal ® Elixir, and Donnatal Capsules and submitted additional data regarding these products.
On December 22, 2011, the FDA formally recognized the transfer of the ANDAs for Donnatal ® Tablets, Donnatal ® Elixir, and Donnatal ® Capsules from Wyeth to PBM Pharmaceuticals, Inc. and recognized that the ANDAs were still in effect. On July 24, 2012, through a Federal Register notice, the FDA acknowledged the original requests for hearings were still in effect. On May 15, 2014, PBM Pharmaceuticals, Inc. completely transferred all rights relating to Donnatal ® to the Corporation. See General Development and Description of the Business - General Development of the Business - Donnatal ® Acquisition and Legacy Pharmaceuticals Division - Legacy Products - Donnatal ® .
The Corporation may not be able to protect and maintain its intellectual property and licensing arrangements which could impact the Corporations ability to compete in its targeted markets and lead to uncertainty regarding the applicability of the Corporations proprietary information.
The Corporations success will depend in part on its ability to protect and maintain intellectual property rights and licensing arrangements for its products. No assurance can be given that the Corporations intellectual property rights or the licenses used by the Corporation will not be challenged, invalidated, infringed or circumvented, or that the rights granted thereunder will provide any competitive advantage to the Corporation. The Corporations success will also depend in part on the Corporation not infringing patents or proprietary rights of others and not breaching the licenses granted to it. There can be no assurance that the Corporation will be able to obtain a license to any third party technology that may be required to conduct the Corporations business or that such technology can be licensed at a reasonable cost. There is no certainty that the Corporation will not be challenged by the applicable licensors for non-compliance with its existing or future licensing arrangements. Consequently, licensing arrangements could be withdrawn or otherwise terminated with no compensation or other monetary payment made to the Corporation.
The Corporation relies on trade secrets, know-how and other proprietary information, as well as requiring employees and certain other third parties (including suppliers) to sign confidentiality agreements. However, these confidentiality agreements may be breached and the Corporation may not have adequate remedies for such breaches. Others may independently develop substantially equivalent proprietary information without infringing upon any proprietary technology. Third parties may otherwise gain access to the Corporations proprietary information and adopt it in a competitive manner.
Any loss of intellectual property protection or issues that arise in respect of third-party technology required by the Corporation could have a material adverse effect on the Corporations business, financial condition and results of operations.
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The Corporation may be subject to product liability claims, which can be expensive, difficult to defend and may result in large judgments or settlements.
The administration of drugs to humans, whether in clinical trials or after marketing clearance is obtained, can result in product liability claims. Product liability claims can be expensive, difficult to defend and may result in large judgments or settlements against the Corporation. In addition, third-party collaborators and licensees may not protect the Corporation from product liability claims.
The Corporation currently maintains product liability insurance in connection with the marketing of its legacy pharmaceutical products and certain products of CLI. The Corporation may not be able to obtain or maintain adequate protection against potential liabilities arising from product sales. In addition, the Corporation could become subject to potential liabilities as successor owner of an asset, product or business (even if not specifically assumed by the Corporation). In such circumstances, the Corporations insurance policies may not provide enough coverage for such liabilities. If the Corporation is unable to obtain sufficient levels of insurance at acceptable cost or otherwise protect against potential product liability claims, the Corporation will be exposed to product liability claims. A successful product liability claim in excess of the Corporations insurance coverage could have a material adverse effect on the Corporations business, financial condition and results of operations and prevent or interfere with the Corporations product commercialization efforts. In addition, any successful claim may prevent the Corporation from obtaining adequate product liability insurance in the future on commercially desirable terms or at all. Even if a claim is not successful, defending such a claim may be time-consuming and expensive. Product liability claims, whether or not merited, could also result in negative perception of the Corporation and its products which could have a material adverse effect on the Corporations business, financial condition and results of operations.
The Corporation is subject to risks related to patent infringement actions.
The Corporation could become involved in patent infringement actions which are uncertain, costly and time-consuming and could have a material adverse effect on the Corporations business, financial condition and results of operations. The pharmaceutical industry historically has generated and continues to generate substantial litigation concerning the manufacture, use and sale of products. As a result, patents related to the Corporations products could be challenged, and the Corporations patents may not be upheld. In order to protect or enforce patent rights, the Corporation may initiate litigation against third parties. If the Corporation is not successful in defending an attack on its patents and maintaining exclusive rights to market one or more of the Corporations products that are under patent protection, the Corporation could lose a significant portion of sales in a very short period.
The Corporation could also become subject to infringement claims by third parties and may have to defend against charges that the Corporations products infringed patents or the proprietary rights of third parties. If the Corporation infringes the intellectual property rights of others, the Corporation could lose its right to develop, manufacture or sell products, including its generic products, or could be required to pay monetary damages or royalties to license proprietary rights from third parties. The outcomes of patent infringement actions are uncertain and such infringement actions are costly and divert technical and management personnel from their normal responsibilities.
The Corporation is subject to risks related to general commercial litigation, class actions, employment claims and other litigation claims, as well as potential administrative and regulatory actions, as part of its operations.
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In the course of its business, the Corporation receives general commercial claims related to the conduct of its business and the performance of its products and services, employment claims and other litigation claims and the Corporation also could become subject to class actions. Litigation resulting from these claims could be costly and time-consuming and could divert the attention of management and other key personnel from the Corporations business and operations. The complexity of any such claims and the inherent uncertainty of commercial, class action, employment and other litigation increases these risks. In recognition of these considerations, the Corporation could suffer significant litigation expenses in defending any of these claims and may enter into settlement agreements. If the Corporation is unsuccessful in its defense of material litigation claims or is unable to settle the claims, the Corporation may be faced with significant monetary damage awards or other remedies against it including injunctive relief that could have a material adverse effect on the Corporations business, financial condition and results of operations. Administrative or regulatory actions against the Corporation or its employees could also have a material adverse effect on the Corporations business, financial condition and results of operations.
The Corporation is subject to risks associated with compliance with regulations related to marketing, promotional and pricing practices.
The marketing, promotional and pricing practices of pharmaceutical companies, as well as the manner in which companies, in-house or third-party sales forces interact with purchasers, prescribers and patients, are subject to extensive regulation, any breach of which may result in the imposition of civil and/or criminal penalties, injunctions, and/or limitations on marketing practices for the Corporations products. Many companies have been the subject of claims related to these practices asserted by federal authorities. These claims historically have resulted, and any future claims could result, in fines and other consequences.
Companies may not promote drugs for off-label uses, that is, uses that are not described in the products labeling and that differ from those approved by the FDA or other applicable regulatory agencies. A company that is found to have improperly promoted off-label uses may be subject to significant liability, including civil and administrative remedies as well as criminal sanctions. In addition, managements attention could be diverted from business operations and the Corporations reputation could be damaged.
The Corporation is subject to risks related to fraud and abuse laws, anti-bribery laws, environmental laws and privacy and security regulations.
Pharmaceutical companies in the United States and elsewhere have faced lawsuits and investigations pertaining to violations of health care fraud and abuse laws, such as the federal False Claims Act , the federal Foreign Corrupt Practices Act , Anti-Kickback Statutes, and other state and federal laws and regulations. The Corporation is also subject to increasingly strict data privacy and security laws in the United States and in other countries, the violation of which could result in fines and other sanctions. The United States Department of Health and Human Services Office of Inspector General recommends, and increasingly states require, pharmaceutical companies to have comprehensive compliance programs and to disclose certain payments made to healthcare providers or funds spent on marketing and promotion of drug products. The United States federal government has published regulations that identify safe harbour or exemptions for certain payment arrangements that do not violate the Anti-Kickback Statutes. While the Corporation has developed corporate compliance programs based on what the Corporation believes to be current best practices, the Corporation cannot assure investors that its employees or agents are or will be in compliance with all applicable federal, state or foreign regulations and laws. If the Corporation or any of its employees or agents are in violation of any of these requirements or any such actions are instituted against the Corporation, and the Corporation is not successful in defending itself or asserting its rights, those actions could have a significant impact on the Corporations business, including
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the imposition of significant fines, the exclusion of the Corporation from federal healthcare programs and other sanctions.
Anti-Kickback Statutes and similar worldwide anti-bribery laws generally prohibit companies and their intermediaries from making improper payments to officials for the purpose of obtaining or retaining business or a business advantage. The Corporations policies mandate compliance with these anti-bribery laws. The Corporation may operate in many parts of the world that have experienced governmental corruption to some degree and in certain circumstances, strict compliance with anti-bribery laws may conflict with local customs and practices or may require the Corporation to interact with doctors and hospitals, some of which may be state controlled, in a manner that is different than in the United States and Canada. The Corporation cannot assure investors that its internal control policies and procedures will protect the Corporation from reckless or criminal acts committed by its employees or agents. Violations of any of these laws, or allegations of such violations, could disrupt the Corporations business and result in criminal or civil penalties or remedial measures, any of which could have a material adverse effect on the Corporations business, financial condition and results of operations.
The Corporation is also subject to various privacy and security regulations, including but not limited to HIPAA, as amended by the United States federal Health Information Technology for Economic and Clinical Health Act of 2009. HIPAA mandates, among other things, the adoption of uniform standards for the electronic exchange of information in common health care transactions (e.g. health care claims information and plan eligibility, referral certification and authorization, claims status, plan enrolment, coordination of benefits and related information), as well as standards relating to the privacy and security of individually identifiable health information, which require the adoption of administrative, physical and technical safeguards to protect such information. In addition to many other jurisdictions, several states have enacted comparable laws addressing the privacy and security of health information, some of which are more stringent than HIPAA. Failure to comply with any of these laws could result in the imposition of significant civil and criminal penalties. The costs of compliance with these laws or similar laws in other countries and the potential liability associated with any failure to comply with these laws could have a material adverse effect on the Corporations business, financial condition and results of operations.
Legislative or regulatory reform of the health care system may affect the Corporations ability to sell its products profitably.
In the United States and certain foreign jurisdictions, there have been a number of legislative and regulatory proposals to change the healthcare system in ways that could impact the Corporations ability to sell its products profitably. The Health Care Reform Act, may affect the operational results of companies in the pharmaceutical industry, including the Corporation, by imposing on them additional costs. For example, effective January 1, 2010, the Health Care Reform Act increased the minimum Medicaid drug rebates for pharmaceutical companies, expanded the 340B drug discount program, and made changes that impact the Medicare Part D coverage gap. The law also revised the definition of average manufacturer price for reporting purposes, which has the potential to impact the amount of the Corporations Medicaid drug rebates to states. Beginning in 2011, the law imposed a significant annual fee on companies that manufacture or import branded prescription drug products.
The Health Care Reform Act also added substantial new provisions affecting compliance therewith, some of which may require the Corporation to modify its business practices with health care practitioners. Pharmaceutical manufacturers are required to comply with the United States federal Physician Payments Sunshine Act , which was passed as part of the Health Care Reform Act and which requires pharmaceutical companies to monitor and report payments, gifts, the provision of samples and other remuneration made to physicians and other health care professionals and health care organizations.
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The Corporation is unable to predict the future course of federal or state health care legislation. A variety of federal and state agencies are in the process of implementing the Health Care Reform Act, including through the issuance of rules, regulations or guidance that materially affect the Corporations business. The risk of the Corporation being found in violation of these rules and regulations is increased by the fact that many of them have not been fully interpreted by applicable regulatory authorities or the courts, and their provisions are open to a variety of different interpretations. The Health Care Reform Act and further changes to health care laws or regulatory framework that reduce the Corporations revenues or increase the Corporations costs could have a material adverse effect on the Corporations business, financial condition and results of operations.
The Corporations business is subject to limitations imposed by government regulations.
In domestic and foreign markets, the formulation, manufacturing, packaging, labeling, handling, distribution, importation, exportation, licensing, sale and storage of the Corporations products are affected by extensive laws, governmental regulations, administrative determinations, court decisions and other constraints which are beyond the Corporations control. Such laws, regulations, determinations, decisions and other constraints may exist at all levels of government. There can be no assurance that the Corporation is or will be in compliance with all of these laws, regulations, determinations, decisions and other constraints. Failure to comply with these laws, regulations, determinations, decisions and other constraints or new laws, regulations, determinations, decisions or other constraints could lead to the imposition of significant penalties or claims and could have a material adverse effect on the Corporations business, financial condition and results of operations. In addition, the adoption of new laws, regulations, determinations, decisions or other constraints or changes in the interpretations of such requirements may result in significant compliance costs or lead the Corporation to discontinue product sales and may have an adverse effect on the marketing of the Corporations products, resulting in significant loss of sales and which could have a material adverse effect on the Corporations business, financial condition and results of operations.
In the United States, the FDA perceives any written or verbal statement used to promote or sell a product that associates an unapproved nutrient with a disease (whether written by the Corporation, the content of a testimonial endorsement or contained within a scientific publication) to be evidence of intent to sell an unapproved new drug. If any such evidence is found with respect to any of the Corporations products, the FDA may take action against the Corporation, ranging from a warning letter necessitating cessation of use of the statement to injunctions against product sale, seizures of products so promoted, and civil and criminal prosecution of the Corporations executives. Any such actions could have a detrimental effect on sales and could have a material adverse effect on the Corporations business, financial condition and results of operations.
Other legislation or regulatory proposals may affect the Corporations revenues and profitability.
Existing and proposed changes in the laws and regulations affecting public companies may cause the Corporation to incur increased costs as the Corporation evaluates the implications of new rules and responds to new requirements. Failure to comply with new rules and regulations could result in enforcement actions or the assessment of other penalties. New laws and regulations could make it more difficult to obtain certain types of insurance, including directors and officers liability insurance, and the Corporation may be forced to accept reduced policy limits and coverage or incur substantially higher costs to obtain the same or similar coverage, to the extent that such coverage remains available. The impact of these events could also make it more difficult for the Corporation to attract and retain qualified persons to serve on the Board, or as executive officers. The Corporation may be required to hire additional personnel and utilize additional outside legal, accounting and advisory services, all of which could cause the Corporations general and administrative costs to increase beyond what the Corporation
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currently has planned. Although the Corporation evaluates and monitors developments with respect to new rules and laws, the Corporation cannot predict or estimate the amount of the additional costs the Corporation may incur or the timing of such costs with respect to such evaluations and/or compliance and cannot provide assurances that such additional costs will render the Corporation compliant with such new rules and laws.
If the Corporation experiences a data security breach and confidential information is disclosed, the Corporation may be subject to penalties and experience negative publicity.
The Corporation and its customers could suffer harm if personal and health information were accessed by third parties due to a system security failure. The collection of data requires the Corporation to receive and store a large amount of personally identifiable data. Recently, data security breaches suffered by well-known companies and institutions have attracted a substantial amount of media attention, prompting legislative proposals addressing data privacy and security. The Corporation may become exposed to potential liabilities with respect to the data that it collects, manages and processes, and may incur legal costs if information security policies and procedures are not effective or if the Corporation is required to defend its methods of collection, processing and storage of personal data. Future investigations, lawsuits or adverse publicity relating to its methods of handling such information could have a material adverse effect on the Corporations business, financial condition and results of operations due to the costs and negative market reaction relating to such developments.
Unexpected product safety or efficacy concerns may arise and maintenance of expected levels of market acceptance is uncertain.
Unexpected safety or efficacy concerns can arise with respect to the Corporations products, whether or not scientifically justified, potentially resulting in product recalls, withdrawals and/or declining sales, as well as product liability, consumer fraud and/or other claims. Any of the foregoing could have a material adverse effect on the Corporations business, financial condition and results of operations.
The market perception and reputation of the Corporations products and their safety and efficacy are important to the Corporations business and the continued acceptance of its products. Any negative publicity about any of the Corporations products, such as the discovery of safety issues with its products, adverse events involving its products, or even public rumors about such events, could have a material adverse effect on the Corporations business, financial condition and results of operation. In addition, the discovery of one or more significant problems with a product similar to one of the Corporations products that implicate (or are perceived to implicate) an entire class of products or the withdrawal or recall of such similar products could have an adverse effect on sales of the Corporations products. New data about the Corporations products, or products similar to its products, could cause the Corporation reputational harm and could negatively impact demand for the Corporations products due to real or perceived side effects or uncertainty regarding safety or efficacy and, in some cases, could result in product withdrawal. If any of the Corporations products fail to gain, or lose, market acceptance, the Corporations revenues could be adversely impacted which could have a material adverse effect on the Corporations business, financial condition and results of operations.
The Corporation is subject to risks associated with anti-trust and competition laws.
Pharmaceutical companies in the United States have faced lawsuits and investigations pertaining to violations of antitrust and competition laws. The Corporations drug products and products acquired from Covis could be subject to antitrust or competition law challenge that, if successful, could affect the Corporations ability to set prices for its drug products or enter into agreements with respect thereto. A successful antitrust or competition law challenge against the Corporation could result in the imposition of
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significant fines by one or more authorities, and/or in decisions preventing the Corporation from further expanding its business, and/or third parties (such as competitors and customers) initiating civil litigation claiming damages caused by anticompetitive practices. A violation of any such law could result in civil penalties, mitigation, significant capital expenditures or require changes in the Corporations business practices, which could have a material adverse effect on the Corporations business, financial condition and results of operations.
On February 12, 2015, Concordia received a CID from the FTC regarding Kapvay ® and the Competitive Supply Agreement. The CID is a request for documentation and information to determine whether CPI, the counterparty to the Competitive Supply Agreement or their affiliates or any other person has engaged in unfair methods of competition in or affecting commerce by entering into agreements relating to Kapvay ® . CPI and Concordia are cooperating with the information requests. The Corporation is unable to assess potential outcomes of the investigation at this time. See Legacy Pharmaceuticals Division - Legacy Products - Kapvay ® - Genericization of Kapvay ® and Legal Proceedings and Regulatory Matters .
Failure to obtain or maintain orphan drug exclusivity could impact revenues.
If the Corporation fails to obtain or maintain orphan drug exclusivity for some or all of the Corporations products, the Corporations competitors may sell products to treat the same conditions and the Corporations revenues could be reduced. As part of its business strategy, the Corporation may acquire some drugs that may be eligible for FDA and EU orphan drug designation. Under the ODA, the FDA may designate a product as an orphan drug if it is intended to treat a rare disease or condition, defined as a patient population of fewer than 200,000 in the United States. The company that first obtains FDA approval for a designated orphan drug for a given rare disease or condition receives marketing exclusivity for use of that drug for the stated disease or condition for a period of seven years. However, orphan drug exclusive marketing rights may be lost if the FDA later determines that the request for designation was materially defective or if the manufacturer is unable to assure a sufficient supply of the drug. Similar regulations exist in the EU with a ten-year period of market exclusivity. Because the extent and scope of patent protection for some of the Corporations drug products is limited, orphan drug designation is especially important for products that are eligible for orphan drug designation. If the Corporation does not obtain orphan drug exclusivity for drug products that do not have broad patent protection, the Corporations competitors may then sell the same drug to treat the same condition and this could have a material adverse effect on the Corporations business, financial condition and results of operations.
Cost adjustments could negatively impact demand for the Corporations pharmaceutical products.
The Corporation has made cost adjustments, and may continue to make cost adjustments, to its pharmaceutical products based on market assessments. There can be no assurances that sales of the Corporations pharmaceutical products will be unaffected by these cost adjustments. If cost adjustments negatively affect demand for any of the Corporations pharmaceutical products, this could have a material adverse effect on the Corporations business, financial condition and results of operations. In addition, there can be no assurances that increased expenditures on marketing and promotion will lead to increased sales of the Corporations pharmaceutical products. Increased expenditures on promotional efforts without corresponding increases in sales could have a material adverse effect on the Corporations business, financial condition and results of operations.
Increases in sales may attract generic competition.
If sales of the Corporations legacy pharmaceutical products were to increase substantially, competitors may be more likely to develop generic formulations that compete directly with the Corporations
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products. Increased competition from generic drugs could have a material adverse effect on the Corporations business, financial condition and results of operations.
The markets in which the Corporation operates and proposes to operate are highly competitive and subject to rapid and significant technological change, which could render the Corporations products obsolete or uncompetitive.
In addition to competition from generic drugs, the Corporations products will face competition from new products that treat the same diseases and address some of the same conditions as the Corporations products. Many of the Corporations competitors have greater financial resources and selling and marketing capabilities. The Corporation will face further competition from pharmaceutical and drug development companies and medical equipment/supply companies that focus their efforts on developing and marketing products that are similar in nature to its products, but that in some instances offer improvements over, or are less expensive than, the Corporations products. The Corporations competitors may succeed in developing technologies and products that are more effective or less expensive to use than any of the Corporations products or any products that the Corporation may acquire or license. These developments could render the Corporations products obsolete or uncompetitive, which could have a material adverse effect on the Corporations business, financial condition and results of operations. In addition, academic institutions, government agencies and other public and private organizations conducting research may seek patent protection with respect to potentially competitive products. They may also establish exclusive collaborative or licensing relationships with the Corporations competitors.
The Corporation faces competition for future acquisitions of products.
The Corporations growth strategy is partially predicated on its ability to acquire additional products at reasonable prices or for a price which the Corporation believes is lower than the accretive value to the Corporation of such products. The Corporation currently competes to acquire products with other participants in the pharmaceutical industry. Some of these companies may have greater resources than the Corporation. In addition, although the Corporation is aware of other entities that are focused on acquiring products primarily for the purpose of generating a stream of stable revenues and cash flow, there can be no assurances that additional entities will not adopt this strategy in the future. If the Corporation is unable to acquire additional products at reasonable or otherwise appropriate prices, its ability to expand its business and to pay, increase or maintain dividends, as applicable, may be adversely affected and this could have a material adverse effect on the Corporations business, financial condition and results of operations.
The Corporations Legacy Pharmaceuticals Division derives most of its revenue from sales of a limited number of products.
The Corporation currently derives most of its revenue from its legacy pharmaceutical products, in particular Donnatal ® , and revenue from these products is expected to continue to account for much of the Corporations revenue in the near term after the acquisition of the Covis Portfolio. Accordingly, if demand for any of the Corporations legacy pharmaceutical products declines more significantly than expected, it could have a material adverse effect on the Corporations business, financial condition and results of operations.
The publication of negative results of studies or clinical trials may adversely impact the Corporations business.
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From time to time, studies or clinical trials on various aspects of pharmaceutical products are conducted by academics or others, including government agencies. The results of these studies or trials, when published, may have a significant effect on the market for the pharmaceutical product that is the subject of the study. The publication of negative results of studies or clinical trials related to products in the Corporations Legacy Pharmaceuticals Division or Orphan Drugs Division or the therapeutic areas in which the Corporations products compete could adversely affect the sales of, the prescription trends for, and the reputation of the Corporations products, which in turn could have a material adverse effect on the Corporations business, financial condition and results of operations.
The Corporation depends on key managerial personnel for its continued success.
The Corporation is highly dependent upon qualified managerial personnel. The Corporations current and anticipated growth may require additional expertise and the addition of new qualified personnel. There is intense competition for qualified personnel in the pharmaceutical field. Therefore, the Corporation may not be able to attract and retain the qualified personnel necessary for the development of the Corporations business. The Corporation must continue to retain and motivate executives, including the Corporations Chief Executive Officer, Mark Thompson, and other key employees, and the Corporation may also need to recruit additional key executives. The loss of the services of existing personnel, as well as the failure to recruit additional key executives in a timely manner, could harm the Corporations business development programs and the Corporations ability to manage day-to-day operations, attract collaboration partners, attract and retain other employees, and generate revenues, which in turn could have a material adverse effect on the Corporations business, financial condition and results of operations. Except for Mark Thompson, there is no key person life insurance on any of the Corporations employees.
The Corporations ability to obtain third-party reimbursement for the cost of products and related treatment may not be adequate and the Corporation could lose the ability to obtain third-party reimbursement.
The Corporations ability to successfully market the Corporations products may depend in part on whether appropriate reimbursement levels for the cost of the products and related treatments are obtained from government authorities and private health insurers and other organizations, such as HMOs and MCOs. The Corporation also could lose the ability to access such reimbursement by government authorities and private health insurers and other organizations as a result of changing laws, policies and practices of such entities.
Third-party payors increasingly challenge the pricing of pharmaceutical products. In addition, the trend toward managed health care in the United States, the growth of organizations such as HMOs and MCOs and legislative proposals to reform health care and government insurance programs could significantly influence the purchase of pharmaceutical products, resulting in price changes and/or a reduction in product demand. Such cost containment measures and health care reform could affect the Corporations ability to sell its products, which could have a material adverse effect on the Corporations business, financial condition and results of operations.
Failure to be included in formularies developed by MCOs and other organizations may impact use of the Corporations products.
MCOs and other third-party payors try to negotiate the pricing of medical services and products to control their costs. MCOs and pharmacy benefit managers typically develop formularies to reduce their cost for medications. Formularies can be based on the prices and therapeutic benefits of the available products. The breadth of the products covered by formularies varies considerably from one MCO to another, and many formularies include alternative and competitive products for treatment of particular medical
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conditions. Failure to be included in such formularies or to achieve favourable formulary status may negatively impact the use of the Corporations products. If the Corporations products are not included within an adequate number of formularies or adequate reimbursement levels are not provided, or if those policies increasingly favour generic products, the Corporations market share and gross margins could be adversely impacted, which could have a material adverse effect on the Corporations business, financial condition and results of operations.
Rising insurance costs could negatively impact the Corporations profitability.
The cost of insurance, including director and officer, workers compensation, property, product liability and general liability insurance, has risen significantly in recent years and is expected to continue to increase. In response, the Corporation may increase deductibles and/or decrease certain coverage to mitigate these costs. These increases, and the Corporations increased risk due to increased deductibles and reduced coverage, could have a material adverse effect on the Corporations business, financial condition and results of operations.
Policies regarding returns, allowances and chargebacks may reduce revenues in future fiscal periods.
The Corporation establishes estimates of the impact that policies regarding returns, allowances and chargebacks may have in subsequent periods. The Corporation cannot ensure that the reserves are adequate or that actual product returns, allowances and chargebacks will not exceed its estimates, which could have a material adverse effect on the Corporations business, financial condition and results of operations.
The Corporation is subject to risks associated with the industry in which it operates.
Currently, the Corporation primarily operates in the North American healthcare industry with a primary focus on the United States market. The Corporations Canadian commercial activities are limited to the distribution of PDT with Photofrin ® through a third party, which has been minimal. Accordingly, the Corporation is subject to risks associated with operating in a single industry in a concentrated geographic location. Any event affecting this industry could have a material adverse effect on the Corporations business, financial condition and results of operations. Moreover, the Corporations projected revenues and operating results are based on assumptions concerning certain levels of product purchases in these markets. Any failure to attain the Corporations projected revenues and operating results as a result of adverse economic or market conditions could have a material adverse effect on the Corporations business, financial condition and results of operations.
The Corporation is subject to foreign currency risk.
Currency exchange rate fluctuations can affect the Corporations results of operations to the extent that any of the Corporations future equity financings are denominated in Canadian dollars and if the Corporations functional currency continues to be in United States dollars. Consequently, the Corporation may experience currency gains and losses on the conversion of Canadian equity financing proceeds into United States dollars required for business operations. Foreign exchange gains or losses will be taken into account in computing the Corporations Canadian taxable income.
Also, the price of the Common Shares may be independently impacted by the exchange rate alone as the market price of the Corporations securities are denominated in Canadian dollars while the financial results of the Corporations operations are denominated in United States dollars. Consequently, the market price of the Corporations securities may be negatively affected by changes in the Canadian/United States dollar exchange rate.
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The Corporation is subject to certain risks as a holding company.
As a holding company with no material assets other than the shares of the Corporations operating subsidiaries, nearly all of the Corporations funds generated from operations are generated by the Corporations operating subsidiaries. Accordingly, if the Corporations operating subsidiaries are unable, due to regulatory restrictions or otherwise, to pay the Corporation dividends and make other payments to the Corporation when needed, the Corporation may be unable to satisfy the Corporations obligations when they arise.
The Corporation currently conducts certain of its operations through foreign subsidiaries and certain of its assets are held in such entities.
The Corporation currently conducts certain of its operations through foreign subsidiaries and certain of its assets are held in such entities. The ability of such subsidiaries to make payments to the Corporation may be constrained by certain factors including the level of taxation, particularly corporate profits and withholding taxes, in the countries in which they operate. Any limitation on the transfer of cash or other assets between the parent corporation and such entities, or among such entities, could restrict the Corporations ability to fund its operations. Any such limitations, or the perception that such limitations may exist now or in the future, could have a material adverse effect on the Corporations business, financial condition and results of operations.
Some of the Corporations assets and subsidiaries are incorporated outside of Canada.
The majority of the Corporations assets and subsidiaries are located outside of Canada. In addition, some of the Corporations directors and officers are nationals and/or residents of countries other than Canada, and all or a substantial portion of such persons assets may be located outside of Canada. As a result, it may be difficult for investors to enforce, within Canada, any judgments obtained against the Corporation or the Corporations non-resident officers or directors, including judgments predicated upon the civil liability provisions of the securities laws of Canada or any province thereof. Consequently, investors effectively may be prevented from pursuing remedies against the Corporation under Canadian securities laws.
The Corporation may not be able to secure additional financing.
The Corporation may need to raise additional funds through, among other ways, public or private debt or equity financings in order to: (i) fund ongoing operations; (ii) take advantage of opportunities, including more rapid expansion of the Corporations business or the acquisition of complementary businesses; or (iii) respond to competitive pressures. There can be no assurance that the Corporation will be able to raise the additional funding, or to raise such funding on economic or commercially reasonable terms, that it needs to fund ongoing operations, carry out its growth objectives or respond to competitive pressures. The Corporation cannot predict the size of future issuances of Common Shares or other securities or the effect, if any, that future issuances and sales of such securities will have on the market price of the Common Shares or value of other securities of the Corporation. Sales or issuances of substantial numbers of Common Shares or other securities by the Corporation, or the perception that such sales could occur, may adversely affect prevailing market prices of the Common Shares or the value of other securities of the Corporation.
If additional financing is raised by the issuance of Common Shares, shareholders may suffer additional dilution. Capital raised through debt financing would require periodic interest payments and may impose restrictive covenants on the conduct of the Corporations business.
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The Corporation faces certain risks associated with debt financing.
The Corporations credit facilities and the agreements governing the Corporations existing and future indebtedness impose, or may impose, significant operating and other restrictions on the Corporation. Such facilities and agreements contain or may contain financial and non-financial covenants, such as requirements that the Corporation comply with one or more financial ratios and change of control provisions. Complying with such covenants may at times necessitate that the Corporation forego other favourable business opportunities, such as acquisitions. Moreover, the Corporations failure to comply with any of these covenants would likely constitute a default under such facilities and agreements and could give rise to an acceleration of some, if not all, of the Corporations then outstanding indebtedness, which could have a material adverse effect on the Corporations business, financial condition and results of operations.
The Corporations indebtedness may grow as the Corporations business grows and/or the Corporation makes new acquisitions. The Corporation has a significant amount of indebtedness. The Corporations ability to satisfy its debt obligations will depend principally upon its future operating performance. As a result, prevailing economic conditions and financial, business and other factors, many of which are beyond the Corporations control, may affect its ability to make payments on its debt. If the Corporations income from operations underperforms, the Corporation may have to utilize cash flow or capital resources to fund its debt service payments. If the Corporations cash flow and capital resources are insufficient to service amounts owed under the Corporations current or any future indebtedness, as applicable, the Corporation may be forced to reduce or delay capital expenditures, dispose of assets, issue equity or incur additional debt to obtain necessary funds, or restructure its debt, any or all of which could have a material adverse effect on the Corporations business, financial condition and results of operations. In addition, the Corporation cannot guarantee that it would be able to take any of these actions on terms acceptable to it, or at all, that these actions would enable the Corporation to continue to satisfy its capital requirements or that these actions would be permitted under the terms of the Corporations various debt agreements.
The Corporations ability to restructure or refinance its debt will depend on a number of factors (including the capital markets) and the Corporations financial condition at such time, as well as the willingness of the Corporations lenders to allow such restructuring or refinancing. Any refinancing of the Corporations debt could be at higher interest rates and may require it to comply with more onerous covenants, which could further restrict its business operations.
Repayment of the Corporations indebtedness is dependent on the generation of cash flow by its subsidiaries and their ability to make such cash available to the Corporation, by dividend, debt repayment or otherwise. Concordias subsidiaries may not be able to, or may not be permitted to, make distributions to enable it to make payments in respect of the Corporations indebtedness. In the event that the Corporation does not receive distributions from its subsidiaries, it may be unable to make required principal and interest payments on its indebtedness.
Additionally, a significant portion of the Corporations financial indebtedness is subject to cross default provisions. Breach of any of these restrictive covenants or the Corporations inability to comply with one or more financial ratios would result in a default under the other applicable debt instruments. If any such default occurs, the lenders may elect to declare all outstanding borrowings, together with accrued interest and other fees, to be immediately due and payable. If the Corporation is unable to repay outstanding borrowings when due, the lenders will have the right to exercise their rights and remedies against the Corporation, including taking possession of, selling, and/or liquidating the Corporations assets, and there can be no assurance that the Corporations assets would be sufficient to repay in full its obligations.
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The Corporations credit facilities and the agreements governing the Corporations existing and future indebtedness may be secured by all or substantially all of the Corporations undertaking, property (including intellectual property) and assets. The Corporation may be required to seek additional sources of financing to satisfy liquidity needs. These additional sources of financing may not be available on commercially reasonably terms or at all. Even if they are available, these financings may result in dilution to shareholders.
The Corporation is exposed to risks related to interest rates.
The GE Amended Credit Agreement bears interest at the United States Prime Rate or LIBOR plus applicable margins based on a leverage table. Thus, a change in the short-term interest rate environment could increase the Corporations interest payment obligations under the GE Amended Credit Agreement, which in turn could have a material adverse effect on the Corporations business, financial condition and results of operations.
The Corporations operating results and financial condition may fluctuate.
The Corporations operating results and financial condition may fluctuate from period to period for a number of reasons, including as a result of the following events or occurrences, among others:
| development and launch of new competitive products; |
| changes in costs and/or reimbursement for the Corporations products; |
| the timing and receipt of FDA approvals or lack of approvals; |
| costs related to business development transactions; |
| changes in the amount the Corporation spends to market its products; |
| delays between the Corporations expenditures to acquire new products, technologies or businesses and the generation of revenues from those acquired products, technologies or businesses; |
| changes in treatment practices of physicians that currently prescribe certain of the Corporations products; |
| increases in the cost of raw materials used to manufacture the Corporations products; |
| manufacturing and supply interruptions; |
| the Corporations responses to price competition; |
| expenditures as a result of legal actions (and settlements thereof), including the defense of the Corporations intellectual property; |
| market acceptance of the Corporations products; |
| the timing of wholesaler and distributor purchases; and |
| general economic and industry conditions, including potential fluctuations in foreign currency and interest rates. |
As a result, the Corporation believes that quarter-to-quarter comparisons of results from operations, or any other similar period-to-period comparisons, should not be construed as reliable indicators of the Corporations future performance. The above factors may cause the Corporations operating results to fluctuate and could have a material adverse effect on the Corporations business, financial condition and results of operations. In any period, the Corporations results may be below the expectations of market analysts and investors, which could cause the trading price of the Common Shares to decline.
Goodwill and intangible assets represent a significant portion of the Corporations total assets and potential impairment of goodwill and other intangible assets may significantly impact the Corporations profitability. Finite-lived intangible assets are subject to an impairment analysis whenever events or changes in circumstances indicate the carrying amount of the asset may not be recoverable. Goodwill and
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indefinite-lived intangible assets are tested for impairment annually, or more frequently if events or changes in circumstances indicate that the asset may be impaired. If an impairment exists, the Corporation would be required to take an impairment charge with respect to the impaired asset. Events giving rise to impairment are difficult to predict and are an inherent risk in the pharmaceutical industry. As a result of the significance of goodwill and intangible assets should such an impairment of goodwill or intangible assets occur, it could have a material adverse effect on the Corporations business, financial condition and results of operations.
Risk Factors Related to the Common Shares
The market price of the Common Shares is unpredictable and may be volatile, which could cause the value of a shareholders investment to decline.
Publicly-traded securities such as those of the Corporation will not necessarily trade at values determined by reference to the underlying value of its business. The prices at which the Common Shares will trade cannot be predicted. The market price of the Common Shares could fluctuate significantly for various reasons, many of which are beyond the Corporations control, including the following:
| changes or perceived changes in the condition (including financial condition), operations, results or prospects of the Corporations businesses and market assessments of these changes or perceived changes; |
| the Corporations announcements or those of its competitors regarding new products or services, enhancements, significant contracts, acquisitions or strategic investments; |
| changes in the Corporations capital structure, such as future issuances of securities, sales of large blocks of Common Shares by the Corporations shareholders or the Corporations incurrence of additional debt; |
| significant acquisitions or business combinations, strategic partnerships, joint ventures or capital commitments by or involving the Corporation or its competitors; |
| changes in governmental regulations or proposals, or new government regulations or proposals, affecting the Corporation; |
| the addition or departure of the Corporations executive officers and other key personnel; |
| expiration of lock-up periods applicable to the Corporation and its directors and executive officers; |
| the Corporations quarterly or annual earnings or those of other companies in the Corporations industry and anticipated fluctuations in respect thereof; |
| operating and stock price performance of companies that investors deem comparable to the Corporation; |
| changes in earnings estimates or recommendations by securities analysts who track the Common Shares; |
| changes in industry conditions; |
| developments related to investigations, regulatory proceedings, or litigation that involve the Corporation; |
| news reports relating to trends, concerns, technological or competitive developments, regulatory changes and other related issues in the Corporations industry or target markets; and |
| changes in general market, economic and political conditions in the United States, Canada and global economies or financial markets in which the Corporation does business, including those resulting from natural disasters, terrorist attacks, acts of war and responses to such events. |
Financial markets have recently experienced significant price and volume fluctuations that have particularly affected the market prices of equity securities of companies and that have often been unrelated or disproportionate to the operating performance, underlying asset values or prospects of such
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companies. Accordingly, the market price of the Common Shares may decline even if the Corporations operating results, underlying asset values or prospects have not changed. These factors, as well as other related factors, may cause decreases in asset values that are deemed to be other than temporary, which may result in impairment losses. In addition, in the past, following periods of volatility in the overall market and the market price of a companys securities, securities class action litigation has often been instituted against these companies. This litigation, if instituted against the Corporation, could result in substantial costs and diversion of managements attention and resources.
There can be no assurance that continuing fluctuations in price and volume will not occur. If such increased levels of volatility and market turmoil continue, the Corporations operations could be adversely impacted and the trading price of the Common Shares may be materially adversely affected.
Future sales or issuances of the Common Shares in the public markets, or the perception of such sales, could depress the trading price of the Common Shares.
The sale of a substantial number of Common Shares or other equity-related securities in the public markets, or the perception that such sales could occur, could depress the market price of the Common Shares and impair the Corporations ability to raise capital through the sale of additional equity securities. The Corporation cannot predict the effect that future sales of Common Shares or other equity-related securities would have on the market price of the Common Shares.
All of the Corporations debt obligations, and any future indebtedness the Corporation may incur, will have priority over the Common Shares with respect to payment in the event of a liquidation, dissolution or winding up.
In any liquidation, dissolution or winding up of the Corporation, the Common Shares would rank below all debt claims against the Corporation. In addition, any convertible or exchangeable securities or other equity securities that the Corporation may issue in the future may have rights, preferences and privileges more favourable than those of the Common Shares. As a result, holders of the Common Shares will not be entitled to receive any payment or other distribution of assets upon the liquidation or dissolution until after the Corporations obligations to its debt holders and holders of equity securities that rank senior to the Common Shares have been satisfied.
Enforcement of judgments against foreign persons may not be possible.
Leith Tessy, the Chief Financial Officer and Secretary of the Corporation, as well as certain of the experts named in this Annual Information Form, are located outside of Canada and, as a result, it may not be possible for investors in Common Shares to effect service of process within Canada upon these persons. All or a substantial portion of the assets of these persons are likely to be located outside of Canada and, as a result, it may not be possible to satisfy a judgment against such persons in Canada or to enforce a judgment obtained in Canadian courts against such persons outside of Canada.
The Corporation is subject to risks related to publication of inaccurate or unfavourable research by securities analysts or other third parties.
The trading market for the Common Shares relies in part on the research and reports that securities analysts and other third parties choose to publish about the Corporation. The Corporation does not control these analysts or other third parties. The price of the Common Shares could decline if one or more securities analysts downgrade the Common Shares or if one or more securities analysts or other third parties publish inaccurate or unfavourable research about the Corporation or cease publishing reports about the Corporation. If one or more analysts cease coverage of the Corporation or fail to regularly
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publish reports on the Corporation, the Corporation could lose visibility in the financial markets, which in turn could cause the price or trading volume of the Common Shares to decline.
The Corporation is subject to risks related to global financial conditions.
As widely reported, global credit and financial markets have experienced extreme disruptions in the past several years, including with respect to severely diminished liquidity and credit availability, declines in consumer confidence, declines in economic growth, increases in unemployment rates and uncertainty about economic stability. There can be no assurance that further deterioration in credit and financial markets and confidence in economic conditions will not occur. Any such economic downturn, volatile business environment or continued unpredictable and unstable market conditions could have a material adverse effect on the Corporations business, financial condition and results of operations. These factors may impact the ability of the Corporation to obtain equity or debt financing in the future and, if obtained, on terms favourable to the Corporation. Increased levels of volatility and market turmoil can adversely impact the Corporations operations and the value and the price of the Common Shares could be adversely affected. In addition, there is a risk that one or more of the Corporations current manufacturers or other service providers may themselves be adversely impacted by difficult economic circumstances, which could directly affect the Corporations ability to run its business as currently contemplated.
The Corporation is subject to risks related to additional regulatory burden and controls over financial reporting.
The Corporation is subject to the continuous and timely disclosure requirements of Canadian securities laws and the rules, regulations and policies of the TSX and the OTCQX marketplace. These rules, regulations and policies relate to, among other things, corporate governance, corporate controls, internal audit, disclosure controls and procedures and financial reporting and accounting systems. The Corporation has made, and will continue to make, changes in these and other areas, including the Corporations internal controls over financial reporting. However, there is no assurance that these and other measures that it may take will be sufficient to allow the Corporation to satisfy its obligations as a public company on a timely basis. In addition, compliance with reporting and other requirements applicable to public companies create additional costs for the Corporation and require the time and attention of management of the Corporation. The Corporation cannot predict the amount of the additional costs that the Corporation may incur, the timing of such costs or the impact that managements attention to these matters will have on the Corporations business.
In addition, Concordias inability to maintain effective internal controls over financial reporting could increase the risk of an error in its financial statements. Concordias management, with the participation of the Corporations Chief Executive Officer and Chief Financial Officer, is responsible for establishing and maintaining adequate internal control over financial reporting. The Corporations internal control over financial reporting is a process designed to provide reasonable assurance regarding the reliability of financial reporting and the preparation of financial statements for external purposes in accordance with IFRS. Internal control over financial reporting cannot provide absolute assurance of achieving financial reporting objectives due to its inherent limitations. Internal control over financial reporting is a process that involves human diligence and compliance and is therefore subject to error, improper override or improper application of the internal controls. Because of such limitations, there is a risk that material misstatements may not be prevented or detected on a timely basis, and although it is possible to incorporate into the financial reporting process safeguards to reduce this risk, they cannot be guaranteed to entirely eliminate it. If the Corporation fails to maintain effective internal control over financial reporting, then there is an increased risk of an error in the Corporations financial statements that could result in the Corporation being required to restate previously issued financial statements at a later date.
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Future sales of Common Shares by existing shareholders could reduce market price.
Sales of a substantial number of Common Shares in the public market could occur at any time following, or in connection with, the completion of any offering. These sales, or the market perception that the holders of a large number of Common Shares intend to sell Common Shares, could reduce the market price of the Common Shares. A decline in the market price of the Common Shares could impair the Corporations ability to raise additional capital through the sale of securities should it desire to do so. As a result of the application of Canadian tax laws, holders of options, restricted share units and deferred share units of the Corporation may need to sell Common Shares purchased or issued, as applicable, on the exercise of their options or the vesting of their RSUs/DSUs in the same year that they exercise their options or at the time of the vesting of their RSUs/DSUs, as applicable. This may result in a greater number of Common Shares being sold in the public market, and fewer long-term holders of Common Shares by the Corporations management and employees. In addition, the issuance of Common Shares upon the exercise of options or the vesting of restricted/deferred share units would decrease the proportionate ownership and voting power of all other shareholders. This dilution could cause the price of the Common Shares to decline and it could result in the creation of new control persons. In addition, the Corporations shareholders could suffer dilution in the net book value per share.
There can be no assurance of dividends and the market value of Common Shares may decline if dividends are not paid.
Management of the Corporation currently intends that the Corporation will continue to pay quarterly dividends; however, there can be no assurance that the Corporations revenues or earnings will enable the Corporation to continue to pay quarterly dividends or any dividends at all. The Corporations dividend policy could be reviewed from time to time by the Board in the context of the Corporations earnings, financial condition and other relevant factors. If the Corporation does not continue to pay dividends, the Corporations shareholders will not be able to receive a return on their Common Shares unless they sell them. In addition, any dividend to be approved by the Board may require third party consents under the Corporations debt facility agreements. In addition, in the event that the Corporation is not in compliance with its obligations under its debt facility agreements, the Corporations ability to pay dividends on its shares may be restricted by such facilities. The market value of the Common Shares may deteriorate if the Corporation is unable to meet its dividend targets in the future, and that deterioration may be material. In addition, the composition of cash dividends for tax purposes may change over time and may affect the after-tax return for investors.
Shareholders of the Corporation could experience dilution in holdings.
The Corporation is authorized to issue an unlimited number of Common Shares for such consideration and on such terms and conditions as shall be established by the Board without shareholder approval. The Corporations shareholders will have no pre-emptive rights in connection with such further issues. Accordingly, future issuances of Common Shares by the Corporation could result in dilution to the shareholders of the Corporation, and such dilution may be substantial.
There is no guarantee that an active, liquid market for Common Shares will be maintained.
There is no guarantee that an active. liquid trading market for the Common Shares will be maintained on the TSX. Investors may not be able to sell their Common Shares quickly or at the latest market price if trading in the Common Shares is not active.
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Shareholders could lose their entire investment.
An investment in Common Shares is speculative and may result in the loss of an investors entire investment. Only investors who are comfortable investing in a company with limited operating history and can afford to lose their entire investment should consider an investment in the Corporation.
DIVIDEND POLICY
There are no restrictions in the Corporations articles preventing the Corporation from paying dividends. Any dividend to be approved by the Board may require third-party consents under the Corporations credit facilities. In addition, in the event that the Corporation is not in compliance with its obligations under the GE Amended Credit Agreement, the Corporations ability to pay distributions or dividends on its Common Shares may be restricted by the GE Amended Credit Agreement. All of the Common Shares are entitled to an equal share in any dividends declared and paid. The Board will determine if, and when, dividends will be declared and paid in the future from funds properly applicable to the payment of dividends based on the Corporations financial position at the relevant time. See Risk Factors .
Commencing during the six month period ended June 30, 2014, the Corporation has paid a quarterly dividend of $0.075 per Common Share. Future dividend decisions will consider the Corporations then-current business results, cash requirements and financial condition.
DESCRIPTION OF CAPITAL STRUCTURE
Common Shares
The authorized capital of the Corporation consists of an unlimited number of Common Shares. As at December 31, 2014, 28,861,239 Common Shares were issued and outstanding. As at March 18, 2015, 28,873,739 Common Shares were issued and outstanding.
There are no special rights or restrictions attached to the Common Shares. The Common Shares rank equally as to all benefits which might accrue to the holders thereof, including the right to receive dividends out of monies of the Corporation properly applicable to the payment of dividends, if and when declared by the Board, and to participate ratably in the remaining assets of the Corporation in any distribution on a dissolution or winding-up. There are no provisions restricting the issuance of Common Shares or any other material restrictions.
All shareholders are entitled to receive a notice of all meetings of shareholders to be convened by the Corporation. At any meeting of shareholders, on a show of hands, every shareholder who is present in person or by proxy and entitled to vote has one vote, and on a poll, every shareholder who is entitled to vote has one vote for each Common Share held and may exercise such vote either in person or by proxy.
Stock Option Plan
The Corporations stock option plan (the Stock Option Plan ) was approved by the shareholders of the Corporation at the special meeting of shareholders held on December 16, 2013. As part of an ongoing review of the Corporations compensation strategies, on May 22, 2014, the Board approved certain amendments to the Stock Option Plan, which amendments were approved by shareholders of the Corporation at the annual general and special meeting of shareholders held on June 27, 2014. On November 13, 2014, the Board approved further amendments to the Stock Option Plan to clarify the sections of the Stock Option Plan relating to the cashless exercise of options. Such amendment was of a housekeeping nature and did not require shareholder approval.
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The following is a summary of the principal provisions of the Stock Option Plan and is qualified in its entirety by the full text of the amended Stock Option Plan which is attached to the Corporations management information circular dated May 23, 2014, available on SEDAR, online at www.sedar.com.
The Stock Option Plan provides that the Board may from time to time, in its discretion, grant to directors, officers, employees, consultants and any other person or entity engaged to provide ongoing services to the Corporation non-transferable options to purchase Common Shares, provided that the number of Common Shares reserved for issuance under the Stock Option Plan shall not exceed 10% of the issued and outstanding Common Shares of the Corporation from time to time on a non-diluted basis, inclusive of any Common Shares reserved for issuance pursuant to any other security based compensation arrangement of the Corporation (including the Long Term Incentive Plan). Under the Stock Option Plan the Board has the right, from time to time, to increase such percentage, subject to the approval of the shareholders and such regulatory authorities, stock exchanges or over-the-counter markets having jurisdiction over the affairs of the Corporation. The Board has the power, where consistent with the general purpose and intent of the Stock Option Plan, to determine the terms upon which options will vest (including vesting schedules, if any) and be exercisable. The exercise price of options shall not be less than the lesser of: (i) the closing trading price of the Common Shares on the TSX or, if not listed on the TSX, then such other principal market on which the Common Shares trade as designated by the Board, on the date an option is granted; and (ii) the Market Price of the Common Shares on the date the option is granted. For the purposes of the Stock Option Plan, Market Price means the volume-weighted average price of the Common Shares on the stock exchange where the majority of trading volume and value of the Common Shares occurs, for the five trading days immediately preceding the relevant date on which the Market Price is to be determined. In the event that the Common Shares are not listed for trading on a stock exchange, the Market Price shall be the fair market value of the Common Shares as determined by the Board.
Under the Stock Option Plan the number of Common Shares reserved for issuance to any one person shall not exceed 5% of the issued and outstanding Common Shares. The aggregate number of Common Shares issued to insiders of the Corporation within any 12-month period, or issuable to insiders of the Corporation at any time, under the Stock Option Plan and any other security-based compensation arrangement of the Corporation, may not exceed 10% of the total number of issued and outstanding Common Shares of the Corporation at such time.
The Stock Option Plan also provides that:
(i) | Common Shares that were the subject of options granted under the Stock Option Plan that have been exercised, surrendered, lapsed, cancelled or terminated shall thereupon no longer be in reserve and may once again be subject to an option granted under the Stock Option Plan; |
(ii) | a holder of an option may elect a cashless exercise of any options; |
(iii) | the expiry date for an option shall not in any circumstance be later than the lesser of the 10th anniversary of the date an option is granted and the maximum period of time allowed by the Stock Exchange (as defined in the Stock Option Plan); and |
(iv) | subject to certain exceptions outlined in the Stock Option Plan, all options held by an officer or employee of the Corporation shall expire and terminate, and such employee optionee shall cease to be an eligible person, immediately upon the termination date of such employee optionee or the date of such employee optionees death, disability or retirement. |
The Board may amend the Stock Option Plan from time to time without Shareholder approval except for amendments relating to:
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(i) | the maximum number of Common Shares reserved for issuance under the Stock Option Plan; |
(ii) | a reduction in the exercise price for options held by insiders of the Corporation; |
(iii) | an extension to the term of any option held by insiders of the Corporation; |
(iv) | an increase in any limit on grants of options to insiders of the Corporation; and |
(v) | any amendment that is not (a) determined to be necessary or desirable to ensure continuing compliance with applicable laws, regulations, requirements, rules or policies of any governmental authority or stock exchange; or (b) of a housekeeping nature, which includes amendments to eliminate any ambiguity or correct or supplement any provision contained in the Stock Option Plan which may be incorrect or incompatible with any other provision of the Stock Option Plan. |
As at December 31, 2014, there were 2,002,280 outstanding options to purchase 2,002,280 Common Shares under the Stock Option Plan.
Long Term Incentive Plan
On May 22, 2014 the Board approved the Corporations long term incentive plan (the Long Term Incentive Plan or LTIP ), a copy of which is attached to the Corporations management information circular dated May 23, 2014, available on SEDAR, online at www.sedar.com. The LTIP was approved by shareholders of the Corporation at the annual general and special meeting of shareholders held on June 27, 2014.
The purpose of the LTIP is to advance the interests of the Corporation: (a) through the motivation, attraction and retention of key employees and directors of the Corporation; (b) by aligning the interests of eligible participants with the interests of shareholders of the Corporation generally; and (c) by furnishing eligible participants with an additional incentive in their efforts on behalf of the Corporation.
Under the terms of the LTIP, the Board or, if authorized by the Board, the Human Resources and Compensation Committee may grant units ( Units ), which may be either restricted share units ( Restricted Share Units or RSUs ) or deferred share units ( Deferred Share Units or DSUs ) to officers, directors, employees or consultants of the Corporation. Each Unit represents the right to receive one Common Share in accordance with the terms of the LTIP. Participation in the LTIP is voluntary and, if an eligible participant agrees to participate, the grant of Units will be evidenced by an agreement between the Corporation and the participant. The interest of any participant in any Unit may not be transferred or assigned except by testamentary disposition or in accordance with the laws governing the devolution of property upon death.
The maximum number of Common Shares which may be reserved and set aside for issue under the LTIP in respect of awards of DSUs to DSU Participants, and for payments in respect of awards of RSUs to RSU Participants, shall not exceed 10% of the Common Shares issued and outstanding from time to time on a non-diluted basis (for purposes of clarity, the maximum number of Common Shares reserved and set aside for issue under the LTIP shall be inclusive of any Common Shares reserved for issuance pursuant to any other security based compensation arrangement of the Corporation, including the Stock Option Plan), provided that the Board shall have the right, from time to time, to increase such percentage subject to the approval of shareholders and such regulatory authorities, stock exchanges or over-the-counter markets having jurisdiction over the affairs of the Corporation. Common Shares that were the subject of awards that have expired, been surrendered, lapsed, cancelled or terminated shall thereupon no longer be in
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reserve and may once again be subject to an award granted under the LTIP, effectively resulting in a reloading of the number of RSUs and DSUs available for awards under the LTIP.
The LTIP, together with all other previously established or proposed security based compensation arrangements of the Corporation, including the Stock Option Plan, as amended, may not result in:
(i) | the number of Common Shares reserved for issuance to insiders at any time exceeding 10% of the outstanding issue; |
(ii) | the issuance to insiders of the Corporation of a number of Common Shares exceeding, within a one-year period, 10% of the outstanding issue; or |
(iii) | the issuance to any one insider of the Corporation, within a one-year period, of a number of Common Shares exceeding 5% of the outstanding issue. |
Restricted Share Units
An officer, director, employee or consultant of the Corporation who has been designated by the Corporation for participation in the LTIP and who agrees to participate in the LTIP is an eligible participant to receive RSUs under the LTIP (an RSU Participant ).
Unless otherwise approved by the Board, an RSU will vest as to 33 1 ⁄ 3 % on each of the first, second and third anniversary dates of the grant date, provided that all RSUs granted under a particular award shall vest on or before December 31 st of the calendar year which is three years following the calendar year in which the service was performed in respect of which the particular award was made (the Final Vesting Date ). In the event that a vesting date occurs within a blackout period or within five business days thereafter, the vesting date shall be ten business days after the blackout period ends (the Extension Period ). If an additional blackout period is subsequently imposed during the Extension Period, then the Extension Period will commence following the end of such additional blackout period. Despite the foregoing, a vesting date will not be extended beyond the Final Vesting Date.
On each vesting date, the Corporation will decide, in its sole discretion, whether to make all payments in respect of vested RSUs to the RSU Participant in cash, Common Shares issued from treasury or a combination thereof based on the fair market value of the Common Shares as at such date. For the purposes of the LTIP, the fair market value of a Common Share is the weighted average trading price of the Common Shares on the TSX for the five trading days immediately preceding the vesting date or DSU Termination Date in respect of DSUs, as applicable.
If an RSU Participant ceases to be an eligible participant under the LTIP due to termination with cause or voluntary termination by the RSU Participant, all unvested RSUs previously credited to the participants account are terminated and forfeited as of the termination date. If an RSU Participant ceases to be an eligible participant under the LTIP due to termination without cause, death, total or permanent long-term disability or retirement, any unvested RSUs previously credited to the participants account will continue to vest in accordance with their terms or, at the discretion of the Board, be terminated and forfeited as of the termination date.
In the event the Corporation pays a dividend on the Common Shares subsequent to the granting of a RSU award, the number of RSUs relating to such award shall be increased to reflect the amount of the dividend.
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Deferred Share Units
A director of the Corporation who has been designated by the Corporation for participation in the LTIP and who agrees to participate in the LTIP is an eligible participant to receive DSUs under the LTIP (a DSU Participant ).
All DSUs awarded to a DSU Participant will vest on the date on which the DSU Participant ceases to be a director of the Corporation (the DSU Termination Date ).
On the DSU Termination Date, payment in respect of a DSU Participants DSUs becomes payable and the Corporation will decide, in its sole discretion, whether to make the payment in cash, Common Shares issued from treasury or a combination thereof based on the fair market value of the Common Shares as at the DSU Termination Date.
In the event the Corporation pays a dividend on the Common Shares subsequent to the granting of a DSU award, the number of DSUs relating to such award shall be increased to reflect the amount of the dividend.
Amendments
The Corporation retains the right without the approval of shareholders of the Corporation:
(i) | to amend the LTIP or any RSUs or DSUs to: |
(a) | make amendments of a grammatical, typographical, clerical and administrative nature and any amendments required by a regulatory authority or to comply or conform with applicable laws; |
(b) | change vesting provisions of the LTIP or any Restricted Share Units or Deferred Share Units; |
(c) | make any other amendments of a non-material nature; |
(d) | make amendments to the definition of DSU Participant and/or RSU Participant or the eligibility requirements of participating in the LTIP, where such amendment would not have the potential of broadening or increasing insider participation; |
(e) | make amendments to the manner in which eligible participants may elect to participate in the LTIP; |
(f) | make any amendments to the provisions concerning the effect of the termination of a participants employment or services on such participants status under the LTIP; or |
(g) | make any amendment which is intended to facilitate the administration of the LTIP; or |
(ii) | to suspend, terminate or discontinue the terms and conditions of the LTIP and the Restricted Share Units and Deferred Share Units granted under the LTIP by resolution of the Board, provided that: |
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(a) | no such amendment to the LTIP shall cause the LTIP in respect of Restricted Share Units to cease to be a plan described in paragraph (k) of the definition of salary deferral arrangement in subsection 248(1) of the ITA or any successor to such provision; |
(b) | no such amendment to the LTIP shall cause the LTIP in respect of Deferred Share Units to cease to be a plan described in regulation 6801(d) of the ITA or any successor to such provision; and |
(c) | any amendment shall be subject to the prior consent of any applicable regulatory bodies, including the TSX, as may be required. |
Any amendment to the LTIP which changes the vesting provisions of the LTIP or any RSUs or DSUs, or any suspension, termination or discontinuance of the terms and conditions of the LTIP and the Restricted Share Units and Deferred Share Units granted under the LTIP, shall take effect only with respect to awards granted after the effective date of such amendment, provided that it may apply to any outstanding award with the mutual consent of the Corporation and the participants to whom such awards have been granted.
Any amendment to the LTIP other than as described above shall require the approval of shareholders of the Corporation given by the affirmative vote of a simple majority of the Common Shares (or, where required, disinterested shareholder approval) represented at a meeting of shareholders at which a motion to approve the LTIP or an amendment to the LTIP is presented. Specific amendments requiring shareholder approval include:
(i) | to increase the number of Common Shares reserved under the LTIP; |
(ii) | to change the definition of RSU Participants or DSU Participants or the eligibility requirements of participating in the LTIP, where such amendment would have the potential of broadening or increasing insider participation; |
(iii) | the extension of any right of a participant under the Plan beyond the date on which such right would originally have expired; |
(iv) | to permit RSUs or DSUs to be transferred other than by testamentary disposition or in accordance with the laws governing the devolution of property in the event of death; |
(v) | to permit awards other than RSUs and DSUs under the LTIP; and |
(vi) | to amend the amendment provisions of the LTIP so as to increase the ability of the Board to amend the LTIP without shareholder approval. |
DEBT FINANCING
GE Amended Credit Agreement
As at December 31, 2014, the Corporation had outstanding indebtedness under the GE Amended Credit Agreement in the principal amount of $260.75 million. The GE Amended Credit Agreement bears a variable interest rate and matures on May 14, 2019, with fixed repayments required over the term to maturity, as well as mandatory repayments based on excess cash flow generated by the Corporation as defined in the GE Amended Credit Agreement, calculated annually. Interest rates are calculated at the
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United States Prime Rate or LIBOR plus applicable margins based on a leverage table. The GE Amended Credit Agreement is secured by the assets of the Corporation and the assets of its material subsidiaries.
MARKET FOR SECURITIES
Trading Price and Volume
The Common Shares are currently listed on the TSX under the trading symbol CXR. The following table sets forth the reported intraday high and low prices and the trading volume for the Common Shares on the TSX during the Corporations most recently completed financial year.
TSX (1) | ||||||||||||
Month |
High | Low | Volume | |||||||||
(C$) | (C$) | |||||||||||
2014 |
||||||||||||
January |
12.38 | 7.60 | 1,515,013 | |||||||||
February |
16.05 | 11.89 | 4,491,138 | |||||||||
March |
17.75 | 13.57 | 6,053,405 | |||||||||
April |
25.00 | 15.99 | 6,583,954 | |||||||||
May |
33.05 | 24.60 | 4,679,257 | |||||||||
June |
35.65 | 29.92 | 5,490,520 | |||||||||
July |
38.75 | 33.74 | 2,944,954 | |||||||||
August |
36.32 | 32.58 | 3,050,006 | |||||||||
September |
37.22 | 32.81 | 4,950,997 | |||||||||
October |
43.01 | 33.42 | 4,697,327 | |||||||||
November |
49.00 | 40.20 | 4,063,579 | |||||||||
December |
48.31 | 41.34 | 4,068,435 |
Note :
(1) | High and low price based on intraday high and low share prices. Source for data in the above table is the TSX. Past performance should not be seen as an indicator of future performance. |
Prior Sales
Common Shares
The following table summarizes details of the Common Shares issued by the Corporation during and since the end of the Corporations most recently completed financial year:
Date of Issuance |
Price per Security | Number of Securities | ||||||
January 21, 2014 |
C$ | 4.81 | (1) | 23,918 | (2) | |||
January 23, 2014 |
C$ | 6.25 | 22,080 | (3) | ||||
February 18, 2014 |
C$ | 6.25 | 57,900 | (3) | ||||
March 11, 2014 |
C$ | 11.75 | 5,750,000 | (4) | ||||
March 20, 2014 |
C$ | 4.81 | (2) | 2,079 | (2) | |||
March 20, 2014 |
C$ | 6.25 | 19,380 | (3) | ||||
May 15, 2014 |
C$ | 30.50 | 4,605,833 | (5) | ||||
July 29, 2014 |
C$ | 11.50 | 50,000 | (6) | ||||
September 4, 2014 |
$ | 3.00 | 300,000 | (7) | ||||
February 23, 2015 |
$ | 3.00 | 12,500 | (8) |
Notes :
(1) | Deemed price on a post-Consolidation basis. |
(2) | Issued upon exercise of options held by former directors of the Corporation. These stock options were granted in connection with the Corporations initial public offering completed on May 6, 2010, with each option having an exercise price of C$0.10 per share (or an exercise price of C$4.81 on a post-Consolidation basis). |
(3) | Issued upon exercise of Agents Options. |
(4) | Issued in connection with a short form prospectus offering which closed on March 11, 2014. |
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(5) | Issued in connection with the Donnatal ® acquisition based on the closing price of the Common Shares on May 15, 2014 of C$30.50 per share converted to United States dollars using the May 15, 2014 Bank of Canada closing exchange rate of $1.00 = C$1.0877. See General Description and Development of the Business - Development of the Business - Donnatal ® Acquisition . |
(6) | Issued upon exercise of 50,000 options exercised by an executive officer of the Corporation. |
(7) | Issued upon exercise of 300,000 options exercised by an executive officer of the Corporation. |
(8) | Issued upon exercise of 12,500 options exercised by an employee of the Corporation. |
Stock Options
The following table summarizes details of the stock options issued by the Corporation during and since the end of the Corporations most recently completed financial year:
Date of Issuance |
Price per Security | Number of Securities | ||||||
January 1, 2014 |
C$ | 6.25 | 100,000 | (1) | ||||
January 29, 2014 |
C$ | 11.50 | 330,000 | (1) | ||||
March 11, 2014 |
C$ | 14.95 | 335,000 | (1) | ||||
April 17, 2014 |
C$ | 21.50 | 50,000 | (1) | ||||
June 2, 2014 |
C$ | 32.50 | 5,000 | (1) | ||||
August 15, 2014 |
C$ | 34.30 | 95,000 | (1) | ||||
February 11, 2015 |
C$ | 58.38 | 50,000 | (1) |
Note:
(1) | Issued to certain employees under the Stock Option Plan. |
In addition, the Board approved the grant of 370,000 stock options to certain executive officers of the Corporation on November 11, 2014. As the Corporation was in a blackout period at the time of the approval of the grant, and continues to be in a blackout period as at March 18, 2015, these stock options have been neither priced nor issued and will not be priced nor issued until 24 hours after the expiration of the blackout period.
Restricted Share Units
The following table summarizes details of the RSUs issued by the Corporation during and since the end of the Corporations most recently completed financial year:
Date of Issuance |
Price per Security | Number of Securities | ||||||
February 13, 2015 |
N/A | 1,000 | (1) |
Note:
(1) | Issued to a former non-executive director of the Corporation. These RSUs vested on February 27, 2015 and were paid out by the Corporation in cash in the amount of $55,326.86. |
The Board approved the grant of 4,000 RSUs to the non-executive directors of the Corporation on November 11, 2014. As the Corporation was in a blackout period at the time of the approval of the grant, and continues to be in a blackout period as at March 18, 2015, these RSUs have not been granted, and will not be granted until 24 hours after the expiration of the blackout period.
The Board also approved an employee bonus proposal which provides for the granting of RSUs having an aggregate value of $833,365 to certain employees of the Corporation in connection with the performance of such employees during the fiscal year ended December 31, 2014. As the Corporation was in a blackout period at the time of the approval of the proposal, and continues to be in a blackout period as at March 18, 2015, these RSUs have not been granted and will not be granted until 24 hours after the expiration of the blackout period.
The Board approved the grant of such number of RSUs having a value of $125,000 to each of the non-executive directors for each fiscal year commencing on and after January 1, 2015. As the Corporation was in a blackout period at the time of the approval of the grant, and continues to be in a blackout period as at
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March 18, 2015, the RSUs to be granted for fiscal 2015 have not been granted and will not be granted until 24 hours after the expiration of the blackout period.
The Board also approved the grant of 15,000 RSUs to an employee of the Corporation on November 11, 2014. As the Corporation was in a blackout period at the time of the approval of the grant, and continues to be in a blackout period as at March 18, 2015, these RSUs have not been granted, and will not be granted until 24 hours after the expiration of the blackout period.
On March 17, 2015, the Board approved the grant of such number of RSUs having an aggregate value of up to $175,000 to certain newly hired employees of the Corporation. As the Corporation was in a blackout period at the time of the approval of the grant, and continues to be in a blackout period as at March 18, 2015, these RSUs have not been granted, and will not be granted until 24 hours after the expiration of the blackout period.
Deferred Share Units
The Corporation did not issue any DSUs under the LTIP during and since the end of the Corporations most recently completed financial year.
Escrowed Securities and Securities Subject to Contractual Restriction on Transfer
The following table summarizes details of the Corporations securities of each class held, to the Corporations knowledge, in escrow or that are subject to a contractual restriction on transfer as at December 31, 2014:
Designation of class |
Number of securities and percentage of class (1) | |||
Common Shares |
278,096 (2) (0.96 | %) |
Notes :
(1) | Based on the number of outstanding securities of that class as at December 31, 2014. |
(2) | As at December 31, 2014, 278,096 Common Shares were held in escrow by Wilmington Trust, National Association in connection with the acquisition of Pinnacle. Such Common Shares (less any Common Shares that are the subject of a claim at such time) will be released from escrow on the first business day after the expiration of the claims period pursuant the Pinnacle Purchase Agreement, being June 20, 2015. |
DIRECTORS AND EXECUTIVE OFFICERS OF THE CORPORATION
Directors and Executive Officers, Positions and Security Holdings
The following table sets out the name; city, state/province and country of residence; position with the Corporation; and number and percentage of the Common Shares beneficially held by each of the Corporations directors and executive officers as at March 18, 2015:
Name, province or state and
|
Position with the Corporation |
Principal Occupation During the Past Five Years |
Period as Director
and/or
|
Number of
Common Shares and Approximate Percentage |
||||||
Mark Thompson Oakville, Ontario, Canada |
Founder, Director, President and Chief Executive Officer | CEO, President (from April 2013) and a director of Concordia Private Co., Managing Director of Distinct Capital Partners from January 2012 to April 2013, Vice President Business Development and Co-Founder of Trimel Pharmaceuticals Corporation from August 2007 to December 2011. | December 2013 to present. |
|
2,105,850
7.29 |
% |
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Leith Tessy Lexington, Massachusetts, United States |
Chief Financial Officer, Secretary- Treasurer | CFO of Concordia Private Co. from November, 2013, Senior Vice-President, Nuance Communications from 2011 to 2012, COO of LG-Nortel/LG-Ericsson from 2008 to 2011. | December 2013 to present. |
|
102,000
0.35 |
% |
||||
John McCleery St. George, Barbados |
Managing Director and Chief Financial Officer of CPI and CLI | Managing Director and CFO of CPI since July 2013, Vice-President, General Manager and CFO of Trimel BioPharma SRL from November, 2009 to June 2013, Principal of J. McCleery and Associates, October 2008 to October 2009. | December 2013 to present. |
|
250,000
0.87 |
(7)
% |
||||
Ron Schmeichel (4)(5) Toronto, Ontario, Canada |
Director (6) Non-executive Chairman of the Board |
Chairman and CEO of JJR Private Capital Inc. (including its predecessor JJR Capital Partners) since February 2003; Former President and CEO of Windsor Private Capital Inc. from 2011 to 2014. | December 2013 to present. |
|
32,300
0.11 |
% |
||||
John Huss (3)(4)(5) Westmount, Quebec, Canada |
Director (6) | President, H&P Labs Inc. since June 2013, President and CEO of Theratechnologies Inc. from December 2010 to October 2012, Chief of Staff of Sanofi-Aentis groupe from August 2009 to November 2010, CEO of Sanofi-Aventis Switzerland from February 2007 to July 2009. | December 2013 to present. |
|
8,000
0.03 |
% |
||||
Douglas Deeth (3)(5) Toronto, Ontario, Canada |
Director | Partner, Deeth Williams Wall LLP. | December 2013 to present. |
|
5,000
0.02 |
% |
||||
Jordan Kupinsky (3)(4) Toronto, Ontario, Canada |
Director (6) | President, JJR Private Capital Inc. Former Managing Director, Windsor Private Capital Inc. from 2008 to 2014. | December 2013 to present. |
|
735,232
2.55 |
(8)
% |
||||
Wayne Kreppner Georgetown, Ontario, Canada |
Chief Operating Officer | Vice-President of Product Development at Trimel Pharmaceuticals. Various senior roles in regulatory affairs and operations with Biovail Corporation. | January 2014 to present. |
|
5,000
0.02 |
% |
||||
Robert Altman Chicago, Illinois, United States |
President of Pinnacle | Chief Commercial Officer at Pinnacle Biologics, Inc., Founder, CEO and president of Marathon Pharmaceuticals. | December 2013 to present. |
|
2,394
0.01 |
% |
||||
|
|
|
||||||||
TOTAL |
3,245,776 | 11.24 | % | |||||||
|
|
|
Notes :
(1) | Paul Manning was elected as a director of the Corporation at the annual general and special meeting of shareholders held on June 27, 2014. Effective January 2, 2015, Paul Manning resigned as a director of the Corporation. |
(2) | Each director listed will hold his position as a director of the Corporation until the next annual meeting of shareholders. December 2013 is listed as the date in which each director became a director of the Corporation pursuant to the Qualifying Transaction. |
(3) | Member of the Nominating and Corporate Governance Committee of the Corporation. |
(4) | Member of the Audit Committee of the Corporation. |
(5) | Member of the Human Resources and Compensation Committee of the Corporation. |
(6) | Independent director. |
(7) | Beneficially held through 4M Holdings Inc. |
(8) | 543,750 beneficially held through HJR 2013 Family Trust; 186,682 beneficially held through Justley Capital Corporation; and 4800 beneficially held through Nicky Cohen. |
Biographies
The following are brief profiles of the directors and the executive officers of the Corporation.
Executive Officers
Mark Thompson is the CEO, President, founder and a director of the Corporation. Former Senior Vice President and General Counsel of Legacy Pharma Limited Partnership, co-founder of Trimel Pharmaceuticals and Tribute Pharmaceuticals Inc. From 2001 to 2005, Mr. Thompson was employed by Biovail Corporation (currently Valeant), where he held the title of Vice-President, Business Development and, before that, Associate General Counsel. While at Biovail, Mr. Thompson was actively involved in M&A transactions valued at over $2 billion. Prior to joining Biovail, Mr. Thompson was an associate at
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Osler, Hoskin and Harcourt LLP. Mark holds an H.B.A., and M.A. from York University and an L.L.B. from the University of Ottawa.
Leith Tessy has 26 years of international experience as a finance and operations executive. Mr. Tessy has been successful driving M&A transactions (with total transaction value exceeding $1 billion), integrating acquired companies and expanding operating margins. Previous roles held include: CFO then COO of LG Nortel, a JV between Nortel Networks and LG Electronics based in Seoul, South Korea (under Mr. Tessys leadership, the company grew from approximately $500 million to approximately $1 billion, delivering 30% EBITDA margin), CFO of Nortel Networks Global Carrier Networks group (at approximately $5 billion revenue, Nortels largest, most profitable division), and SVP Finance at Nuance Communications. Mr. Tessy holds an Industrial Engineering degree from University of Toronto and an MBA from Ivey School of Business, University of Western Ontario.
John McCleery is the Managing Director and CFO of CPI and CLI. Mr. McCleery has over 30 years of international experience as a senior financial and operational executive. He developed and managed the Enterprise Risk Management and Compliance program for Valeant Pharmaceuticals International Inc. (formerly Biovail Corporation), reporting company risks to the board of directors. Mr. McCleery chaired the Compliance Committee and the Canadian Investment (RSP; DPSP) Committee. Mr. McCleery served as Vice President and General Manager of Valeant Laboratories (Barbados) SRL (formerly Biovail Laboratories International SRL) the principal operating subsidiary where he had responsibility for managing intellectual property, treasury activities, research and development programs and business partner relationships with Merck, Johnson and Johnson, Wyeth, Forest and Teva. He was also a Director and Vice President, Treasurer of Valeant Insurance Incorporated (formerly Biovail Insurance Incorporated). Mr. McCleery served as Vice President, General Manager and Chief Financial Officer of Trimel BioPharma SRL and was responsible for all operational and financial management of the principal operating subsidiary of Trimel Pharmaceuticals Corporation. Mr. McCleery is a Chartered Professional Accountant (CPA) and a Chartered Accountant (CA) having earned his designations with the Toronto office of PricewaterhouseCoopers.
Wayne Kreppner is the COO of the Corporation. Mr. Kreppner has over 15 years of experience as a pharmaceutical operations and R&D executive. A co-founder and former Vice-President of Product Development at Trimel Pharmaceuticals, Mr. Kreppner was responsible for all Scientific Operations including R&D, Clinical Development, Manufacturing and Supply Chain. From 1997 to 2008 Mr. Kreppner held various senior roles in Operations and Regulatory Affairs with Biovail Corporation, where he was involved in the discovery, development, approval and launch of the product pipeline including Wellbutrin XL and Tiazac. Mr. Kreppner holds a Hons. B.Sc. degree in Biochemistry from the University of Western Ontario, a M.Sc. in Medical Science from McMaster University and an MBA from the Ivey School of Business, University of Western Ontario.
Robert Altman is the President of Pinnacle, a subsidiary of the Corporation. Previously, Dr. Altman was founder, CEO and President of Marathon Pharmaceuticals, a fully integrated, specialty pharmaceutical company focusing on rare diseases. Prior to Marathon, Dr. Altman worked for Astellas Pharma, where he was Senior Vice President of Commercial Operations and responsible for commercial strategy and leadership covering North America. Before joining Astellas, Dr. Altman spent 17 years at Abbott Laboratories, where he held numerous positions including Vice President General Manager of several of the companys Therapeutic Drug Franchises. Dr. Altman earned his BS Chemistry at University of California, Riverside, a PhD in Physical Chemistry from Harvard University and an MBA from the University of Chicago - Booth School of Business.
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Directors
Ron Schmeichel has over 19 years of experience in high-yield credit, leveraged loans, buy-outs and equity capital markets in Canada and the United States. He has specialized in providing credit and equity lines for management buy-outs, recapitalizations, bridge and mezzanine loans and minority equity ownership to small/mid-market companies in Canada. Mr. Schmeichel was one of the founders and partners of JJR Private Capital in 2003. Mr. Schmeichel also served as a President and CEO of Windsor Private Capital Inc. from 2010 to 2014. Mr. Schmeichel currently serves as the non-executive Chairman of the Board. Mr. Schmeichel has been on the board of 15 TSX and TSX-V public companies. For the past 13 years, Mr. Schmeichel has been a guest lecturer at the University of Western Ontario, Faculty of Law, as well as a guest lecturer at the Ivey School of Business. He currently serves as a member of the Ontario Local Area Committee to the Toronto Stock Exchange-Venture Group. Mr. Schmeichel received a BA degree, with Merit, from York University in 1992 and a Juris Doctorate degree from the University of Western Ontario in 1995.
John Huss founded H&P Labs Inc., a biotechnology company focused on early stages of drug development (Phase I & II) in humans, after 20 years in the pharmaceutical and biotechnology industry. Before that Mr. Huss was President and CEO of Theratechnologies Inc. in Montreal. Since his return to Canada in 2010, he sits on the Board of BioQuebec and since 2012 he also serves on its Executive Committee, as Vice-President. Mr. Huss worked for Sanofi from 1999 to 2010 in Germany, Canada, Switzerland and France. He joined Sanofi in 1999 as a Business Unit Director for the German affiliate. In 2001, Mr. Huss joined the Canadian affiliate as Vice-President, Sales and Marketing in Toronto and moved to Montreal after the acquisition of Aventis. He became General Manager of the Swiss affiliate of Sanofi-Aventis in January 2007, based in Geneva. In August 2009, Mr. Huss joined the Head Office in Paris and worked next to the Chief Executive Officer, Chris Viehbacher, as Chief of Staff. Mr. Huss joined the pharmaceutical industry in 1990 and for six years performed various Sales and Marketing functions for Merck & Co. in the United States, Germany and Switzerland. In 1996, he was offered a position with F. Hoffman-La Roche as an Internal Product Manager at their Basel headquarters.
Douglas Deeth is a partner with the law firm of Deeth Williams Wall LLP. He is the former President of the Intellectual Property Law section of the Canadian Bar Association and has over 35 years of experience working with the pharmaceutical industry. Doug has been recognized in several international reviews as one of Canadas leading intellectual property lawyers. His practice combines his extensive litigation experience with an expertise in negotiating and completing license and product development agreements. He provides timely, practical and pragmatic advice to clients on the clearance, protection and enforcement of all forms of technology and intellectual property rights, and has particular expertise in chemical and pharmaceutical products and processes. Doug was admitted to the Bar of Ontario in 1976 and has more than thirty-five years of litigation experience, ranging from the most complex and sophisticated intellectual property litigation to judicial review proceedings and interlocutory injunction applications. He appears regularly before the Federal Court of Canada and the courts of the Province of Ontario. He has a B.A.Sc. in Chemical Engineering from the University of Waterloo (1970) and an LL.B. from the University of Toronto (1974), and has taught, written and spoken extensively on intellectual property law. He has lectured at McMaster University, the University of Toronto and Osgoode Hall law schools and the McGill courses on Patent and Copyright Law.
Jordan Kupinsky is President of JJR Private Capital. He has been with JJR since 2008. From January 2011 through July 2014, Mr. Kupinsky was also Managing Director with Windsor Private Capital, a private equity merchant banking firm. Prior to joining JJR Capital, Mr. Kupinsky was a Vice President at Greenhill & Co., an independent global investment banking firm, listed on the NYSE, focused on mergers & acquisitions and financial restructuring from March 2006 to May 2008. Prior to joining Greenhill, Mr. Kupinsky held the positions of Vice President of Corporate Development and General Counsel at Minacs
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Worldwide Inc., a publicly traded company on the TSX from July 2002 to February 2005. Mr. Kupinsky began his career practicing corporate and securities law at Torys LLP in Toronto (from 1997 to 1999) and was also an investment banking associate at Houlihan Lokey Howard & Zukin from 1999 to 2002. He holds a joint MBA and JD degree from the Schulich School of Business and Osgoode Hall Law School at York University. Mr. Kupinsky is currently a director of, Atlas Financial Holdings Inc., and Mira IV Acquisition Corp. Mr. Kupinsky also served as a director of Xceed Mortgage Corporation from May 2012 through July 2013 when the sale of Xceed to MCAN Mortgage Corporation was completed.
Corporate Cease Trade Orders or Bankruptcies
Except as described below, no individual who is a director, officer or promoter of or a securityholder anticipated to hold sufficient securities of the Corporation to affect materially the control of the Corporation, is, or has been within the past ten years, a director, officer or promoter of any other person or company that, while such person was acting in that capacity, was:
(a) | the subject of a cease trade or similar order or an order that denied the person or company access to any exemptions under applicable securities law for a period of more than 30 consecutive days; or |
(b) | was declared bankrupt or made a proposal under any legislation relating to bankruptcy or insolvency or been subject to or instituted any proceedings, arrangement or compromise with creditors or had a receiver, receiver manager or trustee appointed to hold the assets of that person. |
In August 2012, while John Huss was the President and CEO of Theratechnologies Inc., Theratechnologies Inc. received a notice from the NASDAQ listing qualification department that it no longer met the minimum bid price requirement of $1.00 per listed share to continue trading on the NASDAQ and had 180 days to regain compliance with such requirement. In January 2013, while Mr. Huss was no longer with Theratechnologies Inc., Theratechnologies Inc. filed documents with the SEC to voluntarily delist its common shares from NASDAQ and delisting became effective as of February 5, 2013.
Penalties or Sanctions
No director, officer or promoter of the Corporation or a securityholder holding sufficient securities of the Corporation to affect materially the control of the Corporation, has been subject to any penalties or sanctions imposed by a court relating to securities legislation or by a securities regulatory authority or has entered into a settlement agreement with a securities regulatory authority or been subject to any other penalties or sanctions imposed by a court or regulatory body, including a self-regulatory body, that would be likely to be considered important to a reasonable securityholder making an investment decision.
Individual Bankruptcies
No director, officer or promoter of the Corporation or a securityholder holding sufficient securities of the Corporation to affect materially the control of the Corporation, or a personal holding company of any such person, has, within the ten years before the date of this Annual Information Form, become bankrupt, made a proposal under any legislation relating to bankruptcy or insolvency or been subject to or instituted any proceedings, arrangement or compromise with creditors, or had a receiver, receiver manager or trustee appointed to hold the assets of that individual.
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Conflicts of Interest
There are no known existing or potential conflicts of interest between the Corporation or a subsidiary of the Corporation and a director or officer of the Corporation or a subsidiary of the Corporation except that there is a potential for conflict of interest between Douglas Deeths role as a director of the Corporation and his capacity as partner of a law firm that has provided advice to Concordia Private Co. and the Corporation.
PROMOTER
Mark Thompson, the CEO, President, founder and a director of the Corporation, may be considered a promoter of the Corporation. As at March 18, 2015, Mr. Thompson beneficially owns, controls or directs, directly or indirectly, 2,105,850 Common Shares, comprising 7.29% of the issued and outstanding Common Shares as at that date.
LEGAL PROCEEDINGS AND REGULATORY MATTERS
Other than as disclosed herein, to the knowledge of the Corporation, there are no material legal proceedings or regulatory actions known or known to be contemplated against the Corporation or to which any of its property is or may be subject. No penalties or sanctions have been imposed against the Corporation by a court relating to securities legislation or by a securities regulatory authority and no settlement agreements have been entered into by the Corporation before a court relating to securities legislation or with a securities regulatory authority.
On February 12, 2015, Concordia received a CID from the FTC regarding Kapvay ® and the Competitive Supply Agreement. CPI and Concordia are cooperating with the information requests. See Legacy Pharmaceuticals Division - Legacy Products - Kapvay ® - Genericization of Kapvay ® .
Prior to Concordia Private Co.s acquisition of the business of the SHD Division, Global Medical Direct and Midwest Medical Services (the predecessor companies to the SHD Division) were investigated in February of 2012 by the United States Department of Justice and the United States Attorneys Offices for the Districts of Louisiana and Kansas. See Specialty Healthcare Distribution Division - Corporate Compliance .
INTEREST OF MANAGEMENT AND OTHERS IN MATERIAL TRANSACTIONS
Other than as disclosed herein, to the knowledge of the Corporation, none of: (i) the directors, executive officers or persons that beneficially own, or control or direct, directly or indirectly, more than 10% of the outstanding securities of the Corporation; or (ii) any associate or affiliate of the persons referred to in (i), has or has had any material interest, direct or indirect, in any transaction within the three most recently completed financial years or during the current financial year that has materially affected or will materially affect the Corporation or any of its subsidiaries.
AUDIT COMMITTEE
The Board has established an audit committee comprised of three directors (the Audit Committee ). The Audit Committee is chaired by Jordan Kupinsky and the other committee members are John Huss and Ron Schmeichel. The relevant education and experience of each member of the Audit Committee is provided above, under the heading Directors and Executive Officers of the Corporation - Biographies . All of the Audit Committee members are independent of management of the Corporation as required by National Instrument 52-110 - Audit Committees and each member is financially literate in that each has
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the ability to read and understand a set of financial statements that present a breadth and level of complexity of accounting issues that are generally comparable to the breadth and complexity of the issues that can reasonably be expected to be raised by the Corporations financial statements.
The mandate of the Audit Committee is set out in the written Charter of the Audit Committee. A copy of the Audit Committee charter is included as Schedule A attached hereto.
Reliance on Certain Exemptions
At no time since the commencement of the Corporations most recently completed financial year has the Corporation relied on the exemptions in Section 2.4 of National Instrument 52-110 ( De Minimis Non-audit Services ), Section 3.2 of National Instrument 52-110 ( Initial Public Offerings ), Section 3.4 of National Instrument 52-110 ( Events Outside of Control of Member ), Section 3.5 of National Instrument 52-110 ( Death, Disability or Resignation of Audit Committee Member ), or an exemption from National Instrument 52-110, in whole or in part, granted under Part 8 of National Instrument 52-110.
Additionally, at no time since the commencement of the Corporations most recently completed financial year has the Corporation relied on the exemptions in subsection 3.3(2) of National Instrument 52-110 ( Controlled Companies ), Section 3.6 of National Instrument 52-110 ( Temporary Exemption for Limited and Exceptional Circumstances ) or Section 3.8 of National Instrument 52-110 ( Acquisition of Financial Literacy ).
Audit Committee Oversight
At no time since the commencement of the Corporations most recently completed financial year was a recommendation of the Audit Committee to nominate or compensate an external auditor not adopted by the Board.
Pre-Approval Policies and Procedures
The Audit Committee is authorized by the Board to review the performance of the Corporations external auditors and approve in advance the provision of services other than auditing and to consider the independence of the external auditors, including reviewing the range of services provided. The Audit Committee may delegate to any independent member of the Audit Committee the authority to pre-approve any non-audit services.
External Auditor Service Fees
A summary of the external auditor service fees and billings paid or payable to the Corporations external auditors in respect of the last two fiscal years ended December 31, 2013, is set out below:
Fiscal Year |
Audit Fees | Audit-Related Fees | Tax Fees | All Other Fees | Total | |||||||||||||||
2013 |
C$ | 342,500 | (1) | C$ | 338,000 | (2) | C$ | 2,000 | (3) | Nil | C$ | 682,500 | ||||||||
2014 |
C$ | 250,000 | C$ | 275,300 | (4) | C$ | 53,100 | (3) | C$ | 129,200 | (4) | C$ | 707,600 |
Notes :
(1) | The amount relates primarily to audit fees charged in connection with the acquisitions, financing and Qualifying Transaction. |
(2) | The amount shown is principally comprised of fees charged by the Corporations external auditors in connection with services performed as part of the Qualifying Transaction. |
(3) | The amount relates primarily to fees charged for assistance with tax compliance in the United States and Canada. |
(4) | The amount relates primarily to audit-related fees charged in connection with quarterly reviews, financings and business acquisition reporting. |
(5) | The amount relates primarily to other fees charged in connection with services performed to support acquisitions and financings. |
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TRANSFER AGENT AND REGISTRAR
The Transfer Agent and Registrar for the Common Shares is Equity Financial Trust Company, 200 University Avenue, Suite 300, Toronto, Ontario, M5H 4H1.
MATERIAL CONTRACTS
The Corporation and/or its subsidiaries, as applicable, have entered into the following material contracts since the beginning of the Corporations most recently completed financial year or before the Corporations most recently completed financial year if any such contract is still in effect, and which are outside of the ordinary course of the Corporations business. A description and summary of each material contract listed below has been cross-referenced in this Annual Information Form:
1. | Agency Agreement (see General Development and Description of the Business - Development of the Business - 2013 Private Placement ); |
2. | Covis Purchase Agreement (see General Development and Description of the Business - General Development of the Business - Covis Portfolio Acquisition ); |
3. | Donnatal Purchase Agreement (see General Development and Description of the Business - Development of the Business - Donnatal Acquisition ); |
4. | GE Amended Credit Agreement (see General Development and Description of the Business - Development of the Business - Zonegran ® Acquisition and Debt Financing - GE Amended Credit Agreement ); |
5. | Global Purchase Agreement (see General Development and Description of the Business - Development of the Business - SHD Division Acquisition ); |
6. | Pinnacle Purchase Agreement (see General Development and Description of the Business - Development of the Business - Photofrin ® Acquisition ); |
7. | Shionogi Purchase Agreement (see General Development and Description of the Business - General Development of the Business - Acquisition of Kapvay ® , Orapred ODT ® and Ulesfia ® ); |
8. | Underwriting Agreement (see General Development and Description of the Business - General Development of the Business - 2014 Public Offering ); and |
9. | Zonegran Purchase Agreement (see General Development and Description of the Business - General Development of the Business - Zonegran Acquisition ). |
Copies of the above listed material contracts are available on the Corporations profile on SEDAR at www.sedar.com or upon request from the Corporation at 277 Lakeshore Rd. East, Suite 302, Oakville, Ontario, L6J 1H9.
INTEREST OF EXPERTS
The auditors of the Corporation are Collins Barrow Toronto LLP, Chartered Accountants, 11 King St. West, Suite 700, Box 27, Toronto, Ontario M5H 4C7. They have been the Corporations auditors since January 21, 2010. Collins Barrow Toronto LLP, was the auditor in respect of the consolidated financial statements of the Corporation as at December 31, 2014 and the financial statements in respect of Zonegran ® included in the business acquisition report of the Corporation dated December 12, 2014, as set forth in its reports thereon. Collins Barrow Toronto LLP has advised the Corporation that it is independent of the Corporation in accordance with the Rules of Professional Conduct of the Institute of Chartered Accountants of Ontario.
Keiter, Certified Public Accounts and Consultants, was the auditor in respect of the financial statements in respect of Donnatal ® included in the business acquisition report dated June 9, 2014, as set forth in its
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report thereon. Keiter has advised the Corporation that it is independent of the Corporation under the SECs rules on auditor independence.
No director, officer or employee of any of the aforementioned companies, is or is expected to be elected, appointed or employed as a director, officer or employee of the Corporation or any associate or affiliate of the Corporation.
ADDITIONAL INFORMATION
Additional information including directors and officers remuneration and indebtedness, the executive compensation for named executive officers of the Corporation, principal holders of the Corporations securities, interests of insiders in material transactions, as applicable, and securities authorized for issuance under equity compensation plans will be contained in the Corporations management information circular for its most recent annual meeting of securityholders that involved the election of directors.
Additional financial information is provided in the Corporations financial statements and managements discussion and analysis for the year ended December 31, 2014. A copy of the management information circular, financial statements and managements discussion and analysis may be obtained upon request from the Corporation and those documents and other information in respect of the Corporation are also available on SEDAR at www.sedar.com.
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SCHEDULE A
CONCORDIA HEALTHCARE CORP.
AUDIT COMMITTEE CHARTER
There shall be a committee of the board of directors (the Board ) of Concordia Healthcare Corp. (the Company ) known as the Audit Committee.
PURPOSE OF AUDIT COMMITTEE
The Audit Committee has been established to assist the Board in fulfilling its oversight responsibilities with respect to the following principal areas:
(a) | the Companys external audit function; including the qualifications, independence, appointment and oversight of the work of the external auditors; |
(b) | the Companys accounting and financial reporting requirements; |
(c) | the Companys reporting of financial information to the public; |
(d) | the Companys compliance with law and regulatory requirements; |
(e) | the Companys risks and risk management policies; |
(f) | the Companys system of internal controls and management information systems; and |
(g) | such other functions as are delegated to it by the Board. |
Specifically, with respect to the Companys external audit function, the Audit Committee assists the Board in fulfilling its oversight responsibilities relating to: the quality and integrity of the Companys financial statements; the independent auditors qualifications; and the performance of the Companys independent auditors.
MEMBERSHIP
The Audit Committee shall consist of as many members as the Board shall determine but, in any event not fewer than three directors appointed by the Board. Each member of the Audit Committee shall continue to be a member until a successor is appointed, unless the member resigns, is removed or ceases to be a director of the Company. The Board may fill a vacancy that occurs in the Audit Committee at any time.
Members of the Audit Committee shall be independent and selected based upon the following and in accordance with applicable laws, rules and regulations:
(a) | Financially Literate. Each member shall be financially literate or must become financially literate within a reasonable period of time after his or her appointment to the Audit Committee. For these purposes, an individual is financially literate if he or she has the ability to read and understand a set of financial statements that present a breadth and level of complexity of accounting issues that are generally comparable to the breadth and complexity of the issues that can reasonably be expected to be raised by the Companys financial statements. |
CHAIR AND SECRETARY
The Chair of the Audit Committee shall be designated by the Board. If the Chair is not present at a meeting of the Audit Committee, the members of the Audit Committee may designate an interim Chair for the meeting by majority vote of the members present. The Secretary of the Company shall be the Secretary of the Audit Committee, provided that if the Secretary is not present, the Chair of the meeting may appoint a secretary for the meeting with the consent of the Audit Committee members who are present. A member of the Audit Committee may be designated as the liaison member to report on the deliberations of the Audit Committees of affiliated companies (if applicable).
MEETINGS
The Chair of the Audit Committee, in consultation with the Audit Committee members, shall determine the schedule and frequency of the Audit Committee meetings provided that the Audit Committee will meet at least four times in each fiscal year and at least once in every fiscal quarter with the management and external auditor. The Audit Committee shall have the authority to convene additional meetings as circumstances require.
Notice of every meeting shall be given to the external and internal auditors of the Company, and meetings shall be convened whenever requested by the external auditors or any member of the Audit Committee in accordance with applicable law. The Audit Committee shall meet separately and periodically with management, legal counsel and the external auditors. The Audit Committee shall meet separately with the external auditors at every meeting of the Audit Committee at which external auditors are present.
MEETING AGENDAS
Agendas for meetings of the Audit Committee shall be developed by the Chair of the Audit Committee in consultation with the management and the corporate secretary, and shall be circulated to Audit Committee members as far in advance of each Audit Committee meeting as is reasonable.
RESOURCES AND AUTHORITY
The Audit Committee shall have the resources and the authority to discharge its responsibilities, including the authority, in its sole discretion, to engage, at the expense of the Company, outside consultants, independent legal counsel and other advisors and experts as it determines necessary to carry out its duties, without seeking approval of the Board or management.
The Audit Committee shall have the authority to conduct any investigation necessary and appropriate to fulfilling its responsibilities, and has direct access to and the authority to communicate directly with the internal and external auditors, the counsel of the Company and other officers and employees of the Company.
The members of the Audit Committee shall have the right for the purpose of performing their duties to inspect all the books and records of the Company and its subsidiaries and to discuss such accounts and records and any matters relating to the financial position, risk management and internal controls of the Company with the officers and external and internal auditors of the Company and its subsidiaries. Any member of the Audit Committee may require the external or internal auditors to attend any or every meeting of the Audit Committee.
A-2
RESPONSIBILITIES
The Companys management is responsible for preparing the Companys financial statements and the external auditors are responsible for auditing those financial statements. The Audit Committee is responsible for overseeing the conduct of those activities by the Companys management and external auditors, and overseeing the activities of the internal auditors.
The specific responsibilities of the Audit Committee shall include those listed below. The enumerated responsibilities are not meant to restrict the Audit Committee from examining any matters related to its purpose.
1. | Financial Reporting Process and Financial Statements |
The Audit Committee shall:
(a) | in consultation with the external auditors and the internal auditors, review the integrity of the Companys financial reporting process, both internal and external, and any major issues as to the adequacy of the internal controls and any special audit steps adopted in light of material control deficiencies; |
(b) | review all material transactions and material contracts entered into between (i) the Company or any subsidiary of the Company, and (ii) any subsidiary, director, officer, insider or related party of the Company, other than transactions in the ordinary course of business; |
(c) | review and discuss with management and the external auditors: (i) the preparation of Companys annual audited consolidated financial statements and its interim unaudited consolidated financial statements; (ii) whether the financial statements present fairly (in accordance with Canadian and United States generally accepted accounting principles) in all material respects the financial condition, results of operations and cash flows of the Company as of and for the periods presented; (iii) any matters required to be discussed with the external auditors according to Canadian and United States generally accepted auditing standards; (iv) an annual report by the external auditors describing: (A) all critical accounting policies and practices used by the Company; (B) all material alternative accounting treatments of financial information within generally accepted accounting principles that have been discussed with management of the Company, including the ramifications of the use such alternative treatments and disclosures and the treatment preferred by the external auditors; and (C) other material written communications between the external auditors and management; |
(d) | following completion of the annual audit, review with each of: (i) management; (ii) the external auditors; and (iii) the internal auditors, any significant issues, concerns or difficulties encountered during the course of the audit; |
(e) | resolve disagreements between management and the external auditors regarding financial reporting; |
(f) | review the interim quarterly and annual financial statements and annual and interim press releases prior to the release of earnings information; and |
(g) |
review and be satisfied that adequate procedures are in place for the review of the public disclosure of financial information by the Company extracted or derived from the Companys |
A-3
financial statements, other than the disclosure referred to in (f), and periodically assess the adequacy of those procedures. |
2. | External auditors |
The Audit Committee shall:
(a) | require the external auditors to report directly to the Audit Committee; |
(b) | be directly responsible for the selection, nomination, compensation, retention, termination and oversight of the work of the Companys external auditors engaged for the purpose of preparing or issuing an auditors report or performing other audit, review or attest services for the Company, and in such regard recommend to the Board the external auditors to be nominated for approval by the shareholders; |
(c) | approve all audit engagements and must pre-approve the provision by the external auditors of all non-audit services, including fees and terms for all audit engagements and non-audit engagements, and in such regard the Audit Committee may establish the types of non-audit services the external auditors shall be prohibited from providing and shall establish the types of audit, audit related and non-audit services for which the Audit Committee will retain the external auditors. The Audit Committee may delegate to one or more of its members the authority to pre-approve non-audit services, provided that any such delegated pre-approval shall be exercised in accordance with the types of particular non-audit services authorized by the Audit Committee to be provided by the external auditor and the exercise of such delegated pre-approvals shall be presented to the full Audit Committee at its next scheduled meeting following such pre-approval; |
(d) | review and approve the Companys policies for the hiring of partners and employees and former partners and employees of the external auditors; |
(e) | consider, assess and report to the Board with regard to the independence and performance of the external auditors; and |
(f) | request and review the audit plan of the external auditors as well as a report by the external auditors to be submitted at least annually regarding: (i) the external auditing firms internal quality-control procedures; (ii) any material issues raised by the external auditors own most recent internal quality-control review or peer review of the auditing firm, or by any inquiry or investigation by governmental or professional authorities within the preceding five years respecting one or more independent audits carried out by the external auditors, and any steps taken to deal with any such issues. |
3. | Accounting Systems and Internal Controls |
The Audit Committee shall:
(a) | oversee managements design and implementation of and reporting on internal controls. The Audit Committee shall also receive and review reports from management, the internal auditors and the external auditors on an annual basis with regard to the reliability and effective operation of the Companys accounting system and internal controls; and |
(b) | review annually the activities, organization and qualifications of the internal auditors and discuss with the external auditors the responsibilities, budget and staffing of the internal audit function. |
A-4
4. | Legal and Regulatory Requirements |
The Audit Committee shall:
(a) | receive and review timely analysis by management of significant issues relating to public disclosure and reporting; |
(b) | review, prior to finalization, periodic public disclosure documents containing financial information, including the Managements Discussion and Analysis and Annual Information Form, if required; |
(c) | prepare the report of the Audit Committee required to be included in the Companys periodic filings; |
(d) | review with the Companys counsel legal compliance matters, significant litigation and other legal matters that could have a significant impact on the Companys financial statements; and |
(e) | assist the Board in the oversight of compliance with legal and regulatory requirements and review with legal counsel the adequacy and effectiveness of the Companys procedures to ensure compliance with legal and regulatory responsibilities. |
5. | Additional Responsibilities |
The Audit Committee shall:
(a) | discuss policies with the external auditor, internal auditor and management with respect to risk assessment and risk management; |
(b) | establish procedures and policies for the following |
(i) | the receipt, retention, treatment and resolution of complaints received by the Company regarding accounting, internal accounting controls or auditing matters; and |
(ii) | the confidential, anonymous submission by directors or employees of the Company of concerns regarding questionable accounting or auditing matters or any potential violations of legal or regulatory provisions; |
(c) | prepare and review with the Board an annual performance evaluation of the Audit Committee; |
(d) | report regularly to the Board, including with regard to matters such as the quality or integrity of the Companys financial statements, compliance with legal or regulatory requirements, the performance of the internal audit function, and the performance and independence of the external auditors; and |
(e) | review and reassess the adequacy of the Audit Committees Charter on an annual basis. |
6. | Limitation on the Oversight Role of the Audit Committee |
Nothing in this Charter is intended, or may be construed, to impose on any member of the Audit Committee a standard of care or diligence that is in any way more onerous or extensive than the standard to which all members of the Board are subject.
A-5
Each member of the Audit Committee shall be entitled, to the fullest extent permitted by law, to rely on the integrity of those persons and organizations within and outside the Company from whom he or she receives financial and other information, and the accuracy of the information provided to the Company by such persons or organizations.
While the Audit Committee has the responsibilities and powers set forth in this Charter, it is not the duty of the Audit Committee to plan or conduct audits or to determine that the Companys financial statements and disclosures are complete and accurate and in accordance with generally accepted accounting principles in Canada and the United States and applicable rules and regulations. These are the responsibility of management and the external auditors.
A-6
Exhibit 99.4
Consolidated Financial Statements of
Concordia Healthcare Corp.
December 31, 2014 and 2013
Table of Contents
Independent Auditors Report |
3 | |||
Consolidated Balance Sheets |
4 | |||
Consolidated Statements of Income and Comprehensive Income |
5 | |||
Consolidated Statements of Changes in Equity |
6 | |||
Consolidated Statements of Cash Flows |
7 | |||
Notes to Consolidated Financial Statements |
8-49 |
|
Collins Barrow Toronto LLP Collins Barrow Place 11 King Street West |
|||
Suite 700, Box 27 | ||||
Toronto, Ontario | ||||
M5H 4C7 Canada | ||||
INDEPENDENT AUDITORS REPORT | T. | 416.480.0160 | ||
F. | 416.480.2646 | |||
To the Shareholders of Concordia Healthcare Corp. | www.collinsbarrow.com |
We have audited the accompanying consolidated financial statements of Concordia Healthcare Corp. and its subsidiaries, which comprise the consolidated balance sheets as at December 31, 2014 and 2013 and the consolidated statements of income and comprehensive income, changes in equity, and cash flows for the years then ended, and a summary of significant accounting policies and other explanatory information.
Managements Responsibility for the Consolidated Financial Statements
Management is responsible for the preparation and fair presentation of these consolidated financial statements in accordance with International Financial Reporting Standards, and for such internal control as management determines is necessary to enable the preparation of consolidated financial statements that are free from material misstatement, whether due to fraud or error.
Auditors Responsibility
Our responsibility is to express an opinion on these consolidated financial statements based on our audits. We conducted our audits in accordance with Canadian generally accepted auditing standards. Those standards require that we comply with ethical requirements and plan and perform the audit to obtain reasonable assurance about whether the consolidated financial statements are free from material misstatement.
An audit involves performing procedures to obtain audit evidence about the amounts and disclosures in the consolidated financial statements. The procedures selected depend on the auditors judgment, including the assessment of the risks of material misstatement of the consolidated financial statements, whether due to fraud or error. In making those risk assessments, the auditor considers internal control relevant to the entitys preparation and fair presentation of the consolidated financial statements in order to design audit procedures that are appropriate in the circumstances, but not for the purpose of expressing an opinion on the effectiveness of the entitys internal control. An audit also includes evaluating the appropriateness of accounting policies used and the reasonableness of accounting estimates made by management, as well as evaluating the overall presentation of the consolidated financial statements.
We believe that the audit evidence we have obtained in our audits is sufficient and appropriate to provide a basis for our audit opinion.
Opinion
In our opinion, the consolidated financial statements present fairly, in all material respects, the financial position of Concordia Healthcare Corp. and its subsidiaries as at December 31, 2014 and 2013, and its financial performance and its cash flows for the years then ended in accordance with International Financial Reporting Standards.
Licensed Public Accountants
Chartered Accountants
March 19, 2015
Toronto, Ontario
[3]
Concordia Healthcare Corp.
Consolidated Balance Sheets
As at December 31, 2014 and 2013
(Stated in thousands of U.S. Dollars, except per share amounts)
2014 | 2013 | |||||||
Assets |
||||||||
Current |
||||||||
Cash |
$ | 42,770 | $ | 42,899 | ||||
Accounts receivable (Note 6) |
29,371 | 23,012 | ||||||
Inventory (Note 7) |
6,718 | 4,030 | ||||||
Prepaid expenses and other current assets (Note 8) |
5,793 | 2,407 | ||||||
|
|
|
|
|||||
84,652 | 72,348 | |||||||
Fixed assets (Note 9) |
760 | 444 | ||||||
Deferred taxes (Note 13) |
861 | 24 | ||||||
Intangible assets (Note 10) |
470,168 | 61,700 | ||||||
Goodwill (Note 11) |
36,259 | 36,249 | ||||||
|
|
|
|
|||||
Total Assets |
$ | 592,700 | $ | 170,765 | ||||
|
|
|
|
|||||
Liabilities |
||||||||
Current |
||||||||
Accounts payable |
$ | 6,773 | $ | 21,669 | ||||
Accrued liabilities |
3,849 | 7,734 | ||||||
Provisions (Note 12) |
21,799 | 24,208 | ||||||
Royalties payable |
3,141 | 3,093 | ||||||
Dividend payable |
2,165 | | ||||||
Taxes payable |
13,309 | 987 | ||||||
Senior and subordinate debt (Note 14) |
| 14,966 | ||||||
Current portion of notes payable (Note 15) |
1,372 | 662 | ||||||
Current portion of long-term debt (Note 14) |
27,336 | | ||||||
Current portion of purchase consideration payable (Note 16) |
2,065 | 2,786 | ||||||
|
|
|
|
|||||
$ | 81,809 | $ | 76,105 | |||||
Long-term debt (Note 14) |
226,145 | | ||||||
Notes payable (Note 15) |
3,890 | 5,104 | ||||||
Purchase consideration payable (Note 16) |
23,043 | 21,599 | ||||||
Deferred taxes (Note 13) |
17 | 6,415 | ||||||
Other liabilities |
246 | 20 | ||||||
|
|
|
|
|||||
Total Liabilities |
335,150 | 109,243 | ||||||
|
|
|
|
|||||
Shareholders Equity |
||||||||
Share capital (Note 17) |
247,035 | 57,521 | ||||||
Reserve for share based compensation (Note 19) |
5,028 | 1,555 | ||||||
Accumulated other comprehensive income (loss) |
(274 | ) | 15 | |||||
Retained earnings |
5,761 | 2,431 | ||||||
|
|
|
|
|||||
Total Shareholders Equity |
257,550 | 61,522 | ||||||
|
|
|
|
|||||
Total Liabilities and Shareholders Equity |
$ | 592,700 | $ | 170,765 | ||||
|
|
|
|
Commitments and contingencies (Note 21)
Subsequent events (Note 26)
Approved and authorized for issue by the Board of Directors on March 19, 2015.
Jordan Kupinsky | Mark Thompson | |||
Director (Signed) | Director (Signed) |
The accompanying notes are an integral part of these consolidated financial statements.
[4]
Concordia Healthcare Corp.
Consolidated Statements of Income and Comprehensive Income
For the years ended December 31, 2014 and 2013
(Stated in thousands of U.S. Dollars, except per share amounts)
2014 | 2013 | |||||||
Revenue |
$ | 122,191 | $ | 40,447 | ||||
Cost of sales |
17,989 | 8,338 | ||||||
|
|
|
|
|||||
Gross profit |
104,202 | 32,109 | ||||||
|
|
|
|
|||||
Operating expenses |
||||||||
General and administrative |
20,663 | 6,545 | ||||||
Business acquisition related costs |
13,521 | 3,692 | ||||||
Selling and marketing |
10,229 | 2,464 | ||||||
Research and development |
9,301 | 1,931 | ||||||
Share-based compensation |
4,484 | 1,070 | ||||||
Depreciation expense |
131 | 18 | ||||||
Exchange listing expenses |
| 2,404 | ||||||
|
|
|
|
|||||
Total operating expenses |
58,329 | 18,124 | ||||||
|
|
|
|
|||||
|
||||||||
|
|
|
|
|||||
Operating income |
45,873 | 13,985 | ||||||
|
|
|
|
|||||
Other income and expense |
||||||||
Interest and accretion expense |
12,194 | 6,382 | ||||||
Amortization of intangible assets |
11,039 | 120 | ||||||
Change in fair value of contingent consideration |
2,629 | | ||||||
Foreign exchange loss |
696 | 129 | ||||||
Other (income) expense |
203 | (150 | ) | |||||
Change in fair value of derivative warrants |
| 4,648 | ||||||
|
|
|
|
|||||
Income before tax |
19,112 | 2,856 | ||||||
|
|
|
|
|||||
Income taxes |
||||||||
Current |
14,756 | 502 | ||||||
Recovery |
(7,234 | ) | (77 | ) | ||||
|
|
|
|
|||||
Net Income |
11,590 | 2,431 | ||||||
|
|
|
|
|||||
Other comprehensive income (loss) |
||||||||
Exchange differences on translation of foreign operations |
(289 | ) | 15 | |||||
|
|
|
|
|||||
Total comprehensive income for the period |
$ | 11,301 | $ | 2,446 | ||||
|
|
|
|
|||||
Earnings per share (Note 18) |
||||||||
Basic earnings per share |
$ | 0.45 | $ | 0.38 | ||||
Diluted earnings per share |
$ | 0.43 | $ | 0.38 |
The accompanying notes are an integral part of these consolidated financial statements.
[5]
Concordia Healthcare Corp.
Consolidated Statements of Changes in Equity
For the years ended December 31, 2014 and 2013
(Stated in thousands of U.S. Dollars, except per share amounts)
Share Capital | ||||||||||||||||||||||||
Number of
Shares |
Amount |
Reserve for
Share Based Compensation |
Accumulated
Other Comprehensive Income (Loss) |
Retained
Earnings |
Total
Shareholders Equity |
|||||||||||||||||||
Balances, January 1, 2013 |
1,500,000 | $ | | $ | | $ | | $ | | $ | | |||||||||||||
Issuance of Common Stock during the period |
16,485,889 | 57,521 | | | | 57,521 | ||||||||||||||||||
Share based compensation expense |
| | 1,555 | | | 1,555 | ||||||||||||||||||
Net income |
| | | | 2,431 | 2,431 | ||||||||||||||||||
Foreign currency translation adjustment |
| | | 15 | | 15 | ||||||||||||||||||
|
|
|
|
|
|
|
|
|
|
|
|
|||||||||||||
Balances, December 31, 2013 |
17,985,889 | $ | 57,521 | $ | 1,555 | $ | 15 | $ | 2,431 | $ | 61,522 | |||||||||||||
|
|
|
|
|
|
|
|
|
|
|
|
|||||||||||||
Issuance of Common Stock during the period |
10,355,833 | 186,150 | | | | 186,150 | ||||||||||||||||||
Dividends |
| | | | (8,260 | ) | (8,260 | ) | ||||||||||||||||
Exercise of options |
519,517 | 3,364 | (1,011 | ) | | | 2,353 | |||||||||||||||||
Share based compensation expense |
| | 4,484 | | | 4,484 | ||||||||||||||||||
Net income |
| | | | 11,590 | 11,590 | ||||||||||||||||||
Foreign currency translation adjustment |
| | | (289 | ) | | (289 | ) | ||||||||||||||||
|
|
|
|
|
|
|
|
|
|
|
|
|||||||||||||
Balances, December 31, 2014 |
28,861,239 | $ | 247,035 | $ | 5,028 | $ | (274 | ) | $ | 5,761 | $ | 257,550 | ||||||||||||
|
|
|
|
|
|
|
|
|
|
|
|
The accompanying notes are an integral part of these consolidated financial statements.
[6]
Concordia Healthcare Corp.
Consolidated Statements of Cash Flows
For the years ended December 31, 2014 and 2013
(Stated in thousands of U.S. Dollars, except per share amounts)
2014 | 2013 | |||||||
Cash flows from operating activities |
||||||||
Net income after tax |
$ | 11,590 | $ | 2,431 | ||||
Adjustments to reconcile net income to net cash flows from operating activities: |
||||||||
Interest and accretion expense |
12,194 | 6,382 | ||||||
Depreciation and amortization |
11,170 | 138 | ||||||
Share based compensation expense |
4,484 | 1,070 | ||||||
Share based transaction and listing expense |
| 4,593 | ||||||
Change in fair value of contingent consideration |
2,629 | | ||||||
Change in fair value of derivative warrants |
| 4,648 | ||||||
Income tax provision |
7,522 | 265 | ||||||
Loss on sale of equipment |
120 | | ||||||
Cash income taxes paid |
(2,324 | ) | | |||||
|
|
|
|
|||||
47,385 | 19,527 | |||||||
Changes in operating assets and liabilities, excluding effect of acquisitions |
||||||||
Accounts receivable |
(7,116 | ) | (19,454 | ) | ||||
Inventory |
(66 | ) | 313 | |||||
Prepaid expenses and other current assets |
(2,424 | ) | (816 | ) | ||||
Accounts payable |
(15,596 | ) | 20,395 | |||||
Accrued liabilities |
(4,571 | ) | 2,597 | |||||
Provisions |
(4,448 | ) | 24,208 | |||||
Royalties payable |
49 | 3,093 | ||||||
Other liabilities |
245 | | ||||||
|
|
|
|
|||||
Net cash provided by operating activities |
13,458 | 49,863 | ||||||
|
|
|
|
|||||
Cash flows from investing activities |
||||||||
Purchase consideration paid |
(294,085 | ) | (59,259 | ) | ||||
Purchase of fixed assets and software |
(651 | ) | (107 | ) | ||||
Proceeds from sale of equipment |
4 | | ||||||
|
|
|
|
|||||
Net cash used in investing activities |
(294,732 | ) | (59,366 | ) | ||||
|
|
|
|
|||||
Cash flows from financing activities |
||||||||
Proceeds from credit facilities |
265,000 | 3,000 | ||||||
Net proceeds from issuance of common stock |
56,998 | 39,064 | ||||||
Proceeds from senior and subordinated debt |
| 21,150 | ||||||
Transaction cost paid on long-term debt |
(8,561 | ) | (1,100 | ) | ||||
Proceeds from exercise of options |
2,353 | | ||||||
Payment of senior and subordinated debt |
(15,742 | ) | (5,408 | ) | ||||
Payment of notes payable |
(488 | ) | | |||||
Payment of credit facility |
(4,250 | ) | (3,000 | ) | ||||
Interest paid |
(8,114 | ) | (1,304 | ) | ||||
Dividends paid |
(6,095 | ) | | |||||
|
|
|
|
|||||
Net cash provided by financing activities |
281,101 | 52,402 | ||||||
|
|
|
|
|||||
Net change in cash |
(173 | ) | 42,899 | |||||
Unrealised foreign exchange gain in cash and cash equivalents |
44 | | ||||||
Cash at beginning of period |
42,899 | | ||||||
|
|
|
|
|||||
Cash at end of period |
$ | 42,770 | $ | 42,899 | ||||
|
|
|
|
The accompanying notes are an integral part of these consolidated financial statements.
[7]
Concordia Healthcare Corp.
Notes to Consolidated Financial Statements
For the years ended December 31, 2014 and 2013
(Stated in thousands of U.S. Dollars, except per share amounts)
1. | Description of Business and General Information |
Concordia Healthcare Corp. (the Company, Concordia or the Group) is an integrated healthcare company that targets three areas: (a) legacy pharmaceutical products; (b) specialized healthcare distribution that services the growing diabetic market; and (c) the acquisition and/or development of orphan drugs.
These three business units are run as separate divisions but are inter-related. The cash-flow from legacy pharmaceutical products is used to fund operations and is also intended to fund the expansion of indications for potential orphan drugs. The specialized healthcare distribution division provides additional growth and cash-flow generation. Additionally, through its registered pharmacy operation, this business is intended to provide a specialty distribution capability for orphan drugs once acquired and/or developed. The three business units were acquired during 2013 and are expected to provide the Company with an increased market share of the related products, as well as savings in costs through economies of scale. During 2014, the Company has grown the Legacy Pharmaceuticals Division through the acquisition of Donnatal ® and Zonegran ® .
On December 20, 2013 the Company entered into an amalgamation agreement (the Amalgamation Agreement) and completed its qualifying transaction (the Qualifying Transaction). The Qualifying Transaction proceeded by way of a three-cornered amalgamation among Mercari Acquisition Corp. (Mercari), a capital pool company listed on the NEX board of the TSX Venture Exchange, Mercari Subco Inc., a wholly-owned subsidiary of Mercari, and Concordia Healthcare Inc., (CHI), a private Ontario corporation incorporated on December 5, 2012. On December 18, 2013, Mercari changed its name to Concordia Healthcare Corp. and completed a consolidation of its share capital on a basis of one post-consolidation common share for every 48.08 common shares existing immediately before the consolidation. The Qualifying Transaction resulted in a reverse takeover of Mercari by the shareholders of CHI (the Reverse Takeover).
Immediately upon completion of the Qualifying Transaction, the shareholders of CHI held 98.5% of the shares of the amalgamated corporation, and for accounting purposes CHI was deemed to be the acquirer. The Qualifying Transaction constituted a reverse takeover but did not meet the definition of a business combination under International Financial Reporting Standards (IFRS) 3, Business Combinations; accordingly the Company has accounted for the transaction in accordance with IFRS 2, Share-based Payment. The assets and liabilities of Mercari have been included in the Companys consolidated balance sheet at fair value, which approximate their pre-combination carrying values.
Mercaris shares were delisted from the NEX board of the TSX Venture Exchange. Concordia Healthcare Corp.s shares were listed for trading on the TSX under the symbol CXR on December 24, 2013.
The registered and head office of the Company is located at 277 Lakeshore Rd. East, Suite 302, Oakville, Ontario, L6J 1H9.
[8]
Concordia Healthcare Corp.
Notes to Consolidated Financial Statements
For the years ended December 31, 2014 and 2013
(Stated in thousands of U.S. Dollars, except per share amounts)
2. | Significant Accounting Policies |
(a) | Basis of Presentation |
These consolidated financial statements have been prepared in accordance with IFRS and International Financial Reporting Interpretations Committee (IFRIC) interpretations. The consolidated financial statements have been prepared under the historical cost convention, except for certain financial instruments that are measured at fair values, as explained in the accounting policies below. The accounting policies have been consistently applied throughout the period unless otherwise stated.
The preparation of financial statements in conformity with IFRS requires the use of certain critical accounting estimates. It also requires management to exercise its judgment in the process of applying the Companys accounting policies. The areas involving a higher degree of judgment or complexity, or areas where assumptions and estimates are significant to the consolidated financial statements are disclosed in note 3.
CHI was incorporated on December 5, 2012, however, the entity was not capitalized and did not commence operations until May of 2013. During the year, Hawthorn Drug Group Inc. was incorporated but was not capitalized and did not commence operations.
(b) | Business Combinations |
Acquisitions during the year ended December 31, 2014 and 2013 have been accounted for as business combinations using the acquisition method. The consideration transferred in a business combination is measured at fair value at the date of acquisition. Acquisition-related transaction costs are recognized in income and comprehensive income as incurred.
At the acquisition date, the identifiable assets acquired and the liabilities assumed are recognized at their fair value, except that:
| deferred tax assets or liabilities, and assets or liabilities related to employee benefit arrangements are recognized and measured in accordance with IAS 12 and IAS 19 respectively; and |
| liabilities or equity instruments related to share-based payment arrangements of the acquiree or share-based payment arrangements of the Group entered into to replace share-based payment arrangements of the acquiree are measured in accordance with IFRS 2 Share-based Payment at the acquisition date. |
Goodwill is measured as the excess of the sum of the consideration transferred, the amount of any non-controlling interests in the acquiree, and the fair value of the acquirers previously held equity interest in the acquiree (if any) over the net of the acquisition-date amounts of the identifiable assets acquired and liabilities assumed exceeds the sum of the consideration transferred, the amount of any non-controlling interests in the acquiree and the fair value of the acquirers previously held interest in the acquiree (if any), the excess is recognized immediately in profit or loss as a bargain purchase gain.
[9]
Concordia Healthcare Corp.
Notes to Consolidated Financial Statements
For the years ended December 31, 2014 and 2013
(Stated in thousands of U.S. Dollars, except per share amounts)
2. | Significant Accounting Policies (continued) |
(b) | Business Combinations (continued) |
When the consideration transferred by the Group in a business combination includes assets or liabilities resulting from a contingent consideration arrangement, the contingent consideration is measured at its acquisition-date fair value and included as part of the consideration transferred in a business combination. Changes in the fair value of the contingent consideration that qualify as measurement period adjustments are adjusted retrospectively, with corresponding adjustments against goodwill. Measurement period adjustments are adjustments that arise from additional information obtained during the measurement period (which cannot exceed one year from the acquisition date) about facts and circumstances that existed at the acquisition date.
The subsequent accounting for changes in the fair value of the contingent consideration that do not qualify as measurement period adjustments depends on how the contingent consideration is classified. Contingent consideration that is classified as equity is not remeasured at subsequent reporting dates and its subsequent settlement is accounted for within equity. Contingent consideration that is classified as an asset or a liability is remeasured at subsequent reporting dates in accordance with IAS 39, or IAS 37 Provisions, Contingent Liabilities and Contingent Assets, as appropriate, with the corresponding gain or loss being recognized in profit or loss.
(c) | Recent Accounting Pronouncements |
The following pronouncements were issued by the International Accounting Standards Board (IASB) or the International Financial Reporting Interpretations Committee (IFRIC). The adoption of the pronouncements did not have a material impact on the Companys financial statements, unless otherwise noted below.
Consolidated Financial Statements
In October 2012, the IASB issued amendments to IFRS 10 Consolidated financial statements to require investment entities to measure subsidiaries at fair value through profit or loss. In addition, IFRS 12 Disclosure of interests in other entities has been amended to include disclosure requirements for investment entities. IAS 27 Separate financial statements has been amended to require investment entities to measure investments in subsidiaries at fair value through profit or loss when separate financial statements are presented. The amendments are effective for annual periods beginning on or after January 1, 2014.
Financial Instruments: Presentation
IAS 32 Financial Instruments: Presentation was amended by the IASB in December 2011. Offsetting Financial Assets and Financial Liabilities amendment addresses inconsistencies identified in applying some of the offsetting criteria. The amendment is effective for annual periods beginning on or after January 1, 2014.
Impairment of Assets
IAS 36 Impairment of Assets was amended by the IASB in June 2013. Recoverable Amount Disclosures for Non-Financial Assets amendment modifies certain disclosure requirements about the recoverable amount of impaired assets if that amount is based on fair value less costs to sell. The amendment is effective for annual periods beginning on or after January 1, 2014.
[10]
Concordia Healthcare Corp.
Notes to Consolidated Financial Statements
For the years ended December 31, 2014 and 2013
(Stated in thousands of U.S. Dollars, except per share amounts)
2. | Significant Accounting Policies (continued) |
(c) | Recent Accounting Pronouncements (continued) |
Levies
IFRIC Interpretation 21, Levies, was issued by the IFRIC in May 2013. The Interpretation on the accounting for levies imposed by governments clarifies the obligating event that gives rise to a liability to pay a levy. IFRIC 21 is effective for annual periods beginning on or after January 1, 2014.
(d) | Future Accounting Changes |
The following pronouncements were issued by the IASB or the IFRIC. Those pronouncements that are not applicable or do not have a significant impact to the Company have been excluded from the summary below. The following have not yet been adopted and are being evaluated to determine the resultant impact on the Company.
Financial Instruments
IFRS 9 Financial Instruments was issued in final form in July 2014 by the IASB and will replace IAS 39 Financial Instruments: Recognition and Measurement. IFRS 9 uses a single approach to determine whether a financial asset is measured at amortized cost or fair value, replacing the multiple rules in IAS 39. The approach in IFRS 9 is based on how an entity manages its financial instruments in the context of its business model and the contractual cash flow characteristics of the financial assets. Most of the requirements in IAS 39 for classification and measurement of financial liabilities were carried forward unchanged to IFRS 9. The new standard also requires a single impairment method to be used, replacing the multiple impairment methods in IAS 39. IFRS 9 also includes requirements relating to a new hedge accounting model, which represents a substantial overhaul of hedge accounting which will allow entities to better reflect their risk management activities in the financial statements.
The most significant improvements apply to those that hedge non-financial risk, and so these improvements are expected to be of particular interest to non-financial institutions. IFRS 9 is effective for annual periods beginning on or after January 1, 2018. Earlier application is permitted.
Presentation of Financial Statements
IAS 1 Presentation of Financial Statements was amended by the IASB in December 2014. The amendments are designed to further encourage companies to apply professional judgement in determining what information to disclose in their financial statements. For example, the amendments make clear that materiality applies to the whole of financial statements and that the inclusion of immaterial information can inhibit the usefulness of financial disclosures. Furthermore, the amendments clarify that companies should use professional judgement in determining where and in what order information is presented in the financial disclosures. The amendments are effective for annual periods beginning on or after January 1, 2016. Earlier application is permitted.
[11]
Concordia Healthcare Corp.
Notes to Consolidated Financial Statements
For the years ended December 31, 2014 and 2013
(Stated in thousands of U.S. Dollars, except per share amounts)
2. | Significant Accounting Policies (continued) |
(d) | Future Accounting Changes (continued) |
Revenue from Contracts with Customers
In May 2014, IASB issued IFRS 15 Revenue from Contracts with Customers. The core principle of the new standard is for companies to recognize revenue to depict the transfer of goods or services to customers in amounts that reflect the consideration (that is, payment) to which the company expects to be entitled in exchange for those goods or services. The new standard will also result in enhanced disclosures about revenue, provide guidance for transactions that were not previously addressed comprehensively (for example, service revenue and contract modifications) and improve guidance for multiple-element arrangements. The new standard is effective for annual periods beginning on or after January 1, 2017. Earlier application is permitted. IFRS 15 supersedes the following standards: IAS 11 Construction Contracts, IAS 18 Revenue, IFRIC 13 Customer Loyalty Programmes, IFRIC 15 Agreements for the Construction of Real Estate, IFRIC 18 Transfers of Assets from Customers, and SIC-31 RevenueBarter Transactions Involving Advertising Services.
Property, Plant, Equipment, and Intangible Assets
In May 2014, IASB amended IAS 16 Property, Plant and Equipment and IAS 38 Intangible Assets to clarify that the use of revenue-based methods to calculate the depreciation of an asset is not appropriate and that revenue is generally presumed to be an inappropriate basis for measuring the consumption of the economic benefits embodied in an intangible asset. This presumption, however, can be rebutted in certain limited circumstances. The amendments are effective for annual periods beginning on or after January 1, 2016. Earlier application is permitted.
Joint Arrangements
In May 2014, IASB amended IFRS 11 Joint Arrangements to add new guidance on how to account for the acquisition of an interest in a joint operation that constitutes a business. The amendment is effective for annual periods beginning on or after January 1, 2016. Earlier application is permitted.
(e) | Basis of Consolidation |
The wholly owned subsidiaries of the Company are consolidated to produce the financial results for the consolidated corporation. All intercompany transactions, balances, income and expenses on transactions between the subsidiaries are fully eliminated. Profits and losses resulting from intercompany transactions that were recognized are also fully eliminated.
These consolidated financial statements include the following wholly owned subsidiaries of the Company: Concordia Healthcare, Inc. (CHI); Concordia Pharmaceuticals Inc. (CPI); Concordia Healthcare (USA) Inc. (CHUSA), Complete Medical Homecare, Inc. (CMH); Concordia Laboratories Inc. (CLI); Concordia Labs Inc. (Labs); Pinnacle Biologics, Inc. (Pinnacle), and Pinnacles wholly owned material subsidiaries, Pinnacle Biologics B.V., Pinnacle Oncology LLC and Compagnie Biologiques Pinnacle (Quebec).
When necessary, adjustments are made to the financial statements of subsidiaries to bring their accounting policies in line with those followed by other members of the Company.
[12]
Concordia Healthcare Corp.
Notes to Consolidated Financial Statements
For the years ended December 31, 2014 and 2013
(Stated in thousands of U.S. Dollars, except per share amounts)
2. | Significant Accounting Policies (continued) |
(f) | Segment Reporting |
Operating segments are reported in a manner consistent with the internal reporting provided to the chief operating decision makers.
The chief operating decision makers, who are responsible for allocating resources and assessing performance of the operating segments, have been identified as the Chief Executive Officer and Chief Financial Officer of the Company.
(g) | Foreign Currency Translation |
Items included in the financial statements of each of the Companys entities are measured using the currency of the primary economic environment in which the entity operates (their functional currency). The Company has determined that the functional currency of all of its major entities is the United States Dollar. The consolidated financial statements are presented in thousands of United States dollars, which in the opinion of management is the most appropriate functional currency as it is used to a significant extent in, or has a significant impact on, the operations of the Company and reflects the economic substance of the underlying events and circumstances relevant to the Company.
In preparing the financial statements of each individual group entity, transactions in currencies other than the entitys functional currency (foreign currencies) are recognized at the rates of exchange prevailing at the dates of the transactions. At the end of each reporting period, monetary items denominated in foreign currencies are retranslated at the rates prevailing at the date when the fair value was determined. Non-monetary items that are measured in terms of historical cost in a foreign currency are not retranslated.
Exchange differences on monetary items are recognized in profit or loss in the period in which they arise except for:
| exchange differences on foreign currency borrowings relating to assets under construction for future productive use, which are included in the cost of those assets when they are regarded as an adjustment to interest costs on those foreign currency borrowings; |
| exchange differences on translations entered into in order to hedge certain foreign currency risks; and |
| exchange differences on monetary items receivable from or payable to a foreign operation for which settlement is neither planned nor likely to occur (therefore forming part of the net investment in the foreign operation), which are recognized initially in other comprehensive income and reclassified from equity to profit or loss on repayment of the monetary items. |
For the purpose of presenting consolidated financial statements, the assets and liabilities of the Companys foreign operations are translated into United States Dollars using exchange rates for the period, unless exchange rates fluctuate significantly during that period, in which case the exchange rates at the dates of the transactions are used. Exchange differences arising, if any, are recognized in other comprehensive income and accumulated in equity.
[13]
Concordia Healthcare Corp.
Notes to Consolidated Financial Statements
For the years ended December 31, 2014 and 2013
(Stated in thousands of U.S. Dollars, except per share amounts)
2. | Significant Accounting Policies (continued) |
(h) | Fixed Assets |
Fixed assets are stated at cost less accumulated depreciation and impairment losses. Depreciation is recorded as follows:
Computers and IT equipment | Straight-line over 4 years | |
Office furniture and fixtures | Straight-line over 5 years | |
Equipment | Straight-line over 3 years | |
Leasehold improvements | Over the lease term |
Repair and maintenance expenditures that extend the useful life of the asset are capitalized and minor repair and maintenance costs are expensed as incurred to the statement of income and comprehensive income. The assets residual values and useful lives are reviewed, and adjusted if appropriate, at the end of each reporting period. An assets carrying amount is written down immediately to its recoverable amount if the assets carrying amount is greater than its estimated recoverable amount. Gains and losses on disposals are determined by comparing the proceeds with the carrying amount and are recognized within the statement of income and comprehensive income.
(i) | Leases |
Leases are classified as finance leases when the lease arrangement transfers substantially all of the risks and rewards related to the ownership of the leased asset. The related asset is then recognized at the inception of the lease at the fair value of the leased asset or, if lower, the present value of the lease payments plus incidental payments, if any. A corresponding amount is recognized as a finance lease liability. Lease payments are apportioned between finance expenses and reduction of the lease obligation so as to achieve a constant rate of interest on the remaining balance of the liability. Depreciation methods and useful lives for assets held under finance lease agreements correspond to those applied to comparable assets which are legally owned by the Company. The corresponding finance lease liability is reduced by lease payments net of imputed interest. All other leases are treated as operating leases. Payments on operating lease agreements are recognized as an expense on a straight-line basis over the lease term. Associated costs, such as maintenance and insurance, are expensed as incurred.
(j) | Goodwill |
Goodwill represents the excess amount of consideration given over the fair value of the underlying assets in a business combination, and is measured at cost less accumulated impairment losses. Goodwill is not amortized, but is tested for impairment on an annual basis or more frequently if there are indications that goodwill may be impaired. For the purposes of impairment testing, goodwill is allocated to each of the Companys cash generating units (CGU) that are expected to benefit from the synergies of the acquisitions. If the recoverable amount of the CGU is less than the carrying amount, the impairment loss is allocated first to reduce the carrying amount of any goodwill and then to other assets of the CGU.
[14]
Concordia Healthcare Corp.
Notes to Consolidated Financial Statements
For the years ended December 31, 2014 and 2013
(Stated in thousands of U.S. Dollars, except per share amounts)
2. | Significant Accounting Policies (continued) |
(k) | Intangible assets |
Intangible assets are measured at cost less accumulated amortization and accumulated impairment losses. Amortization is recorded as follows:
Acquired product rights | Straight-line over 15-30 years | |
Intellectual property | Straight-line over 20 years | |
Customer lists | Straight-line over 4 years |
The estimated useful life is reviewed at the end of each reporting period with the effect of any changes in estimate being accounted for on a prospective basis. Intangible assets with indefinite lives are subject to annual impairment tests.
(l) | Impairment of Non-Financial Assets |
The Company reviews assets such as property and equipment and intangible assets with finite useful lives for impairment whenever events or changes in circumstances indicate that the carrying amount may not be recoverable.
Intangible assets with indefinite lives are tested for impairment annually or more frequently if events or changes in circumstances indicate that they may be impaired.
For the purpose of measuring recoverable amounts, assets are grouped at the lowest levels for which there are separately identifiable cash flows (CGUs). Recoverable amount is the higher of an assets fair value less the cost of disposal and value in use, (being the present value of the expected future cash flows of the relevant asset or CGU), as determined by management.
Any impairment losses are recognized immediately in the consolidated statement of income and comprehensive income. Non-financial assets other than goodwill that suffered impairment are reviewed for possible reversal of the impairment at each reporting date.
(m) | Provisions |
Provisions are recognized when present (legal or constructive) obligations as a result of a past event will lead to a probable outflow of economic resources and amounts can be estimated reliably. Provisions are measured at managements best estimate of the expenditure required to settle the present obligation, based on the most reliable evidence available at the reporting date, including the risks and uncertainties associated with the present obligation.
The Company performs evaluations to identify onerous contracts and, where applicable, records provisions for such contracts. All provisions are reviewed at each reporting date and adjusted to reflect the current best estimate. In those cases where the possible outflow of economic resources as a result of present obligations is considered remote, no liability has been recognized.
[15]
Concordia Healthcare Corp.
Notes to Consolidated Financial Statements
For the years ended December 31, 2014 and 2013
(Stated in thousands of U.S. Dollars, except per share amounts)
2. | Significant Accounting Policies (continued) |
(n) | Income Taxes |
Income taxes are accounted for using the liability method. Deferred tax assets and liabilities are recognized for the differences between the tax basis and carrying amounts of assets and liabilities, for operating losses and for tax credit carry-forwards. Deferred tax assets are recognized to the extent that it is probable that future taxable profit will be available against which temporary differences can be utilized. Deferred tax assets and liabilities are measured using enacted or substantially enacted tax rates and laws.
Deferred tax is recognized on temporary differences between the carrying amounts of assets and liabilities in the consolidated financial statements and the corresponding tax bases used in the computation of taxable profit. Deferred tax liabilities are generally recognized for all taxable temporary differences. Deferred tax assets are generally recognized for all deductible temporary differences to the extent that it is probable that taxable profits will be available against which those deductible temporary differences can be utilized. Such deferred tax assets and liabilities are not recognized if the temporary difference arises from goodwill or from the initial recognition (other than in a business combination) of other assets and liabilities in a transaction that affects neither the taxable profit nor the accounting profit.
The carrying amount of deferred tax assets is reviewed at the end of each reporting period and reduced to the extent that is no longer probable that sufficient taxable profits will be available to the allow all or part of the asset to be recovered. Deferred tax liabilities and assets are measured at the tax rates that are expected to apply in the period in which the liability is settled or the asset realized, based on tax rates (and tax laws) that have been enacted or substantively enacted by the end of the reporting period. The measurement of deferred tax liabilities and assets reflects the tax consequences that would follow from the manner in which the Company expects, at the end of the reporting period, to recover or settle the carrying amount of its assets and liabilities.
Current and deferred tax are recognized in profit or loss, except when they relate to items that are recognized in other comprehensive income or directly in equity, in which case, the current and deferred tax are also recognized in other comprehensive income or directly in equity respectively. Where current tax or deferred tax arises from the initial accounting for a business combination, the tax effect is included in the accounting for the business combination.
(o) | Financial Instruments |
The Company classifies all financial instruments as held-to-maturity, available-for-sale, fair value through profit or loss (FVTPL), loans and receivables or other liabilities. Financial assets held-to maturity, loans and receivables and financial liabilities other than those classified as FVTPL, are measured at amortized cost using the effective interest method. Available-for-sale instruments are measured at fair value with unrealized gains and losses recognized in other comprehensive income (loss). Financial liabilities are classified as either financial liabilities classified as FVTPL or other financial liabilities. Financial liabilities are classified as FVTPL when the liability is either classified as held-for-trading or it is designated as FVTPL. A financial liability may be designated at FVTPL upon initial recognition if it forms part of a contract containing one or more embedded derivatives. Instruments classified as FVTPL are measured at fair value with unrealized gains and losses recognized in net income (loss). Other financial liabilities are subsequently measured at amortized cost using the effective interest method.
Transaction costs associated with FVTPL financial assets are expensed as incurred, while transaction costs associated with all other financial liabilities are included in the initial carrying amount of the asset.
[16]
Concordia Healthcare Corp.
Notes to Consolidated Financial Statements
For the years ended December 31, 2014 and 2013
(Stated in thousands of U.S. Dollars, except per share amounts)
2. | Significant Accounting Policies (continued) |
(o) | Financial Instruments (continued) |
The Company has classified its financial instruments as follows:
Financial Instruments |
Loans and
Receivables |
Other Financial
Liabilities |
FVTPL |
As at December 31,
2014 |
||||||||||||
Cash |
$ | 42,770 | $ | | $ | | $ | 42,770 | ||||||||
Accounts receivable |
29,371 | | | 29,371 | ||||||||||||
Accounts payable |
| 6,773 | | 6,773 | ||||||||||||
Accrued liabilities |
| 3,849 | | 3,849 | ||||||||||||
Royalties payable |
| 3,141 | | 3,141 | ||||||||||||
Notes payable |
| 5,262 | | 5,262 | ||||||||||||
Long-term debt |
| 253,481 | | 253,481 | ||||||||||||
Other liabilities |
| 246 | | 246 | ||||||||||||
Purchase consideration payable |
| 5,122 | 19,986 | 25,108 | ||||||||||||
|
|
|
|
|
|
|
|
|||||||||
$ | 72,141 | $ | 277,874 | $ | 19,986 | $ | 370,001 | |||||||||
|
|
|
|
|
|
|
|
Financial Instruments |
Loans and
Receivables |
Other Financial
Liabilities |
FVTPL |
As at December 31,
2013 |
||||||||||||
Cash |
$ | 42,899 | $ | | $ | | $ | 42,899 | ||||||||
Accounts receivable |
23,012 | | | 23,012 | ||||||||||||
Accounts payable |
| 21,669 | | 21,669 | ||||||||||||
Accrued liabilities |
| 7,734 | | 7,734 | ||||||||||||
Royalties payable |
| 3,093 | | 3,093 | ||||||||||||
Senior and subordinate debt |
| 14,966 | | 14,966 | ||||||||||||
Notes payable |
| 5,766 | | 5,766 | ||||||||||||
Other liabilities |
| 20 | | 20 | ||||||||||||
Purchase consideration payable |
| 5,735 | 18,650 | 24,385 | ||||||||||||
|
|
|
|
|
|
|
|
|||||||||
$ | 65,911 | $ | 58,983 | $ | 18,650 | $ | 143,544 | |||||||||
|
|
|
|
|
|
|
|
Fair value is the price that would be received to sell an asset or paid to transfer a liability in an orderly transaction between market participants at the measurement date. The fair value measurement is based on the presumption that the transaction to sell the asset or transfer the liability takes place either:
| In the principal market for the asset or liability, or |
| In the absence of a principal market, in the most advantageous market for the asset or liability. |
The principal or the most advantageous market must be accessible by the Company.
The fair value of an asset or a liability is measured using the assumptions that market participants would use when pricing the asset or liability, assuming that market participants act in their economic best interest.
The Company uses valuation techniques that are appropriate in the circumstances and for which sufficient data are available to measure fair value, maximizing the use of relevant observable inputs and minimizing the use of unobservable inputs.
[17]
Concordia Healthcare Corp.
Notes to Consolidated Financial Statements
For the years ended December 31, 2014 and 2013
(Stated in thousands of U.S. Dollars, except per share amounts)
2. | Significant Accounting Policies (continued) |
(o) | Financial Instruments (continued) |
All assets and liabilities for which fair value is measured or disclosed in the consolidated financial statements are categorized within the fair value hierarchy, described, as follows, based on the lowest-level input that is significant to the fair value measurement as a whole:
Level 1: Valuations based on quoted prices (unadjusted) in active markets for identical assets or liabilities;
Level 2: Valuations based on directly or indirectly observable inputs in active markets for similar assets or liabilities, other than Level 1 prices, such as quoted interest or currency exchange rates; and
Level 3: Valuations based on significant inputs that are not derived from observable market data, such as discounted cash flow methodologies based on internal cash flow forecasts.
Purchase price consideration payable is considered as a Level 3 financial instrument in the hierarchy.
(p) | Warrants |
In connection with the issuance of debt, the Company issued warrants denominated in a foreign currency, with an option for a cashless exercise in which the settlement price caused the conversion ratio to be variable. Accordingly the warrants were initially classified as a liability. Gains and losses on re-measurement are presented separately on the statement of income and comprehensive income.
The warrants were exercised via a non-cash exercise during the period ended December 31, 2013, with the change in fair value from the initial issuance of the warrants to the date of non-cash exercise being recognized in the statement of income.
(q) | Share Based Compensation |
The Company has a stock option plan as described in Note 19 that allows for the issuance of stock options to employees, directors, officers, and others as determined by the Board of Directors. Under IFRS, each option installment is treated as a separate option grant with graded-vesting features, forfeitures are estimated at the time of grant and revised if actual forfeitures are likely to differ from previous estimates, and options granted to parties other than employees are measured at their fair value on the date goods or services are received. The fair value of the goods and services received are determined indirectly by reference to the fair value of the instrument granted, unless the fair value of the goods and services received is reliably determinable. Over the vesting period of the option grants, the fair value is recognized as compensation expense and a related credit is recorded as reserve for share-based compensation. The reserve for share-based compensation is reduced as options are exercised through a credit to share capital. The consideration paid by option holders is credited to share capital when the options are exercised.
[18]
Concordia Healthcare Corp.
Notes to Consolidated Financial Statements
For the years ended December 31, 2014 and 2013
(Stated in thousands of U.S. Dollars, except per share amounts)
2. | Significant Accounting Policies (continued) |
(r) | Earnings Per Share |
Basic income per share is calculated by dividing the net income by the weighted average number of common shares outstanding during the period. Diluted income per share is calculated by dividing the applicable net earnings by the sum of the weighted average number of shares outstanding during the year and all additional common shares that would have been outstanding if potentially dilutive common shares had been issued during the period.
(s) | Revenue Recognition |
Revenue is recognized in the consolidated statement of income when goods are delivered and titles have been passed, at which time all the following conditions are satisfied:
| the Company has transferred to the buyer the significant risks and rewards of ownership of the goods; |
| the Company retains neither continuing managerial involvement to the degree usually associated with ownership nor effective control over the goods sold; |
| the amount of revenue can be measured reliably; |
| it is probable that the economic benefits associated with the transaction will flow to the Company; and |
| the costs incurred or to be incurred in respect of the transaction can be measured reliably. |
Revenue represents the amounts receivable after the deduction of discounts, harmonized sales tax, other sales taxes, allowances given, provisions for chargebacks, other price adjustments and accruals for estimated future rebates and returns. The methodology and assumptions used to estimate rebates and returns are monitored and adjusted in light of contractual and historical information.
Revenue from licensing and profit-sharing arrangements is recognized on an accrual basis in accordance with the substance of the relevant agreement. Arrangements determined on a time basis are recognized on a straight-line basis over the period of the agreement. Arrangements that are based on production, sales and other measures are recognized by reference to the underlying arrangement.
(t) | Inventory |
Inventories consist of raw materials, work-in-progress and finished goods. Inventory is valued at the lower of cost based on weighted average price and net realizable value. Net realizable value is the estimated selling prices less applicable selling expenses and costs to complete. If the carrying value exceeds the net realizable value, a write-down is recognized.
A reserve is taken on inventory for quantities not expected to be consumed. This reserve offsets the inventory balance. There were no reversals of inventory reserve for the period presented.
3. | Critical Accounting Estimates and Judgments and Key Sources of Estimation Uncertainty |
When preparing the consolidated financial statements, management undertakes a number of judgments, estimates and assumptions regarding recognition and measurement of assets, liabilities, income and expenses. Information about the judgments, estimates and assumptions that have the most significant effect on the recognition and measurement of assets, liabilities, income and expenses are discussed below.
[19]
Concordia Healthcare Corp.
Notes to Consolidated Financial Statements
For the years ended December 31, 2014 and 2013
(Stated in thousands of U.S. Dollars, except per share amounts)
3. | Critical Accounting Estimates and Key Sources of Estimation Uncertainty (continued) |
Revenue recognition:
i. | Chargebacks |
The provision for chargebacks is a significant and complex estimate used in the recognition of revenue. In the USA, the Company sells its products directly to wholesale distributors. The wholesale distributors sell directly to independent pharmacies, managed care organizations, hospitals and group purchasing organizations (indirect customers). The difference between what price the Company sells to the wholesaler and what price the wholesaler sells to the indirect customer is called a chargeback. The provision for chargebacks is based on historical sales levels to wholesalers. As sales are made to large wholesale customers, the Company continually monitors the provision for chargebacks and makes adjustments when it believes that actual chargebacks may differ from estimated provisions.
ii. | Returns |
The provision for returns is a significant and complex estimate used in the recognition of revenue. The Company has a returns policy that allows wholesalers to return the product within a specified period prior to and subsequent to the expiration date. Provisions for returns are recognized in the period in which the underlying sales are recognized, as a reduction of sales revenue. The Company estimates provisions for returns based upon historical experience, representing managements best estimate. While such experience has allowed for reasonable estimations in the past, history may not always be an accurate indicator of future returns. The Company continually monitors provisions for returns and makes adjustments when it believes that actual product returns may differ from established reserves.
iii. | Rebates |
The provision for rebates is a significant and complex estimate used in the recognition of revenue. Rebates are granted to healthcare authorities and under contractual arrangements with certain customers. Products sold in the USA are covered by various programs (such as Medicaid and Medicare) under which products are sold at a discount. The Company estimates its provisions for rebates based on current contractual terms and conditions as well as the historical experience, changes to business practices and credit terms. While such experience has allowed for reasonable estimations in the past, history may not always be an accurate indicator of future rebate liabilities. The Company continually monitors the provision for rebates and makes adjustments when it believes that actual rebates may differ from establishes provisions. All rebates are recognized in the period in which the underlying sales are recognized as a reduction of sales revenue.
iv. | Other price adjustments |
The provision for other price adjustments is a significant and complex estimate used in the recognition of revenue. Other price adjustments are credits issued by the wholesaler to reflect various decreases in the selling price. The price that the Company sells to the wholesaler is called the Wholesale Acquisition Cost (or WAC). Decreases to WAC are discretionary decisions made by the Wholesalers to reflect competitive market conditions. Amounts recorded for other price adjustments are based upon estimated decline in market prices. The Company regularly monitors these and other factors and re-evaluates the provision as additional information becomes available.
[20]
Concordia Healthcare Corp.
Notes to Consolidated Financial Statements
For the years ended December 31, 2014 and 2013
(Stated in thousands of U.S. Dollars, except per share amounts)
3. | Critical Accounting Estimates and Key Sources of Estimation Uncertainty (continued) |
Share-based payments and compensation
The compensation expense related to share-based payments is determined using the Black-Scholes option pricing model. The assumptions used in the model are weighted average share price at the grant date, exercise price, volatility, dividend yield, expected option life, forfeiture rate and risk free interest rate. Additional information is disclosed in Note 19.
Impairment of non-financial assets
The Company reviews amortized non-financial assets for impairment whenever events or changes in circumstances indicate that the carrying amount of the assets may be impaired. It also reviews annually non-financial assets with indefinite life for impairment. If the recoverable amount of the respective non-financial asset is less than its carrying amount, it is considered to be impaired. In the process of measuring the recoverable amount, management makes assumptions about future events and circumstances. The actual results may vary and may cause significant adjustments.
Amortization of intangible and other assets
The amortization expense related to intangible and other assets is determined using estimates relating to the useful life of the related assets. Additional information is disclosed in Note 10.
Income taxes
The Company is subject to income taxes in different jurisdictions and therefore uses judgment to determine the provision for income taxes. There are transactions and calculations for which the ultimate tax determination is uncertain. Provisions for uncertain tax positions are recorded based on managements estimate of the most likely outcome. Where the final tax outcome of these matters is different from the amounts that were initially recorded, such differences will impact the current and deferred income tax assets and liabilities in the period in which such determination is made.
Fair value of warrants
The fair values of warrants that are not traded in an active market are determined using valuation techniques. The Company uses its judgment to select a variety of methods and make assumptions that are mainly based on market conditions existing at the end of each reporting period. Additional information is disclosed in Note 14.
Accounting for acquisitions
The Company assesses whether an acquisition should be accounted for as an asset acquisition or a business combination under IFRS 3. This assessment requires management to make judgements on whether the assets acquired and liabilities assumed constitute a business as defined in IFRS 3 and if the integrated set of activities, including inputs, processes acquired, is capable of being conducted and managed as a business and the Company obtains control of the business. The Companys acquisitions have been accounted for as business combinations.
Other area of estimation includes the determination of the purchase price contingent consideration on business combinations, allowance for doubtful accounts, amortization rates and weighted average cost of capital used in various cash flow projections.
[21]
Concordia Healthcare Corp.
Notes to Consolidated Financial Statements
For the years ended December 31, 2014 and 2013
(Stated in thousands of U.S. Dollars, except per share amounts)
4. | Reverse Takeover Transaction |
The Mercari Transaction
As described in Note 1, the Company entered into the Amalgamation Agreement on December 20, 2013. Outstanding options to acquire the shares of Mercari Acquisition Corp. were exchanged for options to acquire the shares of the Company. The Mercari options were converted on a basis of one option to acquire the Companys stock for every 48.08 options existing immediately before the consolidation. Options of the Company issued to Mercari option holders were valued using the Black-Scholes option pricing model using the following weighted average parameters:
The options have been recorded as an expense during the year ended December 31, 2013. The related credit has been recorded as a reserve for share-based compensation.
The purchase price had been allocated as follows:
Total | ||||
Cash |
$ | 168 | ||
Prepaid and other current assets |
94 | |||
Accrued expenses and other current liabilities |
(168 | ) | ||
Expensed as exchange listing expenses |
1,594 | |||
|
|
|||
$ | 1,688 | |||
|
|
|||
Consideration Comprised of: |
||||
Conversion of Mercari shares to Common Stock |
$ | 1,624 | ||
Share-based payment |
64 | |||
|
|
|||
$ | 1,688 | |||
|
|
[22]
Concordia Healthcare Corp.
Notes to Consolidated Financial Statements
For the years ended December 31, 2014 and 2013
(Stated in thousands of U.S. Dollars, except per share amounts)
5. | Acquisitions |
The Shionogi Transaction
CPI acquired its legacy pharmaceutical business assets from Shionogi Inc. (Shionogi) on May 6, 2013 through a business combination. These legacy pharmaceutical assets are comprised of three FDA approved drug patents: Kapvay (patent), which is used to effectively treat Attention Deficit Hyperactivity Disorder, Ulesfia (patent), which is a topical treatment for pediculosis (head lice), and Orapred (in-licenced third party patent), an anti-inflammatory used in the treatment of certain pulmonary diseases such as asthma.
The purchase price paid to Shionogi was $28,704 comprised of $27,912 in cash consideration and $792 of contingent consideration, terms and conditions described in Note 16.
Following closing, as additional consideration for the sale, transfer, conveyance and assignment of the assets and the grant of the Ulesfia license, CPI must pay Shionogi thirty percent (30%) of worldwide Net Sales of Kapvay and Royalty Income relating to Kapvay if sales exceed $1,500 (in the aggregate) during each calendar quarter commencing with the Calendar Quarter beginning October 1, 2013 (the Kapvay Contingency Payments) until the Kapvay Contingency Payments equal $6,000 in aggregate.
As the Company expects to meet some of the sales requirements, a provision for the purchase price contingent consideration payable in the amount of $792 has been recorded as additional purchase price. This amount is shown as a current liability and therefore has not been discounted.
The purchase price has been allocated as follows:
Total | ||||
Acquired product rights |
$ | 26,020 | ||
Goodwill |
372 | |||
Inventory |
2,312 | |||
|
|
|||
$ | 28,704 | |||
|
|
|||
Consideration Comprised of: |
||||
Cash |
$ | 27,912 | ||
Purchase price contingent consideration payable |
792 | |||
|
|
|||
$ | 28,704 | |||
|
|
The goodwill arising on acquisition is deductible for tax purposes.
[23]
Concordia Healthcare Corp.
Notes to Consolidated Financial Statements
For the years ended December 31, 2014 and 2013
(Stated in thousands of U.S. Dollars, except per share amounts)
5. | Acquisitions (continued) |
The Global Medical Direct Transaction
CHUSA acquired its specialty healthcare distribution business assets from Global Medical Direct LLC and affiliated entities (collectively Global) on October 25, 2013 with an effective date of August 1, 2013.
The Companys specialty healthcare distribution business is a United States national internet and mail-order provider of diabetes testing supplies and other healthcare products. This business also includes a full-service pharmacy with full fulfilment capacity and can ship medications across the United States.
The Company acquired the specialty healthcare distribution business for total consideration of $13,157 comprised of $5,000 of cash, a vendor note with a fair value on the date of acquisition of $5,625 and an additional earn-out payment with an estimated present value of $2,532 payable in Common Shares of Concordia, subject to meeting certain performance metrics as described in Note 16.
The purchase price has been allocated as follows:
Total | ||||
Cash |
$ | 1,424 | ||
Accounts receivable |
1,958 | |||
Inventory |
404 | |||
Prepaid and other current assets |
113 | |||
Fixed assets |
169 | |||
Goodwill |
7,923 | |||
Customer list |
3,000 | |||
Accounts payable |
(1,165 | ) | ||
Income taxes payable |
(646 | ) | ||
Lease obligations |
(23 | ) | ||
|
|
|||
$ | 13,157 | |||
|
|
|||
Consideration Comprised of: |
||||
Cash |
$ | 5,000 | ||
Notes payable |
5,625 | |||
Purchase price contingent consideration payable |
2,532 | |||
|
|
|||
$ | 13,157 | |||
|
|
The goodwill arising on acquisition is deductible for tax purposes.
[24]
Concordia Healthcare Corp.
Notes to Consolidated Financial Statements
For the years ended December 31, 2014 and 2013
(Stated in thousands of U.S. Dollars, except per share amounts)
5. | Acquisitions (continued) |
The Pinnacle Biologics, Inc. Transaction
On November 8, 2013, CHI and certain of its subsidiaries, entered into an Agreement and Plan of Merger with Pinnacle (the Pinnacle Purchase Agreement). Pursuant to the Pinnacle Purchase Agreement, on December 20, 2013, the Company acquired 100% of the shares of Pinnacle for total consideration of $58,017 comprised of $32,672 of cash consideration, $5,000 of common shares of CHI issued at a price of CAD $5.63 per common share, 10 annual cash payments with an estimated present value of $5,019 and milestone and other contingency payments with an estimated value of $15,326, subject to meeting certain milestone and performance targets as described in Note 16. The common shares of CHI were subsequently exchanged for common shares of the Company pursuant to the Qualifying Transaction.
The purchase price has been allocated as follows:
Total | ||||
Cash |
$ | 4,901 | ||
Accounts receivable |
1,600 | |||
Inventory |
1,627 | |||
Prepaid and other current assets |
1,376 | |||
Fixed assets |
197 | |||
Deferred taxes |
(6,038 | ) | ||
Goodwill |
27,954 | |||
Intellectual property |
32,800 | |||
Accounts payable and accrued liabilities |
(5,259 | ) | ||
Other liabilities |
(1,141 | ) | ||
|
|
|||
$ | 58,017 | |||
|
|
|||
Consideration Comprised of: |
||||
Cash |
$ | 32,672 | ||
Common Stock |
5,000 | |||
Present value of annual payments |
5,019 | |||
Purchase price contingent consideration payable |
15,326 | |||
|
|
|||
$ | 58,017 | |||
|
|
The goodwill arising on acquisition is not deductible for tax purposes.
[25]
Concordia Healthcare Corp.
Notes to Consolidated Financial Statements
For the years ended December 31, 2014 and 2013
(Stated in thousands of U.S. Dollars, except per share amounts)
5. | Acquisitions (continued) |
The Donnatal Transaction
On May 15, 2014, Concordia, through its wholly owned subsidiary, CPI, completed the purchase of Donnatal ® , pursuant to the terms and conditions of a definitive agreement, from a privately held specialty pharmaceutical company carrying on business as Revive Pharmaceuticals. Donnatal ® is an adjunctive therapy in the treatment of irritable bowel syndrome (IBS) and acute enterocolitis.
The purchase price paid to Revive Pharmaceuticals was $329,151 comprised of $200,000 in cash and an aggregate of 4,605,833 common shares of the Company valued at $129,151 based on the closing price of the Companys stock on May 15, 2014 of CAD$30.50 per share converted to USD using the May 15, 2014 Bank of Canada closing USD: CAD exchange rate of 1:1.0877.
The Company paid for the cash component of the acquisition through a combination of available cash and debt financing. Accordingly, the Company entered into a secured credit facility having a principal amount of up to $195,000, consisting of a $170,000 term loan and a $25,000 operating line (the Credit Facility) (Note 14). The Credit Facility is secured by the assets of the Company and the assets of its material subsidiaries. The Company expensed $8,314 of transaction costs in relation to the acquisition.
The purchase price has been allocated as follows:
Total | ||||
Inventory |
$ | 1,339 | ||
Prepaid expenses and deposits net of accrued liabilities |
279 | |||
Acquired product rights |
327,523 | |||
Goodwill |
10 | |||
|
|
|||
$ | 329,151 | |||
|
|
|||
Consideration Comprised of: |
||||
Cash |
$ | 200,000 | ||
Equity issued |
129,151 | |||
|
|
|||
$ | 329,151 | |||
|
|
The goodwill arising on acquisition is deductible for tax purposes.
[26]
Concordia Healthcare Corp.
Notes to Consolidated Financial Statements
For the years ended December 31, 2014 and 2013
(Stated in thousands of U.S. Dollars, except per share amounts)
5. | Acquisitions (continued) |
The Zonegran Transaction
On September 30, 2014, Concordia, through its wholly owned subsidiary CPI, completed the purchase of Zonegran ® for commercialization and sale in the United States, including Puerto Rico, from Eisai Inc. (Eisai), pursuant to the terms and conditions of a definitive agreement. Zonegran ® is an adjunctive therapy in the treatment of partial seizures in adults with epilepsy.
The purchase price paid to Eisai was $91,402 in cash, which included approximately $1,402 for purchased inventory.
The Company paid for the acquisition through debt financing. Accordingly, the Company entered into an incremental senior credit facility of $95,000 (the Incremental Term Loan) (Note 14) by way of an amendment and restatement of the Credit Facility. All obligations of the Company under the Incremental Term Loan and the amended Credit Facility are secured by the assets of the Company and the assets of its material subsidiaries. The Company expensed $3,849 of transaction costs in relation to the acquisition.
The purchase price has been allocated as follows:
Net Assets Acquired |
||||
Inventory |
$ | 1,402 | ||
Accrued liabilities |
(2,040 | ) | ||
Acquired product rights |
92,040 | |||
|
|
|||
Total net assets acquired |
$ | 91,402 | ||
|
|
|||
Consideration Comprised of: |
||||
Cash |
$ | 91,402 | ||
|
|
|||
Total Consideration |
$ | 91,402 | ||
|
|
6. | Accounts Receivable |
Accounts receivable, as at December 31, consist of the following:
2014 | 2013 | |||||||
Accounts Receivable |
$ | 29,668 | $ | 23,373 | ||||
Allowance for Doubtful Accounts |
(297 | ) | (361 | ) | ||||
|
|
|
|
|||||
Net Accounts Receivable |
$ | 29,371 | $ | 23,012 | ||||
|
|
|
|
There were $1,954 of write-offs recorded during the year ended December 31, 2014 (2013 - $nil).
[27]
Concordia Healthcare Corp.
Notes to Consolidated Financial Statements
For the years ended December 31, 2014 and 2013
(Stated in thousands of U.S. Dollars, except per share amounts)
7. | Inventory |
Inventory, as at December 31, consists of the following:
2014 | 2013 | |||||||
Finished goods |
$ | 4,863 | $ | 2,713 | ||||
Raw materials and work in process |
2,660 | 1,634 | ||||||
Obsolescence provision |
(805 | ) | (317 | ) | ||||
|
|
|
|
|||||
Inventory (net of obsolescence reserve) |
$ | 6,718 | $ | 4,030 | ||||
|
|
|
|
Inventory amounts charged to cost of sales during the year is $7,493 (2013 $5,813). The Company increased its reserve for obsolete inventory by $488 during the year. There were no inventory write-downs charged to cost of sales during the year, other than the current reserve.
8. | Prepaid Expenses and Other Current Assets |
Prepaid expenses and other current assets, as at December 31, consist of the following:
2014 | 2013 | |||||||
Prepaid clinical trial costs |
$ | 2,313 | $ | | ||||
Manufacturing deposits |
1,294 | 557 | ||||||
Other assets |
800 | 342 | ||||||
Taxes receivable |
760 | 1,079 | ||||||
Prepaid insurance |
422 | 77 | ||||||
Prepaid license fees |
154 | 304 | ||||||
Prepaid rent |
50 | 48 | ||||||
|
|
|
|
|||||
Total prepaids and other current assets |
$ | 5,793 | $ | 2,407 | ||||
|
|
|
|
9. | Fixed Assets |
[28]
Concordia Healthcare Corp.
Notes to Consolidated Financial Statements
For the years ended December 31, 2014 and 2013
(Stated in thousands of U.S. Dollars, except per share amounts)
9. | Fixed Assets (continued) |
10. | Intangible Assets |
Acquired
Product Rights |
Customer
List |
Intellectual
Property |
Total | |||||||||||||
Balance, January 1, 2013 |
$ | | $ | | $ | | $ | | ||||||||
Additions |
26,020 | 3,000 | 32,800 | 61,820 | ||||||||||||
Amortization |
| (120 | ) | | (120 | ) | ||||||||||
|
|
|
|
|
|
|
|
|||||||||
Balance, December 31, 2013 |
$ | 26,020 | $ | 2,880 | $ | 32,800 | $ | 61,700 | ||||||||
|
|
|
|
|
|
|
|
|||||||||
Additions |
419,563 | | | 419,563 | ||||||||||||
Impact of foreign exchange |
| | (55 | ) | (55 | ) | ||||||||||
Amortization |
(8,720 | ) | (680 | ) | (1,640 | ) | (11,040 | ) | ||||||||
|
|
|
|
|
|
|
|
|||||||||
Balance, December 31, 2014 |
$ | 436,863 | $ | 2,200 | $ | 31,105 | $ | 470,168 | ||||||||
|
|
|
|
|
|
|
|
Acquired product rights include brands, trademarks and patents that were acquired as part of the transactions described in Note 5. In 2014 the Company reassessed the useful lives of its intangible assets and changed the estimate for certain acquired product rights from an indefinite life to useful lives ranging from 15 to 30 years. As a result, amortization for these assets in 2014 was $11,040 and will be $20,820 on an annual basis starting in 2015 through the end of their respective useful life.
The customer list was acquired effective August 1, 2013 from Global as described in Note 5.
The intellectual property was acquired on December 20, 2013 as part of the acquisition of Pinnacle and its subsidiaries as described in Note 5.
[29]
Concordia Healthcare Corp.
Notes to Consolidated Financial Statements
For the years ended December 31, 2014 and 2013
(Stated in thousands of U.S. Dollars, except per share amounts)
11. | Goodwill |
Goodwill was acquired as part of the acquisitions described in Note 5 and, as at December 31, consists of:
2014 | 2013 | |||||||
Opening balance |
$ | 36,249 | $ | | ||||
Additions |
10 | 36,249 | ||||||
|
|
|
|
|||||
Total |
$ | 36,259 | $ | 36,249 | ||||
|
|
|
|
The carrying value of goodwill is reviewed at each reporting date to determine whether there exist any indications of impairment. As at December 31, 2014 there was no impairment and no impairment loss has been recognized. The Company determined the recoverable amount based on value-in-use, which was calculated using a cash flow projection for each of CGUs over a period of five years and a terminal value. The projected cash flows included a growth rate of 5% and were discounted using a rate of 10%.
12. | Provisions |
The following table describes movements in the Companys provisions balance:
2014 | 2013 | |||||||
Opening Balance |
$ | 24,208 | $ | | ||||
Additions |
33,820 | 49,775 | ||||||
Utilization |
(36,229 | ) | (25,567 | ) | ||||
|
|
|
|
|||||
Closing Balance |
$ | 21,799 | $ | 24,208 | ||||
|
|
|
|
The closing balance relates to provisions made to estimate the liabilities arising from chargebacks, returns, rebates and other price adjustments as explained in Note 3. Although these estimates and provisions relate to revenue recognition transactions, namely the sales of products, the payments made for the underlying transactions are made directly to the claimants concerned and not to the original customer. Payments are expected within 12 months from the balance sheet date. Invoices received for such charges and estimates are shown in the Accounts Payable when received. The provision is for the uninvoiced portion of the charges and estimates.
13. | Income Taxes |
Income tax expense is recognized based on managements best estimate of the weighted average annual income tax rate expected for the full financial year. The 2014 average rates used in the year ended December 31, 2014 for Canada, USA and Barbados were 26.5%, 34.66% and 1.03%, respectively (2013 26.5%, 34.66% and 2.26%, respectively).
In Barbados, the Concordia subsidiaries are classified as an International Business Corporations (IBC) where there is a sliding scale corporate tax rate with a ceiling rate of 2.5% on income up to Barbados Dollar (BBD) $10 million and a minimum floor rate of 0.25% when income exceeds BBD$30 million. The rate declines by 0.5% for each incremental BBD$10 million until the floor rate is achieved.
[30]
Concordia Healthcare Corp.
Notes to Consolidated Financial Statements
For the years ended December 31, 2014 and 2013
(Stated in thousands of U.S. Dollars, except per share amounts)
13. | Income Taxes (continued) |
The difference between the amount of the provision for income taxes and the amount computed by multiplying income before taxes by the statutory Canadian, United States, and Barbados rates are reconciled as follows:
2014 | 2013 | |||||||
Profit before income taxes |
$ | 19,112 | $ | 2,856 | ||||
Income tax at Canadian corporate tax rate 26.5% |
5,065 | 757 | ||||||
Difference in tax rates of foreign subsidiary |
(8,693 | ) | (5,267 | ) | ||||
Tax effect of permanent differences - Canada at 26.5% |
5,142 | 4,865 | ||||||
Change in tax benefits not recognized |
6,206 | | ||||||
Other |
(198 | ) | 70 | |||||
|
|
|
|
|||||
Closing Balance |
$ | 7,522 | $ | 425 | ||||
|
|
|
|
Deferred income tax:
2014 | 2013 | |||||||
Non-capital losses |
$ | 182 | $ | | ||||
Other non-deductible reserves |
282 | 151 | ||||||
Property and equipment |
(152 | ) | (84 | ) | ||||
Intangibles |
532 | (6,458 | ) | |||||
|
|
|
|
|||||
Deferred income tax assets (liabilities), net |
$ | 844 | $ | (6,391 | ) | |||
|
|
|
|
|||||
Deferred income tax assets |
$ | 861 | $ | 24 | ||||
Deferred income tax liabilities |
(17 | ) | (6,415 | ) | ||||
|
|
|
|
|||||
$ | 844 | $ | (6,391 | ) | ||||
|
|
|
|
Unrecognized deferred tax assets
Deferred tax assets are recognized for the carry-forward or unused tax losses and unused tax credits to the extent that it is probable that taxable profits will be available against which the unused tax losses/credits can be utilized. The following represent the deductible temporary differences which have not been recognized in the financial statements.
Deferred income tax assets:
2014 | 2013 | |||||||
Non-capital loss carry-forward |
$ | 5,466 | $ | 3,679 | ||||
Share and debt issue costs |
1,698 | 3,157 | ||||||
Unrealized foreign exchange |
| 64 | ||||||
Property and equipment |
61 | 2 | ||||||
|
|
|
|
|||||
$ | 7,225 | $ | 6,902 | |||||
|
|
|
|
[31]
Concordia Healthcare Corp.
Notes to Consolidated Financial Statements
For the years ended December 31, 2014 and 2013
(Stated in thousands of U.S. Dollars, except per share amounts)
13. | Income Taxes (continued) |
The Companys non-capital losses that can be applied against future taxable profit are summarized below:
Country | Amount | Expiry date | ||||||
Canada |
$ | 201 | 2029 | |||||
Canada |
$ | 189 | 2030 | |||||
Canada |
$ | 17 | 2031 | |||||
Canada |
$ | 4,328 | 2032 | |||||
Canada |
$ | 154 | 2033 | |||||
Canada |
$ | 15,737 | 2034 | |||||
Barbados |
$ | 7,285 | 2023 |
14. | Debt Financing and Warrants |
Term Facility
On May 14, 2014, the Company entered into the Credit Facility of $170,000 with GE Capital Canada Finance, Inc. and a syndicate of lenders. The Credit Facility is secured by the assets of the Company and the assets of its material subsidiaries. The Credit Facility bears a variable interest rate and matures on May 14, 2019 with fixed repayments required over the term to maturity, as well as mandatory repayments based on excess cash flow generated by the Company as defined in the Credit Facility agreement, calculated annually.
On September 30, 2014, the Company amended the Credit Facility to facilitate the acquisition of Zonegran ® . An incremental term loan of $95,000 was added to the Credit Facility solely for the acquisition of Zonegran ® and related expenses. This amended Credit Facility matures on October 1, 2020. All obligations of the Company under the amended Credit Facility are secutred by assets of the Company and the assets of its material subsidiaries.
Interest rates are calculated at the U.S. Prime Rate or LIBOR plus applicable margins based on a leverage table. The Credit Facility contains standard events of default which if not remedied within a cure period would trigger the repayment of any outstanding balance. As at December 31, 2014 no such events of default have occurred.
Under the terms of the Credit Facility the Company is required to comply with certain financial covenants, as defined under the Credit Facility, under which the Companys total leverage ratio cannot exceed 4.25:1.00, the senior leverage ratio cannot exceed a certain cap ranging from 3.25:1.00 to 2.25:1.00, and the fixed charge ratio cannot be less than 1.11:1. Throughout the year ended December 31, 2014, the Company was in compliance with all of the financial covenants.
Transaction costs associated with the Credit Facility have been included as a reduction to the carrying amount of the liability and will be amortized through interest and accretion expense using the effective interest rate method. During the year ended December 31, 2014, the Company recognized $1,292 in accretion interest using an effective interest rate of 4.941% for the original term loan and 6.190% for the additional term loan. Interest expense on the Credit Facility was $5,040 for the year ended December 31, 2014.
[32]
Concordia Healthcare Corp.
Notes to Consolidated Financial Statements
For the years ended December 31, 2014 and 2013
(Stated in thousands of U.S. Dollars, except per share amounts)
14. | Debt Financing and Warrants (continued) |
Term Facility (continued)
2014 | 2013 | |||||||
Face value of the loans on issuance |
$ | 265,000 | $ | | ||||
Less: Transaction costs |
(8,561 | ) | | |||||
|
|
|
|
|||||
Book value upon issuance |
256,439 | | ||||||
Repayment of principal |
(4,250 | ) | | |||||
Accretion interest |
1,292 | | ||||||
|
|
|
|
|||||
Carrying value |
$ | 253,481 | $ | | ||||
Less: current portion |
(27,336 | ) | | |||||
|
|
|
|
|||||
Long-term portion |
$ | 226,145 | $ | | ||||
|
|
|
|
Senior and subordinate debt
On May 6, 2013, the Company entered into two loan and security agreements: (1) a loan under a senior loan agreement (including a working capital loan) (the Senior Loan Agreement) in the principal amount of $19,000 bearing interest at 12% per annum, calculated daily, maturing on October 30, 2015 with interest paid monthly in arrears, and (2) two loans under a subordinate loan agreement (the Subordinate Loan Agreement) in the aggregate principal amount of $5,150 bearing interest at 18% per annum, calculated daily, maturing on October 30, 2015 with interest paid monthly in arrears only if the loan under the Senior Loan Agreement was repaid.
The Senior Loan Agreement included a working capital loan of $3,000 where the interest rate was 12%. The working capital loan was repaid and cancelled on August 7, 2013.
The debt featured mandatory repayments based on free cash flow generated by the business as defined in the Senior Loan Agreement and the Subordinate Loan Agreement, calculated monthly. The loans were subject to a prepayment feature and repayment on demand at any time had certain events of default occurred. On March 28, 2014, the Company repaid in full its senior and subordinate debt. Senior and subordinated debt as at December 31, 2014 and 2013 are summarized as follows:
2014 | 2013 | |||||||
Face value of the loans on issuance |
$ | | $ | 21,150 | ||||
Less: Fair value of warrants issued |
| (4,607 | ) | |||||
Less: Transaction costs |
| (1,100 | ) | |||||
|
|
|
|
|||||
Book value upon issuance |
| 15,443 | ||||||
Repayment of principal |
| (5,408 | ) | |||||
Accretion interest |
| 4,287 | ||||||
|
|
|
|
|||||
Carrying value |
| $ | 14,322 | |||||
Accrued interest |
| 644 | ||||||
|
|
|
|
|||||
Senior and Subordinate Debt |
$ | | $ | 14,966 | ||||
|
|
|
|
[33]
Concordia Healthcare Corp.
Notes to Consolidated Financial Statements
For the years ended December 31, 2014 and 2013
(Stated in thousands of U.S. Dollars, except per share amounts)
14. | Debt Financing and Warrants (continued) |
Credit Facility
On May 14, 2014, the Company entered into a senior secured revolving credit facility (the Revolving Facility) in the principal amount of $25,000 with GE Capital Canada Finance, Inc. and a syndicate of lenders. The revolving credit facility is for working capital requirements and is repayable on demand. Loans under the Revolving Facility are repayable without any prepayment penalties, and bear interest at U.S. Prime Rate or LIBOR plus applicable margins based on a leverage table. The Company has not borrowed against this facility and there is no balance outstanding against this facility as at December 31, 2014.
15. | Notes Payable |
Notes payable, as at December 31, consist of the following:
2014 | 2013 | |||||||
Notes payable issued related to acquisition of Global assets |
$ | 5,262 | $ | 5,766 | ||||
Less: Current portion |
(1,372 | ) | (662 | ) | ||||
|
|
|
|
|||||
Long-term portion of Notes payable |
$ | 3,890 | $ | 5,104 | ||||
|
|
|
|
The notes payable of $5,262 as at December 31, 2014 represents the value of the notes issued by the Company related to the acquisition of Global assets as described in Note 5. The notes are unsecured, have a total face value of $7,000 and a coupon interest rate of 6%. The notes have been recorded at the present value of expected payments with a market representative interest rate of 12%. Interest expense and accretion expense amount to $647 and $69 respectively for the year ended December 31, 2014 ($112 and $35 respectively for the year ended December 31, 2013). The effective interest rate has been determined to be 13.67%. Principal repayments are due subject to the achievement of certain EBITDA thresholds. The Company made a principal repayment of $488 in the current year. For the year ended December 31, 2014, $732 of the notes payable have been offset against accounts receivable.
16. | Purchase Consideration Payable |
2014 | 2013 | |||||||
Contingent purchase consideration |
||||||||
Due to Shionogi Inc. (1) |
$ | 410 | $ | 792 | ||||
Due to former owner of Global (2) |
2,452 | 2,532 | ||||||
Due to former owners of Pinnacle (3) |
17,124 | 15,326 | ||||||
|
|
|
|
|||||
Total contingent purchase consideration |
$ | 19,986 | $ | 18,650 | ||||
|
|
|
|
|||||
Non-contingent purchase consideration |
||||||||
Fair value of annual payments due to former owners of Pinnacle (4) |
4,772 | 5,019 | ||||||
Consideration assumed on acquisition of Pinnacle |
350 | 716 | ||||||
|
|
|
|
|||||
Total non-contingent purchase consideration |
5,122 | 5,735 | ||||||
|
|
|
|
|||||
Total purchase consideration payable |
25,108 | 24,385 | ||||||
Less: Current portion |
(2,065 | ) | (2,786 | ) | ||||
|
|
|
|
|||||
Purchase consideration payable |
$ | 23,043 | $ | 21,599 | ||||
|
|
|
|
[34]
Concordia Healthcare Corp.
Notes to Consolidated Financial Statements
For the years ended December 31, 2014 and 2013
(Stated in thousands of U.S. Dollars, except per share amounts)
16. | Purchase Consideration Payable (continued) |
(1) | Following the closing of the Shionogi transaction, as additional consideration for the sale, transfer, conveyance and assignment of the assets and the grant of the Ulesfia ® license, the Company is required to pay Shionogi thirty percent (30%) of worldwide net sales of Kapvay ® that exceeds $1,500 (in the aggregate) during each calendar quarter commencing with the calendar quarter beginning October 1, 2013 until such payments equal $6,000 in the aggregate. |
(2) | As part of the consideration for the Global transaction, the Company is obligated to pay an additional earn-out payment of up to $4,000 payable in common shares of the Company subject to meeting certain performance metrics. The earn-out payment provisions provide that on each earn-out calculation date, if the aggregate adjusted EBITDA of CMH exceeds $7,000 for the preceding year then an earn-out payment of common shares will be made which is equal in value to the aggregate adjusted EBITDA of CMH for the preceding year multiplied by 14.285714%. The number of common shares of the Company to be paid is calculated by dividing the dollar value of the earn-out payment by the dollar volume weighted average trading price of the common shares of the Company on the TSX. The aggregate earn-out payments are subject to a $4,000 cap. |
(3) | As part of the consideration for the acquisition of Pinnacle, the Company is obligated to pay additional payments of up to $5,000 based on the achievement of certain milestones related to clinical trials. The Company is also obligated to pay additional earn-out payments equal to 15% of worldwide sales of Photofrin ® in excess of $25,000 over the 10 calendar years following the Companys acquisition of Pinnacle. The fair value of these obligations as at December 31, 2014 and 2013 is $17,124 and $15,326, respectively. The change in fair value from December 31, 2013 of $1,798 has been recorded as an expense in the current year. |
(4) | As part of the consideration for the acquisition of Pinnacle, the Company is obligated to make 10 annual payments of $1,000, with the first payment due on December 31, 2014. The obligation is subordinated and is not subject to interest. The obligation has been recorded at the present value of required payments with a market representative interest rate of 15%. Interest expense amounted to $768 for the year ended December 31, 2014. |
An estimate of the range of outcomes for the contingent purchase consideration is as follows:
Contingent Purchase Consideration Payable | Lower range | Upper range | ||||||
Due to Shionogi |
$ | 410 | $ | 6,000 | ||||
Due to former owner of Global Medical Direct LLC |
$ | Nil | $ | 4,000 | ||||
Due to former owners of Pinnacle Biologics Inc. |
$ | 5,000 | $ | 42,500 |
17. | Share Capital |
The Company is authorized to issue an unlimited number of common shares.
On May 5, 2013 CHI completed a private placement of 6,000,000 common shares at a price of $1.00 per share. Total proceeds from the transaction were $6,000.
On various dates in August of 2013, CHI completed private placements of a total of 1,166,666 shares at a price of $3.00 per share. Total proceeds from the transactions were $3,500.
On October 25, 2013 CHI issued an additional 1,000,000 common shares as compensation for consulting services and finders fees related to the Global transaction. The value of the consulting services and finders fees was $3,000. The value was based on recent private placements for the shares of the Company at $3 per share.
[35]
Concordia Healthcare Corp.
Notes to Consolidated Financial Statements
For the years ended December 31, 2014 and 2013
(Stated in thousands of U.S. Dollars, except per share amounts)
17. | Share Capital (continued) |
On December 19, 2013 CHI completed a private placement (the Private Placement) of subscription receipts (the Subscription Receipts) conducted by a syndicate of agents. Pursuant to the Private Placement, CHI issued 5,520,000 Subscription Receipts at a price of CAD $6.25 per Subscription Receipt. Each Subscription Receipt was exchanged for one common share of CHI, which common shares were then exchanged for Common Shares of Concordia on a one-for-one basis pursuant to the Companys Qualifying Transaction. Net proceeds from the transaction were $29,563 after deducting transaction expenses and underwriters fees of $2,846.
In connection with the Private Placement, the Company issued 220,800 agents options (the Agents Options) to the syndicate of agents that conducted the Private Placement. Each Agent Option is exchangeable for one common share of the Company at an exercise price of CAD $6.25 for a period of two years. The Agents Options have been valued using a Black-Scholes option-pricing model at $422 and this amount has been offset against the net proceeds from the Private Placement.
A pricing model with observable market based inputs was used to estimate the fair value of the Agents Options issued. The variables used to compute the values were as follows: an expected life of one year; a risk free rate of 0.96%; a volatility rate of 81.03%; and an exercise price and market price of $5.87. The Agents Options had an average fair value of $1.87 per Agent Option.
As described in note 1, on December 20, 2013 the Company entered into the Amalgamation Agreement and completed its Qualifying Transaction. The Qualifying Transaction proceeded by way of a three-cornered amalgamation among Mercari, Mercari Subco Inc., and CHI. On December 18, 2013, and prior to the completion of the Qualifying Transaction, Mercari changed its name to Concordia Healthcare Corp. and completed a consolidation of its share capital on a basis of one post-consolidation common share for every 48.08 common shares existing immediately before the consolidation. This resulted in the former shareholders of Mercari owning 276,616 common shares of Concordia, immediately upon completion of the Qualifying Transaction.
Prior to the Qualifying Transaction, all warrants issued by the Company in connection with the Senior Loan Agreement and Subordinate Loan Agreement were exercised pursuant to a cashless exercise option. As a result of this exercise, CHI issued 1,576,385 common shares to the warrant holders.
On December 20, 2013, immediately prior to the Qualifying Transaction, CHI issued 946,222 common shares at a price of CAD $5.625 per common share (being a 10% discount to the price of the Subscription Receipts issued under the Private Placement) in connection with the acquisition of Pinnacle.
On December 20, 2013 pursuant to the Qualifying Transaction, all common shares of CHI were exchanged on a one-for-one basis for shares of Concordia.
On March 11, 2014 the Company announced the completion of a short-form prospectus offering, on a bought deal basis, of 5,750,000 common shares of Concordia, which included an exercise by the underwriters of an over-allotment option of 15% (the Offering). Aggregate gross proceeds of the Offering were CAD $67,563. Net proceeds to the Company, after the deduction of underwriters fees and transaction expenses of CAD $4,469, were CAD $63,094.
The Offering was completed at a price per common share of CAD $11.75.
The Company recorded net proceeds of $56,999.
On May 15, 2014, the Company issued an aggregate of 4,605,833 common shares to PBM Pharmaceuticals Inc. (carrying on business as Revive Pharmaceuticals) for the purchase of Donnatal ® , valued at $129,151 based on the closing price of the Companys stock on the TSX on May 15, 2014 of CAD$30.50 per share converted to USD using the May 15, 2014 Bank of Canada closing USD: CAD exchange rate of 1:1.0877.
[36]
Concordia Healthcare Corp.
Notes to Consolidated Financial Statements
For the years ended December 31, 2014 and 2013
(Stated in thousands of U.S. Dollars, except per share amounts)
17. | Share Capital (continued) |
The Companys board of directors approved a $0.30 per common share annualized eligible dividend with $0.075 per common share being paid to shareholders on a quarterly basis.
The below table sets forth changes in issued and outstanding common shares and warrants for the period from incorporation to December 31, 2014.
Common
Shares |
Warrants/
Options |
Common
Shares |
Warrant/
Option Liability |
|||||||||||||
Issued on Incorporation |
1,500,000 | | $ | | $ | | ||||||||||
Issuance of Common Shares: |
||||||||||||||||
May Private Placement |
6,000,000 | | 6,000 | | ||||||||||||
August Private Placement |
1,166,666 | | 3,500 | | ||||||||||||
Global Transaction |
1,000,000 | | 3,000 | | ||||||||||||
December Private Placement |
5,520,000 | | 29,142 | | ||||||||||||
Mercari on Amalgamation |
276,616 | | 1,624 | | ||||||||||||
Acquisition of Pinnacle |
946,222 | | 5,000 | | ||||||||||||
Issuance of Warrants: |
||||||||||||||||
Term Facilities, first issuance |
| 1,875,000 | | 4,531 | ||||||||||||
Term Facilities, second issuance |
| 39,465 | | 76 | ||||||||||||
Cashless exercise related to term facilities |
1,576,385 | (1,914,465 | ) | 9,255 | (4,607 | ) | ||||||||||
|
|
|
|
|
|
|
|
|||||||||
Balances as at December 31, 2013 |
17,985,889 | | $ | 57,521 | $ | | ||||||||||
|
|
|
|
|
|
|
|
|||||||||
Issuance of Common Shares: |
||||||||||||||||
March Private Placement |
5,750,000 | | 56,999 | | ||||||||||||
Acquisition of Donnatal |
4,605,833 | | 129,151 | | ||||||||||||
Exercise of stock options |
519,517 | | 3,364 | | ||||||||||||
|
|
|
|
|
|
|
|
|||||||||
Balances as at December 31, 2014 |
28,861,239 | | $ | 247,035 | $ | | ||||||||||
|
|
|
|
|
|
|
|
18. | Earnings Per Share |
2014 | 2013 | |||||||
Net Income for the period attributable to shareholders |
$ | 11,590 | $ | 2,431 | ||||
|
|
|
|
|||||
Weighted average number of ordinary shares in issue |
25,793,068 | 6,332,281 | ||||||
Adjustments for: |
||||||||
Dilutive Stock Options and agent warrants |
1,416,836 | 100,106 | ||||||
|
|
|
|
|||||
Weighted average number of fully diluted shares |
27,209,904 | 6,432,387 | ||||||
|
|
|
|
|||||
Earnings per share: |
||||||||
Basic |
$ | 0.45 | $ | 0.38 | ||||
Diluted |
$ | 0.43 | $ | 0.38 | ||||
|
|
|
|
[37]
Concordia Healthcare Corp.
Notes to Consolidated Financial Statements
For the years ended December 31, 2014 and 2013
(Stated in thousands of U.S. Dollars, except per share amounts)
19. | Share Based Compensation |
Employee Stock Option Plan
The Company has an incentive stock option plan that permits it to grant options to acquire common shares to its directors, officers, employees, and others. The maximum number of common shares which may be reserved for issue under the stock option plan cannot exceed up to ten percent (10%) of the common shares of the Company, issued and outstanding from time to time, on a non-diluted basis (which maximum number is inclusive of any common shares reserved for issuance pursuant to the Companys long-term incentive plan), as determined by the Board of Directors. The exercise price at which any option may be exercised to acquire a common share of the Company must be not less than the lesser of (i) the closing trading price of the common shares on the TSX on the date of grant and (ii) the volume-weighted average price of the common shares on the TSX for the five trading days immediately preceding the date of grant. As at December 31, 2014, the company had issued a total of 2,275,000 options to executive officers, employees and non-management members of the Board of Directors (2013 1,375,000).
During the year ended December 31, 2014, 350,000 employee stock options were exercised, leaving an outstanding balance of 1,925,000 unexercised options outstanding as at December 31, 2014.
As at December 31, 2014, 422,883 stock options (December 31, 2013 1,322,883) were available for grant under the stock option plan.
The Black-Scholes model was used to compute option values. Key assumptions used to value each grant are set forth in the table below:
Date of Grant |
January 1,
2014 |
January 29,
2014 |
March 14,
2014 |
April 17,
2014 |
June 2,
2014 |
August 15,
2014 |
||||||||||||||||||
Number of options granted |
100,000 | 330,000 | 335,000 | 50,000 | 5,000 | 95,000 | ||||||||||||||||||
Market price |
$ | 5.88 | $ | 10.32 | $ | 13.46 | $ | 19.52 | $ | 29.82 | $ | 31.50 | ||||||||||||
Fair value of each option granted |
$ | 4.53 | $ | 5.37 | $ | 6.86 | $ | 10.07 | $ | 15.39 | $ | 16.48 | ||||||||||||
Assumptions: |
||||||||||||||||||||||||
Risk-Free Interest Rate |
1.63 | % | 1.63 | % | 1.63 | % | 1.63 | % | 1.63 | % | 1.63 | % | ||||||||||||
Expected Life |
3 | 3 | 3 | 3 | 3 | 3 | ||||||||||||||||||
Volatility |
84.22 | % | 79.48 | % | 77.36 | % | 78.55 | % | 78.61 | % | 80.10 | % | ||||||||||||
Expected Forfeitures |
NIL | NIL | NIL | NIL | NIL | NIL |
Exercise price for each of the stock options issued agreed to the market prices at the date of issue.
As historical volatility of the Companys common shares is not available, expected volatility is based on the historical performance of the common shares of other corporations with similar operations.
All the options issued have different vesting terms ranging from immediate vesting to vesting over a period of 3 years. All options issued have a life of 10 years.
For the year ended December 31, 2014, the total compensation charged against income with respect to all stock options granted was $4,484 (2013 $1,070). An amount of $4,484 (2013 $1,070) has been recognized in shareholders equity related to these options for the year ended December 31, 2014.
[38]
Concordia Healthcare Corp.
Notes to Consolidated Financial Statements
For the years ended December 31, 2014 and 2013
(Stated in thousands of U.S. Dollars, except per share amounts)
19. | Share Based Compensation (continued) |
Mercari Options
In connection with the Qualifying Transaction, the Company issued 25,998 options to the former directors of Mercari (the Mercari Options). Each one of the Mercari Options is exchangeable for one common share of the Company at an exercise price of CAD $4.81 for a period of ten years. The Mercari Options were valued using a Black-Scholes option-pricing model at $63.
A pricing model with observable market based inputs was used to estimate the fair value of the Mercaris options issued. The variables used to compute the values were as follows: an expected life of two years; a risk free rate of 1.2%; a volatility rate of 100%; and an exercise price and market price of CAD $4.81. All of the Mercari Options were exercised in the first quarter of 2014.
Agent Options
As described in Note 17, in connection with the Private Placement, the Company issued 220,800 Agents Options to the syndicate of agents that conducted the Private Placement. The Agents Options have been valued using a Black-Scholes option-pricing model at $422 and this amount has been offset against the net proceeds from the Private Placement.
The fair value of Agent Options cannot be measured reliably by the Company, thus the equity instrument has been measured based on the amount recognized for goods received or services rendered during the vesting period based on the number of options expected to vest. The Company measures the fair value of Agent Options using the Black-Scholes option-pricing model.
Each Agents Option is exchangeable for one common share of the Company at an exercise price of CAD $6.25 for a period of two years. During year ended December 31, 2014, 143,520 Agents Options were exercised, leaving an outstanding balance of 77,280 unexercised options outstanding as at December 31, 2014.
Information with respect to stock option transactions for the year ended December 31, 2014 and December 31, 2013 is as follows:
Number of
Stock Options |
Weighted
Average Exercise Price |
|||||||
Balance, January 1, 2013 |
| | ||||||
Granted during the year |
1,621,798 | $ | 3.86 | |||||
Cancelled during the year |
| | ||||||
Exercised during the year |
| | ||||||
|
|
|
|
|||||
Balance, December 31, 2013 |
1,621,798 | $ | 3.86 | |||||
|
|
|
|
|||||
Weighted-average exercise price of options exerciseable as at December 31, 2013 |
$ | 3.68 | ||||||
Granted during the period |
915,000 | 13.80 | ||||||
Cancelled during the period |
(15,001 | ) | 10.52 | |||||
Exercised during the period |
(519,517 | ) | 2.45 | |||||
|
|
|
|
|||||
Balance, December 31, 2014 |
2,002,280 | $ | 8.72 | |||||
|
|
|
|
|||||
Weighted-average exercise price of options exerciseable as at December 31, 2014 |
$ | 4.25 |
[39]
Concordia Healthcare Corp.
Notes to Consolidated Financial Statements
For the years ended December 31, 2014 and 2013
(Stated in thousands of U.S. Dollars, except per share amounts)
19. | Share Based Compensation (continued) |
Agent Options (continued)
For the options exercised during the year ended December 31, 2014, the weighted average market price on the date of exercise was $29.35.
As at December 31, 2014 outstanding stock options were as follows:
Year of Expiry |
Exercise
Price |
Number of
Stock Options |
Exercisable | |||||||||
2015 |
$ | 5.87 | 77,280 | 77,280 | ||||||||
2023 |
$ | 3.00 | 825,000 | 612,500 | ||||||||
2023 |
$ | 5.87 | 250,000 | 125,000 | ||||||||
2024 |
$ | 5.88 | 100,000 | 25,000 | ||||||||
2024 |
$ | 10.32 | 265,000 | 28,750 | ||||||||
2024 |
$ | 13.46 | 335,000 | 83,750 | ||||||||
2024 |
$ | 19.52 | 50,000 | 12,500 | ||||||||
2024 |
$ | 29.82 | 5,000 | 1,250 | ||||||||
2024 |
$ | 31.50 | 95,000 | | ||||||||
|
|
|
|
|
|
|||||||
2,002,280 | 966,030 | |||||||||||
|
|
|
|
|
|
20. | Related Party Transactions |
The Company had the following related party transactions during the years ended December 31, 2014 and 2013:
2014 | 2013 | |||||||
Legal fees paid or payable to firms affiliated with directors (a) |
61 | 139 | ||||||
Finance fees paid to firms affiliated with directors (b) |
| 150 | ||||||
Interest costs paid and payable to firms affiliated with directors (b) |
| 98 | ||||||
|
|
|
|
|||||
$ | 61 | $ | 387 | |||||
|
|
|
|
(a) | Legal fees include professional services for advice relating to intellectual property matters. |
(b) | This relates to fees and interest paid for a loan, where two of the directors were officers of the lender. The loan for $3,000,000 was repaid in 2013. |
[40]
Concordia Healthcare Corp.
Notes to Consolidated Financial Statements
For the years ended December 31, 2014 and 2013
(Stated in thousands of U.S. Dollars, except per share amounts)
21. | Commitments and Contingencies |
Lease Commitments
The Company leases facilities under operating leases in Canada, Barbados and the United States. The leases typically run for a period of months up to five years.
The below table sets forth the Companys obligations under operating leases:
Minimum
Lease Payments |
||||
2015 |
$ | 748 | ||
2016 |
712 | |||
2017 |
639 | |||
2018 |
509 | |||
2019 |
386 | |||
Thereafter |
525 | |||
|
|
|||
$ | 3,519 | |||
|
|
The Canadian facility lease expires on June 30, 2018 with an option to renew the lease for an additional 5 years after that date. The Barbados office lease expires in October of 2016. The facility leases in the United States expire during 2014, 2015 and 2020.
Royalties
The Company has a commitment to pay royalties on sales of each of the drugs acquired as part of the Shionogi transaction at certain prescribed rates. These royalties are payable on a quarterly basis.
Guarantees
All directors and officers of the Company, and each of the Companys various subsidiaries, are indemnified by the Company for various items including, but not limited to, all costs to settle lawsuits or actions due to their association with the Company, subject to certain restrictions. The Company has purchased directors and officers liability insurance to mitigate the cost of any potential future lawsuits or actions.
In the normal course of business, the Company has entered into agreements that include indemnities in favour of third parties, such as purchase and sale agreements, confidentiality agreements, engagement letters with advisors and consultants, leasing contracts, license agreements, information technology agreements and various product, service, data hosting and network access agreements. These indemnification arrangements may require the applicable Concordia entity to compensate counterparties for losses incurred by the counterparties as a result of breaches in representations, covenants and warranties provided by the particular Concordia entity or as a result of litigation or other third party claims or statutory sanctions that may be suffered by the counterparties as a consequence of the relevant transaction.
In connection with the acquisition of Zonegran ® , the Company guaranteed the payment, performance and discharge of CPIs payment and indemnification obligations under the asset purchase agreement and each ancillary agreement entered into by CPI in connection therewith that contained payment or indemnification obligations. Pursuant to the Covis Purchase Agreement (see Note 26) the Company guaranteed the payments due by CPI of CPIs obligations under the Covis Purchase Agreement.
[41]
Concordia Healthcare Corp.
Notes to Consolidated Financial Statements
For the years ended December 31, 2014 and 2013
(Stated in thousands of U.S. Dollars, except per share amounts)
21. | Commitments and Contingencies (continued) |
Litigation and Arbitration
In the normal course of business the Company may be the subject of litigation claims. As at December 31, 2014, there are no material claims against the Company. On February 12, 2015, Concordia announced that it received a civil investigative demand (CID) from the United States Federal Trade Commission regarding its attention deficit hyperactivity disorder product Kapvay ® and a competitive supply agreement entered into with a generic drug manufacturer (the Competitive Supply Agreement). The CID is a request for documentation and information to determine whether CPI, the counterparty to the Competitive Supply Agreement or their affiliates or any other person engaged in unfair methods of competition in or affecting commerce by entering into agreements relating to Kapvay ® . CPI and Concordia are cooperating with the information requests.
22. | Financial Instruments and Management of Risk |
The Companys financial instruments are exposed to certain financial risks, including currency risk, interest rate risk, credit risk and liquidity risk.
Currency Risk
The Company is exposed to currency risk related to the fluctuation of foreign exchange rates. The Company operates primarily in United States dollars. The Companys Barbados office incurs a small number of transactions in Barbados dollars and has a small bank balance, the totals of which are considered to have an insignificant effect on financial reporting. The Company has not entered into any foreign exchange derivative contracts.
The Company does not believe it is exposed to currency risk on its net assets denominated in Barbados dollars as the currency is fixed to the U.S. dollar. The Company, however, is exposed to currency risk though its net assets denominated in Canadian dollars.
2014 | 2013 | |||||||
CAD$ | CAD$ | |||||||
Cash |
$ | 520 | $ | 1,171 | ||||
Accounts payable and accrued liabilities (Net of accounts receivable) |
(352 | ) | (2,297 | ) | ||||
|
|
|
|
|||||
$ | 168 | $ | (1,126 | ) | ||||
|
|
|
|
Interest Rate Risk
Interest rate risk is the risk that the fair value or future cash flows of a financial instrument will fluctuate because of changes in market interest rates. The long term debt bears interest at floating rates and as such is subject to interest rate cash flow risk resulting from market fluctuations in interest rates. Contingent consideration payable and notes payable bear interest at a fixed rate of interest, and as such are subject to interest rate price risk resulting from changes in fair value from market fluctuations in interest rates. A 1% appreciation (depreciation) in the interest rate would result in the following:
[42]
Concordia Healthcare Corp.
Notes to Consolidated Financial Statements
For the years ended December 31, 2014 and 2013
(Stated in thousands of U.S. Dollars, except per share amounts)
22. | Financial Instruments and Management of Risk (continued) |
Interest Rate Risk (continued)
2014 | 2013 | |||||||
Impact of a 1% increase in interest rates for contingent purchase consideration payable on net income |
$ | (328 | ) | $ | (1,159 | ) | ||
Impact of a 1% decrease in interest rates for contingent purchase consideration payable on net income |
328 | 1,159 | ||||||
Impact of a 1% increase in interest rates for long-term debt on net income |
(1,324 | ) | | |||||
Impact of a 1% decrease in interest rates for long-term debt on net income |
$ | 1,324 | $ | |
Credit Risk
Credit risk is the risk of a financial loss to the Company if a customer or counterparty to a financial instrument fails to meet its contractual obligation. Financial instruments that potentially expose the Company to significant concentrations of credit risk consist of cash, accounts receivables and other receivables. The Companys investment policies are designed to mitigate the possibility of deterioration of principal, enhance the Companys ability to meet its liquidity needs and provide high returns within those parameters. Cash is on deposit with a Canadian chartered bank located in Canada and Barbados. Management monitors the collectability of accounts receivable and estimates an allowance for doubtful accounts. As at December 31, 2014, the allowance for doubtful accounts was $297 (2013 $361) and the accounts that were past due amounted to $1,382 (2013 $701).
The Company has concentration risk, as approximately 65% of total sales came from four customers (e.g. wholesalers) and 59% of total accounts receivable came from four customers (e.g. wholesalers).
Liquidity Risk
Liquidity risk is the risk that the Company will encounter difficulties in meeting its financial liability obligations as they become due. The Company has a planning and budgeting process in place to help determine the funds required to support the Companys normal operating requirements on an ongoing basis. Since inception, the Company has financed its cash requirements primarily through issuances of securities, short-term borrowings and issuances of long-term debt. The Company controls liquidity risk through management of working capital, cash flows and the availability and sourcing of financing.
[43]
Concordia Healthcare Corp.
Notes to Consolidated Financial Statements
For the years ended December 31, 2014 and 2013
(Stated in thousands of U.S. Dollars, except per share amounts)
22. | Financial Instruments and Management of Risk (continued) |
Liquidity Risk (continued)
The following tables summarize the Companys significant contractual undiscounted cash flows as at December 31, 2014 and 2013:
December 31, 2014 |
||||||||||||||||||||||||||||
Financial Instruments |
< 3 months |
3 to 6
months |
6 months to
1 year |
1 to 2 years | 2 to 5 years | Thereafter | Total | |||||||||||||||||||||
Accounts payable and accrued liabilities |
$ | 10,622 | $ | | $ | | $ | | $ | | $ | | $ | 10,622 | ||||||||||||||
Provisions |
| 21,799 | | | | | 21,799 | |||||||||||||||||||||
Royalties payable |
| 3,141 | | | | | 3,141 | |||||||||||||||||||||
Taxes payable |
13,309 | | | | | | 13,309 | |||||||||||||||||||||
Current portion of long-term debt |
| 5,950 | 21,386 | | | | 27,336 | |||||||||||||||||||||
Long-term debt |
| | | 109,280 | 110,407 | 13,727 | 233,414 | |||||||||||||||||||||
Current portion of purchase consideration payable |
855 | 33 | | | | | 888 | |||||||||||||||||||||
Purchase consideration payable |
1,500 | 2,072 | 8,743 | 38,744 | 51,059 | |||||||||||||||||||||||
Current portion of note payable |
| | | | | | | |||||||||||||||||||||
Notes payable |
| | 1,000 | 1,200 | 4,000 | | 6,200 | |||||||||||||||||||||
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|||||||||||||||
$ | 24,786 | $ | 30,923 | $ | 23,886 | $ | 112,552 | $ | 123,150 | $ | 52,471 | $ | 367,768 | |||||||||||||||
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|||||||||||||||
December 31, 2013 |
||||||||||||||||||||||||||||
Financial Instruments |
< 3 months |
3 to 6
months |
6 months to
1 year |
1 to 2 years | 2 to 5 years | Thereafter | Total | |||||||||||||||||||||
Accounts payable and accrued liabilities |
$ | 29,403 | $ | | $ | | $ | | $ | | $ | | $ | 29,403 | ||||||||||||||
Provisions |
2,421 | 6,052 | 15,735 | | | | $ | 24,208 | ||||||||||||||||||||
Royalties payable |
| 3,093 | | | | | $ | 3,093 | ||||||||||||||||||||
Taxes payable |
| 987 | | | | | $ | 987 | ||||||||||||||||||||
Senior and subordinate debt |
16,830 | | | | | | $ | 16,830 | ||||||||||||||||||||
Current portion of purchase consideration payable |
| | 2,786 | | | | $ | 2,786 | ||||||||||||||||||||
Notes payable |
| | | 1,800 | 4,200 | 1,000 | $ | 7,000 | ||||||||||||||||||||
Purchase consideration payable |
| | 1,527 | 9,815 | 39,744 | $ | 51,086 | |||||||||||||||||||||
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|||||||||||||||
$ | 48,654 | $ | 10,132 | $ | 18,521 | $ | 3,327 | $ | 14,015 | $ | 40,744 | $ | 135,393 | |||||||||||||||
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Fair Value
The fair value of the purchase consideration payable and notes payable was determined using a Level III valuation technique by using discounted cash flow models that use discount rates that reflect the Companys borrowing rate as at December 31, 2013. The Companys own non-performance risk was assessed to be insignificant as at December 31, 2014.
[44]
Concordia Healthcare Corp.
Notes to Consolidated Financial Statements
For the years ended December 31, 2014 and 2013
(Stated in thousands of U.S. Dollars, except per share amounts)
23. | Capital Management |
The Companys capital management objectives are to safeguard its ability to provide returns for shareholders and benefits for other stakeholders, by ensuring it has sufficient cash resources to fund its activities, to pursue its commercialization efforts and to maintain its ongoing operations. The Company includes long-term debt and shareholders equity in the definition of capital.
The below table sets forth the Companys capital structure:
2014 | 2013 | |||||||
Senior and subordinate debt |
$ | | $ | 14,966 | ||||
Long-term debt |
253,481 | | ||||||
Notes payable |
5,262 | 5,766 | ||||||
Shareholders Equity |
257,550 | 61,522 | ||||||
|
|
|
|
|||||
$ | 516,293 | $ | 82,254 | |||||
|
|
|
|
24. | Segmented Reporting |
Operating Segments
The Company has three reportable operating segments: The Legacy Pharmaceuticals Division, The Orphan Drugs Division and The Specialty Healthcare Distribution Division. A brief description of each segment follows below.
The Legacy Pharmaceuticals Division
The Legacy Pharmaceuticals Division focuses on the management and acquisition of legacy pharmaceutical products, both with patent life and exclusivity remaining (pre-legacy) and products that have reached full maturity but continue on a predictable revenue generation path, collectively referred to as legacy products.
The Orphan Drugs Division
The Orphan Drugs Division is intended to provide growth opportunities through the expansion into new indications for existing orphan products or the acquisition of approved orphan drugs and further expansion within their identified markets.
The Specialty Healthcare Distribution Division
The Speciality Healthcare Distribution Division is a nation-wide provider of diabetes testing supplies and other healthcare products in the United States.
[45]
Concordia Healthcare Corp.
Notes to Consolidated Financial Statements
For the years ended December 31, 2014 and 2013
(Stated in thousands of U.S. Dollars, except per share amounts)
24. | Segmented Reporting (continued) |
Operating Segments (continued)
The below table sets forth operating income, interest and accretion expense, change in fair value of contingent consideration, income taxes, total assets and total liabilities by reportable operating segment for the year ended December 31, 2014 and 2013:
[46]
Concordia Healthcare Corp.
Notes to Consolidated Financial Statements
For the years ended December 31, 2014 and 2013
(Stated in thousands of U.S. Dollars, except per share amounts)
24. | Segmented Reporting (continued) |
Operating Segments (continued)
Legacy
Pharmaceuticals |
Orphan
Drugs |
Specialty
Healthcare Distribution |
Corporate | Eliminations |
Year ended
December 31, 2013 |
|||||||||||||||||||
Revenue |
$ | 36,884 | $ | 10 | $ | 3,553 | $ | 2,889 | $ | (2,889 | ) | $ | 40,447 | |||||||||||
Cost of sales |
7,391 | 34 | 913 | | | 8,338 | ||||||||||||||||||
|
|
|
|
|
|
|
|
|
|
|
|
|||||||||||||
Gross profit |
29,493 | (24 | ) | 2,640 | 2,889 | (2,889 | ) | 32,109 | ||||||||||||||||
|
|
|
|
|
|
|
|
|
|
|
|
|||||||||||||
Operating expenses |
||||||||||||||||||||||||
General and administrative |
4,209 | 160 | 1,609 | 567 | | 6,545 | ||||||||||||||||||
Business acquisition related costs |
| 367 | 3,325 | | | 3,692 | ||||||||||||||||||
Selling and marketing |
1,857 | | 607 | | 2,464 | |||||||||||||||||||
Research and development |
1,931 | 1,931 | ||||||||||||||||||||||
Management fees |
2,889 | | | | (2,889 | ) | | |||||||||||||||||
Share based compensation |
| | | 1,070 | | 1,070 | ||||||||||||||||||
Depreciation expense |
3 | | 12 | 3 | | 18 | ||||||||||||||||||
Exchange listing expenses |
| | | 2,404 | | 2,404 | ||||||||||||||||||
|
|
|
|
|
|
|
|
|
|
|
|
|||||||||||||
Total operating expenses |
8,958 | 527 | 5,553 | 5,975 | (2,889 | ) | 18,124 | |||||||||||||||||
|
|
|
|
|
|
|
|
|
|
|
|
|||||||||||||
|
|
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|
|
|
|
|
|
|
|
|
|||||||||||||
Operating income |
20,535 | (551 | ) | (2,913 | ) | (3,086 | ) | | 13,985 | |||||||||||||||
|
|
|
|
|
|
|
|
|
|
|
|
|||||||||||||
Interest and accretion expense |
| | | 6,382 | | 6,382 | ||||||||||||||||||
Amortization of intangible assets |
| | | 120 | | 120 | ||||||||||||||||||
Foreign exchange loss |
| | | 129 | | 129 | ||||||||||||||||||
Other (income) expense |
| | | (150 | ) | | (150 | ) | ||||||||||||||||
Change in fair value of derivative warrants |
| | | 4,648 | | 4,648 | ||||||||||||||||||
|
|
|
|
|
|
|
|
|
|
|
|
|||||||||||||
Income (loss) before tax |
20,535 | (551 | ) | (2,913 | ) | (14,215 | ) | | 2,856 | |||||||||||||||
|
|
|
|
|
|
|
|
|
|
|
|
|||||||||||||
Income taxes |
238 | | 187 | | | 425 | ||||||||||||||||||
|
|
|
|
|
|
|
|
|
|
|
|
|||||||||||||
Net income (loss) |
20,297 | (551 | ) | (3,100 | ) | (14,215 | ) | | 2,431 | |||||||||||||||
|
|
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|
|
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|
|
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|||||||||||||
|
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|
|
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|
|
|
|||||||||||||
Total assets |
97,476 | 69,858 | 11,718 | 62,299 | (70,586 | ) | 170,765 | |||||||||||||||||
|
|
|
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|
|
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|
|
|
|||||||||||||
|
|
|
|
|
|
|
|
|
|
|
|
|||||||||||||
Total liabilities |
49,341 | 32,225 | 7,516 | 20,161 | | 109,243 | ||||||||||||||||||
|
|
|
|
|
|
|
|
|
|
|
|
Geographic Segments
The Companys revenue by country of origin of external customer is all in the United States, with the exception of $2,105 of revenue in the Orphan Drugs segment that originates from customers outside of the United States.
The Company has operations in Barbados, Canada and the United States. The below table sets forth assets and liabilities by geographic location (excluding inter-company balances and investments in subsidiaries):
[47]
Concordia Healthcare Corp.
Notes to Consolidated Financial Statements
For the years ended December 31, 2014 and 2013
(Stated in thousands of U.S. Dollars, except per share amounts)
24. | Segmented Reporting (continued) |
Geographic Segments (continued)
Barbados | Canada |
United
States |
Netherlands |
As at
December 31, 2014 |
||||||||||||||||
Current assets |
$ | 61,544 | $ | 12,532 | $ | 9,566 | $ | 1,010 | $ | 84,652 | ||||||||||
Non-current assets |
481,752 | 274 | 26,022 | | 508,048 | |||||||||||||||
|
|
|
|
|
|
|
|
|
|
|||||||||||
Total Assets |
543,296 | 12,806 | 35,588 | 1,010 | 592,700 | |||||||||||||||
|
|
|
|
|
|
|
|
|
|
|||||||||||
Current liabilities |
34,194 | 32,081 | 15,000 | 534 | 81,809 | |||||||||||||||
Non-current liabilities |
20,418 | 226,145 | 6,778 | | 253,341 | |||||||||||||||
|
|
|
|
|
|
|
|
|
|
|||||||||||
Total Liabilities |
$ | 54,612 | $ | 258,226 | $ | 21,778 | $ | 534 | $ | 335,150 | ||||||||||
|
|
|
|
|
|
|
|
|
|
|||||||||||
Barbados | Canada |
United
States |
Netherlands |
As at
December 31, 2013 |
||||||||||||||||
Current assets |
$ | 54,416 | $ | 4,656 | $ | 11,909 | $ | 1,391 | $ | 72,372 | ||||||||||
Non-current assets |
26,456 | 38 | 70,012 | 1,887 | 98,393 | |||||||||||||||
|
|
|
|
|
|
|
|
|
|
|||||||||||
Total Assets |
80,872 | 4,694 | 81,921 | 3,278 | 170,765 | |||||||||||||||
|
|
|
|
|
|
|
|
|
|
|||||||||||
Current liabilities |
49,341 | 19,137 | 7,285 | 342 | 76,105 | |||||||||||||||
Non-current liabilities |
| | 32,934 | 204 | 33,138 | |||||||||||||||
|
|
|
|
|
|
|
|
|
|
|||||||||||
Total Liabilities |
$ | 49,341 | $ | 19,137 | $ | 40,219 | $ | 546 | $ | 109,243 | ||||||||||
|
|
|
|
|
|
|
|
|
|
25. | Directors and key management compensation |
Compensation, consisting of salaries, bonuses and director fees to key management personnel and directors for the year ended December 31, 2014 amounted to $1,907 (2013 $1,192).
Share based compensation, including the amortized cost of the share-based compensation issued for the key management and directors, for the year ended December 31, 2014 amounted to $1,274 (2013 $979).
26. | Subsequent events |
On March 9, 2015, Concordia announced that it and CPI had entered into a definitive asset purchase agreement (the Covis Asset Purchase Agreement) to acquire substantially all of the commercial assets of privately held Covis Pharma S.à.r.l and Covis Injectables, S.à.r.l (together Covis) for $1.2 billion in cash. The Covis drug portfolio being acquired (the Portfolio) consists of 18 branded and authorized generic products. The Portfolio includes branded pharmaceuticals, injectables and authorized generics that address medical conditions in various therapeutic areas including cardiovascular, central nervous system, oncology and acute care markets.
[48]
Concordia Healthcare Corp.
Notes to Consolidated Financial Statements
For the years ended December 31, 2014 and 2013
(Stated in thousands of U.S. Dollars, except per share amounts)
26. | Subsequent events (continued) |
The acquisition is structured as an all-cash transaction with a purchase price of $1.2 billion for the Portfolio. The Company plans to pay for the acquisition through the net proceeds of the 2015 Offering (as defined below) and debt financing. Accordingly, the Company has entered into a commitment letter (the Commitment Letter) with Royal Bank of Canada (RBC), pursuant to which, RBC has agreed to provide senior secured credit facilities on the closing date of the acquisition of the Portfolio (the Acquisition Closing Date) in an aggregate principal amount of up to $750 million comprising of: (1) a senior secured revolving credit facility in an aggregate principal amount of up to $100 million and (ii) a senior secured term loan facility in an aggregate principal amount of up to $650 million (together the RBC Facilities). All obligations of the Company under the RBC Facilities will be guaranteed by all material subsidiaries of the Company and secured by first priority (subject to permitted liens) perfected security interests in the assets of the Company and the assets of and equity interests in its material subsidiaries.
In addition, RBC has agreed to provide the Company: (i) a senior unsecured bridge facility (the Bond Bridge Facility) on the Acquisition Closing Date in an aggregate principal amount of up to $710 million less the aggregate gross proceeds provided by any senior unsecured notes and gross proceeds in excess of $150 million provided by any new equity issued by the Company, including the 2015 Subscription Receipts (as defined below) to be issued under the 2015 Offering, on or prior to the Acquisition Closing Date; and (ii) a senior unsecured equity bridge facility (the Equity Bridge Facility) on the Acquisition Closing Date in an aggregate principal amount of up to $150 million less the aggregate amount of any new equity issued by the Company, including the 2015 Subscription Receipts to be issued under the 2015 Offering, on or prior to the Acquisition Closing Date (collectively with the RBC Facilities, the RBC Credit Facilities). All obligations of the Company under the Bond Bridge Facility and the Equity Bridge Facility will be guaranteed by all material subsidiaries of the Company. The RBC Credit Facilities are subject to the completion of definitive documentation which will contain customary representations and warranties and restrictive covenants for facilities of this nature.
On March 17, 2015, the Company announced that it had entered into a letter agreement with RBC Dominion Securities Inc., as sole bookrunner and co-lead manager, and GMP Securities L.P. as co-lead manager (and together with RBC Dominion Securities Inc. and other underwriters who may join the syndicate, the 2015 Underwriters), pursuant to which the 2015 Underwriters agreed to purchase, on a bought deal basis, 3,764,720 subscription receipts of the Company (the 2015 Subscription Receipts) at a price of CAD$85.00 per 2015 Subscription Receipt (the Offering Price) for aggregate gross proceeds to the Company of CAD$320 million (the 2015 Offering). Each 2015 Subscription Receipt will entitle the holder thereof to receive, upon the closing of the acquisition of the Portfolio, without payment of additional consideration or further action, one common share of the Company in exchange for each 2015 Subscription Receipt. In connection with the 2015 Offering, the Company agreed to grant the 2015 Underwriters an over-allotment option to purchase up to an additional 564,708 2015 Subscription Receipts at the Offering Price, exercisable in whole or in part, at any time up to 30 days following the closing of the 2015 Offering (so long as the Covis Asset Purchase Agreement has not been terminated before or by such time or it has been announced that the acquisition of the Portfolio will not be completed). If this option is exercised in full, an additional CAD$48 million will be raised pursuant to the 2015 Offering and the aggregate gross proceeds will be CAD$368 million. The 2015 Underwriters will receive, as consideration for their services, a commission equal to 4% of the aggregate gross proceeds payable to the Company in respect of the 2015 Offering. Net proceeds are expected to be used, in part, to fund the acquisition of the Portfolio.
[49]
Exhibit 99.5
Managements Discussion and Analysis
For the year ended December 31, 2014
Dated: March 19, 2015
Table of Contents
FORWARD-LOOKING STATEMENTS |
3 | |||
CRITICAL ACCOUNTING ESTIMATES |
4 | |||
COMPANY OVERVIEW |
6 | |||
HISTORY AND KEY DEVELOPMENTS |
7 | |||
Q UALIFYING T RANSACTION |
7 | |||
F INANCINGS AND A CQUISITIONS |
7 | |||
RECENT EVENTS |
9 | |||
SELECTED ANNUAL FINANCIAL INFORMATION |
10 | |||
SELECTED QUARTERLY FINANCIAL INFORMATION |
12 | |||
RESULTS OF OPERATIONS |
13 | |||
F ACTORS A FFECTING R ESULTS FROM O PERATIONS 2014 VS . 2013 |
14 | |||
F ACTORS A FFECTING R ESULTS FROM O PERATIONS Q4-2014 VS . Q4-2013 |
17 | |||
FINANCIAL POSITION |
19 | |||
LIQUIDITY AND CAPITAL RESOURCES |
21 | |||
C ASH F LOWS |
21 | |||
INDEBTEDNESS |
22 | |||
T ERM AND C REDIT F ACILITIES |
22 | |||
N OTES P AYABLE |
23 | |||
N ON -C ONTINGENT P URCHASE C ONSIDERATION |
23 | |||
CONTRACTUAL OBLIGATIONS |
23 | |||
RELATED PARTY TRANSACTIONS |
23 | |||
DIRECTORS AND KEY MANAGEMENT COMPENSATION |
24 | |||
CONTINGENCIES |
24 | |||
OFF BALANCE SHEET ARRANGEMENTS |
25 | |||
RECENT ACCOUNTING PRONOUNCEMENTS |
25 | |||
C ONSOLIDATED F INANCIAL S TATEMENTS |
25 | |||
F INANCIAL I NSTRUMENTS : P RESENTATION |
25 | |||
I MPAIRMENT OF A SSETS |
25 | |||
L EVIS |
25 | |||
NON IFRS FINANCIAL MEASURES |
26 | |||
EBITDA |
26 | |||
A DJUSTED EBITDA |
26 | |||
A DJUSTED EPS |
27 | |||
OUTSTANDING SHARE DATA |
28 | |||
DISCLOSURE CONTROLS AND PROCEDURES AND INTERNAL CONTROL OVER FINANCIAL REPORTING |
28 | |||
D ISCLOSURE C ONTROLS AND P ROCEDURES |
28 | |||
I NTERNAL C ONTROLS OVER F INANCIAL R EPORTING |
28 | |||
A SSESSMENT OF DC&P AND ICFR |
28 |
[2]
The following Managements Discussion and Analysis ( MD&A ) was prepared as of March 19, 2015 and should be read in conjunction with the audited consolidated financial statements and related notes for the years ended December 31, 2014 and 2013 of Concordia Healthcare Corp. ( Concordia or the Company ), which were prepared in accordance with International Financial Reporting Standards ( IFRS ). Amounts are stated in thousands of U.S. Dollars, which is the functional currency of the Company, unless otherwise noted.
Some of the statements contained in this MD&A constitute forward-looking statements within the meaning of applicable Canadian securities legislation. See Forward-Looking Statements for a discussion of risks, uncertainties, and assumptions relating to these statements. Additional information relating to the Company, including the Companys Annual Information Form, is available on SEDAR at www.sedar.com . The results of operations, business prospects and financial condition of Concordia will be affected by, among other things, the Risk factors set out in Concordias Annual Information Form dated March 19, 2015 available on SEDAR at www.sedar.com .
Certain measures used in this MD&A do not have any standardized meaning under IFRS. When used, these measures are defined in such terms as to allow the reconciliation to the closest IFRS measure. See Selected Financial Information, Results of Operations and Non-IFRS Financial Measures.
Forward-looking Statements
This MD&A may contain forward-looking information and forward-looking statements (collectively, forward-looking information) regarding Concordia and its business. This forward-looking information is not based on historical facts but rather on the expectations of Concordias management ( Management ) regarding the future growth of the Company, its results of operations, performance and business prospects and opportunities. Forward-looking information may include financial and other projections, as well as statements regarding future plans, objectives or economic performance, or the assumptions underlying any of the foregoing. This MD&A uses words such as will, expects, anticipates, intends, estimates, or similar expressions to identify forward-looking information. Such forward-looking information reflects the current beliefs of Management based on information currently available to them, and are based on assumptions and subject to risks and uncertainties.
Forward-looking information included in this MD&A is based in part, on assumptions that may change, thus causing actual future results or anticipated events to differ materially from those expressed or implied in any forward-looking information. Such assumptions include that:
| Concordia will sustain or increase profitability, and will be able to fund its operations with existing capital, and/or it will be able to raise additional capital to fund future acquisitions; |
| Concordia will be able to attract and retain qualified staff, equipment and services in a timely and efficient manner; |
| Concordia will be able to acquire any necessary technology, products or businesses and effectively integrate such acquisitions; |
| Concordia will be successful in developing and clinically testing products under development; |
| Concordia will be successful in obtaining all necessary approvals for commercialization of its products from the U.S. Food and Drug Administration, or other regulatory authorities; |
| The results of continuing and future safety and efficacy studies by industry and government agencies relating to Concordias products will be favorable; |
| Concordias products will not be adversely impacted by competitive products and pricing; |
| Raw materials and finished products necessary for Concordias products will continue to be available; |
| Concordias ability to generate sufficient cash flow from operations and to access existing and proposed credit facilities and the capital markets to meet its future obligations on acceptable terms; |
| Concordia will be able to continue to rely on third party contract manufacturers to manufacture the Companys products on favorable terms; |
[3]
| Concordia will be able to maintain and enforce the protection afforded by any patents or other intellectual property rights; |
| Concordias products will be successfully licensed to third parties to market and distribute such products on favorable terms; |
| Concordias key strategic alliances, out licensing and partnering arrangements, now and in the future, will remain in place and in force; |
| The general regulatory environment will not change in a manner adverse to the business of Concordia, including the areas of taxation, environmental protection, consumer safety and health regulation; |
| The tax treatment of Concordia and its subsidiaries will remain constant and the Company will not become subject to any material legal proceedings; |
| Concordia will be able to comply with its contractual obligations, including, without limitation, its obligations under debt arrangements; |
| Future currency exchange and interest rates; |
| General economic, financial, market and political conditions impacting the industry in which the Company operates; |
| Timely receipt of any required regulatory approvals; |
| The ability of the Company to complete the transactions under the asset purchase agreement with Covis and the financing described under Recent Events in this MD&A; |
| The ability of Concordia to conduct operations in a safe, efficient and effective manner; and |
| The ability of Concordia to successfully market its products and services. |
Management cautions that the foregoing list of assumptions is not exhaustive. Forward-looking information involves known and unknown risks, uncertainties and other factors that may cause the actual results, performance or achievements of the Company to differ materially from any future results, performance or achievements expressed or implied by the forward-looking information. Risks related to forward-looking information include those risks referenced to in the Companys filings with the Canadian Securities Regulators, including risks described in the Companys Annual Information Form dated March 19, 2015 under the heading Risk Factors. Actual results, performance or achievement could differ materially from that expressed in, or implied by, any forward-looking information in this MD&A, and, accordingly, investors should not place undue reliance on any such forward-looking information. Further, any forward-looking information speaks only as of the date on which such forward-looking information is made and the Company undertakes no obligation to update any forward-looking information to reflect the occurrence of unanticipated events, except as required by law, including applicable securities laws. New factors emerge from time to time and the importance of current factors may change from time to time and it is not possible for Management to predict all of such factors, changes in such factors and to assess in advance the impact of each such factors on the business of Concordia or the extent to which any factor, or combination of factors, may cause actual results to differ materially from those contained in any forward-looking information contained in this MD&A.
Trademarks
This MD&A includes trademarks which are protected under applicable intellectual property laws and are the property of Concordia or its affiliates. Solely for convenience, the trademarks of Concordia referred to in this MD&A may appear with or without the ® or TM symbol, but such references or the absence thereof are not intended to indicate, in any way, that the Company or its affiliates will not assert, to the fullest extent under applicable law, the respective rights or the rights of the applicable licensor to these trademarks. Any other trademarks used in the MD&A are the property of their respective owners.
Critical Accounting Estimates
In preparing the Companys consolidated financial statements, Management is required to make estimates and assumptions that affect the reported amounts of assets and liabilities, the disclosure of contingent liabilities at the date of the consolidated financial statements and the reported amounts of expenses during the reporting periods.
[4]
Significant estimates made by Management include: gross to net deductions; allowance for doubtful accounts; inventory reserves; useful lives of amortizable tangible and intangible assets; fair value of contingent consideration; weighted average cost of capital; determining the fair value of share-based payments and the provision for income taxes and the ability to realize deferred tax assets. On an ongoing basis, Management reviews its estimates to ensure that these estimates appropriately reflect changes in the Companys business and new information as it becomes available. If historical experience and other factors used by Management to make these estimates do not reasonably reflect future activity, the Companys consolidated financial statements could be materially impacted.
Chargebacks
The provision for chargebacks is an estimate used in the recognition of revenue. In the United States, Concordia sells its products directly to wholesale distributors. The wholesale distributors sell directly to independent pharmacies, managed care organizations, hospitals and group purchasing organizations (indirect customers). The difference between the price that Concordia sells to wholesalers and the price the wholesaler sells to indirect customers is referred to as a chargeback. The provision for chargebacks is calculated based upon historical experience. As sales are made to large wholesale customers, Concordia continually monitors the provision for chargebacks and makes adjustments when it believes that actual chargebacks may differ from estimated provisions.
Returns
The provision for returns is an estimate used in the recognition of revenue. Concordia has a returns policy that allows wholesalers to return the product within a specified period prior to and subsequent to the expiration date. Provisions for returns are recognized in the period in which the underlying sales are recognized, as a reduction of sales revenue. Concordia estimates provisions for returns based upon historical experience, which represents Managements best estimate. Concordia continually monitors provisions for returns and makes adjustments when it believes that actual product returns may differ from established reserves.
Rebates
The provision for rebates is an estimate used in the recognition of revenue. Rebates are granted to healthcare authorities and under contractual arrangements with certain customers. Products sold in the United States are covered by various programs (such as Medicaid and Medicare) under which products are sold at a discount. Concordia estimates its provisions for rebates based on current contractual terms and conditions as well as the historical experience, changes to business practices and credit terms. Concordia continually monitors the provision for rebates and makes adjustments when it believes that actual rebates may differ from established provisions. All rebates are recognized in the period in which the underlying sales are recognized as a reduction of sales revenue.
Other price adjustments
The provision for other price adjustments is a significant and complex estimate used in the recognition of revenue. Other price adjustments are credits issued by the wholesaler to reflect various decreases in the selling price. The price that Concordia sells to the Wholesaler is known as the Wholesale Acquisition Cost ( WAC ). Decreases to WAC are discretionary decisions made by the wholesalers to reflect competitive market conditions. Amounts recorded for other price adjustments are based upon estimated declines in market prices. Concordia regularly monitors these and other factors and re-evaluates the provision as additional information becomes available.
Share-based compensation
IFRS 2 requires that each installment of options be treated as a separate share option grant with graded-vesting features. Forfeitures are estimated at the time of grant and revised if actual forfeitures are likely to differ from previous estimates. Options granted to parties other than employees are measured at their fair values. Share-based compensation is recognized as compensation in the statement of comprehensive earnings based on the fair values of the underlying options at the time of the grant, with the compensation expense amortized over the vesting period for the grantee. Concordia uses the Black-Scholes option pricing model to price its options in computing share based compensation, which requires certain assumptions on numerous variables including the stock price volatility rate for a publicly held corporation.
[5]
Due to the absence of a company specific volatility rate given the limited trading history of the Companys stock, Concordia uses comparable rates to other companies in the pharmaceutical industry. The selection of a different option pricing model (binomial model) and a different volatility rate could produce a different value for share based compensation, which could impact results.
Impairment of non-financial assets
The Company reviews amortized non-financial assets for impairment whenever events or changes in circumstances indicate that the carrying amount of the assets may be impaired. The Company also reviews, on an annual basis, non-financial assets with indefinite life for impairment. If the recoverable amount of the respective non-financial assets is less than its carrying amount, it is considered to be impaired. In the process of measuring the recoverable amount, Management makes assumptions about future events and circumstances. The actual results may vary and may cause significant adjustments.
Income taxes
Concordia is subject to income taxes in different jurisdictions and therefore uses judgment to determine the provision for income taxes. There are transactions and calculations for which the ultimate tax determination is uncertain. Provisions for uncertain tax positions are recorded based on Managements estimate of the most likely outcome. Where the final tax outcome of these matters is different from the amounts that were initially recorded, such differences will impact the current and deferred income tax assets and liabilities in the period that such determination is made.
Acquisition-Related Contingent Purchase Consideration
Some of the acquisitions Concordia has completed include contingent consideration to be potentially paid based upon the occurrence of future events, such as sales performance and the achievement of certain future development, regulatory and sales milestones.
Acquisition-related contingent consideration associated with an acquisition is initially recognized at fair value and then re-measured each reporting period, with changes in fair value recorded in the consolidated statements of income (loss). The estimates of fair value contain uncertainties as they involve assumptions about the likelihood of achieving specified milestone criteria, projections of future financial performance, and assumed discount rates. Changes in the fair value of the acquisition-related contingent consideration obligations result from several factors including changes in discount periods and rates, changes in the timing and amount of revenue estimates and changes in probability assumptions with respect to the likelihood of achieving specified milestone criteria. A change in any of these assumptions could produce a different fair value, which could impact results.
Company Overview
Concordia is an integrated healthcare company with three operating segments:
1. | The Legacy Pharmaceuticals Division |
The Legacy Pharmaceuticals Division focuses on the management and acquisition of legacy pharmaceutical products, both with patent life and exclusivity remaining (pre-legacy) and products that have reached full maturity but continue on a predictable revenue path, collectively referred to as legacy pharmaceutical products. Regardless of stage of the life cycle the targeted products have a well-established record of safety and efficacy and a history of stable, predictable prescription demand.
2. | The Orphan Drugs Division |
The Orphan Drugs Division is intended to provide growth opportunities through the expansion into new indications for existing products or the acquisition of approved orphan drugs and further expansion within their identified markets and new indications.
[6]
3. | The Specialty Healthcare Distribution Division |
The Speciality Healthcare Distribution ( SHD ) Division is a nation-wide provider of diabetes testing supplies, pharmaceuticals, diabetic shoes, orthotic braces and other home medical equipment in the United States.
These three business units are run as separate divisions but are inter-related. The cash-flow from legacy pharmaceutical products is used to fund operations, provide capital for future acquisitions and is also intended to fund the development of new indications for orphan drugs. The SHD division provides additional growth and cash-flow generation. Additionally, through its registered pharmacy operation, this business is intended to provide a distribution capability for specialty drugs once acquired and/or developed.
These three divisions are identified as reportable segments under IFRS for the purposes of disclosure in the Companys consolidated financial statements.
History and Key Developments
Qualifying Transaction
On December 20, 2013 the Company entered into an amalgamation agreement (the Amalgamation Agreement ) and completed its qualifying transaction pursuant to the policies of the TSX Venture Exchange (the Qualifying Transaction ). The Qualifying Transaction proceeded by way of a three-cornered amalgamation among Mercari Acquisition Corp. ( Mercari ), a capital pool company listed on the NEX board of the TSX Venture Exchange, Mercari Subco Inc., a wholly-owned subsidiary of Mercari, and Concordia Healthcare Inc. ( CHI ), a private Ontario corporation incorporated on December 5, 2012. On December 18, 2013, and prior to the completion of the Qualifying Transaction, Mercari changed its name to Concordia Healthcare Corp. and completed a consolidation of its share capital on a basis of one post-consolidation common share for every 48.08 common shares existing immediately before the consolidation. The Qualifying Transaction resulted in a reverse takeover of Mercari by the shareholders of CHI.
Immediately upon completion of the Qualifying Transaction, the shareholders of CHI held 98.5% of the shares of the amalgamated corporation, and for accounting purposes CHI was deemed the acquirer. The Qualifying Transaction constituted a reverse takeover but did not meet the definition of a business combination under IFRS 3; accordingly the Company has accounted for the transaction in accordance with IFRS 2. The assets and liabilities of Mercari have been included in the Companys consolidated balance sheet at fair value, which approximate their pre-combination carrying values.
Mercaris shares were delisted from the NEX board of the TSX Venture Exchange. Concordias shares were listed for trading on the Toronto Stock Exchange (the TSX ) under the symbol CXR on December 24, 2013.
Financings and Acquisitions
Term and Credit Facilities
On May 6, 2013, CHI entered into two loan and security agreements: (1) a loan under a senior loan agreement (the Senior Loan Agreement ) in the principal amount of $19.0 million bearing interest at 12% per annum, calculated daily, maturing on October 30, 2015 with interest paid monthly in arrears, and (2) two loans under a subordinate loan agreement (the Subordinate Loan Agreement ) in the aggregate principal amount of $5.15 million bearing interest at 18% per annum, calculated daily, maturing on October 30, 2015 with interest paid monthly in arrears only if the loan under the Senior Loan Agreement was repaid. The Senior Loan Agreement included a working capital loan of $3.0 million where the interest rate was 12% per annum. The working capital loan was repaid and cancelled on August 7, 2013. On March 28, 2014 the Company repaid in full its senior and subordinate debt.
[7]
On September 19, 2013, the Company entered into a senior secured revolving credit facility (the Revolving Facility ) in the principal amount of $3.0 million. The Company did not draw on the Revolving Facility and cancelled it on May 13, 2014.
On May 14, 2014, the Company entered into a secured credit facility with GE Capital Canada Finance, Inc. and a syndicate of lenders having a principal amount of up to US$195 million, consisting of a $170 million term loan and a $25 million revolving credit facility. On September 30, 2014, the Company amended and restated the secured credit facility entered into on May 14, 2014 whereby incremental term loans of $95 million were added to the secured credit facility (the Credit Facility ). The Credit Facility bears a variable interest rate and matures on October 1, 2020 with fixed repayments required over the term to maturity, as well as mandatory repayments based on excess cash flow generated by the Company as defined in the Credit Facility, calculated annually. Interest rates are calculated at the U.S. Prime Rate or LIBOR plus applicable margins based on a leverage table. The Credit Facility is secured by the assets of the Company, and the assets of the Companys material subsidiaries.
Private Placements
On May 5, 2013, CHI completed a private placement of 6,000,000 common shares at a price of $1.00 per share. Total proceeds from the transaction were $6 million.
On various dates in August of 2013, CHI completed private placements of a total of 1,166,666 shares at a price of $3.00 per share. Total proceeds from the transactions were $3.5 million.
On December 19, 2013, CHI completed a private placement (the Private Placement ) of subscription receipts (the Subscription Receipts ) conducted by a syndicate of agents. Pursuant to the Private Placement, CHI issued 5,520,000 Subscription Receipts at a price of $6.25 Canadian Dollars ( CAD ) per Subscription Receipt for total gross proceeds to CHI of CAD $34.5 million. Each Subscription Receipt was exchanged for one common share of CHI, which common shares were then exchanged for common shares of the Company on a one-for-one basis pursuant to the Qualifying Transaction.
Public Offerings
On March 11, 2014, the Company announced the completion of a short-form prospectus offering, on a bought deal basis, of 5,750,000 common shares of Concordia, which included the exercise by the underwriters of an over-allotment option of 15%, for aggregate gross proceeds of CAD $67,562,500. Net proceeds to the Company, after the deduction of underwriters fees, were CAD $63,508,750.
This offering was completed at a price per common share of CAD $11.75 by a syndicate of underwriters co-led by GMP Securities L.P. and Canaccord Genuity Corp. and including Barclays Capital Canada Inc., Beacon Securities Limited and Cormark Securities Inc.
Acquisitions
Concordia Pharmaceuticals Inc. ( CPI ), a subsidiary of the Company, acquired legacy pharmaceutical business assets from Shionogi Inc. ( Shionogi ) on May 6, 2013 (the Shionogi Transaction ). These legacy pharmaceutical assets are comprised of three FDA approved drugs: Kapvay ® , which is used to treat Attention Deficit Hyperactivity Disorder, Ulesfia ® , which is a topical treatment for pediculosis (head lice), and Orapred ® , an anti-inflammatory used in the treatment of certain pulmonary diseases such as asthma. The purchase price paid to Shionogi was $28.7 million and included $25.6 million paid for the products, $2.3 million paid for inventory including raw material, work in process and finished goods and $0.8 million in contingent consideration, subject to meeting certain performance metrics.
Concordia Healthcare (USA) Inc. ( CHUSA ), a subsidiary of the Company, acquired its specialty healthcare distribution business assets from Global Medical Direct LLC and affiliated entities (collectively, Global ) on October 25, 2013 with an effective date of August 1, 2013 (the Global Transaction ). The
[8]
Companys specialty healthcare distribution business is a United States national Internet and mail-order provider of diabetes testing supplies, pharmaceuticals, diabetic shoes, orthotic braces and other home medical equipment. This business also includes a full-service pharmacy with full fulfillment capacity and can ship medications across the United States. The Company acquired the specialty healthcare distribution business for total consideration of $13.2 million comprised of $5.0 million in cash, a vendor note with a fair value on the date of acquisition of $5.6 million and an additional earn-out payment with an estimated present value on the date of acquisition of $2.6 million payable in common shares of the Company subject to meeting certain performance metrics. In addition, 1 million common shares of the Company at US$3.00 per share were issued as finders fees in connection with the acquisition of the SHD Division.
On November 8, 2013, CHI and certain of its affiliates entered into an agreement to acquire 100% of the shares of Pinnacle Biologics Inc. ( Pinnacle ) for total consideration of $58.0 million (the Pinnacle Transaction ) comprised of $32.7 million of cash consideration, $5.0 million of CHIs common shares issued at a price of $5.63 per common share (being a 10% discount to the CAD $6.25 price per Subscription Receipt issued as part of the Private Placement, 10 annual cash payments with an estimated present value of $5.0 million and milestone and other contingency payments with an estimated value of $15.3 million. The acquisition of Pinnacle closed on December 20, 2013. The acquisition of Pinnacle was financed through available cash, which included net proceeds of CAD $34.5 million received by the Company through the Private Placement of Subscription Receipts of CHI, which closed on December 19, 2013. Pinnacles Photofrin ® , now owned by CLI, a subsidiary of the Company, is FDA approved for the treatment of three rare forms of cancer.
On March 19, 2014, the Company, through its subsidiary CPI, entered into a definitive agreement to acquire Donnatal ® , an adjunctive therapy in the treatment of irritable bowel syndrome ( IBS ) and acute enterocolitis, from a privately held specialty pharmaceutical company carrying on business as Revive Pharmaceuticals ( Revive Pharmaceuticals ). The acquisition of Donnatal ® closed on May 15, 2014.
CPI acquired Donnatal ® for $200 million in cash and an aggregate of 4,605,833 common shares of Concordia, representing approximately 16.17% of the Companys outstanding common shares on a non-diluted basis (approximately 14.96% on a fully-diluted basis) as at the date of acquisition and after giving effect to the acquisition.
The Company paid for the cash component of the acquisition through a combination of available cash and debt financing from the Credit Facility.
On September 30, 2014, the Company, through its subsidiary CPI, completed the purchase of Zonegran ® for commercialization and sale in the United States, including Puerto Rico, from Eisai Inc., pursuant to the terms and conditions of a definitive agreement entered into as of September 3, 2014. Zonegran ® is an adjunctive therapy in the treatment of partial seizures in adults with epilepsy.
CPI acquired Zonegran ® for $91.4 million in cash, which included approximately $1.4 million for purchased inventory. CPI paid for the acquisition through debt financing from the Credit Facility.
On October 1, 2014 Concordia Laboratories Inc. ( CLI ), a subsidiary of the Company incorporated in Barbados, acquired certain intellectual property from Pinnacle, a subsidiary of the Company incorporated in the United States. The inter-company sale of the intellectual property triggered a cash tax liability of $13.5 million, which was paid by the Company in the first quarter of 2015.
Recent Events
On March 9, 2015, Concordia announced that it and CPI had entered into a definitive asset purchase agreement (the Covis Asset Purchase Agreement ) to acquire substantially all of the commercial assets of privately held Covis Pharma S.à.r.l and Covis Injectables, S.à.r.l (together Covis ) for $1.2 billion in cash. The Covis drug portfolio being acquired (the Portfolio ) consists of 18 branded and authorized generic products. The Portfolio includes branded pharmaceuticals, injectables and authorized generics that
[9]
address medical conditions in various therapeutic areas including cardiovascular, central nervous system, oncology and acute care markets.
The acquisition is structured as an all-cash transaction with a purchase price of $1.2 billion for the Portfolio. The Company plans to pay for the acquisition through the net proceeds of the 2015 Offering (as defined below) and debt financing. Accordingly, the Company has entered into a commitment letter (the Commitment Letter ) with Royal Bank of Canada ( RBC ), pursuant to which, RBC has agreed to provide senior secured credit facilities on the closing date of the acquisition of the Portfolio (the Acquisition Closing Date ) in an aggregate principal amount of up to $750 million comprising of: (1) a senior secured revolving credit facility in an aggregate principal amount of up to $100 million and (ii) a senior secured term loan facility in an aggregate principal amount of up to $650 million (together the RBC Facilities ). All obligations of the Company under the RBC Facilities will be guaranteed by all material subsidiaries of the Company and secured by first priority (subject to permitted liens) perfected security interests in the assets of the Company and the assets of and equity interests in its material subsidiaries.
In addition, RBC has agreed to provide the Company: (i) a senior unsecured bridge facility (the Bond Bridge Facility ) on the Acquisition Closing Date in an aggregate principal amount of up to $710 million less the aggregate gross proceeds provided by any senior unsecured notes and gross proceeds in excess of $150 million provided by any new equity issued by the Company, including the 2015 Subscription Receipts (as defined below) to be issued under the 2015 Offering, on or prior to the Acquisition Closing Date; and (ii) a senior unsecured equity bridge facility (the Equity Bridge Facility ) on the Acquisition Closing Date in an aggregate principal amount of up to $150 million less the aggregate amount of any new equity issued by the Company, including the 2015 Subscription Receipts to be issued under the 2015 Offering, on or prior to the Acquisition Closing Date (collectively with the RBC Facilities, the RBC Credit Facilities ). All obligations of the Company under the Bond Bridge Facility and the Equity Bridge Facility will be guaranteed by all material subsidiaries of the Company. The RBC Credit Facilities are subject to the completion of definitive documentation which will contain customary representations and warranties and restrictive covenants for facilities of this nature.
On March 17, 2015, the Company announced that it had entered into a letter agreement with RBC Dominion Securities Inc., as sole bookrunner and co-lead manager, and GMP Securities L.P. as co-lead manager (and together with RBC Dominion Securities Inc. and other underwriters who may join the syndicate, the 2015 Underwriters), pursuant to which the 2015 Underwriters agreed to purchase, on a bought deal basis, 3,764,720 subscription receipts of the Company (the 2015 Subscription Receipts) at a price of CAD$85.00 per 2015 Subscription Receipt (the Offering Price) for aggregate gross proceeds to the Company of CAD$320 million (the 2015 Offering). Each 2015 Subscription Receipt will entitle the holder thereof to receive, upon the closing of the acquisition of the Portfolio, without payment of additional consideration or further action, one common share of the Company in exchange for each 2015 Subscription Receipt. In connection with the 2015 Offering, the Company agreed to grant the 2015 Underwriters an over-allotment option to purchase up to an additional 564,708 2015 Subscription Receipts at the Offering Price, exercisable in whole or in part, at any time up to 30 days following the closing of the 2015 Offering (so long as the Covis Asset Purchase Agreement has not been terminated before or by such time or it has been announced that the acquisition of the Portfolio will not be completed). If this option is exercised in full, an additional CAD$48 million will be raised pursuant to the 2015 Offering and the aggregate gross proceeds will be CAD$368 million. The 2015 Underwriters will receive, as consideration for their services, a commission equal to 4% of the aggregate gross proceeds payable to the Company in respect of the 2015 Offering. Net proceeds are expected to be used, in part, to fund the acquisition of the Portfolio.
Selected Annual Financial Information
The following table sets forth selected financial information for Concordia as at December 31, 2014 and 2013:
[10]
2014 | 2013 | |||||||
Revenue |
122,191 | 40,447 | ||||||
Gross profit |
104,202 | 32,109 | ||||||
Operating income |
45,873 | 13,985 | ||||||
Net income |
11,590 | 2,431 | ||||||
Basic EPS |
$ | 0.45 | $ | 0.38 | ||||
Diluted EPS |
$ | 0.43 | $ | 0.38 | ||||
Adjusted EPS (1) |
$ | 1.88 | $ | 2.23 | ||||
Total assets |
592,700 | 170,765 | ||||||
Total liabilities |
335,150 | 109,243 | ||||||
EBITDA (1) |
42,476 | 9,376 | ||||||
Adjusted EBITDA (1) |
64,009 | 21,169 |
Notes:
(1) | Represents a non-IFRS measure. For the relevant definitions and reconciliation to reported results, see Non-IFRS Financial Measures. |
Concordias operating results reflect the Companys growth through strategic acquisitions in 2013 and 2014. Revenues, gross profit and operating income, and total assets for the current year were greater than the prior year primarily due to the contribution from Donnatal ® commencing from the second quarter of 2014 and Zonegran ® in the fourth quarter of 2014.
The corresponding sequential increases in total liabilities in 2014 reflect the impact of additional debt financing to fund acquisitions. The Company added $170.0 million of debt in the second quarter and an additional $95.0 million of debt in the third quarter pursuant to the Credit Facility.
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Selected Quarterly Financial Information
The following table sets forth selected unaudited financial information for Concordia as at December 31, 2014 and for the previous six quarters:
Q4-2014 | Q3-2014 | Q2-2014 | Q1-2014 | Q4-2013 | Q3-2013 | Q2-2013 | ||||||||||||||||||||||
Revenue |
42,896 | 36,432 | 26,053 | 16,810 | 16,684 | 14,725 | 9,038 | |||||||||||||||||||||
Gross profit |
37,811 | 31,936 | 21,499 | 12,956 | 12,628 | 12,147 | 7,334 | |||||||||||||||||||||
Operating income |
23,335 | 14,868 | 2,731 | 4,939 | 292 | 7,897 | 5,796 | |||||||||||||||||||||
Net income (Loss) |
3,718 | 10,535 | (827 | ) | (1,836 | ) | (7,083 | ) | 5,364 | 4,150 | ||||||||||||||||||
Cash |
42,770 | 30,945 | 32,708 | 77,973 | 42,899 | 23,426 | 14,100 | |||||||||||||||||||||
Total assets |
592,700 | 587,323 | 490,135 | 194,146 | 170,765 | 79,370 | 50,171 | |||||||||||||||||||||
Total liabilities |
335,150 | 332,314 | 246,010 | 76,045 | 109,243 | 59,727 | 40,021 | |||||||||||||||||||||
EBITDA (1) |
23,007 | 14,272 | 1,651 | 3,546 | (4,320 | ) | 7,908 | 5,788 | ||||||||||||||||||||
Adjusted EBITDA (1) |
25,406 | 20,259 | 12,441 | 5,903 | 6,818 | 8,555 | 5,796 | |||||||||||||||||||||
Earnings (Loss) per share |
||||||||||||||||||||||||||||
Basic |
$ | 0.13 | $ | 0.37 | $ | (0.03 | ) | $ | (0.09 | ) | $ | (1.12 | ) | $ | 0.66 | $ | 2.52 | |||||||||||
Diluted |
$ | 0.12 | $ | 0.35 | $ | (0.03 | ) | $ | (0.09 | ) | $ | (1.12 | ) | $ | 0.61 | $ | 1.18 | |||||||||||
Adjusted (1) |
$ | 0.74 | $ | 0.57 | $ | 0.38 | $ | 0.05 | $ | 0.40 | $ | 0.69 | $ | 1.18 |
Notes:
(1) | Represents a non-IFRS measure. For the relevant definitions and reconciliation to reported results see Non-IFRS Financial Measures. |
The increase in revenue, gross profit and operating income over the past several quarters is driven primarily by the Companys acquisitions of Donnatal ® in the second quarter of 2014 and Zonegran ® at the end of the third quarter of 2014.
Fourth quarter 2014 results include the addition of revenue, gross profit and operating income related to Zonegran ® .
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Results of Operations
The following table sets forth the audited consolidated results of operations of the Company for the years ended December 31, 2014 and 2013:
2014 | 2013 | |||||||
Revenue |
$ | 122,191 | $ | 40,447 | ||||
Cost of sales |
17,989 | 8,338 | ||||||
|
|
|
|
|||||
Gross profit |
104,202 | 32,109 | ||||||
|
|
|
|
|||||
Operating expenses |
||||||||
General and administrative |
20,663 | 6,545 | ||||||
Business acquisition related costs |
13,521 | 3,692 | ||||||
Selling and marketing |
10,229 | 2,464 | ||||||
Research and development |
9,301 | 1,931 | ||||||
Share based compensation |
4,484 | 1,070 | ||||||
Depreciation expense |
131 | 18 | ||||||
Exchange listing expenses |
| 2,404 | ||||||
|
|
|
|
|||||
Total operating expenses |
58,329 | 18,124 | ||||||
|
|
|
|
|||||
|
||||||||
|
|
|
|
|||||
Operating income |
45,873 | 13,985 | ||||||
|
|
|
|
|||||
Other income and expense |
||||||||
Interest expense |
12,194 | 6,382 | ||||||
Amortization of intangible assets |
11,039 | 120 | ||||||
Change in fair value of contingent consideration |
2,629 | | ||||||
Foreign exchange loss |
696 | 129 | ||||||
Other (income) expense |
203 | (150 | ) | |||||
Change in fair value of convertible warrants |
| 4,648 | ||||||
|
|
|
|
|||||
Profit before tax |
19,112 | 2,856 | ||||||
|
|
|
|
|||||
Income taxes |
||||||||
Current |
14,756 | 502 | ||||||
Recovery |
(7,234 | ) | (77 | ) | ||||
|
|
|
|
|||||
Net income |
$ | 11,590 | $ | 2,431 | ||||
|
|
|
|
|||||
EBITDA (1) |
$ | 42,476 | $ | 9,376 | ||||
Adjusted EBITDA (1) |
$ | 64,009 | $ | 21,169 |
Notes:
(1) | Represents a non-IFRS measure. For the relevant definitions and reconciliation to reported results, see Non-IFRS Financial Measures. |
[13]
Factors Affecting Results from Operations 2014 vs. 2013
Revenue and Gross Profit
The following table sets forth audited revenue and gross profit by operating segment for the year ended December 31, 2014 and 2013:
Legacy
Pharmaceuticals |
Orphan
Drugs |
Specialty
Healthcare Distribution |
Total | |||||||||||||
Year ended December 31, 2014 |
||||||||||||||||
Revenue |
$ | 94,277 | $ | 10,664 | $ | 17,250 | $ | 122,191 | ||||||||
Cost of sales (including royalties) |
12,784 | 1,857 | 3,348 | 17,989 | ||||||||||||
|
|
|
|
|
|
|
|
|||||||||
Gross profit |
$ | 81,493 | $ | 8,807 | $ | 13,902 | $ | 104,202 | ||||||||
|
|
|
|
|
|
|
|
|||||||||
Year ended December 31, 2013 |
||||||||||||||||
Revenue |
$ | 36,884 | $ | 10 | $ | 3,553 | $ | 40,447 | ||||||||
Cost of sales (including royalties) |
7,391 | 34 | 913 | 8,338 | ||||||||||||
|
|
|
|
|
|
|
|
|||||||||
Gross profit |
$ | 29,493 | (24 | ) | $ | 2,640 | $ | 32,109 | ||||||||
|
|
|
|
|
|
|
|
Legacy Pharmaceuticals Division
Legacy Pharmaceuticals Division revenue in 2014 was $94.3 million, compared to $36.9 million in 2013. The additions of Donnatal ® and Zonegran ® in the second and third quarters of 2014, respectively, accounted for the majority of the increase in revenue over the prior year. In addition, revenue in 2014 reflects a full year of revenue from the legacy pharmaceutical assets acquired from Shionogi, compared to less than three quarters of revenue in 2013. The impact of the additions of Donnatal ® and Zonegran ® was partially offset by the expected decline in revenue from Kapvay ® due to the loss of exclusivity on the product in the fourth quarter of 2013.
Gross profit for the Legacy Pharmaceuticals Division in 2014 was $81.5 million compared to $29.5 million in the prior year. The increase of $52.0 million was primarily due to sales growth in the division, with the acquisition of Donnatal ® and Zonegran ® accounting for the majority of the increase.
Cost of sales for 2014 and 2013 were $12.8 million and $7.4 million, respectively, and reflect the costs of active pharmaceutical ingredients, excipients, packaging, freight costs and royalties. Legacy Pharmaceuticals Division gross margin in 2014 was 86.4% compared with 80.0% in 2013. The increase in gross margin is primarily driven by Donnatal ® and Kapvay ® .
Orphan Drugs Division
Net revenues for the Orphan Drugs Division were $10.7 million and $0.01 million for the year ended December 31, 2014 and December 31, 2013, respectively. Revenue in 2014 reflects a full four quarters of operations compared to less than 10 days of results in 2013. Revenue for the Orphan Drugs Division represents the sales of Photofrin ® , Ethyol ® , lasers and fibers. Orphan Drugs revenue for 2014 was impacted in the second quarter of 2014 by a reduction in end user inventory of Photofrin ® as hospitals continued to optimize inventory holdings and by a product expiry issue which required the Company to replace certain channel inventory at no cost.
Cost of sales for 2014 was $1.9 million, which includes a reversal of a take or pay provision of $0.6 million in the second quarter of 2014. During the second quarter the Company, in consultation with external advisors, determined that it did not have an obligation to pay its manufacturer for the provision.
[14]
Gross profits were $8.8 million for the year ended December 31, 2014 compared to a loss of $0.024 million in December 31, 2013.
Specialty Healthcare Distribution Division
Net revenues for the SHD Division were $17.3 million and $3.6 million for the year ended December 31, 2014 and December 31, 2013, respectively, and related primarily to sales and distribution of diabetes testing supplies and orthotics for diabetic patients. Revenue in 2014 reflects a full four quarters of operations compared to two months of operations in 2013.
Costs of sales for 2014 were $3.3 million and $0.9 million for 2013 and related to the cost of products, warehousing and freight.
Gross profits were $13.9 million and $2.6 million for year ended December 31, 2014 and December 31, 2013, respectively.
General and Administrative Expenses
General and administrative expenses reflect the costs related to salaries and benefits, professional and consulting fees, public company costs, transition services agreement expenses, travel, facility leases and other administrative expenditures.
General and administrative expenses increased from $6.5 million in 2013 to $20.7 million in 2014. The increase of $14.2 million was partially driven by full year impact of the Orphan Drugs and SHD Divisions, which together had general and administrative expenses of $10.2 million during 2014 compared with $1.7 million in the prior year. The remainder of the increase is driven by the full year impact of general and administrative spending in the Legacy Pharmaceuticals Division and at the corporate level.
Selling and Marketing Expenses
Selling and marketing expenses reflect costs incurred by the Company for the marketing, promotion and selling of the Companys portfolio of products across the Legacy Pharmaceuticals, Special Healthcare Distribution and Orphan Drugs divisions.
Selling and marketing expenses increased from $2.5 million in 2013 to $10.2 million in 2014. The increase of $7.7 million was primarily driven by full year impact of the SHD and Orphan Drugs divisions, which together incurred selling and marketing expenses of $4.0 million in 2014 compared with $0.6 million in 2013. Selling and marketing expenses also increased in the Legacy Pharmaceuticals division by $4.4 million, primarily driven by transition service costs related to the acquisition of Donnatal ® .
Research and Development Expenses
Research and development expenses reflect costs for clinical trial activities, product development, professional and consulting fees and services associated with the activities of the medical, clinical and scientific affairs in addition to quality assurance costs and regulatory compliance and drug safety costs (Pharmacovigilence) of the Company.
Research and development expenses increased from $1.9 million in 2013 to $9.3 million in 2014. The increase of $7.4 million was primarily driven by full year impact of the Orphan Drugs Division, which had research and development expenses of $7.2 million during 2014. This included spending of $3.5 million for the Phase 3 clinical trial to expand the indication of Photodynamic ( PDT ) therapy with Photofrin ® for the treatment of cholangiocarcinoma. The remainder of the increase is driven by the overall expansion of the Companys Legacy Pharmaceuticals division.
[15]
Share Based Compensation
Share based compensation expense for the year ended December 31, 2014 and 2013 were $4.5 million and $1.1 million, respectively, and relates to the fair value of share based option awards to management and directors of the Company.
The Company issued 915,000 options to management and employees during 2014.
The fair value is calculated using the Black-Scholes option-pricing model. Assumptions that affect the application of the fair value model include the determination of volatility of the Companys common shares, risk-free interest rate and the life of the options issued.
Business Acquisition Related Costs
Business acquisition related costs for year ended December 31, 2014 were $13.5 million compared to $3.7 million for year ended December 31, 2013. Business acquisition related costs include legal, accounting, advisory and professional fees directly incurred by the Company. In 2014 these costs were primarily driven by the acquisitions of Donnatal ® , Zonegran ® and inter-company sale of intellectual property from Pinnacle to CLI.
Interest Expense
Interest expense for the year ended December 31, 2014 and December 31, 2013 was $12.2 million and $6.4 million, respectively, and relate primarily to interest and accretion interest incurred on the Companys Credit Facility as described above. In the first quarter of 2014 the Company incurred interest and accretion expense of $4.7 million, which included minimum interest payments related to the early retirement of the Companys Senior Loan Agreement and Subordinate Loan Agreement.
Change in Fair Value of Contingent Consideration
The change in the fair value of contingent consideration expensed during the year ended December 31, 2014 was $2.7 million. The expense is primarily driven by the change in the present value of contingent consideration due to the previous owners of Pinnacle for milestone and earn-out payments related to the clinical trial and worldwide sales of Photofrin ® . During the second quarter of 2014, the Company also increased its estimated payment to Shionogi for earn out payments related to quarterly sales of Kapvay ® by $0.4 million.
In 2013 the Company did not recognize any expense related to the change in fair value of contingent consideration primarily due to the fact that the valuations of contingent consideration related to the Shionogi, Pinnacle and Global transactions were finalized in the third and fourth quarters of 2013.
Amortization of Intangible Assets
Amortization of intangible assets during the year ended December 31, 2014 was $11.0 million and related to the amortization of acquired product rights, a customer list and intellectual property.
Amortization related to acquired product rights was $8.7 million for the year ended December 31, 2014. In the fourth quarter of 2014 the Company finalized the valuation and associated purchase price allocation of intangible assets related to both the acquisitions of Donnatal ® and Zonegran ® . The Company estimates that the useful lives of the product rights acquired as part of the Donnatal ® and Zonegran ® transactions are 30 years and 15 years, respectively. In conjunction with this valuation process, the Company assessed the useful life of its intangible assets and changed the estimated useful life of intangible assets acquired as part of the Shionogi Transaction in May of 2013 from indefinite life to useful lives ranging from 15 to 20 years. The Company amortizes acquired product rights on a straight-line basis over their estimated useful lives.
[16]
Amortization related to the customer list acquired as part of the Global Transaction was $0.68 million in 2014. The customer list is amortized on a straight-line basis over an estimated useful life of 4 years and 5 months. Amortization related to the intellectual property acquired as part of the Pinnacle Transaction was $1.6 million in 2014. The intellectual property is amortized on a straight-line basis over an estimated useful life of 20 years. No amortization was recorded in 2013 because Pinnacle was acquired on December 20, 2013. Amortization of intangible assets was $0.1 million in 2013 and related solely to 2 months of amortization on the customer list acquired as part of the Global Transaction as described above.
Foreign Exchange Loss
The foreign exchange loss for year ended December 31, 2014 was $0.7 million and was primarily due to the charge related to the conversion of the proceeds of the March 2014 equity raise from Canadian to US dollars. The loss was incurred in the first quarter of 2014.
Factors Affecting Results from Operations - Q4-2014 vs. Q4-2013
The following table sets forth selected unaudited financial information for Concordia as at December 31, 2014 and for the December 31, 2013:
Q4-2014 | Q4-2013 | |||||||
Revenue |
42,896 | 16,684 | ||||||
Gross profit |
37,811 | 12,628 | ||||||
Operating income |
23,335 | 292 | ||||||
Net income (Loss) |
3,718 | (7,083 | ) | |||||
Cash |
42,770 | 42,899 | ||||||
Total assets |
592,700 | 170,765 | ||||||
Total liabilities |
335,150 | 109,243 | ||||||
EBITDA (1) |
23,007 | (4,320 | ) | |||||
Adjusted EBITDA (1) |
25,406 | 6,818 | ||||||
Earnings (Loss) per share |
||||||||
Basic |
$ | 0.13 | $ | (1.12 | ) | |||
Diluted |
$ | 0.12 | $ | (1.12 | ) | |||
Adjusted (1) |
$ | 0.74 | $ | 0.40 |
The following table sets forth audited revenue and gross profit by operating segment for the three months ended December 31, 2014 and 2013:
[17]
Legacy
Pharmaceuticals |
Orphan
Drugs |
Specialty
Healthcare Distribution |
Total | |||||||||||||
Three months ended December 31, 2014 |
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Revenue |
$ | 36,200 | $ | 3,287 | $ | 3,409 | $ | 42,896 | ||||||||
Cost of sales (including royalties) |
3,580 | 783 | 722 | 5,085 | ||||||||||||
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Gross profit |
$ | 32,620 | $ | 2,504 | $ | 2,687 | $ | 37,811 | ||||||||
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Three months ended December 31, 2013 |
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Revenue |
$ | 13,121 | $ | 10 | $ | 3,553 | $ | 16,684 | ||||||||
Cost of sales (including royalties) |
3,109 | 34 | 913 | $ | 4,056 | |||||||||||
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Gross profit |
$ | 10,012 | (24 | ) | $ | 2,640 | $ | 12,628 | ||||||||
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Legacy Pharmaceuticals Division
Legacy Pharmaceuticals Division revenue for the three months ended December 31, 2014 was $36.2 million, compared to $13.1 million in same quarter of 2013. The additions of Donnatal ® and Zonegran ® in the second and third quarters of 2014, respectively, accounted for the majority of the increase in revenue over the same quarter in the prior year.
Gross profit for the Legacy Pharmaceuticals Division for the three months ended December 31, 2014 was $32.6 million compared to $10.0 million in the same quarter of the prior year. The increase of $22.6 million was primarily due to sales growth in the division, with the acquisitions of Donnatal ® and Zonegran ® accounting for the majority of the increase.
Cost of sales for the three months ended 2014 and 2013 were $3.6 million and $3.1 million, respectively, and reflect the costs of active pharmaceutical ingredients, excipients, packaging, freight costs and royalties. Legacy Pharmaceuticals Division gross margin in the three months ended 2014 was 90.1% compared with 76.3% in the same quarter of 2013. The increase in gross margin is primarily driven by Donnatal ® and Kapvay ® .
Orphan Drugs Division
Net revenues for the Orphan Drugs Division were $3.3 million and $0.01 million for the three months ended December 31, 2014 and 2013, respectively. Revenue in 2014 reflects a full quarter of operations compared to less than 10 days of results in 2013. Revenue for Orphan Drugs Division represents the sales of Photofrin ® , Ethyol ® , lasers and fibers.
Cost of sales for the three months ended December 31, 2014 was $0.8 million, compared to $0.03 million in the same quarter of 2013.
Gross profits were $2.5 million for the three months ended December 31, 2014 compared to a loss of $0.024 million in December 31, 2013.
Specialty Healthcare Distribution Division
Net revenues for the Specialty Healthcare Distribution division were $3.4 million and $3.5 million for the three months ended 31, 2014 and 2013, respectively, and related primarily to sales and distribution of diabetes testing supplies and orthotics for diabetic patients.
Costs of sales for the three months ended 2014 were $0.7 million and $0.9 million for 2013 and related to the cost of products, warehousing and freight.
[18]
Gross profits were $2.7 million and $2.6 million for three months ended December 31, 2014 and December 31, 2013, respectively.
Financial Position
The following table presents a summary of Companys financial position as at December 31, 2014 and December 31, 2013:
As at
December 31, 2014 |
As at
December 31, 2013 |
Change |
||||||||||||||
$ | % | |||||||||||||||
Working capital |
$ | 49,090 | $ | 15,644 | $ | 33,446 | 213.8 | % | ||||||||
Long-lived assets |
508,048 | 98,417 | 409,631 | 416.2 | % | |||||||||||
Other current liabilities |
46,247 | 19,401 | 26,846 | 138.4 | % | |||||||||||
Long-term liabilities |
253,341 | 33,138 | 220,203 | 664.5 | % | |||||||||||
Shareholders equity |
257,550 | 61,522 | 196,028 | 318.6 | % |
Working capital
Concordia defines working capital as current assets less accounts payable, accrued liabilities, provisions and royalties payable. The $33.4 million increase in working capital from December 31, 2013 to December 31, 2014 is primarily due to the following:
| $18.8 million decrease in accounts payable and accrued liabilities due to timing of payments to vendors and service providers for the year ended December 31, 2014. |
| $2.4 million decrease in provision due to payments made in 2014 that related to sales provisions recorded in 2013. |
| $6.3 million increase in accounts receivable primarily driven by increase in revenue from Donnatal ® and Zonegran ® . |
| $3.4 million increase in prepaid expenses and other current assets primarily driven by advanced funding of clinical trial costs and manufacturing deposits. |
| $2.7 million increase in inventory due to the additions of Donnatal ® and Zonegran ® in 2014. |
Offset by:
| $0.1 million decrease in cash primarily driven by cash outflow from operating activities. |
Long-lived assets
Long-lived assets consist of fixed assets, intangible assets and goodwill.
Fixed assets consist of computers, leasehold improvements and equipment. The net book value of fixed assets increased from $0.4 million as at December 31, 2013 to $0.8 million as at December 31, 2014. The increase of $0.4 million was primarily due to net additions of $0.3 million mostly relating to equipment and office furniture offset by depreciation of $0.01 million.
Intangible assets consist of acquired product rights, customer lists, intellectual property and goodwill. Intangible assets increased from $61.7 million as at December 31, 2013 to $470.2 million as at December 31, 2014. The increase was driven by $419.6 million in acquired product rights as part of the Donnatal ® and Zonegran ® acquisitions, offset by $8.7 million of amortization during the year.
Goodwill increased by $0.1 million to $36.3 million at December 31, 2014, which was due to the goodwill recognized upon the acquisition of Donnatal ® . The carrying value of goodwill is reviewed at year end to
[19]
determine if any indications of impairment exist. As at December 31, 2014, there was no impairment loss recognized.
Other current liabilities
Other current liabilities consist of dividends payable, taxes payable and the current portions of notes payable, long-term debt and purchase consideration payable.
Taxes payable increased from $1.0 million as at December 31, 2013 to $13.3 million as at December 31, 2014. The increase of $12.3 million is primarily driven by estimated tax liability of $13.5 million on the sale of certain intellectual property from Pinnacle to CLI.
Senior and subordinate debt of $15.0 million as at December 31, 2013 was repaid in full on March 28, 2014.
Long-term obligations
Long-term obligations consist of long-term debt, notes payable and purchase consideration payable, and deferred taxes.
On May 14, 2014, the Company entered into the Credit Facility of $170.0 million to partially finance the acquisition of Donnatal ® . The Credit Facility bears a variable interest rate that is calculated at the U.S. Prime Rate or LIBOR plus applicable margins. On September 30, 2014, the Company amended the Credit Facility to facilitate the acquisition of Zonegran ® for commercialization and sale in the United States, including Puerto Rico. An incremental term loan of $95.0 million was added to the Credit Facility solely for the acquisition of Zonegran ® and related expenses. On October 1, 2014, the Company made a principal payment of $4.25 million.
Purchase consideration payable represents the contingent and non-contingent payments in connection with the Shionogi, Global and Pinnacle transactions. The increase of $1.4 million in purchase consideration payable relates to the acquisition of Pinnacle. As part of the consideration for the acquisition of Pinnacle, the Company is obligated to pay additional payments of up to $5.0 million based on the achievement of certain milestones related to clinical trials. The Company is also obligated to pay additional earn-out payments equal to 15% of worldwide sales of Photofrin ® in excess of $25.0 million over the 10 calendar years following the Companys acquisition of Pinnacle. The Company recorded a contingent obligation of $17.1 million at December 31, 2014 ($15.3 million at December 31, 2013). During the fourth quarter of 2014, the Company made an annual payment of $1.0 million and a milestone payment of $0.5 million to the former owners of Pinnacle.
Shareholders equity
Shareholders equity increased from $61.5 million as at December 31, 2013 to $257.5 million as at December 31, 2014. The increase of $196.0 million primarily relates to:
| The Companys public offering of 5.75 million shares in the first quarter of 2014 resulting in net proceeds of $57.0 million and the issuance of approximately 4.6 million shares valued at $129.1 million as part of the purchase consideration for the acquisition of Donnatal ® in the second quarter of 2014. |
| $11.6 million in net income for the year of 2014. |
| Share based compensation of $4.5 million. |
| $2.4 million in proceeds received for the exercise of stock options. |
Offset by:
| $8.3 million in dividends. |
[20]
Liquidity and Capital Resources
Cash Flows
Management believes that ongoing operations and associated cash flow provide sufficient liquidity to support Concordias business operations for at least the next 12 months.
As at December 31, 2014, the Company held cash and cash equivalents of $42.7 million and had an additional $25.0 million available from the Credit Facility, which provides further flexibility to meet any unanticipated cash requirements.
Liquidity risk is the risk that the Company will encounter difficulty in meeting obligations associated with financial liabilities. The Company manages liquidity risk through the management of its capital structure. Accounts payable are all due within the current operating period.
In managing the Companys capital, Management estimates future cash requirements by preparing a budget and a multi-year plan for review and approval by the Companys board of directors (the Board of Directors ). The budget establishes the approved activities for the upcoming year and estimates the costs associated with those activities. The multi-year plan estimates future activity along with the potential cash requirements and is based upon Managements assessment of current progress along with the expected results from the coming years activity. Budget to actual variances are prepared and reviewed by Management and are presented quarterly to the Board of Directors.
The purpose of liquidity management is to ensure that there is sufficient cash to meet all the financial commitments and obligations of Concordia as they come due. Since inception Concordia has financed its cash requirements primarily through the issuances of securities, short-term borrowings, long-term debt as well as income from operations.
The below table sets forth the Companys net cash flows provided by and used in operating, investing and financing activities:
2014 | 2013 | |||||||
Net cash provided by operating activities |
13,458 | 49,863 | ||||||
Net cash used in investing activities |
(294,732 | ) | (59,366 | ) | ||||
Net cash provided by financing activities |
281,101 | 52,402 | ||||||
|
|
|
|
|||||
Increase (decrease) in Cash |
(173 | ) | 42,899 | |||||
|
|
|
|
|||||
Unrealised foreign exchange gain in cash and cash equivalents |
44 | | ||||||
Beginning Cash |
42,899 | | ||||||
|
|
|
|
|||||
Ending Cash |
42,770 | 42,899 | ||||||
|
|
|
|
Net Cash Provided by Operating Activities
Net cash provided by operating activities was $13.5 million for the year ended December 31, 2014. Adjustments to reconcile net income of $11.6 million to net cash flow from operating activities include:
| $11.2 million in depreciation and amortization expense; |
| $4.5 million in share based compensation expense; |
| $2.6 million related to change in fair value of contingent consideration; |
| $5.2 million related to income taxes not paid in cash during the year; and |
| $12.2 million related to interest and accretion expense. |
[21]
The above adjustments are offset by increases in operating assets of $9.6 million and decreases in operating liabilities of $24.3 million.
Net cash provided by operating activities was $49.9 million for the year ended December 31, 2013 and was driven by the operations of the Legacy Pharmaceuticals Division.
Net Cash Used in Investing Activities
Net cash used in investing activities was $294.7 million for the year ended December 31, 2014, and was primarily due to cash payments of:
| $200 million related to the acquisition of Donnatal ® ; |
| $91.4 million related to the acquisition of Zonegran ® ; and |
| $2.7 million related to contingent and other consideration payments related to the Shionogi Transaction and Pinnacle Transaction. |
Net cash used in investing activities was $59.4 million for the year ended December 31, 2013 and was primarily due to cash payments, net of cash acquired, of:
| $27.9 million related to the acquisition of three FDA approved drugs from Shionogi; |
| $3.6 million related to the Global Transaction; and |
| $27.8 million related to the acquisition of Pinnacle Transaction. |
Net Cash Provided by Financing Activities
Net cash provided by financing activities was $281.1 million for the year ended December 31, 2014 and was primarily driven by net proceeds from the issuance of debt of $256.4 million and net proceeds from the issuance of equity of $59.4 million. The above cash inflows from financing activities were partially offset by:
| Payments of $15.7 million for retirement of the Companys senior and subordinate debt; |
| $4.25 million in principal repayments related to the Companys credit facilities; |
| $8.1 million in cash interest paid; and |
| $6.1 million in dividends paid. |
Net cash provided by financing activities was $52.4 million for the year ended December 31, 2013 and was primarily driven by net proceeds from issuance of common stock of $39.1 million and proceeds from the Senior Loan Agreement and the Subordinate Loan Agreement of $21.15 million. The company made principal repayments against the Senior Loan Agreement of $5.4 million during the year ended December 31, 2013.
Indebtedness
Term and Credit Facilities
On May 14, 2014, the Company entered into the Credit Facility, as amended on September 30, 2014. (See Financings and Acquisitions Term and Credit Facilities above) The Credit Facility bears a variable interest rate and matures on October 1, 2020 with fixed repayments required over the term to maturity, as well as mandatory repayments based on excess cash flow generated by the Company as defined in the Credit Facility, calculated annually. Interest rates are calculated at the U.S. Prime Rate or LIBOR plus applicable margins based on a leverage table. The Credit Facility is secured by the assets of the Company, and the assets of the Companys material subsidiaries.
[22]
Notes Payable
As part of the consideration for the acquisition of the Global assets on October 25, 2013, the Company issued notes payable that have a fair value of $5.3 million as at December 31, 2014. The notes are unsecured, have a total face value of $7,000 and a coupon interest rate of 6%. The notes have been recorded at the present value of expected payments using a market representative interest rate at the time of issuance of 12% per annum. Principal repayments are due subject to the achievement of certain EBITDA thresholds by Complete Medical Homecare ( CMH ), a subsidiary of the Company. The company recorded principal payments of $0.5 million during the year ended 2014.
Non-Contingent Purchase Consideration
As part of the consideration for the acquisition of Pinnacle the Company is obligated to make 10 annual payments of $1 million, with the first payment due and paid on December 31, 2014. The obligation is subordinated and is not subject to interest. The Company has recorded an obligation of $5.1 million as at December 31, 2014, which represents the present value of required payments using a market representative interest rate of 15% at the time of the Pinnacle transaction. Upon the acquisition of Pinnacle the Company also assumed a liability related to purchase consideration, which had a value of $0.4 million as at December 31, 2014.
Contractual Obligations
The following table summarizes Concordias material contractual obligations as at December 31, 2014:
As at December 31, 2014 |
Total | 2015 | 2016 | 2017 | 2018 | 2019 | Thereafter | |||||||||||||||||||||
Finance lease obligation |
65 | 31 | 27 | 7 | | | | |||||||||||||||||||||
Operating leases |
3,454 | 717 | 685 | 632 | 509 | 386 | 525 | |||||||||||||||||||||
Notes payable |
6,200 | 1,000 | 1,200 | 1,400 | 1,600 | 1,000 | | |||||||||||||||||||||
Non-contingent purchase consideration |
9,000 | 1,000 | 1,000 | 1,000 | 1,000 | 5,000 | | |||||||||||||||||||||
Long-term debt (a) |
260,750 | 27,336 | 59,314 | 49,966 | 76,349 | 34,058 | 13,727 | |||||||||||||||||||||
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Total contractual obligations |
$ | 279,469 | $ | 30,084 | $ | 62,226 | $ | 53,005 | $ | 79,458 | $ | 40,444 | $ | 14,252 | ||||||||||||||
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Notes:
(a) | In connection with the acquisition of the Portfolio and related financing, the Company intends to refinance the Credit Facility. |
Related Party Transactions
The Company had the following related party transactions during the year ended December 31, 2014 and December 31, 2013:
For the Year Ended
December 31, |
||||||||
2014 | 2013 | |||||||
Legal fees paid or payable to firms affiliated with directors (a) |
61 | 139 | ||||||
Finance fees paid to firms affiliated with directors (b) |
| 150 | ||||||
Interest costs paid and payable to firms affiliated with directors (b) |
| 98 | ||||||
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$ | 61 | $ | 387 | |||||
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(a) | Legal fees include professional services for advice relating to intellectual property matters. |
[23]
(b) | This relates to fees and interest paid for a loan, where two of the directors were officers of the lender. The loan for $3,000,000 was repaid in 2013. |
Directors and Key management compensation
Compensation, consisting of salaries, bonuses and director fees to key management personnel and directors for the year ended December 31, 2014 amounted to $1,907 (2013-$1,192). The amortized cost of share-based compensation issued for the key management and directors was $1,274 for the year ended December 31, 2914 (2013-$979).
Contingencies
Following the closing of the Shionogi Transaction as additional consideration for the sale, transfer, conveyance and assignment of the assets and the grant of the Ulesfia ® license, the Company is required to pay Shionogi thirty percent (30%) of worldwide net sales of Kapvay ® that exceeds $1.5 million (in the aggregate) during each calendar quarter commencing with the calendar quarter beginning October 1, 2013 until such payments equal $6.0 million in the aggregate.
As part of the consideration for the Global Transaction, the Company is obligated to pay an additional earn-out payment of up to $4.0 million payable in common shares of the Company subject to meeting certain performance metrics. The earn-out payment provisions provide that on each earn-out calculation date, if the aggregate adjusted EBITDA of CMH, exceeds $7.0 million for the preceding year then an earn-out payment of common shares will be made which is equal in value to the aggregate adjusted EBITDA of CMH for the preceding year multiplied by 14.285714%. The number of common shares to be paid is calculated by dividing the dollar value of the earn-out payment by the dollar volume weighted average trading price of the Companys common shares on the TSX. The aggregate earn-out payments are subject to a $4.0 million cap. The Company did not make a payment in 2014 related to this earn-out provision.
As part of the consideration for the Pinnacle Transaction, the Company is obligated to pay additional payments of up to $5.0 million based on the achievement of certain milestones related to clinical trials. The Company made a payment in the fourth quarter of 2014 of $0.5 million related to this contingent obligation. The Company is also obligated to pay additional earn-out payments equal to 15% of worldwide sales of Photofrin ® in excess of $25.0 million over the 10 calendar years following the Companys acquisition of Pinnacle.
Royalties
The Company has a commitment to pay royalties on sales of each of the drugs acquired as part of the Shionogi Transaction at certain prescribed rates. These royalties are payable on a quarterly basis.
Guarantees
All directors and officers of the Company, and each of the Companys various subsidiaries, are indemnified by the Company for various items including, but not limited to, all costs to settle lawsuits or actions due to their association with the Company, subject to certain restrictions. The Company has purchased directors and officers liability insurance to mitigate the cost of any potential future lawsuits or actions.
In the normal course of business, the Company has entered into agreements that include indemnities in favor of third parties, such as purchase and sale agreements, confidentiality agreements, engagement letters with advisors and consultants, leasing contracts, license agreements, information technology agreements and various product, service, data hosting and network access agreements. These indemnification arrangements may require the applicable Concordia entity to compensate counterparties for losses incurred by the counterparties as a result of breaches in representations, covenants and warranties provided by the particular Concordia entity or as a result of litigation or other third party claims or statutory sanctions that
[24]
may be suffered by the counterparties as a consequence of the relevant transaction.
In connection with the acquisition of Zonegran ® , the Company guaranteed the payment, performance and discharge of CPIs payment and indemnification obligations under the asset purchase agreement and each ancillary agreement entered into by CPI in connection therewith that contained payment or indemnification obligations. Pursuant to the Covis Purchase Agreement, Concordia guaranteed the due and punctual payment by CPI of CPIs obligations under the Covis Purchase Agreement.
Litigation and Arbitration
In the normal course of business the Company may be the subject of litigation claims. As at December 31, 2014, there are no material claims against the Company. On February 12, 2015, Concordia announced that it received a civil investigative demand (CID) from the United States Federal Trade Commission regarding its attention deficit hyperactivity disorder product Kapvay ® . See the disclosure under the heading Legacy Pharmaceuticals Division Legacy Products Kapvay ® - Genericization of Kapvay ® and Legal Proceedings, and Regulatory Matters in the Companys Annual Information Form.
Off Balance Sheet Arrangements
The Company leases facilities under operating leases in Canada, Barbados and the United States. The leases typically run for a period of months up to five years. The Company also has operating leases for office equipment. There are no other off balance sheet arrangements as at December 31, 2014.
Recent Accounting Pronouncements
Consolidated Financial Statements
In October 2012, the IASB issued amendments to IFRS 10 Consolidated Financial Statements to require investment entities to measure subsidiaries at fair value through profit or loss. In addition, IFRS 12 Disclosure of Interests in Other Entities has been amended to include disclosure requirements for investment entities. IAS 27 Separate financial statements has been amended to require investment entities to measure investments in subsidiaries at fair value through profit or loss when separate Financial Statements are presented. The amendments are effective for annual periods beginning on or after January 1, 2014.
Financial Instruments: Presentation
IAS 32 Financial Instruments: Presentation was amended by the IASB in December 2011. Offsetting Financial Assets and Financial Liabilities amendment addresses inconsistencies identified in applying some of the offsetting criteria. The amendment is effective for annual periods beginning on or after January 1, 2014.
Impairment of Assets
IAS 36 Impairment of Assets was amended by the IASB in June 2013. Recoverable Amount Disclosures for Non-Financial Assets amendment modifies certain disclosure requirements about the recoverable amount of impaired assets if that amount is based on fair value less costs to sell. The amendment is effective for annual periods beginning on or after January 1, 2014.
Levis
IFRIC Interpretation 21, Levies, was issued by the IFRIC in May 2013. The interpretation on the accounting for levies imposed by the government clarifies the obligating event that gives rise to a liability to pay levy. IFIC 21 is effective for annual periods beginning on or after January 1, 2014.
[25]
Non IFRS Financial Measures
This MD&A makes reference to certain non-IFRS measures. These non-IFRS measures are not recognized measures under IFRS and do not have a standardized meaning prescribed by IFRS, and are therefore unlikely to be comparable to similar measures presented by other companies. When used, these measures are defined in such terms as to allow the reconciliation to the closest IFRS measure. These measures are provided as additional information to complement those IFRS measures by providing further understanding of the Companys results of operations from Managements perspective. Accordingly, they should not be considered in isolation nor as a substitute for analyses of the Companys financial information reported under IFRS. Management uses non-IFRS measures such as EBITDA, Adjusted EBITDA and Adjusted EPS to provide investors with a supplemental measure of the Companys operating performance and thus highlight trends in the Companys core business that may not otherwise be apparent when relying solely on IFRS financial measures. Management also believes that securities analysts, investors and other interested parties frequently use non-IFRS measures in the evaluation of issuers. Management also uses non-IFRS measures in order to facilitate operating performance comparisons from period to period, prepare annual operating budgets, and to assess its ability to meet future debt service, capital expenditure, and working capital requirements.
The definition and reconciliation of EBITDA, Adjusted EBITDA and Adjusted EPS used and presented by the Company to the most directly comparable IFRS measures follows below.
EBITDA
EBITDA is defined as net income adjusted for net interest expense, income tax expense, depreciation and amortization. Management uses EBITDA to assess the Companys operating performance. A reconciliation of net income to EBITDA is provided below.
Adjusted EBITDA
Adjusted EBITDA is defined as EBITDA adjusted for one-time charges including costs associated with acquisitions, and the Companys listing on the TSX, non-recurring gains, non-cash items such as unrealized gains / losses on derivative instruments, share based compensation, change in fair value of contingent consideration, and realized / unrealized gains / losses related to foreign exchange revaluation. Management uses Adjusted EBITDA as the key metric in assessing business performance when comparing actual results to budgets and forecasts. Management believes adjusted EBITDA is an important measure of operating performance and cash flow, and provides useful information to investors because it highlights trends in the underlying business that may not otherwise be apparent when relying solely on IFRS measures.
The table below sets forth the reconciliation of net income to EBITDA and to Adjusted EBITDA for the year ended December 31, 2014 and 2013:
[26]
2014 | 2013 | |||||||
Net Income |
$ | 11,590 | $ | 2,431 | ||||
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|
|||||
Interest and accretion expense |
12,194 | 6,382 | ||||||
Income Taxes |
7,522 | 425 | ||||||
Depreciation expense |
131 | 18 | ||||||
Amortization of intangible assets |
11,039 | 120 | ||||||
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EBITDA |
$ | 42,476 | $ | 9,376 | ||||
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Business acquisition related costs |
13,521 | 3,692 | ||||||
Share based compensation |
4,484 | 1,070 | ||||||
Change in fair value of contingent consideration |
2,629 | | ||||||
Foreign exchange loss |
696 | 129 | ||||||
Other (income) expense |
203 | (150 | ) | |||||
Change in fair value of convertible warrants |
| 4,648 | ||||||
Exchange listing expenses |
| 2,404 | ||||||
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Adjusted EBITDA |
$ | 64,009 | $ | 21,169 | ||||
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Adjusted EPS
Adjusted EPS is defined as adjusted net income divided by the weighted average number of fully diluted shares outstanding. Adjusted net income is defined as net income (loss) adjusted for one-time charges including costs associated with acquisitions, the Companys listing on the TSX, non-recurring gains, non-cash items such as unrealized gains / losses on derivative instruments, share based compensation, change in fair value of contingent consideration, realized / unrealized gains / losses related to foreign exchange revaluation, the tax impact of the above items and one-time tax expenses associated with one-time gains. Management believes Adjusted EPS is an important measure of operating performance and cash flow, and provides useful information to investors.
FY2014 | Q4-2014 | Q3-2014 | Q2-2014 | Q1-2014 | FY2013 | Q4-2013 | Q3-2013 | Q2-2013 | ||||||||||||||||||||||||||||
Weighted average number of fully diluted shares |
27,209,904 | 30,439,316 | 30,127,443 | 27,826,313 | 21,588,635 | 6,432,387 | 10,389,617 | 8,792,924 | 3,522,945 | |||||||||||||||||||||||||||
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Net income (loss) |
11,590 | 3,718 | 10,535 | (827 | ) | (1,836 | ) | 2,431 | (7,083 | ) | 5,364 | 4,150 | ||||||||||||||||||||||||
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Adjustments: |
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Share-based compensation |
4,484 | 1,090 | 1,258 | 1,380 | 756 | 1,070 | 426 | 644 | | |||||||||||||||||||||||||||
Exchange listing expenses |
| | | | | 2,404 | 2,404 | | | |||||||||||||||||||||||||||
Business acquisition related costs |
13,521 | 940 | 4,093 | 8,314 | 174 | 3,692 | 3,692 | | | |||||||||||||||||||||||||||
Depreciation |
131 | 41 | 40 | 16 | 34 | 18 | 4 | 14 | | |||||||||||||||||||||||||||
Amortization |
11,039 | 9,299 | 580 | 580 | 580 | 120 | 120 | | | |||||||||||||||||||||||||||
Change in fair value of contingent consideration |
2,629 | 500 | 579 | 983 | 567 | | | | | |||||||||||||||||||||||||||
Change in fair value of derivative warrants |
| | | | | 4,648 | 4,648 | | | |||||||||||||||||||||||||||
Foreign exchange loss (gain) |
696 | (242 | ) | 73 | | 865 | 129 | 116 | 5 | 8 | ||||||||||||||||||||||||||
Other (income) expense |
203 | 111 | (16 | ) | 113 | (5 | ) | (150 | ) | (148 | ) | (2 | ) | | ||||||||||||||||||||||
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Tax adjustments |
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Tax effect |
(136 | ) | (14 | ) | (48 | ) | (66 | ) | (8 | ) | | | | | ||||||||||||||||||||||
Transfer of IP |
7,012 | 7,012 | | | | | | | | |||||||||||||||||||||||||||
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Adjusted net income |
51,169 | 22,455 | 17,094 | 10,493 | 1,127 | 14,362 | 4,179 | 6,025 | 4,158 | |||||||||||||||||||||||||||
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Adjusted EPS - diluted |
$ | 1.88 | $ | 0.74 | $ | 0.57 | $ | 0.38 | $ | 0.05 | $ | 2.23 | $ | 0.40 | $ | 0.69 | $ | 1.18 | ||||||||||||||||||
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[27]
Outstanding Share Data
The authorized capital of the Company consists of an unlimited number of common shares. As at December 31, 2014 and March 19, 2015, the Company had, respectively, 28,861,239 and 28,873,739 common shares issued and outstanding. As at December 31, 2014 and March 19, 2015, there were, respectively, 2,002,280 and 2,039,780 options outstanding that entitle the holders thereof to purchase one common share per option of the Company.
Disclosure Controls and Procedures and Internal Control over Financial Reporting
Disclosure Controls and Procedures
The Company is required to review and report on the effectiveness of its disclosure controls and procedures ( DC&P ) in accordance with National Instrument 52-109, Certification of Disclosure in Issuers Annual and Interim Filings ( NI 52-109 ), issued by the Canadian Securities Administrators. NI 52-109 requires a Chief Executive Officer ( CEO ) and Chief Financial Officer ( CFO ) to certify that they are responsible for establishing and maintaining DC&P for the Company, that DC&P have been designed and are effective in providing reasonable assurance that material information relating to the Company is made known to them, that they have evaluated the effectiveness of the Companys DC&P and that their conclusions about the effectiveness of those DC&P at the end of the period covered by the relevant annual filings have been disclosed by the Company.
A control system, no matter how well conceived and operated, can provide only reasonable, not absolute, assurance that its objectives are met. Due to inherent limitations in all such systems, no evaluations of controls can provide absolute assurance that all control issues within a company have been detected. In addition, the design of any system of control is based upon certain assumptions about the likelihood of future events and there can be no assurance that any design will succeed in achieving its stated goals under all future events, no matter how remote, or that the degree of compliance with the policies or procedures may not deteriorate. Accordingly, the Companys DC&P are effective in providing reasonable, not absolute, assurance that the objectives of its disclosure control system have been met.
Internal Controls over Financial Reporting
NI 52-109 also requires CEOs and CFOs to certify that they are responsible for establishing and maintaining internal controls over financial reporting ( ICFR ) for the Company, that the ICFR have been designed and are effective in providing reasonable assurance regarding the reliability of financial reporting and the preparation of financial statements in accordance with IFRS, and that the Company has disclosed any change in its internal controls during its most recent interim period that has materially affected, or is reasonably likely to materially affect, its ICFR.
The design and operating effectiveness of the Companys ICFR were evaluated by Management in accordance with Internal Controls over Financial Reporting Guidance for Smaller Public Companies, as published by the Committee of Sponsoring Organizations of the Treadway Commission ( COSO ), and NI 52-109, as at December 31, 2014.
Assessment of DC&P and ICFR
Based on the evaluation of the Companys DC&P and ICFR as at December 31, 2014, the CEO and CFO concluded that the Companys DC&P and ICFR were effective.
[28]
Exhibit 99.6
ANNUAL INFORMATION FORM
CONCORDIA HEALTHCARE CORP.
For the year ended December 31, 2013
March 31, 2014
TABLE OF CONTENTS
GLOSSARY OF TERMS |
1 | |||
EXPLANATORY NOTES |
7 | |||
Currency |
7 | |||
FORWARD-LOOKING INFORMATION |
7 | |||
BACKGROUND AND CORPORATE STRUCTURE |
9 | |||
Name, Address and Incorporation |
9 | |||
Intercorporate Relationships |
10 | |||
GENERAL DEVELOPMENT AND DESCRIPTION OF THE BUSINESS |
10 | |||
General Description of the Business |
10 | |||
General Development of the Business |
11 | |||
Growth Strategy |
13 | |||
Competitive Strengths |
15 | |||
Corporate Operations |
16 | |||
Employees |
16 | |||
The Pharmaceutical Market |
17 | |||
Customers |
20 | |||
Competitive Conditions |
20 | |||
Proprietary Protection |
21 | |||
LEGACY PHARMACEUTICALS DIVISION |
21 | |||
Legacy Pharmaceuticals Division Overview |
21 | |||
Industry Overview |
22 | |||
Legacy Products - Kapvay |
26 | |||
Legacy Products - Orapred |
29 | |||
Legacy Products - Ulesfia |
31 | |||
SPECIALTY HEALTHCARE DISTRIBUTION DIVISION |
33 | |||
SHD Division Overview |
33 | |||
Industry Overview |
33 | |||
SHD Division Operations |
35 | |||
SHD Division Products |
37 | |||
SHD Division Marketing |
38 | |||
SHD Division Suppliers |
38 | |||
SHD Division Competition |
39 | |||
Corporate Compliance |
39 | |||
Medicare Competitive Bidding |
39 | |||
ORPHAN DRUGS DIVISION |
40 | |||
Orphan Drugs Division Overview |
40 | |||
Industry Overview |
40 | |||
PDT with Photofrin |
42 | |||
Existing Indications |
42 | |||
New Indications |
43 | |||
Special Protocol Assessment |
43 | |||
RISK FACTORS |
44 | |||
DIVIDEND POLICY |
57 |
DESCRIPTION OF CAPITAL STRUCTURE |
57 | |||
Common Shares |
57 | |||
Stock Option Plan |
57 | |||
DEBT FINANCING |
59 | |||
HSBC Credit Facility |
59 | |||
Term Facilities |
59 | |||
MARKET FOR SECURITIES |
60 | |||
Trading Price and Volume |
60 | |||
Prior Sales |
60 | |||
DIRECTORS AND EXECUTIVE OFFICERS OF THE CORPORATION |
62 | |||
Directors and Executive Officers, Positions and Security Holdings |
62 | |||
Biographies |
63 | |||
Corporate Cease Trade Orders or Bankruptcies |
65 | |||
Penalties or Sanctions |
66 | |||
Individual Bankruptcies |
66 | |||
Conflicts of Interest |
66 | |||
PROMOTER |
66 | |||
LEGAL PROCEEDINGS AND REGULATORY MATTERS |
66 | |||
INTEREST OF MANAGEMENT AND OTHERS IN MATERIAL TRANSACTIONS |
67 | |||
AUDIT COMMITTEE |
67 | |||
TRANSFER AGENT AND REGISTRAR |
68 | |||
MATERIAL CONTRACTS |
69 | |||
INTEREST OF EXPERTS |
69 | |||
ADDITIONAL INFORMATION |
70 |
SCHEDULE A | CHARTER OF THE AUDIT COMMITTEE |
GLOSSARY OF TERMS
In addition to terms defined elsewhere, the following are defined terms used in this annual information form:
2014 Offering | has the meaning ascribed to that term under the heading General Development and Description of the Business in the Annual Information Form. | |
ADHD | means Attention Deficit Hyperactivity Disorder. | |
AG | means an authorized generic. | |
AIF | means this Annual Information Form. | |
Agency Agreement | means the Agency Agreement by and among the Agents and Concordia Healthcare Inc. dated December 19, 2013. | |
Agents | has the meaning ascribed to that term under the heading Background and Corporate Structure - Name, Address and Incorporation in the Annual Information Form. | |
Agents Options | has the meaning ascribed to that term under the heading Background and Corporate Structure - Name, Address and Incorporation in the Annual Information Form. | |
Amalgamation | has the meaning ascribed to that term under the heading Background and Corporate Structure - Name, Address and Incorporation in the Annual Information Form. | |
Amalgamation Agreement | has the meaning ascribed to that term under the heading Market for Securities - Prior Sales - Common Shares in the Annual Information Form. | |
ANDA | means the Abbreviated New Drug Application. | |
Annual Information Form | means this Annual Information Form. | |
Anti-Kickback Statutes | means the Foreign Corrupt Practices Act and the United States federal Anti-Kickback Statute. | |
Audit Committee | Has the meaning ascribed to that term under the heading Audit Committee in the Annual Information Form. | |
Big Pharma | means large branded pharmaceutical companies. | |
CAGR | means compound annual growth rate. | |
cGMP | means current good manufacturing practices. | |
CHIP | means the Childrens Health Insurance Program which provides free or low-cost health coverage for more than 7 million United States children up to age 19. CHIP covers United States citizens and eligible immigrants. |
CHUSA | means Concordia Healthcare USA Inc., a Delaware corporation incorporated on April 16, 2013 and a wholly-owned subsidiary of the Corporation. | |
CIMA | means CIMA Labs Inc. | |
CLI | means Concordia Labs Inc., a Barbados corporation, incorporated on October 29, 2013 and a wholly-owned subsidiary of the Corporation. | |
CMS | means the Centers for Medicare and Medicaid Services. | |
CNS | means central nervous system. | |
Common Shares | means the common shares in the capital of the Corporation. | |
Complete Medical Homecare Share Purchase Agreement | means the Share Purchase Agreement dated August 30, 2013 among CHUSA, and Complete Medical Homecare, Inc., Robert Shea, Joseph Corso and Mark Franz for the purchase by CHUSA of the issued and outstanding shares of Complete Medical Homecare Inc., a company which is in the business of selling durable medical equipment and supplies. | |
Concordia Private Co. | has the meaning ascribed to that term under the heading Background and Corporate Structure Name, Address and Incorporation in the Annual Information Form. | |
Consolidation | has the meaning ascribed to that term under the heading Background and Corporate Structure Name, Address and Incorporation in the Annual Information Form. | |
Corporation | means Concordia Healthcare Corp. (formerly Mercari Acquisition Corp.), an Ontario corporation, incorporated on January 20, 2010. | |
CPAP | means continuous positive airway pressure. | |
CPI | means Concordia Pharmaceuticals Inc., a Barbados corporation, incorporated on December 19, 2012 and a wholly-owned subsidiary of the Corporation. | |
CPL | means Contract Pharmaceuticals Limited. | |
DME | means durable medical equipment. | |
Earnout Calculation Date | means the date which is the anniversary date of the closing of the purchase of Global for each of the five years following the date of the closing of the Global purchase. | |
Earnout Payment | means the payment which is equal in value to the aggregate adjusted EBITDA of Global for the preceding year multiplied by 14.285714%. | |
EBITDA | means earnings before interest, taxes, depreciation and amortization. | |
EU | means the European Union. |
2
FDA | means the United States Food and Drug Administration. | |
forward-looking statements | Has the meaning ascribed to it under the heading Forward-Looking Information in the Annual Information Form. | |
Global | means Global Medical Direct LLC and its affiliated entities acquired by CHUSA on October 25, 2013 with an effective date of August 1, 2013. | |
Global Medical Direct Asset Purchase Agreement | means the Asset Purchase Agreement dated August 30, 2013 among CHUSA and Global Medical, Inc., Global Medical Direct, LLC, Joseph Corso, Mark Franz and Robert Shea for the purchase of assets relating to the development, manufacturing, marketing, claims processing, distribution and selling of durable medical equipment products of Global Medical, Inc. and Global Medical Direct, LLC. | |
Global Purchase Agreement | means, collectively, the Midwest Asset Purchase Agreement, the Global Medical Direct Asset Purchase Agreement and the Complete Medical Homecare Share Purchase Agreement. | |
Health Care Reform Act | means the Patient Protection and Affordable Care Act , as amended by the Health Care and Education Reconciliation Act of 2010. | |
HIPPA | means the Health Insurance Portability and Accountability Act of 1996, as amended by the HPAA. | |
HME | means home medical equipment. | |
HMO | means health maintenance organization. | |
HPPA | means the Health Information Technology for Economic and Clinical Health Act of 2009. | |
IFRS | means International Financial Reporting Standards. | |
Lachlan | has the meaning ascribed to that term under the heading Legacy Pharmaceuticals Division - Products - Ulesfia - Distribution Agreement with Lachlan Pharmaceuticals in the Annual Information Form. | |
Legacy Pharmaceutical Division | means the Corporations healthcare business carried on by the Corporations subsidiary, CPI, which includes the management and acquisition of legacy pharmaceutical products. | |
Legacy Products | means all or any one of the Corporations following legacy pharmaceutical products, as the context may require, consisting of Kapvay (clonidine extended release tablets), Ulesfia (benzyl alcohol) Lotion 5%, and Orapred ODT (prednisolone sodium phosphate orally disintegrating tablets). | |
LOE | means loss of exclusivity. | |
MCO | means a Managed Care Organization. | |
Medicare Bidding Program | means the Centers for Medicare and Medicaid national mail-order competitive bidding program. |
3
Midwest Asset Purchase Agreement | means the Asset Purchase Agreement dated August 30, 2013 among CHUSA and Midwest Medical Services, Inc., Joseph Corso, Mark Franz, and Robert Shea for the purchase of assets relating to the development, manufacturing, marketing, claims processing, distribution and selling of durable medical equipment products of Midwest Medical Services, Inc. | |
Midwest Medical Services | means Midwest Medical Services. | |
Mylan | means Mylan Inc. | |
NEX | means the NEX board of the TSX-V. | |
NDA or New Drug Application | means a formal proposal to the FDA to approve a new pharmaceutical for sale and marketing in the U.S. | |
New Credit Facilities | has the meaning ascribed to that term under the heading Debt Financing - HSBC Credit Facility in the Annual Information Form. | |
NSCLC | means non-small cell lung cancer. | |
OBCA | means the Business Corporations Act (Ontario). | |
OD Act | means the Orphan Drug Act of 1983. | |
ODT | means orally disintegrating tablet. | |
OOPD | means the FDA Office of Orphan Products Development. | |
Optum | means OptumInsight, the provider of regulatory affairs services, medical and drug information provision, and quality assurance services. | |
Orphan Drugs Division | means the Corporations orphan drugs division. | |
OS | means oral suspension. | |
OTC | means over-the-counter. | |
PDT | has the meaning ascribed to that term under the heading Orphan Drugs Division - Photodynamic Therapy with Photofrin in the Annual Information Form. | |
Pinnacle | means Pinnacle Biologics Inc. and its affiliated entities, Pinnacle Oncology LLC, Pinnacle Biologics B.V. and Compagnie Biologiques Pinnacle, which were acquired by Concordia Private Co. on December 20, 2013 and which are subsidiaries of the Corporation. | |
Pinnacle Purchase Agreement | means the Agreement and Plan of Merger of November 8, 2013 among Pinnacle, the Stockholders Representative, Concordia Private Co., CLI, and CHUSA, pursuant to which Concordia Private Co. acquired a legacy pharmaceutical product which has orphan drug potential. | |
PPS | means Pharmaceutical Packaging Service. |
4
Private Placement | has the meaning ascribed to that term under the heading Background and Corporate Structure - Name, Address and Incorporation in the Annual Information Form. | |
Qualifying Transaction | has the meaning ascribed to that term under the heading Background and Corporate Structure - Name, Address and Incorporation in the Annual Information Form. | |
Revolving Facility | has the meaning ascribed to that term under the heading Debt Financing - HSBC Credit Facility in the Annual Information Form. | |
SDC | means the Shionogi Distribution Centre. | |
SEDAR | means the System for Electronic Document Analysis and Retrieval, which is the mandatory document filing and retrieval system for all Canadian public companies. | |
Senior Loan Agreement | means the Loan Agreement made May 6, 2013 among Concordia Private Co., CPI, CHUSA, Fulcrum Capital Partners Inc. and Windsor Private Capital Limited Partnership in respect of the provision to Concordia Private Co. of term loan facilities in the aggregate amount of $19,000,000. | |
Shionogi | means Shionogi Inc., the company from which CPI acquired its legacy pharmaceutical business assets in May, 2013. | |
Shionogi Purchase Agreement | means the Asset Purchase Agreement dated May 6, 2013 between CPI and Shionogi for the purchase by CPI of the Kapvay, Orapred and Ulesfia legacy pharmaceuticals from Shionogi. | |
SPA | has the meaning ascribed to that term under the heading Orphan Drugs Division - Special Protocol Assessment in the Annual Information Form. | |
Specialty Healthcare Distribution Division or SHD Division | means the Corporations Speciality Healthcare Distribution Division. | |
Specialty Pharma | means smaller specialty and niche-market pharmaceutical companies. | |
SPS | means Cardinal Specialty Pharmaceutical Services. | |
Stock Option Plan | has the meaning ascribed to that term under the heading Description of Capital Structure - Stock Options. | |
Stockholders Representative | means Guillermo Herrera. | |
Subordinate Loan Agreement | means the Loan Agreement made May 6, 2013 among Concordia Private Co., CPI, CHUSA, BG Capital Group Limited and Universal Casualty Company in respect of the provision to Concordia Private Co. of term loan facilities in the aggregate amount of $5,000,000. |
5
Subscription Receipts | has the meaning ascribed to that term under the heading Background and Corporate Structure - Name, Address and Information in the Annual Information Form. | |
TSX | means the Toronto Stock Exchange. | |
TSX-V | means the TSX Venture Exchange. | |
Underwriting Agreement | means the underwriting agreement by and among GMP Securities L.P, Canaccord Genuity Corp., Barclays Capital Canada Inc., Beacon Securities Limited, Cormark Securities Inc. and the Corporation dated February 24, 2014, which was entered into in connection with the 2014 Offering. | |
VAT | means value added tax. | |
VWAP | means the dollar volume weighted average trading price of the Common Shares for the 10 days preceding the Earnout Calculation Date. | |
Zylera | has the meaning ascribed to that term under the heading Legacy Pharmaceuticals Division - Products - Ulesfia - Distribution Agreement with Lachlan Pharmaceuticals in the Annual Information Form. |
6
EXPLANATORY NOTES
Unless otherwise stated, the information in this Annual Information Form is stated as of December 31, 2013, and all references to the Corporations fiscal year are to the year ended December 31, 2013. In this Annual Information Form, the Corporation and its subsidiaries are collectively referred to as Concordia.
Any reference in this document to intellectual property rights held by the Corporation or Concordia and related commercializing efforts are for convenience purposes only and in no way change or limit the rights held by the Corporation or Concordia.
Currency
All dollar amounts set forth in this Annual Information Form are in United States Dollars, except where otherwise indicated.
FORWARD-LOOKING INFORMATION
Certain statements contained in this Annual Information Form, or incorporated herein by reference, constitute forward-looking information within the meaning of applicable securities laws ( forward-looking statements ), which are based upon the Corporations current internal expectations, estimates, projections, assumptions and beliefs. Statements concerning the Corporations objectives, goals, strategies, intentions, plans, beliefs, expectations and estimates, and the business, operations, future financial performance and condition of the Corporation and its subsidiaries are forward-looking statements. The words believe, expect, anticipate, estimate, intend, may, will, would and similar expressions and the negative of such expressions are intended to identify forward-looking statements, although not all forward-looking statements contain these identifying words. These statements are not guarantees of future performance and involve known and unknown risks, uncertainties and other factors that may cause actual results or events to differ materially from those anticipated in the forward-looking statements.
In addition, this Annual Information Form may contain forward-looking statements attributed to third-party industry sources. By their nature, forward-looking statements involve numerous assumptions, known and unknown risks and uncertainties, both general and specific, that contribute to the possibility that the predictions, forecasts, projections and other forward-looking statements will not occur. Such forward-looking statements in this Annual Information Form speak only as of the date of this Annual Information Form. Forward-looking statements in this Annual Information Form include, but are not limited to, statements with respect to:
| the performance of Concordia business and operations; |
| capital expenditure programs; |
| future development and the timing thereof; |
| estimated future contractual obligations; |
| future liquidity and financial capacity; |
| supply and demand for pharmaceutical products and services similar to the Corporations products and services; |
| expectations regarding the Corporations ability to raise capital; |
| treatment under government regulatory and taxation regimes; |
| the Corporations net sales of its Legacy Products and PDT with Photofrin; and |
| sales relating to the Corporations DME division. |
7
With respect to the forward-looking statements contained in this Annual Information Form, the Corporation has made assumptions regarding, among other things:
| future currency exchange and interest rates; |
| the Corporations ability to generate sufficient cash flow from operations and to access existing and proposed credit facilities and the capital markets to meet its future obligations on acceptable terms; |
| general economic, financial market and political conditions in which Concordia operates; |
| government regulation in the areas of taxation, environmental protection, consumer safety and health regulation; |
| the impact of increasing competition; |
| the timely receipt of any required regulatory approvals; |
| the ability of Concordia to obtain and retain qualified staff, equipment and services in a timely and cost efficient manner; |
| the ability of Concordia to conduct operations in a safe, efficient and effective manner; and |
| the ability of Concordia to successfully market its products and services. |
Forward-looking statements contained in this Annual Information Form are based on the key assumptions described herein. The reader is cautioned that such information, although considered reasonable by the Corporation, may prove to be incorrect. Actual results achieved during the forecast period will vary from the information provided in this Annual Information Form as a result of numerous known and unknown risks and uncertainties and other factors.
Some of the risks and other factors which could cause actual results to differ materially from those expressed in the forward-looking statements contained in this Annual Information Form include, but are not limited to, the risk factors included under the heading Risk Factors in this Annual Information Form.
Management of the Corporation has included the above summary of assumptions and risks related to forward-looking statements included in this Annual Information Form in order to provide readers with a more complete perspective on the Corporations future operations and results. Readers are cautioned that this information may not be appropriate for other purposes. Readers are cautioned that the foregoing lists of factors are not exhaustive. The forward-looking statements contained in this Annual Information Form are expressly qualified by this cautionary statement. Information contained on the website of the Corporation shall not be deemed to be a part of this Annual Information Form or incorporated hereby reference and should not be relied upon by readers for the purpose of determining whether to invest in the Common Shares or any other securities of the Corporation.
Such forward-looking statements are made as of the date of this Annual Information Form, or in the case of any documents incorporated by reference herein, as of the dates of such documents, and the Corporation disclaims any intent or obligation to update publicly any such forward-looking statements, whether as a result of new information, future events or results or otherwise, other than as required by applicable Canadian securities laws.
All of the forward-looking statements made in this Annual Information Form are qualified by these cautionary statements and other cautionary statements or factors contained herein, and there can be no assurance that the actual results or developments will be realized or, even if substantially realized, that they will have the expected consequences to, or effects on, the Corporation.
8
BACKGROUND AND CORPORATE STRUCTURE
Name, Address and Incorporation
Concordia Healthcare Corp. was incorporated pursuant to the provisions of the Business Corporations Act (Ontario) (the OBCA ) on January 20, 2010, under the name Mercari Acquisition Corp. The Corporation completed its initial public offering on May 6, 2010, and was listed on the TSX-V as a capital pool company and subsequently on the NEX board of the TSX-V until it completed its qualifying transaction on December 20, 2013 (the Qualifying Transaction ). The Qualifying Transaction proceeded by way of a three-cornered amalgamation among the Corporation, Mercari Subco Inc., a wholly-owned subsidiary of the Corporation, and Concordia Healthcare Inc. ( Concordia Private Co. ), a private Ontario corporation existing prior to the Corporations Qualifying Transaction. The Qualifying Transaction resulted in a reverse takeover of the Corporation by the shareholders of Concordia Private Co.
In connection with the Qualifying Transaction, among other things, Concordia Private Co. amalgamated with the Corporations wholly-owned subsidiary, Mercari Subco Inc. (the Amalgamation ) and the securityholders of Concordia Private Co. received securities of the Corporation in exchange for their securities of Concordia Private Co.
As a result of the Qualifying Transaction and upon its completion, former Concordia Private Co. shareholders held approximately 98.5% of the Common Shares and shareholders of the Corporation, prior to the Qualifying Transaction, held approximately 1.5% of the Common Shares.
On December 18, 2013, and prior to the completion of the Qualifying Transaction, the Corporation changed its name to Concordia Healthcare Corp. and completed a consolidation of its share capital on a basis of one post-consolidation common share for every 48.08 common shares existing immediately before the consolidation (the Consolidation ), and the Ontario Ministry of Government Services issued a Certificate and Articles of Amendment of the Corporation giving effect to the change of the Corporations name to Concordia Healthcare Corp. and to the Consolidation.
Prior to the Amalgamation, Concordia Private Co. completed a private placement (the Private Placement ) of subscription receipts (the Subscription Receipts ) conducted by a syndicate of agents co-led by GMP Securities L.P. and Canaccord Genuity Corp., and including Beacon Securities Limited, Cormark Securities Inc. and National Bank Financial Inc. (collectively, the Agents ). Pursuant to the Private Placement, Concordia Private Co. issued 5,520,000 Subscription Receipts at a price of $CAD 6.25 per Subscription Receipt for total gross proceeds to the Corporation of $CAD 34,500,000. Each Subscription Receipt was exchanged for one common share of Concordia Private Co., which common shares were then exchanged for Common Shares on a one-for-one basis pursuant to the Qualifying Transaction.
The Agents received options to purchase 220,800 common shares of Concordia Private Co. at an exercise price of $CAD 6.25 (the Agents Options ). The Agents Options are exercisable until December 20, 2015. In connection with the Qualifying Transaction, the Agents Options were exchanged for compensation options of the Corporation on the same terms as those contained in the Agents Options.
The Corporations shares were delisted from the NEX board of the TSX-V and relisted for trading on the TSX under the symbol CXR on December 24, 2013.
The registered and head office of the Corporation is located at 277 Lakeshore Rd. East, Suite 302, Oakville, Ontario, L6J 1H9.
9
Intercorporate Relationships
The Corporations business is carried on through its various subsidiaries. The following chart illustrates, as at December 31, 2013 the Corporations significant subsidiaries, including their respective jurisdiction of incorporation and percentage of voting securities in each that are held by the Corporation either directly or indirectly:
GENERAL DEVELOPMENT AND DESCRIPTION OF THE BUSINESS
General Description of the Business
Prior to the Qualifying Transaction, the Corporation did not own any assets other than cash and had not conducted any active business operations. Since its incorporation and prior to the Qualifying Transaction, the principal activities of the Corporation consisted of the financing through its initial public offering and a non-brokered private placement of 5,800,000 Common Shares at $CAD 0.05 per Common Share for gross proceeds of $CAD 290,000 completed on January 15, 2013.
As a result of the Amalgamation and the Qualifying Transaction, the Corporation is currently an integrated healthcare company that targets three areas through its various divisions: (a) legacy pharmaceutical products (Legacy Pharmaceuticals Division); (b) specialized healthcare distribution that
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services the growing diabetic market (Specialty Healthcare Distribution Division); and (c) the acquisition and/or development of orphan drugs (Orphan Drugs Division). These three business units are run as separate divisions but are inter-related. The cash-flow from legacy pharmaceutical products is used to fund operations and is also intended to fund the expansion of indications for potential orphan drugs. The specialized healthcare distribution division provides additional growth and cash-flow generation. Additionally, through its registered pharmacy operation, this business provides a specialty distribution capability for specialty pharmaceutical products and orphan drugs once acquired and/or developed. All three of these divisions are operated through a corporate organization that provides executive leadership, industry experience and financial and capital markets experience.
These three divisions are identified as reportable segments under IFRS for the purposes of disclosure in the Corporations audited consolidated financial statements.
General Development of the Business
On May 6, 2013, Concordia Private Co. closed the Senior Loan Agreement and the Subordinate Loan Agreement, pursuant to which Concordia Private Co. borrowed an aggregate of $24 million. See Debt Financing - Term Facilities. Pursuant to the Senior Loan Agreement, Concordia Private Co. borrowed $19 million from two lenders at an interest rate of 12% per annum and pursuant to the Subordinate Loan Agreement, Concordia Private Co. borrowed $5 million from two lenders at an interest rate of 18% per annum. The loans under both agreements mature on October 30, 2015. Loan proceeds from the Senior Loan Agreement and the Subordinate Loan Agreement were used to acquire certain legacy pharmaceutical business assets from Shionogi, as described below, and for general working capital purposes. The principal amount of $3 million plus interest borrowed pursuant to the Senior Loan Agreement has been repaid by Concordia Private Co.
CPI, a wholly-owned subsidiary of the Corporation, acquired certain of its legacy pharmaceutical business assets from Shionogi on May 6, 2013, pursuant to the Shionogi Purchase Agreement. These legacy pharmaceutical assets are comprised of three FDA approved drugs: (i) Kapvay, which is used to effectively treat ADHD; (ii) Ulesfia, which is a topical treatment for pediculosis (head lice); and (iii) Orapred, an anti-inflammatory used in the treatment of certain pulmonary diseases such as asthma. The purchase price paid to Shionogi was $28.7 million and included $25.6 million paid for the above mentioned products, $2.3 million paid for the inventory including raw material, work in process and finished goods and $0.8 million in contingent consideration, subject to meeting certain performance metrics. Following the closing of this acquisition, as additional consideration for the sale, transfer, conveyance and assignment of the assets and the grant of the Ulesfia license, CPI is required to pay Shionogi thirty percent (30%) of worldwide net sales of Kapvay and royalty income relating to Kapvay that exceeds $1.5 million (in the aggregate) during each calendar quarter commencing with the calendar quarter beginning October 1, 2013 until such payments equal $6.0 million in the aggregate. This acquisition was completed by a private entity prior to the Amalgamation and the Qualifying Transaction. Accordingly, the Corporation was not required to file (and has not filed) a Form 51-102F4 Business Acquisition Report, with respect to such acquisition. In September of 2013, Concordia entered into a supply price arrangement with a leading generic drug manufacturer with respect to Kapvay.
CHUSA, a wholly-owned subsidiary of the Corporation, acquired its specialty healthcare distribution business assets from Global on October 25, 2013 with an effective date of August 1, 2013, pursuant to the Global Purchase Agreement. The Corporations specialty healthcare distribution business is a United States national Internet, retail and mail-order provider of diabetes testing supplies, pharmaceuticals, diabetic shoes, orthotic braces and other HME. This business also includes a full-service pharmacy with full fulfillment capacity and can ship medications across the United States. Concordia Private Co. acquired the specialty healthcare distribution business for total consideration of $13.2 million comprised
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of $5 million in cash, a vendor note with a fair value on the date of acquisition of $5.6 million and an additional earn-out payment with an estimated present value on the date of acquisition of $2.6 million, payable in Common Shares subject to meeting certain performance metrics. The earn-out payment provisions provide that on each Earnout Calculation Date, if the aggregate adjusted EBITDA of Global exceeds $7.0 million for the preceding year then an Earnout Payment of Common Shares will be made which is equal in value to the aggregate adjusted EBITDA of Global for the preceding year multiplied by 14.285714%. The number of Common Shares to be paid is calculated by dividing the dollar value of the Earnout Payment by the VWAP. The aggregate Earnout Payments are subject to a $4.0 million cap, based on the VWAP of the Common Shares on the date of issuance of such shares. In addition, 1 million common shares of Concordia Private Co. at $3.00 per share were issued as finders fees in connection with the acquisition of the SHD Division, which common shares were exchanged for Common Shares in connection with the Qualifying Transaction. This acquisition was completed by a private entity prior to the Amalgamation and the Qualifying Transaction. Accordingly, the Corporation was not required to file (and has not filed) a Form 51-102F4 Business Acquisition Report, with respect to such acquisition.
CLI, a wholly owned subsidiary of the Corporation, holds certain legacy pharmaceuticals that have the potential, through further development, to be used to treat additional indications, specifically those indications that may qualify for orphan drug status. On November 8, 2013 Concordia Private Co. entered into the Pinnacle Purchase Agreement. Pursuant to the Pinnacle Purchase Agreement, on December 20, 2013, Concordia Private Co., through its subsidiaries, acquired 100% of the shares of Pinnacle for total consideration of $58.0 million comprised of $32.7 million of cash consideration, $5 million of Concordia Private Co.s common shares issued at a price of $CAD 5.63 per common share (being a 10% discount to the price of the Subscription Receipts issued under the Private Placement), 10 annual cash payments with an estimated present value of $5 million and milestone and other contingency payments with an estimated value of $15.3 million. The acquisition of Pinnacle was financed with available cash, which included net proceeds of $CAD 34.5 million received by Concordia Private Co. through the Private Placement of Subscription Receipts of Concordia Private Co., which closed on December 19, 2013. The completion of this acquisition occurred close in time to the completion of the Qualifying Transaction. Accordingly, the Corporation has filed a Form 51-102F4 Business Acquisition Report in respect of the acquisition of Pinnacle, a copy of which is available on SEDAR, online at www.sedar.com.
On March 11, 2014, the Corporation announced that it had closed a short form prospectus offering, on a bought deal basis, of 5,750,000 Common Shares of the Corporation for aggregate gross proceeds of $CAD 67,562,500 (the 2014 Offering ). The 2014 Offering was completed at a price per Common Share of CAD$ 11.75 by a syndicate of underwriters co-led by GMP Securities L.P. and Canaccord Genuity Corp. and included Barclays Capital Canada Inc., Beacon Securities Limited and Cormark Securities Inc. A copy of the final short form prospectus is available on SEDAR, online at www.sedar.com
On March 20, 2014, the Corporation announced that it had entered into a definitive agreement to acquire Donnatal®, an adjunctive therapy in the treatment of irritable bowel syndrome and acute enterocolitis, from a privately held specialty pharmaceutical company, carrying on business as Revive Pharmaceuticals. The Corporation agreed to acquire Donnatal® for $200 million in cash and an aggregate of 4,605,833 Common Shares. The Common Shares issuable have an aggregate value of approximately $65.3 million based on the closing trading price of the Common Shares on the TSX on March 18, 2014, and represent approximately 16.19% of the Corporations outstanding Common Shares on a non-diluted basis (approximately 14.99% on a fully-diluted basis) after giving effect to the acquisition. Revive Pharmaceuticals will also be entitled to have a representative nominated to the board of directors of the Corporation provided that it maintains a certain shareholding level in the Corporation. Completion of the acquisition is subject to customary closing conditions (including approval of the TSX), and acceptable financing. Management anticipates that the deal will close in the second quarter of 2014.
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Growth Strategy
The Corporation intends to grow its existing businesses (i) by supplementing its Legacy Products by acquiring or in-licensing additional legacy products; (ii) by expanding the Specialty Healthcare Distribution Division by acquiring new customers and by expanding into additional product offerings including specialty pharmaceutical and orphan drugs distribution; (iii) through the development of new indications for Photofrin that will qualify for orphan drug status; and (iv) the acquisition of additional orphan drugs.
Legacy Pharmaceuticals Division Acquisitions
The Corporation focuses on acquiring legacy pharmaceutical products that either enjoy market exclusivity through technical, manufacturing or economic barriers to competition, or otherwise maintain stable and/or predictable prescription demand. As the Corporations focus is not therapeutically driven, management believes that a broad selection of legacy products is available for potential product acquisitions.
Illustration of the United States Pharmaceutical Product Lifecycle
The Corporation focuses on acquiring legacy products that:
| Are known products for doctors |
| minimal safety risk |
| no launch promotion required |
| limited sales and marketing costs |
| Have minimal competitive threats |
| quantifiable generic participation |
| minimal pipeline (alternative product) risk |
| Have a predictive and reliable supply chain |
| active pharmaceutical ingredient readily available |
| long-term stable supply chain |
| alternative manufacturing sources if needed |
| distributed by leading third-party logistics provider |
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| Have financial stability with upside potential |
| attractive cash flow profile |
| pricing inelasticity |
| demonstrated response to promotion and investment |
| opportunity to expand existing indications with a focus on those qualifying for orphan drug status |
The Corporation believes it has developed a rigorous and comprehensive evaluation process to identify and review potential product acquisitions. This process includes in-depth due diligence reviews of all aspects of the business opportunity including legal, medical, regulatory, manufacturing, financial (tax) and commercial reviews that are conducted by experts in their respective fields. At any given time, the Corporation has numerous potential product acquisitions under evaluation.
Legacy Pharmaceuticals Division Post-acquisition Value added by the Corporation
The Corporation has a focused post-acquisition value enhancement program for legacy pharmaceutical acquisitions designed to manage and, where possible, improve the financial performance of acquired drugs. Key components of this program include the following:
| Increase unit pricing |
| Implement authorized generic opportunities |
| Manage regulatory affairs and supply chain |
| Integrate acquisition and intellectual property into the Corporations tax efficient structure |
| Implement changes to marketing plans as required |
Targeted Promotion and Co-Promotion
The Corporation seeks to maintain and grow demand for, and revenues from, its products through a combination of marketing activities and price increases.
The Corporations marketing strategy entails modest spending on a variety of targeted promotional activities. These programs include direct mail, outbound call programs, and web-based initiatives focusing on large audience segments. Additionally, the Corporation has couponing and co-pay assistance programs for its brands. The Corporation believes that this is a necessary measure to maintain its competitive position. Management believes there are robust opportunities within social media and continues to develop various initiatives including search engine marketing initiatives. These activities are aimed at increasing physician, pharmacy and growing consumer awareness of and loyalty to the Corporations products to maintaining and strengthening product demand. Management believes that these activities are particularly effective in positively influencing demand for Ulesfia, as it is the only non-pesticide prescription drug treatment for head lice.
The Corporation also seeks to partner with existing pharmaceutical companies that have sales forces in need of products. These potential co-promotion arrangements would allow the Corporation to leverage an existing sales force without incurring additional fixed costs. Lastly, the Corporation would consider contracting with a contract sales force where appropriate.
Pricing Strategy
Consistent with industry practice, the Corporation monitors opportunities to increase prices for its products on an ongoing basis and implements such pricing increases where appropriate in order to increase revenue. In particular, management increased pricing for its Legacy Products since acquiring
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such products in 2013. In connection with product price increases, the Corporation engages in additional marketing and promotional activities in order to support demand for the affected products. Management believes that increased revenues from price increases will, in the aggregate, more than offset any related increases in marketing and promotional expenses. Since acquiring Kapvay, Ulesfia and Orapred, the Corporation has increased such product prices by 52%, 43% and 10%, respectively, without any adverse prescription volume effect.
SHD Division Growth
Management continues to grow its SHD Division through four primary avenues: (a) expanding the existing patient base; (b) providing new product offerings to current and future patients; (c) developing a specialty distribution business within its pharmacy; and (d) through strategic partnerships. New patients are obtained by investing in new patient leads from lead generation companies. These companies generate leads for diabetic patients that the Corporation may seek to acquire. The Corporation contacts such prospective patients in order to attempt to add them to the Corporations existing patient base. The Corporation intends to expand upon its existing product portfolio through the addition of new pharmaceutical offerings and new device offerings. Finally, the Corporation is creating a specialty pharmaceutical distribution business within its SHD Division. The SHD Division currently has a full service pharmacy with pharmacists and nurses on staff. The SHD Division will offer specialty distribution of pharmaceutical products to physicians who prescribe orphan and specialist medication to patients. These products are typically administered at the physicians office and require a much higher degree of control of the supply chain as many are just in time medications with limited shelf life. Accordingly, these distribution services provide a higher margin than traditional distribution services. The specialty healthcare distribution industry is a fragmented, consolidating industry.
Competitive Strengths
Management of the Corporation believes that the Corporation possesses a number of attributes and competitive advantages that should enable it to maintain and grow revenues and operating cash flow.
Established Branded Legacy Products Portfolio
The Legacy Products provide the Corporation with a portfolio of established, branded legacy products. Each of the Legacy Products has generated and continues to generate income. The Corporations management believes that the Legacy Products will continue to provide a predictable revenue base that may be grown and supplemented through the acquisition of additional legacy products.
Superior Business Model for Acquisition of Legacy and Orphan Drug Products
Specialty Pharma and other niche pharmaceutical companies often focus on acquiring under-promoted or non-promoted products in specific therapeutic areas that can be grown through synergistic, targeted sales and marketing efforts. Management of the Corporation believes that the Corporation has a unique strategy in seeking to acquire legacy products primarily for the purpose of generating a stream of stable revenues and cash flow, which provides the Corporation with the flexibility to consider a broad range of acquisition targets from a variety of therapeutic areas. Therefore, the potential number of product acquisition candidates may be much larger for the Corporation than for most Specialty Pharma companies. Management of the Corporation believes that this approach provides the Corporation with a competitive advantage in acquiring products as it can often purchase diversified bundles of products from a single vendor, whereas other Specialty Pharma and other niche pharmaceutical companies are more likely to focus on individual product acquisitions. With this flexibility, certain vendors may view the Corporation as a preferred purchasing candidate.
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Partnership with Leading Service Providers
The Corporation has entered into outsourcing relationships with leading providers of pharmaceutical contract services for many of the operational functions associated with its business and intends to pursue this strategy in the future. Manufacturing of Kapvay tablets is outsourced to UPM and packaged by PPS. Orapred ODT is manufactured and packaged by CIMA. Ulesfia Lotion is manufactured by CPL and packaged by PPS. Warehousing, distribution, logistics, customer service and accounts receivable were previously outsourced to SDC in Alpharetta, Georgia, and were transitioned to SPS in December of 2013. These operations were transitioned to Cardinal in January of 2014. All aspects of regulatory affairs and pharmacovigilance have been outsourced to Optum. Other compliance-related matters are overseen by Compliance Implementation Services and Beckloff & Associates.
Aligned Management and Board with Product Acquisition Expertise
Members of the Corporations executive management team and board of directors have extensive experience with respect to pharmaceutical product acquisition and operational experience. The Corporations Chief Executive Officer, Mark Thompson, has spent his career in pharmaceutical M&A transactions, having completed over $2 billion of product transactions, and as a result has a strong network of connections within the industry. The Corporations management team is also experienced in early stage pharmaceutical operations, product development, licensing, new product launches and re-launches, sales and marketing. Management and directors of the Corporation also have collective expertise in manufacturing, clinical development and technology transfer. The Corporations Barbados subsidiaries are run by seasoned pharmaceutical executives. In addition, management and the board of directors maintain a material ownership interest in the business in order to further align interests.
Tax-Efficient Capital Structure
By operating the Legacy Pharmaceuticals Division and Orphan Drugs Division through Barbadian subsidiaries, net income of the Legacy Pharmaceuticals Division and Orphan Drugs Division is distributed to the Corporation out of exempt surplus. Profits earned by the Barbadian subsidiaries are subject to a lower corporate tax rate than that of many other jurisdictions and when repatriated to Canada as exempt surplus dividends are not subject to further corporate tax in Canada.
Corporate Operations
The Corporation operates from four primary locations, including its Canadian office located at 277 Lakeshore Road East, Suite 302 Oakville, Ontario L6J 1H9, the Legacy Pharmaceutical Division at 5 Canewood Business Centre, Canewood, St. Michael, BB 11005, Barbados, B.W.I., and the SHD Division located in Kansas City, Missouri, and Pinnacle at Bannockburn, Illinois. The Corporation leases all of its properties. The Corporation believes it has good relationships with its landlords and intends to extend the leases or evaluate desirable alternatives as facility leases approach the end of their terms. Management of the Corporation believes that alternative facilities would be available to the Corporation on market terms. The Corporation does not own any real property.
Employees
As at December 31, 2013, Concordia had 147 full time employees and consultants, none of whom are unionized.
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The Pharmaceutical Market
General
The global pharmaceutical industry is a highly diverse and complex industry generating sales of $962.1 billion 1 in 2012 and is composed of a variety of sectors, including Big Pharma, Specialty Pharma which includes biologics, biotechnology firms, large and small research and drug development organizations that may include orphan drug development companies and generic drug manufacturers. These participants compete for market share based on drug advantages including clinical efficacy and safety, technological innovation or novelty, convenience or ease of administration and cost effectiveness.
The United States is the worlds largest pharmaceutical market with estimated sales of $359 billion in 2012 and that market is expected to reach approximately $475 billion by 2020. Projected CAGR of 3.5% will result in the United States accounting for 54% of the global market by 2020. 2
Total US Pharmaceutical Non-Discounted Sales
United States Pharmaceutical Product Lifecycle
Pharmaceutical products in the United States marketplace follow very similar paths of development from discovery until loss of market exclusivity. This lifecycle includes several key milestones that ultimately affect a products commercial viability and its life-long financial contribution. The key stages in the lifecycle of a pharmaceutical product in the United States can generally be described as follows:
Drug Discovery In the drug discovery phase, researchers identify a target for a new medicine, such as a molecule believed to affect a particular disease, and use the molecule to create thousands of compounds. When a compound is identified that offers the potential to proceed to pre-clinical testing, a patent application is filed claiming the chemical formula that defines the new compound and/or the process by which the new compound is formulated or used. If issued, the patent carries a lifespan of 20 years from the date of filing. During this 20 year period, only the patent holder may use the discovery claimed in the
1 | Source: IMS Health Market Prognosis, June 2013. |
2 | Source: IMS Health (information provided in the table). |
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patent. Due to the risk, high costs and time required to develop new products, industry must prioritize drug development plans and resources based on projections of other new entrants and the market size.
Pre-clinical Testing, Investigational New Drug Review and Clinical Trials Following the discovery process, candidate drugs typically undergo one to three years of extensive pre-clinical laboratory and animal testing to assess safety and demonstrate biological activity against a particular disease. Prior to testing in humans, the drug developer must submit an investigational new drug application to the FDA. Once approval is received, the drug enters three phases of clinical trials, which can take from two to ten years, during which teams of physicians test the new drug to determine its safety and efficacy in patients.
FDA Approval, Product Launch and Growth FDA scientists and advisory committees review all clinical trial results in connection with a new drug application and decide whether the data justifies approval for patient use. Once approved, the drug will be launched into the marketplace. Sales of branded pharmaceutical drugs, often driven by sizeable promotional investment, may rise sharply after introduction as the drug gains popularity and becomes widely prescribed by physicians.
Maturity After several years, sales of a pharmaceutical product may reach a plateau, or continue to grow at a slower rate. While sales patterns vary among products, this phase of the products life cycle is often determined by its efficacy as compared to other newer generation products, promotional and sales force investment, and market capacity and competition. A pharmaceutical product with market exclusivity is defined as being single-sourced with no approved generic equivalent formulation, meaning the branded product is the only product available. Market exclusivity is derived from one or more of the following:
| Patent Exclusivity. Patents granted by the United States Patent and Trademark Office generally have a 20 year lifespan during which time only the patent holder may use the invention claimed in the patent. After this period, the patent expires and the invention becomes public domain, meaning it may be used by anyone. As long as a marketed pharmaceutical product is protected by a patent, that product will generally enjoy exclusivity from generic products and depending on the scope of patent protection, other formulations of the same drug. The time required to complete pre-clinical and clinical trials and to receive FDA approval may be up to 10 years or more. Consequently, most products rarely enjoy the full 20 years of patent protected market exclusivity. |
| FDA Exclusivity. Regardless of patent status, the FDA, upon approving a drug for marketing, grants marketing exclusivity to all newly introduced, innovative pharmaceutical products. The term of the grant is dependent on a number of factors, including the use of the drug, whether the drug already exists in another formulation, and the total number of patients eligible to use the drug. FDA exclusivity can last between six months and seven years, and although this status runs concurrently with patent exclusivity, it is completely independent of any patent protection. With respect to orphan drug products, the FDA provides seven years of exclusivity. |
| Technical and Manufacturing Barriers to Competition. A pharmaceutical product can maintain market exclusivity and remain single-sourced after both patent and FDA exclusivity expire due to technical and manufacturing barriers to competition. |
Economic Barriers to Generic Competition - Sales of a branded product are sometimes too small to warrant the sizable investment necessary to develop and produce a generic formulation of the product. As a result, the product does not face generic competition, thereby maintaining market exclusivity. For approval of a generic product, the FDA requires bioequivalence studies. While not as extensive as a full clinical development plan with an innovative product, a generic drug will be required to demonstrate bioequivalence within an accepted range. Typically, there is no need for a generic manufacturer to
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reproduce any of the clinical studies performed by the drug innovator which is considerably less than discovery. It is for this reason that the generics are predictably less costly than the brands for which they will be substituted. Despite the lesser costs usually incurred by generics, filing costs, bioequivalence studies, packaging and manufacturing and ongoing regulatory requirements do create an economic barrier for generic entries. As a result, if sales of the branded product are relatively low, the expected economic return from sales of a generic product may not justify the significant investment in both time and money required to develop and manufacture the generic product.
An important section of the Hatch-Waxman Act actually encourages generic companies to challenge patents. If a generic company is the first to file its ANDA with a Paragraph IV certification and prevails in the subsequent lawsuit, that generic company is granted a period of market exclusivity of 180 days. The 180-day exclusivity incentive can be significant for a generic company as it would be the only generic version on the market which will allow it to price its product just slightly below the branded version for six months, take market share from the branded product, and maintain its price point before other generics enter the market and erode the price and segment margins. With a recent clarification of the regulations, a Paragraph IV challenge can occur as soon as four years after a product launches.
Following patent expiration and loss of FDA exclusivity and in the absence of technical, manufacturing and economic barriers discussed above, lower-priced generic versions of a branded product will typically enter the market and quickly capture a majority of the market share previously held by the branded product. For most pharmaceutical products, sales fall sharply as a result of multiple generic entrants. Sales of a branded drug will often decline by 80-90% or more in the first year following introduction of generic competition and within three years, sales are frequently less than 10% of peak sales levels. In the event that only one generic competitor enters the market, the decline in sales is generally less severe.
Pre-Legacy Stage - Prior to a products loss of FDA exclusivity a brand name manufacturer may wish to divest its interest in a brand name product. This may occur for a number of reasons including: (i) a companys desire to direct investment elsewhere in its business; (ii) a companys strategic change to focus on other therapeutic areas; (iii) insufficient resources to have a meaningful impact on sales of the brand; (iv) lack of profitability; and (v) low volume. This creates a market of legacy products that are for sale but which maintain a limited period of market exclusivity.
Authorized Generic - An AG is a drug marketed as a generic under private label (unique name). Within the United States marketplace there is a familiarity with AGs by consumers who wish to continue to take the brand name but at a reduced price. The goal of launching an AG is to win market share and have the AG widely distributed prior to LOE. By launching an AG prior to another generic competitor, the brand company can create a revenue stream from the AG, while continuing to receive a revenue stream from brand sales.
Legacy Stage - Management of the Corporation believes a branded product generally maintains up to 10% (and on rare occasions more depending on other factors which are discussed below) of the total market share for the remaining life of the product. This is due to patients with drug plans that reimburse branded products regardless of the presence of generic equivalents or to patients who insist on being prescribed branded versus generic products despite the difference in cost. Therefore, while market share is small, demand for these products remains relatively constant year after year, often with little or no marketing investment. These products are considered legacy products.
Furthermore, as indicated above, some drugs retain market exclusivity beyond the expiration of patent and FDA exclusivity as a result of technical, manufacturing or economic barriers to competition. Since these drugs do not face generic competition, their average market share is generally maintained during this stage of the product lifecycle. These products are also considered legacy products.
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The continuous introduction of new drugs to treat heart disease, cancer, arthritis, diabetes and HIV, as well as the development of lifestyle pharmaceutical products aimed at helping an aging population look and feel younger (e.g., Viagra and Botox), suggests that the pool of legacy products may continue to grow. As these drugs lose market exclusively, they will become legacy products that may eventually be divested by their original owners.
Customers
The Corporation sells most of its pharmaceutical products directly to three major wholesalers in the United States: AmerisourceBergen, McKesson Corporation and Cardinal Health, Inc. Other direct buyers include additional smaller wholesalers and distributors, in addition to certain pharmacy chains and food stores that warehouse the products internally. Additional key customer groups include:
| Physicians and allied health professionals including nurses, physician assistants, and pharmacists. While physicians and allied health professionals are not themselves direct buyers of the Corporations products, they are the key decision-makers in terms of recommending or prescribing the Corporations products to patients. |
| Patients and their families/caregivers. In the United States, patients are faced with having to bear an increasing share of the cost of healthcare. Therefore, the industry has increasingly turned to promotional and educational initiatives that directly target patients and their families. The Corporation does not generally engage in activities that directly target patients, except for the provision of various product and disease specific patient education materials that may be passed along to patients by physicians. |
| Third-party payors such as managed care organizations and group purchasing organizations. Third-party payors, like certain insurance companies and employers, make purchasing and reimbursement decisions based on a number of health outcomes and economic variables. The Corporation does not attempt to influence the historical level of reimbursement for its products. |
| State and federal government health agencies. Certain federal government agencies like the Department of Veteran Affairs, the Department of Defence, prison systems and Indian Health Services may purchase pharmaceutical products directly from the Corporation or provide third-party reimbursement to those that do purchase the Corporations products. In addition, Medicaid programs at the state level may also reimburse patients in the purchase of the Corporations products. The historical utilization/reimbursement activity of the Corporations products for these government agencies has been low and the Corporation expects this to continue. However, as discussed below under the heading Legacy Pharmaceuticals Division - Industry Overview - Medicare Coverage, the 2006 adoption of Part D prescription drug coverage for patients aged 65 and over may expand the potential market for certain legacy products. |
Competitive Conditions
Competitors in the pharmaceutical market range from large multinational pharmaceutical development corporations to small, single product companies that may limit their activities to a particular therapeutic area, region or territory. Competition also comes from generic companies, which develop and commercialize formulations that are identical to marketed brands. The Corporation competes with a variety of drug companies. At the present time only Kapvay is facing generic competition in the market. Orapred is likely to face generic competition beginning in or about April 2014 and generic competition
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for Ulesfia is not expected until 2024 at the earliest. Because of its biologic drug and device combination, Photofrin is unlikely to face generic competition.
With respect to its acquisition strategy, the Corporation competes principally with three types of competitors: (a) other pharmaceutical companies who seek to acquire mature pharmaceutical products as part of their growth strategy; (b) other pharmaceutical companies that are seeking to acquire orphan drug candidates; and (c) companies developing drugs which could one day compete with the Corporations drugs. With respect to the legacy business, these companies, however, typically focus on under-promoted products in specific therapeutic niches that offer growth potential through synergistic sales and marketing efforts. To the Corporations knowledge, few, if any, companies are currently seeking to acquire legacy products solely for the purpose of generating a stream of consistent cash flow. In addition, since the Corporation is not focused on specific therapeutic classes, it has the ability to purchase diversified products and product bundles. With respect to other companies seeking orphan targets, the Corporation leverages its capital structure to provide it with a competitive advantage over its competitors.
Proprietary Protection
The patents associated with Kapvay have expired. Ulesfias several patents expire in stages on August 11, 2017, July 11, 2022 and May 19, 2024 and the patents on Orapred expire on April 9, 2018 and November 24, 2019. PDT with Photofrin is a multi-faceted process (requiring the drug and two Class III devices) for which Concordia maintains proprietorship at multiple levels. Further, Concordia is developing the product for Orphan indications that may receive FDA-granted marketing exclusivity for extended periods.
To protect its products, Concordia relies on trade secrets, know-how and other proprietary information that relates to the manufacture or formulation of the products. These proprietary rights are expected to prevent or reduce the likelihood of competitors copying the Corporations products because of the difficulty in duplicating the formulation and manufacturing process. Without access to this know-how, competitors face significant technological hurdles in attempting to formulate or manufacture competing brands. The Corporations ability to maintain market exclusivity in its products depends, in part, on its ability to maintain these proprietary rights.
Below is a list of the Corporations trademarks along with registration information.
Jurisdiction |
Trademark |
Application Number |
Reg. Number |
Filing Date |
Registration Date |
|||||
United States | Kapvay | 77/864,611 | 4,365,005 | November 4, 2009 | July 9, 2013 | |||||
United States | Orapred | 75/284,813 | 2,185,127 | May 1, 1997 | August 25, 1998 | |||||
United States | Orapred ODT | 78/642,154 | 3,248,392 | June 2, 2005 | May 29, 2007 | |||||
Korea |
|
40-2012-0029768 | 40-0959504 | May 8, 2012 | March 20, 2013 | |||||
United States | Photofrin | 73/437,839 | 1367281 | August 4,1983 | October 29, 1985 | |||||
Canada | Photofrin | 0552103 | TMA347707 | November 7, 1985 | November 10, 1988 |
LEGACY PHARMACEUTICALS DIVISION
Legacy Pharmaceuticals Division Overview
The Corporation operates a healthcare business which includes the management and acquisition of legacy pharmaceutical products, both with patent life and exclusivity remaining (pre-legacy) and products that have reached full maturity but continue on a predictable revenue generation path, collectively referred to as legacy products. Regardless of stage of the life cycle the targeted products have a well-established record of safety and efficacy and a history of stable, predictable prescription demand.
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The Legacy Products consist of Kapvay (clonidine extended release tablets), Ulesfia (benzyl alcohol) Lotion 5%, Orapred ODT (prednisolone sodium phosphate orally disintegrating tablets). Kapvay, Ulesfia and Orapred were acquired from Shionogi in May 2013 for a total consideration of $27.9 million, excluding transaction costs.
In addition to the Legacy Products, the Corporation aims to acquire additional legacy pharmaceutical products that offer stable earnings with modest investment. The Corporation derives synergies within its other businesses and utilizes its expertise in manufacturing, supply and commercialization to enhance profitability. In its Legacy Pharmaceutical Division, the Corporation focuses on products that either enjoy market exclusivity through technical, manufacturing or economic barriers to competition, or otherwise maintain stable and/or predictable prescription demand. The Corporation also focuses on acquiring legacy drugs that have the potential, through further development, to be used to treat additional indications, specifically those indications that may qualify for orphan drug status. The Corporations focus is not therapeutically driven (meaning one specific disease or category of diseases), allowing it to build a diversified product portfolio without being limited to any specific therapeutic class. The Corporation leverages its network of outside functional experts to assist in managing key business functions such as supply, manufacturing, regulatory, medical information and sales and marketing, thereby minimizing the need for significant overhead and providing the flexibility to adapt to market conditions in a timely and cost effective manner.
The following graph sets out the gross revenue by drug in the Legacy Pharmaceutical Division since the first quarter of 2011 and for the forecast period ending the fourth quarter of 2014. The significant revenue decline for Kapvay in the third quarter of 2013 is a result of the introduction of a single generic into the market and the loss of patent exclusivity in October of 2013.
Concordia Net Sales by Legacy Drug
Note: Historical Net Sales are based on IMS data for gross sales up to Q3 2013, adjusted for deductions and chargebacks (normalized historical deductions estimated at 47% for Kapvay, 80% for Orapred ODT, 54% for Orapred OS, and 71% for Ulesfia). Q3 and Q4 figures are based on the Corporations financial information. Forecasts are management estimates from January 2014 forward.
Industry Overview
Management believes that a number of trends in the pharmaceutical industry create a favourable environment for the Legacy Products.
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Demographics
Demographic trends that are expected to maintain or increase the demand for all pharmaceutical products, including legacy products, include longer life expectancies and a growth of older segments of the population.
As is demonstrated by the following chart, the life expectancy of a United States citizen has increased by approximately 8 years since the 1960s.
Life Expectancy
1960 - 2010
As a result of this increased life expectancy, the United States is expected to experience rapid growth of the older segments of its population. According to a Census Bureau report, there were 40.3 million people aged 65 and older on April 1, 2010, up 5.3% from 35 million in 2000 (and just 3.1 million in 1900). Average life expectancy is expected to increase more rapidly over the next decade as more baby boomers turn 65. It is during these later years in life that pharmaceutical consumption increases. More than 10% of older Americans use five or more prescription drugs per month. 3
Trends in the Percentage of Persons Using Prescription
Drugs in the United States
Source: CDC/NCHS, National Health and Nutrition Examination Survey
3 | Qato DM, Alexander GC, Conti RM, Johnson M, Schumm P, Lindau ST. Use of prescription and over-the-counter medications and dietary supplements among older adults in the United States. JAMA 300(24):2867-78. 2008. |
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Demographics Using at Least One Prescription Drug
Source: CDC/NCHS, National Health and Nutrition Examination Survey
Medicare Coverage
In the United States, Medicare, which provides health care coverage for citizens aged 65 and over, currently provides almost no coverage for prescription drugs other than those drugs administered during a hospital stay. Medicare Part D, the outpatient prescription drug benefit, provides seniors and individuals with disabilities access to affordable prescription drug coverage. Part D allows beneficiaries to choose from a range of private plans that best meet their needs. Ninety percent (90%) of Medicare beneficiaries receive comprehensive prescription drug coverage. Part D represented only 10% of Medicare spending in 2012. This third-party reimbursement is expected to enlarge the potential market of patients for prescription drugs, including certain legacy products.
Healthcare Reform - The Patient Protection and Affordable Care Act
The Patient Protection and Affordable Care Act increases the quality, accessibility and affordability of health insurance in the United States. The law prevents patients from being denied insurance due to pre-existing conditions, it prevents insurance companies from dropping patients when they are sick, protects against gender discrimination, expands free preventative services and health benefits, expands Medicaid and CHIP, improves Medicare, mandates larger employers to insure employees and creates a marketplace for subsidized insurance, the result of which provides tens of millions of individuals, families and small businesses with free or low-cost health insurance. Medicaid and CHIP are expanded to provide insurance for up to 16 million of the poorest individuals in the United States.
The implication of this is that the pool of patients that previously did not have access to health insurance and drug reimbursement will expand significantly.
Product Divestitures
Management of the Corporation believes that pharmaceutical companies are increasingly choosing to divest their legacy products for a number of reasons, including, but not limited to:
| Normal Course Divestiture of Non-Strategic Assets. Pharmaceutical companies typically divest products in the normal course of business in order to align their product portfolios with their overall business strategies. |
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| Financially Motivated Divestitures. Pharmaceutical companies may elect to divest products to address specific near-term cash needs or to fund long-term financial goals. |
| Ongoing Industry Consolidation. Consolidation within the pharmaceutical industry has accelerated the trend toward portfolio rationalization as business combinations often result in overlapping, redundant and/or non-core drugs in the merged portfolio. In addition, business combinations may result in the divesture of certain products as required by antitrust or competition authorities. |
| Funding the Development, Acquisition or Licensing of Early Stage Drugs. Big Pharma is seeking to expand internal product pipelines by: (i) increasing expenditures on internal discovery; and/or (ii) acquiring or licensing products from (typically) smaller, research-focused companies. Management of the Corporation believes that Big Pharmas motivation for divesting legacy products relates to its desire to invest the proceeds into development stage products, thereby expanding the number of promising new products in the pipeline. |
| Reallocation of Manufacturing Resources. In certain instances, the continued manufacturing of lower-volume products becomes economically unattractive to Big Pharma. Big Pharma often seeks to optimize manufacturing resources by divesting lower-volume products when opportunities exist to reallocate manufacturing capacity to newer, more strategic or higher volume products. |
As a result, management of the Corporation believes that there is an active market for the acquisition and divestiture of legacy products and that this market will continue to grow. Management of the Corporation has identified more than 100 transactions that have occurred in the United States since 2001 involving the divestiture or acquisition of approximately 130 pharmaceutical products, many of them legacy products.
Government Regulation
The Corporation utilizes Optum as its provider of regulatory affairs services, medical and drug information provision, and quality assurance services. These services include storage and maintenance of all regulatory dossiers, all routine and ad-hoc reporting and communications with the FDA and adverse drug reporting and provision of medical information relating to the products to physicians and patients. The Corporations outsource agreement with Optum provides for a cost of service which is fixed for normal functions associated with the medical and regulatory maintenance of the products, with additional costs based on an hourly consulting rate for services as may be needed outside of normal maintenance. Optum is owned by United Healthcare in the United States and currently services a large number of North American and European pharmaceutical and biotechnology companies in similar capacities.
In addition to providing regulatory, pharmacovigilance and medical information services, Optum also provides expert market access strategies for the pharmaceutical, healthcare and biotech industry. Optums senior consultants have extensive pharmaceutical regulatory consulting experience. As one of the largest regulatory affairs and market access consulting firms in North America, Optums volume of product submissions is often larger than that of many biotechnology and pharmaceutical companies.
The Corporation also outsources to Optum all activities that typically involve written responses to questions from patients or healthcare providers regarding the Corporations products. The Corporation, through Optum, has established a dedicated toll-free phone number and mailing address for these drug information requests.
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Legacy Products - Kapvay
Overview
A class of drugs called psychostimulants or stimulants have been used to effectively treat ADHD for several decades. These medicines help those with ADHD to focus their thoughts and ignore distractions. Stimulant medications are effective in 70% to 80% of patients. 4
This class of drugs is used to treat both moderate and severe ADHD. They may be helpful in children, adolescents, and adults who are having difficulty with ADHD symptoms at school or at work, as well as at home. Some stimulants are approved for use in children over three, while others are approved for children over six.
Kapvay (clonidine), a non-stimulant treatment for ADHD, is the newest entry into the market and was approved on September 28, 2010. Kapvay is the only formulation of clonidine hydrochloride approved by the FDA for the treatment of ADHD, and is the first and only FDA-approved non-stimulant ADHD treatment indicated for use as add-on therapy to stimulant medication. Kapvay can also be used as monotherapy when treating ADHD. The underlying molecule, clonidine has other uses such as the treatment of high blood pressure.
Market
ADHD is the most frequently diagnosed childhood psychiatric disorder, affecting 11% of school-aged children in the United States. 5 A total of $7.2 billion was spent in ADHD medication in the United States in 2011. 6 The United States accounts for 90% of the global ADHD market and the United States ADHD drug market has grown at a CAGR of 20% since 2000.
In cases where stimulants do not work or cause unpleasant side effects, physicians may prescribe Kapvay. The first non-stimulant medication approved by the FDA was Strattera. It is now used in children, adolescents, and adults. The FDA then approved a second non-stimulant drug, Intuniv, for children and teens between ages 6 and 17 and recently approved the non-stimulant Kapvay for use alone or in combination with a stimulant to enhance effectiveness. These medications can all improve concentration and impulse control.
The following graph sets out the units of Kapvay sold since introduction into the market in 2010 as compared to Strattera and Intuniv, the only other non-stimulant pharmaceutical treatments for ADHD. Kapvay has successfully captured 7% market share in this period and should continue to benefit from being the only approved non-stimulant treatment that can be used in combination with traditional stimulant drugs (Ritalin) to treat ADHD.
4 | WebMD. |
5 | Source: New York Times ADHD Seen in 11% of US Children as Diagnosis Rises Alan Schwarz March 31, 2013. |
6 | Source: New York Times ADHD Seen in 11% of US Children as Diagnosis Rises Alan Schwarz March 31, 2013. |
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Non-Stimulant ADHD Treatments
Source: Wolters Kluwer
The following graph sets out the number of Kapvay pills sold since Q1 2011. Since the purchase of Kapvay from Shionogi, the Corporation has implemented three price increases with no adverse impact on volumes. The decline in volumes in the forecast period is a result of the entry into the market of a generic alternative to Kapvay.
Kapvay
Unit Sales and Price
Source: IMS for historical data up to Q3 2013. The Corporations financial information for Q3 and Q4 2013. Management estimates for forecasts from January 2014.
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Marketing Strategy
From the time of the acquisition of Kapvay by Concordia Private Co., the Corporation understood that LOE (the FDA exclusivity) was imminent. This dictated a maintenance marketing strategy. Promotion for Kapvay has been limited to direct mail and ongoing support for the Kapvay co-pay assistance card program. The two initiatives were combined to ensure an ample supply of co-pay cards in targeted physicians offices. Price increases were implemented in July 2013 (35%), September 2013 (6%) and January 2014 (5%).
Competition
Other than new generics for Kapvay (see Legacy Pharmaceuticals Division - Products - Kapvay - Genericization of Kapvay below) there is no competitor to Kapvay which is an FDA approved non-stimulant ADHD treatment indicated for use as add-on therapy to stimulant medication such as Ritalin.
Genericization of Kapvay
Par Pharmaceuticals entered the market on October 7, 2013 with a generic entrant to Kapvay. To date, Par Pharmaceuticals represents the only generic threat to Kapvay.
The following chart sets out the decline rate of a sub-set of CNS drugs post-genericization alongside the decline rate curves modeled for Kapvay that management has forecasted. The Corporations management considers the decline of prescriptions for Kapvay to a normalized state of 9.5% of pre-genericization levels to be a conservative estimate based upon normalized levels experienced for pediatric CNS drugs.
Branded CNS Products
Total Prescription Market Share Erosion
Kapvay forecast includes only branded market share retained.
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Legacy Products - Orapred
Overview
Orapred (prednisolone) is a corticosteroid used in the treatment of pediatric asthma. The OS was approved on December 14, 2000, and the ODT formulation was approved on June 1, 2006. Orapred ODT is indicated for the control of severe or incapacitating allergic conditions such as atopic dermatitis, and seasonal and perennial allergic rhinitis which are intractable to adequate trials of conventional treatment.
Many oral corticosteroids have a very bitter taste that discourages patients from correctly taking their medication for the full duration of their treatment plans. Orapred ODT was developed with a truly unique and effective taste masking technology, using a tri-layer process that encapsulates the active ingredient deep inside the tablet. It is the first and only orally disintegrating prednisolone tablet and was developed to be both patient-friendly and caregiver-friendly.
Market
Asthma affects 7 million children in the United States and is the most prevalent pediatric chronic condition. Of asthmatic children, 45.7% receive benefits from Medicaid or other publicly funded programs. 7 Orapred ODT currently holds 4.0% of prednisolone market share. 8
The following graph sets out the market share for Orapred as well as the branded and generic competitor prednisolone drugs in the market. The graph illustrates Orapreds leading position among branded prednisone products.
Prednisolone Market
Source: Wolters Kluwer
7 | Source: IMS. |
8 | Source: IMS. |
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The following graph sets out the historical quarterly unit sales and price of Orapred ODT as well as the Corporations forecast volumes through Q4 2014. The forecast decline in Q2 2014 is due to the entry of Mylans generic into the market.
Orapred ODT
Unit Sales and Price
Source: IMS for historical data up to Q3 2013. The Corporations financial information for Q3 and Q4 2013. Management estimates for forecasts from January 2014.
Marketing Strategy
The Corporation is reviewing opportunities with a generic drug manufacturer to produce an authorized generic for the Orapred ODT product. The Corporation continues to focus its efforts on the existing marketing plan which emphasizes Orapreds taste-masking technology which is both kid and parent friendly.
Competition
There are several generic prednisolone, and prednisone preparations available in the market. However, these preparations have a very bitter taste. Orapred ODT is the only orally disintegrating tablet that has a pleasant taste. Accordingly, parents of patients typically prefer Orapred ODT as it is easier to administer to their children.
Genericization of Orapred
Shionogi entered into a Paragraph IV settlement with Mylan that will allow Mylan to launch a generic Orapred ODT on April 1, 2014. Management of Concordia is currently reviewing authorized generic opportunities for Orapred and intends to implement an authorized generic strategy.
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Legacy Products - Ulesfia
Overview
Ulesfia is a topical treatment of head lice in patients 6 months of age and older and was approved by the FDA on April 9, 2009. It is the only prescription head lice product that is not an insecticide. Patents for Ulesfia expire on August 11, 2017, July 11, 2022 and May 19, 2024. Expiration of such patents may bring about additional competition. However, Ulesfia will be more difficult to genericize because it is a topical treatment and there is no current generic pathway to develop a generic version of Ulesfia.
Ulesfia Lotion is a white topical lotion containing benzyl alcohol, 5% (50 mg/g of lotion) and comes as a package containing two individual 8 fl. oz. polypropylene bottles with a nit comb. Ulesfia Lotion is non-neurotoxic and is used as part of an overall lice management program that includes the use of a fine-tooth comb or special nit comb to remove dead lice and nits (eggs).
Ulesfia Lotion works by suffocating head lice. The active ingredient stuns the breathing holes, or lungs, of head lice. The other ingredients then clog the breathing holes, killing the lice. There is evidence that head lice are becoming resistant to some treatments. Ulesfia has a unique mode of action and is intended to work in such a way that resistance is reduced.
Market
There are over 12 million head lice infestations annually in the United States. Of treated cases in the last year, 85% were treated with OTC products and 15% with prescription products. 9 Ulesfia currently enjoys a market share of approximately 31% of prescription sales and is the second largest prescription product based on unit volume.
The following graph sets out product volume sold by Ulesfia and its prescription competitors, as well as OTC competitive products for the treatment of head lice. The graph illustrates the leading position held by Ulesfia among the prescription drug treatments, as well as the potential market share gains available to the Corporation through capturing OTC sales in treating this condition.
Pediculosis Treatements
Source: Wolters Kluwer, IMS
9 | Source: IMS. |
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The following chart illustrates the sales volume by quarter achieved by Ulesfia since 2011. Management of the Corporation believes that volume sales will continue to rise notwithstanding the price increase due to the products positioning as the only non-insecticidal treatment for head lice. As this is a prescription product, it is reimbursable under prescription drug plans, a key benefit over OTC products.
Ulesfia
Unit Sales and Price
Source: IMS for historical data up to Q3 2013. The Corporations financial information for Q3 and Q4 2013. Management estimates for forecasts from January 2014.
Marketing Strategy
Ulesfia will enjoy market exclusivity for the foreseeable future and management expects that a generic entry for Ulesfia is not likely given that: (a) there are three listed patents; and (b) there is not a clear pathway at present for generic lotions.
The Corporation continues to support its favorable position in various states within the United States with Medicare reimbursement. This supports both those patients who rely on Medicare but also enhances physician attitudes and drives the non-Medicare use of Ulesfia. Co-pay assistance coupons will continue for those patients with insurance.
Distribution Agreement with Lachlan Pharmaceuticals
On January 6, 2014, the Corporation announced that it entered into an Exclusive Distribution Agreement with Lachlan Pharma Holdings ( Lachlan ), a global pharmaceutical company, with a term of five years for the exclusive distribution of Ulesfia Lotion in the United States. Lachlan has an agreement with Zylera Pharmaceuticals, LLC ( Zylera ) to commercialize Ulesfia Lotion in the United States.
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The Exclusive Distribution Agreement for Ulesfia Lotion with Lachlan provides the Corporation with access to Zyleras sales force, as well as its wholesale and retail network. The Corporation believes that this partnership should help grow the existing sales of Ulesfia Lotion across the United States.
Competition
There are a number of OTC and prescription drug treatments for head lice. OTC products currently constitute the majority of sales for treatment of this condition. Of the prescription drug treatments, Ulesfia is a market leader as it is able to leverage its brand and positioning as the only non-insecticide prescription treatment. Other prescription treatments include Stromectol marketed by Merck, Lindane marketed by Morton Grove Pharmaceuticals, and Ovide which is marketed by Medicis (Valeant).
SPECIALTY HEALTHCARE DISTRIBUTION DIVISION
SHD Division Overview
The SHD Division was acquired in October, 2013, with an effective date of August 1, 2013. Concordia Private Co. acquired the SHD Division for total consideration of $15 million inclusive of a $7 million vendor note. In addition, there is the potential for a vendor to receive additional consideration of up to $4 million if the Corporation meets certain performance metrics. See General Development and Description of the Business. The SHD Division is a nation-wide provider of diabetes testing supplies, pharmaceuticals, diabetic shoes, orthotic braces and other HME in the United States.
The SHD Division operates primarily out of an office and warehouse facilities located in and around Lenexa, Kansas, fifteen miles south of Kansas City, Kansas. The Corporation is in the process of consolidating the office and warehouse locations into a single location which is expected to result in the SHD Division realizing greater operating efficiencies.
The SHD Division provides a reliable method for its patients to obtain medical supplies through the mail. It has created a completely seamless process for the customer by directly billing insurance companies, collecting and maintaining prescriptions, ordering and delivering the goods to the customer, while keeping the customer informed throughout the process. The SHD Division has invested substantially in the area of diabetes education for its customers. Every product sent to customers includes valuable diabetes-related educational materials, an informative newsletter and recipes. Customers with online connectivity may access the Corporations extensive resource library at the website: www.myrewards.globalmeddirect.com, which contains a wide variety of educational materials about diabetes as well as the latest news and information on a number of related topics such as Medicare. The SHD Divisions customers can also access an interactive blog which helps increase the awareness of diabetes-related illnesses and also fosters a sense of community amongst the customer base. The SHD Division maintains a quality control program which monitors customer satisfaction, and has maintained a satisfaction rating exceeding 93% in all categories.
Industry Overview
United States domestic healthcare spending is expected to increase by approximately $2.1 trillion from $2.7 trillion in 2011 to $4.8 trillion in 2021, according to the CMS.
The Corporations Specialty Healthcare Distribution Division has historically targeted seniors and diabetics. As the baby boomer population ages, CMS estimates that the number of Americans over the age of 65 will increase from an estimated 42.1 million in 2012 to 55.9 million in 2021. According to research by the Robert Wood Johnson Foundation, over 90% of Americans over the age of 65 have at
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least one chronic condition, and over 70% of this population has multiple chronic conditions. The Corporations SHD Division is currently seeking to expand into specialty distribution and pediatrics.
According to HME News, the current home health care market is a highly fragmented industry of over 100,000 companies, with about 60 companies having annual sales in excess of $10 million. The products that the Corporation distributes are classified as durable medical equipment. CMS estimates that the national expenditures within the DME market will increase by over $30 billion from $39.7 billion in 2011 to $70.7 billion in 2021. The number of DME companies with Medicare billings less than $300,000 has been declining, or consolidating, over the last few years according to HME News, primarily as a result of increased Medicare accreditation and bonding requirements implemented in 2009.
Diabetes Market
In 2012, there were approximately 25.8 million children and adults in the United States that have diabetes, which is 8.3% of the population. Of this 25.8 million, 18.8 million people have been diagnosed with diabetes and an additional 7 million people are undiagnosed. There were 1.9 million new cases of diabetes diagnosed in people over the age of 20 in 2010.
The cost of the total diagnosed diabetes market in the United States in 2012 was $245 billion, which breaks down to $176 billion in direct medical costs and $69 billion in reduced productivity. The total estimated costs of diagnosed diabetes have increased 41% to $245 billion in 2012 from $174 billion in 2007, a compound annual growth rate of 7.1%. Most of this cost for diabetes care in the United States, (62.4%) is provided by government insurance (including Medicare, Medicaid, and the military). The rest is paid for by private insurance (34.4%) or by the uninsured (3.2%). 10
Medicare Competitive Bidding
On July 1, 2013, CMS implemented a national mail-order competitive bidding program for diabetes testing supplies. Beneficiaries with Medicare benefits who obtain their diabetes testing supplies through the mail have been required to obtain their supplies from a contracted supplier.
Medicare states that the Medicare Bidding Program replaces the outdated prices Medicare has been paying with lower, more accurate prices. Under this program, suppliers submitted bids to provide certain medical equipment and supplies at a lower price than what Medicare had previously paid for these items. Medicare used these bids to set the amount it would pay for equipment and supplies under the competitive bidding program. Qualified, accredited suppliers with winning bids were chosen as Medicare-contract suppliers.
Medicare states that the program will save money, ensure beneficiary access to quality medical equipment, supplies and services from suppliers who are trustworthy and will help to limit fraud and abuse in the Medicare program. Implemented on July 1, 2013, the diabetes testing supplies are a nationwide item that Medicare beneficiaries must obtain from one of the 20 companies that was awarded a bid, or obtain their supplies from their local pharmacy.
Government Regulation
The FDA and comparable regulatory agencies in state and local jurisdictions and in foreign countries impose substantial requirements on the distribution and marketing of pharmaceutical and other healthcare products. These agencies and other federal, state and local entities regulate quality control, safety,
10 | Source: American Diabetes Association. |
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effectiveness, labelling, packaging, storage, handling, distribution, record keeping, approval, advertising, and promotion of pharmaceutical products.
The Corporations operations are also subject to federal and state anti-kickback laws. Such laws prohibit entities such as Concordia from knowingly and willingly offering, paying, soliciting or receiving any form of remuneration (including any kickbacks, bribe or rebate) in return for the referral of items or services for which payment may be made under a federal health care program, or in return for the recommendation, arrangement, purchase, lease or order of items or services for which payment may be made under a federal health care program. Violation of the federal anti-kickback law is a felony, punishable by criminal fines and imprisonment for up to five years or both. In addition, the Department of Health and Human Services in the United States may impose civil penalties and exclude violators from participation in federal health care programs such as Medicare and Medicaid. Many states have adopted similar prohibitions against payments intended to induce referrals of products or services paid by Medicaid or other third-party payors.
SHD Division Operations
The SHD Division has streamlined its processes, beginning with the intake of the customer from the lead generation source, to shipment of the customers supplies from the warehouse, and through to the periodic reorder process. The operations of the SHD Division are one of its key success factors, with a highly trained, professional staff of 133 employees (including the sales team) that services its customer base. The following operational functional descriptions apply to the majority of the SHD Divisions business.
Lead Generation
The SHD Division works with lead generation companies who conduct marketing campaigns primarily through the internet. The SHD Division works with these companies to gain new customers who have a need and inclination to receive their diabetes testing supplies through the mail. Customer service representatives are specifically trained to communicate with customers, helping them to follow their doctors orders and manage their chronic diseases.
Enrolment
Pre-qualified leads from the lead generation company are provided to the SHD Divisions Enrolment Department. The SHD Divisions enrolment representatives then contact the customers and verify information that the customer has provided to the lead generation company, including matters related to benefits and insurance status, after which the enrollment representative proceeds with the sales process.
The Enrollment Department handles each account according to HIPAA and regulations and ensures the accuracy of the customer information is accurate. The Enrolment Department also educates customers on the SHD Divisions product offerings, as well as the benefits and advantages of working with the Corporation. This department maintains a record of success with an average of approximately 88% of qualified potential customers agreeing to partner with the Corporation for their diabetes testing supply needs.
Document Retrieval
The Document Retrieval Department is responsible for obtaining new prescriptions, refill prescriptions and medical documentation. The department employs staff review prescriptions. Prescriptions are received through a utility, which collects and sorts all faxes received. The employees that review the
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prescriptions review approximately 150 prescriptions each day for accuracy and completeness. The prescription is verified for completeness and accuracy and then saved to the customers medical file.
Insurance Department
Once a valid prescription has been received, the Insurance Department is notified and then verifies the customers insurance coverage. This is where it is determined whether the supplies will go through the customers medical or pharmacy benefit. Employees in the Insurance Department are specialized in verifying the customers eligibility and benefits with the insurance companies with whom the Corporation has contracts (the Corporation has contracts with approximately 50 insurance companies). Each specialist can verify benefits for up to 200 customers per day. Once the customer has a valid prescription and their insurance benefits have been verified, the order is set up in the system, and is made ready for shipment.
Pharmacy
The SHD Division has a full-service pharmacy with accredited and licensed pharmacists on staff and with sufficient resources to nationally service a wide customer base with multiple products. This pharmacy has full fulfillment capacity and can ship medications across the United States. The SHD Division strives to expand the delivery of medications to existing customers and expand its product offerings into niche medications that diabetics administer.
The Corporation is developing the specialty pharmacy aspect of this pharmacy operation, and intends to flow additional pharmaceutical products, including its own proprietary products and potential orphan drugs, through the SHD Divisions pharmacy.
Warehouse and Shipping Department
Once the pharmacy adjudication has been done or the medical order set, the packing slips are mass printed and sent to the warehouse to fulfill the orders. When the supplies are picked, they are scanned individually and confirmed in the system immediately. The warehouse typically holds less than 20 days worth of inventory at any given time.
Reorders Department
If a customer receives supplies through their medical benefit, the Reorders Department is primarily responsible for processing those customers orders. Each time a reorder of supplies is due to be shipped, the reorder representative calls and confirms the order with the customer. While speaking with the customer, the reorder representative also educates the customer on the other pain and life management products offered by the SHD Division, in order to seek additional sales.
The function of the Reorder Department is to process and ship as many orders as possible each month, with an average process rate of approximately 1,800 orders per month.
Customer Service
The Customer Service Department is a key strength of the SHD Division, with employees handling upwards of 400 calls per day and taking a personal interest in each customer that calls in. When someone calls into the 800 number, they do not receive an automated prompt. The SHD Division remains committed to the personal touch that comes with interacting with a live agent every time.
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Billing Department
The Billing Department collects payments on an average of 1,700 claims billed per day. The average Days Sales Outstanding, which is the average number of days to collect on receivables, is 50 days. Maintaining a lower than average denial rate, the Billing Department is efficient at following up on outstanding claims, as well as resubmitting when there are billing errors, and decreasing the amount of write offs.
SHD Division Products
The following are some of the key products of the SHD Division.
Diabetes Testing Supplies and Pharmaceutical Products
The SHD Division provides a full range of diabetic testing supplies required to meet the Corporations customers needs, including: test strips, blood monitoring equipment/meters, lancets, lancing devices, control solutions, batteries, etc. Diabetic testing supplies comprises the majority of the total revenue of the Corporations SHD Division (approximately 75%). If a customer has an insurance provider other than Medicare, the SHD Division provides supplies for these customers and accepts assignment of insurance. Most of the diabetes supply business now runs through the pharmacy as most insurance plans consider these supplies to be part of the pharmacy benefit.
The SHD Division carries major brands of testing supplies, including: Bayer, Roche, Lifescan, and Abbott. Additionally, generic products are sold (e.g., approximately 50% of the test strips sold are generic products).
Diabetic Footwear
Diabetes causes nerve damage and reduced circulation that can be hazardous to feet. Deterioration of peripheral nerves is called neuropathy, which reduces sensation in extremities. Poor blood circulation can also make it difficult for foot injuries and infections to heal. Even a small bump or cut can result in serious consequences if it does not receive timely medical attention. Prescription diabetic footwear can help prevent more serious foot health complications that can arise as a result of diabetes.
Within their lifetime, 14% of people with diabetes will experience a foot ulcer and between 14% and 24% of those with a foot ulcer will require amputation. Diabetes is the leading cause of amputation of the lower limbs. At least half of these amputations might be prevented through simple but effective foot care practices. At least half of the amputations that occur each year in people with diabetes can be prevented through screening for high risk customers and the provision of proper foot care.
In partnership with Dr. Comfort® custom footwear, the SHD Division has become a national leader in providing diabetic footwear to customers across the United States. Customers have access to one of the largest networks of pedorthists and certified shoe fitters in the United States. The leadership and extensive coverage in the pedorthic area provides customers with a one-on-one, in-home fitting for their diabetic shoes. This benefit to customers results in substantial healthcare savings to both public and private insurance carriers due to the reduction in lower extremity complications.
The SHD Division has a staff of pedorthists and certified shoe fitters across the United States, who service customers for diabetic shoes. Customers who are enrolled in Medicare or a Medicare Advantage plan may be eligible to receive one pair of diabetic shoes and three pairs of inserts every calendar year. A certified diabetic shoe fitter sets up an appointment to have the customers feet measured. An impression
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of the foot is taken so that custom inserts can be manufactured specifically to the customers foot. The SHD Division carries recognized brands of shoes and inserts (e.g., Dr. Comfort, MMar, Ped-Lite).
Wound Care Supplies
Fifteen percent (15%) of all diabetic patients develop a lower extremity wound. Each year there are approximately 82,000 diabetic amputations in the United States. Complications with diabetes make it more difficult for wounds to heal, including nerve damage, a weakened immune system and narrow arteries. The SHD Division has teamed with DeRoyal wound care products to present the customer with an easy to use, seamless process for obtaining their wound care supplies. The SHD Division and DeRoyal work closely with the doctor to determine a treatment approach and stay in touch with the doctors office and the customer to ensure proper healing of the wound. With DeRoyals industry leading products and the SHD Divisions superior customer service and delivery model, the Corporation believes that receiving wound care supplies through the mail has never been easier.
Urologicals Catheters
There are many reasons that someone may require a urinary catheter. The SHD Divisions Catheter Supply Specialists are trained on products for both male and female catheterizing, and the Corporation supplies an extensive line of catheter supplies available to its customers. The catheter-related business of the SHD Division is not limited to diabetic customers.
Other Products
The SHD Division also sells orthotic braces, continuous positive airway pressure ( CPAP ) supplies, hospital beds, wheelchairs, oxygen supplies, and therapeutic products for the treatment of erectile dysfunction.
SHD Division Marketing
The SHD Division operates through the trade name Complete Medical Homecare. The SHD Division has historically undertaken a number of different approaches to marketing its products, including the following:
| inserting box stuffers with shipments to promote some of its other products (e.g., CPAP, Wound Care products, Catheters); |
| managing a reward program, whereby customers were rewarded with various gifts for their loyalty (e.g., diabetic cookbooks); |
| utilizing national online advertising techniques to promote diabetes testing supplies; |
| listing advertisements in local newspapers; and |
| distributing coupons within shipments, as well as posting coupons on the Corporations website. |
SHD Division Suppliers
The SHD Division sources its products from over 25 manufacturers. As sales volumes have increased, partnerships have been developed with large manufacturers, enabling the Corporation to obtain preferred pricing and maintain a readily available supply of products for its customers medical necessities.
For the product areas of wound care supplies and urinary catheters, the Corporations SHD Division developed a relationship with Invacare Supply Group, now Independence Medical. With this relationship in place there is access to fifty or more manufacturers. For these product areas, the Corporation often utilizes Independence Medicals drop ship capabilities.
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The SHD Divisions supplier/manufacturer base includes industry-recognized names such as: Diamond Diabetics Products (meters and supplies), Omnis, Biosense, Arkray, Dr. Comfort and Medicine. The SHD Divisions supplier/manufacturer base is managed through the Corporations Barbados office.
SHD Division Competition
The largest competitors to the SHD Division are Liberty Medical, Liberator Medical, CCS Medical, Arriva Medical, Walgreens, Target, Wal-Mart and CVS Pharmacies.
Management believes that the Corporations SHD Division sets itself apart from its competition by its superior customer service which includes: (a) a personal touch live customer care coordinators versus an automated phone service that many of the competitors use, and (b) a seamless, efficient processing environment.
The subsector of specialty pharmaceutical distribution is dominated by AmerisourceBergen which carries 54% of market distribution through three subsidiaries. Other distributors and their market shares, respectively, are McKesson Specialty (24%), Curascript SD (5%), Metro Medical (4%) and others (13%).
Corporate Compliance
The SHD Division is nationally accredited to conduct Medicare-related business. The SHD Division has strengthened its Corporate Compliance Program. It maintains an ongoing training program for its employees, which includes education on compliance with HIPAA and Medicare regulations, as well as industry and product training. The SHD Division has in place monitoring and auditing processes that allow the detection and prevention of compliance-related issues. The Corporation has implemented a thorough training program for the employees of the SHD Division, educating them on the rules surrounding the method with which customers can be solicited. Each employee is required to take a class and certify their understanding, compliance and adherence to the issue. Additionally, the Corporation has contracted the full-time services of a Medicare Auditor to ensure that appropriate internal controls are in place to assure full compliance. The Medicare Auditor has been dedicated to reviewing and improving the compliance-related processes across the Corporations SHD Division.
Medicare Competitive Bidding
On July 1, 2013, CMS implemented the Medicare Bidding Program for diabetes testing supplies. Under this program, Medicare beneficiaries must obtain their diabetes testing supplies from one of the 20 companies that were awarded a contract, or obtain their supplies from their local pharmacy. The SHD Division did not apply for a contract under that competitive bidding program and elected to focus on private insurance.
The SHD Division was awarded contracts under Medicare Bidding Program for other selected medical equipment, including hospital beds and oxygen.
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ORPHAN DRUGS DIVISION
Orphan Drugs Division Overview
The Orphan Drugs Division is intended to provide growth opportunities through the expansion into new indications for existing legacy products or the acquisition of approved orphan drugs and further expansion within their identified markets. In the initial execution of its orphan drug strategy, Concordia Private Co., through its subsidiaries, acquired Pinnacle. Pinnacles pharmaceutical product was approved by the FDA to treat three rare forms of cancer.
Orphan and specialty products require a direct relationship with patients and doctors and require that the distributor of these products have the capacity to carry-out these functions. As many of these products are shipped just in time for administration, the distributor must have the pharmacist and distribution channel that will enable the doctors to liaise directly with the distributor. Moreover, after administration, the nursing staff within the distributor will have direct contact with the patients to monitor patient outcomes.
These are high value distribution activities. By carrying out these activities within the SHD Division, the Corporation ensures that specialty and orphan products are delivered on a timely basis and that there is direct accountability for the supply of these products. The SHD Division also has the capacity to carry-out the direct-to-patient dialogue through its nursing staff in order to ensure the best possible patient outcome. By having the capacity to carry-out these functions internally, the Corporation ensures control over the distribution of high value products.
Industry Overview
The OD Act provides the framework for drug development to support the research of drugs for rare diseases. The OD Act defines rare diseases as those with prevalence of disease in the population of less than 200,000 people. Alternatively, the OD Act states that when the drug developer could have no reasonable expectation of profitability after developing a drug for a rare disease in the United States, the FDA may designate such a product as an orphan drug.
The worldwide orphan drug market was estimated to be $50 billion in 2011. The CAGR of the orphan drug market between 2001 and 2010 was 25.8%, compared to only 20.1% for a matched control group of non-orphan drugs.
The OOPD states that its mission is to advance the evaluation and development of products that demonstrate promise for the diagnosis and/or treatment of rare diseases or conditions. In fulfilling that task, OOPD evaluates scientific and clinical data submissions from sponsors to identify and designate products as promising for rare diseases and to further advance scientific development of such promising medical products.
The OOPD also provides incentives for sponsors to develop products for rare diseases. The program has successfully enabled the development and marketing of more than 400 drugs and biologic products for rare diseases since 1983. In contrast, fewer than 10 such products supported by industry came to market between 1973 and 1983. The Orphan Grants Program has been used to bring more than 45 products to marketing approval.
The National Institute of Health currently lists approximately 7,000 rare diseases, the majority of which are heritable or congenital and which affect approximately 25 million Americans. To receive orphan designation, a drug manufacturer must: (a) certify that the product is for a rare condition; (b) provide a scientific rationale for using the drug for that rare condition; and (c) provide supporting epidemiologic data.
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Once a disease has obtained the orphan designation, the OD Act provides the manufacturer of a product that treats the orphan disease the following benefits: (a) 7 years market exclusivity from the date of approval, meaning that no generic competitor can enter the market regardless of whether the innovator has a patent; (b) federal tax credits equal to 50% of clinical research expenditure to aid in the funding of development; (c) an exemption from the fee for FDA approval which fee is in excess of $1.1 million; and (d) priority FDA review (accelerated approval process).
During the first two decades of the OD Act, treatments were developed and marketed primarily by biotech start-ups that evolved to become major pharmaceutical companies including Genentech, Celgene, Genzyme, Shire HGT, and BioMarin Pharmaceutical. Genentechs product Rituxan, an oncology treatment, is the second most profitable drug in the world with an estimated present value of over $150 billion. This evolution was in part due to development programs that go beyond the original disease and repositioning with other rare diseases or expansion of the diseases or indications for which the drug was initially developed.
Management of the Corporation believes that orphan drugs are particularly attractive for two other reasons: (a) these products have tended to be priced higher than traditional pharmaceutical products; and (b) the selling and promotional expenses are substantially lower than for traditional pharmaceutical products and physician uptake is much faster given the relatively small targeted population.
The following table sets out a sample of orphan drug treatments approved in the United States. Of significance are the accepted annual treatment costs which drive the relatively high revenues and margins in an otherwise small market (incidence of disease among total population).
Company |
Product |
Indication |
Incidence | Annual Treatment Cost | ||||||||
BioMarin |
Kuvan | Phenylketonuria | 1-2/20,000 | $ | 80,000+ | |||||||
Genzyme |
Cerezyme | Gaucher Disease | 1/20,000 | $ | 165,000+ | |||||||
Genzyme |
Myozyme | Pompe Disease | 1/40,000 | $ | 300,000+ | |||||||
Shire |
Elaprase | Hunter Syndrome | 1/81,000 males | $ | 300,000+ | |||||||
Genzyme/BioMarin |
Aldurazyme | MPS I | 1/100,000-600,000 | $ | 175,000+ | |||||||
BioMarin |
Naglazyme | MPS VI | 1/250,000-600,000 | $ | 300,000+ | |||||||
Alexion |
Soliris | aHUS | ~2/1,000,000 | $ | 409,000+ | |||||||
Alexion |
Soliris | PNH | 1-5/1,000,000 | $ | 409,000+ |
Source: Torreya Partners
As orphan drugs target very rare diseases, the physician community that treats patients with a specific orphan disease is typically very small. As a result, communication with this physician base requires a much smaller number of sales representatives. Where a drug treats a prevalent indication such as high blood pressure there are thousands of physicians that treat the disease and thousands of sales representatives are required to market the drug. Additionally, the uptake of the drug by the physician base is typically much faster as the disease state may have no alternate therapy.
In reviewing orphan drug opportunities, management of the Corporation seeks products that are: (a) already approved for one indication but can be developed to treat other indications; or (b) are already being used for a specific disease state but are not yet approved by the FDA. In certain cases, a product may already be approved for a specific indication, but the company lacks the resources to continue the development for the follow-on indication. As the product is already approved, its safety and efficacy have been reviewed and accepted by the FDA.
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In many cases orphan drugs will generate less than $100,000,000 in sales. As a result, these drugs are not attractive to larger pharmaceutical companies as they do not provide sufficient return for these companies. Management of the Corporation believes that there are several attractive orphan drug candidates available and the Corporation may seek to acquire such products.
PDT with Photofrin
Pinnacle Biologics Inc.
On November 8, 2013, Concordia Private Co. and its subsidiaries entered into the Pinnacle Purchase Agreement. The acquisition of Pinnacle was completed on December 20, 2013. The Corporations European subsidiary, Pinnacle Biologics BV, is a Netherlands private limited liability entity, and is a wholly-owned subsidiary of Pinnacle. The entity was established in 2008 to commercialize pharmaceutical products outside of North America, consistent with the overall strategy of Pinnacle. Pinnacle Biologics BV has no employees; Dutch operations are managed through a service agreement with Trust Company Amsterdam. Compagnie Biologiques Pinnacle is a Quebec, Canada, entity incorporated to employ individuals residing in Canada, and is a wholly-owned subsidiary of Pinnacle. Pinnacle Oncology LLC is a partnership between Pinnacle, the University of Chicago and two individuals associated with the university. The purpose of this entity is to develop Pinnacle Oncology LLCs licensed patents to bring pharmaceutical products to the market in the field of protection against genotoxic mutagenesis.
Photodynamic Therapy with Photofrin
The legacy pharmaceutical product owned and marketed by Pinnacle, Photodynamic Therapy ( PDT ) with Photofrin is a light-based (cancer) treatment that uses sodium porfimer (brand name Photofrin), a photosensitizing drug derived from oxygen binding proteins found in blood. Photofrin is intravenously administered and is differentially absorbed by tumorous cells. When activated by 630 nanometer lasers, Photofrin produces reactive singlet oxygen that kills tumors through multiple tumoricidal cascades, including:
| Direct cell kill |
| Induction of apoptosis (programmed cell death) |
| Destruction of malignant neovasculature |
| Initiation of an immune response against the cancer |
PDT with Photofrin has three oncology indications approved by the FDA; Esophageal Cancer, Barretts Esophagus and Non-Small Cell Lung Cancer. PDT with Photofrin is being further developed for the treatment of an additional rare form of cancer, cholangiocarcinoma.
Management believes that the patent portfolio that protects the product, in combination with certain manufacturing and regulatory hurdles, makes the product very difficult to genericize.
Existing Indications
Esophageal Cancer
PDT with Photofrin is indicated to help lessen symptoms of esophageal (food pipe) cancer when the cancer blocks the esophagus or when the cancer cannot be treated with laser alone. The American Cancer Society estimates that there are approximately 16,000 new cases of esophageal diagnosed annually in the United States. In general, the prognosis of esophageal cancer is quite poor, because most patients present with advanced disease.
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Barretts Esophagus
PDT with Photofrin is indicated for the ablation of high-grade dysplasia in Barretts esophagus patients who do not have part or all of their esophagus removed with surgery. The American Cancer Society estimates that there are approximately 18,000 new cases of Barretts esophagus diagnosed annually in the United States. Barrett esophagus is a premalignant condition. Its malignant sequela, esophageal adenocarcinoma, has a mortality rate of over 85%.
Non-Small Cell Lung Cancer
Photofrin is indicated for the treatment of microinvasive endobronchial NSCLC in patients for who surgery and radiotherapy are not indicated. Photofrin is indicated for the reduction of blockage and symptom relief in patients with endobronchial NSCLC that partially or totally blocks the bronchi (airways entering the lungs). In these patients, PDT with Photofrin is used to relieve symptoms with endobronchial NSCLC when the cancer obstructs or blocks the airway. The American Cancer Society estimates that there are approximately 225,000 new cases of lung cancer diagnosed annually in the United States, of which a proportion are NSCLC and a proportion of those are candidates for treatment with Photofrin.
New Indications
New Indication, Cholangiocarcinoma
Future growth is expected to come from clinically developing and marketing PDT with Photofrin for new indications, the first one being cholangiocarcinoma. PDT with Photofrin has been used by physicians off-label to treat cholangiocarcinoma for many years. Along with a marketable indication and corresponding product labeling, additional benefits of clinically developing PDT with Photofrin for cholangiocarcinoma include Orphan Drug Designation and subsequent market exclusivity benefits in the United States and the EU.
Special Protocol Assessment
On January 13, 2014, the Corporation announced that Pinnacle had reached an agreement with the FDA under a special protocol assessment (the SPA ) to enroll patients with an advanced form of bile duct cancer in a pivotal Phase 3 clinical trial. There is currently no approved therapy for this cancer type. The SPA is a written agreement between Pinnacle and the FDA regarding the design, endpoints and planned statistical analysis approach of the trial to be used in support of a potential New Drug Application submission. The clinical trial will study the efficacy and safety of PDT with Photofrin as treatment for unresectable advanced perihilar cholangiocarcinoma Bismuth type III/IV.
As with other oncology pharmaceutical products Pinnacles oncology pharmaceutical products are prescribed on compassionate use bases for other indications where doctors believe that patients will benefit from the treatment and there is some clinical support for the efficacy of the products. Management intends to complete the clinical work necessary to file these follow-on indications and seek FDA approval. This clinical work is funded by the Corporations operating cash flows.
On March 26, 2014, the Corporation announced that Pinnacle was granted FDA premarket supplemental approval for its Optiguide® DCYL700 Fiber Optic Diffuser Series flexible fiber. The Optiguide DCYL700 Fiber Optic Diffuser Series is a light delivery system used in PDT with Photofrin. The system features a more flexible, narrower cylindrical diffuser design that may assist physicians by providing greater access to tumors located in the right upper lobe of the lung and by improving maneuverability in other potentially challenging anatomic areas of the bronchus. The Optiguide®DCYL700 Fiber Optic Diffuser Series is the latest addition to Pinnacles portfolio of photodynamic products.
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RISK FACTORS
The following sets forth certain risks and uncertainties that could have a material adverse effect on Concordias business, financial condition and/or results of operations and the trading price of the Corporations common shares, which may decline, and investors may lose all or part of their investment. Additional risks and uncertainties that the Corporation does not presently know or that it currently deems to be immaterial also may impair Concordias business operations. The Corporation cannot assure you that it will successfully address these risks. In addition, other currently unknown risks exist that may affect Concordias business. The risks described below address the material factors that may affect Concordias future operating results and financial performance.
The Corporation has a limited operating history
Concordia Private Co. was formed in December, 2012, and acquired the Legacy Products, durable medical equipment products and Pinnacle in 2013. Concordia Private Co. had no operations prior to acquiring such assets. The Corporation had no operations prior to acquiring Concordia Private Co. The Corporations lack of operating history may make it difficult for investors to evaluate the Corporations prospects for success and its ability to make cash distributions to shareholders of the Corporation. There is no assurance that the Corporation will continue to be successful and the likelihood of ongoing success must be considered in light of its relatively early stage of operations.
The Corporation has grown at a very rapid pace. The Corporations inability to properly manage or support this growth could have a material adverse effect on the Corporations business, financial condition and results of operations and could cause the market value of the Common Shares to decline
The Corporations rapid growth has put significant demands on the Corporations processes, systems and personnel. The Corporation has made and expects to make further investments in additional personnel, systems and internal control processes to help manage its growth. If the Corporation is unable to successfully manage and support its rapid growth and the challenges and difficulties associated with managing a larger, more complex business, this could cause a material adverse effect on the Corporations business, financial position and results of operations, and the market value of the Common Shares could decline.
The Corporation relies on third parties to manufacture the Corporations products
The Corporation does not have the internal capability to manufacture pharmaceutical products and relies on third parties to manufacture its products. The Corporation currently relies on a distinct single source for the manufacture of each of its pharmaceutical products. The Corporation cannot be certain that manufacturing sources will continue to be available or that the Corporation can continue to out-source the manufacturing of the Corporations products on reasonable or acceptable terms. Any loss of a manufacturer or any difficulties that could arise in the manufacturing process could significantly affect the Corporations inventories and supply of products available for sale. If the Corporation is unable to supply sufficient amounts of its products to its customers on a timely basis, the Corporations market share could decrease and, correspondingly, the Corporations revenues could decrease.
All of the Corporations contract manufacturers must comply with the applicable FDA regulations, which include quality control and quality assurance requirements, as well as the corresponding maintenance of records and documentation and manufacture of products according to the specifications contained in the applicable regulatory file. If the Corporations contract manufacturers do not or cannot comply with these requirements, the availability of marketed products for sale could be reduced.
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If the Corporation encounters delays or difficulties with contract manufacturers, packagers or distributors, sales of the Corporations products could be delayed. If the Corporation changes the source or location of supply or modifies the manufacturing process, regulatory authorities will require the Corporation to demonstrate that the product produced by the new source or from the modified process is equivalent to the product used in any clinical trials that were conducted. If the Corporation is unable to demonstrate this equivalence, the Corporation will be unable to manufacture products from the new source or location of supply, or use the modified process, the Corporation may incur substantial expenses in order to ensure equivalence, and it may harm the Corporations ability to generate revenues.
The Corporation may pursue strategic partnerships, including product supply arrangements with certain manufacturers which would be expected to yield significant revenue to the Corporation. The aforementioned risks associated with a distinct single-source manufacturer for each pharmaceutical product can also therefore present significant risks to the Corporations revenue stream.
If the Corporations supply of finished products for one of its products is interrupted, the Corporations ability to maintain inventory levels could suffer and future revenues may be delayed and/or not realized
Supply interruptions may occur and the Corporations inventory may not always be adequate. Numerous factors could cause interruptions in the supply of the Corporations finished products, including failure to have a third-party supply chain validated in a timely manner, shortages in raw material required by the Corporations manufacturers, changes in the Corporations sources for manufacturing, the Corporations failure to timely locate and obtain replacement manufacturers as needed and conditions affecting the cost and availability of raw materials.
The Corporations Legacy Pharmaceutical Division derives all of its revenue from sales of a limited number of products
The Corporations Legacy Pharmaceutical Division currently derives all of its revenue from sales of three legacy products and revenue from these products is expected to continue to account for all of the Legacy Pharmaceutical Divisions revenue in the near term, unless the Corporation acquires other legacy products. Accordingly, if demand for any of the Legacy Products declines significantly, the business, financial condition and operating results of the Corporations Legacy Pharmaceutical Division would be adversely affected.
The Corporations planned pricing increases could negatively impact demand for the Legacy Products
The Corporation may increase the prices at which it sells its Legacy Products. There can be no assurances that sales of the Legacy Products will be unaffected by these pricing increases. If the pricing increases negatively affect demand for any of the Legacy Products, the Corporations business, financial condition and operating results would be adversely affected. In addition, there can be no assurances that increased expenditures on marketing and promotion will translate into increased sales of the Legacy Products. Increased expenditures on promotional efforts without corresponding increases in sales would adversely affect the Corporations financial and operating results.
The expiration of core patent protection for Kapvay and Orapred could result in significant competition from generic products resulting in a significant reduction in sales
The patent protecting the Corporations Kapvay product has expired and the Orapred patents will shortly expire, which could result in significant competition from generic products and could result in a significant reduction in sales. In order to continue to obtain commercial benefits from the Corporations Kapvay and Orapred products, the Corporation will continue to rely on product manufacturing trade
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secrets, know-how and related non-patent intellectual property. The effect of these patent expirations on the Corporation and its financial results depends, among other things, upon the nature of the market and the position of the Corporations products in the market from time to time, the growth of the market, the complexities and economics of manufacture of a competitive product and regulatory approval requirements of generic drug laws. Accordingly, these patent expirations could have a material and adverse effect on the Corporations business, financial condition, results of operation and cash flow.
The publication of negative results of studies or clinical trials may adversely impact the Corporations Orphan Drugs Division
From time to time, studies or clinical trials on various aspects of pharmaceutical products are conducted by academics or others, including government agencies. The results of these studies or trials, when published, may have a dramatic effect on the market for the pharmaceutical product that is the subject of the study. The publication of negative results of studies or clinical trials related to products in the Corporations Orphan Drugs Division or the therapeutic areas in which the Corporations orphan drugs compete could adversely affect the Corporations sales, the prescription trends for the Corporations orphan drugs and the reputation of the Corporations orphan drugs. In the event of the publication of negative results of studies or clinical trials related to the Corporations orphan drugs or the therapeutic areas in which the Corporations orphan drugs compete, the Corporations business, financial condition, results of operation and cash flows could be materially adversely affected.
The Corporation relies on third parties to perform distribution, logistics, invoicing, regulatory and sales services for its products
The Corporation relies on third parties to provide distribution, logistics, invoicing, regulatory and sales services including warehousing of finished product, accounts receivable management, billing, collection, record keeping and processing of invoices with insurance companies. If the third parties cease to be able to provide the Corporation with these services, do not provide these services in a timely or professional manner or contracts with such third parties are terminated for any reason, the Corporation may not be able to successfully manage the product revenues or integrate new products into its business, which may result in decreases in sales. The termination of any such contracts or services with such third parties could also have a material and adverse effect on the Corporations business, financial condition and operating results. Additionally, any delay or interruption in the process or in payment could result in a delay delivering products to its customers, which could have a material and adverse effect on the Corporations business, financial condition and operating results.
Uncertainty can arise regarding the applicability of the Corporations proprietary information
The Corporation relies on trade secrets, know-how and other proprietary information, as well as requiring employees and other investors and suppliers to sign confidentiality agreements. However, these confidentiality agreements may be breached, and the Corporation may not have adequate remedies for such breaches. Others may independently develop substantially equivalent proprietary information without infringing upon any proprietary technology. Third parties may otherwise gain access to the Corporations proprietary information and adopt it in a competitive manner. Any loss of intellectual property protection is likely to adversely affect the Corporations operating results.
Increases in sales may attract generic competition
The Corporation expects the Legacy Products, which have market exclusivity, to continue to enjoy market exclusivity due to a number of factors, including economic barriers to competition. If sales of the Legacy Products were to increase substantially, competitors may be more likely to develop generic formulations
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that compete directly with the Corporations products. Increased generic competition would have a material adverse effect on the Corporations business and financial results.
The markets in which the Corporation operates and proposes to operate are highly competitive and subject to rapid and significant technological change, which could render the Corporations products obsolete or uncompetitive
The Corporations products will face competition from new products that treat some of the same diseases and address some of the same conditions as the Corporations products. Many of the Corporations competitors have greater financial resources and selling and marketing capabilities. The Corporation will face further competition from pharmaceutical and drug development companies and medical equipment/supply companies that focus their efforts on developing and marketing products that are similar in nature to its products, but that in some instances offer improvements of the Corporations products. The Corporations competitors may succeed in developing technologies and products that are more effective or less expensive to use than any that the Corporation may acquire or licence. These developments could render the Corporations products obsolete or uncompetitive, which would have a material adverse effect on the Corporations business, financial condition and operating results. In addition, academic institutions, government agencies and other public and private organizations conducting research may seek patent protection with respect to potentially competitive products. They may also establish exclusive collaborative or licensing relationships with the Corporations competitors.
The Corporation faces competition for future acquisitions of products
The Corporations growth strategy is partially predicated on its ability to acquire additional products at reasonable prices. The Corporation currently competes to acquire products with other participants in the pharmaceutical industry. In particular, many specialty pharmaceutical companies have adopted business strategies that entail acquiring legacy products with a view to increasing sales through focused marketing efforts and some of these companies may have greater resources than the Corporation. In addition, although the Corporation is currently unaware of any other entities that are focused on acquiring products primarily for the purpose of generating a stream of stable revenues and cash flow, there can be no assurances that other entities will not adopt this strategy in the future. If the Corporation is unable to acquire additional products at reasonable prices, its ability to expand its business and to pay, increase or maintain distributions, as applicable, may be adversely affected.
The Corporation may be unsuccessful in evaluating material risks involved in completed and future investments
The Corporation regularly reviews investment opportunities and as part of the review, conducts business, legal and financial due diligence with the goal of identifying and evaluating material risks involved in any particular transaction. Despite the Corporations efforts, it may be unsuccessful in ascertaining or evaluating all such risks. As a result, it might not realize the intended advantages of any given investment and may not identify all of the risks relating to the investment. If the Corporation fails to realize the expected benefits from one or more investments, or does not identify all of the risks associated with a particular investment, the Corporations business, results of operations and financial condition could be adversely affected.
The Corporation may be unable to identify, acquire, close or integrate acquisition targets successfully
Part of the Corporations business strategy includes acquiring and integrating complementary businesses, products, pharmaceuticals or other assets, and forming strategic alliances, joint ventures and other business combinations, to help drive future growth. The Corporation may also in-licence new products or
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pharmaceuticals. Acquisitions or similar arrangements may be complex, time consuming and expensive. The Corporation may not consummate some negotiations for acquisitions or other arrangements, which could result in significant diversion of management and other employee time, as well as substantial out-of-pocket costs. In addition, there are a number of risks and uncertainties relating to closing transactions. If such transactions are not completed for any reasons, the Corporation will be subject to several risks, including the following: (i) the market price of the Common Shares may reflect a market assumption that such transactions will occur, and a failure to complete such transactions could result in a negative perception by the market of the Corporation generally resulting in a decline in the market price of the Common Shares; and (ii) many costs relating to such transactions may be payable by the Corporation whether or not such transactions are completed.
If an acquisition is consummated, the integration of the acquired business, product or other assets into the Corporation may also be complex and time-consuming and, if such businesses, products and assets are not successfully integrated, the Corporation may not achieve the anticipated benefits, cost-savings or growth opportunities. Potential difficulties that may be encountered in the integration process include the following:
| integrating personnel, operations and systems, while maintaining a focus on selling and promoting existing and newly-acquired products; |
| coordinating geographically dispersed organizations; |
| distracting management and employees from operations; |
| retaining existing customers and attracting new customers; and |
| managing inefficiencies associated with integrating the operations of the Corporation. |
Furthermore, these acquisitions and other arrangements, even if successfully integrated, may fail to further the Corporations business strategy as anticipated, expose the Corporation to increased competition or challenges with respect to the Corporations products or geographic markets, and expose the Corporation to additional liabilities associated with an acquired business, product, technology or other asset or arrangement. Any one of these challenges or risks could impair the Corporations ability to realize any benefit from the Corporations acquisition or arrangement after the Corporation has expended resources on them.
The Corporation depends on key managerial personnel for the Corporations continued success
The Corporation is highly dependent upon qualified managerial personnel. The Corporations anticipated growth may require additional expertise and the addition of new qualified personnel. There is intense competition for qualified personnel in the pharmaceutical field. Therefore, the Corporation may not be able to attract and retain the qualified personnel necessary for the development of the Corporations business. The Corporation must continue to retain, motivate and recruit executives, including the Corporations Chief Executive Officer, Mark Thompson, and other key employees. The loss of the services of existing personnel, as well as the failure to recruit additional key managerial personnel in a timely manner, could harm the Corporations business development programs, and the Corporations ability to manage day-to-day operations, attract collaboration partners, attract and retain other employees, generate revenues, and could have a material adverse impact on the Corporations business, financial condition and results of operations and could cause the market value of the Common Shares to decline. Except for Mark Thompson, the Corporation does not maintain key person life insurance on any of the Corporations employees.
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The Corporations ability to obtain third-party reimbursement for the cost of products and related treatment may not be adequate and the Corporation could lose the ability to obtain third-party reimbursement
The Corporations ability to successfully market the Corporations products and product candidates may depend in part on whether appropriate reimbursement levels for the cost of the products and related treatments are obtained from government authorities and private health insurers and other organizations, such as HMOs and MCOs. The Corporation is also subject to losing the ability to access such reimbursement by government authorities and private health insurers and other organizations due to changing laws, policies and practices of such entities.
Third-party payors increasingly challenge the pricing of pharmaceutical products. In addition, the trend toward managed health care in the United States, the growth of organizations such as HMOs and MCOs and legislative proposals to reform health care and government insurance programs could significantly influence the purchase of pharmaceutical products, resulting in price changes and/or a reduction in product demand. Such cost containment measures and health care reform could affect the Corporations ability to sell the Corporations products and may have a material adverse effect on the Corporations business, results of operations, cash flows and financial condition.
Failure to be included in formularies developed by managed care and other organizations
Managed care organizations and other third-party payors try to negotiate the pricing of medical services and products to control their costs. Managed care organizations and pharmacy benefit managers typically develop formularies to reduce their cost for medications. Formularies can be based on the prices and therapeutic benefits of the available products. Due to their lower costs, generic products are often favoured. The breadth of the products covered by formularies varies considerably from one managed care organization to another, and many formularies include alternative and competitive products for treatment of particular medical conditions. Failure to be included in such formularies or to achieve favourable formulary status may negatively impact the utilization of the Corporations products. If the Corporations products are not included within an adequate number of formularies or adequate reimbursement levels are not provided, or if those policies increasingly favour generic products, the Corporations market share and gross margins could be adversely impacted, as could the Corporations business, financial condition, results of operations and cash flows.
The Corporations business is subject to limitations imposed by government regulations
In domestic and foreign markets, the formulation, manufacturing, packaging, labelling, handling, distribution, importation, exportation, licensing, sale and storage of the Corporations products are affected by extensive laws, governmental regulations, administrative determinations, court decisions and similar constraints which are beyond the Corporations control. Such laws, regulations, determinations, decisions and other constraints may exist at all levels of government. There can be no assurance that the Corporation is or will be in compliance with all of these laws, regulations, determinations, decisions and other constraints. Failure to comply with these laws, regulations, determinations, decisions and other constraints or new laws, regulations, determinations, decisions or constraints could lead to the imposition of significant penalties or claims and could negatively impact the Corporations business. In addition, the adoption of new laws, regulations, determinations, decisions or other constraints or changes in the interpretations of such requirements may result in significant compliance costs or lead the Corporation to discontinue product sales and may have an adverse effect on the marketing of the Corporations products, resulting in significant loss of sales and a material and adverse effect on the Corporations business, results of operations, cash flows and financial condition.
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In the United States, the FDA perceives any written or verbal statement used to promote or sell a product that associates an unapproved nutrient with a disease (whether written by the Corporation, the content of a testimonial endorsement or contained within a scientific publication) to be evidence of intent to sell an unapproved new drug. If any such evidence is found with respect to the Corporations products, the FDA may take adverse action against the Corporation, ranging from a warning letter necessitating cessation of use of the statement to injunctions against product sale, seizures of products promoted with the statements, and civil and criminal prosecution of the Corporations executives. Such actions could have a detrimental effect on sales and a material and adverse effect on the Corporations business, results of operations, cash flows and financial condition.
Legislative or regulatory reform of the health care system may affect the Corporations ability to sell its products profitably and could adversely affect the Corporations business
In the United States and certain foreign jurisdictions, there have been a number of legislative and regulatory proposals to change the healthcare system in ways that could impact the Corporations ability to sell its products profitably. The Health Care Reform Act may affect the operational results of companies in the pharmaceutical industry, including the Corporation, by imposing on them additional costs. For example, effective January 1, 2010, the Health Care Reform Act increased the minimum Medicaid drug rebates for pharmaceutical companies, expanded the 340B drug discount program, and made changes to affect the Medicare Part D coverage gap, or donut hole. The law also revised the definition of average manufacturer price for reporting purposes, which has the potential to affect the amount of the Corporations Medicaid drug rebates to states. Beginning in 2011, the law imposed a significant annual fee on companies that manufacture or import branded prescription drug products.
The Health Care Reform Act also added substantial new provisions affecting compliance therewith, some of which may require the Corporation to modify its business practices with health care practitioners. Pharmaceutical manufacturers are required in 2013 to comply with the federal Physician Payments Sunshine Act, which was passed as part of the Health Care Reform Act and requires pharmaceutical companies to monitor and report payments, gifts, the provision of samples and other remuneration made to physicians and other health care professionals and health care organizations.
The Corporation is unable to predict the future course of federal or state health care legislation. A variety of federal and state agencies are in the process of implementing the Health Care Reform Act, including through the issuance of rules, regulations or guidance that materially affect the Corporations business. The risk of the Corporation being found in violation of these rules and regulations is increased by the fact that many of them have not been fully interpreted by applicable regulatory authorities or the courts, and their provisions are open to a variety of interpretations. The Health Care Reform Act and further changes to health care laws or regulatory framework that reduce the Corporations revenues or increase the Corporations costs could also have a material adverse effect on the Corporations business, financial condition, results of operations and cash flows, and could cause the market price of the Common Shares to decline.
Other legislation or regulatory proposals may adversely affect the Corporations revenues and profitability
Existing and proposed changes in the laws and regulations affecting public companies, including the provisions of the Sarbanes-Oxley Act of 2002 in the United States and Bill 198 in Ontario and related rules, may cause the Corporation to incur increased costs as the Corporation evaluates the implications of new rules and responds to new requirements. Failure to comply with the new rules and regulations could result in enforcement actions or the assessment of other penalties. The new laws and regulations could make it more difficult to obtain certain types of insurance, including directors and officers liability
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insurance, and the Corporation may be forced to accept reduced policy limits and coverage or incur substantially higher costs to obtain the same or similar coverage. The impact of these events could also make it more difficult for the Corporation to attract and retain qualified persons to serve on the Corporations board of directors, or as executive officers. The Corporation may be required to hire additional personnel and utilize additional outside legal, accounting and advisory services, all of which could cause the Corporations general and administrative costs to increase beyond what the Corporation currently has planned. The Corporation is presently evaluating and monitoring developments with respect to these rules, and the Corporation cannot predict or estimate the amount of the additional costs the Corporation may incur or the timing of such costs.
Rising insurance costs could negatively impact the Corporations profitability
The cost of insurance, including director and officer, workers compensation, property, product liability and general liability insurance, has risen significantly in recent years and is expected to continue to increase. In response, the Corporation may increase deductibles and/or decrease certain coverage to mitigate these costs. These increases, and the Corporations increased risk due to increased deductibles and reduced coverage, could have a negative impact on the Corporations results of operations, financial condition and cash flows.
Policies regarding returns, allowances and chargebacks may reduce revenues in future fiscal periods
The Corporation establishes estimates of the impact that policies regarding returns, allowances and chargebacks may have in subsequent periods. The Corporation cannot ensure that the reserves are adequate or that actual product returns, allowances and chargebacks will not exceed the estimates, which could have a material adverse effect on the results of operations, financial condition and cash flows.
The Corporation may be subject to product liability claims, which can be expensive, difficult to defend and may result in large judgments or settlements
The administration of drugs to humans, whether in clinical trials or after marketing clearance is obtained, can result in product liability claims. Product liability claims can be expensive, difficult to defend and may result in large judgments or settlements against the Corporation. In addition, third-party collaborators and licensees may not protect the Corporation from product liability claims.
The Corporation currently maintains product liability insurance in connection with the marketing of the Legacy Products and certain products of Pinnacle. The Corporation may not be able to obtain or maintain adequate protection against potential liabilities arising from product sales. If the Corporation is unable to obtain sufficient levels of insurance at acceptable cost or otherwise protect against potential product liability claims, the Corporation will be exposed to product liability claims. A successful product liability claim in excess of the Corporations insurance coverage could harm the Corporations financial condition, results of operations and prevent or interfere with the Corporations product commercialization efforts. In addition, any successful claim may prevent the Corporation from obtaining adequate product liability insurance in the future on commercially desirable terms. Even if a claim is not successful, defending such a claim may be time-consuming and expensive. Product liability claims could also result in negative perception of the Corporations products which could have a material and adverse effect on the Corporations business, results of operations, sales, financial results and cash flow.
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Unexpected product safety or efficacy concerns may arise
Unexpected safety or efficacy concerns can arise with respect to marketed products, whether or not scientifically justified, leading to product recalls, withdrawals or declining sales, as well as product liability, consumer fraud and/or other claims. This could have a material adverse effect on the Corporations business, financial condition and results of operations.
Risks related to patent infringement actions
The Corporation could become involved in infringement actions which are uncertain, costly and time-consuming and could have a material adverse effect on the Corporations business, financial condition and results of operations and could cause the market value of the Common Shares to decline. The pharmaceutical industry historically has generated substantial litigation concerning the manufacture, use and sale of products and management of the Corporation expects this litigation activity to continue. As a result, patents related to the Corporations products could be challenged, and the Corporations patents may not be upheld. In order to protect or enforce patent rights, the Corporation may initiate litigation against third parties. If the Corporation is not successful in defending an attack on its patents and maintaining exclusive rights to market one or more of the Corporations products still under patent protection, the Corporation could lose a significant portion of sales in a very short period. The Corporation could also become subject to infringement claims by third parties and may have to defend against charges that the Corporations products infringed patents or the proprietary rights of third parties. If the Corporation infringes the intellectual property rights of others, the Corporation could lose its right to develop, manufacture or sell products, including its generic products, or could be required to pay monetary damages or royalties to license proprietary rights from third parties. The outcomes of infringement actions are uncertain and infringement actions are costly and divert technical and management personnel from their normal responsibilities.
Compliance with regulations related to marketing, promotional and pricing practices
The marketing, promotional and pricing practices of pharmaceutical companies, as well as the manner in which companies, in-house or third-party sales forces interact with purchasers, prescribers and patents, are subject to extensive regulation, enforcement of which may result in the imposition of civil and/or criminal penalties, injunctions, and/or limitations on marketing practices for the Corporations products. Many companies have been the subject of claims related to these practices asserted by federal authorities. These claims have resulted in fines and other consequences.
Companies may not promote drugs for off-label uses that is, uses that are not described in the products labeling and that differ from those approved by the FDA, Health Canada or other applicable regulatory agencies. A company that is found to have improperly promoted off-label uses may be subject to significant liability, including civil and administrative remedies as well as criminal sanctions. In addition, managements attention could be diverted from business operations and the Corporations reputation could be damaged.
Risks related to fraud and abuse laws, anti-bribery laws, environmental laws and privacy and security regulations
Pharmaceutical companies in the United States have faced lawsuits and investigations pertaining to violations of health care fraud and abuse laws, such as the federal False Claims Act, Anti-Kickback Statutes and other state and federal laws and regulations. The Corporation is also subject to increasingly strict data privacy and security laws in the United States and in other countries, the violation of which could result in fines and other sanctions. The United States Department of Health and Human Services
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Office of Inspector General recommends, and increasingly states require, pharmaceutical companies to have comprehensive compliance programs and to disclose certain payments made to healthcare providers or funds spent on marketing and promotion of drug products. The United States federal government has published regulations that identify safe harbour or exemptions for certain payment arrangements that do not violate the anti-kickback statutes. The Corporation will seek to continue its compliance with the safe harbour. While the Corporation has developed corporate compliance programs based on what the Corporation believes to be current best practices, the Corporation cannot assure you that its employees or agents are or will be in compliance with all applicable federal, state or foreign regulations and laws. If the Corporation or any of its employees or agents are in violation of any of these requirements or any such actions are instituted against the Corporation, and the Corporation is not successful in defending itself or asserting its rights, those actions could have a significant impact on the Corporations business, including the imposition of significant fines, exclusion from federal healthcare programs or other sanctions.
Anti-Kickback Statutes and similar worldwide anti-bribery laws generally prohibit companies and their intermediaries from making improper payments to officials for the purpose of obtaining or retaining business. The Corporations policies mandate compliance with these anti-bribery laws. The Corporation may operate in many parts of the world that have experienced governmental corruption to some degree and in certain circumstances, strict compliance with anti-bribery laws may conflict with local customs and practices or may require the Corporation to interact with doctors and hospitals, some of which may be state controlled, in a manner that is different than in the United States and Canada. The Corporation cannot assure you that its internal control policies and procedures will protect the Corporation from reckless or criminal acts committed by its employees or agents. Violations of these laws, or allegations of such violations, could disrupt the Corporations business and result in criminal or civil penalties or remedial measures, any of which could have a material adverse effect on the Corporations business, financial condition and results of operations and could cause the market value of the Common Shares to decline.
The Corporation is also subject to various privacy and security regulations, including but not limited to HIPAA. HIPAA mandates, among other things, the adoption of uniform standards for the electronic exchange of information in common health care transactions (e.g. health care claims information and plan eligibility, referral certification and authorization, claims status, plan enrolment, coordination of benefits and related information), as well as standards relating to the privacy and security of individually identifiable health information, which require the adoption of administrative, physical and technical safeguards to protect such information. In addition, many states have enacted comparable laws addressing the privacy and security of health information, some of which are more stringent than HIPAA. Failure to comply with these laws can result in the imposition of significant civil and criminal penalties. The costs of compliance with these laws and the potential liability associated with the failure to comply with these laws could adversely affect the Corporations financial condition, results of operations and cash flows.
Industry Risk
The Corporation currently operates only in the North American healthcare industry. Accordingly, the Corporation is subject to risks associated with operating in a single industry in a concentrated geographic location. Any event effecting this industry could have a material and adverse effect on the Corporations business, financial condition, results of operations and cash flows.
The Corporation may not be able to secure additional financing
The Corporation may need to raise additional funds through public or private debt or equity financings in order to: (a) fund ongoing operations; (b) take advantage of opportunities, including more rapid expansion of the Corporations business or the acquisition of complementary businesses; or (c) respond to
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competitive pressures. There can be no assurance that the Corporation will be able to raise the additional funding that it needs to carry out its growth objectives. The Corporation cannot predict the size of future issuances of securities or the effect, if any, that future issuances and sales of securities will have on the market price of the Common Shares. Sales or issuances of substantial numbers of Common Shares, or the perception that such sales could occur, may adversely affect prevailing market prices of the Common Shares.
The development of the Corporations business depends upon prevailing capital market conditions, business performance and its ability to obtain financing through joint ventures, debt financing, equity financing or other means. There is no assurance that the Corporation will be successful in obtaining required financing as and when needed or at all. If additional financing is raised by the issuance of shares from treasury, shareholders may suffer additional dilution. Capital raised through debt financing would require periodic interest payments and may impose restrictive covenants on the conduct of the Corporations business. Furthermore, additional financings may not be available on terms favourable to the Corporation, and may not be available at all. A failure to obtain additional funding could prevent the Corporation from making acquisitions or other expenditures that may be required to implement the Corporations growth strategy and grow or maintain the Corporations operations.
Debt Financing
The Corporations credit facilities and the agreements governing the Corporations existing and future indebtedness contain or will contain financial and non-financial covenants, such as requirements that the Corporation comply with one or more financial ratios and change of control provisions. Complying with such covenants may at times necessitate that the Corporation must forego other favourable business opportunities, such as acquisitions. Moreover, the Corporations failure to comply with any of these covenants would likely constitute a default under such facilities and agreements and could give rise to an acceleration of some, if not all, of the Corporations then outstanding indebtedness, which would have a material adverse effect on the Corporations business. The Corporations indebtedness may grow as the Corporations business grows and/or the Corporation makes new acquisitions. If the Corporations income from operations underperforms, the Corporation may have to utilize cash flow or capital resources to fund its debt service payments. If the Corporations cash flow and capital resources are insufficient to service amounts owed under the Corporations current or any future indebtedness, as applicable, the Corporation may be forced to reduce or delay capital expenditures, dispose of assets, issue equity or incur additional debt to obtain necessary funds, or restructure its debt, any or all of which could have a material adverse effect on the Corporations business, financial condition and results of operations. In addition, the Corporation cannot guarantee that it would be able to take any of these actions on terms acceptable to it, or at all, that these actions would enable the Corporation to continue to satisfy its capital requirements or that these actions would be permitted under the terms of the Corporations various debt agreements.
The Corporations effective tax rates may increase
The Corporation has operations in various countries that have differing tax laws and rates. The Corporations tax reporting is supported by current domestic tax laws in the countries in which the Corporation operates and the application of tax treaties between the various countries in which the Corporation operates. The Corporations income tax reporting is and will continue to be subject to audit by domestic and foreign authorities. The Corporations effective tax rate may change from year to year based on changes in the mix of activities and income earned among the different jurisdictions in which the Corporation operates; changes in tax laws in these jurisdictions; changes in the tax treaties between various countries in which the Corporation operates; changes in the Corporations eligibility for benefits under those tax treaties; and changes in the estimated values of deferred tax assets and liabilities. Such
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changes could result in a substantial increase in the effective tax rate on all or a portion of the Corporations income.
The Corporations provision for income taxes is based on certain estimates and assumptions made by management. The Corporations consolidated income tax rate is affected by the amount of net income earned in its various operating jurisdictions, the availability of benefits under tax treaties, and the rates of taxes payable in respect of that income. The Corporation enters into many transactions and arrangements in the ordinary course of business in respect of which the tax treatment is not entirely certain. The Corporation therefore makes estimates and judgments based on the Corporations knowledge and understanding of applicable tax laws and tax treaties, and the application of those tax laws and tax treaties to the Corporations business, in determining its consolidated tax provision. For example, certain countries could seek to tax a greater share of income than may be provided for by the Corporation. The final outcome of any audits by taxation authorities may differ from the estimates and assumptions that the Corporation may use in determining its consolidated tax provisions and accruals. This could result in a material adverse effect on the Corporations consolidated income tax provision, financial condition and the net income for the period in which such determinations are made.
Foreign currency risk
Currency exchange rate fluctuations can affect the Corporations results of operations to the extent that the Corporations equity financing is denominated in Canadian dollars and the Corporations functional currency is the United States dollar. Consequently, the Corporation may experience currency gains and losses on the conversion of Canadian equity financing proceeds into United States dollars required for business operations. One half of any foreign exchange gains or losses will be included in the Corporations Canadian taxable income. Any foreign exchange gain will result in a corresponding reduction in the Corporations available Canadian Non-Capital losses, Scientific Research and Experimental Development Pool, and/or Investment Tax Credit carry forward balances.
Also, the price of the Common Shares may be independently impacted by the exchange rate alone as the market price of the Corporations securities will be denominated in Canadian dollars while the financial results of the Corporations operations will be denominated in United States dollars. Consequently, the market price of the Corporations securities may be negatively affected by adverse changes in the Canadian/US dollar exchange rate.
Seasonality of Operating Results
Demand for certain of the Corporations products may be impacted by seasonality. This seasonality may cause the Corporations operating results to fluctuate.
Failure to obtain or maintain orphan drug exclusivity
If the Corporation fails to obtain or maintain orphan drug exclusivity for some or all of the Corporations products, the Corporations competitors may sell products to treat the same conditions and the Corporations revenues will be reduced. As part of its business strategy, the Corporation may acquire some drugs that may be eligible for FDA and EU orphan drug designation. Under the OD Act, the FDA may designate a product as an orphan drug if it is intended to treat a rare disease or condition, defined as a patient population of fewer than 200,000 in the United States. The company that first obtains FDA approval for a designated orphan drug for a given rare disease receives marketing exclusivity for use of that drug for the stated condition for a period of seven years. Orphan drug exclusive marketing rights may be lost if the FDA later determines that the request for designation was materially defective or if the manufacturer is unable to assure sufficient quantity of the drug. Similar regulations are available in the
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EU with a ten-year period of market exclusivity. Because the extent and scope of patent protection for some of the Corporations drug products is limited, orphan drug designation is especially important for products that are eligible for orphan drug designation. For eligible drugs, the Corporation plans to rely on the exclusivity period under the OD Act to maintain a competitive position. If the Corporation does not obtain orphan drug exclusivity for drug products that do not have broad patent protection, the Corporations competitors may then sell the same drug to treat the same condition and the Corporations revenues will be reduced.
Holding Company
As a holding company with no material assets other than the stock of the Corporations operating subsidiaries, nearly all of the Corporations funds generated from operations are generated by the Corporations operating subsidiaries. Accordingly, if the Corporations operating subsidiaries are unable, due to regulatory restrictions or otherwise, to pay the Corporation dividends and make other payments to the Corporation when needed, the Corporation may be unable to satisfy the Corporations obligations when they arise.
Foreign Subsidiaries
The Corporation currently conducts certain of its operations through foreign subsidiaries and certain of its assets are held in such entities. The ability of such subsidiaries to make payments to the Corporation may be constrained by certain factors including the level of taxation, particularly corporate profits and withholding taxes, in the countries in which they operate. Any limitation on the transfer of cash or other assets between the parent corporation and such entities, or among such entities, could restrict the Corporations ability to fund its operations efficiently. Any such limitations, or the perception that such limitations may exist now or in the future, may adversely affect the Corporations business and results of operations and cash flows.
Some of the Corporations Assets and Subsidiaries are Incorporated Outside Of Canada
Certain of the Corporations assets and subsidiaries are located outside of Canada. In addition, some of the Corporations directors and officers are nationals and/or residents of countries other than Canada, and all or a substantial portion of such persons assets may be located outside of Canada. The board of directors of the Corporation has effective control over the subsidiaries in two principal ways; namely, at least one director or officer of the Corporation is a director of each of the subsidiaries, and the Corporation is a shareholder of the subsidiaries having legal rights (e.g. the fiduciary obligations of officers and directors owed to the subsidiary, derivative actions and oppression remedies) that the Corporation is willing to enforce. With the Corporation being the sole or majority shareholder of the subsidiaries, as applicable, the Corporation can resolve in a limited period of time to remove directors or officers without the requirement of a shareholder meeting. As a result, it may be difficult for investors to enforce, within Canada, any judgments obtained against the Corporations officers or directors, including judgments predicated upon the civil liability provisions of the securities laws of Canada or any province thereof. Consequently, investors may be effectively prevented from pursuing remedies against the Corporation under Canadian securities laws.
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DIVIDEND POLICY
There are no restrictions in the Corporations articles which prevent the Corporation from paying dividends. Any dividend to be approved by the board of directors of the Corporation would require third-party consents under the Corporations Senior Loan Agreement and Subordinate Loan Agreement. In addition, in the event that the Corporation is not in compliance with its obligations under the New Credit Facilities, the Corporations ability to pay distributions or dividends on its shares may be restricted by the New Credit Facilities. All of the Common Shares are entitled to an equal share in any dividends declared and paid. The directors of the Corporation will determine if, and when, dividends will be declared and paid in the future from funds properly applicable to the payment of dividends based on Concordias financial position at the relevant time. See Risk Factors.
The Corporation has not paid any dividends on the Common Shares since the Qualifying Transaction to the date hereof.
DESCRIPTION OF CAPITAL STRUCTURE
Common Shares
The authorized capital of the Corporation consists of an unlimited number of Common Shares. As at December 31, 2013, 17,985,889 Common Shares were issued and outstanding.
There are no special rights or restrictions attached to the Common Shares. The Common Shares rank equally as to all benefits which might accrue to the holders thereof, including the right to receive dividends out of monies of the Corporation properly applicable to the payment of dividends if and when declared by the board of directors of the Corporation and to participate rateably in the remaining assets of the Corporation in any distribution on a dissolution or winding-up. There are no provisions restricting the issuance of Common Shares or any other material restrictions.
All registered shareholders are entitled to receive a notice of all meetings of shareholders to be convened by the Corporation. At any general meeting, subject to the restrictions on joint registered owners of Common Shares, on a show of hands every registered shareholder who is present in person or by proxy and entitled to vote has one vote, and on a poll, every registered shareholder who is entitled to vote has one vote for each Common Share held and may exercise such vote either in person or by proxy.
Stock Option Plan
The Corporations stock option plan ( Stock Option Plan) provides that the board of directors of the Corporation may from time to time, in its discretion, grant to directors, officers, employees, consultants and any other person or entity engaged to provide ongoing services to the Corporation non-transferable options to purchase Common Shares, provided that the number of Common Shares reserved for issuance under the Stock Option Plan shall not exceed a number which is equal to 15% of the issued and outstanding Common Shares. The exercise price of options shall not be less than the lesser of: (i) the closing trading price of the Common Shares on the TSX or, if not listed on the TSX, then such other principal market on which the Common Shares trade as designated by the board of directors, on the date an option is granted; and (ii) the Market Price of the Common Shares on the date the option is granted. For the purposes of the Stock Option Plan, Market Price means the volume-weighted average price of the Common Shares on the stock exchange where the majority of trading volume and value of the Common Shares occurs, for the five trading days immediately preceding the relevant date on which the Market Price is to be determined. In the event that the Common Shares are not listed for trading on a stock exchange, the Market Price shall be the fair market value of the Common Shares as determined by the board of directors of the Corporation.
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Under the Stock Option Plan the number of Common Shares reserved for issuance to any one person shall not exceed 5% of the issued and outstanding Common Shares. The aggregate number of Common Shares issued to insiders of the Corporation within any 12-month period, or issuable to insiders of Concordia at any time, under the Stock Option Plan and any other security-based compensation arrangement of the Corporation, may not exceed 10% of the total number of issued and outstanding Common Shares of the Corporation at such time.
The Stock Option Plan also provides that:
(i) Common Shares that were the subject of options granted under the Stock Option Plan that have been surrendered, lapsed, cancelled or terminated shall thereupon no longer be in reserve and may once again be subject to an option granted under the Stock Option Plan;
(ii) a holder of an option may, rather than exercise such option, elect a cashless exercise payable in Common Shares equaling the in-the-money value of the option;
(iii) the expiry date for an option shall not in any circumstance be later than the lesser of the 10 th anniversary of the date an option is granted and the maximum period of time allowed by the Stock Exchange (as defined in the Stock Option Plan); and
(iv) subject to certain exceptions outlined in the Stock Option Plan, all options held by an officer or employee of the Corporation shall expire and terminate, and such employee optionee shall cease to be an eligible person, immediately upon the termination date of such employee optionee or the date of such employee optionees death, disability or retirement.
The board of directors of the Corporation may amend the Stock Option Plan from time to time without shareholder approval except for amendments relating to:
(i) the maximum number of Common Shares reserved for issuance under the Stock Option Plan;
(ii) a reduction in the exercise price for options held by insiders of the Corporation (as defined in the Securities Act (Ontario));
(iii) an extension to the term of any option held by insiders of the Corporation;
(iv) an increase in any limit on grants of options to insiders of the Corporation; and
(v) any amendment that is not necessary or desirable to ensure continuing compliance with applicable laws or of a housekeeping nature.
As at December 31, 2013 there were 1,375,000 outstanding options to purchase 1,375,000 Common Shares under the Stock Option Plan with a weighted average exercise price of $CAD 3.00 for 1,125,000 options with a weighted average remaining contractual life of 10 years and a weighted average exercise price of $CAD 6.25 for 250,000 options with a weighted average contractual life of 10 years.
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DEBT FINANCING
HSBC Credit Facility
The Corporation has implemented a financing strategy that maintains flexibility to appropriately manage the Corporations short-term cash needs and the funding of future growth, including the acquisition of new products.
In this regard, Concordia Private Co. entered into an agreement with HSBC pursuant to which HSBC has provided a senior secured revolving credit facility (the Revolving Facility) in the principal amount of $3 million and a MasterCard facility in the amount of $CAD 50,000.00 with HSBC Bank Canada (collectively, the New Credit Facilities) . The Revolving Facility is for working capital requirements and is repayable on demand. Loans under the Revolving Facility are repayable without any prepayment penalties, and bear interest at a floating rate based on the HSBCs US Base Rate plus 2.25% per annum.
Pursuant to the New Credit Facilities, security has been granted over all of Concordia Private Co.s assets including those held by its subsidiaries in the United States and in Barbados. Concordia Private Co. has also provided a pledge of securities of each of its subsidiaries.
The New Credit Facilities are subject to customary terms and conditions for borrowers of this nature, including limits on incurring additional indebtedness, granting liens or selling assets without the consent of HSBC Bank Canada. The New Credit Facilities are also subject to the maintenance of a minimum consolidated EBITDA, a maximum ratio of Total Funded Debt to consolidated EBITDA and a maximum ratio of Senior Funded Debt to consolidated EBITDA (as each term is defined in the credit agreement between Concordia Private Co. and HSBC Bank Canada). A change of ownership in the corporate structure of Concordia Private Co. and/or the guarantors under the New Credit Facilities requires the prior written consent of HSBC Bank Canada. The New Credit Facilities do not restrict the Corporations ability to pay distributions or dividends on its shares unless, either prior to or after such payments are made, the Corporation is not in compliance with all obligations under the New Credit Facilities.
Term Facilities
As at December 31, 2013, the Corporation had outstanding indebtedness under two term facilities: (i) a loan under the Senior Loan Agreement in the principal amount of $19,000,000 bearing interest at 12% per annum, calculated daily, maturing on October 30, 2015 with interest paid monthly in arrears, and (ii) two loans under the Subordinate Loan Agreement in the aggregate principal amount of $5,150,000 bearing interest at 18% per annum, calculated daily, maturing on October 30, 2015 with interest paid monthly in arrears only if the loan under the Senior Loan Agreement had been repaid. As general and continuing security for the due payment and performance of all obligations, the Corporation had granted security over all of its assets to the lenders of the two term facilities described above. The Senior Loan Agreement was subject to 12 months of minimum interest and the Subordinate Loan Agreement was subject to 24 months of minimum interest. In addition, each of the Senior Loan Agreement and Subordinate Loan Agreement were subject to loan prepayments based on the performance of the business of the Corporation. All outstanding amounts on these loans were paid in full on March 28, 2014.
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MARKET FOR SECURITIES
Trading Price and Volume
The Common Shares are currently listed on the TSX under the trading symbol CXR. Prior to the completion of the Qualifying Transaction, the Common Shares of the Corporation were listed on the TSX-V and subsequently the NEX board of the TSX-V, under the trading symbol MV.H. The following table sets forth the reported intraday high and low prices and the trading volume for the Common Shares on the TSX and the TSX-V, as applicable, during the Corporations most recently completed financial year.
Month |
High (CAD$) | Low (CAD$) | Volume | |||||||||
January 2013 |
0.04 | 0.04 | 10,000 | |||||||||
February 2013 |
| | NIL | |||||||||
March 2013 |
0.02 | 0.01 | 20,000 | |||||||||
April 2013 |
| | NIL | |||||||||
May 2013 |
| | NIL | |||||||||
June 2013 |
0.10 | 0.01 | 85,600 | |||||||||
July 2013 |
0.10 | 0.02 | 1,391,000 | |||||||||
August 2013 |
0.11 | 0.10 | 50,000 | |||||||||
September 2013 |
0.15 | 0.10 | 248,500 | |||||||||
October 2013 (1) |
| | NIL | |||||||||
November 2013 |
| | NIL | |||||||||
December 2013 (2) |
8.99 | 6.25 | 320,847 |
Notes :
(1) | The Common Shares were halted on October 24, 2013, in connection with the announcement of the entering into of the letter of intent dated October 23, 2013, between the Corporation and Concordia Private Co. with respect to the Qualifying Transaction. |
(2) | On December 24, 3013, the Common Shares commenced trading on the TSX following the completion of the Qualifying Transaction. Subsequent to December 31, 2013, the Common Shares were listed and quoted for trading on the OTCQX. |
Prior Sales
Common Shares
The following table summarizes details of the Common Shares issued by the Corporation during and since the end of the Corporations most recently completed financial year:
Date of Issuance |
Security |
Price per Security
(CAD$) |
Number of
Securities |
|||||||
December 20, 2013 |
Common Shares (1) | $ | 6.25 | (2) | 16,763,051 | |||||
December 20, 2013 |
Common Shares (3) | $ | 5.63 | (3) | 946,222 | |||||
January 21, 2014 |
Common Shares (4) | $ | 4.81 | (5) | 23,918 | |||||
January 23, 2014 |
Common Shares (6) | $ | 6.25 | 22,080 | ||||||
February 18, 2014 |
Common Shares (6) | $ | 6.25 | 57,900 | ||||||
March 11, 2014 |
Common Shares (7) | $ | 11.75 | 5,750,000 | ||||||
March 20, 2014 |
Common Shares (4) | $ | 4.81 | (5) | 2,079 | |||||
March 20, 2014 |
Common Shares (6) | $ | 6.25 | 19,380 |
Notes :
(1) | Issued to former shareholders of Concordia Private Co. pursuant to the amalgamation agreement dated December 13, 2013, between the Corporation, Concordia Private Co. and Mercari Subco Inc. (the Amalgamation Agreement) as further described under the heading Background and Corporate Structure - Name, Address and Incorporation. Pursuant to the Private Placement, each Subscription Receipt was exchanged for one common share of Concordia Private Co., which common shares were then exchanged for Common Shares on a one-for-one basis pursuant to the Qualifying Transaction. This figure includes the Common Shares issued to holders of such Subscription Receipts. |
(2) | Deemed price on a post-Consolidation basis. |
(3) | Issued in connection with the acquisition of Pinnacle. These Common Shares were issued pursuant to the Amalgamation Agreement and at a discount of 10% of the price per Subscription Receipt under the Private Placement. |
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(4) | Issued upon exercise of options held by former directors of the Corporation. These stock options were granted in connection with the Corporations initial public offering completed on May 6, 2010, with each option having an exercise price of $CAD 0.10 per share (or an exercise price on a post-Consolidation basis). |
(5) | Deemed price on a post-Consolidation basis. |
(6) | Issued upon exercise of Agents Options. |
(7) | Issued in connection with a short form prospectus offering which closed on March 11, 2014. |
Stock Options
The following table summarizes details of the stock options issued by the Corporation during and since the end of the Corporations most recently completed financial year:
Date of Issuance |
Security |
Price per Security
(CAD$) |
Number of
Securities |
|||||||
December 20, 2013 |
Agents Options (1) | $ | 6.25 | (2) | 220,800 | |||||
December 20, 2013 |
options (3) | US$ | 3.00 | (4) | 1,125,000 | |||||
December 20, 2013 |
options (5) | $ | 6.25 | 250,000 | ||||||
January 1, 2014 |
options (5) | $ | 6.25 | 100,000 | ||||||
January 29, 2014 |
options (5) | $ | 11.50 | 330,000 | ||||||
March 14, 2014 |
options (5) | $ | 14.95 | 335,000 |
Notes:
(1) | Pursuant to the Amalgamation Agreement, these Agents Options were issued to the Agents in connection with the exchange of the options of Concordia Private Co. held by the Agents. See Background and Corporate Structure - Name, Address and Incorporation. |
(2) | Exercise price on a post-Consolidation basis and expiring on December 20, 2015. |
(3) | Pursuant to the Amalgamation Agreement, these options were issued to various optionholders in connection with the exchange of the options of Concordia Private Co. held by such optionholders. See Background and Corporate Structure - Name, Address and Incorporation. |
(4) | Exercise price on a post-Consolidation basis, with expiry dates ranging from August, 2023 to September, 2023. |
(5) | Granted under the Corporations stock option plan with expiry dates ranging from August, 2023 to March, 2024. |
Securities Subject to Contractual Restriction on Transfer
Designation of class |
Number of securities
subject to a contractual restriction on transfer and percentage of class (3) |
|||
Common Shares |
11,133,051 (1) (46.6 | %) | ||
options |
1,125,000 (1) (81 | %) | ||
Common Shares |
3,281,162 (2) (13.7 | %) | ||
options |
1,100,000 (2) (80 | %) |
Notes:
(1) | The Common Shares relate to voluntary lock-up agreements entered into on December 20, 2013, by certain shareholders pursuant to the Private Placement. 50% of such securities are subject to a 180 day contractual restriction on transfer and 50% of such securities are subject to a 360 day contractual restriction on transfer. Certain of these securities are subject only to a 180 day contractual restriction on transfer. |
(2) | These securities relate to voluntary lock-up agreements entered into on March 11, 2014, by each of the directors and officers of the Corporation pursuant to the 2014 Offering. These securities are subject to a 90 day contractual restriction on transfer. |
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DIRECTORS AND EXECUTIVE OFFICERS OF THE CORPORATION
Directors and Executive Officers, Positions and Security Holdings
The following table sets out the name; city, state/province and country of residence; position with the Corporation; and number and percentage of the Corporations Common Shares held by each of the Corporations directors and executive officers as at March 28, 2014:
Name, province or state and
|
Position with the
|
Principal Occupation During the Past Five Years |
Period as
Director and/or Officer (1) |
Number of
Common Shares and Approximate Percentage of Common Shares Held |
||||||
Mark Thompson (2) Toronto, Ontario, Canada |
Founder, Director, President and Chief Executive Officer |
CEO, President (from April 2013) and a director of Concordia Private Co., Managing Director of Distinct Capital Partners from January 2012 to April 2013, Vice President Business Development and Co-Founder of Trimel Pharmaceuticals Corporation from August 2007 to December 2011 |
December
2013 to present. |
|
2,115,850
(8.8 |
%) |
||||
Leith Tessy Lexington, Massachusetts, U.S.A. |
Chief Financial Officer, Secretary- Treasurer | CFO of Concordia Private Co. from November, 2013, Senior Vice-President, Nuance Communications from 2011 to 2012, COO of LG-Nortel/LG-Ericsson from 2008 to 2011 |
December
2013 to present. |
|
168,000
(0.7 |
%) |
||||
John McCleery St. George, Barbados |
Managing Director and Chief Financial Officer of CPI and CLI | Managing Director and CFO of CPI since July 2013, Vice-President, General Manager and CFO of Trimel BioPharma SRL from November, 2009 to June 2013, Principal of J. McCleery and Associates, October 2008 to October 2009 |
December
2013 to present. |
|
266,000
(1.1 |
%) |
||||
John Huss (3)(4) Westmount, Quebec, Canada |
Director (5) | President, H&P Labs Inc. since June 2013, President and CEO of Theratechnologies Inc. from December 2010 to October 2012, Chief of Staff of Sanofi-Aentis groupe from August 2009 to November 2010, CEO of Sanofi-Aventis Switzerland from February 2007 to July 2009 |
December
2013 to present. |
|
8,000
(0.03 |
%) |
||||
Ron Schmeichel (3)(4) Toronto, Ontario, Canada |
Director (5) Non-executive Chairman of the Board |
President and CEO of Windsor Private Capital Inc. since January 2011; President and CEO of JJR Capital Corp. (including its predecessor JJR Capital Partners) since February 2003 |
December
2013 to present. |
|
72,040
(0.3 |
%) |
||||
Douglas Deeth (2)(4) Toronto, Ontario, Canada |
Director | Partner, Deeth Williams Wall LLP |
December
2013 to present. |
|
5,000
(0.02 |
%) |
||||
Jordan Kupinsky (2)(3) Toronto, Ontario, Canada |
Director (5) | Managing Director, Windsor Private Capital since 2008 |
December
2013 to present. |
|
907,272
(3.8 |
%) |
||||
Wayne Kreppner Georgetown, Ontario, Canada |
Chief Operating Officer | Vice-President of Product Development at Trimel Pharmaceuticals. Various senior roles in regulatory affairs and operations with Biovail Corporation |
January
2014 to present. |
|
5,000
(0.02 |
%) |
||||
Robert Altman Chicago, Illinois, United States |
President of Pinnacle | Chief Commercial Officer at Pinnacle Biologics, Inc., Founder, CEO and president of Marathon Pharmaceuticals |
December
2013 to present. |
|
2,394
(0.01 |
%) |
||||
|
|
|||||||||
TOTAL |
|
3,549,556
(14.9 |
%) |
|||||||
|
|
Notes :
(1) | Each Director listed will hold his position as a Director of the Corporation until the next annual meeting of shareholders. December 2013 is listed as the date in which each director became a Director of the Corporation pursuant to the Amalgamation and the Qualifying Transaction. |
(2) | Member of Corporate Governance and Nominating Committee of the Corporation. |
(3) | Member of Audit Committee of the Corporation. |
(4) | Member of Compensation Committee of the Corporation. |
(5) | Independent director. |
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Biographies
The following are brief profiles of the directors and the executive officers of the Corporation.
Executive Officers
Mark Thompson , age 46, is the CEO, President, founder and a director of the Corporation. Former Senior Vice President and General Counsel of Legacy Pharma Limited Partnership, co-founder of Trimel Pharmaceuticals and Tribute Pharmaceuticals Inc. From 2001 to 2005, Mr. Thompson was employed by Biovail Corporation (currently Valeant), where he held the title of Vice-President, Business Development and, before that, Associate General Counsel. While at Biovail, Mr. Thompson was actively involved in M&A transactions valued at over $2 billion. Prior to joining Biovail, Mr. Thompson was an associate at Osler, Hoskin and Harcourt LLP. Mark holds an H.B.A., and M.A. from York University and an L.L.B. from the University of Ottawa.
Leith Tessy , age 52, has 25 years of international experience as a finance and operations executive. Mr. Tessy has been successful driving M&A transactions (with total transaction value exceeding $1 billion), integrating acquired companies and expanding operating margins. Previous roles held include: CFO then COO of LG Nortel, a JV between Nortel Networks and LG Electronics based in Seoul, South Korea (under Mr. Tessys leadership, the company grew from approximately $500 million to approximately $1 billion, delivering 30% EBITDA margin), CFO of Nortel Networks Global Carrier Networks group (at approximately $5 billion revenue, Nortels largest, most profitable division), and SVP Finance at Nuance Communications. Mr. Tessy holds an Industrial Engineering degree from University of Toronto and an MBA from Ivey School of Business, University of Western Ontario.
John McCleery , age 56, is the Managing Director and CFO of CPI and CLI. Mr. McCleery has 30 years of international experience as a senior financial and operational executive. He developed and managed the Enterprise Risk Management and Compliance program for Valeant Pharmaceuticals International Inc. (formerly Biovail Corporation), reporting company risks to the board of directors. Mr. McCleery chaired the Compliance Committee and the Canadian Investment (RSP; DPSP) Committee. Mr. McCleery served as Vice President and General Manager of Valeant Laboratories (Barbados) SRL (formerly Biovail Laboratories International SRL) the principal operating subsidiary where he had responsibility for managing intellectual property, treasury activities, research and development programs and business partner relationships with Merck, Johnson and Johnson, Wyeth, Forest and Teva etc. He was also a Director and Vice President, Treasurer of Valeant Insurance Incorporated (formerly Biovail Insurance Incorporated). Mr. McCleery served as Vice President, General Manager and Chief Financial Officer of Trimel BioPharma SRL and was responsible for all operational and financial management of the principal operating subsidiary of Trimel Pharmaceuticals Corporation. Mr. McCleery is a Chartered Professional Accountant (CPA) and a Chartered Accountant (CA) having earned his designations with the Toronto office of PricewaterhouseCoopers.
Wayne Kreppner , age 41, is the COO of the Corporation. Mr. Kreppner has over 15 years of experience as a pharmaceutical operations and R&D executive. A co-founder and former Vice-President of Product Development at Trimel Pharmaceuticals, Mr. Kreppner was responsible for all Scientific Operations including R&D, Clinical Development, Manufacturing and Supply Chain. From 1997 to 2008 Mr. Kreppner held various senior roles in Operations and Regulatory Affairs with Biovail Corporation, where he was involved in the discovery, development, approval and launch of the product pipeline including Wellbutrin XL and Tiazac. Mr. Kreppner holds a Hons. B.Sc. degree in Biochemistry from the University of Western Ontario, an M.Sc. in Medical Science from McMaster University and an MBA from the Ivey School of Business, University of Western Ontario.
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Robert Altman , age 61, is the President of Pinnacle, a subsidiary of the Corporation. Previously, Dr. Altman was founder, CEO and President of Marathon Pharmaceuticals, a fully integrated, specialty pharmaceutical company focusing on rare diseases. Prior to Marathon, Dr. Altman worked for Astellas Pharma, where he was Senior Vice President of Commercial Operations and responsible for commercial strategy and leadership covering North America. Before joining Astellas, Dr. Altman spent 17 years at Abbott Laboratories, where he held numerous positions including Vice President General Manager of several of the companys Therapeutic Drug Franchises. Dr. Altman earned his BS Chemistry at University of California, Riverside, a PhD in Physical Chemistry from Harvard University and an MBA from the University of Chicago Booth School of Business.
Directors
John Huss , age 50. After 20 years in the pharmaceutical and biotechnology industry, Mr. Huss founded H&P Labs Inc., a biotechnology company focused on early stages of drug development (Phase I & II) in humans. Before that Mr. Huss was President and CEO of Theratechnologies in Montreal. Since his return to Canada in 2010, he sits on the Board of BioQuebec and since 2012 he also serves on its Executive Committee, as Vice-President. Mr. Huss worked for sanofi from 1999 to 2010 in Germany, Canada, Switzerland and France. He joined sanofi in 1999 as a Business Unit Director for the German affiliate. In 2001, Mr. Huss joined the Canadian affiliate as Vice-President, Sales and Marketing in Toronto and moved to Montreal after the acquisition of Aventis. He became General Manager of the Swiss affiliate of sanofi-aventis in January 2007, based in Geneva. In August 2009, Mr. Huss joined the Head Office in Paris and worked next to the Chief Executive Officer, Chris Viehbacher, as Chief of Staff. Mr. Huss joined the pharmaceutical industry in 1990 and for 6 years performed various Sales and Marketing functions for Merck & Co. in the United States, Germany and Switzerland. In 1996, he was offered a position with F. Hoffman-La Roche as an Internal Product Manager at their Basel headquarters.
Ron Schmeichel , age 46, has 18 years of experience in financial transactions including high-yield credit, leveraged loans, buy-outs and equity capital markets with a focus on middle market companies in Canada and the United States. For the past 4 years, he has served as the President & CEO of Windsor Private Capital, a private equity and credit fund that specializes in mezzanine and bridge financing, leveraged buy-outs, recapitalizations and equity capital. Prior to this, Mr. Schmeichel was a co-founder and managing partner of JJR Capital Corp., a Toronto based merchant banking firm that specialized in reverse merger transactions on the Toronto Stock Exchange. Mr. Schmeichel serves as the non-executive Chairman of the board of directors of the Corporation, and since Concordia Private Co.s inception, Mr. Schmeichel advised on six pharmaceutical/healthcare transactions, including two foundational acquisitions that formed the company. Mr. Schmeichel has served on the boards of more than 18 TSX/ TSXV listed companies. For the past 12 years, Mr. Schmeichel has been a guest lecturer at the University of Western Ontario, Faculty of Law, with a focus on entrepreneurial finance and securities law as well as a guest lecturer at the Ivey School of Business. He currently serves as a member of the Ontario Local Area Committee to the Toronto Stock Exchange-Venture Group. Mr. Schmeichel received a BA degree, with Merit, from York University in 1992 and a Juris Doctorate degree from the University of Western Ontario in 1995.
Douglas Deeth , age 66, is a partner with the law firm of Deeth Williams Wall LLP. He is the former President of the Intellectual Property Law section of the Canadian Bar Association and has over 35 years of experience working with the pharmaceutical industry. Doug has been recognized in several international reviews as one of Canadas leading intellectual property lawyers. His practice combines his extensive litigation experience with an expertise in negotiating and completing license and product development agreements. He provides timely, practical and pragmatic advice to clients on the clearance, protection and enforcement of all forms of technology and intellectual property rights, and has particular expertise in chemical and pharmaceutical products and processes. Doug was admitted to the Bar of
64
Ontario in 1976 and has more than thirty-five years of litigation experience, ranging from the most complex and sophisticated intellectual property litigation to judicial review proceedings and interlocutory injunction applications. He appears regularly before the Federal Court of Canada and the courts of the Province of Ontario. He has a B.A.Sc. in Chemical Engineering from the University of Waterloo (1970) and an LL.B. from the University of Toronto (1974), and has taught, written and spoken extensively on intellectual property law. He has lectured at McMaster University, the University of Toronto and Osgoode Hall law schools and the McGill courses on Patent and Copyright Law.
Jordan Kupinsky , age 41. Since 2008, Mr. Kupinsky has been a Managing Director with Windsor Private Capital Inc. and its predecessor JJR Capital Corp. Prior to joining Windsor, he was a Vice President at Greenhill & Co., an independent global investment banking firm, listed on the NYSE, focused on mergers & acquisitions and financial restructuring from March 2006 to May 2008. Prior to joining Greenhill, Mr. Kupinsky held the positions of Vice President of Corporate Development and General Counsel at Minacs Worldwide Inc., a publicly traded company on the TSX from July 2002 to February 2005. Mr. Kupinsky began his career practicing corporate and securities law at Torys LLP in Toronto (from 1997 to 1999) and was also an investment banking associate at Houlihan Lokey Howard & Zukin from 1999 to 2002. He holds a joint MBA and JD degree from the Schulich School of Business and Osgoode Hall Law School at York University. Mr. Kupinsky is currently a director of Atlas Financial Holdings Inc. (AFH: NASDAQ) where he chairs the audit committee. Mr. Kupinsky has served as a director of companies on the TSX and on the TSX-V, including having served as a director of Xceed Mortgage Corporation from May 2012 through July 2013 when the sale of Xceed to MCAN Mortgage Corporation was completed.
Corporate Cease Trade Orders or Bankruptcies
Except as described below, no individual who is a director, officer or promoter of or a securityholder anticipated to hold sufficient securities of the Resulting Issuer to affect materially the control of the Resulting Issuer, is, or has been within the past ten years, a director, officer or promoter of any other person or company that, while such person was acting in that capacity, was:
(a) the subject of a cease trade or similar order or an order that denied the person or company access to any exemptions under applicable securities law for a period of more than 30 consecutive days; or
(b) was declared bankrupt or made a proposal under any legislation relating to bankruptcy or insolvency or been subject to or instituted any proceedings, arrangement or compromise with creditors or had a receiver, receiver manager or trustee appointed to hold the assets of that person.
In August 2012, while John Huss was the President and CEO of Theratechnologies Inc., Theratechnologies Inc. received a notice from the NASDAQ listing qualification department that it no longer met the minimum bid price requirement of $1.00 per listed share to continue trading on NASDAQ and had 180 days to regain compliance with such requirement. In January 2013, while Mr. Huss was no longer with Theratechnologies Inc., Theratechnologies Inc. filed documents with the Securities and Exchange Commission to voluntarily delist its common shares from NASDAQ and delisting became effective as of February 5, 2013.
Kevin Taylor, the sole shareholder and sole director of Terei International Limited, a significant shareholder of the Corporation, in his capacity as a Senior Vice President and General Manager for Nortel Networks Corporations operating subsidiary, Nortel Networks Cala Inc., was subject to a management cease trade order issued by the Ontario Securities Commission on April 10, 2006 for failure of Nortel to make the required filings under Ontario securities laws, which order was revoked on June 8, 2006. At no time was Mr. Taylor a director or executive officer of Nortel.
65
Penalties or Sanctions
No director, officer or promoter of the Corporation or a securityholder holding sufficient securities of the Corporation to affect materially the control of the Corporation, has been subject to any penalties or sanctions imposed by a court relating to securities legislation or by a securities regulatory authority or has entered into a settlement agreement with a securities regulatory authority or been subject to any other penalties or sanctions imposed by a court or regulatory body, including a self-regulatory body, that would be likely to be considered important to a reasonable securityholder making an investment decision.
Individual Bankruptcies
No director, officer or promoter of the Corporation or a securityholder holding sufficient securities of the Corporation to affect materially the control of the Corporation, or a personal holding company of any such person, has, within the ten years before the date of this Annual Information Form, become bankrupt, made a proposal under any legislation relating to bankruptcy or insolvency or been subject to or instituted any proceedings, arrangement or compromise with creditors, or had a receiver, receiver manager or trustee appointed to hold the assets of that individual.
Conflicts of Interest
There are no known existing or potential conflicts of interest between the Corporation or a subsidiary of the Corporation and a director or officer of the Corporation or a subsidiary of the Corporation except that there is a potential for conflict of interest between Douglas Deeths role as a director of the Corporation and his capacity as partner of a law firm that has provided advice to Concordia Private Co. and the Corporation.
PROMOTER
Mark Thompson, the CEO, President, founder and a director of the Corporation, may be considered a promoter of the Corporation. As at March 28, 2014, Mr. Thompson beneficially owned, controlled or directed, directly or indirectly, 2,115,850 Common Shares and 300,000 options to acquire 300,000 Common Shares of the Corporation. If such options are exercised, Mr. Thompson could hold 2,415,850 Common Shares, comprising 10.1% of the issued and outstanding Common Shares as at March 28, 2014. Pursuant to the Amalgamation Agreement, the Common Shares and options were issued to Mr. Thompson in exchange for an equal number of common shares and options held by Mr. Thompson in Concordia Private Co. See Background and Corporate Structure - Name, Address and Incorporation.
LEGAL PROCEEDINGS AND REGULATORY MATTERS
Other than as disclosed herein, to the knowledge of the Corporation, there are no material legal proceedings or regulatory actions known or known to be contemplated against the Corporation or to which any of its property is or may be subject. No penalties or sanctions have been imposed against the Corporation by a court relating to securities legislation or by a securities regulatory authority and no settlement agreements have been entered into by the Corporation before a court relating to securities legislation or with a securities regulatory authority.
Prior to Concordia Private Co.s acquisition of the business of the SHD Division, Global Medical Direct and Midwest Medical Services (the predecessor companies to the Corporations SHD Division) were investigated in February of 2012 by the United States Department of Justice and the United States Attorneys Offices for the Districts of Louisiana and Kansas. The investigation centered on the companies lead generation/marketing arrangements. The companies were accused of violating the anti-kickback statute and submitting false claims for diabetic supplies being provided to beneficiaries of
66
federally funded healthcare programs. The companies owners have settled the case, and were mandated to sell the assets of the companies and pay restitution. Concordia Private Co. purchased the assets free and clear of any future claims from the government in relation to the investigations and resultant settlement. The SHD Division has hired an accredited Medicare Auditor and strengthened its internal compliance processes to mitigate the issues that led to this case.
INTEREST OF MANAGEMENT AND OTHERS IN MATERIAL TRANSACTIONS
Other than as disclosed herein, to the knowledge of the Corporation, none of (i) the directors, officers or persons that beneficially owns, or controls or directs, directly or indirectly, more than 10% of the outstanding securities of the Corporation; or (ii) any associate or affiliate of the persons referred to in (i), has or has had any material interest, direct or indirect, in any transaction within the three most recently completed financial years or during the current financial year that has materially affected or will materially affect the Corporation or any of its subsidiaries.
Pursuant to the Senior Loan Agreement, Windsor Private Capital Limited Partnership, in respect of which Ron Schmeichel and Jordan Kupinsky are senior officers, advanced a short-term working capital loan to Concordia Private Co. in the amount of CAD$3 million with interest at 12% per annum. The loan was incurred by Concordia Private Co. in the ordinary course of business. This loan was repaid in full in July 2013.
As at December 31, 2013, Terei International Limited held 3,072,500 Common Shares representing approximately 17.08% of the issued and outstanding Common Shares as at that date, and is considered to be an insider of the Corporation according to the Securities Act (Ontario). Kevin Taylor is the sole shareholder and director of Terei International Limited. Other than through his indirect securityholdings, Mr. Taylor has no direct involvement with the Corporation or its business.
AUDIT COMMITTEE
The directors of the Corporation have established an audit committee comprised of three directors (the Audit Committee) . The Audit Committee is chaired by Jordan Kupinsky and the other committee members are John Huss and Ron Schmeichel. The relevant education and experience of each member of the Audit Committee is provided above, under the heading Directors and Executive Officers of the Corporation - Biographies. All of the Audit Committee members are independent of management of the Corporation as required by National Instrument 52-110 Audit Committees and each member is financially literate in that each has the ability to read and understand a set of financial statements that present a breadth and level of complexity of accounting issues that are generally comparable to the breadth and complexity of the issues that can reasonably be expected to be raised by the Corporations financial statements.
The mandate of the Audit Committee is set out in the written Charter of the Audit Committee. A copy of the Audit Committee charter is included as Schedule A attached hereto.
Reliance on Certain Exemptions
At no time since the commencement of the Corporations most recently completed financial year has the Corporation relied on the exemptions in Section 2.4 of National Instrument 52-110 ( De Minimis Non-audit Services), Section 3.2 of National Instrument 52-110 ( Initial Public Offerings), Section 3.4 of
67
National Instrument 52-110 ( Events Outside of Control of Member), Section 3.5 of National Instrument 52-110 ( Death, Disability or Resignation of Audit Committee Member), or an exemption from National Instrument 52-110, in whole or in part, granted under Part 8 of National Instrument 52-110.
Additionally, at no time since the commencement of the Corporations most recently completed financial year has the Corporation relied on the exemptions in subsection 3.3(2) of National Instrument 52-110 ( Controlled Companies), Section 3.6 of National Instrument 52-110 ( Temporary Exemption for Limited and Exceptional Circumstances) or Section 3.8 of National Instrument 52-110 ( Acquisition of Financial Literacy).
Audit Committee Oversight
At no time since the commencement of the Corporations most recently completed financial year was a recommendation of the Audit Committee to nominate or compensate an external auditor not adopted by the board of directors of the Corporation.
Pre-Approval Policies and Procedures
The Audit Committee is authorized by the Corporations board of directors to review the performance of the Corporations external auditors and approve in advance the provision of services other than auditing and to consider the independence of the external auditors, including reviewing the range of services provided. The Audit Committee may delegate to any independent member of the Audit Committee the authority to pre-approve any non-audit services.
External Auditor Service Fees
A summary of the external auditor service fees and billings paid or payable to the Corporations external auditors in respect of the last two fiscal years ended December 31, 2013, is set out below:
Fiscal Year |
Audit Fees | Audit-Related Fees | Tax Fees | All Other Fees | Total | |||||||||||||||
2012 (1) |
7,500 | NIL | 2,000 | NIL | 9,500 | |||||||||||||||
2013 (2) |
342,500 | (3) | 338,000 | (4) | 2,000 | NIL | 682,500 |
Notes :
(1) | The amounts provided for 2012 relate to Mercari Acquisition Corp. |
(2) | The amounts provided for 2013 relate to Concordia Healthcare Corp. |
(3) | The amount relates primarily to audit fees charged in connection with the acquisitions, financing and Qualifying Transaction. |
(4) | The amount shown is principally comprised of fees charged by the Corporations external auditors in connection with services performed as part of the Qualifying Transaction. |
TRANSFER AGENT AND REGISTRAR
The Transfer Agent and Registrar for the Corporations Common Shares is Equity Financial Trust Company, 200 University Avenue, Suite 300, Toronto, Ontario, M5H 4H1.
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MATERIAL CONTRACTS
The Corporation and/or its subsidiaries, as applicable, have entered into the following material contracts, or material contracts with the following parties, since the date of Concordia Private Co.s incorporation, December 5, 2012 and which are outside of the ordinary course of the Corporations business, a description and summary of each has been cross-referenced in this Annual Information Form:
1. | Amalgamation Agreement (see Background and Corporate Structure - Name, Address and Incorporation ); |
2. | Shionogi Purchase Agreement (see General Development and Description of the Business ); |
3. | Global Purchase Agreement (see General Development and Description of the Business ); |
4. | Pinnacle Purchase Agreement (see General Development and Description of the Business ); |
5. | Agency Agreement (see Background and Corporate Structure - Name, Address and Incorporation ); |
6. | Senior Loan Agreement (see Debt Financing - Term Facilities ); |
7. | Subordinate Loan Agreement (see Debt Financing - Term Facilities ); |
8. | New Credit Facilities (see Debt Financing - HSBC Credit Facility ); and |
9. | Underwriting Agreement (discussed directly below). |
Copies of the above listed material contracts are available on the Corporations profile on SEDAR at www.sedar.com or upon request from the Corporation at 277 Lakeshore Rd. East, Suite 302, Oakville, Ontario, L6J 1H9.
On March 11, 2014, and pursuant to the Underwriting Agreement, the Corporation raised aggregate gross proceeds of $CAD 67,562,500 on a bought deal basis pursuant to the filing of a short form prospectus through which the Corporation issued 5,750,000 Common Shares at a price of $CAD 11.75 per Common Share.
INTEREST OF EXPERTS
The auditors of the Corporation are Collins Barrow Toronto LLP, Chartered Accountants, 11 King St. West, Suite 700, Box 27, Toronto, Ontario M5H 4C7. They have been the Corporations auditors since January 21, 2010. Collins Barrow Toronto LLP is independent with respect to the Corporation in accordance with the Rules of Professional Conduct of the Institute of Chartered Accountants of Ontario.
FGMK LLC, Certified Public Accounts and Consultants, was the auditor in respect of the financial statements of Pinnacle included in the business acquisition report dated February 10, 2014. FGMK LLC is independent of the Corporation under the SECs rules on auditor independence.
No director, officer or employee of any of the aforementioned companies, is or is expected to be elected, appointed or employed as a director, officer or employee of the Corporation or any associate or affiliate of the Corporation.
69
ADDITIONAL INFORMATION
Additional information including directors and officers remuneration and indebtedness, the executive compensation for named executive officers of the Corporation, principal holders of the Corporations securities, interests of insiders in material transactions, as applicable, and securities authorized for issuance under equity compensation plans will be contained in the Corporations management information circular for its first post-Consolidation annual meeting of securityholders which will involve the election of directors.
Additional financial information is provided in the Corporations financial statements and managements discussion and analysis for the year ended December 31, 2013. A copy of the management information circular, financial statements and managements discussion and analysis may be obtained upon request from the Corporation and those documents and other information in respect of the Corporation are also available on SEDAR at www.sedar.com.
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SCHEDULE A
CONCORDIA HEALTHCARE CORP.
AUDIT COMMITTEE CHARTER
There shall be a committee of the board of directors (the Board ) of Concordia Healthcare Corp. (the Company ) known as the Audit Committee.
PURPOSE OF AUDIT COMMITTEE
The Audit Committee has been established to assist the Board in fulfilling its oversight responsibilities with respect to the following principal areas:
(a) the Companys external audit function; including the qualifications, independence, appointment and oversight of the work of the external auditors;
(b) the Companys accounting and financial reporting requirements;
(c) the Companys reporting of financial information to the public;
(d) the Companys compliance with law and regulatory requirements;
(e) the Companys risks and risk management policies;
(f) the Companys system of internal controls and management information systems; and
(g) such other functions as are delegated to it by the Board.
Specifically, with respect to the Companys external audit function, the Audit Committee assists the Board in fulfilling its oversight responsibilities relating to: the quality and integrity of the Companys financial statements; the independent auditors qualifications; and the performance of the Companys independent auditors.
MEMBERSHIP
The Audit Committee shall consist of as many members as the Board shall determine but, in any event not fewer than three directors appointed by the Board. Each member of the Audit Committee shall continue to be a member until a successor is appointed, unless the member resigns, is removed or ceases to be a director of the Company. The Board may fill a vacancy that occurs in the Audit Committee at any time.
Members of the Audit Committee shall be independent and selected based upon the following and in accordance with applicable laws, rules and regulations:
(a) | Financially Literate. Each member shall be financially literate or must become financially literate within a reasonable period of time after his or her appointment to the Audit Committee. For these purposes, an individual is financially literate if he or she has the ability to read and understand a set of financial statements that present a breadth and level of complexity of accounting issues that are generally comparable to the breadth and complexity of the issues that can reasonably be expected to be raised by the Companys financial statements. |
CHAIR AND SECRETARY
The Chair of the Audit Committee shall be designated by the Board. If the Chair is not present at a meeting of the
Audit Committee, the members of the Audit Committee may designate an interim Chair for the meeting by majority vote of the members present. The Secretary of the Company shall be the Secretary of the Audit Committee, provided that if the Secretary is not present, the Chair of the meeting may appoint a secretary for the meeting with the consent of the Audit Committee members who are present. A member of the Audit Committee may be designated as the liaison member to report on the deliberations of the Audit Committees of affiliated companies (if applicable).
MEETINGS
The Chair of the Audit Committee, in consultation with the Audit Committee members, shall determine the schedule and frequency of the Audit Committee meetings provided that the Audit Committee will meet at least four times in each fiscal year and at least once in every fiscal quarter with the management and external auditor. The Audit Committee shall have the authority to convene additional meetings as circumstances require.
Notice of every meeting shall be given to the external and internal auditors of the Company, and meetings shall be convened whenever requested by the external auditors or any member of the Audit Committee in accordance with applicable law. The Audit Committee shall meet separately and periodically with management, legal counsel and the external auditors. The Audit Committee shall meet separately with the external auditors at every meeting of the Audit Committee at which external auditors are present.
MEETING AGENDAS
Agendas for meetings of the Audit Committee shall be developed by the Chair of the Audit Committee in consultation with the management and the corporate secretary, and shall be circulated to Audit Committee members as far in advance of each Audit Committee meeting as is reasonable.
RESOURCES AND AUTHORITY
The Audit Committee shall have the resources and the authority to discharge its responsibilities, including the authority, in its sole discretion, to engage, at the expense of the Company, outside consultants, independent legal counsel and other advisors and experts as it determines necessary to carry out its duties, without seeking approval of the Board or management.
The Audit Committee shall have the authority to conduct any investigation necessary and appropriate to fulfilling its responsibilities, and has direct access to and the authority to communicate directly with the internal and external auditors, the counsel of the Company and other officers and employees of the Company.
The members of the Audit Committee shall have the right for the purpose of performing their duties to inspect all the books and records of the Company and its subsidiaries and to discuss such accounts and records and any matters relating to the financial position, risk management and internal controls of the Company with the officers and external and internal auditors of the Company and its subsidiaries. Any member of the Audit Committee may require the external or internal auditors to attend any or every meeting of the Audit Committee.
RESPONSIBILITIES
The Companys management is responsible for preparing the Companys financial statements and the external auditors are responsible for auditing those financial statements. The Audit Committee is responsible for overseeing the conduct of those activities by the Companys management and external auditors, and overseeing the activities of the internal auditors. The specific responsibilities of the Audit Committee shall include those listed below. The enumerated responsibilities are not meant to restrict the Audit Committee from examining any matters related to its purpose.
1. | Financial Reporting Process and Financial Statements |
The Audit Committee shall:
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a. | in consultation with the external auditors and the internal auditors, review the integrity of the Companys financial reporting process, both internal and external, and any major issues as to the adequacy of the internal controls and any special audit steps adopted in light of material control deficiencies; |
b. | review all material transactions and material contracts entered into between (i) the Company or any subsidiary of the Company, and (ii) any subsidiary, director, officer, insider or related party of the Company, other than transactions in the ordinary course of business; |
c. | review and discuss with management and the external auditors: (i) the preparation of Companys annual audited consolidated financial statements and its interim unaudited consolidated financial statements; (ii) whether the financial statements present fairly (in accordance with Canadian and United States generally accepted accounting principles) in all material respects the financial condition, results of operations and cash flows of the Company as of and for the periods presented; (iii) any matters required to be discussed with the external auditors according to Canadian and United States generally accepted auditing standards; (iv) an annual report by the external auditors describing: (A) all critical accounting policies and practices used by the Company; (B) all material alternative accounting treatments of financial information within generally accepted accounting principles that have been discussed with management of the Company, including the ramifications of the use such alternative treatments and disclosures and the treatment preferred by the external auditors; and (C) other material written communications between the external auditors and management; |
d. | following completion of the annual audit, review with each of: (i) management; (ii) the external auditors; and (iii) the internal auditors, any significant issues, concerns or difficulties encountered during the course of the audit; |
e. | resolve disagreements between management and the external auditors regarding financial reporting; |
f. | review the interim quarterly and annual financial statements and annual and interim press releases prior to the release of earnings information; and |
g. | review and be satisfied that adequate procedures are in place for the review of the public disclosure of financial information by the Company extracted or derived from the Companys financial statements, other than the disclosure referred to in (f), and periodically assess the adequacy of those procedures. |
2. | External auditors |
The Audit Committee shall:
a. | require the external auditors to report directly to the Audit Committee; |
b. | be directly responsible for the selection, nomination, compensation, retention, termination and oversight of the work of the Companys external auditors engaged for the purpose of preparing or issuing an auditors report or performing other audit, review or attest services for the Company, and in such regard recommend to the Board the external auditors to be nominated for approval by the shareholders; |
c. |
approve all audit engagements and must pre-approve the provision by the external auditors of all non-audit services, including fees and terms for all audit engagements and non-audit engagements, and in such regard the Audit Committee may establish the types of non-audit services the external auditors shall be prohibited from providing and shall establish the types of audit, audit related and non-audit services for which the Audit Committee will retain the external auditors. The Audit Committee may delegate to one or more of its members the authority to pre-approve non-audit services, provided that any such delegated pre-approval shall be exercised in accordance with the types of particular non-audit services authorized by the Audit Committee to be provided by the external auditor and the exercise of |
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such delegated pre-approvals shall be presented to the full Audit Committee at its next scheduled meeting following such pre-approval; |
d. | review and approve the Companys policies for the hiring of partners and employees and former partners and employees of the external auditors; |
e. | consider, assess and report to the Board with regard to the independence and performance of the external auditors; and |
f. | request and review the audit plan of the external auditors as well as a report by the external auditors to be submitted at least annually regarding: (i) the external auditing firms internal quality-control procedures; (ii) any material issues raised by the external auditors own most recent internal quality-control review or peer review of the auditing firm, or by any inquiry or investigation by governmental or professional authorities within the preceding five years respecting one or more independent audits carried out by the external auditors, and any steps taken to deal with any such issues. |
3. | Accounting Systems and Internal Controls |
The Audit Committee shall:
a. | oversee managements design and implementation of and reporting on internal controls. The Audit Committee shall also receive and review reports from management, the internal auditors and the external auditors on an annual basis with regard to the reliability and effective operation of the Companys accounting system and internal controls; and |
b. | review annually the activities, organization and qualifications of the internal auditors and discuss with the external auditors the responsibilities, budget and staffing of the internal audit function. |
4. | Legal and Regulatory Requirements |
The Audit Committee shall:
a. | receive and review timely analysis by management of significant issues relating to public disclosure and reporting; |
b. | review, prior to finalization, periodic public disclosure documents containing financial information, including the Managements Discussion and Analysis and Annual Information Form, if required; |
c. | prepare the report of the Audit Committee required to be included in the Companys periodic filings; |
d. | review with the Companys counsel legal compliance matters, significant litigation and other legal matters that could have a significant impact on the Companys financial statements; and |
e. | assist the Board in the oversight of compliance with legal and regulatory requirements and review with legal counsel the adequacy and effectiveness of the Companys procedures to ensure compliance with legal and regulatory responsibilities. |
5. | Additional Responsibilities |
The Audit Committee shall:
a. | discuss policies with the external auditor, internal auditor and management with respect to risk assessment and risk management; |
b. | establish procedures and policies for the following |
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(i) the receipt, retention, treatment and resolution of complaints received by the Company regarding accounting, internal accounting controls or auditing matters; and
(ii) the confidential, anonymous submission by directors or employees of the Company of concerns regarding questionable accounting or auditing matters or any potential violations of legal or regulatory provisions;
c. | prepare and review with the Board an annual performance evaluation of the Audit Committee; |
d. | report regularly to the Board, including with regard to matters such as the quality or integrity of the Companys financial statements, compliance with legal or regulatory requirements, the performance of the internal audit function, and the performance and independence of the external auditors; and |
e. | review and reassess the adequacy of the Audit Committees Charter on an annual basis. |
6. | Limitation on the Oversight Role of the Audit Committee |
Nothing in this Charter is intended, or may be construed, to impose on any member of the Audit Committee a standard of care or diligence that is in any way more onerous or extensive than the standard to which all members of the Board are subject.
Each member of the Audit Committee shall be entitled, to the fullest extent permitted by law, to rely on the integrity of those persons and organizations within and outside the Company from whom he or she receives financial and other information, and the accuracy of the information provided to the Company by such persons or organizations.
While the Audit Committee has the responsibilities and powers set forth in this Charter, it is not the duty of the Audit Committee to plan or conduct audits or to determine that the Companys financial statements and disclosures are complete and accurate and in accordance with generally accepted accounting principles in Canada and the United States and applicable rules and regulations. These are the responsibility of management and the external auditors.
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Exhibit 99.7
FORM 51-102F3
MATERIAL CHANGE REPORT
Item 1 Name and Address of Company:
Concordia Healthcare Corp.
277 Lakeshore Rd. East
Suite 302
Oakville, ON
L6J 1H9
Item 2 Date of Material Changes:
April 21, 2015
Item 3 News Release:
A news releases in respect of the completion of the Acquisition (as defined below) was disseminated over CNW on April 21, 2015.
Item 4 Summary of Material Change:
On April 21, 2015, Concordia Healthcare Corp. (Concordia or the Company) announced that it has completed the previously announced acquisition by the Company of 18 products, being comprised of 12 branded products and five authorized generic contracts and a product distributed by a third party in Australia pursuant to the terms of a distribution agreement, from Covis Pharma S.à.r.l and Covis Injectables, S.à.r.l (collectively, Covis) for $1.2 billion in cash (the Acquisition). All financial references in this material change report are in U.S. dollars unless otherwise noted.
Item 5 Full Description of Material Change:
5.1 | Full Description of Material Change |
On April 21, 2015, Concordia announced that it completed the previously announced Acquisition for $1.2 billion in cash.
The distinctive product portfolio Concordia has acquired includes branded pharmaceuticals, injectables and authorized generics that address life threatening and other serious medical conditions in various therapeutic areas including cardiovascular, central nervous system, oncology and acute care markets.
Key products are Nilandron®, for the treatment of metastatic prostate cancer; Dibenzyline®, for the treatment of pheochromocytoma; Lanoxin®, for the treatment of
mild-to-moderate heart failure and atrial fibrillation; and, Plaquenil®, for the treatment of lupus and rheumatoid arthritis.
The Acquisition was structured as an all-cash transaction with a purchase price of $1.2 billion. The Company paid for the Acquisition through a mix of term loans, bonds and equity (as further described below). RBC Capital Markets acted as financial advisor to Concordia on the Acquisition.
Senior Notes due 2023
In connection with the Acquisition, Concordia also closed its previously announced private offering of $735,000,000 of its 7.00% Senior Notes due 2023 (the Notes). The Notes were priced at an issue price of 100.00% of their face amount to yield 7.00%.
The Notes were offered and sold to qualified institutional buyers pursuant to Rule 144A under the Securities Act of 1933, as amended (the Securities Act), and to certain non-U.S. persons, including persons resident in Canada, in accordance with Regulation S under the Securities Act and other applicable securities laws. The Notes will not be registered under the Securities Act or the securities laws of any state or any other jurisdiction and may not be offered or sold in the United States absent an effective registration statement or an applicable exemption from the registration requirements under the Securities Act and applicable state securities laws and foreign securities laws. Any offer or sale of the Notes in Canada was made on a private placement basis in a manner that was exempt from the prospectus requirements of applicable Canadian securities laws.
The net proceeds of the offering of the Notes were used to partially fund (i) the purchase price for the Acquisition; and (ii) the fees and expenses incurred in connection with the Acquisition.
Equity Offering
On April 8, 2015, Concordia announced the closing of its short form prospectus offering, on a bought deal basis, of 4,329,428 subscription receipts (Subscription Receipts) of the Company, which included the exercise by the Underwriters (as defined below) of an over-allotment option of 15%, for aggregate gross proceeds of C$368,001,380 (the Offering). The Offering was completed at a price per Subscription Receipt of C$85.00 by a syndicate of underwriters led by RBC Capital Markets, as sole bookrunner and co-lead manager, and including GMP Securities L.P., as co-lead manager, and TD Securities Inc. (collectively, the Underwriters). Upon closing of the Offering, the Underwriters received payment for their expenses and 50% of their commission under the Offering. Upon closing of the Acquisition each holder of Subscription Receipts automatically received, without payment of additional consideration or further action, one Concordia common share in exchange for each Subscription Receipt held. The Subscription Receipts ceased trading on or about the
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closing of the Acquisition and the underlying Concordia common shares commenced trading shortly thereafter.
Pursuant to the agreement governing the Subscription Receipts, certain proceeds from the Offering which had been held in escrow have been released from escrow on behalf of Concordia to fund a portion of the purchase price for the Acquisition and pay the balance of the Underwriters commission under the Offering. Sufficient funds to pay a dividend equivalent amount equal to $0.075 per Subscription Receipt (less applicable withholding taxes, if any), as a result of the dividends declared on each Common Share by Concordia with a record date of April 15, 2015, will continue to be held in escrow. Funds to pay such dividend equivalent amount will be released from escrow and paid concurrent with the payment of the Companys dividend to all holders of Common Shares on April 30, 2015. Any funds in excess of the amount required to satisfy the dividend equivalent amount will be remitted to the Company once such dividend equivalent amount is paid to the former holders of Subscription Receipts.
Credit Facility
Concurrent with the closing of the Acquisition, Concordia announced that it entered into a credit agreement (Credit Agreement) dated April 21, 2015, by and among the Company, certain of the Companys subsidiaries, the Royal Bank of Canada, Morgan Stanley Senior Funding, Inc., TD Securities (USA) LLC, GE Capital Markets, Inc., Fifth Third Bank and certain lenders party thereto (collectively, the Lenders). Pursuant to the terms of the Credit Agreement, the Lenders agreed to provide senior secured credit facilities in an aggregate principal amount of up to $700 million comprising: (i) a senior secured revolving credit facility (the Revolving Facility) in an aggregate principal amount of up to $125 million; and (ii) a senior secured term loan facility (the Term Facility) in an aggregate principal amount of $575 million (together, the Bank Facilities). All obligations of the Company under the Bank Facilities are guaranteed by all material subsidiaries of the Company and will be secured by first priority (subject to permitted liens) perfected security interests in the assets of the Company and the assets of and equity interests in its material subsidiaries. The Term Facility will mature on the seventh anniversary of the Acquisition date (unless extended by the lenders under the Term Facility) and the Revolving Facility will mature on the fifth anniversary of the Acquisition date (unless extended by the lenders under the Revolving Facility).
The funds made available to the Company under the Term Facility were used to partially fund (i) the purchase price for the Acquisition; (ii) the fees and expenses incurred in connection with the Acquisition; and (iii) the repayment and retirement of the Companys outstanding debt issued pursuant to the terms and provisions of the amended and restated senior secured credit facility with GE Capital Canada Finance Inc. and a syndicate of lenders dated September 30, 2014.
5.2 | Disclosure for Restructuring Transactions |
Not applicable.
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Item 6 Reliance on subsection 7.1(2) of National Instrument 51-102:
Not applicable.
Item 7 Omitted Information:
Not applicable.
Item 8 Executive Officer:
Leith Tessy, Chief Financial Officer and Secretary-Treasurer, 905-842-5150
Item 9 Date of Report:
May 1, 2015
Notice regarding forward-looking statements:
This material change report includes forward-looking statements regarding Concordia and its business, which may include, but are not limited to, statements with respect to the Acquisition, the impact of the Acquisition on Concordias financial performance (including with respect to its revenues), Concordias growth and other factors. Often, but not always, forward-looking statements can be identified by the use of words such as plans, is expected, expects, scheduled, intends, contemplates, anticipates, believes, proposes or variations (including negative and grammatical variations) of such words and phrases, or state that certain actions, events or results may, could, would, might or will be taken, occur or be achieved. Such statements are based on the current expectations of Concordias management, and are based on assumptions and subject to risks and uncertainties. Although Concordias management believes that the assumptions underlying these statements are reasonable, they may prove to be incorrect. The forward-looking events and circumstances discussed in this material change report may not occur by certain specified dates or at all and could differ materially as a result of known and unknown risk factors and uncertainties affecting Concordia, including risks relating to the use of Concordias products to treat certain diseases, the pharmaceutical industry, the failure to obtain regulatory approvals, risks associated with the acquisition of pharmaceutical products including the Acquisition, economic factors, market conditions, acquisition opportunities, the inability to complete acquisitions, the equity markets generally, risks associated with growth and competition, general economic and stock market conditions and many other factors beyond the control of Concordia. Although Concordia has attempted to identify important factors that could cause actual actions, events or results to differ materially from those described in forward-looking statements, there may be other factors that cause actions, events or results to differ from those anticipated, estimated or intended. No forward-looking statement can be guaranteed. Except as required by applicable securities laws, forward-looking statements speak only as of the date on which they are made and Concordia undertakes no obligation to publicly update or revise any forward-looking statement, whether as a result of new information, future events, or otherwise.
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Exhibit 99.8
FORM 51-102F3
MATERIAL CHANGE REPORT
Item 1 Name and Address of Company:
Concordia Healthcare Corp.
277 Lakeshore Rd. East
Suite 302
Oakville, ON
L6J 1H9
Item 2 Date of Material Changes:
April 6, 2015 and April 13, 2015
Item 3 News Release:
News releases in respect of an intended offering of Notes (as defined below) were disseminated over CNW on April 6, 2015 and April 13, 2015.
Item 4 Summary of Material Change:
On April 6, 2015, Concordia Healthcare Corp. (Concordia or the Company) announced that it intends, subject to market and other conditions, to offer US$610,000,000 aggregate principal amount of its Senior Notes due 2023 (the Notes) to qualified institutional buyers pursuant to Rule 144A under the Securities Act of 1933, as amended (the Securities Act), and to certain non-U.S. persons, including persons resident in Canada, in accordance with Regulation S under the Securities Act and other applicable securities laws.
On April 13, 2015, Concordia announced the upsizing and pricing of the Notes. The principal amount of the Notes has been increased from US$610,000,000 to US$735,000,000 and the Notes were priced at an issue price of 100.00% of their face amount to yield 7.00%. Concordia also announced that the completion of the Notes offering and the Acquisition (as defined below) are expected to occur concurrently on or about April 21, 2015.
Item 5 Full Description of Material Change:
5.1 | Full Description of Material Change |
Concordia announced on April 6, 2015 that it intends, subject to market and other conditions, to offer US$610,000,000 aggregate principal amount of Notes to qualified institutional buyers pursuant to Rule 144A under the Securities Act, and to certain non-U.S.
persons, including persons resident in Canada, in accordance with Regulation S under the Securities Act and other applicable securities laws.
The Notes will be senior unsecured obligations of Concordia and will be guaranteed, jointly and severally, on a senior unsecured basis by certain of Concordias existing and future wholly-owned subsidiaries. The net proceeds of the offering of the Notes will be used to partially fund (i) the proposed acquisition by the Company of 18 products, being comprised of 12 branded products and five authorized generic contracts and a product distributed by a third party in Australia pursuant to the terms of a distribution agreement, from Covis Pharma S.à.r.l and Covis Injectables, S.à.r.l (the Acquisition); (ii) the fees and expenses incurred in connection with the Acquisition; and (iii) the repayment and retirement of the Companys outstanding debt issued pursuant to the terms and provisions of the amended and restated senior secured credit facility with GE Capital Canada Finance Inc. and a syndicate of lenders dated September 30, 2014.
The Notes will not be registered under the Securities Act or the securities laws of any state or any other jurisdiction and may not be offered or sold in the United States absent an effective registration statement or an applicable exemption from the registration requirements under the Securities Act and applicable state securities laws and foreign securities laws. Any offer or sale of the Notes in Canada will be made on a private placement basis in a manner that is exempt from the prospectus requirements of applicable Canadian securities laws.
Concordia announced on April 13, 2015 that the principal amount of the Notes has been increased from US$610,000,000 to US$735,000,000 and the Notes were priced at an issue price of 100.00% of their face amount to yield 7.00%. Concordia also announced that the completion of the Notes offering and the Acquisition are expected to occur concurrently on or about April 21, 2015.
5.2 | Disclosure for Restructuring Transactions |
Not applicable.
Item 6 Reliance on subsection 7.1(2) of National Instrument 51-102:
Not applicable.
Item 7 Omitted Information:
Not applicable.
Item 8 Executive Officer:
Leith Tessy, Chief Financial Officer and Secretary-Treasurer, 905-842-5150
Item 9 Date of Report:
April 14, 2015
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Notice regarding forward-looking statements:
This material change report includes forward-looking statements regarding Concordia and its business, which may include, but are not limited to, the completion of the offering for the Notes and the timing thereof, the use of proceeds, and the completion of the Acquisition and the timing thereof. Often, but not always, forward-looking statements can be identified by the use of words such as plans, is expected, expects, scheduled, intends, contemplates, anticipates, believes, proposes or variations (including negative and grammatical variations) of such words and phrases, or state that certain actions, events or results may, could, would, might or will be taken, occur or be achieved. Such statements are based on the current expectations of Concordias management, and are based on assumptions and subject to risks and uncertainties. Although Concordias management believes that the assumptions underlying these statements are reasonable, they may prove to be incorrect. The forward-looking events and circumstances discussed in this material change report may not occur by certain specified dates or at all and could differ materially as a result of known and unknown risk factors and uncertainties affecting Concordia, including risks relating to the use of Concordias products to treat certain diseases, the pharmaceutical industry, the failure to obtain regulatory approvals including those related to the Acquisition, risks associated with the acquisition of pharmaceutical products including the Acquisition, economic factors, market conditions, acquisition opportunities, the inability to complete acquisitions including the Acquisition, the equity markets generally, risks associated with growth and competition, general economic and stock market conditions and many other factors beyond the control of Concordia. Although Concordia has attempted to identify important factors that could cause actual actions, events or results to differ materially from those described in forward-looking statements, there may be other factors that cause actions, events or results to differ from those anticipated, estimated or intended. No forward-looking statement can be guaranteed. Except as required by applicable securities laws, forward-looking statements speak only as of the date on which they are made and Concordia undertakes no obligation to publicly update or revise any forward-looking statement, whether as a result of new information, future events, or otherwise.
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Exhibit 99.9
FORM 51-102F3
MATERIAL CHANGE REPORT
Item 1 Name and Address of Company:
Concordia Healthcare Corp.
277 Lakeshore Rd. East
Suite 302
Oakville, Ontario
L6J 1H9
Item 2 Date of Material Change:
March 17, 2015
Item 3 News Release:
A news release in respect of the Offering (as defined below) of Subscription Receipts (as defined below) was disseminated over Marketwired on March 17, 2015.
Item 4 Summary of Material Change:
On March 17, 2015, Concordia Healthcare Corp. (Concordia or the Company) announced that it entered into an agreement with a syndicate of underwriters led by RBC Capital Markets (RBC), as sole bookrunner and co-lead manager and including GMP Securities L.P. as co-lead manager (collectively, the Underwriters), pursuant to which the Underwriters have agreed to purchase, on a bought deal basis, 3,764,720 subscription receipts (the Subscription Receipts) of the Company, at a price of C$85.00 per Subscription Receipt (the Offering Price) for aggregate gross proceeds to Concordia of C$320,001,200 (the Offering).
Item 5 Full Description of Material Change:
5.1 | Full Description of Material Change |
On March 17, 2015, Concordia announced that it entered into an agreement with the Underwriters, pursuant to which the Underwriters agreed to purchase, on a bought deal basis pursuant to the filing of a short form prospectus, 3,764,720 Subscription Receipts at the Offering Price for aggregate gross proceeds to Concordia of C$320,001,200.
The Company has granted the Underwriters an option to purchase from the Company up to an additional 564,708 Subscription Receipts (equal to 15% of initial Subscription Receipts being offered) at the Offering Price to cover over-allotments, if any (the Over-Allotment Option). The Over-Allotment Option is exercisable, in whole or in
part, at any time up to the earlier of: (i) the 30 th day after and including the date of the closing of the Offering and (ii) the occurrence of a Termination Event (as defined below). If the Over-Allotment Option is exercised in full, an additional C$48,000,180 will be raised pursuant to the Offering and the aggregate gross proceeds of the Offering will be C$368,001,380.
The net proceeds of the Offering will be used to partially fund (i) the proposed acquisition by the Company of substantially all of the commercial assets of privately held Covis Pharma S.à.r.l and Covis Injectables, S.à.r.l (the Acquisition); (ii) the fees and expenses incurred in connection with the Acquisition; and (iii) the repayment and retirement of the Companys outstanding debt issued pursuant to the terms and provisions of the amended and restated senior secured credit facility with General Electric Capital Corporation, Health Financial Services and a syndicate of lenders dated September 30, 2014.
Each Subscription Receipt will entitle the holder thereof to receive, upon the closing of the Acquisition, without payment of additional consideration or further action, one Concordia common share (Common Share) in exchange for each Subscription Receipt.
Concordia will file a short form prospectus qualifying the issuance of the Subscription Receipts. The Offering is expected to close on or about April 8, 2015 and is subject to certain conditions including, but not limited to, the receipt of all necessary approvals including the approval of the Toronto Stock Exchange.
The Subscription Receipts will be issued pursuant to a subscription receipt agreement (the Subscription Receipt Agreement). Pursuant to the Subscription Receipt Agreement, the proceeds of the Offering, less the costs and expenses of the Underwriters and 50% of the Underwriters fee payable in connection therewith, will be held in escrow pending delivery of notice of the closing of the Acquisition. If: (i) the Acquisition closing does not occur prior to 5:00 p.m. (Toronto time) on September 5, 2015; (ii) the asset purchase agreement in respect of the Acquisition is terminated at an earlier time; or (iii) Concordia advises the subscription receipt agent and RBC, or announces to the public, that it will not proceed with the Acquisition (any of the events in (i), (ii) or (iii) being a Termination Event), the subscription receipt agent and Concordia will return to holders of Subscription Receipts an amount per Subscription Receipt equal to the Offering Price plus a pro rata share of the interest earned or deemed to be earned on the escrowed funds, net of any applicable withholding taxes.
5.2 | Disclosure for Restructuring Transactions |
Not applicable.
Item 6 Reliance on subsection 7.1(2) of National Instrument 51-102:
Not applicable.
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Item 7 Omitted Information:
Not applicable.
Item 8 Executive Officer:
Leith Tessy, Chief Financial Officer and Secretary-Treasurer, 905-842-5150
Item 9 Date of Report:
March 17, 2015
Notice regarding forward-looking statements:
This material change report includes forward-looking statements regarding Concordia and its business, which may include, but are not limited to, the filing of the preliminary short form prospectus and the timing thereof, the completion of the Offering and the timing thereof, the use of proceeds, and the completion of the Acquisition and the timing thereof. Often, but not always, forward-looking statements can be identified by the use of words such as plans, is expected, expects, scheduled, intends, contemplates, anticipates, believes, proposes or variations (including negative and grammatical variations) of such words and phrases, or state that certain actions, events or results may, could, would, might or will be taken, occur or be achieved. Such statements are based on the current expectations of Concordias management, and are based on assumptions and subject to risks and uncertainties. Although Concordias management believes that the assumptions underlying these statements are reasonable, they may prove to be incorrect. The forward-looking events and circumstances discussed in this release may not occur by certain specified dates or at all and could differ materially as a result of known and unknown risk factors and uncertainties affecting Concordia, including risks relating to the use of Concordias products to treat certain diseases, the pharmaceutical industry, the failure to obtain regulatory approvals including those related to the Acquisition, risks associated with the acquisition of pharmaceutical products including the Acquisition, economic factors, market conditions, acquisition opportunities, the inability to complete acquisitions including the Acquisition, the equity markets generally, risks associated with growth and competition, general economic and stock market conditions and many other factors beyond the control of Concordia. Although Concordia has attempted to identify important factors that could cause actual actions, events or results to differ materially from those described in forward-looking statements, there may be other factors that cause actions, events or results to differ from those anticipated, estimated or intended. No forward-looking statement can be guaranteed. Except as required by applicable securities laws, forward-looking statements speak only as of the date on which they are made and Concordia undertakes no obligation to publicly update or revise any forward-looking statement, whether as a result of new information, future events, or otherwise.
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Exhibit 99.10
FORM 51-102F3
MATERIAL CHANGE REPORT
Item 1 Name and Address of Company:
Concordia Healthcare Corp.
277 Lakeshore Rd. East
Suite 302
Oakville, Ontario
L6J 1H9
Item 2 Date of Material Change:
March 9, 2015
Item 3 News Release:
A news release in respect of the Acquisition (as defined below) was disseminated over CNW Group on March 9, 2015.
Item 4 Summary of Material Change:
On March 9, 2015, Concordia Healthcare Corp. (Concordia) announced that it and its subsidiary, Concordia Pharmaceuticals Inc. (CPI), entered into a definitive asset purchase agreement to acquire substantially all of the commercial assets of privately held Covis Pharma S.à.r.l and Covis Injectables, S.à.r.l (collectively, Covis) for US$1.2 billion in cash.
Item 5 Full Description of Material Change:
5.1 | Full Description of Material Change |
Concordia, announced that it entered into a definitive asset purchase agreement to acquire substantially all of the commercial assets of privately held Covis for US$1.2 billion in cash (the Acquisition). All financial references disclosed in this material change report are in U.S. dollars unless otherwise noted.
The Covis drug portfolio being acquired (the Portfolio) consists of 18 branded and authorized generic products with stable revenue, strong margins and free cash flow. The distinctive product portfolio includes branded pharmaceuticals, injectables and authorized generics that address life threatening and other serious medical conditions in various therapeutic areas including cardiovascular, central nervous system, oncology and acute care markets. Key products are Nilandron®, for the treatment of metastatic prostate cancer; Dibenzyline®, for the treatment of
pheochromocytoma; Lanoxin®, for the treatment of mild-to-moderate heart failure and atrial fibrillation; and, Plaquenil®, for the treatment of lupus and rheumatoid arthritis.
In its fourth quarter of 2014, Covis expects to have revenue between US$47 and US$52 million related to the Portfolio. Overall for 2014, Covis expects to have revenue between US$140 and US$145 million.
Concordia believes that it can integrate the Portfolio it is acquiring into its existing business and leverage its existing infrastructure. Through the elimination of redundant distribution and G&A expenses, Concordia expects to recognize immediate synergies of approximately $20 million.
The Acquisition is structured as an all-cash transaction with a purchase price of US$1.2 billion for the Portfolio being acquired. CPI plans to pay for the Acquisition through a mix of term loans, bonds and equity. Concordia has entered into a commitment letter with Royal Bank of Canada (RBC), pursuant to which, RBC has agreed to provide credit facilities and bridge commitments of up to US$1.6 billion (the Credit Facilities) to fully pay for the Acquisition price and refinance all outstanding Concordia debt. The Credit Facilities are subject to a number of customary conditions. All obligations of Concordia under the term loans will be secured by first priority perfected security interests in the assets of Concordia and the assets of and equity interests in its subsidiaries. The bridge commitments will be unsecured.
The Acquisition, which is expected to close in the second quarter of 2015, is subject to satisfaction of customary closing conditions (including receipt of required regulatory approvals). The Board of Directors of all parties to the transaction have approved the acquisition.
5.2 | Disclosure for Restructuring Transactions |
Not applicable.
Item 6 Reliance on subsection 7.1(2) of National Instrument 51-102:
Not applicable.
Item 7 Omitted Information:
Not applicable.
Item 8 Executive Officer:
Leith Tessy, Chief Financial Officer and Secretary-Treasurer, 905-842-5150
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Item 9 Date of Report:
March 16, 2015
Notice regarding future-oriented financial information:
To the extent any forward-looking statements in this material change report constitutes future-oriented financial information or financial outlooks within the meaning of securities laws, such information is being provided to demonstrate the potential benefits of the Acquisition and the financing described herein and readers are cautioned that this information may not be appropriate for any other purpose and that they should not place undue reliance on such future-oriented financial information and financial outlooks. Future-oriented financial information and financial outlooks, as with forward-looking information generally, are, without limitation, based on the assumptions and subject to the risks set out below under Notice regarding forward-looking statements.
Notice regarding forward-looking statements:
This material change report includes forward-looking statements and forward-looking information (collectively, forward-looking statements) regarding Concordia and its business, which may include, but is not limited to, statements with respect to the acquisition and the completion and timing thereof, synergies resulting from the acquisition including the elimination of redundant distribution expenses and the ability to achieve greater cost efficiencies and higher margins, the completion of the financing, the entering into of documentation with respect to the financing, the impact of the acquisition on Concordias financial performance (including with respect to its revenues, margins, earnings per share (EPS) and EBITDA), financial results and performance of Concordia and Covis for fiscal 2014 and the fourth quarter of 2014, Concordias growth and other factors. Often, but not always, forward-looking statements can be identified by the use of words such as plans, is expected, expects, scheduled, intends, contemplates, anticipates, believes, proposes or variations (including negative and grammatical variations) of such words and phrases, or state that certain actions, events or results may, could, would, might or will be taken, occur or be achieved. Such statements are based on the current expectations of Concordias management, and are based on assumptions and subject to risks and uncertainties. Although Concordias management believes that the assumptions underlying these statements are reasonable, they may prove to be incorrect. The forward-looking events and circumstances discussed in this material change report may not occur by certain specified dates or at all and could differ materially as a result of known and unknown risk factors and uncertainties affecting Concordia, including risks regarding the pharmaceutical industry, regulatory investigations, the failure to comply with applicable laws, the failure to obtain regulatory approvals, risks relating to the use of Concordias products to treat certain diseases, risks relating to distribution arrangements, risks relating to the markets in which Concordia operates and/or distributes its products, possible failure to realize the anticipated benefits of the acquisition (including synergies and accretion), risks associated with the integration of the Portfolio into Concordias business, increased indebtedness, ability to achieve the full amount of cost synergies, the fact that historical and pro forma combined financial information may not be representative of Concordias results post acquisition, the reliance on information provided by Covis, economic factors, market conditions, the equity markets generally, risks associated with growth and competition, risks associated with the acquisition and financing of the acquisition and many other factors beyond the control of Concordia. Although Concordia has attempted to identify important factors that could cause actual actions, events or results to differ materially from those described in forward-looking statements, there may be other factors that cause actions, events or results to differ from those anticipated, estimated or intended. No forward-looking statement can be guaranteed. Except as required by applicable securities laws, forward-looking statements speak only as of the date on which they are made and Concordia undertakes no obligation to publicly update or revise any forward-looking statement, whether as a result of new information, future events, or otherwise.
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Exhibit 99.11
CONCORDIA HEALTHCARE CORP.
CODE OF CONDUCT
Message from the President and Chief Executive Officer (CEO)
Dear Colleagues,
The standards of ethical excellence that Concordia was founded upon remain as important as ever today. The healthcare industry faces increasing regulatory oversight, legal requirements, and global competitive challenges. Our customers, suppliers, and patients expect us to conduct business with integrity and honesty. As we move forward, our reputation remains our most valuable asset. To protect and uphold our reputation, it requires every one of us to use good judgment and make the right choices. This Code of Conduct serves as our framework for integrity, a current reflection of the standards that govern how our employees conduct and support both commercial and non-commercial activities.
We recognize that each individual at Concordia plays an important role in defining our corporate culture. As such, all employees are individually responsible for making sure that they are in compliance with the laws, regulations, and guidelines that govern our industry. If you encounter misconduct that might violate our standards or the law, voice that concern. We are counting on you to speak up.
When our actions align with our standards, we communicate to our stakeholders and to the marketplace that we are trustworthy. As our business and our world changes ever more rapidly, that trustworthiness will be vital to our continued success.
Mark Thompson
President and Chief Executive Officer (CEO)
Code of Conduct | ||||
Policy Number: 1 | Version: 1 | Effective Date: 7-July-2014 | ||
Supersedes: N/A |
1. | INTRODUCTION |
1.1. | Purpose |
Concordia Healthcare Corp. (Concordia or the Company) and its affiliates are committed to maintaining the highest ethical standards in its dealings with all parties involved in the Companys business activities, including employees, vendors, contractors and third parties. This Code of Conduct (the Code) which has been approved by Concordias CEO and the Concordia Board of Directors has been put in place to summarize the key ethical and legal principles that everyone at Concordia is required to adhere to. While this Code does not cover every issue that may arise, this Code is intended to promote honest and ethical conduct among all individuals employed by or associated with Concordia.
1.2. | Scope |
We expect every individual, all staff and management, consultants, and contract workers (full time or temporary) to read, understand, and comply with this Code and all other applicable laws, regulations and Company policies. This Code and the spirit of its purpose also apply to all Concordia locations, affiliates and subsidiaries. However, to the extent that some Concordia affiliates and subsidiaries may operate in varying industry segments or jurisdictions, this Code may be supplemented by additional policies and/or processes to address specific regulatory requirements or local laws. Employees who would like to seek further information or have questions on the information contained in the Code should speak with the CEO, Chief Financial Officer of Concordia (the CFO) or their supervisor.
2. | WORKPLACE STANDARDS |
2.1. | Overview |
Concordia recognizes its employees are a valuable asset of the Company. We value employees who are ethical, innovative and hard workers. Accordingly, we work to retain and recruit individuals by providing competitive compensation, excellent growth opportunities and a diverse workplace free from bias.
2.2. | Equal Opportunity |
Concordia is committed to providing equal opportunity in employment to all employees and applicants. This commitment applies to recruitment, hiring, employment, and employment-related decisions (including, but not limited to, hiring, firing, workforce reductions, work assignments, transfers, promotions, wage/salary adjustments, and/or bonuses). We are also committed to complying with all applicable laws regarding nondiscrimination in employment. This allows us to provide a discrimination-free work environment for all employees, regardless of race, color, religion, sexual orientation,
Corporate Compliance Policies & Guidelines
1
Code of Conduct | ||||
Policy Number: 1 | Version: 1 | Effective Date: 7-July-2014 | ||
Supersedes: N/A |
age, gender identity or gender expression, national origin, citizenship, ancestry, marital status, disability, genetic information, veteran status, or other characteristics protected by applicable laws.
2.3. | Discrimination and Harassment |
Concordia respects diversity and the personal dignity of its employees. Concordia employees are expected to treat all colleagues with respect and dignity. As such, Concordia strives to ensure that the Companys work environment is free of discrimination and harassment.
Discrimination is defined as the treatment or consideration of, or making a distinction in favor of or against, a person or thing based on the group, class, or category to which that person or thing belongs rather than on individual merit.
Concordia will not tolerate any form of harassment, whether physical, verbal, or visual.
Harassment is defined as any unwelcome or inappropriate conduct that demonstrates hostility or an aversion toward another on the basis of any characteristic.
Employees shall not tolerate any type of discrimination or harassment and shall report these actions immediately to the Concordia CEO and CFO.
2.4. | Drugs and Alcohol |
Concordia prohibits the use of illegal drugs and the abuse of alcohol and/or over-the-counter or prescription drugs. This allows an employees productivity and efficiency to remain at the highest level of performance and keeps a safe working environment. All employees are prohibited from working in Company facilities, operating a Company vehicle or a vehicle subsidized by the Company, or conducting Concordia business if they are under the influence of or impaired by alcohol or drugs. Occasionally, alcohol may be served in connection with a Concordia sponsored function or event and if served, must be consumed responsibly.
Concordia is committed to providing a safe and healthy working environment to its employees through the adherence to applicable health and safety laws. If you are aware of any conditions or practices in the workplace that pose a threat to health, safety, or the environment, you are responsible for reporting them to the CEO and CFO immediately.
3. | MARKETPLACE STANDARDS |
3.1. | Overview |
Corporate Compliance Policies & Guidelines
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Code of Conduct | ||||
Policy Number: 1 | Version: 1 | Effective Date: 7-July-2014 | ||
Supersedes: N/A |
Concordias reputation for integrity and excellence requires careful adherence to all applicable laws and regulations as well as commitment to the highest standards of conduct of corporate and personal integrity. We maximize productivity when we act ethically, responsibly, and professionally. Concordia expects all Concordia employees to conduct Company business in an ethical manner. To do so, we must each be informed and appropriately trained so that we understand relevant law as well as Company policy.
Concordia operates in a highly regulated industry and therefore is subject to laws of various countries, provinces, states, and organizations, some of which may also apply across borders. Wherever an employee conducts Company business, the employee should know the policies and work requirements that apply to that location. If local laws are more restrictive than Company policies, the employee should conduct their activities in accordance with the more restrictive requirements.
At times, the ethically or legally correct thing to do, or specific Concordia policy, may be unclear. In these situations, employees are expected to seek guidance by speaking with your supervisor, if appropriate, the CEO, the CFO or the Compliance Officer.
3.2. | Compliance with Laws and Regulations |
Concordia is obligated to sustain a culture of compliance to stay in compliance with federal, state, provincial and local laws applicable to our business activities. As an employee, you must strive to fully understand which laws pertain to your area of work and what is required to be in compliance with these laws. Since these laws are very complicated, this Code cannot include a summary of every law that applies to our Company business. If you have any questions or concerns about a particular law or this Code or any other Company policy, please discuss your questions or concerns with your supervisor, if appropriate, the CEO, the CFO or the Compliance Officer. Listed below are some of the most important laws and guidelines that govern Concordias business:
| Federal and State Anti-Kickback Statutes (AKS) - AKS laws prohibit anyone from offering, paying, soliciting, or receiving anything of value (including a kickback, bribe, or rebate) in return for referring an individual for an item or service reimbursed under a federal or state healthcare program. |
| Federal and State False Claims Acts (FCA) - The FCA and similar state laws prohibit the submission of false or fraudulent claims or information for payment or approval to federal or state government and healthcare programs. Violations of these laws include providing false information to customers related to coding, pricing, or submission of claims for government programs and the promotion of products for unapproved uses. |
|
The Foreign Corrupt Practices Act (FCPA) The FCPA provides specific laws on conducting business with foreign government officials. Under the FCPA, a company (and its directors, agents, officers and employees) is prohibited from directly or indirectly offering, promising to pay or authorizing the payment of money or anything of value to a foreign government official to win or retain business or favorable treatment. In addition, the FCPA requires Concordia to |
Corporate Compliance Policies & Guidelines
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Code of Conduct | ||||
Policy Number: 1 | Version: 1 | Effective Date: 7-July-2014 | ||
Supersedes: N/A |
keep accurate books and records and maintain an adequate system of internal accounting controls. |
| Additional Foreign Laws and Regulations - Concordia employees shall abide by applicable laws and regulations in all counties in which Concordia may operate or otherwise conduct business. This includes, but is not limited to, laws and regulations that prohibit bribery, corruption or the conduct of business with specified individuals, companies, or countries. |
| Pharmaceutical Research and Manufacturers of America (PhRMA) PhRMA has issued the PhRMA Code on Interactions with Healthcare Professionals (also known as the PhRMA Code). This voluntary code for member companies focuses on interactions between pharmaceutical company representatives and healthcare professionals (HCPs). The PhRMA Code provides guidance on marketing medicines to HCPs and developing relationships focused on, among other things, informing HCPs about products, providing scientific and educational information, supporting medical research and education, making charitable donations, entering into research agreements and consulting agreements, authoring publications, and providing gifts and entertainment. Concordia abides by the PhRMA Code and all Concordia employees shall ensure that interactions with HCPs are completely appropriate and are of the highest ethical standards. |
| Canadas Research-Based Pharmaceutical Companies (Rx&D) Similar to PhRMAs mission, Rx&D is an association of leading research-based pharmaceutical companies. Rx&D is dedicated to improving the health of all Canadians through the discovery and development of new medicines and vaccines. Rx&D has published a Code of Ethical Practices with HCPs which sets standards by establishing clear guidelines and expectations on how the relationship between and HCP and pharmaceutical company should be conducted to ensure that the health and well-being of patients is the priority. |
| OIG Compliance Program Guidance for Pharmaceutical Manufacturers - The Office of Inspector General (OIG) of the Department of Health and Human Services (HHS) has developed guidelines for pharmaceutical manufacturers to consider when developing, implementing, or evaluating a Corporate Compliance Program. The OIG has also highlighted the seven elements they feel make up an effective compliance program. The guidance is intended to assist with the development and implementation of internal controls and procedures that promote adherence to applicable statutes, regulations, and requirements of the federal healthcare programs. |
|
Stark Law - All Concordia employees should be fully aware of and abide by the Stark Law (Stark). Stark is similar to the AKS and includes a conflict of interest component. Stark prohibits a physician from referring patients for designated health services (eleven specific categories are included in the law) to an entity with which the physician or an immediate family member has an investment or compensation interest. Physician-owned medical companies are permissible if |
Corporate Compliance Policies & Guidelines
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Code of Conduct | ||||
Policy Number: 1 | Version: 1 | Effective Date: 7-July-2014 | ||
Supersedes: N/A |
they are structured in a way that no direct or indirect compensation arrangements are created with a provider of designated health services or if they fall within one of the compensation exceptions provided by Stark. |
| The Patient Protection and Affordable Care Act (PPACA) The PPACA requires pharmaceutical manufacturers to report any payment or transfer of value to a HCP. A transfer of value is any form of payment, including but not limited to, cash or cash equivalents, meals, gifts, services, employment offers, loans, travel expenses, entertainment, political contributions, charitable donations, subsidies, per diem payments, sponsorships, honoraria, or provision of any other asset, even if nominal in value. These requirements place additional restrictions and requirements on pharmaceutical manufacturers regarding interactions and activities conducted with HCPs, such as the tracking and disclosure of spending associated with those interactions and activities. In instances where state requirements and laws are more restrictive than Concordia policies, Concordia employees shall conduct activities in accordance with the more restrictive state requirements. |
| Health Insurance Portability and Accountability Act (HIPAA) - HIPAA, as amended by the Health Information Technology for Economic and Clinical Health (HITECH) Act, addresses the security and privacy of health information, who is responsible for maintaining the security and privacy of such information, and who may access and/or use such information. Violations can lead to severe penalties including criminal and/or civil fines and/or imprisonment. |
3.3. | Anti-trust and Fair Competition |
In a competitive marketplace, Concordia understands the importance of complying with all applicable anti-trust and fair competition laws. Anti-trust and fair competition laws are meant to prevent restraints on trade or the abuse of a dominant market position, and a competitive marketplace ensures that the greatest benefit can be realized by both consumers of healthcare products and services (i.e. patients, healthcare providers) and suppliers of those products/services. Each employee is expected to understand and comply with anti-trust and fair competition laws and not to enter into business contracts or engage in activities that violate, or give the appearance of violating these laws. Specifically, when dealing with competitors:
| Concordia will not enter into agreements or understandings which propose, or give the appearance of, limiting competition. |
| Concordia will not enter into agreements or understandings which propose, or give the appearance of, sharing price, price-related terms, sales terms or other conditions. |
Violations of these laws by any Concordia employee carry severe penalties for both the Company and the individual depending on the severity of the violation. Anti-trust and fair competition laws are complex; therefore you must contact the CEO, CFO or the
Corporate Compliance Policies & Guidelines
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Code of Conduct | ||||
Policy Number: 1 | Version: 1 | Effective Date: 7-July-2014 | ||
Supersedes: N/A |
Compliance Officer for approval of any business practice conducted on behalf of the Company that may involve an interpretation of these laws.
3.4. | The Food, Drug, and Cosmetic and Prescription Drug Marketing Acts |
Concordia must comply with all U.S. Food and Drug Administration (FDA) laws and regulations including all applicable laws and regulations that govern the manufacturing, labeling, sale, and promotion of prescription pharmaceutical drugs. Specifically, Concordia is required to comply with the following:
| FDA regulation of off-label promotion When patients and HCPs seek drug-related information about products, they are looking for the most accurate and complete information. Therefore, when the FDA approves a drug, it does so for certain purposes and indications only. A drug product is approved for the use stated in its label. Any other use is considered off-label. Off-label information can include information regarding disease state, dosing, patient populations, use of concomitant medications, duration of therapy, comparison to other therapies, etc. To avoid any risk of promoting an off-label use of our products, each employee is responsible for learning and understanding the on-label use of the Companys promoted products. |
The FDA prohibits pharmaceutical companies from marketing or promoting a drug off-label use. However, the FDA does not prevent HCPs from prescribing or discussing off-label information with their patients. The Companys Medical Affairs department is permitted to respond to unsolicited requests for off-label information for a Company product. Unsolicited requests are direct, spontaneous question(s) from a HCP that is neither directly nor indirectly encouraged nor prompted by a Concordia employee. Concordia has drafted and implemented written policies and procedures that provide guidance to employees on how to handle off-label requests from HCPs.
| Drug Sampling The Prescription Drug Marketing Act of 1987 (PDMA) and the Prescription Drug Amendments of 1992 were enacted to address certain prescription drug marketing practices that have contributed to the diversion of large quantities of drugs into a secondary grey market. The PDMA also established certain controls for drug sample product distribution. |
3.5. | Business Gratuities and Transfers of Value |
In the United States, the U.S. FCPA makes it illegal for employees of U.S. companies to directly or indirectly give anything of value to a non-U.S. government official in order to gain an improper business advantage. In pursuit of our commitment to uphold the highest ethical standards, we must not seek, nor accept, any gift as a condition of doing business. Similarly, Concordia employees are prohibited from giving, offering, or promising anything of value which may be perceived to influence the prescribing habits of a HCP.
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Code of Conduct | ||||
Policy Number: 1 | Version: 1 | Effective Date: 7-July-2014 | ||
Supersedes: N/A |
Under the following circumstances, Concordia permits its employees to accept and provide transfers of value, gratuities and entertainment by employees if:
| If it is of nominal value ($100 or less) and not cash |
| Not intended to improperly influence Company business decisions |
| Offered/received consistent with all of Concordias applicable policies and procedures |
| Offered/received consistent with applicable industry standards and laws, rules and regulations |
3.6. | Marketing of Our Products |
The release of confidential information about Concordia or its business or products may harm the Company. It is expressly prohibited for our employees to discuss or communicate information about unapproved products or any information that is not consistent with an approved product label. Additionally, only marketing and promotional materials that are approved by the Promotional Review Board (PRB) may be used to aid discussions regarding Concordia or its products with HCPs or other third parties.
| The Office of Prescription Drug Promotion (OPDP), formerly the Division of Drug Marketing, Advertising and Communications (DDMAC), is an FDA division with responsibility for reviewing prescription drug advertising and promotional labeling to ensure that the information contained in promotional materials are not false or misleading. All promotional materials approved by the PRB for dissemination by or on behalf of Concordia must meet OPDP requirements. When appropriate, approved materials will be submitted to the OPDP by the PRB. |
| The Pharmaceutical Advertising Advisory Board (PAAB) is an independent review agency, recognized by Health Canada, whose primary role is to ensure that healthcare product communication for prescription, non-prescription, biological and natural health products is accurate, balanced and evidence-based, and reflects current and best practice. Promotional materials approved by the PRB will meet all guidelines set forth by the PAAB and their Code of Advertising Acceptance. |
3.7. | Interactions with Healthcare Professionals (HCPs) and Organizations (HCOs) |
Building strong, appropriate and ethical relationships with HCPs are an integral part of Concordias business operations. The PhRMA Code provides guidance on what is acceptable during these interactions to ensure that HCPs have the most up to date and accurate information on prescription medicines. As such, all Concordia employees must conduct themselves in the most appropriate and compliant manner when interacting with a HCP.
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Code of Conduct | ||||
Policy Number: 1 | Version: 1 | Effective Date: 7-July-2014 | ||
Supersedes: N/A |
Concordia understands that any relationships with a HCP must be compliant with applicable federal and state healthcare fraud and abuse laws. These laws prohibit giving or offering anything, of certain value, to influence prescribing or purchasing decisions. Furthermore, the laws and regulations prohibit the submission of false claims or statements to federal or state healthcare programs. To ensure compliance with state and federal regulation pertaining to interactions with HCPs and HCOs, Concordia has drafted and implemented written policies and procedures that provide guidance to employees regarding appropriate interactions with these groups.
3.8. | Consulting Arrangements with Healthcare Professionals |
We may, from time to time, hire a HCP as a consultant to obtain information or advice on topics including, but not limited to, the marketplace, products, therapeutic areas and patient needs. We base decisions to select or retain a consultant based on defined criteria such as medical expertise, reputation, knowledge and experience regarding a particular therapeutic area.
We provide compensation to consultants for their services and reimbursement for travel, lodging and meal expenses actually incurred in connection with providing such services, as long as such compensation and reimbursement is reasonable and based on Fair Market Value (FMV).
3.9. | Speaker Programs and Training |
At times, we may engage HCPs to participate as speakers to help educate and inform other HCPs about the benefits, risks and appropriate uses of our products. We base our decisions to select or retain a speaker based on defined criteria such as medical expertise, reputation, knowledge and experience regarding a particular therapeutic area, as well as communication skills. We are accountable for the presentations of our speakers, and therefore speakers must undergo speaker training prior to speaking. HCPs who participate act as speakers on Concordias behalf may be offered compensation for their time spent in training and providing speaker programs, as well as reimbursement for travel, lodging and meal expenses when such compensation and reimbursement is reasonable and provided at FMV.
3.10. | Informational Presentations and Accompanying Business Meals |
Concordia employees may make presentations to, and have discussions with, HCPs that provide scientific and educational information and/or value during a business meal. Concordia employees may provide business meals to HCPs and their staff attending such presentations under the following conditions:
| The Business Meals are: |
| Permitted by state, provincial and/or local law; |
| In accordance with all other Concordia policies; |
| Modest as judged by local standards; |
| Not part of an entertainment or recreational event; and |
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Code of Conduct | ||||
Policy Number: 1 | Version: 1 | Effective Date: 7-July-2014 | ||
Supersedes: N/A |
| Are provided in a manner conducive to informational communication. |
| Business Meals provided by Concordias sales personnel and their immediate managers are limited to in-office or in-hospital settings. |
| An HCPs spouse or other guest may not attend a business meal, unless they are an appropriate HCP. |
3.11. | Gifts |
Concordias sales and promotional interactions with HCPs are intended to inform HCPs about our products and provide relevant scientific and educational information to support patient care and the practice of medicine. We do not use gifts, meals, hospitality, entertainment, recreation, and other items or activities of value to influence HCPs to prescribe, use, purchase, recommend, or make favorable formulary recommendations concerning our products. Items of modest value ($100 or less) may be given only if they are designed primarily for the education of patients or HCPs (e.g., medical texts or journals, treatment guidelines, anatomical models, patient-self assessment tools), are approved by the Head of the respective Business Unit, are allowed by applicable laws, and otherwise comply with this Code. Unless otherwise stipulated by applicable law, the value of a particular item is based on what it would otherwise cost a HCP to obtain the item, not on what it costs Concordia to procure it.
3.12. | Federal and State Laws Regulating Payments or Transfers of Value to Healthcare Professionals |
Various states have laws regulating prescription drug manufacturers payments or transfers of value to healthcare professionals. State laws may include behavioral prohibitions, as well as disclosure, audit, and code of conduct requirements. Sunshine provisions in the Patient Protection and Affordable Care Act (PPACA) also require disclosure of payments and transfers of value to healthcare professionals. If a federal or state law is more restrictive than Concordias Code and other policies, Concordia employees must comply with the applicable federal or state law.
3.13. | Privacy |
On occasion, Concordia may also receive information in addition to Protected Health Information (PHI), such as personal and private information for legitimate business purposes including, but not limited to, information concerning colleagues, job applicants, research study subjects, research investigators, patients, consultants, HCPs, vendors, and suppliers. Concordia is committed to compliance with applicable legal and regulatory requirements protecting the privacy of PHI, other confidential information and safeguarding this information in a manner consistent with applicable laws.
As defined by HIPAA, PHI refers to all medical, mental, dental, vision, and benefit records, or other data that contains any type of health-related information that that relates to the individuals past,
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Code of Conduct | ||||
Policy Number: 1 | Version: 1 | Effective Date: 7-July-2014 | ||
Supersedes: N/A |
present or future physical or mental health or condition and identifies the covered person by either name, social security number, birth date, address, age, other identifiers etc., that is either stored or transmitted by Concordia in any form, such as electrical, paper, or oral transmission.
Concordia respects individual privacy and adheres to applicable data privacy regulations. All Concordia employees are expected to protect individually identifiable information as it pertains to employees, applicants, clinical trial and research study patients, and customers.
3.14. | Product Complaints and Adverse Event Reporting |
Concordia strives to ensure that all products are safe and effective. It is crucial that we closely monitor the safety of our products and immediately evaluate any concerns that arise. Concordia has implemented procedures which allow product complaints and adverse event information to be reported to the Companys third party vendor handling adverse event and product complaints, Optum. This may include information regarding an adverse event experienced by a patient who is currently using, or who recently used, a Concordia product. The procedures in place allow product complaints and adverse event reports to be documented and handled in accordance with applicable laws and regulations. Employees who become aware of an adverse event or product complaint must report it by calling 1-877-370-1142, within 24 hours of becoming aware of the potential adverse event or product complaint.
3.15 | Corporate Opportunities |
Employees are prohibited from (a) taking for themselves personally corporate opportunities that are discovered through the use of Concordias property, information or position; (b) using Concordias property, information or position for personal gain; and (c) competing with Concordia. Employees owe a duty to Concordia to advance its legitimate interests when the opportunity to do so arises.
3.16 | Fair Dealing |
Each employee should endeavor to deal fairly with Concordias shareholders, customers, suppliers, competitors and employees. None should take unfair advantage of anyone through manipulation, concealment, abuse of privileged information, misrepresentation of material facts, or any other unfair dealing practice.
4. | BUSINESS STANDARDS |
4.1. | Overview |
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Code of Conduct | ||||
Policy Number: 1 | Version: 1 | Effective Date: 7-July-2014 | ||
Supersedes: N/A |
At Concordia, we work together to adhere to applicable laws and regulations. This includes a personal responsibility to protect our corporate assets and integrity. To achieve such high standards Concordia employees must adhere to all applicable laws and regulations. In doing so, we will steer clear of any conflicts of interest that may affect Concordias reputation. We must uphold Concordia values while conducting business within the letter and spirit of the law.
4.2. | Conflicts of Interest |
As Concordia employees, we have a responsibility to the Company, our co-workers, and ourselves to avoid conflicts of interest. A conflict of interest may arise when personal interests compromise, or have the appearance of compromising, our judgment. Concordia employees have a duty to avoid conflicts of interest whenever possible, keeping the Companys best interest in mind at all times. Your decisions should not be made for personal gain that conflicts with your professional or ethical obligations to Concordia. Three general rules in avoiding conflicts of interest are:
| Business activities with suppliers, customers and other individuals or entities should be conducted in a fair and objective manner |
| Do not personally profit, in kind or in cash, from Concordia business transactions |
| Avoid any conflict of interest with family members by not recommending or using family members businesses, services or products |
In the event that an actual conflict of interest arises between the personal, professional or financial duties of a Concordia employee, the employee involved in this conflict of interest should address, disclose and handle the matter in the utmost ethical manner and in accordance with this Code, including disclosing such conflict of interest to the CEO or CFO.
4.3. | Insider Trading |
Insider trading involves the purchase or sale of securities of a reporting issuer with knowledge of a material fact or material change with respect to the reporting issuer that has not been generally disclosed. The prohibition against insider trading also applies to trading in the securities of any publicly traded company about which a Concordia employee, director, or agent may receive inside information during the course of his or her relationship with Concordia. Employees, officers, stockholders and directors (and their families) are obligated to abide by both United States and Canadian laws and regulations prohibiting trading in the securities markets based on inside information or communicating inside information about Concordia or its business partners, competitors, customers, or suppliers. Any Concordia employee, officer, or director who has a question regarding stock trading or the sharing of Concordia information with third parties should review the Disclosure, Securities Trading and Confidentiality Policy and/or contact Concordias CEO or CFO.
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Code of Conduct | ||||
Policy Number: 1 | Version: 1 | Effective Date: 7-July-2014 | ||
Supersedes: N/A |
In addition, only certain officers of Concordia are authorized to discuss Concordia business with brokers, analysts, stockholders, and the media. All Concordia employees, officers, and directors must exercise reasonable care not to disclose inside information to outsiders, either intentionally or inadvertently, under any circumstances. If questioned by the media, an analyst, or an investor, all Concordia employees are to direct inquiries to the CEO. Any employee who becomes aware of information that may be considered material should advise a member of the Oversight Committee so that a proper determination can be made about whether the information should be publicly disclosed.
4.4. | Competitive Intelligence |
Concordia believes in free and open competition in the marketplace. Keeping up with the competition means having the ability to produce proper business plans, which sometimes include an assessment of competitors products, services, or business. However, Concordia respects the privacy and confidentiality of its competitors information and only wishes to gather such information pertaining to competitive advantages in a reasonable and ethical manner.
Obtaining a competitors confidential, non-public information through unlawful practices is not permitted. The improper gathering of competitive information could subject Concordia and the employee to criminal and civil liability. Any Concordia employee who has acquired a competitors private and confidential information unlawfully is subject to disciplinary and if necessary, legal actions and will be required to immediately destroy the confidential information that is obtained.
4.5. | Confidential Information |
It is imperative that any confidential scientific and business information regarding Concordia, as well as the Companys trade secrets, be protected to ensure the Companys success. It is our duty as Concordia employees to safeguard this confidential information. Confidential Information includes, but is not limited to:
| Unpublished financial information including, but not limited to, financial models, sales and revenue information and pre-commercial product launch information. |
| Inventions, trade secrets, know-how. |
| Operational and/or marketing plans, systems, techniques, information and budgets. |
| Personal information including, but not limited to, compensation, wage and benefits information. |
| Information pertaining to specific customer, customer information and customer requirements. |
| Patient information or PHI (i.e. individually identifiable health information such as name, address, birth date, social security number, etc.). |
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Code of Conduct | ||||
Policy Number: 1 | Version: 1 | Effective Date: 7-July-2014 | ||
Supersedes: N/A |
| Information pertaining to Concordia relationship with existing or potential strategic partners, suppliers, distributors, consultants and any other information that is not publicly available. |
| Information that might affect Concordias competitive position. |
Employees must maintain the privacy of confidential information pertaining to Concordias business at all times. Confidential information known by an employee must remain confidential both during and after employment with the Company (whether such termination is voluntary or involuntary). Any Concordia employee who improperly uses or discloses confidential information will be subject to disciplinary action, up to and including termination of employment without notice and legal action, even if they do not personally benefit from the disclosure. When leaving the employ of Concordia, an employee must return all confidential information in any form and all copies which are, or may have been, in his or her possession.
If an employee has any doubt as to the confidentiality of specific information, he or she should discuss it with the CEO or CFO.
4.6. | Company Assets |
Concordia offers employees access to a variety of the Companys resources such as Company property, information, resources, systems and many other supplies. These resources are intended to be used by employees for Company business and the employee assumes the responsibility to protect against theft, loss, misappropriation and misuse. These resources should be used only for Company business and not for any personal use, though incidental personal use may be permitted at times.
It is important to recognize that any and all data and/or other information linked to these assets, such as email, documents and any other files, are the property of Concordia. The Company reserves the right to retain and inspect this data and/or information, including any electronic communications transmitted over any Concordia network, with or without an employees or third partys knowledge, consent or approval, in accordance with applicable law, except in each case as may be limited by applicable foreign laws.
All Concordia employees shall provide reasonable and appropriate care when dealing with Concordias assets, resources, and property. Any misuse of Concordias assets, resources and/or property that an employee becomes aware of should be reported to his or her supervisor, if appropriate, the CEO and/or CFO.
4.7. | Training |
Keeping up with any additions, changes, removals or implementations of laws, regulations, guidance and standards is imperative to ensure that Concordia is performing its operations compliantly. In order to inform our employees of such changes, we will conduct trainings annually, quarterly and on an ad-hoc basis. Attendance at all training sessions is mandatory. If any employee is unable to attend, they should give their supervisor notice one week prior to date of the training session
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Code of Conduct | ||||
Policy Number: 1 | Version: 1 | Effective Date: 7-July-2014 | ||
Supersedes: N/A |
and must reschedule the training. An attendance sheet must be signed by each employee in attendance containing the topic, date and instructor.
4.8. | Record Retention and Documentation |
On a daily basis, new information is being discussed, shared and generated by Concordia employees, in paper form, through emails, voicemails, CDs, DVDs, audio clips and more. Only information and records that are complete and accurate provide benefit to the Company. It is the responsibility of each Concordia employee to properly capture accurate and complete records in line with any regulatory, legal and financial requirements.
It is also our duty to make sure that the information is stored in a secure manner and complete records are identified, indexed for retrieval, securely stored, and disposed of in the appropriate manner. We must retain records for immediate use, as well as possible long term use for litigation purposes, historical reference, contractual obligations, regulatory or legal requirements, or for other purposes as determined by Concordia. When a record supersedes the necessary retention period or is simply no longer needed, they may be discarded. Should a current or potential lawsuit, audit or internal investigation be initiated, discarding of records should be suspended. If a Concordia employee is unsure as to whether a document should or should not be disposed, he or she should contact the CFO.
5. | PUBLIC STANDARDS |
5.1. | Overview |
Concordia is committed to being a good corporate citizen in the communities in which it does business. We must provide an accurate and consistent message to the public when speaking of, or representing, Concordia.
5.2. | Charitable Contributions |
As Concordia employees, we are encouraged to give back to the community through charitable contributions. While such contributions to the community can make a difference, we must ensure that these contributions are provided in accordance with Company policies and applicable laws and regulations. If a charitable contribution is to be made by Concordia, it must be approved through the proper channels. Questions with regards to charitable contributions may be directed to the CFO.
5.3. | Political Contributions and Activities |
Concordia encourages its employees to engage in political activities, such as the right to vote. However, it is imperative that all employees understand that these engagements should not be conducted on behalf of the Company or in any way that is likely to give the impression that the Company is taking a stance to support or endorse any candidate or
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Code of Conduct | ||||
Policy Number: 1 | Version: 1 | Effective Date: 7-July-2014 | ||
Supersedes: N/A |
political party. Such activities must also be done on personal time and without the involvement of any Concordia resources. Questions with regards to political contributions and activities may be directed to the CFO.
5.4. | Media and Public Inquiries |
It is extremely important that any message to the public be accurate, consistent and authorized by the appropriate person at Concordia. All employees must be aware of, and adhere to, Concordias guidelines on communicating with the public through the media, press releases, promotional materials or other means. Any requests for information from Concordia by an outside party should be immediately referred to the Concordia CEO.
5.5. | Social Media |
Concordia respects the right of all employees to use social media tools as a form of self expression, for networking and research and, in some cases, for furthering Concordias interests. However, when participating in social media platforms or online conversations that reference Concordia (or an employees relationship with Concordia) it is expected that all employees take reasonable steps to ensure that he or she is not seen as speaking for or acting on behalf of Concordia, and that all content is appropriate.
6. | CONCORDIA COMPLIANCE PROGRAM |
6.1. | Compliance Program and Leadership |
Concordia has adopted policies, procedures, training programs and mechanisms to promote an atmosphere of open, honest and ethical communication throughout Concordia. Constantly monitoring the compliance of Concordia through audits and other reviews allow the investigation of any allegations of non-compliance with Concordia policies and/or applicable laws and regulations and the opportunity to correct any systems or discipline employees associated with such non-compliance. These audits and reviews allow Concordia to uphold the ethical principles described above. All of these things and any similar processes or systems we may adopt in the future constitute our Compliance Program.
Concordia has designated a Compliance Officer. In this role, the Compliance Officer is primarily responsible for oversight of the Compliance Program, but all of us play an important role in building and supporting the Compliance Program for Concordia. Employees should refer to Concordias Compliance Committee Charter for further information regarding the Companys Compliance Program and the role of the Compliance Officer and Compliance Committee.
6.2. | Reporting of Any Known or Suspected Violations |
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Code of Conduct | ||||
Policy Number: 1 | Version: 1 | Effective Date: 7-July-2014 | ||
Supersedes: N/A |
As one Company working together, Concordia is committed to ensure compliance with Company policies and applicable laws and regulations to preserve the Companys reputation, ensure the safety of its customers, and to continue to be successful. This is all possible because of the Companys dedication to compliance with all applicable laws and regulations and Company policies.
If a Concordia employee knows of or suspects a violation of a Company policy or applicable law or regulation, he or she has an ethical obligation to report it to the Compliance Officer immediately. Employees are also encouraged to report other ethical concerns or issues even if they do not relate directly to a law, regulation or Company policy. Concordia encourages all employees to report such violations to his or her supervisor, if appropriate; the CEO or CFO or through Concordias reporting systems (i.e. hotline). Concordia expects employees to report concerns so that the Company can evaluate the reports and identify and correct any problems promptly.
6.3. | Compliance Hotline |
Concordia has established a compliance reporting mechanism for anyone who wants to report a concern related to unethical or illegal conduct or violations of this Code. The hotline is intended to supplement, not replace, other channels for communicating questions and concerns within our Company. It should be used when you have exhausted other avenues of communication, are uncomfortable with disclosing your identity when reporting a concern, or if you feel that your complaint was not addressed when raised through another channel. Your call will not be traced or audio-recorded. The hotline may be used to anonymously report violations or suspected violations of the law. The hotline may be accessed:
| By calling toll free hotline at 1-855-562-5982 |
| By directly contacting the Compliance Officer at 650-227-2401 |
6.4. | Investigation and Enforcement |
Reports of suspected misconduct and compliance violations made in good faith will be subject to investigation immediately and thoroughly by the appropriate persons. This information will be treated as confidential and remain anonymous unless disclosure to a third party is deemed necessary for the investigation. Depending on the severity of the reported misconduct, Concordia will either investigate using internal compliance resources but may also seek external resources such as legal, human resources or audit groups to assist. Cooperation is imperative during internal investigations by each Concordia employee involved in such investigations.
6.5. | Retaliation is Prohibited |
Reports of suspected misconduct may be made anonymously. Should you choose to identify yourself, every reasonable effort will be made to maintain confidentiality. Retaliation against employees making reports in good faith will not be tolerated, even if the report is found to be inaccurate. If you have been subject to retaliation, or know of
Corporate Compliance Policies & Guidelines
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Code of Conduct | ||||
Policy Number: 1 | Version: 1 | Effective Date: 7-July-2014 | ||
Supersedes: N/A |
someone who has, notify your supervisor or the Compliance Officer. On the other hand, reports that are not made in good faith, such as false claims made about the Company or members of the Company will not be tolerated.
Concordia reserves the right to discipline any person who knowingly makes a false accusation of misconduct or provides the Company with false information during the course of an investigation.
6.6. | Disciplinary Actions |
This Code is provided to give Concordia employees the tools to understand and adhere to the laws and regulations that guide our Company and allow us to achieve the highest standards of conduct. Therefore, employees are subject to disciplinary action for authorizing or participating in an activity that results in a violation of the law, Company policies or any other standards and procedures listed.
Each situation will be evaluated and handled individually by Concordia. Based on the severity of the problem and circumstances involved, the disciplinary actions will vary. If disciplinary action is warranted, subject to local law, it may range anywhere from a warning to termination of employment. In certain circumstances, an individual employee may be subject to criminal fines, imprisonment, and an official prohibition on working in the pharmaceutical industry.
6.7. | Waivers and Amendments |
From time to time, Concordia may waive certain provisions of this Code on a case by case basis. Should a Concordia employee feel that he or she merits a waiver regarding this Code, he or she should contact his or her manager, who should contact the CEO and CFO directly. Any waivers of this Code require approval from the CEO and CFO. All waivers of this Code will be disclosed as required under applicable law and regulations. This Code may be amended at anytime without prior notice. If necessary, amendments to the Code should be provided by the CEO and CFO. Amendments to this Code will be promptly disclosed to Concordia employees.
6.8. | Expectations of Concordia Employees |
We expect our employees to be a part of Concordias achievements. Compliance with applicable laws, regulations, Company policies and other best practices applicable to companies in our industry is critical to Concordias success. On an annual basis, all Concordia employees shall certify that he or she has read and understood Concordias Code of Conduct, in order to demonstrate their dedication to conducting themselves in the utmost ethical and professional manner.
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Code of Conduct | ||||
Policy Number: 1 | Version: 1 | Effective Date: 7-July-2014 | ||
Supersedes: N/A |
Code of Conduct Certificate of Compliance
I have read, understand, and will comply with the policies set forth in the Concordia Code of Conduct. I certify that, to the best of my knowledge, I am not violating any of the policies and will not do so in the future. I am not aware of any unreported violations of the policies in the Concordia Code of Conduct.
|
Print Name |
|
Signature |
|
Date |
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Code of Conduct | ||||
Policy Number: 1 | Version: 1 | Effective Date: 7-July-2014 | ||
Supersedes: N/A |
APPENDIX A
CODE OF CONDUCT REFERENCES
Office of Inspector General (OIG), OIG Compliance Program Guidance for Pharmaceutical Manufacturers, 68 Fed. Reg. 23731 (May 5, 2003)
False Claims Act, 31 U.S.C. §§ 3729-3733
Anti-Kickback Statute, 42 U.S.C. § 1320a-7b(b)
21 CFR 202, Prescription Drug Advertising
21 USC 321, Federal Food, Drug and Cosmetic Act
Dissemination of Information on Unapproved/New Uses for Marketed Drugs, Biologics, and Devices, 63 Fed. Reg. 64,556 (Nov. 20, 1998).
HIPAA Privacy Rule - 45 C.F.R. § 160
Federal Food, Drug, and Cosmetic Act (FFDCA), Pub. L. No. 75-717, 52 Stat. 1040 (1938) §§ 301, 501, 502, 505.
The Pharmaceutical Advertising Advisory Board (PAAB) Code of Advertising Acceptance. Available at: http://www.paab.ca/paab-code.htm
Social Security Act (the Act) (42 U.S.C. 1395nn), also known as the physician self-referral law and commonly referred to as the Stark Law.
FDA, Draft Guidance for Industry: Responding to Unsolicited Requests for Off-Label Information About Prescription Drugs and Medical Devices, available at http://www.fda.gov/downloads/drugs/guidancecomplianceregulatoryinformation/guidances/ucm285145.pdf.
Rx&D Code of Ethical Practices of 2012. Available at: http://www.canadapharma.org/CMFiles/Commitment_to_Ethics/ WithHealthCareProfessionals/Code_of_Ethical_Practices/2012_CodeofEthicalPractices_ENFinal.pdf
PhRMA Code on Interactions with Healthcare Professionals, Available at:
http://www.phrma.org/sites/default/files/108/phrma_marketing_code_2008.pdf.
Foreign Corrupt Practices Act, 15 U.S.C. § 78dd-1 et seq.
The Patient Protection and Affordable Care Act, Pub. L. No. 111-148, 124 Stat. 119, §6002 Transparency Reports and Reporting of Physician Ownership or Investment Interests. 42 CFR parts 402 and 403.
Cal. Health & Safety Code §119400-119402
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Code of Conduct | ||||
Policy Number: 1 | Version: 1 | Effective Date: 7-July-2014 | ||
Supersedes: N/A |
Conn. Pub. Act 10-117 §94
Conn. Pub. Act 14-12 §36
D.C. Code § 48-833.01 - Requirement to disclose prescription drug marketing costs; D.C. Mun. Regs. Tit. 22, §§ 1800-1899 Prescription Drug Marketing Costs;
D.C. Mun. Regs. tit. 17 §8300, et seq. (2010) District of Columbia Municipal Regulations for Pharmaceutical Detailers
Section 2-11.1(s) of the Code of Miami-Dade County, FL
Mass. Gen Laws Ann. ch 111N, §1-9, Pharmaceutical and Medical Device Manufacturer Conduct; 100 Mass. Code Regs. 970.000 Pharmaceutical and Medical Device Manufacturer Conduct
Minn. Stat. Ann. §151.47, Wholesale drug distributor licensing requirements; Minn. Stat. Ann. §151.461, Gifts to Practitioners Prohibited; Prohibited Frequently Asked Questions
AB128, Statutes of Nevada, Chapter 409; Effective Oct 1, 2007; Nev. Rev. Stat. §639.570 (2007), Pharmacists and Pharmacy Wholesalers and Wholesale Distribution Business Practices
Vt. Stat. Ann. tit. 18 §4631a - Expenditures by Manufacturers of Prescribed Products; Vt. Stat. Ann. tit. 18 §4632 Disclosure of allowable expenditures and gifts by manufacturers of prescribed products
W. VA Code 5A-3C-13; Legislative Rule Prescription Drug Advertising Expense Reporting, West Virginia Code Regs. § 206
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Exhibit 99.12
EXECUTION COPY
ASSET PURCHASE AND SALE AGREEMENT
between
PBM PHARMACEUTICALS, INC.
as Seller
and
CONCORDIA PHARMACEUTICALS INC.
as Purchaser
Dated as of March 19, 2014
TABLE OF CONTENTS
Page | ||||||
ARTICLE 1 DEFINITIONS |
1 | |||||
1.1 |
Definitions |
1 | ||||
1.2 |
Other Definitional Provisions |
13 | ||||
ARTICLE 2 PURCHASE AND SALE |
14 | |||||
2.1 |
Purchase and Sale of Purchased Assets |
14 | ||||
2.2 |
Excluded Assets |
15 | ||||
2.3 |
Assumed Liabilities |
15 | ||||
2.4 |
Excluded Liabilities |
16 | ||||
2.5 |
Consent of Third Parties |
16 | ||||
2.6 |
Purchase Price |
17 | ||||
2.7 |
Risk of Loss |
17 | ||||
ARTICLE 3 CLOSING |
17 | |||||
3.1 |
Closing |
17 | ||||
3.2 |
Transactions at Closing |
17 | ||||
ARTICLE 4 REPRESENTATIONS AND WARRANTIES OF SELLER |
18 | |||||
4.1 |
Organization |
18 | ||||
4.2 |
Due Authorization |
18 | ||||
4.3 |
No Conflicts; Enforceability |
18 | ||||
4.4 |
Title of Assets; Condition; Sufficiency |
19 | ||||
4.5 |
Intellectual Property |
19 | ||||
4.6 |
Litigation |
21 | ||||
4.7 |
Consents |
21 | ||||
4.8 |
Taxes |
21 | ||||
4.9 |
No Adverse Notice |
21 | ||||
4.10 |
Regulatory Matters |
21 | ||||
4.11 |
Brokers, Etc. |
23 | ||||
4.12 |
Inventory |
23 | ||||
4.13 |
Financial Statements |
23 | ||||
4.14 |
Absence of Certain Changes |
23 | ||||
4.15 |
Material Contracts |
24 | ||||
4.16 |
Customers and Suppliers |
25 |
- i -
4.17 |
Employment Matters |
26 | ||||
4.18 |
Real Property |
26 | ||||
4.19 |
Environmental Matters |
27 | ||||
4.20 |
Acquisition for Investment |
28 | ||||
4.21 |
Investment Experience |
29 | ||||
4.22 |
Information |
29 | ||||
4.23 |
Restricted Securities |
29 | ||||
4.24 |
Rule 144 |
31 | ||||
4.25 |
No Registration Statement |
31 | ||||
4.26 |
Foreign Issuer |
31 | ||||
4.27 |
Related Party Transactions |
31 | ||||
ARTICLE 5 REPRESENTATIONS AND WARRANTIES OF PURCHASER AND PARENT |
31 | |||||
5.1 |
Organization |
31 | ||||
5.2 |
Due Authorization |
32 | ||||
5.3 |
No Conflicts; Enforceability |
32 | ||||
5.4 |
Litigation |
32 | ||||
5.5 |
Consents |
32 | ||||
5.6 |
Financing |
33 | ||||
5.7 |
Brokers, Etc. |
33 | ||||
5.8 |
Consideration Shares |
33 | ||||
5.9 |
Taxes |
34 | ||||
ARTICLE 6 COVENANTS PRIOR TO CLOSING |
34 | |||||
6.1 |
Conduct with respect to the Product |
34 | ||||
6.2 |
Required Approvals and Consents |
35 | ||||
6.3 |
HSR Act |
36 | ||||
6.4 |
Transition Activities |
37 | ||||
6.5 |
Employees and Employee Benefits |
37 | ||||
6.6 |
Notifications |
38 | ||||
6.7 |
No Negotiation |
38 | ||||
6.8 |
Access to Information |
38 | ||||
6.9 |
Further Assurances; Further Documents |
39 | ||||
ARTICLE 7 CONDITIONS TO CLOSING |
40 | |||||
7.1 |
Conditions Precedent to Obligations of Purchaser and Seller |
40 | ||||
7.2 |
Conditions Precedent to Purchasers Obligations |
41 |
- ii -
7.3 |
Conditions Precedent to Sellers Obligations |
41 | ||||
ARTICLE 8 ADDITIONAL COVENANTS |
42 | |||||
8.1 |
Confidentiality; Publicity |
42 | ||||
8.2 |
Seller Brands |
44 | ||||
8.3 |
Product Responsibility |
45 | ||||
8.4 |
Product Returns, Rebates and Chargebacks |
46 | ||||
8.5 |
Government Price Reporting |
47 | ||||
8.6 |
Seller Governmental Payments and Other Contractual Obligations |
49 | ||||
8.7 |
Purchaser Governmental Payments and Other Contractual Obligations |
49 | ||||
8.8 |
Regulatory Matters |
50 | ||||
8.9 |
Tax Matters |
51 | ||||
8.10 |
Parent Board Matters |
53 | ||||
ARTICLE 9 TERMINATION AND SURVIVAL |
54 | |||||
9.1 |
Termination |
54 | ||||
9.2 |
Procedure and Effect of Termination |
55 | ||||
ARTICLE 10 INDEMNIFICATION AND DISPUTE RESOLUTION |
55 | |||||
10.1 |
Indemnification |
55 | ||||
10.2 |
Indemnification Procedures |
57 | ||||
10.3 |
Sole Remedy |
58 | ||||
10.4 |
Limitation on Liability |
59 | ||||
10.5 |
Adjustment to Purchase Price |
59 | ||||
ARTICLE 11 MISCELLANEOUS |
59 | |||||
11.1 |
Assignment; Binding Effect |
59 | ||||
11.2 |
Expenses |
59 | ||||
11.3 |
Notices |
59 | ||||
11.4 |
Severability |
60 | ||||
11.5 |
Entire Agreement |
61 | ||||
11.6 |
No Third Party Beneficiaries |
61 | ||||
11.7 |
Waiver |
61 | ||||
11.8 |
Governing Law; Jurisdiction |
61 | ||||
11.9 |
Injunctive Relief |
61 | ||||
11.10 |
Amendment |
62 | ||||
11.11 |
Headings |
62 | ||||
11.12 |
Counterparts |
62 |
- iii -
11.13 |
Specific Performance |
62 | ||||
11.14 |
Construction |
62 | ||||
11.15 |
Parent Guarantee |
62 |
LIST OF EXHIBITS | ||||
Exhibit A | - | Assignment and Assumption Agreement | ||
Exhibit B | - | Intellectual Property Assignment Agreement | ||
Exhibit C | - | Bill of Sale | ||
Exhibit D | - | Transition Services Agreement | ||
LIST OF SCHEDULES | ||||
Schedule 1.1(a) | - | Assigned Contracts | ||
Schedule 1.1(b) | - | Knowledge | ||
Schedule 1.1(c) | - | Leased Real Property | ||
Schedule 1.1(d) | - | Leases | ||
Schedule 1.1(e) | - | NDAs | ||
Schedule 1.1(f) | - | Owned Real Property | ||
Schedule 1.1(g) | - | Product Domain Names | ||
Schedule 1.1(h) | - | Product Marks | ||
Schedule 1.1(i) | - | Product Trade Dress | ||
Schedule 1.1(j) | - | Promotional Materials | ||
Schedule 1.1(k) | - | Registrations | ||
Schedule 1.1(l) | - | Sales Training Modules | ||
Schedule 1.1(m) | - | Seller Brands | ||
Schedule 1.1(n) | - | Tangible Personal Property | ||
Schedule 1.1(o) | - | Tooling | ||
Schedule 2.6 | - | Wire Instructions | ||
Schedule 4.3 | - | No Conflicts | ||
Schedule 4.4.1 | - | Title of Assets | ||
Schedule 4.4.2 | - | Condition | ||
Schedule 4.5.1 | - | Product Intellectual Property Actions and Governmental Orders | ||
Schedule 4.5.2 | - | Material Intellectual Property Agreements | ||
Schedule 4.6 | - | Litigation | ||
Schedule 4.7 | - | Consents | ||
Schedule 4.9 | - | Adverse Notice | ||
Schedule 4.10.1 | - | Regulatory Status of Donnatal Elixir, Donnatal Tablets and Donnatal Capsules | ||
Schedule 4.10.2 | - | Regulatory Status of Donnatal Extentabs | ||
Schedule 4.10.3 | - | Manufacturing of Donnatal at IriSys under NOOH | ||
Schedule 4.10.4 | - | Seller and West-Ward Pharmaceuticals Inc. |
- iv -
Schedule 4.10.5 | - | Drug Master Files | ||
Schedule 4.10.6 | - | Records | ||
Schedule 4.10.7 | - | Reimbursement Coverage of Donnatal | ||
Schedule 4.10.8 | - | Import Matter | ||
Schedule 4.10.9 | - | Existing Registrations | ||
Schedule 4.10.11 | - | Current Permits | ||
Schedule 4.12 | - | Inventory | ||
Schedule 4.14 | - | Certain Changes | ||
Schedule 4.15.1 | - | Material Contracts | ||
Schedule 4.16.1 | - | Material Customers | ||
Schedule 4.16.2 | - | Material Suppliers | ||
Schedule 4.17.1 | - | Employees, Independent Contractors and Consultants | ||
Schedule 4.17.3 | - | Employment Actions | ||
Schedule 4.19.2 | - | Environmental Permits | ||
Schedule 4.19.5 | - | Storage Tanks | ||
Schedule 4.19.6 | - | Off-Site Hazardous Materials Treatment, Storage, or Disposal Facilities or Locations | ||
Schedule 4.27 | - | Related Party Transactions | ||
Schedule 6.1 | - | Conduct with Respect to the Product | ||
Schedule 6.5 | - | Employees | ||
Schedule 7.2.6 | - | Closing Consents | ||
Schedule 8.4.2 | - | Joint Notice |
- v -
ASSET PURCHASE AND SALE AGREEMENT
THIS ASSET PURCHASE AND SALE AGREEMENT (this Agreement ), dated as of March 19, 2014 (the Execution Date ), is entered into by and between PBM Pharmaceuticals, Inc., a Delaware corporation, with an address at 200 Garrett Street, Suite O, Charlottesville, Virginia 22902 ( Seller ) and Concordia Pharmaceuticals Inc., an international business company incorporated under the laws of Barbados, having a place of business at Chancery House, High Street, Bridgetown, St. Michael, Barbados, BB11128 ( Purchaser ). Seller and Purchaser are sometimes referred to herein, individually, as a Party and, collectively, as the Parties.
RECITALS
WHEREAS , Seller desires to sell to Purchaser, and Purchaser desires to purchase from Seller, its assets relating to the pharmaceutical products marketed under the Donnatal® trademark in the Territory (as defined below), as a drug product that is Identical, Related or Similar to Donnatal under the request for hearing filed in response to the Notice of Opportunity for Hearing ( NOOH ) published in 1983, and under ANDA numbers 86-676, 86-661 and 86-677, upon the terms and subject to the conditions set forth herein.
NOW, THEREFORE , in consideration of the foregoing premises and the agreements contained herein, and for other good and valuable consideration, the Parties, intending to be legally bound, agree as follows:
ARTICLE 1
DEFINITIONS
1.1 Definitions . The following terms shall have the meanings set forth below for purposes of this Agreement:
Accountants means an accounting firm of national reputation (excluding each of Sellers and Purchasers respective regular outside accounting firms) as may be mutually acceptable to the Parties; provided , however , if the Parties are unable to agree on such accounting firm within ten (10) days of the Execution Date or any such mutually selected accounting firm is unwilling or unable to serve, then Seller shall deliver to Purchaser a list of three (3) other accounting firms of national reputation, and Purchaser shall select one of such three (3) accounting firms.
Act means the United States Federal Food, Drug, and Cosmetic Act, as amended, and regulations promulgated thereunder from time to time.
Action means any claim, action, suit, arbitration, complaint, inquiry, audit, proceeding or investigation, in each case, by or before any applicable Governmental Authority.
Acquisition Proposal has the meaning set forth in Section 6.7.
Affiliate of a Party or Person means any Person, whether de jure or de facto , that directly or indirectly, through one or more intermediaries, controls, is controlled by, or is under
1
common control with such Party or Person, as applicable. Solely as used in this definition, control means (a) direct or indirect ownership of more than fifty percent (50%) of the equity (or such lesser percentage which is the maximum allowed to be owned by a foreign corporation in a particular jurisdiction) having the power to vote on or direct the affairs of such Party or Person, as applicable, or (b) the possession, directly or indirectly, of the power to direct or cause the direction of the policies and management of such Party or Person, as applicable, whether by the ownership of voting securities, by contract, or otherwise.
Agreement has the meaning set forth in the Preamble of this Agreement.
AMP has the meaning set forth in Section 8.5.1.
ANDA(s) means the Abbreviated New Drug Application(s) and conditionally approved Abbreviated New Drug Application(s).
API means active pharmaceutical ingredients.
ASP means the Products average sales price as reported under Medicare Part B requirements and defined at 42 U.S.C. § 1395w-3a(c).
Asset Acquisition Statement has the meaning set forth in Section 8.9.2.
Assets of any Person means all assets and properties of any kind, nature, character and description (whether real, personal or mixed, whether tangible or intangible, whether absolute, accrued, contingent, fixed or otherwise and wherever situated), and the goodwill related thereto, operated, owned or leased by such Person, including chattel paper, documents, instruments, general intangibles, equipment, inventory, goods and Intellectual Property (but does not include cash, Cash Equivalents, and accounts and notes receivables).
Assigned Contracts means (i) all Contracts relating to the Product, the other Purchased Assets or the Business; and (ii) those Contracts set forth on Schedule 1.1(a) .
Assignment and Assumption Agreement means the Assignment and Assumption Agreement, in the form attached hereto as Exhibit A .
Assumed Liabilities has the meaning set forth in Section 2.3.
Best Price has the meaning set forth in 42 U.S.C. § 1396r-8(c)(1)(C).
Bill of Sale means the Bill of Sale, in the form attached hereto as Exhibit C .
Bulk Product Inventory means, as of the first Business Day following the Closing Date, Sellers existing bulk goods inventory of Products intended for sale in the Territory.
Business has the meaning set forth in Section 4.4.3.
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Business Day means a day (other than a Saturday or Sunday) on which banks are open for business in Charlottesville, Virginia and in the province of Ontario, Canada, and in the parish of St. Michael, Barbados.
Business Permits has the meaning set forth in Section 4.10.11.
Calendar Quarter means a period of three (3) consecutive months ending on the last day of March, June, September, or December, respectively.
Calendar Year means the twelve (12) month period commencing on January 1 and ending on December 31.
Canadian Securities Laws means, collectively, securities statutes in each of the Provinces of Canada (other than Quebec) and the respective rules and regulations made thereunder, together with applicable multilateral or national instruments, orders and rulings issued or adopted by the securities commissions or regulatory authorities of such Provinces.
CERCLA means the Comprehensive Environmental Response, Compensation, and Liability Act of 1980, as amended by the Superfund Amendments and Reauthorization Act of 1986, 42 U.S.C. §§ 9601 et seq.
Cash Equivalents means cash, checks, money orders, marketable securities, short-term instruments and other cash equivalents, funds in time and demand deposits or similar accounts, and any evidence of indebtedness issued or guaranteed by any Governmental Authority.
Change Notice has the meaning set forth in Section 6.6.
Claim has the meaning set forth in Section 10.2.1.
Closing means the closing of the purchase and sale of the Purchased Assets and assignment and assumption of the Assumed Liabilities contemplated by this Agreement.
Closing Date has the meaning set forth in Section 3.1.
Code means the Internal Revenue Code of 1986, as amended, or any successor statute thereto.
Confidential Information has the meaning set forth in Section 8.1.1.
Confidentiality Agreement means that certain Confidential Disclosure Agreement, dated January 17, 2014, between Seller and Purchaser.
Consideration Shares means the number of shares of Parent Common Stock equal to the quotient of (A) Fifty Million Dollars ($50,000,000) converted into Canadian dollars at the Currency Exchange Rate, divided by (B) the lesser of (x) 12.00 CAD and (y) the volume weighted average price on the TSX of one share of Parent Common Stock based on the previous five (5) Trading Days prior to the execution of this Agreement.
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Contracts means any and all commitments, contracts, purchase orders, leases, licenses, easements, permits, instruments, commitments, arrangements, undertakings, practices or other agreements to which Seller is a party, in effect as of the Closing Date, in each case whether written or oral, which are used exclusively by Seller for the Product.
CMS means the Centers for Medicare and Medicaid Services.
Currency Exchange Rate means the rate used to convert United States dollars to Canadian dollars, which rate is quoted in the National Edition of The Wall Street Journal on the Business Day prior to the execution of this Agreement.
Director Eligibility Requirements has the meaning set forth in Section 8.10.1(a).
Distribution or Distribute means any and all activities related to the distribution, marketing, promoting, offering for sale and selling of the Product in the Territory, including advertising, detailing, educating, planning, promoting, reporting, storing, handling, shipping and communicating with Governmental Authorities and Third Parties in connection therewith.
Encumbrance means any security interest, charge, claim, pledge, hypothecation, mortgage, condition, equitable interest, lien (statutory or other), option, encumbrance, right of first refusal, or restriction of any kind, including any restriction on use, voting, transfer, receipt of income or exercise of any other attribute of ownership.
Environmental Claim means any Action, Governmental Order, lien, fine, penalty, or, as to each, any settlement or judgment arising therefrom, by or from any Person alleging liability of whatever kind or nature (including liability or responsibility for the costs of enforcement proceedings, investigations, cleanup, governmental response, removal or remediation, natural resources damages, property damages, personal injuries, medical monitoring, penalties, contribution, indemnification and injunctive relief) arising out of, based on or resulting from: (a) the presence, Release of, or exposure to, any Hazardous Materials; or (b) any actual or alleged non-compliance with any Environmental Law or term or condition of any Environmental Permit.
Environmental Law means any applicable Law, and any Governmental Order: (a) relating to pollution (or the cleanup thereof) or the protection of natural resources, endangered or threatened species, human health or safety, or the environment (including ambient air, soil, surface water or groundwater, or subsurface strata); or (b) concerning the presence of, exposure to, or the management, manufacture, use, containment, storage, recycling, reclamation, reuse, treatment, generation, discharge, transportation, processing, production, disposal or remediation of any Hazardous Materials. The term Environmental Law includes, without limitation, the following (including their implementing regulations and any state analogs): the Comprehensive Environmental Response, Compensation, and Liability Act of 1980, as amended by the Superfund Amendments and Reauthorization Act of 1986, 42 U.S.C. §§ 9601 et seq.; the Solid Waste Disposal Act, as amended by the Resource Conservation and Recovery Act of 1976, as amended by the Hazardous and Solid Waste Amendments of 1984, 42 U.S.C. §§ 6901 et seq.; the Federal Water Pollution Control Act of 1972, as amended by the Clean Water Act of 1977, 33 U.S.C. §§ 1251 et seq.; the Toxic Substances Control Act of 1976, as amended, 15 U.S.C. §§ 2601 et seq.; the Emergency Planning and Community Right-to-Know Act of 1986, 42 U.S.C. §§
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11001 et seq.; the Clean Air Act of 1966, as amended by the Clean Air Act Amendments of 1990, 42 U.S.C. §§ 7401 et seq.; and the Occupational Safety and Health Act of 1970, as amended, 29 U.S.C. §§ 651 et seq.
Environmental Notice means any written (i) directive, (ii) notice of violation or infraction, or (iii) notice respecting any Environmental Claim, in each case, relating to actual or alleged non-compliance with any Environmental Law or any term or condition of any Environmental Permit.
Environmental Permit means any Permit, letter, clearance, consent, exemption, written decision or other action required under or issued, granted, given, authorized by or made pursuant to Environmental Law.
Excluded Assets has the meaning set forth in Section 2.2.
Excluded Liabilities has the meaning set forth in Section 2.4.
Excluded Liability Claims has the meaning set forth in Section 10.1.1(a).
Execution Date means the date set forth in the Preamble of this Agreement.
Existing Finished Product Inventory means three (3) months of Sellers existing finished goods inventory of Products intended for sale in the Territory all of which shall have an expiration date in excess of twelve (12) months from the Closing Date.
FDA means the United States Food and Drug Administration, or any successor agency thereto.
Financial Statements has the meaning set forth in Section 4.13.
Finished Product has the meaning set forth in Section 8.4.2.
Fraud Claims has the meaning set forth in Section 10.1.1(c).
Fundamental Representation Claims has the meaning set forth in Section 10.1.1(b).
GAAP means United States generally accepted accounting principles in effect from time to time.
General Claims has the meaning set forth in Section 10.1.1(d).
Global Purchase Shares means the estimated 603,774 shares of Parent Common Stock at 6.25 CAD per share and an assumed exchange rate of 1.06 CAD per $1.00 as part of the consideration for Parents purchase of the specialty healthcare distribution business in respect of which Parent agreed to issue up to Four Million Dollars ($4,000,000) worth of Parent Common Stock in annual payments of shares for five (5) years following closing at the market price of the shares at time of issue, based upon achieving specified earnings metrics.
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Governmental Authority means any nation or government, any provincial, state, regional, local or other political subdivision thereof, any supranational organization of sovereign states, any self-regulated organization or other non-governmental regulatory authority or quasi-governmental authority (to the extent and only to the extent that the rules, regulations or orders of such organization or authority have the force of Law), or any arbitrator, court or tribunal of competent jurisdiction and any entity, department, commission, bureau, agency, authority, board, court, official or officer, domestic or foreign, exercising executive, judicial, regulatory or administrative functions of or pertaining to government or any of the foregoing.
Governmental Order means any order, writ, judgment, injunction, decree, stipulation, determination or award entered by or with any Governmental Authority.
Governmental Price Reports means (a) any and all data required to be reported relating to the Product(s) under the Medicaid drug rebate program, including without limitation the AMP and the Best Price; (b) any and all data required to be reported relating to the Product(s) under state drug price reporting requirements; (c) any and all data required to be reported relating to the Product(s) under Medicare Part B, including without limitation the ASP; (d) Federal Ceiling Prices required to be reported relating to the Product(s) under 38 U.S.C. § 8126; (e) any and all data required to be reported relating to the Products under a Tricare retail rebate agreement or otherwise under 10 U.S.C. § 1074f(g); (f) any and all data required to be reported relating to the Products under a Pharmaceutical Pricing Agreement under Section 340B of the PHS Act, 42 U.S.C. § 256b; (g) any and all data required to be reported relating to the Medicare Coverage Gap Discount Program for purposes of Sections 1860D-14A and 1860D-43 of the Social Security Act, as set forth in the Patient Protection and Affordable Care Act of 2010 ( PPACA ), Pub. L. 111-148, and the Health Care and Education Reconciliation Act of 2010, ( HCERA ) Pub. L. 111-152; and (h) any and all data required to be reported relating to the Products under the Pharmaceutical Manufacturer Industry Fee Program pursuant to Section 9008 of the PPACA, Public Law 111-148 (124 Stat. 119 (2010)), as amended by Section 1404 of the HCERA, Public Law 111-152 (124 Stat. 1029 (2010)).
Hazardous Materials means: (a) any material, substance, chemical, waste, product, derivative, compound, mixture, solid, liquid, mineral or gas, in each case, whether naturally occurring or manmade, that is hazardous, acutely hazardous, toxic, or words of similar import or regulatory effect under Environmental Laws; and (b) any petroleum or petroleum-derived products, radon, radioactive materials or wastes, asbestos in any form, lead or lead-containing materials, urea formaldehyde foam insulation and polychlorinated biphenyls.
HSR Act means the U.S. Hart-Scott-Rodino Antitrust Improvements Act of 1976, as amended, and the rules and regulations promulgated thereunder.
Indemnification Basket has the meaning set forth in Section 10.1.5(a).
Indemnification Cap has the meaning set forth in Section 10.1.5(a).
Intellectual Property means intellectual property rights in and to Trademarks, copyrightable subject matter (whether registered or unregistered), and patents, and all applications and registrations therefor, domain names, web sites, Know-How, Confidential
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Information, trade secrets, and similar proprietary rights in confidential inventions, discoveries, analytic models, improvements, processes, techniques, devices, methods, formulations and specifications.
Intellectual Property Agreements means all licenses, sublicenses, consent to use agreements, settlements, coexistence agreements, covenants not to sue, permissions and other Contracts (including any right to receive or obligation to pay royalties or any other consideration), whether written or oral, relating to any Intellectual Property that is used in or necessary for the conduct of the Business as currently conducted, to which Seller is a party, beneficiary or is otherwise bound.
Intellectual Property Assignment Agreement means the Intellectual Property Assignment Agreement in the form attached hereto as Exhibit B .
Intellectual Property Registrations means all issuances, registrations, applications and other similar filings for Product Intellectual Property by, to or with any Governmental Authority or authorized private registrar in any jurisdiction, including registered trademarks, domain names and copyrights, issued and reissued patents, and pending applications for any of the foregoing.
Interim Balance Sheet has the meaning set forth in Section 4.13.
IRS means the United States Internal Revenue Service.
Know-How means proprietary, undisclosed research and development information, validation methods and procedures, unpatented inventions, knowledge, trade secrets, technical or other data or information, or other materials, methods, procedures, processes, flow diagrams, materials, developments or technology, including all biological, chemical, pharmacological, toxicological, clinical, manufacturing, analytical, safety, quality assurance, quality control and other information or data, other than such information which is or becomes the subject of an issued claim of an unexpired patent that shall not have been withdrawn, canceled or disclaimed, or held invalid or unenforceable by a court of competent jurisdiction in an unappealed or unappealable decision.
Knowledge or any other similar knowledge qualification, means, with respect to a Party, the actual knowledge of any of the individuals of such Party listed on Schedule 1.1(b) .
Law means each provision of any federal, provincial, state, local or foreign law, statute, ordinance, order, code, rule or regulation, promulgated or issued by any applicable Governmental Authority, as well as any judgments, decrees, injunctions or agreements issued or entered into by any applicable Governmental Authority.
Leased Real Property means, collectively each parcel of real property leased by Seller and used in the conduct of the Business as currently conducted (together with all rights, title and interest of Seller in and to leasehold improvements relating thereto, including, but not limited to, security deposits, reserves or prepaid rents paid in connection therewith) all of which shall be set forth by Seller on Schedule 1.1(c) .
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Leases means, collectively, all leases, subleases, licenses, concessions and other agreements (whether written or oral), including all amendments, extensions renewals, guaranties and other agreements with respect thereto, pursuant to which Seller holds any Leased Real Property, all of which shall be set forth by Seller on Schedule 1.1(d) .
Liability or Liabilities means, collectively, any indebtedness, guaranty, endorsement, claim, loss, damage, deficiency, cost, expense, obligation or responsibility, fixed or unfixed, known or unknown, choate or inchoate, liquidated or unliquidated, secured or unsecured, direct or indirect, matured or unmatured, or absolute, or contingent, including any product liability.
Losses means, with respect to any claim or matter, all losses, expenses, obligations and other Liabilities or other damages (whether absolute, accrued, contingent, fixed or otherwise, or whether known or unknown, or due or to become due or otherwise), diminution in value, monetary damages, fines, fees, penalties, interest obligations, deficiencies, losses and expenses (including amounts paid in settlement, interest, court costs, costs of investigators, fees and expenses of attorneys, accountants, financial advisors and other experts, and other expenses of litigation).
Manufacture means those certain activities required to manufacture and supply the Finished Product, inclusive of the active pharmaceutical ingredients of the Product, and testing, packaging, storing, warehousing, and handling thereof.
Material Adverse Effect means any change or effect that, individually or in the aggregate, is materially adverse to the Purchased Assets and/or the Assumed Liabilities, taken as a whole, or the ability of Seller to consummate the transactions contemplated hereby on a timely basis but shall exclude any change, effect or circumstance resulting or arising from: (a) the announcement of or consummation of the Transactions, (b) events, circumstances, changes or effects that generally affect the pharmaceutical industry, (c) general economic or political conditions, (d) changes caused by a material worsening of current conditions caused by acts of terrorism or war (whether or not declared) occurring after the Execution Date, and/or (e) any changes in Law; provided , however , that any event, occurrence, fact, condition or change referred to in clauses (b) through (e) immediately above shall be taken into account in determining whether a Material Adverse Effect has occurred to the extent that such event, occurrence, fact, condition or change has a disproportionate effect on the Business compared to other participants in the industries in which the Business operates.
Material Contracts has the meaning set forth in Section 4.15.1 Material Customers has the meaning set forth in Section 4.16.1 Material Suppliers has the meaning set forth in Section 4.16.2
Misrepresentation has the meaning ascribed thereto in the Securities Act (Ontario).
NDA(s) means the New Drug Application(s), ANDAs and conditionally approved ANDAs set forth on Schedule 1.1(e) .
NDC means the National Drug Code , which is the eleven digit code, including the labeler code, product code and package code, with respect to a pharmaceutical product registered
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by a company with the FDA pursuant to Section 510(j) of the Act and applicable FDA rules and regulations.
NI 51-102 means National Instrument 51-102 Continuous Disclosure Obligations of the Canadian Securities Administrators.
NOOH has the meaning set forth in the Preamble of this Agreement.
Other Agreements means, collectively, the Assignment and Assumption Agreement, the Intellectual Property Assignment Agreement, the Bill of Sale and the Transition Services Agreement.
Outside Date has the meaning set forth in Section 9.1.1(b).
Owned Real Property means, collectively, each parcel of real property owned by Seller and used in the conduct of the Business as currently conducted (together with all buildings, fixtures, structures and improvements situated thereon and all easements, rights-of-way and other rights and privileges appurtenant thereto), including with respect to each property, the address location and use all of which shall be set forth by Seller on Schedule 1.1(f) of the Seller Disclosure Schedule.
Parent means Concordia Healthcare Corp.
Parent Board has the meaning set forth in Section 8.10.1.
Parent Common Stock means the shares in the capital of the Parent designated as common shares as traded on the TSX.
Party or Parties has the meaning set forth in the Preamble of this Agreement.
PDMA means the Prescription Drug Marketing Act of 1987, as amended, and regulations promulgated thereunder from time to time.
Permits means all permits, licenses, franchises, approvals, authorizations, registrations, certificates, variances and similar rights obtained, or required to be obtained, from Governmental Authorities.
Permitted Encumbrances means (a) statutory liens for current Taxes of Seller not yet due and payable or Taxes of Seller being contested in good faith by appropriate proceedings with respect to which Seller ultimately prevails, (b) mechanics, carriers, workmens, repairmens or other like liens arising or incurred in the ordinary course of business consistent with past practice or amounts that are not delinquent; (c) easements, rights of way, zoning ordinances and other similar encumbrances affecting Real Property which do not prohibit or interfere with the current operation of any Real Property and which do not render title to any Real Property unmarketable; or (d) other than with respect to Owned Real Property, liens arising under original purchase price conditional sales contracts and equipment leases with third parties, in each case with respect to clauses (a) through (d) above, which are not, individually or in the aggregate, material to the Business, the Purchased Assets or Assumed Liabilities.
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Person means any individual, corporation, partnership, firm, association, joint venture, joint stock company, trust or other entity, or any government or regulatory administrative or political subdivision or agency, department or instrumentality thereof.
PHS means the Public Health Service Act, as amended from time to time.
Post-Closing Tax Period means any Tax period beginning after the Closing Date and the portion of any Straddle Period beginning after the Closing Date.
Pre-Closing Tax Period means any Tax period ending on or before the Closing Date and the portion of any Straddle Period ending on the Closing Date.
Product means (i) Donnatal® Elixir containing Phenobarbital, USP, Hyoscyamine Sulfate, USP, Atropine Sulfate, USP, and Scopolamine Hydrobromide, USP supplied in 4 fl oz (118 mL) bottles, Grape Flavored (NDC 66213-0423-04), 1 Pint (473 mL) bottles, Grape Flavored (NDC 66213-0423-16), 4 fl oz (118 mL) bottles, Mint Flavored (NDC 66213-0422-04) and 1 Pint (473 mL) bottles, Mint Flavored (NDC 66213-0422-16); (ii) Donnatal® Tablets, containing Phenobarbital; USP, Hyoscyamine Sulfate, USP, Atropine Sulfate, USP, and Scopolamine Hydrobromide, USP supplied as white, D-shaped tablets debossed D on one side and Donnatal on the other side in bottles of 100 tablets (NDC 66213-0425-10) and 1000 tablets (NDC 66213-0425-11); and (iii) any other pharmaceutical product marketed by or on behalf of Seller under the Donnatal® trademark.
Product Copyrights means any rights in and to registered or unregistered copyrightable works owned by Seller used solely in connection with the Product in the Territory, including all copyright rights in Promotional Materials.
Product Domain Names means the domain names set forth on Schedule 1.1(g) hereto.
Product Intellectual Property means the Product Copyrights, the Product Domain Names, Product Know-How, Product Marks and Product Trade Dress.
Product Know-How means the Know-How which is used exclusively by Seller for the Product in the Territory.
Product Marks means all Trademarks used by Seller on or in connection with the Product (including those set forth on Schedule 1.1(h) hereto).
Product Records means, to the extent permitted by Law and maintained by, or under the control of, Seller, all written or electronic books and records relating to the Product, provided , however , that Seller may retain copies of any such books and records to the extent necessary for Tax, accounting, litigation or other valid business purposes required by this Agreement, the Other Agreements or at the written request of Purchaser, which copy shall be deemed to be Purchaser Proprietary Information from and after the Closing Date and subject to the provisions of Section 8.1. For the avoidance of doubt, the following will be excluded from the definition of Product Records: all books, documents, records, files or other items that are bids received from other parties and strategic, financial or Tax analyses relating to the divestiture
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of the Purchased Assets, the Assumed Liabilities, the Product and similar materials prepared in connection with or relating to the Transactions.
Product Trade Dress means the trade dress used by Seller on or in connection with the Product (including that set forth on Schedule 1.1(i) hereto), but specifically excluding all Seller Brands used thereon with the exception of the Product Marks.
Promotional Materials means all .pdf files or other electronic data files containing, or physical materials constituting, promotional materials for the Product, all of which shall be set forth by Seller on Schedule 1.1(j) .
Purchase Price has the meaning set forth in Section 2.6.
Purchased Assets has the meaning set forth in Section 2.1.1.
Purchaser has the meaning set forth in the Preamble of this Agreement.
Purchaser Claim has the meaning set forth in Section 10.1.1.
Purchaser Indemnitees has the meaning set forth in Section 10.1.1.
Purchaser Losses has the meaning set forth in Section 10.1.1.
Purchaser Proprietary Information has the meaning set forth in Section 8.1.2.
Real Property means, collectively, the Owned Real Property and the Leased Real Property.
Registrations means the regulatory approvals (excluding Intellectual Property Registrations), authorizations, licenses, master drug files, applications, agreements, permits, NDAs, ANDAs, conditionally approved ANDAs, ability to market products that are Identical, Similar, or Related under an outstanding Notice of Opportunity for a Hearing, and Environmental Permits issued by Governmental Authorities in the Territory including those set forth on Schedule 1.1(k) hereto.
Release means any actual or threatened release, spilling, leaking, pumping, pouring, emitting, emptying, discharging, injecting, escaping, leaching, dumping, abandonment, disposing or allowing to escape or migrate into or through the environment (including, without limitation, ambient air (indoor or outdoor), surface water, groundwater, land surface or subsurface strata or within any building, structure, facility or fixture).
Representatives means, with respect to any Person, the directors, managers, employees, independent contractors, agents or consultants of such Person.
Sales Training Materials means those sales training modules which were used exclusively to train sales personnel to sell only the Product which modules are generally described on Schedule 1.1(l) .
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SEC means the United States Securities and Exchange Commission.
Securities Act means the Securities Act of 1933, as amended, and the rules and regulations promulgated thereunder.
Seller has the meaning set forth in the Preamble of this Agreement.
Seller Brands means the Trademarks set forth on Schedule 1.1(m) hereto owned, licensed, controlled or used by Seller, whether or not registered.
Seller Brand License has the meaning set forth in Section 8.2.1.
Seller Claim has the meaning set forth in Section 10.1.3.
Seller Disclosure Schedule means the disclosure schedules delivered by Seller to Purchaser in connection with this Agreement and attached hereto.
Seller Excluded Claims has the meaning set forth in Section 10.1.4(c).
Seller Indemnitees has the meaning set forth in Section 10.1.3.
Seller Losses has the meaning set forth in Section 10.1.3.
Seller Nominee has the meaning set forth in Section 8.10.1.
Seller Proprietary Information has the meaning set forth in Section 8.1.3.
Standard Listing Conditions has meaning set forth in Section 7.1.3.
Statement of Allocation has the meaning set forth in Section 8.9.2.
Straddle Period means any Tax period beginning before the Closing Date and ending after the Closing Date.
Tangible Personal Property means all furniture, fixtures, equipment, machinery, tools, vehicles, office equipment, supplies, computers (with resident software and associated shrink-wrap, click-wrap or similar licenses, pursuant to the terms thereof), and other tangible personal property relating to the Business all of which shall be set forth by Seller on Schedule 1.1(n) .
Tax or Taxes means any and all taxes, assessments, levies, tariffs, duties or other charges, or impositions in the nature of a tax (together with any and all interest, penalties, additions to tax and additional amounts imposed with respect thereto) imposed by any applicable Governmental Authority.
Tax Period means any period prescribed by any Governmental Authority for which a Tax Return is required to be filed or a Tax is required to be paid or measured.
Tax Return means any report, return (including any information return), claim for refund, election, estimated Tax filing or payment, request for extension, document, declaration or
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other information or filing required to be supplied to any applicable Governmental Authority with respect to Taxes, including attachments thereto and amendments thereof.
Termination Fee has the meaning set forth in Section 11.2.2.
Territory means the United States of America.
Third Party(ies) means any Person other than the Parties or their respective Affiliates.
Tooling means all of the tooling relating to the Product including that identified on Schedule 1.1(o) .
Trademark means registered and unregistered trademarks, service marks, certification marks, trade dress, trade names, identifying symbols, logos or insignia, distinct product names, company names and slogans, applications and registrations therefor, all common law rights therein, and all goodwill associated therewith.
Trading Day means a day in which the TSX is open for business.
Transactions means the transactions contemplated by this Agreement and the Other Agreements.
Transfer Taxes means any and all transfer, documentary, sales, use, gross receipts, stamp, registration, value added, recording, escrow and other similar Taxes and fees (including any penalties and interest) incurred in connection with the Transactions (including recording and escrow fees and any real property or leasehold interest transfer or gains tax and any similar Tax).
Transition Services Agreement means that certain Transition Services Agreement between Seller and Purchaser, in the form attached hereto as Exhibit D .
Treasury Regulation(s) means the regulations promulgated under the Code.
TSX means the Toronto Stock Exchange.
TSX Approval has the meaning set forth in Section 7.1.3.
Union has the meaning set forth in Section 4.17.2.
1.2 Other Definitional Provisions .
1.2.1 When a reference is made in this Agreement to an Article, Section, Exhibit or Schedule, such reference is to an Article or Section of, or an Exhibit or Schedule to, this Agreement unless otherwise indicated.
1.2.2 The words hereof , herein , hereto and hereunder and words of similar import, when used in this Agreement, shall refer to this Agreement as a whole and not to any particular provision of this Agreement.
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1.2.3 The terms defined in the singular have a comparable meaning when used in the plural, and vice versa.
1.2.4 Words of one gender include the other gender.
1.2.5 References to a Person are also to its successors and permitted assigns.
1.2.6 The terms dollars and $ mean United States dollars.
1.2.7 The term CAD means Canadian dollars.
1.2.8 The word including means including without limitation and the words include and includes have corresponding meanings.
1.2.9 For purposes of this Agreement, all references to the Business as presently conducted and words of similar import, assumes the Business as presently conducted in the jurisdictions in which it is presently conducted.
ARTICLE 2
PURCHASE AND SALE
2.1 Purchase and Sale of Purchased Assets . At the Closing, subject to the terms and conditions hereof and in consideration of the Purchase Price, Seller shall sell, convey, transfer, assign and to deliver to Purchaser (and/or an Affiliate of Purchaser), and Purchaser (and/or an Affiliate of Purchaser) shall purchase, take delivery of and acquire from Seller, free and clear of any Encumbrances other than Permitted Encumbrances, all of Sellers right, title and interest in, to and under the Purchased Assets.
2.1.1 Purchased Assets . The Purchased Assets means, collectively, only the Assets relating to the Business listed below:
(a) the Registrations;
(b) the Assigned Contracts;
(c) the Product Intellectual Property;
(d) the Tooling;
(e) Existing Finished Product Inventory;
(f) Bulk Product Inventory, including any API;
(g) Real Property;
(h) Tangible Personal Property;
(i) Promotional Materials and non-printed packaging components;
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(j) Sales Training Materials;
(k) Product Records;
(l) all rights to any Actions of any nature available to or being pursued by Seller to the extent related to the Purchased Assets or the Assumed Liabilities, whether arising by way of counterclaim or otherwise, including Sellers rights to any hearing before FDA regarding the Products or any products identical, related or similar to the Products;
(m) a royalty-free, perpetual, worldwide, non-exclusive license to use in any way in the conduct of the Business and solely in the conduct of the Business rights in and to (i) registered or unregistered copyrightable works (other than the Seller-Brands) owned by Seller and used but not used solely in connection with the Product in the Territory and (ii) Know-How used in the Business but not used exclusively for the Product in the Territory;
(n) all prepaid production deposits; and
(o) all of Sellers rights under warranties, indemnities and all similar rights against third parties to the extent related to any Purchased Assets.
2.2 Excluded Assets . All properties, assets, and rights of Seller not specifically listed and identified in Section 2.1 are not part of the sale and purchase contemplated hereunder, are excluded from the Purchased Assets, and shall remain the property of Seller after the Closing (the Excluded Assets ).
2.3 Assumed Liabilities . As of the Closing, Purchaser (and/or an Affiliate of Purchaser) shall assume and pay, perform or otherwise discharge, in accordance with their respective terms and subject to their respective conditions thereof, only the following Liabilities (collectively, the Assumed Liabilities ):
2.3.1 Purchasers obligations under this Agreement and the Other Agreements;
2.3.2 any claims for Liability relating to the Product which arise from events or circumstances not disclosed in this Agreement occurring after the Closing, other than (a) any Liability for which Seller is required to indemnify Purchaser under the Transition Services Agreement, or (b) any Liability for Taxes for any Pre-Closing Tax Period (other than with respect to Purchasers obligation for Transfer Taxes pursuant to Section 8.9.4);
2.3.3 any claims for Liability relating to the Product for which Purchaser is required to indemnify Seller under this Agreement or the Transition Services Agreement;
2.3.4 any claims by the states or federal government for issues related to drug price, drug sales or rebates under federal or state drug reimbursement programs, in each case which arise from events or circumstances occurring after the Closing; and
2.3.5 any claims under any qui tam actions which arise from events or circumstances occurring after the Closing.
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2.4 Excluded Liabilities . Other than the Assumed Liabilities, Seller shall retain and shall be responsible for paying, performing and discharging when due, and Purchaser shall not assume or have any responsibility for, any Liabilities of Seller of any kind, character or description whatsoever (the Excluded Liabilities ), including:
2.4.1 any Liabilities to the extent relating to or arising out of the Excluded Assets;
2.4.2 any claims for Liability relating to the Product, the Purchased Assets or the Business which arise from events or circumstances occurring prior to the Closing (other than those assumed pursuant to Section 2.3.2);
2.4.3 Sellers obligations under this Agreement and the Other Agreements;
2.4.4 any claims for Liability relating to the Product for which Seller is required to indemnify a Purchaser Indemnitee under this Agreement or the Transition Services Agreement;
2.4.5 any Liabilities related to (a) income or similar Taxes of Seller, or (b) all other Taxes relating to the Business or the Purchased Assets attributable to any Pre-Closing Tax Period (other than with respect to Purchasers obligation for Transfer Taxes pursuant to Section 8.9.4).
2.4.6 any Liabilities of Seller for any present or former employees, officers, directors, retirees, independent contractors or consultants of Seller, including, without limitation, any Liabilities associated with any claims for wages or other benefits, bonuses, accrued vacation, workers compensation, severance, retention, termination or other payments arising or occurring prior to the Closing; and
2.4.7 any Environmental Claims, or Liabilities under Environmental Laws, to the extent arising out of or relating to facts, circumstances or conditions existing on or prior to the Closing or otherwise to the extent and only to the extent arising out of any actions or omissions of Seller.
2.5 Consent of Third Parties . On the Closing Date, Seller shall assign to Purchaser, and Purchaser will assume, the Assigned Contracts, in each case, to the extent permitted by, and in accordance with, applicable Law. Notwithstanding anything herein to the contrary, if the assignment or assumption of all or any portion of any rights or obligations under any Assigned Contract shall require the consent of any other party thereto or any other Third Party that has not been obtained prior to the Closing Date, this Agreement shall not constitute an agreement to assign, license, sublicense, lease, sublease, convey or otherwise transfer any rights or obligations under any such Assigned Contract, and Seller, at its expense, shall use its reasonable commercial efforts to obtain any such required consent(s) as promptly as possible. If any such consent shall not be obtained or if any attempted assignment would be ineffective or would impair Purchasers rights under the Purchased Asset in question so that Purchaser would not in effect acquire the benefit of all such rights, Seller, to the maximum extent permitted by law and the Purchased Asset, shall act after the Closing as Purchasers agent in order to obtain for it the benefits thereunder and shall cooperate, to the maximum extent permitted by Law and the Purchased
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Asset, with Purchaser in any other reasonable arrangement designed to provide such benefits to Purchaser.
2.6 Purchase Price . In consideration of the sale, assignment, conveyance, and delivery of the Purchased Assets, Purchaser shall, upon the Closing, assume the Assumed Liabilities and pay to Seller a payment of Two Hundred Million dollars ($200,000,000) in cash and transfer, or cause to be transferred, to Seller the Consideration Shares (the Purchase Price ). The cash portion of the Purchase Price shall be made in dollars via wire transfer of immediately available funds to bank account identified by Seller in Schedule 2.6 .
2.7 Risk of Loss . Until the Closing, any loss of or damage to the Purchased Assets from fire, flood, casualty or any other similar occurrence shall be the sole responsibility of Seller. Title to the Purchased Assets shall be transferred to Purchaser at Closing.
ARTICLE 3
CLOSING
3.1 Closing . Upon the terms and subject to the conditions of this Agreement, the Closing shall be held on a date to be specified by the Parties (the Closing Date ) after the satisfaction or waiver of all of the conditions set forth in Article 7, and not later than the Outside Date, at a mutually convenient location agreed to by the Parties.
3.2 Transactions at Closing . At the Closing, subject to the terms and conditions hereof:
3.2.1 Seller shall deliver or cause to be delivered to Purchaser:
(a) executed counterparts of the Assignment and Assumption Agreement, Intellectual Property Assignment Agreement, Bill of Sale and Transition Services Agreement to which it is a Party;
(b) a letter from Seller to the FDA, duly executed by Seller, transferring the rights to the Registrations to Purchaser;
(c) a certificate of a duly authorized officer of Seller certifying as to the matters set forth in Sections 7.2.1 and 7.2.2;
(d) a certificate, in form and substance reasonably satisfactory to Purchaser, certifying that the transactions contemplated by this Agreement are exempt from withholding under Section 1445 of the Code; and
(e) such other documents and instruments as may be reasonably necessary to effect or evidence the Transactions.
3.2.2 Purchaser shall deliver or cause to be delivered to Seller:
(a) the Purchase Price, which for greater certainty shall include delivery of the Consideration Shares in the form of one or more definitive share certificates
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representing the Consideration Shares registered in the name of Seller or registered in the name of CDS & Co., as nominee for Seller, and/or in such other name or names as Seller may direct Purchaser and Parent in writing not less than three (3) Business Days prior to the Closing Date;
(b) executed counterparts of the Assignment and Assumption Agreement, Intellectual Property Assignment Agreement, Bill of Sale and Transition Services Agreement to which it is a Party;
(c) a letter from Purchaser to the FDA duly executed by Purchaser, assuming responsibility for the Registrations from Seller;
(d) a certificate of a duly authorized officer of Purchaser certifying as to the matters set forth in Sections 7.3.1 and 7.3.2; and
(e) such other documents and instruments as may be reasonably necessary to effect or evidence the Transactions.
ARTICLE 4
REPRESENTATIONS AND WARRANTIES OF SELLER
Except as set forth on the Seller Disclosure Schedule, Seller hereby represents and warrants to Purchaser, as of the Execution Date and as of the Closing Date, as follows (except to the extent a separate date is specified within the representation and warranty, in which case, the date set forth therein shall apply):
4.1 Organization . Seller is a Corporation duly organized, validly existing and in good standing under the laws of Delaware. Seller is in good standing in each jurisdiction where such qualification is required except for any jurisdiction where failure to so qualify would not have a Material Adverse Effect. Seller has all requisite corporate power and authority to own, lease and operate, as applicable, the Purchased Assets and the Business.
4.2 Due Authorization . Seller has all requisite corporate power and authority to execute, deliver and perform its obligations under this Agreement and the Other Agreements (as applicable), and the execution and delivery of this Agreement and the Other Agreements (as applicable), the performance of all of its obligations hereunder and thereunder have been duly authorized by Seller and, to the extent required by Law, contract or otherwise, its stockholders. No other proceedings on the part of the Seller is necessary to authorize this Agreement or the Other Agreements.
4.3 No Conflicts; Enforceability . The execution, delivery and performance of this Agreement and the Other Agreements by Seller (a) are not prohibited or limited by, and will not result in the breach of or a default under, any provision of the certificate of incorporation or bylaws of Seller, (b) assuming all of the consents, approvals, authorizations and permits described in Section 4.7 have been obtained and all the filings and notifications described in Section 4.7 have been made and any waiting periods thereunder have terminated or expired, does not, in any material respect, conflict with any Law applicable to Seller, and (c) other than with respect to the consents listed on Schedule 4.3 , does not, in any material respect, conflict with, result in a breach of, constitute (with or without due notice or lapse of time or both) a default
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under, result in the acceleration of obligations under, create in any party the right to terminate, modify or cancel, or require any notice, consent or waiver under, any agreement or instrument binding on Seller or any applicable order, writ, injunction or decree of any court or applicable Governmental Authority to which Seller is a party or by which Seller is bound or to which any of its Assets is subject, including the Purchased Assets. This Agreement and the Other Agreements have been duly executed and delivered by Seller, and constitute the legal, valid and binding obligations of Seller, enforceable against Seller in accordance with their respective terms, except as enforceability may be limited or affected by applicable bankruptcy, insolvency, moratorium, reorganization or other Laws of general application relating to or affecting creditors rights generally.
4.4 Title of Assets; Condition; Sufficiency .
4.4.1 Except as set forth on Schedule 4.4.1 , Seller owns, leases, licenses or has the right to use the Purchased Assets free and clear of all Encumbrances other than the Permitted Encumbrances, and upon the consummation of the Transactions, Purchaser shall acquire good and marketable title to, and all right, title and interest of Seller in and to, the Purchased Assets, free and clear of all Encumbrances other than the Permitted Encumbrances.
4.4.2 Except as disclosed on Schedule 4.4.2 of the Seller Disclosure Schedule, all tangible assets that are part of the Purchased Assets are in good operating condition and repair (normal wear and tear excluded), are adequate for the uses to which they are being put, are usable in the ordinary course of business, and are not in need of maintenance or repairs except for ordinary, routine maintenance and repairs.
4.4.3 The Purchased Assets, together with the goods and services provided under the Transition Services Agreement, are sufficient for the continued conduct of the business relating to the Product (the Business ), including the Manufacture and Distribution thereof, after the Closing in substantially the same manner as conducted during the period prior to the Closing.
4.5 Intellectual Property .
4.5.1 Except as set forth on Schedule 4.5.1 of the Seller Disclosure Schedule, there are no Actions (including any oppositions, interferences or re-examinations) settled, pending or threatened (including in the form of offers to obtain a license): (i) alleging any infringement, misappropriation, dilution or violation of the Intellectual Property of any Person by Seller in connection with the Business; (ii) challenging the validity, enforceability, registrability or ownership of any Product Intellectual Property or Sellers rights with respect to any Product Intellectual Property; or (iii) by Seller or its Affiliates alleging any infringement, misappropriation, dilution or violation by any Person of any Product Intellectual Property. Except as set forth on Schedule 4.5.1 of the Seller Disclosure Schedule, Seller is not subject to any outstanding or prospective Governmental Order (including any motion or petition therefor) that does or would restrict or impair the use of any Product Intellectual Property.
4.5.2 Schedule 4.5.2 of the Seller Disclosure Schedule lists all material Intellectual Property Agreements (other than any standard shrink-wrap, click-wrap or similar
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licenses of which the Company is a licensee, provided in connection with off-the-shelf or pre-loaded software or online services). Seller has provided Purchaser with true and complete copies of all such Intellectual Property Agreements, including all modifications, amendments and supplements thereto and waivers thereunder. Each Intellectual Property Agreement is valid and binding on Seller in accordance with its terms and, to Sellers Knowledge, is in full force and effect. None of Seller or, to Sellers Knowledge, any other party thereto, is in material breach of or material default under (or is alleged to be in material breach of or material default under), or has provided or received any notice of breach or default of or any intention to terminate, any Intellectual Property Agreement. To Sellers Knowledge, no event or circumstance has occurred that, with notice or lapse of time or both, would constitute an event of default under any Intellectual Property Agreement or result in a termination thereof or would cause or permit the acceleration or other changes of any right or obligation or the loss of any benefit thereunder.
4.5.3 All required filings and fees to effect or maintain the Intellectual Property Registrations have been timely filed with and paid to the relevant Governmental Authorities and authorized registrars, no additional such filings or fees are scheduled to fall due in the six (6) months following the Closing Date and all Intellectual Property Registrations are otherwise in good standing. Seller has provided Purchaser with true and complete copies of file histories, documents, certificates, office actions, correspondence and other materials related to all Intellectual Property Registrations. Seller is the sole and exclusive legal and beneficial, and with respect to the Intellectual Property Registrations, record, owner of all right, title and interest in and to the Product Intellectual Property, and has the valid right to use all other Intellectual Property used in or necessary for the conduct of the Business as currently conducted, in each case, free and clear of Encumbrances other than Permitted Encumbrances.
4.5.4 The Product Intellectual Property and Intellectual Property licensed under the Intellectual Property Agreements are all of the Intellectual Property necessary to operate the Business as presently conducted. The consummation of the transactions contemplated hereunder will not result in the loss or impairment of, or payment of any additional amounts (other than assignment recordation fees, transfer taxes, or any other amount typically required of a purchaser of Intellectual Property) with respect to, nor require the consent of any other Person in respect of, the Purchasers right to own, use or hold for use any Intellectual Property as owned, used or held for use in the conduct of the Business as currently conducted.
4.5.5 Sellers rights in the Product Intellectual Property are valid, subsisting and enforceable. Seller has taken reasonable steps to maintain the Product Intellectual Property and to protect and preserve the confidentiality of all material trade secrets included in the Product Intellectual Property.
4.5.6 The conduct of the Business as currently conducted by Seller, and the Product Intellectual Property and Intellectual Property licensed under the Intellectual Property Agreements as currently owned, licensed or used by Seller, have not infringed, misappropriated, diluted or otherwise violated, and, to Sellers Knowledge, do not and will not infringe, misappropriate, dilute or otherwise violate, the Intellectual Property or other rights of any Person. To Sellers Knowledge, no Person has infringed, misappropriated, diluted or otherwise violated, or is currently infringing, misappropriating, diluting or otherwise violating, any Product Intellectual Property.
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4.6 Litigation . Except as set forth on Schedule 4.6 of the Seller Disclosure Schedule, there is no Action pending or, to Sellers Knowledge, threatened (a) that is related to the Product, the Business, the Purchased Assets, the Assumed Liabilities or the Transactions, (b) that would have a Material Adverse Effect, or (c) that would prevent or delay the consummation by Seller of the Transactions or affect the legality, validity or enforceability of this Agreement or the Other Agreements.
4.7 Consents . Except as set forth on Schedule 4.7 of the Seller Disclosure Schedule, the requisite filings under the HSR Act and the expiration or termination of the waiting period thereunder, the letter to the FDA contemplated by Section 8.8.4, and as may be necessary as a result of any facts or circumstances relating solely to Purchaser, no material notice to, filing with, authorization of, exemption by, or consent of, any Person, including any Governmental Authority, is required for Seller to consummate the Transactions.
4.8 Taxes . All Tax Returns with respect to Seller or the Purchased Assets have been filed in a timely manner (within any applicable extension periods), all such Tax Returns are true and complete in all material respects, and all Taxes, whether or not shown to be due on such Tax Returns, that have become due and payable have been paid, except for Taxes that are being contested in good faith and for which reserves have been established in accordance with GAAP. No written claims related to Taxes have been asserted with respect to Seller or the Purchased Assets, and Seller has no Knowledge of any reasonable basis for the assertion of any such claims related to Taxes. There are no Encumbrances for Taxes upon the Purchased Assets, other than Permitted Encumbrances.
4.9 No Adverse Notice . Except as provided on Schedule 4.9 , Seller has not received any formal or written notice to the effect that, or, to Sellers Knowledge (with due inquiry), otherwise been advised, that, it is not in compliance with any of such permits, government licenses, registrations, approvals, concessions, franchises, authorizations, orders, injunctions, decrees, laws, regulations, guidance or guidelines, including the Act or the PDMA.
4.10 Regulatory Matters . Except as set forth on Schedule 4.10.4 and Schedule 4.10.7 :
4.10.1 All existing Registrations held by Seller as of the date of this Agreement are in full force and effect. Schedule 4.10.1 , Schedule 4.10.2 and Schedule 4.10.9 of the Seller Disclosure Schedule lists all existing Registrations held by Seller as of the date of this Agreement. Seller is the sole and exclusive owner of the Registrations.
4.10.2 The Manufacture and Distribution of the Product has been conducted in compliance with the applicable Registrations as defined in Schedule 4.10.1 , Schedule 4.10.2 , Schedule 4.10.3 and Schedule 4.10.9 and all applicable Laws, including the Act.
4.10.3 Except as stated in Schedule 4.10.1 , Schedule 4.10.2 , Schedule 4.10.8 and Schedule 4.10.9 , Seller has not received any written notice or other notice of proceedings from any applicable Governmental Authority alleging that the Product or any of the Purchased Assets or the ownership, Manufacture or Distribution is in violation of any applicable Law and such violation has not been remedied, except for such violations that would not reasonably be expected to have a Material Adverse Effect.
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4.10.4 Seller has completed and filed the reports as stated in Schedule 4.10.6 in accordance with the Registrations.
4.10.5 To Sellers Knowledge, there are no existing circumstances which would furnish a basis for an action by FDA or any other Governmental Authority to revoke, suspend, cancel, modify or withdraw any Registrations except as stated in Schedule 4.10.1 , Schedule 4.10.2 , Schedule 4.10.3 , Schedule 4.10.5 , Schedule 4.10.6 , Schedule 4.10.8 and Schedule 4.10.9 .
4.10.6 Within the last three (3) years, neither the Seller, nor any employee of the Seller, nor to Sellers Knowledge (after due inquiry) any Person retained by the Seller, has made on behalf of Seller any material false statements or material omissions in any report, application or other submission relating to the Product to the FDA or other Governmental Authority.
4.10.7 The Seller has provided to Purchaser a copy of all (i) FDA or its foreign equivalent inspection reports for Seller, (ii) notices of observations, and (iii) warnings, untitled letters, minutes of meetings or other correspondence from the FDA or other Governmental Authorities concerning the Products in which the FDA or such other Governmental Authority asserted that the operations of the Seller regarding the Product may not be in compliance with Law or that the Product may not be safe, effective, or approvable received within the last three (3) years.
4.10.8 To Sellers Knowledge, Seller has not suffered any unauthorized acquisition, access, use or disclosure of any personal information in connection with the Distribution of the Product that, individually or in the aggregate, materially compromises the security or privacy of such personal information.
4.10.9 Any previous preclinical tests and clinical trials associated with the Product were, to Sellers Knowledge, conducted in all material respects in accordance with the protocols filed by A. H. Robins as the Final Study Report, Protocol 03, The Comparison of Donnatal to Belladonna Alkaloids, Phenobarbital, and Placebo in the Management of the Symptoms of the Irritable Bowel Syndrome on June 30, 1983, and to those materials only.
4.10.10 Seller has complied, and is now complying, in all respects, with all Laws applicable to the conduct of the Business as currently conducted or the ownership and use of the Purchased Assets.
4.10.11 To Sellers Knowledge, all Permits required for Seller to conduct the Business as currently conducted or for the ownership and use of the Purchased Assets have been obtained by Seller and are valid and in full force and effect (the Business Permits ). All fees and charges with respect to such Permits as of the date hereof have been paid in full. Schedule 4.10.11 of the Seller Disclosure Schedule lists all current Permits issued to Seller which are related to the conduct of the Business as currently conducted or the ownership and use of the Purchased Assets, including the names of the Permits and their respective dates of issuance and expiration. To Sellers Knowledge, no event has occurred that, with or without notice or lapse of time or both, would reasonably be expected to result in the revocation, suspension, lapse or limitation of any Permit set forth in Schedule 4.10.11 of the Seller Disclosure Schedule.
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4.10.12 Seller has not entered into, or taken assignment of, any Federal Supply Schedule contract relating to any of the Products. Seller has not entered into, or taken assignment of, any contract with CMS to participate in the Medicare Coverage Gap Discount Program within the last three (3) years. None of the Products are reimbursable under the Medicare program.
4.11 Brokers, Etc. Neither Seller nor any agents of Seller have incurred any obligation or liability, contingent or otherwise, for brokerage or finders fees or agents commissions or other similar payment in connection with this Agreement, other than amounts owed to Lazard Middle Market LLC which shall be paid entirely by Seller.
4.12 Inventory . Except as set forth on Schedule 4.12 of the Seller Disclosure Schedule, all Existing Finished Product Inventory conforms, in all respects, to all applicable specifications in, and have been manufactured in compliance with all applicable Registrations, and the specifications under the Contracts pursuant to which they are supplied.
4.13 Financial Statements . Complete copies of the audited income statement for the fiscal years ended December 31, 2012 and 2013 and balance sheet as of such dates, in each case, of Seller and unaudited financial statements consisting of the balance sheet of the Seller as at January, 2014 (the Interim Balance Sheet ) and the related statements of income for the one-month period then ended (collectively, the Financial Statements ). The Financial Statements are based on the books and records of the Seller, and fairly present, in all material respects, the financial condition of the Seller as of the respective dates they were prepared and the results of the operations of the Seller for the periods indicated. Seller maintains its books and records in accordance with GAAP.
4.14 Absence of Certain Changes . Since December 31, 2013 and except as listed on Schedule 4.14 , there has not been any event, occurrence or development that has had a Material Adverse Effect, and other than in the ordinary course of business consistent with past practice, there has not been any:
4.14.1 material change in any method of accounting or accounting practice for the Business, except as required by GAAP;
4.14.2 entry into any Contract that would constitute a Material Contract;
4.14.3 transfer, assignment, sale or other disposition of any of the Purchased Assets, except for the sale of inventory in the ordinary course of business;
4.14.4 transfer, assignment or grant of any license or sublicense of any material rights under or with respect to any material Product Intellectual Property;
4.14.5 material damage, destruction or loss, or any material interruption in use, of any Purchased Assets, whether or not covered by insurance;
4.14.6 acceleration, termination, material modification to or cancellation of any Assigned Contract or Registration (other than any expiration in accordance with the terms of such assigned Contract or Registration);
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4.14.7 material capital expenditures which would constitute an Assumed Liability;
4.14.8 imposition of any Encumbrance, other than a Permitted Encumbrance, upon any of the Purchased Assets;
4.14.9 any Contract to do any of the foregoing, or any action or omission that would result in any of the foregoing;
4.14.10 (i) grant of any bonuses, whether monetary or otherwise, or increase in any wages, salary, severance, pension or other compensation or benefits in respect of any employees, officers, directors, independent contractors or consultants of the Business, other than as provided for in any written agreements required by applicable Law, or (ii) change in the terms of employment for any employee of the Business or any termination of any employees for which the aggregate costs and expenses exceed $100,000; and
4.14.11 adoption, modification or termination of any: (i) employment, severance, retention or other agreement with any current or former employee, officer, director, independent contractor or consultant of the Business, or (ii) collective bargaining or other agreement with a Union, in each case whether written or oral.
4.15 Material Contracts .
4.15.1 Schedule 4.15.1 of the Seller Disclosure Schedule lists each of the following Contracts (x) by which any of the Purchased Assets are bound or affected or (y) to which Seller is a party or by which it is bound in connection with the Business or the Purchased Assets (such Contracts, all Intellectual Property Agreements and all Leases, being Material Contracts ):
(a) all Contracts involving aggregate annual consideration in excess of $200,000 and which, in each case, cannot be cancelled without penalty or without more than ninety (90) days notice;
(b) all Contracts that require Seller to purchase or sell a stated portion of the requirements or outputs of the Business or that contain take or pay provisions;
(c) all Contracts that provide for the indemnification of any Person or the assumption of any Tax, environmental or other Liability of any Person;
(d) all Contracts that relate to the acquisition or disposition of any business, a material amount of stock or assets of any other Person (whether by merger, sale of stock, sale of assets or otherwise);
(e) all broker, distributor, dealer, manufacturers representative, franchise, agency, sales promotion, market research, marketing consulting and advertising Contracts;
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(f) all employment agreements and Contracts with independent contractors or consultants (or similar arrangements) and which are not cancellable without material penalty or without more than ninety (90) days notice;
(g) all Contracts with any Governmental Authority;
(h) all Contracts that limit or purport to limit the ability of Seller to compete in any line of business or with any Person or in any geographic area or during any period of time;
(i) all joint venture, partnership or similar Contracts;
(j) other than with respect to sales of inventory in the ordinary course of business, all Contracts for the sale of any of the Purchased Assets or for the grant to any Person of any option, right of first refusal or preferential or similar right to purchase any of the Purchased Assets;
(k) all collective bargaining agreements or Contracts with any Union; and
(l) all powers of attorney with respect to the Business or any Purchased Asset; and
4.15.2 Each Material Contract is valid and binding on Seller in accordance with its terms and is in full force and effect. None of Seller or, to Sellers Knowledge, any other party thereto is in breach of or default under (or is alleged to be in breach of or default under) in any material respect, or has provided or received any notice of any intention to terminate, any Material Contract. Complete and correct copies of each Material Contract (including all modifications, amendments and supplements thereto and waivers thereunder) have been made available to Purchaser. There are no material disputes pending or, to Sellers Knowledge, threatened under any Contract included in the Purchased Assets.
4.16 Customers and Suppliers .
4.16.1 Schedule 4.16.1 of the Seller Disclosure Schedule sets forth with respect to the Business (i) each customer who has paid aggregate consideration to Seller for goods or services rendered in an amount greater than or equal to $1,000,000 for each of the two most recent fiscal years (collectively, the Material Customers ); and (ii) the amount of consideration paid by each Material Customer during such periods. Seller has not received any notice that any of the Material Customers has ceased, or intends to cease after the Closing, to use the goods or services of the Business or to otherwise terminate or materially reduce its relationship with the Business.
4.16.2 Schedule 4.16.2 of the Seller Disclosure Schedule sets forth with respect to the Business (i) each supplier to whom Seller has paid consideration for goods or services rendered in an amount greater than or equal to $500,000 for each of the two most recent fiscal years (collectively, the Material Suppliers ); and (ii) the amount of purchases from each Material Supplier during such periods. Seller has not received any notice that any of the
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Material Suppliers has ceased, or intends to cease, to supply goods or services to the Business or to otherwise terminate or materially reduce its relationship with the Business.
4.17 Employment Matters .
4.17.1 Schedule 4.17.1 of the Seller Disclosure Schedule contains a list of the names of all persons who are employees, independent contractors or consultants of the Business as of the date hereof. As of the date hereof, other than wages, commissions and bonuses which are or will be paid in arrears in accordance with Sellers past practices, all compensation, including wages, commissions and bonuses payable to employees, independent contractors or consultants of the Business for services performed on or prior to the date hereof have been paid in full and there are no outstanding agreements, understandings or commitments of Seller with respect to any compensation, commissions or bonuses.
4.17.2 Seller is not, and has not been for the past three (3) years, a party to, bound by, or negotiating any collective bargaining agreement or other Contract with a union, works council or labor organization (collectively, Union ) in connection with the Business, and there is not, and has not been for the past three (3) years, any Union representing or purporting to represent any employee of the Business, and no Union or group of employees is seeking or has sought to organize employees for the purpose of collective bargaining. There has never been, nor has there been any threat of, any strike, slowdown, work stoppage, lockout, concerted refusal to work overtime or other similar labor disruption or dispute affecting Seller or any employees of the Business. Seller has no duty to bargain with any Union.
4.17.3 Seller is and has been in compliance, in all material respects, with all applicable Laws pertaining to employment and employment practices to the extent they relate to employees of the Business, including all Laws relating to labor relations, equal employment opportunities, fair employment practices, employment discrimination, harassment, retaliation, reasonable accommodation, disability rights or benefits, immigration, wages, hours, overtime compensation, child labor, hiring, promotion and termination of employees, working conditions, meal and break periods, privacy, health and safety, workers compensation, leaves of absence and unemployment insurance. All individuals characterized and treated by Seller as consultants or independent contractors of the Business are properly treated as independent contractors under all applicable Laws. All employees of the Business classified as exempt under the Fair Labor Standards Act and state and local wage and hour laws are properly classified. Except as set forth on Schedule 4.17.3 , there are no Actions against Seller pending, or to the Sellers Knowledge, threatened to be brought or filed, by or with any Governmental Authority or arbitrator in connection with the employment of any current or former applicant, employee, consultant or independent contractor of the Business, including, without limitation, any claim relating to unfair labor practices, employment discrimination, harassment, retaliation, equal pay, wages and hours or any other employment related matter arising under applicable Laws.
4.18 Real Property .
4.18.1 Seller owns no Owned Real Property with respect to, or used by, the Business.
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4.18.2 Seller has delivered to Purchaser a true and complete copy of each Lease. With respect to each Lease: (i) such Lease is valid, binding, enforceable and in full force and effect, and Seller enjoys peaceful and undisturbed possession of the Leased Real Property; (ii) Seller is not in breach or default under such Lease; (iii) Seller has not received nor given any written notice of any default or event that with written notice or lapse of time, or both, would constitute a default by Seller under any of the Leases and, to the Knowledge of Seller, no other party is in default thereof, and no party to any Lease has exercised any termination rights with respect thereto; (iv) Seller has not subleased, assigned or otherwise granted to any Person the right to use or occupy such Leased Real Property or any portion thereof; and (v) Seller has not pledged, mortgaged or otherwise granted an Encumbrance on its leasehold interest in any Leased Real Property.
4.18.3 Seller has not received any written notice of (i) violations of building codes and/or zoning ordinances or other governmental or regulatory Laws affecting the Real Property, (ii) existing, pending or threatened condemnation proceedings affecting the Real Property, or (iii) existing, pending or threatened zoning, building code or other moratorium proceedings, or similar matters which could reasonably be expected to adversely affect the ability to operate the Real Property as currently operated. Neither the whole nor any material portion of any Real Property has been damaged or destroyed by fire or other casualty.
4.18.4 The Real Property is sufficient for the continued conduct of the Business after the Closing in substantially the same manner as conducted prior to the Closing and constitutes all of the real property necessary to conduct the Business as currently conducted.
4.19 Environmental Matters .
4.19.1 The operations of Seller with respect to the Business and the Purchased Assets are currently and have been in compliance, in all material respects, with all Environmental Laws. Seller has not received from any Person, with respect to the Business or the Purchased Assets, any: (i) Environmental Notice or Environmental Claim; or (ii) written request for information pursuant to Environmental Law, which, in each case, either remains pending or unresolved, or is the source of ongoing obligations or requirements as of the Closing Date.
4.19.2 Seller has obtained and is in material compliance with all Environmental Permits (each of which is disclosed in Schedule 4.19.2 of the Seller Disclosure Schedule) necessary for the conduct of the Business as currently conducted or the ownership, lease, operation or use of the Purchased Assets and all such Environmental Permits are in full force and effect and shall be maintained in full force and effect by Seller through the Closing Date in accordance with Environmental Law.
4.19.3 None of the Business or the Purchased Assets or any real property currently or formerly owned, leased or operated by Seller in connection with the Business is listed on, or has, to Sellers Knowledge, been proposed for listing on, the National Priorities List (or CERCLIS) under CERCLA, or any similar state list.
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4.19.4 To Sellers Knowledge, there has been no Release of Hazardous Materials in contravention of Environmental Law with respect to the Business or the Purchased Assets or any real property currently owned, leased or operated by Seller in connection with the Business, and Seller has not received an Environmental Notice that any of the Business or the Purchased Assets or real property currently owned, leased or operated by Seller in connection with the Business (including soils, groundwater, surface water, buildings and other structure located thereon) has been contaminated with any Hazardous Material which could reasonably be expected to result in an Environmental Claim against, or a violation of Environmental Law or term of any Environmental Permit by, Seller.
4.19.5 Schedule 4.19.5 of the Seller Disclosure Schedule contains a complete and accurate list of all active or abandoned aboveground or underground storage tanks owned or operated by Seller in connection with the Business or the Purchased Assets.
4.19.6 Schedule 4.19.6 of the Seller Disclosure Schedule contains a complete and accurate list of all off-site Hazardous Materials treatment, storage, or disposal facilities or locations used by Seller in connection with the Business or the Purchased Assets as to which Seller may retain liability, and none of these facilities or locations has been placed or proposed for placement on the National Priorities List (or CERCLIS) under CERCLA, or any similar state list, and Seller has not received any Environmental Notice regarding potential liabilities with respect to such off-site Hazardous Materials treatment, storage, or disposal facilities or locations used by Seller.
4.19.7 Seller has not retained or assumed, by contract, any liabilities or obligations of third parties under Environmental Law.
4.19.8 Seller has provided or otherwise made available to Purchaser: (i) any and all environmental reports, studies, audits, records, sampling data, site assessments, risk assessments, economic models and other similar documents with respect to the Business or the Purchased Assets or any real property currently or formerly owned, leased or operated by Seller in connection with the Business which are in the possession or control of Seller related to compliance with Environmental Laws, Environmental Claims or an Environmental Notice or the Release of Hazardous Materials; and (ii) any and all material documents concerning planned or anticipated capital expenditures required to reduce, offset, limit or otherwise control pollution and/or emissions, manage waste or otherwise ensure compliance with current or future Environmental Laws (including, without limitation, costs of remediation, pollution control equipment and operational changes).
4.20 Acquisition for Investment .
4.20.1 Seller acknowledges it will be acquiring Consideration Shares issuable pursuant to this Agreement for investment for its own account and not as nominees or agents, and not with a view to the resale or distribution of any part thereof, and further represents that it has no present intention of selling, granting any participation in, or otherwise distributing the same. Seller further represents that it does not have any contract, undertaking, agreement or arrangement with any person to sell, transfer or grant participation to such person or to any third person, with respect to any of the Consideration Shares;
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4.20.2 Seller understands that any Consideration Shares issuable hereunder will not be registered under the Securities Act, on the ground that the sale and the issuance of securities hereunder is exempt from registration under the Securities Act pursuant to Section 4(a)(2) thereof, and that the Parents reliance on such exemption is predicated on Sellers representation set forth herein.
4.21 Investment Experience . Seller acknowledges that it can bear the economic risk of the investment, and it has such knowledge and experience in financial and business matters that it is capable of evaluating the merits and risks of the investment in the Consideration Shares. Seller is an accredited investor within the meaning of Rule 501 promulgated under the Securities Act (as amended by Section 413(a) of the Dodd-Frank Wall Street Reform and Consumer Protection Act), and agrees that it will not take any action that could have an adverse effect on the availability of the exemption from registration provided by Section 4(a)(2) of the Securities Act with respect to the sale and the issuance of securities hereunder.
4.22 Information . Seller has carefully reviewed such information as it has deemed necessary. To the full satisfaction of Seller, it has been furnished all materials that it has requested relating to the Parent, and the issuance of Consideration Shares hereunder, and it has been afforded the opportunity to ask questions of representatives of the Parent, to obtain any information necessary to verify the accuracy of any representations or information made or given to them. Notwithstanding the foregoing, nothing herein shall derogate from or otherwise modify the representations and warranties of Purchaser set forth in this Agreement.
4.23 Restricted Securities . Seller understands that the Consideration Shares issuable pursuant to this Agreement may not be sold, transferred, or otherwise disposed of without registration under the Securities Act and applicable state, federal and provincial securities laws or an exemption therefrom, and that in the absence of an effective registration statement covering the Consideration Shares or any available exemption from registration under the Securities Act and applicable state, federal and provincial securities laws, the Consideration Shares must be held indefinitely. Without limitation of the foregoing, the Consideration Shares may not be sold, transferred, or otherwise disposed of by Seller less than four (4) months after issuance to it pursuant to Canadian securities Laws. Unless registered under the Securities Act and applicable state securities laws, the certificates representing the Consideration Shares, received pursuant to Section 2.6, shall bear a legend in the following form:
THE SECURITIES REPRESENTED HEREBY HAVE NOT BEEN AND WILL NOT BE REGISTERED UNDER THE UNITED STATES SECURITIES ACT OF 1933, AS AMENDED, (THE SECURITIES ACT) AND MAY NOT BE OFFERED, SOLD, EXCHANGED, MORTGAGED, PLEDGED, HYPOTHECATED OR OTHERWISE TRANSFERRED WITHIN THE UNITED STATES OR TO OR FOR THE BENEFIT OF ANY NATIONAL, CITIZEN OR RESIDENT OF THE UNITED STATES, ANY CORPORATION, PARTNERSHIP OR OTHER ENTITY CREATED OR ORGANIZED IN OR UNDER THE LAWS OF THE UNITED STATES, EXCEPT: (A) TO THE ISSUER, (B) OUTSIDE THE UNITED STATES IN COMPLIANCE WITH RULE 904 OF REGULATION S UNDER THE SECURITIES ACT AND WITH APPLICABLE STATE SECURITIES LAWS, (C) IN COMPLIANCE WITH (1) RULE 144 OR (2) RULE 144A UNDER THE SECURITIES ACT AND WITH APPLICABLE STATE SECURITIES LAWS, (D) IN CONNECTION WITH
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ANOTHER EXEMPTION UNDER THE SECURITIES ACT, OR (E) WITH THE PRIOR WRITTEN CONSENT OF THE ISSUER, UPON THE ISSUER RECEIVING, IN THE CASE OF CLAUSES (C)(1) AND (D) ABOVE, AN OPINION OF COUNSEL FOR THE HOLDER, STATING THAT SUCH SALE, TRANSFER, ASSIGNMENT OR HYPOTHECATION IS EXEMPT FROM THE REGISTRATION AND PROSPECTUS DELIVERY REQUIREMENTS UNDER THE SECURITIES ACT AND ANY APPLICABLE STATE SECURITIES LAWS.
provided that: (i) at any time Parent or its successor company is a foreign issuer, as defined in Rule 902(e) of Regulation S of the Securities Act, if such securities are being sold in accordance with the requirements of Rule 904 of Regulation S of the Securities Act, as referred to above, and in compliance with local laws and regulations, the legend may be removed by providing a declaration to the issuers transfer agent for such securities, in the form as may be prescribed by the Parent or its successor company from time to time, together with any other evidence, which may include an opinion of counsel of recognized standing reasonably satisfactory to the Parent or its successor company to the effect that such legend is no longer required under applicable requirements of the Securities Act, required by Parent or its successor company or such transfer agent; and (ii) if any such securities are being sold pursuant to Rule 144 under the Securities Act, the legend may be removed by delivery to the registrar and transfer agent for such securities of an opinion of counsel of recognized standing reasonably satisfactory to Parent or its successor company to the effect that such legend is no longer required under applicable requirements of the Securities Act or applicable state securities laws.
Seller acknowledges that the Consideration Shares have not been registered or qualified for distribution in any Province or Territory of Canada, and are not eligible for resale in Canada for a period ending four (4) months plus one (1) day from the Closing Date. Seller is acquiring the Consideration Shares as principal for its own account and not with a view toward, or for sale in connection with, any distribution thereof, or with any present intention of distributing or selling the Consideration Shares in any Province or Territory of Canada. Seller is an accredited investor as defined in National Instrument 45-106 Prospectus and Registration Exemptions of the Canadian Securities Administrators and was not created or used solely to purchase or hold Consideration Shares as an accredited investor and is able to bear the economic risk of an investment in the Consideration Shares.
Seller acknowledges that Parent may be required to file a report with the Canadian securities regulatory authorities containing personal information about Seller, including its full name, address and telephone number, the number and type of securities purchased, the total purchase price paid for the securities, the date of the closing and the exemption relied upon under applicable Canadian Securities Laws.
Seller acknowledges that the Consideration Shares are not freely tradable in Canada and any certificate representing the Consideration Shares, or if the Consideration Shares are entered into a direct registration or other electronic book-entry system then Seller acknowledges notice of such Consideration Shares being subject to the legends set forth below:
UNLESS PERMITTED UNDER SECURITIES LEGISLATION, THE HOLDER OF THIS SECURITY MUST NOT TRADE THE SECURITY BEFORE [Insert four months plus 1 day from the distribution date of the Consideration Shares].
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THE SECURITIES REPRESENTED BY THIS CERTIFICATE ARE LISTED ON THE TORONTO STOCK EXCHANGE (TSX); HOWEVER, THE SAID SECURITIES CANNOT BE TRADED THROUGH THE FACILITIES OF THE TSX SINCE THEY ARE NOT FREELY TRANSFERABLE, AND CONSEQUENTLY ANY CERTIFICATE REPRESENTING SUCH SECURITIES IS NOT GOOD DELIVERY IN SETTLEMENT OF TRANSACTIONS ON THE TSX.
4.24 Rule 144 . Seller understands and acknowledges that (i) if Parent or any successor company is deemed to have been at any time previously an issuer with no or nominal operations and no or nominal assets other than cash and cash equivalents, other than a Capital Pool Company (as such term is defined in the TSXV Corporate Finance Manual), Rule 144 under the Securities Act may not be available for resales of the Consideration Shares and (ii) Parent is not obligated to make Rule 144 under the Securities Act available for resales of such Consideration Shares.
4.25 No Registration Statement . Seller understands and acknowledges that Parent has no obligation or present intention of filing with the SEC or with any state securities administrator any registration statement in respect of resales of the Consideration Shares in the United States.
4.26 Foreign Issuer . Seller understands and acknowledges that Parent or any successor company (i) is not obligated to remain a foreign issuer within the meaning of Rule 902(e) of Regulation S of the Securities Act, (ii) may not, at the time the Consideration Shares are resold by it or at any other time, be a foreign issuer, and (iii) may engage in one or more transactions which could cause Parent or any successor company not to be a foreign issuer, and if Parent or any successor company is not a foreign issuer at the time of sale or transfer of the Consideration Shares pursuant to Rule 904 of Regulation S of the Securities Act, the certificates representing the Consideration Shares may continue to bear the legend described above.
4.27 Related Party Transactions . Except as set forth on Schedule 4.27 of the Seller Disclosure Schedule, Seller does not lease or is not committed to lease any properties or assets from, nor does it owe any amounts to, or use in its business any properties or assets of, nor has it loaned any amount to, or entered into any other contract or agreement with, any Affiliate or holder of its equity or its Affiliates equity or immediate family members or any other officer or director of Seller or any of its Affiliates (other than amounts owed to any such individual in his or her capacity as an officer, employee or director of Seller or any of its Affiliates).
ARTICLE 5
REPRESENTATIONS AND WARRANTIES OF PURCHASER AND PARENT
Purchaser (or Parent where stated explicitly) represents and warrants to Seller as follows:
5.1 Organization . Purchaser is an international business company duly organized and validly existing and in good standing under the laws of Barbados. Parent is a corporation duly incorporated and validly existing under the laws of Ontario, Canada. Purchaser is in good standing in each jurisdiction where such qualification is required except for any jurisdiction where failure to so qualify would not have a material adverse effect on Purchaser. Purchaser and
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Parent have all requisite corporate power and authority to own, lease and operate their respective properties and to carry on their respective businesses as now being conducted.
5.2 Due Authorization . Purchaser and Parent have all requisite corporate power and authority to execute, deliver and perform their respective obligations under this Agreement and the Other Agreements, as applicable, and the execution and delivery of this Agreement and the Other Agreements by each of Purchaser and Parent, as applicable, and the performance by Purchaser and Parent of all of their respective obligations hereunder and thereunder, as applicable, have been duly authorized by each of Purchaser and Parent and, in the case of Purchaser and to the extent required by Law, contract or otherwise, by its stockholders. No other proceedings on the part of Purchaser or Parent are necessary to authorize this Agreement or the Other Agreements, except for any Parent shareholder approval which the TSX may require the Parent to obtain.
5.3 No Conflicts; Enforceability . The execution, delivery and performance of this Agreement and the Other Agreements by each of Purchaser and Parent, as applicable, (a) are not prohibited or limited by, and will not result in the breach of or a default under, any provision of their respective certificates of incorporation, bylaws or any other formation documentation, (b) assuming all of the consents, approvals, authorizations and permits described in Sections 5.5 and 5.8 have been obtained and all the filings and notifications described in Sections 5.5 and 5.8 have been made and any waiting periods thereunder have terminated or expired, does not conflict with any Law applicable to Purchaser or Parent, and (c) does not conflict with, result in a breach of constitute (with or without due notice or lapse of time or both) a default under, result in the acceleration of obligations under, create in any party the right to terminate, modify or cancel, or require any notice, consent or waiver under, any material agreement or instrument binding on Purchaser or Parent or any applicable order, writ, injunction or decree of any court or applicable Governmental Authority to which Purchaser or Parent is a party or by which Purchaser or Parent is bound or to which any of their respective Assets is subject, except in the case of clauses (b) and (c) for such prohibitions, limitation, default, notice, filing, permit, authorization, consent, approval, conflict breach or default which would not prevent or delay the consummation by Purchaser and Parent of the Transactions. This Agreement and the Other Agreements have been duly executed and delivered by Purchaser or Parent, as applicable, and constitute the legal, valid and binding obligations of Purchaser or Parent, as applicable, enforceable against Purchaser or Parent, as applicable, in accordance with their respective terms, except as enforceability may be limited or affected by applicable bankruptcy, insolvency, moratorium, reorganization or other Laws of general application relating to or affecting creditors rights generally.
5.4 Litigation . There is no Action pending or, to Purchasers knowledge or Parents knowledge, threatened that would prevent or delay the consummation by Purchaser or Parent of the Transactions or affect the legality, validity or enforceability of this Agreement or the Other Agreements.
5.5 Consents . Except for the requisite filings under the HSR Act and the expiration or termination of the waiting period thereunder, the letter to the FDA contemplated by Section 8.8.5, pursuant to Section 5.8, and as may be necessary as a result of any facts or circumstances relating solely to Seller, no notice to, filing with, authorization of, exemption by, or consent of, any Person, including any applicable Governmental Authority, is required for Purchaser or
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Parent to consummate the Transactions, except where the failure to make such filings or notifications, or obtain such consents, approvals, authorizations or permits, would not, individually or in the aggregate, prevent or delay the consummation by Purchaser or Parent of the Transactions.
5.6 Financing . Purchaser will have sufficient immediately available funds to pay, in cash, the Purchase Price and all other amounts payable pursuant to this Agreement and the Other Agreements or otherwise necessary to consummate all the Transactions at the time any such payments are due. Upon the consummation of the Transactions, (a) Purchaser will not be insolvent, (b) Purchaser will not have incurred debts beyond its ability to pay such debts as they mature and (c) the capital of Purchaser will not be impaired in any manner that would prevent or prohibit the consummation by Purchaser of the Transactions.
5.7 Brokers, Etc. Any obligation or liability, contingent or otherwise, for brokerage or finders fees or agents commissions or other similar payment in connection with this Agreement, incurred by Purchaser and its officer and agents, is the sole liability and responsibility of Purchaser.
5.8 Consideration Shares .
5.8.1 Parent is a reporting issuer in each of the Provinces of Canada (other than Quebec) and is not in default under the applicable Canadian Securities Laws and is not on the list of defaulting issuers maintained by the applicable securities regulatory authority in such Provinces.
5.8.2 Except for any Parent shareholder approval which may be required by the TSX, no approval, authorization, consent or other order of, and no filing, registration or recording with, any Governmental Authority, securities commission or regulator or any other person in any Province of Canada (other than Quebec) is required of Parent in connection with the issuance and delivery of the Consideration Shares to Seller except: (i) those which have been obtained or those which may be required and shall be obtained prior to the Closing under Canadian Securities Laws or the rules of the TSX, and (ii) such post-Closing notice filings with the securities commission or regulator in any Province of Canada (other than Quebec) (if applicable) and the TSX as may be required in connection therewith.
5.8.3 Parent is in compliance with its timely and continuous disclosure obligations under the Canadian Securities Laws and the policies, rules and regulations of the TSX and, without limiting the generality of the foregoing, there has not occurred any material change (actual, anticipated, contemplated, threatened, financial or otherwise) in the business, assets (including intangible assets), affairs, operations, liabilities (contingent or otherwise), capital, properties, condition (financial or otherwise), results of operations or control of Parent and its subsidiaries taken as a whole since September 30, 2013 which has not been publicly disclosed on a non-confidential basis; all statements set forth in all documents publicly filed by or on behalf of Parent pursuant to Canadian Securities Laws were true, correct and complete in all material respects and did not contain any Misrepresentation as of the date of such statements (except for any Misrepresentation that has been superseded and corrected by a statement in a
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subsequent publicly filed document) and Parent has not filed any confidential material change report which remains confidential as at the date hereof.
5.8.4 At the Closing, the Consideration Shares will have been duly authorized for issuance and delivery to Seller pursuant to this Agreement and when issued and delivered by Parent pursuant to the terms of this Agreement, against delivery of the Purchased Assets as set forth herein, the Consideration Shares will be duly and validly issued and outstanding as fully paid and non-assessable shares in the capital of Parent. Seller will acquire title to the Consideration Shares free and clear of any Encumbrance, except for any Encumbrance created by or in respect of Seller.
5.8.5 The issuance of the Consideration Shares is not subject to the pre-emptive rights of any shareholder of Parent.
5.8.6 The Parent Common Stock is listed and posted for trading on the TSX.
5.8.7 The authorized capital of Parent consists of an unlimited number of shares of Parent Common Stock of which 23,839,787 shares of Parent Common Stock are issued and outstanding as fully paid and non-assessable shares in the capital of Parent as of the date hereof.
5.8.8 No holder of Parent Common Stock is entitled to any pre-emptive or any similar rights to subscribe for any shares of Parent Common Stock or other securities of Parent and, other than stock options to purchase 2,140,000 shares of Parent Common Stock, 140,820 compensation options to purchase 140,820 shares of Parent Common Stock, 2,080 options issued to former directors of Parent to purchase 2,080 shares of Parent Common Stock and the Global Purchase Shares, no rights to acquire, or instruments convertible into or exchangeable for, any shares in the capital of Parent are outstanding.
5.8.9 The form and terms of the certificate representing the Parent Common Stock have been approved and adopted by the board of directors of Parent and the form and terms of the certificate representing the Parent Common Stock do not conflict with any applicable laws or the rules of the TSX.
5.9 Taxes . All Tax Returns with respect to Purchaser have been filed in a timely manner (within any applicable extension periods), all such Tax Returns are true and complete in all material respects, and all Taxes, whether or not shown to be due on such Tax Returns, that have become due and payable have been paid, except for Taxes that are being contested in good faith and for which reserves have been established in accordance with GAAP. No written claims related to Taxes have been asserted with respect to Purchaser, and Purchaser has no knowledge of any reasonable basis for the assertion of any such claims related to Taxes. There are no Encumbrances with respect to Taxes.
ARTICLE 6
COVENANTS PRIOR TO CLOSING
6.1 Conduct with respect to the Product .
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6.1.1 Between the Execution Date and the Closing Date, except as otherwise set forth on Schedule 6.1 , Seller (i) shall continue to procure and Distribute the Product and conduct the Business in the ordinary course of business consistent with past practice, (ii) shall not take any action except in, the ordinary and usual course of its business and consistent with past practices or as contemplated by this Agreement or the Other Agreements or consented to in writing by Purchaser (which consent shall not be unreasonably withheld or delayed), (iii) use reasonable commercial efforts to maintain and preserve intact its current Business organization, operations and franchise and to preserve the rights, franchises, goodwill and relationships of its employees, customers, suppliers, regulators and others having relationships with the Business and without limiting the foregoing (iv) shall:
(a) preserve and maintain all Registrations and the Business Permits;
(b) maintain the properties and assets included in the Purchased Assets in the same condition as they were on the date of this Agreement, subject to reasonable wear and tear;
(c) defend and protect, in its reasonable business judgment consistent with past practice, the properties and assets included in the Purchased Assets from infringement or usurpation;
(d) perform all of its (maturing) obligations under all Assigned Contracts;
(e) maintain the Product Records in accordance with past practice;
(f) comply in all material respects with all Laws applicable to the conduct of the Business or the ownership and use of the Purchased Assets;
(g) maintain Existing Finished Product Inventory and Bulk Product Inventory in amounts consistent with past practice; and
(h) not take or permit any action that would cause any of the changes, events or conditions described in Section 4.14 to occur.
6.1.2 Between the Execution Date and the Closing Date, except as otherwise set forth on Schedule 6.1 or as contemplated by this Agreement or consented to in writing by Purchaser, Seller shall not sell, lease, license or encumber or otherwise voluntarily dispose of, or agree to sell, lease, license, encumber or otherwise dispose of, any of the Purchased Assets, other than sales of inventory and disposition of non-material, unregistered copyrightable works in the ordinary course of business consistent with past practice.
6.2 Required Approvals and Consents . As soon as reasonably practicable after the Execution Date, the Parties shall make all filings required to be made in order to consummate the Transactions, including all filings under the HSR Act in accordance with Section 6.3 and all filings required by applicable securities Laws. The Parties shall also fully cooperate, both before
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and after the Closing Date and at Purchasers expense with respect to the filing fees and the fees of Sellers auditors incurred in seeking the TSX Approval, with each other with respect to all filings and reporting obligations that Purchaser elects to make or must comply with.
6.3 HSR Act .
6.3.1 Each party hereto shall, as promptly as possible, (i) but in no event later than ten (10) Business Days, make, or cause or be made, all filings and submissions (including those under the HSR Act) required under any Law applicable to such party or any of its Affiliates; and (ii) use reasonable commercial efforts to obtain, or cause to be obtained, all consents, authorizations, orders and approvals from all Governmental Authorities that may be or become necessary for its execution and delivery of this Agreement and the performance of its obligations pursuant to this Agreement and the Other Agreements. Each party shall cooperate fully with the other party and its Affiliates in promptly seeking to obtain all such consents, authorizations, orders and approvals. The parties hereto shall not willfully take any action that will have the effect of delaying, impairing or impeding the receipt of any required consents, authorizations, orders and approvals. Purchaser shall pay any and all filing fees with respect to any HSR Act or similar filings.
6.3.2 Seller and Purchaser shall use reasonable commercial efforts to give all notices to, and obtain all consents from, all third parties that are described in Schedule 4.7 of the Seller Disclosure Schedule.
6.3.3 Without limiting the generality of the parties undertakings pursuant to Sections 6.3.1 and 6.3.2, each of the parties hereto shall use all reasonable commercial efforts to:
(a) respond to any inquiries by any Governmental Authority regarding antitrust or other matters with respect to the transactions contemplated by this Agreement or any Other Agreement;
(b) avoid the imposition of any order or the taking of any action that would restrain, alter or enjoin the transactions contemplated by this Agreement or any Other Agreement; and
(c) in the event any Governmental Order adversely affecting the ability of the parties to consummate the transactions contemplated by this Agreement or any Other Agreement has been issued, to have such Governmental Order vacated or lifted.
6.3.4 All analyses, appearances, meetings, discussions, presentations, memoranda, briefs, filings, arguments, and proposals made by or on behalf of either party before any Governmental Authority or the staff or regulators of any Governmental Authority, in connection with the transactions contemplated hereunder (but, for the avoidance of doubt, not including any interactions between Seller with Governmental Authorities in the ordinary course of business, any disclosure which is not permitted by Law or any disclosure containing confidential information) shall be disclosed to the other party hereunder in advance of any filing, submission or attendance, it being the intent that the parties will consult and cooperate with one another, and consider in good faith the views of one another, in connection with any such analyses, appearances, meetings, discussions, presentations, memoranda, briefs, filings,
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arguments, and proposals. Each party shall give notice to the other party with respect to any meeting, discussion, appearance or contact with any Governmental Authority or the staff or regulators of any Governmental Authority, with such notice being sufficient to provide the other party with the opportunity to attend and participate in such meeting, discussion, appearance or contact.
6.3.5 Notwithstanding the foregoing, nothing in this Section 6.3.5 shall require, or be construed to require, Purchaser or any of its Affiliates to agree to (i) sell, hold, divest, discontinue or limit, before or after the Closing Date, any assets, businesses or interests of Purchaser or any of its Affiliates; (ii) any conditions relating to, or changes or restrictions in, the operations of any such assets, businesses or interests which, in either case, could reasonably be expected to result in a Material Adverse Effect or materially and adversely impact the economic or business benefits to Purchaser of the transactions contemplated by this Agreement and the other Transaction Documents; or (iii) any material modification or waiver of the terms and conditions of this Agreement.
6.4 T ransition Activities . At the Closing, the Parties shall enter into a Transition Services Agreement with only such changes to the form attached as Exhibit D which are reasonably acceptable to the parties, to be effective immediately on the Closing Date, providing for the services specified therein pursuant to which Seller shall perform certain transitional services for Purchaser in accordance with the terms thereof.
6.5 Employees and Employee Benefits .
6.5.1 Commencing on the Closing Date, Purchaser (and/or an Affiliate of Purchaser for all of this Section 6.5) shall offer employment to each person listed on Schedule 6.5 , with the terms of such employment to be substantially equivalent to those terms of each such persons current employment arrangement with Seller (including salary, commissions, bonus and benefits), as previously provided to Purchaser by Seller. Seller shall terminate any employee who wishes to accept employment with Purchaser and waive any relevant non-compete solely with respect to employment with Purchaser.
6.5.2 Seller shall be solely responsible, and Purchaser shall have no obligations whatsoever for, any compensation or other amounts payable to any current or former employee, officer, director, independent contractor or consultant of the Business, including, without limitation, hourly pay, commission, bonus, salary, accrued vacation, fringe, pension or profit sharing benefits or severance pay for any period relating to the service with Seller at any time on or prior to the Closing Date and Seller shall pay all such amounts to all entitled persons on or prior to the Closing Date. Purchaser shall indemnify Seller for any and all Liabilities relating to or arising from the WARN ACT or any similar state statute.
6.5.3 Seller shall remain solely responsible for the satisfaction of all claims for medical, dental, life insurance, health accident or disability benefits brought by or in respect of current or former employees, officers, directors, independent contractors or consultants of the Business or the spouses, dependents or beneficiaries thereof, which claims relate to events occurring on or prior to the Closing Date. Seller also shall remain solely responsible for all workers compensation claims of any current or former employees, officers, directors,
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independent contractors or consultants of the Business which relate to events occurring on or prior to the Closing Date. Seller shall pay, or cause to be paid, all such amounts to the appropriate persons as and when due.
6.5.4 Each employee of the Business who becomes employed by Purchaser in connection with the transaction shall be given service credit for the purpose of eligibility under the group health plan and eligibility and vesting only under the defined contribution retirement plan for his or her period of service with the Seller prior to the Closing Date.
6.6 Notifications . Between the Execution Date and the Closing Date, Seller, on the one hand, and Purchaser, on the other hand, shall promptly notify the other Party in writing of any fact, change, condition, circumstance or occurrence or non-occurrence of any event (such notice, a Change Notice ) of which its becomes aware after the execution hereof that (i) will or is reasonably likely to result in any of the conditions set forth in Article 7 becoming incapable of being satisfied, or (ii) with respect to Seller, causes Section 7.2.1 to be untrue, or with respect to Purchaser, causes Section 7.3.1 to be untrue, in each case, if the Closing Date was that day; provided, however , that the delivery of any notice pursuant to this Section 6.6 shall not limit or otherwise affect the remedies available hereunder to the Party receiving such Change Notice, except that such receiving party must inform the party sending the Change Notice within fifteen (15) days of receipt of such Change Notice that it will terminate this Agreement pursuant to either Section 9.1.2 or Section 9.1.3 (as applicable) on the basis of the facts disclosed in the Change Notice or else such receiving party may not terminate the Agreement on the basis of the facts disclosed in the Change Notice.
6.7 No Negotiation . Between the Execution Date and the earlier of (a) the Closing and (b) the termination of this Agreement, Seller shall not directly or indirectly solicit, initiate, encourage or entertain any inquiries or proposals, discuss or negotiate with, provide any information to, or consider the merits of any inquiries or proposals from any Person (other than Purchaser) relating to any transaction involving, in whole or in part, the Product (other than sales or licenses of the Product in the ordinary course of business) (an Acquisition Proposal ), or that would otherwise compromise Sellers ability to consummate the Transactions. In addition to the other obligations under this Section 6.7, Seller shall promptly (and in any event within three (3) Business Days after receipt thereof by Seller or its Representatives) advise Purchaser orally and in writing of any such Acquisition Proposal, any such request for information, or any inquiry with respect to a proposal, the material terms and conditions of such request, Acquisition Proposal or inquiry, and the identity of the Person making the same.
6.8 Access to Information . From the date hereof until the earlier of (a) the Closing and (b) the termination of this Agreement afford Purchaser and its Representatives full and free access to and the right to inspect all of the properties, assets, premises, Product Records, Contracts and other documents and data related to the Business; (b) furnish Purchaser and its Representatives with such financial, operating and other data and information related to the Business as Purchaser or any of its Representatives may reasonably request; and (c) instruct the Representatives of Seller to cooperate with Purchaser in its investigation of the Business. Any investigation pursuant to this Section 6.8 shall be conducted in such manner as not to interfere unreasonably with the conduct of the Business or any other businesses of Seller and shall occur, unless otherwise agreed by Seller, in its sole and absolute discretion, during normal work hours.
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6.9 Further Assurances; Further Documents .
6.9.1 As of the Execution Date, each of the Parties shall use reasonable commercial efforts, (a) to satisfy or cause to be satisfied all the conditions precedent that are set forth in Article 7, as applicable to each of them, (b) to cause the Transactions to be consummated, and (c) without limiting the generality of the foregoing, to obtain all consents and authorizations of Third Parties and to make all filings with, and give all notices to, Third Parties that may be necessary or reasonably required on its part in order to consummate the Transactions. Without limiting the generality of the foregoing, Seller shall provide IriSys Inc. notice prior to the Closing of assignment of that certain Elixir Supply Agreement to Purchaser pursuant to the Transactions, and such notice shall be in conformance with the terms of that agreement.
6.9.2 Each of Purchaser and Seller shall, and shall cause its respective Affiliates to, at the request of the other Party, execute and deliver to such other Party all such further instruments, assignments, assurances and other documents as such other Party may reasonably request in connection with the carrying out of this Agreement and the Transactions.
6.9.3 Parent shall use its commercially reasonable efforts to ensure that the Consideration Shares are (i) prior to Closing, conditionally approved for listing on the TSX subject only to the Standard Listing Conditions, and (ii) when issued, listed and posted for trading on the TSX upon their issuance. Parent shall in a timely manner file or cause to be filed with the TSX all necessary documents and shall take or cause to be taken all necessary steps as are necessary to satisfy its obligations set forth in the immediately preceding sentence (for greater certainty, Parent shall only be required to file documents required of Seller if and to the extent Seller complies with Section 6.9.4(i)). Parent will make all necessary filings and obtain all necessary regulatory consents and approvals (if any) from the Canadian securities commissions or regulators, and Parent will pay all filing, exemption and other fees required to be paid in Canada in connection with, the issuance and delivery of the Consideration Shares. Notwithstanding anything to the contrary in this Agreement, all costs and expenses incurred by Seller and its Affiliates in connection with the performance of its obligations set forth in Section 6.9.4, other than in respect of Personal Information Forms and other documents regarding Seller that are requested by the TSX, but including, without limitation, costs and expenses related to all auditor, legal (except to the extent that legal counsel for Seller reviews the public disclosure documents of Parent in advance of the public dissemination thereof, in accordance with Sellers right to so review set forth in Section 6.9.4) and other professional fees and expenses, shall be borne solely by Parent, and Parent shall reimburse Seller for any costs and expenses promptly, but in any event within three (3) Business Days of Seller providing Parent with reasonable details of such costs and expenses. For greater certainty and notwithstanding the foregoing, Seller shall be responsible for and shall bear all costs of preparing and auditing the Financial Statements and audited financial statements for Seller in respect of its fiscal year ended December 31, 2013 consistent with its past practices. This Section 6.9.3 shall survive the Closing.
6.9.4 Seller shall use its commercially reasonable efforts (i) to assist Parent in securing the acceptance by the TSX of the Transactions including, without limitation, providing as soon as practicable any financial information relating to the Purchased Assets as may be
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required by the TSX and providing all Personal Information Forms as may be required by the TSX in respect of Seller and its shareholders; provided, however , that Parent will use its commercially reasonable efforts to, in its dealings with the TSX, minimize the information relating to the Purchased Assets, Seller and Sellers Affiliates required by the TSX; provided, further , that Seller shall be provided a reasonable opportunity to review and comment on any draft document containing Seller information to be filed with or disclosed to the TSX in advance of the filing or disclosure thereof and Parent will give good faith consideration to any comments of Seller thereon, and (ii) to provide to Parent, as soon as reasonably practicable after the date of the Closing, all information and documents related to the Purchased Assets (including, but not limited to, the Financial Statements and audited financial statements for Seller in respect of its fiscal year ended December 31, 2013) reasonably required by Parent in order to comply with its obligation to prepare and file within the time required under Canadian Securities Laws a business acquisition report (as contemplated in NI 51-102), and Seller shall use its commercially reasonable efforts to (a) cause its auditors to cooperate with Parents accounting professionals and auditors as is reasonably required and (b) make available to Parent and its auditors all financial information related to the Purchased Assets (including, if required, carve-out financial statements related to the Purchased Assets and the Financial Statements and audited financial statements for Seller in respect of its fiscal year ended December 31, 2013, and any required auditor consents) as may be reasonably required by Parent, in each case, to comply with its obligations under Part 8 of NI 51-102; provided, however , that Seller shall be provided a reasonable opportunity to review and comment on any draft disclosure document containing Seller information to be publicly filed in connection with Parents obligations under Part 8 of NI 51-102 in advance of the filing or public disclosure thereof and Parent will give good faith consideration to any comments of Seller thereon. This Section 6.9.4 shall survive the Closing.
6.9.5 Seller will not, during the period ending on the date that is four (4) months plus one (1) day after the date of issuance of the Consideration Shares by Parent to Seller, sell or otherwise effect a trade of any of any Consideration Shares to any person resident in any Province or Territory of Canada or any person acquiring such Consideration Shares for the benefit of another person resident in any Province or Territory Canada, other than in a transaction which will be exempt from the prospectus requirements of applicable Canadian Securities Laws.
ARTICLE 7
CONDITIONS TO CLOSING
7.1 Conditions Precedent to Obligations of Purchaser and Seller . The respective obligations of Purchaser and Seller to consummate the Transactions on the Closing Date are subject to the satisfaction or waiver (in accordance with Section 11.7) at or prior to the Closing Date of the following conditions:
7.1.1 Litigation . No preliminary or permanent injunction or other order has been issued by any court or by any applicable Governmental Authority, body or authority which enjoins, restrains, prohibits or makes illegal pursuant to applicable Law the Transactions on the Closing Date.
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7.1.2 HSR Act . Any waiting period (and any extension thereof) under the HSR Act applicable to the Transactions has expired or been terminated.
7.1.3 TSX . The TSX shall have issued a letter addressed to Parent (the TSX Approval ) stating that the listing and posting for trading on the TSX of the Consideration Shares has been approved subject only to the satisfaction by Parent of such customary and standard post-Closing conditions imposed by the TSX in similar circumstances and set forth in such letter (the Standard Listing Conditions ).
7.2 Conditions Precedent to Purchasers Obligations . Purchasers obligations to consummate the Transactions shall be subject to the fulfillment of each of the following additional conditions, any one or more of which may be waived, at Purchasers sole discretion, in writing by Purchaser:
7.2.1 Representations and Warranties . Each of the representations and warranties of Seller contained in Article 4 and the Other Agreements shall be true and correct in all respects (in the case of any representation or warranty qualified by materiality or Material Adverse Effect) or in all material respects (in the case of any representation or warranty not qualified by materiality or Material Adverse Effect) on and as of the date hereof and on and as of the Closing Date with the same effect as though made at and as of such date (except those representations and warranties that address matters only as of a specified date, the accuracy of which shall be determined as of that specified date in all respects).
7.2.2 Performance . Seller shall have performed and complied in all material respects with each of the covenants, agreements and obligations Seller is required to perform under this Agreement on or before the Closing.
7.2.3 Officers Certificate . Purchaser shall have received a certificate executed by a duly elected, qualified and acting officer of Seller certifying to the satisfaction of the conditions set forth in Sections 7.2.1 and 7.2.2.
7.2.4 Other Agreements . Seller shall have duly executed and delivered to Purchaser the Other Agreements.
7.2.5 FIRPTA Certificate . Purchaser shall have received a certificate, in form and substance reasonably satisfactory to Purchaser, certifying that the transactions contemplated by this Agreement are exempt from withholding under Section 1445 of the Code.
7.2.6 Consents . All authorizations and consents that are listed on Schedule 7.2.6 of the Seller Disclosure Schedules shall have been received, and executed counterparts thereof shall have been delivered to Purchaser at or prior to the Closing.
7.3 Conditions Precedent to Sellers Obligations . Sellers obligation to consummate the Transactions shall be subject to the fulfillment of each of the following additional conditions, any one or more of which may be waived, at Sellers sole discretion, in writing by Seller:
7.3.1 Representations and Warranties . Each of the representations and warranties of Purchaser contained in Article 5 and the Other Agreements shall be true and
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correct in all respects (in the case of any representation or warranty qualified by materiality or Material Adverse Effect) or in all material respects (in the case of any representation or warranty not qualified by materiality or Material Adverse Effect) on and as of the date hereof and on and as of the Closing Date with the same effect as though made at and as of such date (except those representations and warranties that address matters only as of a specified date, the accuracy of which shall be determined as of that specified date in all respects).
7.3.2 Performance . Purchaser shall have performed and complied in all material respects with each of the covenants, agreements and obligations Purchaser is required to perform under this Agreement on or before the Closing.
7.3.3 Officers Certificate . Seller shall have received a certificate executed by a duly elected, qualified and acting officer of Purchaser certifying to the satisfaction of the conditions set forth in Sections 7.3.1 and 7.3.2.
7.3.4 Other Agreements . Purchaser or Parent, as applicable, shall have duly executed and delivered the Other Agreements to Seller.
7.3.5 Delivery of Purchase Price . Purchaser shall have delivered the Purchase Price to Seller.
ARTICLE 8
ADDITIONAL COVENANTS
8.1 Confidentiality; Publicity .
8.1.1 Except with respect to information about Seller that has been filed and made publicly available in connection with the TSX Approval or with the Canadian securities regulatory authorities, for which Seller waives any restrictions, limitations or prohibitions under the Confidentiality Agreement, the terms of the Confidentiality Agreement are hereby incorporated in this Agreement as though fully set forth herein and shall apply to any information provided to Seller or Purchaser pursuant to this Agreement. As used in this Section 8.1, the term Confidential Information shall have the meaning assigned to such term in the Confidentiality Agreement. Upon the Closing Date, the Confidentiality Agreement shall expire and be of no further force and effect with respect to all Confidential Information relating to the Product, the Purchased Assets or the Assumed Liabilities; provided , however , such expiration of the Confidentiality Agreement shall in no way prejudice or adversely affect Sellers or Purchasers ability to seek damages, or any other remedy available to Seller or Purchaser, as appropriate, with respect to a violation by such Party (or its Affiliates or Representatives) of the Confidentiality Agreement prior to or after the Closing Date. Upon and after the Closing Date, the Confidentiality Agreement shall remain in full force and effect pursuant to its terms with respect to all other Confidential Information that does not relate to the Product, the Purchased Assets or the Assumed Liabilities.
8.1.2 From and after the Closing Date, all Confidential Information exclusively concerning the Product, the Purchased Assets and the Assumed Liabilities (the Purchaser Proprietary Information ) shall be used by Seller and its Affiliates solely as required to perform its obligations, exercise or enforce its rights under this Agreement (or any Other Agreement), or
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comply with applicable Law (including applicable securities Laws), and for no other purpose. Seller shall not disclose, or permit the disclosure of any of the Purchaser Proprietary Information to any Person except those Persons to whom such disclosure is necessary to permit Seller to perform its obligations, exercise or enforce its rights under this Agreement (or any Other Agreement), or comply with applicable Law (including applicable securities Laws). Seller shall treat, and will cause its Affiliates and the directors, officers, employees, agents, representatives and advisors of Seller or any of their Affiliates to treat, the Purchaser Proprietary Information as confidential, using the same degree of care as Seller normally employs to safeguard its own confidential information from unauthorized use or disclosure, but in no event less than a reasonable degree of care.
8.1.3 All Confidential Information obtained by Purchaser (or its Affiliates or representatives) from Seller (or its Affiliates or representatives) other than the Purchaser Proprietary Information (the Seller Proprietary Information ) shall be used by Purchaser solely as required to perform its obligations, exercise or enforce its rights under this Agreement (or any Other Agreement), or comply with applicable Law (including applicable securities Laws), and for no other purpose. Purchaser shall not disclose, or permit the disclosure of any of the Seller Proprietary Information to any Person except those Persons to whom such disclosure is necessary to permit Purchaser to perform its obligations, exercise or enforce its rights under this Agreement (or any Other Agreement), or comply with applicable Law (including applicable securities Laws). Purchaser shall treat, and will cause its Affiliates and the directors, officers, employees, agents, representatives and advisors of Purchaser or any of their Affiliates to treat, the Seller Proprietary Information as confidential, using the same degree of care as Purchaser normally employs to safeguard its own confidential information from unauthorized use or disclosure, but in no event less than a reasonable degree of care.
8.1.4 Purchaser acknowledges and agrees that Seller (and its Affiliates) may together retain one (1) or more copies of all or part of the documentation (including written or electronic records, files, manuals, filings, etc.), including any Purchaser Proprietary Information contained therein, that it delivers to Purchaser as part of the Purchased Assets, in accordance with the provisions of and solely for the purposes set forth in this Section 8.1.
8.1.5 In the event either Party is requested pursuant to, or required by, applicable Law to disclose any of the other Partys Confidential Information (including Seller Proprietary Information or Purchaser Proprietary Information, as applicable), it will notify the other Party in a timely manner so that such Party may seek a protective order or other appropriate remedy or, in such Partys sole discretion, waive compliance with the confidentiality provisions of this Agreement. Each Party will cooperate in all reasonable respects, in connection with any reasonable actions to be taken for the foregoing purpose. In any event, the Party requested or required to disclose such Confidential Information may furnish it as requested or required pursuant to applicable Law (subject to any such protective order or other appropriate remedy) without liability hereunder, provided that such Party furnishes only that portion of the Confidential Information which such Party is advised by a reasoned opinion of its counsel is legally required, and such Party exercises reasonable efforts to obtain reliable assurances that confidential treatment will be accorded such Confidential Information.
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8.1.6 The Parties shall jointly agree upon the necessity and content of any press release in connection with the Transactions. Any other publication, news release or other public announcement by a Party relating to this Agreement or to the performance hereunder shall first be reviewed and consented to in writing by the other Party; provided , however , that notwithstanding any contrary term contained in the Confidentiality Agreement, (a) any disclosure that is required by Law (including applicable securities Laws) or stock exchange requirement as advised by the disclosing Partys counsel may be made without the prior written consent of the other Party, (b) any Party may issue a press release or public announcement if the contents of such press release or public announcement have previously been made public other than through a breach of this Agreement by the issuing Party, without the prior written consent of the other Party, and (c) after the Closing, Purchaser may make public disclosures in any scientific publication, marketing material, press release and/or other public announcement in the ordinary course of its business if the contents of such publication relate primarily to the Product itself and not the terms of this Agreement. Other than the disclosures contemplated in clauses (a) through (c) of the previous sentence, to the extent practicable, the disclosing Party shall give at least two (2) Business Days advance notice of any such legally required disclosure to the other Party, and such other Party may provide any comments on the proposed disclosure during such period and if not practicable, such lesser practicable period, if any. Notwithstanding any contrary term contained in the Confidentiality Agreement, to the extent that either Party determines that it or the other Party is required to file or register this Agreement, a summary thereof or a notification thereof to comply with the requirements of an applicable stock exchange, TSX, New York Stock Exchange, or NASDAQ regulation or applicable securities Laws or any applicable Governmental Authority, including without limitation the SEC and/or any Canadian securities regulatory authority or commission, such Party shall use commercially reasonable efforts to give at least two (2) Business Days advance written notice of any such required disclosure to the other Party. Prior to making any such filing, registration or notification, the Parties shall consult with respect thereto regarding confidentiality. The Parties shall cooperate, each at its own expense, in such filing, registration or notification, including without limitation such confidential treatment request, and shall execute all documents reasonably required in connection therewith.
8.2 Seller Brands .
8.2.1 As of the Closing Date, Seller (or Seller on behalf of its Affiliate) hereby grants to Purchaser, and Purchaser hereby accepts, a non-exclusive, non-transferable, royalty-free, limited license in the Territory to display the Seller Brands on Product, solely to the extent necessary to allow the Purchaser to Distribute the Existing Finished Product Inventory (the Seller Brand License ). Purchaser acknowledges that the Seller Brand License is being granted solely for transitional purposes and that Purchaser shall use commercially reasonable efforts to as quickly as is reasonably possible cease its use of the Seller Brands after the Closing Date, all of which such use shall, under any circumstances, cease by the first anniversary of the Closing Date, upon which date the license grated herein shall terminate.
8.2.2 Purchaser shall not (i) add any other labels or marks to, or otherwise alter, the Seller Brands; (ii) change in any way the style of the Seller Brands; (iii) apply for any Intellectual Property Registrations for the Seller Brands or any Trademark similar thereto; or (iv)
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otherwise use the Seller Brands in any manner other than as specifically provided in this Section 8.2.
8.2.3 Purchaser (i) acknowledges Sellers (or its Affiliates) ownership of the Seller Brands; (ii) shall do nothing inconsistent with such ownership; (iii) agrees that all use of the Seller Brands by Purchaser shall inure to the benefit and be on behalf of the Seller (or its Affiliate); and (iv) shall not challenge Sellers (or its Affiliates) title to or right to use, in any manner, the Seller Brands. Nothing in this Agreement shall give Purchaser any right, title or interest in the Seller Brands other than the right to use the Seller Brands strictly in accordance with this Section 8.2. All use of the Seller Brands by Purchaser under this Section 8.2 shall conform to the standards followed by the Seller (or its Affiliate) prior to the Closing Date, and upon reasonable notice to Purchaser, Seller (or its Affiliates) shall have the right to review any materials created or used by or on behalf of Purchaser bearing or referring to the Seller Brands, or the standards used by Purchaser with respect to the Seller Brands, to ensure Purchasers compliance with this requirement.
8.2.4 Purchaser shall not have the right to, and shall not, assign or transfer to any Third Party (including for a pledge or grant of a security interest pursuant to a financing transaction), any rights licensed by the Seller (or its Affiliate) to Purchaser under this Section 8.2 without the Sellers prior written consent.
8.2.5 Nothing in this Section 8.2, or any other provision of this Agreement or any provision of the Other Agreements, shall grant the Purchaser any rights in any of Sellers internet domain names, registrations or applications for registration, or renewals thereof, registered in the United States or any other country or jurisdiction throughout the world, except as such Internet domain names, registrations or applications for registration, or renewals thereof are included as part of the Purchased Assets.
8.2.6 Other than as expressly provided in this Section 8.2 or elsewhere in this Agreement or the Other Agreements, Purchaser shall not use or apply to register, or permit any of its Affiliates or distributors to use or apply to register, any of the Seller Brands or any other corporate signs, Trademarks, names or other Intellectual Property now or hereafter owned, used or held for use by Seller or any of its Affiliates, other than the Product Intellectual Property on the terms provided herein and in the Other Agreements.
8.2.7 The Parties understand and agree that, in addition to all other legal remedies, the Seller (and its Affiliates) shall be entitled to seek immediate injunctive relief in order to enforce the terms of this Section 8.2.
8.3 Product Responsibility .
8.3.1 Except as otherwise set forth in this Agreement, from and after the Closing, Purchaser shall be solely responsible for (i) all regulatory matters with respect to the Product and the Purchased Assets, including without limitation relating to communicating and corresponding, preparing and filing reports, making adverse drug experience reports, and paying applicable fees, with and to applicable Governmental Authorities, under all applicable legal requirements including the Act, the PDMA, and the Prescription Drug User Fee Act of 1992; (ii)
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taking all actions and conducting all communication with Third Parties in respect of Product (whether sold before or after the Closing), including responding to all complaints in respect thereof and all medical information requests, including complaints related to tampering or contamination; and (iii) investigating all complaints and adverse drug experiences in respect of the Product (whether sold before or after the Closing). Seller shall fully indemnify and reimburse Purchaser for all Losses, costs and expenses, including attorney and consultant fees, incurred in connection with any and all such matters arising from Product that was released into the market prior to the Closing.
8.3.2 From and after the Closing, Purchaser shall be solely responsible for conducting, handling or processing all recalls of units of Product, including recalls required by any Governmental Authority or voluntary recalls by Purchaser based on safety, efficacy or similar concerns, with respect to the Product, regardless of whether the Product was sold before or after the Closing. Purchaser shall destroy, or cause to be destroyed, in either case, all recalled Product in a manner consistent with applicable legal requirements. From and after the Closing, Purchaser shall be financially responsible for all recalls of units of Product released into the market after the Closing. For any recalled Product that was released into the market prior to the Closing, Seller shall fully indemnify and reimburse Purchaser for all Losses, costs and expenses, including attorney and consultant fees, incurred in connection with any and all such recalls that are required by any Governmental Authority or are reasonably voluntarily initiated by Purchaser based on safety, efficacy or similar concerns.
8.3.3 As soon as practicable, but in no event later than the expiration of the Seller Brand License, Purchaser will establish new NDC numbers for the Product and thereafter shall cause such NDC numbers to be used on the labeling, packaging and any other materials for the Product. Nothing set forth in this Section 8.3.3 shall prevent or restrict Purchaser from selling Inventory labeled with Seller Brand consistent with, and prior to expiration of, the Seller Brand License. Notwithstanding the foregoing, any Product Manufactured by or on behalf of Purchaser shall not be Manufactured using any existing Seller NDC numbers.
8.4 Product Returns, Rebates and Chargebacks .
8.4.1 NDC Numbers . Following the Closing Date in accordance with Section 8.3.3, Purchaser shall obtain its own NDC numbers for Products and shall use commercially reasonable efforts to have in place as soon as reasonably practicable all artwork and resources such that sales of Product after the Closing Date can be accomplished under the NDC numbers of Purchaser. Purchaser shall use its new NDC numbers on all invoices, orders and other communications with customers and Governmental Authorities as soon as the Existing Finished Product Inventory labeled with Sellers NDC number have been exhausted by Purchaser.
8.4.2 Product Returns .
(a) Subject to Sellers and Purchasers, as applicable, financial responsibility for returns of Product as provided in Section 8.3, Purchaser will be responsible for processing returns of all Product packaged for commercial sale ( Finished Product ) labeled with Sellers NDC number after the Closing Date and shall cause its processor to process trade returns in accordance with Purchasers normal returns procedures. The joint notice set forth on
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Schedule 8.4.2 will notify all customers of the foregoing change in trade return procedures as soon as practicable following the Closing, but in any event no later than one (1) Business Day after the Closing.
(b) For any Finished Product that is returned to one Party but is the processing responsibility of the other Party pursuant to Section 8.4.2(a), the Party receiving such returned Finished Product will destroy, or cause to be destroyed, all such Finished Product. Each of Purchaser and Seller shall destroy, or cause to be destroyed, all such returned Finished Product in a manner consistent with all applicable Law and the costs related to such destruction shall be reimbursed by the Party responsible for processing such returns.
(c) Neither Purchaser nor Seller shall instruct, recommend or attempt to induce customers who have previously purchased any Finished Product from it to: (i) return such Finished Product when that would not otherwise have been the case but for such Partys instructions, recommendations or inducement; or (ii) delay the return of such Finished Product. For the avoidance of doubt, Purchasers shipment of units of Finished Product to customers in the ordinary course will not be deemed to violate this Section 8.4.2(c).
8.5 Government Price Reporting .
8.5.1 Seller shall be responsible for submitting all Governmental Price Reports for all Product(s) bearing an NDC of Seller for all reporting periods ending on or before the Closing Date as required. Unless otherwise agreed, beginning with the reporting period in which the Closing Date occurs, Purchaser shall be responsible for submitting all Governmental Price Reports, with the exception of ASP, for Product(s) bearing an NDC of Seller. Effective with the reporting period in which the Closing Date occurs, Seller shall name Purchaser as a designee, with certification access, in the Drug Data Reporting for Medicaid system for purposes of reporting the Average Manufacturer Price ( AMP ) (as defined at 42 U.S.C. § 1396r-8(k)(1)) and the Best Price (as defined at 42 U.S.C. § 1396r-8(c)(1)(C)) and other required pricing data for the Product(s) bearing an NDC of Seller. If other Product(s) are reported to the CMS by Seller under the labeler of any Product(s), Seller shall remain as the Technical, Invoice and Legal contacts for such Product(s) with CMS. Beginning with the reporting period in which the Closing Date occurs, for ASP, Purchaser shall be responsible for calculating the ASP bearing an NDC of Seller and sending the mandated ASP data, including a signed, original certification document to a designated contact of Seller within five (5) days of the submission due date to CMS.
8.5.2 Seller acknowledges that Purchaser will require certain information from Seller in order to submit the Governmental Price Reports after the Closing Date. Accordingly, Seller agrees that, (a) upon Purchasers request, Seller or Sellers vendor shall provide to Purchaser, within ten (10) days after the end of such calendar month, relevant Product(s) information, including baseline AMPs, and general transactional data up to a year after the Closing Date which Purchaser deems necessary for each NDC of the Product(s) for use in calculating AMP; (a) if the Closing Date is not on the first day of the quarter for the Calendar Quarter in which the Closing Date occurs, Seller shall provide to Purchaser, within twenty-five (25) days after the end of such Calendar Quarter, the Best Price, customary prompt pay discounts, and sales at nominal price, and any additional data needed to comply with state price
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reporting requirements. Regarding state reporting, Purchaser and Seller agree to follow a mutually agreeable process to ensure state price reporting requirements remain in effect for each NDC under the Sellers labeler. Seller further agrees that, for each NDC-11 of any Product(s), it shall provide to Purchaser, within ten (10) days after the Closing Date, the following: (i) if the Closing Date occurs in Calendar Quarters 1, 2, or 3, Seller shall provide the Federal Ceiling Prices in effect during the Calendar Year in which the Closing Date occurs; (ii) if the Closing Date occurs in Calendar Quarter 4, Seller shall provide both the Federal Ceiling Price in effect during the Calendar Year in which the Closing Date occurs and the calculated Federal Ceiling Price for the next Calendar Year. Per the Department of Veteran Affairs Product(s) transfer rules, depending on the Calendar Quarter in which the Closing Date occurs, the Purchaser is required to sell at Sellers calculated Federal Ceiling Prices in effect during the Calendar Year in which the Closing Date occurs or if the Closing Date occurs in Calendar Quarter 4, Purchaser is required to sell at Sellers calculated Federal Ceiling Prices for the next Calendar Year; (iii) commercial sales data required for Non-FAMP calculation for the current Calendar Quarter through the Closing Date, as well as such data for preceding Calendar Quarters within the Federal Fiscal Year (October 1 - September 30) in which the Closing Date occurs; (iv) relevant Non-Federal Average Manufacturer Prices necessary to complete Annual Public Law Update; (v) all commercial sales data for the current Calendar Quarter through the Closing Date, as well as all such data for the preceding Calendar Quarters within the Federal Fiscal Year (October 1 - September 30) in which the Closing Date occurs; and (vi) the most recent Tricare retail pharmacy dispensing data report for the previous four quarters made available by the Department of Defense either on or before the Closing Date. All pricing data furnished by Seller pursuant to this subsection shall be provided in the same format that such data are provided by Seller to CMS and/or the VA in connection with Sellers own Governmental Price Reports, or in a format otherwise prescribed by Purchaser. For pricing and sales data that are required in order to submit Governmental Price Reports, but that are not themselves provided to the CMS and/or the Department of Veterans Affairs, Seller will furnish that data in a format prescribed by Purchaser.
8.5.3 Without limiting the foregoing, any and all data furnished by Seller that are required for the reporting of the Product(s) under the Medicaid drug rebate program (and under Medicare Part B) pursuant to this subsection shall be certified in the same format provided by Seller to CMS. Without limiting the foregoing, Seller agrees that, from and after the Closing Date until the date which is one (1) Calendar Year after the expiration date of the last lot sold bearing an NDC of Seller, Seller shall provide to Purchaser, within ten (10) days after the end of each reporting period, all data or other information to the Governmental Price Reports for such Product(s) reasonably requested by Purchaser for use by Purchaser in completing such Governmental Price Reports.
8.5.4 Seller shall report accurately to Purchaser all data or other information provided from third parties to Seller pursuant to Section 8.5.1, 8.5.2, or 8.5.3 above. Seller shall promptly notify Purchaser upon discovery of any errors on or corrections to the data or other information provided to Purchaser pursuant to Section 8.5.1, 8.5.2, or 8.5.3 above.
8.5.5 Purchaser shall notify Seller of any change in the wholesale acquisition cost of any Product(s) no later than the same time that Purchaser notifies third party vendors of the change in such wholesale acquisition cost.
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8.5.6 Purchaser shall notify Seller of the date(s) of last lot expiration of each Product(s) when the NDC(s) there for are discontinued.
8.6 Seller Governmental Payments and Other Contractual Obligations .
8.6.1 Seller shall be solely and exclusively responsible for processing and payment of any and all Tricare retail rebates owed based on Tricare retail pharmacy dispensing of all Product(s) bearing an NDC of Seller for which utilization data is available or has been made available electronically or in writing on or prior to the Closing Date and until such Product(s) have been deleted from Sellers Pricing Agreement with Tricare Management Activity and added to Purchasers Pricing Agreement with Tricare Management Activity (even if the due date for rebate payment falls after the Closing Date).
8.6.2 Seller shall be solely and exclusively responsible for processing and payment of any and all rebates, chargeback claims and related fees payable under a PHS pharmaceutical pricing agreement for Product(s) sold by it, and in any event for thirty (30) days after the Closing Date and providing the initial PHS prices within five (5) days of the Closing Date for the Product(s) and the subsequent quarters PHS prices within thirty (30) days of the start of the quarter to Purchaser. In the event Purchaser does not have an existing PHS agreement, Seller shall continue to pay rebates/chargebacks for Product(s) bearing an NDC of Seller. Seller shall invoice Purchaser for all rebates, chargeback claims and related fees on distributor invoices for Product(s) sold by Purchaser, and Purchaser shall pay Seller the amount of such invoice with thirty (30) days of receipt of such invoice.
8.6.3 Seller shall notify Purchaser within ten (10) days of notice of any inspection, investigation or other inquiry by, or other material governmental notice or communication from CMS, the Department of Health and Human Services Office of the Inspector General, or any other governmental agency relating to the Manufacture, sale, marketing, promotion, distribution, or use of the Product(s) or relating to any Governmental Price Reports submitted by Seller. This obligation extends to any subsequent revisions to such claims even if made after the Closing Date.
8.6.4 Seller shall be solely and exclusively responsible for processing and payment of any and all Medicaid rebates payable for all Product(s) bearing an NDC of Seller for periods prior to and including the Calendar Quarter in which the Closing Date takes place. Seller shall invoice Purchaser beginning with the Calendar Quarter immediately following the Calendar Quarter during which the Closing Date takes place for payments made on behalf of Purchaser, and Purchaser shall pay the invoiced amounts within thirty (30) days of the receipt of such invoice.
8.7 Purchaser Governmental Payments and Other Contractual Obligations .
8.7.1 Purchaser shall be solely and exclusively responsible for (a) Tricare retail rebates relating to the Product(s) bearing an NDC of Seller which are sold by Purchaser and for which utilization data are first made available by the Department of Defense after the Closing Date; and (b) payment of Product(s) bearing an NDC of Purchaser.
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8.7.2 Purchaser shall be solely and exclusively responsible for PHS rebates, chargeback claims and related fees on distributor invoices dated thirty-one (31) days or more after the Closing Date for Products bearing an NDC of Seller and sold by Purchaser and any Product bearing an NDC of Purchaser.
8.7.3 Purchaser shall be solely and exclusively responsible for (a) Federal Supply Schedule rebates, chargeback claims and related fees (i.e. Industrial Funding Fee) for distributor invoices dated thirty-one (31) days or more after the Closing Date for Products bearing an NDC of Seller and sold by Purchaser; (b) and any Product(s) bearing an NDC of Purchaser.
8.7.4 Purchaser shall be solely and exclusively responsible for (a) reimbursement to Seller for any and all payments required under the Medicare Coverage Gap Discount Agreement for all Seller NDCs that are sold by Purchaser after the Closing Date under the Medicare Coverage Gap Discount Program established by the Secretary under Sections 1860D-14A and 1860D-43 of the Social Security Act; and (b) all payments required under the Medicare Coverage Gap Discount Agreement for Purchaser NDCs.
8.7.5 Purchaser shall be solely and exclusively responsible for (a) reimbursement to Seller of any and all Medicaid rebates paid for claim quarters beginning with the Calendar Quarter immediately following the Calendar Quarter during which the Closing Date takes place for all Products bearing an NDC of Seller; (b) payment of any and all Medicaid rebates payable for all Products bearing an NDC of Purchaser; and (c) Purchaser notifying Seller of any state supplemental contracts for the Products bearing Seller NDC in effect after the Closing Date.
8.8 Regulatory Matters .
8.8.1 Subject to any obligations of Seller under the Transition Services Agreement, from and after the Closing Date, Purchaser, shall be solely responsible for (a) taking all actions, paying all fees and conducting all communication with the applicable Governmental Authority required by Law in respect of the Registrations, including preparing and filing all reports (including adverse drug experience reports) with the applicable Governmental Authority (whether the Product is sold before or after transfer of the Registrations), (b) taking all actions and conducting all communication with Third Parties with respect to Product sold pursuant to the Registrations (whether sold before or after transfer of the Registrations), including responding to all complaints in respect thereof, including complaints related to tampering or contamination, (c) investigating all complaints and adverse drug experiences with respect to Product sold pursuant to the Registrations (whether sold before or after transfer of the Registrations), and (d) carrying out any Phase IV post approval commitment (such as patient surveys).
8.8.2 From and after the Closing Date, Seller shall promptly notify the Purchaser of complaints or reports received of an adverse drug experience with respect to the Product.
8.8.3 Purchaser, at its cost, shall be solely responsible and liable for conducting all voluntary and involuntary recalls of units of the Existing Finished Product Inventory,
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including recalls required by any applicable Governmental Authority and recalls of units of the Existing Finished Product Inventory deemed necessary by Seller in its reasonable discretion; provided , however , that Seller shall fully indemnify and reimburse Purchaser for the Losses, expenses and costs of conducting recalls relating to the Existing Finished Product Inventory, including the costs of notifying customers, the costs associated with shipment of such recalled Existing Finished Product Inventory, and the price paid for such Existing Finished Product Inventory. Seller promptly shall notify Purchaser in the event that a recall of the Existing Finished Product Inventory is necessary, and at Purchasers reasonable request, Seller shall cooperate, at its own expense, in connection with any such recall.
8.8.4 To the extent not otherwise previously completed pursuant to Section 3.2.1(b), Seller shall, within fifteen (15) days of the Closing Date, notify the FDA of the transfer of the Registrations to Purchaser in accordance with all applicable Laws.
8.8.5 To the extent not otherwise previously completed pursuant to Section 3.2.2(c), Purchaser shall, within fifteen (15) days of the Closing Date, notify the FDA of its assumption of the Registrations from Seller in accordance with applicable Laws.
8.8.6 Seller shall be responsible for reporting to CMS any direct or indirect payments or other transfers of value that Seller makes to relating to the Product (whether made on, before, or after the Closing Date), and ownership and investments interests in Seller, as may be required under 42 C.F.R. Part 403 or any similar state payment reporting Law. Purchaser shall be responsible for reporting to CMS any direct or indirect payments or other transfers of value that Purchaser makes relating to the Product (whether made on, before, or after the Closing Date), and ownership and investments interests in Purchaser, as required under 42 C.F.R. Part 403 or any similar state reporting Law.
8.9 Tax Matters .
8.9.1 The Parties waive compliance with any bulk sales law or similar law in connection with the consummation of the transactions contemplated herein
8.9.2 Purchaser and Seller each recognize their mutual obligations pursuant to Section 1060 of the Code to timely file an initial and appropriate supplemental IRS Form 8594 with each of their respective U.S. federal income Tax Returns (the Asset Acquisition Statement ). Accordingly, Purchaser and Seller agree to cooperate in good faith in the preparation of the Asset Acquisition Statement for timely filing in each of their respective U.S. federal income Tax Returns in accordance with a written statement (the Statement of Allocation ), setting forth an allocation of the Purchase Price (which for such purpose shall be increased by the amount of the Assumed Liabilities and any other amounts as allowed under the Code and/or Treasury Regulations and subsequently adjusted for any adjustments to the Purchase Price) between and among each item of the Purchased Assets, covenants and license rights (as applicable for each Statement of Allocation) in accordance with the provisions of Section 1060 of the Code and the Treasury Regulations thereunder. Within ninety (90) days after the Closing Date, Seller shall prepare and deliver to Purchaser a proposed Statement of Allocation. If Purchaser approves the Statement of Allocation, then, unless otherwise prohibited by Law, all federal, state and local income Tax Returns of Purchaser and Seller shall be filed consistently
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with the agreed upon allocations made pursuant to the Statement of Allocation and as set forth in the Asset Acquisition Statement. If Purchaser does not approve the Statement of Allocation, Purchaser and Seller shall make good faith efforts to agree on the allocation of the consideration between and among each item of the Purchased Assets, covenants and license rights. If Purchaser and Seller, after good faith negotiations, cannot agree on the allocation of the consideration within one hundred and fifty (150) days following the Closing Date, then the allocation shall be resolved by the Accountants and the Parties shall file IRS Form 8594 and all Tax Returns in a manner consistent with such allocation.
8.9.3 Seller and Purchaser shall provide reasonable cooperation and information to each other in connection with (a) the preparation or filing of any Tax Return (including Transfer Tax returns), amended Tax Return, Tax election, Tax consent or certification, or any claim for a Tax refund, (b) any determination of liability for Taxes, and (c) any audit, examination or other proceeding in respect of Taxes related to the Product. Any information obtained under this Section 8.9 shall be kept confidential pursuant to Section 8.1, except as may be otherwise necessary in connection with the filing of Tax Returns, claims for a Tax refund or in conducting any audit, examination or other proceeding in respect of Taxes.
8.9.4 All Transfer Taxes (including any Tax arising solely as a result of any of the Purchased Assets being transferred from a non-U.S. jurisdiction to Purchaser pursuant to this Agreement or the Other Agreements) shall be borne one-half by the Purchaser and one-half by the Seller. The cost of recording documents and filing Transfer Tax returns in connection with the transactions contemplated in this Agreement shall be borne equally by the Purchaser and Seller.
8.9.5 All real property Taxes, personal property Taxes and similar ad valorem obligations levied with respect to the Purchased Assets for a taxable period that is a Straddle Period, whether or not imposed or assessed before or after the Closing Date, shall be apportioned between Seller and Purchaser based on the number of days of such taxable period included in the Pre-Closing Tax Period and the number of days of such taxable period included in the Post-Closing Tax Period. Seller shall be liable for the proportionate amount of such Taxes that is attributable to the Pre-Closing Tax Period, and Purchaser shall be liable for the proportionate amount of such Taxes that is attributable to the Post-Closing Tax Period. Upon receipt of any bill for such Taxes, Purchaser or Seller, as applicable, shall present a statement to the other Party setting forth the amount of reimbursement to which it shall be entitled under this Section 8.9.5 upon payment of such bill, together with such supporting evidence as is reasonably necessary to calculate the amount of reimbursement. Payment of such reimbursement amount shall be made by the Party owing it to the Party to which it is owed within ten (10) days after delivery of such statement. In the event that either Seller or Purchaser shall make any payment for which it is entitled to reimbursement under this Section 8.9.5, the other Party shall make such reimbursement promptly but in no event later than ten (10) days after the presentation of a statement setting forth the amount of reimbursement to which the presenting Party is entitled along with such supporting evidence as is reasonably necessary to calculate the amount of reimbursement.
8.9.6 Any dispute, controversy, or claim between Seller, on the one hand, and Purchaser, on the other hand, arising out of or relating to the provisions of this Agreement that
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relates to Taxes that cannot be resolved by negotiations between Seller and Purchaser shall be submitted to Accountants for resolution. Accountants shall control the proceedings related to the dispute resolution and may request such evidence and information as it deems necessary. The resolution reached by Accountants shall be binding on the Seller and Purchaser and their respective affiliates. The expenses of Accountants shall be borne equally by Seller, on the one hand, and Purchaser, on the other hand.
8.10 Parent Board Matters .
8.10.1 Promptly after Closing, Seller shall elect to the board of directors of Parent (the Parent Board ) one (1) nominee selected by Seller (the Seller Nominee ). For so long as Seller holds at least an aggregate of 10% or more of the then issued and outstanding shares of Parent Common Stock, Parent shall (i) recommend (in advance of each meeting of shareholders of Parent) to Parents shareholders entitled to vote on the election of directors that such shareholders vote in favor of or consent to the election of (or against the removal of, as the case may be) the Seller Nominee as a director of Parent, and (ii) cause all properly completed proxies received by Parent in respect of the election or removal of directors at the relevant time to be voted in the manner specified in such proxies, in each case subject to the following terms and conditions:
(a) the Seller Nominee shall be an individual acceptable to the Parent Board, acting reasonably and in good faith and must satisfy all applicable legal and regulatory requirements for directors of Parent, including requirements of the TSX and applicable corporate and Canadian Securities Laws (collectively, the Director Eligibility Requirements ); and
(b) if, at any time (i) the Seller Nominee is unwilling or unable to continue to serve as a nominee of Seller or director of Parent, including as a result of failing to meet the Director Eligibility Requirements or (ii) Seller determines to remove and replace the Seller Nominee, Seller will be entitled in its sole discretion to nominate an alternate director by notice to Parent. In any of the cases described above in this Section 8.10, Seller shall use its commercially reasonably efforts to cause the Seller Nominee to resign from the Parent Board as promptly as practicable, and, following such resignation, provided that such alternate nominee meets the Director Eligibility Requirements, the Parent Board shall, subject to applicable laws regarding the appointment of directors between shareholder meetings, cause such alternate nominee to be appointed to the Parent Board as promptly as practicable.
8.10.2 Seller shall use its reasonable commercial efforts to cause the Seller Nominee to provide his or her consent to act as a director of Parent effective at the time of such election to the Parent Board and to provide all information and documentation (including Personal Information Forms) as the TSX may require or request in connection with his or her appointment to the Parent Board and, if Seller Nominee does not provide such consent or any of such information or documentation or if the TSX does not permit Seller Nominee to act as a director of Parent, then Parent shall have no further obligations to Seller under this Section 8.10 in respect of such Seller Nominee, provided that Seller shall be entitled to appoint an alternate nominee, and provided that such alternate nominee meets the Director Eligibility Requirements, the Parent Board shall, subject to applicable laws regarding the appointment of directors between
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shareholder meetings, cause such alternate to be appointed to the Parent Board as promptly as practicable. Upon Seller ceasing to hold at least an aggregate of 10% of the issued and outstanding shares of Parent Common Stock, Parent shall, in connection with the next following meeting of shareholders, not be required to recommend to Parents shareholders to vote in favor of or consent to the election of (or against the removal of, as the case may be) the Seller Nominee as a director of Parent, following which this Section 8.10.2 and Section 8.10.1 will cease to have any further force or effect.
ARTICLE 9
TERMINATION AND SURVIVAL
9.1 Termination .
9.1.1 This Agreement may be terminated at any time before the Closing Date
(a) by mutual written consent of Purchaser and Seller; or
(b) by either Party if the Closing has not occurred by 11:59 p.m., New York time, on May 19, 2014 (the Outside Date ); provided, however , that the right to terminate this Agreement pursuant to this Section 9.1.1(b) shall not be available to any Party whose breach of any provision of this Agreement results in the failure of the Closing to occur by such time or if this Agreement is terminable pursuant to either Section 9.1.2(c) or Section 9.1.3(c).
9.1.2 This Agreement may be terminated by Seller before the Closing Date, in writing, if:
(a) (i) any representation or warranty of Purchaser set forth in this Agreement shall have become untrue or Purchaser has breached any covenant or agreement of Purchaser set forth in this Agreement, and (ii) such breach or misrepresentation is not capable of being cured within thirty (30) days of written notice from Seller;
(b) a material breach of any provision of this Agreement has been committed by Purchaser, such breach has not been waived by Seller and such breach is not cured by Purchaser within thirty (30) days after written notice thereof or, in the reasonable determination of Seller, is incapable of being cured by Purchaser; or
(c) on the Outside Date, Purchaser does not have the funds available to pay Seller the cash portion of the Purchase Price or Parent is unable to deliver to Seller the Consideration Shares as provided for herein.
9.1.3 This Agreement may be terminated by Purchaser before the Closing Date, in writing, if:
(a) (i) any representation or warranty of Seller set forth in this Agreement shall have become untrue or Seller has breached any covenant or agreement of Seller set forth in this Agreement, and (ii) such breach or misrepresentation is not capable of being cured within thirty (30) days of notice from Purchaser;
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(b) a material breach of any provision of this Agreement has been committed by Seller, such breach has not been waived by Purchaser and such breach is not cured by Seller within thirty (30) days after written notice thereof or, in the reasonable determination of Purchaser, is incapable of being cured by Seller;
(c) on the Outside Date, Purchaser does not have the funds available to pay Seller the cash portion of the Purchase Price or Parent is unable to deliver to Seller the Consideration Shares as provided for herein; or
(d) upon occurrence of a Material Adverse Effect.
9.2 Procedure and Effect of Termination . Upon termination of this Agreement by Seller or Purchaser, as applicable, pursuant to Section 9.1, written notice thereof shall forthwith be given to the other Party, and this Agreement shall terminate and shall forthwith become void and there shall be no liability or obligation on the part of the Parties or their respective Representatives except as set forth in the following sentence. Notwithstanding anything herein to the contrary, termination of this Agreement pursuant to either Section 9.1.2(c) or Section 9.1.3(c) shall terminate all outstanding obligations and liabilities between the Parties arising from this Agreement except those described in Section 11.2.2. Any other termination of this Agreement shall terminate all outstanding obligations and liabilities between the Parties arising from this Agreement except those described in: (i) Section 8.1, this Article 9, Article 10 and Article 11; (ii) the Confidentiality Agreement; and (iii) any other provisions of this Agreement which by their terms survive any such termination.
ARTICLE 10
INDEMNIFICATION AND DISPUTE RESOLUTION
10.1 Indemnification .
10.1.1 Sellers Indemnification Obligations . Subject to Section 10.1.2, Seller shall indemnify, defend and hold harmless Purchaser and its Affiliates and their respective officers, directors, agents, and employees (collectively, the Purchaser Indemnitees ) from and against any and all Liabilities, paid or payable by any Purchaser Indemnitee (collectively, Purchaser Losses ) to the extent that such Purchaser Losses are based on, result from, or arise in connection with (a Purchaser Claim ):
(a) any Excluded Liability (collectively, Excluded Liability Claims );
(b) any Liability arising from any breach of the representations and warranties set forth in Sections 4.1, 4.2, 4.4.1 and 4.11 (collectively, Fundamental Representation Claims );
(c) any Liability arising from fraud, intentional misrepresentation or the cause or Knowledge of a deliberate or willful breach of any representations, warranties or covenants of Seller under this Agreement or in any agreement, document, certificate, schedule or exhibit delivered pursuant hereto (collectively, Fraud Claims );
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(d) other than Excluded Liability Claims, Fundamental Representation Claims, Fraud Claims, any Liability arising from any other breach of (i) any representation, warranty of Seller under this Agreement (collectively, General Claims ) or (ii) covenant of Seller under this Agreement;
10.1.2 Limitations on Sellers Indemnification Obligations . The Liability of Seller to provide any indemnification to any Purchaser Indemnitee and the right of the Purchaser Indemnitees to indemnification under Section 10.1.1 shall be subject to the following provisions:
(a) no claims for indemnification shall be made under this Agreement against Seller, and no indemnification shall be payable to any Purchaser Indemnitees, with respect to General Claims made after the date which is eighteen (18) months following the Closing Date; provided , that claims with respect to a breach of Section 4.8 (Taxes) and Section 4.19 (Environmental Matters) shall survive until the expiration of the applicable statute of limitations; and
(b) claims for indemnification with respect to covenants of Seller under this Agreement, Fundamental Representation Claims, Excluded Liability Claims and Fraud Claims made under this Agreement shall not be subject to any of the limitations set forth in this Section 10.1.2.
10.1.3 Purchasers Indemnification Obligations . Purchaser shall indemnify, defend and hold harmless Seller and its Affiliates and their respective officers, directors, agents and employees (collectively, the Seller Indemnitees ) from and against any and all Liabilities paid or payable by any Seller Indemnitee (collectively, Seller Losses ) to the extent that such Seller Losses are based on, result from, or arise in connection with (a Seller Claim ); the Assumed Liabilities after the Closing or breach of Purchasers representations and warranties set forth in Article 5 and any covenant with respect to Taxes or tax related matters set forth herein or in any Other Agreement, including Section 8.9 of this Agreement;
10.1.4 Limitations on Purchasers Indemnification Obligations . The Liability of Purchaser to provide any indemnification to any Seller Indemnitees and the right of the Seller Indemnitees to indemnification under Section 10.1.3 shall be subject to the following provisions:
(a) no claims for indemnification shall be made under this Agreement against Purchaser, and no indemnification shall be payable to any Seller Indemnitees, with respect to a breach of any other representation and warranty (other than Sections 5.1 and 5.2) or any covenant of Purchaser under this Agreement, made after a date which is eighteen (18) months following the Closing Date;
(b) no claims for indemnification shall be made under this Agreement against Purchaser, and no indemnification shall be payable to any Seller Indemnitees, with respect to a breach of Section 5.9 (Taxes) made after the date that is thirty (30) days after the expiration of all applicable statutes of limitation; and
(c) claims for indemnification with respect to breach of representations and warranties under Sections 5.1 and 5.2, a breach of the covenants of Purchaser under this Agreement, Assumed Liabilities or any Liability arising from fraud, intentional
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misrepresentation or the cause or Knowledge of a deliberate or willful breach of any representations, warranties or covenants of Purchaser under this Agreement or in any agreement, document, certificate, schedule or exhibit delivered pursuant (such claims collectively, Seller Excluded Claims ) shall not be subject to any of the limitations set forth in this Section 10.1.4.
10.1.5 Further Limitations on Indemnification Obligations .
(a) Purchaser shall not be entitled to receive any indemnification payments under Section 10.1.1 for General Claims unless and until the total of all such claims exceeds one million, two hundred and fifty thousand dollars ($1,250,000), whereupon Purchaser shall be entitled to receive indemnity payments for all such Purchaser Losses in excess of $400,000 (the Indemnification Basket ); provided , that the maximum aggregate amount of indemnification payments under Section 10.1.1 for General Claims to which Purchaser shall be entitled shall not exceed twenty five million dollars ($25,000,000) (the Indemnification Cap ).
(b) Neither the Indemnification Basket nor the Indemnification Cap shall apply with respect to Purchaser Losses for any claims made in connection with covenants of Seller under this Agreement, Excluded Liability Claims, Fundamental Representation Claims, and Fraud Claims.
(c) Except with respect to Seller Excluded Claims: Seller shall not be entitled to receive any indemnification payments under Section 10.1.3 unless and until the total of all claims for Seller Losses exceeds one million, two hundred and fifty thousand dollars ($1,250,000), whereupon Seller shall be entitled to receive indemnity payments for all such Seller Losses in excess of $400,000; provided , that the maximum aggregate amount of indemnification payments under Section 10.1.3 for claims, other than Seller Excluded Claims, to which Seller shall be entitled shall not exceed twenty five million dollars ($25,000,000).
10.2 Indemnification Procedures .
10.2.1 Each indemnified party shall notify the indemnifying Party in writing (and in reasonable detail) of the claim within ten (10) Business Days after receipt by such indemnified party of notice of the Purchaser Claim or Seller Claim, as the case may be, or otherwise becoming aware of the existence or threatened existence thereof (such Purchaser Claim or Seller Claim being referred to as a Claim ). Failure to give such notice shall not constitute a defense, in whole or in part, to any Claim by an indemnified party hereunder except and only to the extent that the indemnifying Party forfeits rights or defenses by reason of such failure. The indemnifying Party shall notify the indemnified party of its intentions as to defense of the Claim or potential Claim in writing within ten (10) Business Days after receipt of notice of the Claim.
10.2.2 With respect to any Third Party Claim, the indemnifying Party shall assume exclusive control of the defense and settlement (including all decisions relating to litigation, defense and appeal) of any such Claim (so long as it has confirmed its indemnification obligation responsibility to such indemnified party under this Section 10.2.2 with respect to a given Claim); provided , however , that the indemnifying Party may not settle such Claim in any manner that would require payment by the indemnified party, or would materially adversely
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affect the rights granted to the indemnified party hereunder, or would materially conflict with the terms of this Agreement (or an Other Agreement); provided , further , that if the indemnifying party is Seller, such indemnifying party shall not have the right to defend or direct the defense of any such Third Party Claim that (i) is asserted directly by or on behalf of a Person that is a supplier or customer of the Business, or (ii) seeks an injunction or other equitable relief against the indemnified party with respect to the sale or marketing of the Product.
10.2.3 With respect to any Third Party Claim, the indemnified party shall reasonably cooperate with the indemnifying Party in its defense of the Claim (including, without limitation, making documents and records available for review and copying and making Persons within its control available for pertinent testimony in accordance with the confidentiality provisions of Section 8.1, and neither Party shall be required to divulge privileged material to the other) at the indemnifying Partys expense solely with respect to out-of-pocket expenses incurred by the indemnified party (but excluding internal costs and expenses, including employee time or other internal overhead costs). With respect to any Third Party Claim, if the indemnifying Party assumes defense of the Claim, an indemnified party may participate in, but not control, the defense of such Claim using attorneys of its choice and at its sole cost and expense, with such cost and expense not being covered by the indemnifying Party. With respect to any Third Party Claim, an indemnifying Party shall have no obligation or liability under this Article 10 as to any Claim for which settlement or compromise of such Claim or an offer of settlement or compromise of such Claim is made by an indemnified party without the prior written consent of the indemnifying Party, which consent shall not be unreasonably withheld. With respect to any Third Party Claim, if an indemnifying Party notifies the indemnified party in writing that it will not defend the indemnified party against such a Claim asserted against the indemnified party, or if the indemnifying Party assumes the defense of the Claim in accordance with Section 10.2.2 yet fails to defend or take other reasonable, timely action, in response to such Claim asserted against the indemnified party, the indemnified party shall have the right to defend or take other reasonable action to defend its interests in such proceedings, and shall have the right to litigate, settle or otherwise dispose of any such Claim; provided , however , that no Party shall have the right to settle a Claim in a manner that would adversely affect the rights granted to the other Party hereunder, or would materially conflict with this Agreement, or would require a payment by the other Party.
10.3 Sole Remedy . Each Party acknowledges and agrees that its sole and exclusive remedy after the Closing with respect to any and all claims and causes of action under this Agreement (other than (a) rights, claims and causes of action under the Other Agreements and (b) claims of, or causes of action arising from fraud, intentional misrepresentation, willful misconduct, other tortious acts), shall be pursuant to the indemnification provisions set forth in this Article 10. In furtherance of the foregoing, each Party hereby waives, from and after the Closing, to the fullest extent permitted under applicable Law, any and all rights, claims and causes of action under this Agreement (other than (a) rights, claims and causes of action under the Other Agreements and (b) claims of, or causes of action arising from fraud, intentional misrepresentation, willful misconduct, other tortious acts), it may have against the other Party arising under or based upon any applicable Law or arising under or based upon common law or otherwise (except pursuant to the indemnification provisions set forth in Section 10.1.1 or 10.1.3, as applicable).
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10.4 Limitation on Liability . EXCEPT AS SET FORTH IN SECTION 10.1.1 AND SECTION 10.1.3 WITH RESPECT TO THIRD PARTY CLAIMS, BREACH OF SECTION 8.1 (CONFIDENTIALITY), FRAUD OR WILLFUL MISCONDUCT, IN NO EVENT SHALL EITHER PARTY, ITS DIRECTORS, TRUSTEES, OFFICERS, EMPLOYEES, AGENTS OR AFFILIATES BE LIABLE TO THE OTHER PARTY FOR ANY INDIRECT, INCIDENTAL, PUNITIVE, SPECIAL, EXEMPLARY OR CONSEQUENTIAL DAMAGES, WHETHER BASED UPON A CLAIM OR ACTION OF CONTRACT, WARRANTY, NEGLIGENCE, STRICT LIABILITY OR OTHER TORT, A PRODUCT CLAIM, OR OTHERWISE ARISING OUT OF OR RELATED TO THIS AGREEMENT.
10.5 Adjustment to Purchase Price . Any indemnification payment made pursuant to this Article X shall be treated as an adjustment to the Purchase Price for Tax purposes.
ARTICLE 11
MISCELLANEOUS
11.1 Assignment; Binding Effect . This Agreement shall be binding upon and inure to the benefit of the Parties hereto and their respective successors and assigns; provided , however , that either Party may assign this Agreement and its rights and obligations hereunder without the other Partys consent (a) in connection with the transfer or sale of all or substantially all of such Partys business to which this Agreement relates to a Third Party, whether by merger, sale of stock, sale of assets, license, sublicense or otherwise, or (b) to any Affiliate of such Party, including any successor in interest by way of any reincorporation or other reorganization.
11.2 Expenses .
11.2.1 Except as otherwise specified herein, each Party shall bear its own expenses with respect to the Transactions.
11.2.2 Purchaser agrees to pay a fee (the Termination Fee ) to Seller in an amount equal to 2% of the Purchase Price if this Agreement is terminated pursuant to either Section 9.1.2(c) or Section 9.1.3(c) provided Seller has complied with its obligations contained in Section 6.9.4. Parent unconditionally guarantees to Seller all obligations of Purchaser pursuant to this Section 11.2.2. The payment of the Termination Fee shall be made in dollars by wire transfer of immediately available funds to bank account identified by Seller in Schedule 2.6 within two (2) Business Days following the termination of this Agreement pursuant to either Section 9.1.2(c) or Section 9.1.3(c).
11.3 Notices . All notices, requests, claims, demands and other communications hereunder shall be in writing and shall be deemed to have been duly given (a) when received if delivered personally, (b) when transmitted, if telecopied (which is confirmed), (c) upon receipt, if sent by registered or certified mail (postage prepaid, return receipt requested) and (d) the day after it is sent, if sent for next-day delivery by overnight mail or courier, to the Parties at the following addresses:
If to Seller, to:
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PBM Pharmaceuticals, Inc.
200 Garrett Street, Suite S
Charlottesville, VA 22902
Attention: CEO
Telephone: 1-434-980-8100
With copies sent concurrently to:
PBM Pharmaceuticals, Inc.
200 Garrett Street, Suite S
Charlottesville, VA 22902
Attention: CFO
Telephone: 1-434-980-8100
Kramer Levin Naftalis & Frankel LLP
1177 Avenue of the Americas
New York, NY 10036
Attention: Steven M. Goldman
Telephone: 1-212-715-9143
Facsimile: 1-212-715-8053
If to Purchaser, to:
Concordia Pharmaceuticals Inc.
Chancery House, High Street
Bridgetown, St. Michael, BB11128, BARBADOS
Attention: Managing Director
Telephone: 1-246-621-1860
Facsimile: 1-246-621-1860
With copies sent concurrently to:
Concordia Healthcare Corp.
277 Lakeshore Rd. East, Suite 302
Oakville, Ontario, CANADA, L6J 6J3
Attention: C.E.O.
Telephone: 1-905-842-5150
Facsimile: 1-905-842-5154
provided , however , that if any Party shall have designated a different address by notice to the others, then to the last address so designated.
11.4 Severability . If any term, provision, covenant or restriction of this Agreement is held by a court of competent jurisdiction or other authority to be invalid, void, unenforceable or against its regulatory policy, such determination shall not affect the enforceability of any others or of the remainder of this Agreement; and in connection with such term, provision, covenant or restriction of this Agreement which is held invalid, void, unenforceable or against regulatory policy, the Parties shall negotiate in good faith with a view to the substitution therefor of a
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suitable and equitable solution in order to carry out, so far as may be valid and enforceable, the intent and purpose of such invalid term, provision, covenant or restriction and, absent any agreement by the Parties, such court of competent jurisdiction or other authority shall substitute therefore such term, provision, covenant or restriction as is legal, valid and enforceable but otherwise similar to the invalid term, provision, covenant or restriction.
11.5 Entire Agreement . This Agreement, the Other Agreements and the Confidentiality Agreement contain the entire agreement of the Parties hereto with respect to the Transactions, superseding all negotiations, prior discussions and preliminary agreements made prior to the date hereof.
11.6 No Third Party Beneficiaries . This Agreement is solely for the benefit of the Parties hereto and their respective Affiliates and no provision of this Agreement shall be deemed to confer upon any Third Parties any remedy, claim, liability, reimbursement, claim of action or other right in excess of those existing without reference to this Agreement.
11.7 Waiver . The failure of any Party to enforce any condition or part of this Agreement at any time shall not be construed as a waiver of that condition or part, nor shall it forfeit any rights to future enforcement thereof
11.8 Governing Law; Jurisdiction . This Agreement shall be governed, including as to validity, interpretation and effect, by, and construed in accordance with, the internal Laws of the State of Delaware applicable to agreements made and fully performed within the State of Delaware. Each of the Parties hereby irrevocably and unconditionally submits, for itself and its property, to the exclusive jurisdiction of the Court of Chancery in the City of Wilmington, New Castle County, Delaware except where such court lacks subject matter jurisdiction, in which case, to the exclusive jurisdiction of the federal district court sitting in Wilmington, Delaware or, if such federal district court lacks subject matter jurisdiction, then in the Superior Court in the City of Wilmington, New Castle County, Delaware, in each case, in any Action arising out of or relating to this Agreement or any Other Agreement or the transactions contemplated hereby or thereby or for recognition or enforcement of any judgment relating thereto. Each of the Parties hereby irrevocably and unconditionally (a) agrees not to commence any such Action except in such courts, (b) waives, to the fullest extent it may legally and effectively do so, any objection which it may now or hereafter have to the laying of venue of any such Action in any such court and (c) waives, to the fullest extent permitted by Law, the defense of an inconvenient forum to the maintenance of such Action in any such court. Each of the Parties agrees that a final judgment in any such Action shall be conclusive and may be enforced in other jurisdictions by suit on the judgment or in any other manner provided by Law. Each Party to this Agreement irrevocably consents to service of process in the manner provided for notices in Section 11.3. Nothing in this Agreement will affect the right of any Party to this Agreement to serve process in any other manner permitted by Law.
11.9 Injunctive Relief . Notwithstanding anything to the contrary in this Agreement, either Party will have the right to seek temporary injunctive relief in any court of competent jurisdiction as may be available to such Party under the laws and rules applicable in such jurisdiction with respect to any matters arising out of the other Partys performance of its obligations under this Agreement. The Parties agree that in the event a Party institutes an
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appropriate Action seeking injunctive/equitable relief for specific performance under this Agreement, the Party seeking such relief shall not be required to provide the other Party with service of process of a complaint and summons under the procedures set forth in any non-United States judicial process or system. Under such circumstances, the Party seeking such relief need only provide the other Party with two copies of a true, correct and lawfully issued summons and complaint, via FedEx (priority delivery).
11.10 Amendment . Any amendment, modification or supplement of or to any provision of this Agreement, including the Schedules hereto, shall be effective only in a writing and signed by a duly authorized officer of the Parties.
11.11 Headings . The headings of the sections and subsections of this Agreement are inserted for convenience only and shall not be deemed to constitute a part hereof.
11.12 Counterparts . This Agreement may be executed manually, by facsimile or by portable document format (.pdf) by the Parties, in any number of counterparts, each of which shall be considered one and the same agreement and shall become effective when a counterpart hereof shall have been signed by each of the Parties and delivered to the other Party.
11.13 Specific Performance . Notwithstanding anything to the contrary in this Agreement, The Parties agree that irreparable damage would occur if any provision of this Agreement were not performed in accordance with the terms hereof and that the Parties shall be entitled to specific performance of the terms hereof, in addition to any other remedy to which they are entitled at law or in equity.
11.14 Construction . The language in all parts of this Agreement shall be construed, in all cases, according to its fair meaning. The Parties acknowledge that each Party and its counsel have reviewed and revised this Agreement and that any rule of construction to the effect that any ambiguities are to be resolved against the drafting Party shall not be employed in the interpretation of this Agreement.
11.15 Parent Guarantee . Parent hereby absolutely and unconditionally guarantees Purchasers duties, obligations and responsibilities under this Agreement, including Article II, Article V, Article VII, Article VIII, Article X and Article XI, and shall be deemed to have made, and shall be jointly and severally liable for, all of the representations and warranties, covenants and other agreements of Purchaser contained herein.
* * * * * * * * * * *
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IN WITNESS WHEREOF, the Parties hereto have caused this Asset Purchase and Sale Agreement to be executed by their respective duly authorized officers as of the Execution Date.
PBM PHARMACEUTICALS, INC. | ||
By: |
/s/ Paul B. Manning |
|
Name: | Paul B. Manning | |
Title: | Chief Executive Officer | |
CONCORDIA PHARMACEUTICALS INC. | ||
By: |
/s/ John A. R. McCleery |
|
Name: | John A. R. McCleery | |
Title: | Managing Director and C.F.O. | |
CONCORDIA HEALTHCARE CORP. | ||
By: |
/s/ Mark L. Thompson |
|
Name: | Mark L. Thompson | |
Title: | President and Chief Executive Officer |
[ Signature Page to Asset Purchase and Sale Agreement ]
Exhibit A
FORM OF ASSIGNMENT AND ASSUMPTION AGREEMENT
This ASSIGNMENT AND ASSUMPTION AGREEMENT (this Agreement ), dated as of [ ], 2014, is executed and delivered by PBM PHARMACEUTICALS, INC. , a Delaware corporation ( Seller ), CONCORDIA PHARMACEUTICALS INC. , an international business company incorporated under the laws of Barbados ( Purchaser ), and [name of Purchaser Affiliate], a [ ] corporation (Purchaser Affiliate). Seller, Purchaser Affiliate and Purchaser are sometimes referred to herein, individually, as a Party and, collectively, as the Parties . Capitalized terms used herein but not otherwise defined herein shall have the meaning ascribed to such term in the Purchase Agreement (as defined below).
WHEREAS, Purchaser and Seller are parties to that certain Asset Purchase and Sale Agreement (the Purchase Agreement ), dated as of March 19, 2014;
WHEREAS, on the terms and subject to the conditions set forth in the Purchase Agreement, Seller agreed to, on the Closing Date, sell, convey, transfer, assign and deliver to Purchaser (and/or an Affiliate of Purchaser), and Purchaser (and/or an Affiliate of Purchaser) agreed to, on the Closing Date, purchase, take delivery of and acquire all of Sellers right, title and interest in, to and under the Purchased Assets;
WHEREAS, the Purchased Assets other than the Assigned Contracts and Product Intellectual Property are to be transferred pursuant to a Bill of Sale dated as of the date hereof;
WHEREAS, on the terms and subject to the conditions set forth in the Purchase Agreement, Purchaser (and/or an Affiliate of Purchaser) agreed to, on the Closing Date assume and pay, perform or otherwise discharge, in accordance with their respective terms and subject to their respective conditions thereof the Assumed Liabilities; and
WHEREAS, Seller and Purchaser desire to carry out the intent and purpose of the Purchase Agreement by their execution and delivery of this Agreement.
NOW, THEREFORE, for good and valuable consideration, the receipt and sufficiency of which are hereby acknowledged, Seller and Purchaser agree as follows:
1. Assignment . On the terms and subject to the conditions set forth in the Purchase Agreement, Seller hereby sells, conveys, transfers, assigns and delivers to Purchaser, and Purchaser hereby purchases, takes delivery of and acquires all of Sellers right, title and interest in, to and under the Assigned Contracts other than those set forth on Exhibit A (those set forth on Exhibit A, the Leases , all other Assigned Contracts, the Other Contracts ) which Seller hereby sells, conveys, transfers, assigns and delivers to Purchaser Affiliate, and Purchaser Affiliate hereby purchases, takes delivery of and acquires all of Sellers right, title and interest in, to and under the Leases.
2. Assumed Liabilities . On the terms and subject to the conditions set forth in the Purchase Agreement, Purchaser hereby agrees to assume and pay, perform or otherwise discharge, in accordance with their respective terms and subject to their respective conditions thereof the Assumed Liabilities, except those relating to the Leases which shall be assumed by Purchaser Affiliate.
3. Liabilities Retained by Seller . On the terms and subject to the conditions set forth in the Purchase Agreement, Seller shall retain and shall be responsible for paying, performing and discharging when due, and neither Purchaser nor Purchaser Affiliate shall assume or have any responsibility for, any Excluded Liabilities.
4. Further Assurances . On the terms and subject to the conditions set forth in the Purchase Agreement, each of Purchaser and Seller shall, and shall cause its respective Affiliates to, at the request of another Party, execute and deliver to such other Party all such further instruments, assignments, assurances and other documents as such other Party may reasonably request in connection with the carrying out of this Agreement.
5. No Third Party Beneficiaries . This Agreement is solely for the benefit of the Parties hereto and their respective Affiliates and no provision of this Agreement shall be deemed to confer upon any Third Parties any remedy, claim, liability, reimbursement, claim of action or other right in excess of those existing without reference to this Agreement.
6. Governing Law . This Agreement shall be governed, including as to validity, interpretation and effect, by, and construed in accordance with, the internal Laws of the State of Delaware applicable to agreements made and fully performed within the State of Delaware. Each of the Parties hereby irrevocably and unconditionally submits, for itself and its property, to the exclusive jurisdiction of the Court of Chancery in the City of Wilmington, New Castle County, Delaware except where such court lacks subject matter jurisdiction, in which case, to the exclusive jurisdiction of the federal district court sitting in Wilmington, Delaware or, if such federal district court lacks subject matter jurisdiction, then in the Superior Court in the City of Wilmington, New Castle County, Delaware, in each case, in any Action arising out of or relating to this Agreement or the transactions contemplated hereby or thereby or for recognition or enforcement of any judgment relating thereto. Each of the Parties hereby irrevocably and unconditionally (a) agrees not to commence any such Action except in such courts, (b) waives, to the fullest extent it may legally and effectively do so, any objection which it may now or hereafter have to the laying of venue of any such Action in any such court and (c) waives, to the fullest extent permitted by Law, the defense of an inconvenient forum to the maintenance of such Action in any such court. Each of the Parties agrees that a final judgment in any such Action shall be conclusive and may be enforced in other jurisdictions by suit on the judgment or in any other manner provided by Law. Each Party to this Agreement irrevocably consents to service of process in the manner provided for notices in Section 11.3 of the Purchase Agreement. Nothing in this Agreement will affect the right of any Party to this Agreement to serve process in any other manner permitted by Law.
7. Binding Effect . This Agreement shall be binding upon and inure to the benefit of the Parties hereto and their respective successors and assigns as permitted by Section 11.1 of the Purchase Agreement.
8. Conflicts with Purchase Agreement . Notwithstanding anything contained herein to the contrary, in the event of any inconsistency between the terms of this Agreement and the terms of the Purchase Agreement, the terms of the Purchase Agreement shall govern.
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9. Signatures; Counterparts . This Agreement may be executed manually, by facsimile or by portable document format (.pdf) by the Parties, in any number of counterparts, each of which shall be considered one and the same agreement and shall become effective when a counterpart hereof shall have been signed by each of the Parties and delivered to the other Party.
[ Signature page follows ]
3
IN WITNESS WHEREOF , Seller and Purchaser have executed this Agreement as of the day and year first above written.
PBM PHARMACEUTICALS, INC. | ||
By: |
|
|
Name: | ||
Title: | ||
CONCORDIA PHARMACEUTICALS INC. | ||
By: |
|
|
Name: | ||
Title: | ||
[PURCHASER AFFILIATE] | ||
By: |
|
|
Name: | ||
Title: |
[ Signature Page to Assignment and Assumption Agreement ]
Exhibit B
FORM OF INTELLECTUAL PROPERTY ASSIGNMENT AGREEMENT
This INTELLECTUAL PROPERTY ASSIGNMENT AGREEMENT (this Agreement ), dated as of [ ], 2014, is entered into between PBM PHARMACEUTICALS, INC. , a Delaware corporation ( Assignor ), and CONCORDIA PHARMACEUTICALS INC. , an international business company incorporated under the laws of Barbados ( Assignee ). Assignor and Assignee are sometimes referred to herein, individually, as a Party and, collectively, as the Parties . Capitalized terms used herein but not otherwise defined herein shall have the meaning ascribed to such term in the Purchase Agreement (as defined below).
WHEREAS, Assignor and Assignee are parties to that certain Asset Purchase and Sale Agreement (the Purchase Agreement ), dated as of March 19, 2014, pursuant to which Assignor agreed to sell, convey, transfer, assign and deliver to Assignee all of Assignors right, title, and interest in, to and under the Product Intellectual Property (as defined in the Purchase Agreement).
NOW, THEREFORE, in consideration of the mutual covenants and agreements hereinafter set forth and for other good and valuable consideration, the receipt and sufficiency of which are hereby acknowledged, Assignor and Assignee agree as follows:
1. Product Marks Assignment. Assignor hereby sells, conveys, assigns and delivers to Assignee all of Assignors right, title and interest in, to and under the Product Marks, and any applications and registrations therefor, including the applications and registrations identified on the attached Schedule 1 , together with that part of the goodwill of the business associated with the use of and symbolized by the Product Marks, and all causes of action and rights of recovery for past, present, or future infringement of the Product Marks, to be held and enjoyed by Assignee as fully and entirely as if said interest could have been held and enjoyed by Assignor if this sale, conveyance, transfer and assignment had not been made. Assignor hereby authorizes the appropriate empowered officials at the United States Patent and Trademark Office to transfer all registrations and pending applications for the Product Marks to Assignee as assignee of the entire right, title and interest therein, in accordance with this instrument of assignment.
2. Product Intellectual Property Assignment. Assignor hereby sells, conveys, transfers, assigns and delivers to Assignee all of Assignors right, title and interest in, to and under all Product Intellectual Property (exclusive of the Product Marks, which are governed by Section 1 above) including the Product Domain Names set forth on the attached Schedule 2 , and all causes of action and rights of recovery for past, present, or future infringement of the Product Intellectual Property, to be held and enjoyed by Assignee as fully and entirely as if said interest could have been held and enjoyed by Assignor if this sale, conveyance, transfer and assignment had not been made:
3. Domain Name Transfer Procedure. The Parties acknowledge that in order to effect the assignment and transfer of the registrations of the Product Domain Names listed on Schedule 2 , the Parties must follow certain procedures stipulated by the relevant domain name registrar (the Transfer Procedures ). If any further documents or agreements are required to be executed by the Parties to carry out such Transfer Procedures, such documents or agreements shall form a part of this Agreement. The Parties agree to cooperate fully with each other and
promptly to take all necessary actions in order to comply with the Transfer Procedures so as to effect the transactions contemplated in this Agreement, including as necessary Assignor directing the domain name registrar to release and unlock the Product Domain Names and, upon notice from the registrar that such Product Domain Names have been unlocked, timely requesting that the Product Domain Names be transferred to Assignee.
4. Further Assurances. Each of Assignor and Assignee shall, and shall cause its respective Affiliates to, at the reasonable request of the other Party, execute and deliver to such other Party all such further instruments, assignments, assurances and other documents as such other Party may reasonably request in connection with the carrying out of this Agreement, and Assignor agrees, at Assignees expense, to do all other acts which may be necessary or appropriate, in the reasonable opinion of Assignees counsel, to perfect or record the right or title of Assignee to the Product Intellectual Property transferred hereby.
5. No Third Party Beneficiaries . This Agreement is solely for the benefit of the Parties hereto and their respective Affiliates, and no provision of this Agreement shall be deemed to confer upon any Third Parties any remedy, claim, liability, reimbursement, claim of action or other right in excess of those existing without reference to this Agreement.
6. Governing Law. This Agreement shall be governed, including as to validity, interpretation and effect, by, and construed in accordance with, the internal Laws of the State of Delaware applicable to agreements made and fully performed within the State of Delaware. Each of the Parties hereby irrevocably and unconditionally submits, for itself and its property, to the exclusive jurisdiction of the Court of Chancery in the City of Wilmington, New Castle County, Delaware except where such court lacks subject matter jurisdiction, in which case, to the exclusive jurisdiction of the federal district court sitting in Wilmington, Delaware or, if such federal district court lacks subject matter jurisdiction, then in the Superior Court in the City of Wilmington, New Castle County, Delaware, in each case, in any Action arising out of or relating to this Agreement or the transactions contemplated hereby or thereby or for recognition or enforcement of any judgment relating thereto. Each of the Parties hereby irrevocably and unconditionally (a) agrees not to commence any such Action except in such courts, (b) waives, to the fullest extent it may legally and effectively do so, any objection which it may now or hereafter have to the laying of venue of any such Action in any such court and (c) waives, to the fullest extent permitted by Law, the defense of an inconvenient forum to the maintenance of such Action in any such court. Each of the Parties agrees that a final judgment in any such Action shall be conclusive and may be enforced in other jurisdictions by suit on the judgment or in any other manner provided by Law. Each Party to this Agreement irrevocably consents to service of process in the manner provided for notices in Section 11.3 of the Purchase Agreement. Nothing in this Agreement will affect the right of any Party to this Agreement to serve process in any other manner permitted by Law.
7. Binding Effect . This Agreement shall be binding upon and inure to the benefit of the Parties hereto and their respective successors and assigns as permitted by Section 11.1 of the Purchase Agreement.
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8. Conflicts with Purchase Agreement. Notwithstanding anything contained herein to the contrary, in the event of any inconsistency between the terms of this Agreement and the terms of the Purchase Agreement, the terms of the Purchase Agreement shall govern.
9. Amendment. Any amendment, modification or supplement of or to any provision of this Agreement, including the Schedules hereto, shall be effective only in a writing signed by a duly authorized officer of each of the Parties.
10. Signatures; Counterparts. This Agreement may be executed manually, by facsimile or by portable document format (.pdf) by the Parties, in any number of counterparts, each of which shall be considered one and the same agreement and shall become effective when a counterpart hereof shall have been signed by each of the Parties and delivered to the other Party.
[ Signature page follows ]
3
IN WITNESS WHEREOF , Assignor and Assignee have executed this Agreement as of the day and year first above written.
PBM PHARMACEUTICALS, INC. | ||
(Assignor) | ||
By: |
|
|
Name: | ||
Title: | ||
CONCORDIA PHARMACEUTICALS INC. | ||
(Assignee) | ||
By: |
|
|
Name: | ||
Title: |
[ Signature Page to Intellectual Property Assignment Agreement ]
Schedule 1
Product Marks
Schedule completed as per Form of Bill of Sale
[ Schedule 1 to Intellectual Property Assignment Agreement ]
Schedule 2
Domain Names
www.donnatal.com
www.myibs.com
[ Schedule 2 to Intellectual Property Assignment Agreement ]
Exhibit C
FORM OF BILL OF SALE
This BILL OF SALE (this Agreement ), dated as of [ ], 2014, is executed and delivered by PBM PHARMACEUTICALS, INC. , a Delaware corporation ( Seller ), and CONCORDIA PHARMACEUTICALS INC. , an international business company incorporated under the laws of Barbados ( Purchaser ). Seller and Purchaser are sometimes referred to herein, individually, as a Party and, collectively, as the Parties . Capitalized terms used herein but not otherwise defined herein shall have the meaning ascribed to such term in the Purchase Agreement (as defined below).
WHEREAS, Purchaser and Seller are parties to that certain Asset Purchase and Sale Agreement (the Purchase Agreement ), dated as of March 19, 2014;
WHEREAS, on the terms and subject to the conditions set forth in the Purchase Agreement, Seller agreed to, on the Closing Date sell, convey, transfer, assign and deliver to Purchaser (and/or an Affiliate of Purchaser), and Purchaser (and/or an Affiliate of Purchaser) agreed to, on the Closing Date, purchase, take delivery of and acquire all of Sellers right, title and interest in, to and under the Purchased Assets;
WHEREAS, the Assigned Contracts and Product Intellectual Property (together, the A.A. Assets ) are to be transferred pursuant to an Assignment and Assumption Agreement and an Intellectual Property Assignment Agreement dated as of the date hereof, between Purchaser and Seller; and
WHEREAS, Seller and Purchaser desire to carry out the intent and purpose of the Purchase Agreement by their execution and delivery of this Agreement evidencing the vesting in Purchaser of the Purchased Assets (other than the A.A. Assets) to be conveyed to Purchaser on the Closing Date pursuant to the terms and conditions of the Purchase Agreement.
NOW, THEREFORE, for good and valuable consideration, the receipt and sufficiency of which are hereby acknowledged, Seller and Purchaser agree as follows:
1. Sale of Assets . On the terms and subject to the conditions set forth in the Purchase Agreement, Seller hereby sells, conveys, transfers, assigns and delivers to Purchaser, and Purchaser hereby purchases, takes delivery of and acquires all of Sellers right, title and interest in to the Purchased Assets other than the A.A. Assets.
2. Further Assurances . On the terms and subject to the conditions set forth in the Purchase Agreement, each of Purchaser and Seller shall, and shall cause its respective Affiliates to, at the request of the other Party, execute and deliver to such other Party all such further instruments, assignments, assurances and other documents as such other Party may reasonably request in connection with the carrying out of this Agreement.
3. No Third Party Beneficiaries . This Agreement is solely for the benefit of the Parties hereto and their respective Affiliates and no provision of this Agreement shall be deemed to confer upon any Third Parties any remedy, claim, liability, reimbursement, claim of action or other right in excess of those existing without reference to this Agreement.
4. Governing Law . This Agreement shall be governed, including as to validity, interpretation and effect, by, and construed in accordance with, the internal Laws of the State of Delaware applicable to agreements made and fully performed within the State of Delaware. Each of the Parties hereby irrevocably and unconditionally submits, for itself and its property, to the exclusive jurisdiction of the Court of Chancery in the City of Wilmington, New Castle County, Delaware except where such court lacks subject matter jurisdiction, in which case, to the exclusive jurisdiction of the federal district court sitting in Wilmington, Delaware or, if such federal district court lacks subject matter jurisdiction, then in the Superior Court in the City of Wilmington, New Castle County, Delaware, in each case, in any Action arising out of or relating to this Agreement or the transactions contemplated hereby or thereby or for recognition or enforcement of any judgment relating thereto. Each of the Parties hereby irrevocably and unconditionally (a) agrees not to commence any such Action except in such courts, (b) waives, to the fullest extent it may legally and effectively do so, any objection which it may now or hereafter have to the laying of venue of any such Action in any such court and (c) waives, to the fullest extent permitted by Law, the defense of an inconvenient forum to the maintenance of such Action in any such court. Each of the Parties agrees that a final judgment in any such Action shall be conclusive and may be enforced in other jurisdictions by suit on the judgment or in any other manner provided by Law. Each Party to this Agreement irrevocably consents to service of process in the manner provided for notices in Section 11.3 of the Purchase Agreement. Nothing in this Agreement will affect the right of any Party to this Agreement to serve process in any other manner permitted by Law.
5. Binding Effect . This Agreement shall be binding upon and inure to the benefit of the Parties hereto and their respective successors and assigns as permitted by Section 11.1 of the Purchase Agreement.
6. Conflicts with Purchase Agreement . Notwithstanding anything contained herein to the contrary, in the event of any inconsistency between the terms of this Agreement and the terms of the Purchase Agreement, the terms of the Purchase Agreement shall govern.
7. Signatures; Counterparts . This Agreement may be executed manually, by facsimile or by portable document format (.pdf) by the Parties, in any number of counterparts, each of which shall be considered one and the same agreement and shall become effective when a counterpart hereof shall have been signed by each of the Parties and delivered to the other Party.
[ Signature page follows ]
2
IN WITNESS WHEREOF , Seller and Purchaser have executed this Agreement as of the day and year first above written.
PBM PHARMACEUTICALS, INC. | ||
By: |
|
|
Name: | ||
Title: | ||
CONCORDIA PHARMACEUTICALS INC. | ||
By: |
|
|
Name: | ||
Title: |
[ Signature Page to Bill of Sale ]
Exhibit D
FORM OF
TRANSITION SERVICES AGREEMENT
BY AND BETWEEN
CONCORDIA PHARMACEUTICALS INC. (SERVICE RECIPIENT)
AND
PBM PHARMACEUTICALS, INC. (SERVICE PROVIDER)
Dated as of [ ], 2014
TRANSITION SERVICES AGREEMENT
THIS TRANSITION SERVICES AGREEMENT (this Agreement ) is dated as of [ ], 2014, by and between:
(A) Concordia Pharmaceuticals Inc., a Barbados corporation ( Service Recipient ); and
(B) PBM Pharmaceuticals, Inc., a Delaware corporation ( Service Provider or Seller ).
Capitalized terms which are used but not defined herein shall have the meanings ascribed to such terms in the Asset Purchase Agreement, dated as of March 19, 2014 (the Asset Purchase Agreement ), by and between Service Recipient, Service Provider and Concordia Healthcare Corp.
RECITALS
WHEREAS , the Asset Purchase Agreement provides for the acquisition by Service Recipient of the Purchased Assets; and
WHEREAS , in connection with the transactions contemplated by the Asset Purchase Agreement, the parties contemplate that during the Term (as defined herein), Service Provider will provide certain transitional services to Service Recipient with respect to the Business and the Purchased Assets in accordance with the terms and conditions set forth herein.
NOW, THEREFORE , in consideration of the foregoing recitals and the mutual representations, warranties, covenants and promises contained herein, the adequacy and sufficiency of which are hereby acknowledged, the parties hereto agree as follows:
1. DEFINITIONS.
For the purpose of this Agreement, the following capitalized terms shall have the following meanings. Other capitalized terms defined elsewhere in this Agreement shall have the respective meanings assigned to them at the location of their definition.
Additional Services shall have the meaning set forth in Section 2.7 .
Agreement shall have the meaning set forth in the Preamble and shall include all Transition Service Schedules whether attached hereto or added subsequently pursuant to the terms of this Agreement.
Asset Purchase Agreement shall have the meaning set forth in the Preamble.
Confidential Information shall have the meaning set forth in Section 10.1 .
Data shall have the meaning set forth in Section 7.4 .
Dispute shall have the meaning set forth in Section 3.2 .
Effective Date shall mean the Closing Date, as such term is defined in the Asset Purchase Agreement.
Expenses shall have the meaning set forth in Section 5.2 .
Seller Representative(s) shall mean the individual(s) designated in the Transition Service Schedule to provide the applicable Service.
Service(s) shall mean all services to be provided by Service Provider to Service Recipient as described on any Transition Service Schedule, including any Additional Services.
Service Manager shall have the meaning set forth in Section 3.1 .
Service Provider shall have the meaning set forth in the Preamble.
Service Recipient shall have the meaning set forth in the Preamble.
Service Term shall have the meaning set forth in Section 2.3 .
Term shall have the meaning set forth in Section 4.1 .
Transition Service Schedule shall have the meaning set forth in Section 2.1 .
2. SERVICES
2.1. Schedules and Precedence . This Agreement shall govern the provision of transitional Services described in the schedules attached to and made a part of this Agreement (each individual schedule, a Transition Service Schedule ). If there is any inconsistency between the terms of any Transition Service Schedule and the terms of this Agreement, the terms of such Transition Service Schedule shall govern.
2.2. Performance of Services . Service Provider shall perform the Services set forth in the Transition Service Schedules. The parties hereto acknowledge the transitional nature of the Services. Accordingly, as promptly as practicable following the execution of this Agreement, Service Recipient agrees to use commercially reasonable efforts to make a transition of each Service to its own internal organization or to obtain alternate third-party sources to provide the Services.
2.3. Information . Each Transition Service Schedule shall set forth, among other things:
(a) a description of the Services to be provided;
(b) the term during which each Service will be provided (the Service Term );
(c) the location(s) where Services are to be provided;
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(d) the Seller Representative(s) for such Service and the primary work location of such Seller Representative(s);
(e) the fees due to Service Provider, if any, for each Service; and
(f) any other terms applicable thereto on the Transition Service Schedule.
2.4. Service Levels . Each party shall perform its obligations and activities under this Agreement, including the performance of the Services in the case of Service Provider, in a manner consistent with the terms and conditions contained herein and with the manner in which Service Provider performed the Services prior to the Closing Date, and in accordance with applicable law, and in a manner not involving harassment, discrimination or other wrongful or illegal conduct.
2.5. Additional Resources . Except as may be expressly provided herein or in a Transition Service Schedule for a specific Service, in providing the Services, Service Provider will not be obligated to (a) hire any additional employees; (b) maintain the employment of any specific employee; (c) purchase, lease or license any additional equipment or software; or (d) pay any costs related to the transfer or conversion of Service Recipients Data or to any alternate supplier of Services retained by Service Recipient.
2.6. Remedies . If Service Provider fails to perform any Service in accordance with the service levels set forth in Section 2.4 , Service Recipients sole remedy shall be that Service Provider shall re-perform the Service in conformance with such service levels or, if such re-performance is not possible (or Service Recipient otherwise elects), provide Service Recipient with a refund of any fees paid to Service Provider for any portion of such Service that was not performed.
2.7. Additional Services . During the Term, Service Recipient may request that Service Provider provide additional services to Service Recipient (the Additional Services ), and Service Provider shall consider any such request in good faith. If the parties reach agreement regarding any Additional Services, then such Additional Services would be provided to Service Recipient in the manner provided for herein unless otherwise mutually agreed, in writing, by Service Recipient and Service Provider. Upon agreement, the parties shall execute additional written Transition Service Schedules for such Additional Services.
2.8. Change Order Process . Any change in the scope or duration of any Service described in or other amendment to a Transition Service Schedule must be in writing and signed by both parties.
2.9. Third Party Consents . If any consent or waiver for any third party is needed in connection with Service Providers provision of the Services (including in connection with granting Service Recipient a license or sublicense to any third party Intellectual Property or software), Service Provider will be excused from performing such Service until such consent or waiver is obtained and will use commercially reasonable efforts to obtain such consent or waiver, provided any payments to third parties in connection with obtaining any such consent or waiver shall be at Service Recipients sole cost.
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3. GOVERNANCE.
3.1. Service Manager and Seller Representatives . Service Provider shall appoint one individual to have primary responsibility and oversight for the provisions of all of the Services and to be Service Recipients primary point of contact (the Service Manager ). The initial Service Manager shall be . In addition, the parties hereto shall jointly identify on the applicable Transition Service Schedule one Seller Representative for each Service to have primary responsibility and oversight for the provision of such Service. Service Provider may appoint a new Service Manager by providing Service Recipient with written notice thereof in accordance with Section 13.10 . A new Seller Representative for any Service may be appointed upon written consent of the parties hereto; provided, however, that the consent of Service Recipient shall not be necessary if appointment of a new Seller Representative is required as a result of the termination or resignation of the then-existing Seller Representative.
3.2. Dispute Resolution . Any dispute regarding a partys performance under this Agreement (a Dispute ) shall be initially referred to the Service Manager and a representative appointed by Service Recipient for resolution. The Service Manager and such Service Recipient representative shall meet at a mutually acceptable time and place (or by teleconference) promptly after the Dispute has been referred to them, and thereafter as often as they reasonably deem necessary, to exchange relevant information and to attempt to resolve the Dispute. If the Service Manager and such Service Recipient representative are not able to resolve the Dispute within fifteen (15) days after the Dispute has been referred to them, then either party may thereafter submit such Dispute to any court as permitted by Section 13.6 .
4. TERM AND TERMINATION.
4.1. Term . This Agreement shall commence on the Effective Date and remain in effect until the last day that any Service Term in any Transition Service Schedule remains in effect (the Term ), unless earlier terminated under this Section 4 . With respect to each Service, such Service shall begin upon the applicable start date set forth in the Transition Services Schedule (or the Effective Date if no start date is identified) and shall continue until the end date for such Service set forth in the Transition Services Schedule, unless earlier terminated under this Section 4 .
4.2. Termination .
(a) Service Recipient may terminate this Agreement, either with respect to all or with respect to any one or more of the Services (or a portion thereof) provided to Service Recipient hereunder, for any reason or for no reason, at any time upon at least [thirty (30)] 1 days prior written notice to Service Provider.
1 | Note to Draft : As PBM may be using third party contractors to perform certain services, this timing may be too short. PBM is considering the timing based on this issue. |
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(b) Notwithstanding anything to the contrary contained in this Agreement, Service Provider shall not have any liability to Service Recipient hereunder with respect to any termination by Service Provider for cause, or voluntary resignation, of any Seller Representative during the applicable Service Term. Upon any such termination or resignation, Service Provider shall appoint a new Seller Representative pursuant to the provisions of Section 3.1.
(c) Subject to the provisions of Section 12 below, either party may terminate this Agreement in its entirety or with respect to affected Services if the other party materially breaches a material provision with regard to those Services and does not cure such breach (or does not take reasonable steps required under the circumstances to cure such breach going forward) within thirty (30) days (or ten (10) days in the event of a payment breach) after receiving notice of the breach.
(d) The following provisions shall survive the expiration or termination of this Agreement: Section 4.2(e) , Section 7 , Section 10 , Section 11 , and Section 13 and Service Recipients payment obligations under Section 5 with respect to Services performed by Service Provider in accordance with the terms and conditions of this Agreement prior to the effective date of expiration or termination.
(e) Upon any expiration or termination of this Agreement in whole or in part and for any reason, (i) Service Provider shall deliver the Data to Service Recipient in accordance with Section 7.4 , and (ii) each party shall promptly return to the other party or destroy any and all Confidential Information of such other party in its or its Affiliates possession as of expiration or termination of this Agreement.
5. PAYMENT TERMS.
5.1. Charges for Services . Service Recipient shall pay Service Provider the charges set forth on the applicable Transition Service Schedule for each Service listed therein.
5.2. Taxes . Service Recipient shall be responsible for all sales, use or other taxes imposed or assessed as a result of or in connection with the provision of Services by Service Provider.
5.3. Expenses . Service Recipient shall, for each Service performed, reimburse Service Provider for any documented and reasonable out-of-pocket expenses payable to third parties, including without limitation all related travel expenses for Service Provider personnel, which are incurred by Service Provider or its Affiliates in connection with Service Providers provision of the Services ( Expenses ). Within thirty (30) days (i) after the end of each calendar month during the Term, Service Provider shall provide Service Recipient with a report detailing the non-third party Expenses for such previous month and (ii) after receipt by Service Provider of any third party Expense during the Term, Service Provider will provide Service Recipient with a report detailing such third party Expense.
5.4. Payment Terms . Service Provider shall bill Service Recipient monthly for all charges pursuant to this Agreement. Such invoices shall contain reasonable detail of the Service provided and the charge therefor. Service Recipient shall pay Service Provider for
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all amounts due for Services provided hereunder within thirty (30) days from receipt of an invoice therefor. Late payments will bear interest at the rate of one percent (1%) per month or, if lower, the maximum rate permitted by applicable law, assessed from the date payment was initially due until paid by Service Recipient. The foregoing interest shall automatically accrue without notice. The parties acknowledge and agree that Service Recipients failure to pay amounts due pursuant to the terms of this Agreement will be deemed to be a material breach giving Service Provider the right to terminate this Agreement under Section 4.2(c) .
5.5. No Right of Set-off . Each of the parties hereby acknowledges that it shall have no right under this Agreement to offset any amounts owed (or to become due and owing) to the other party, whether under this Agreement, the Asset Purchase Agreement or otherwise, against any other amount owed (or to become due and owing) to it by the other party.
6. TRANSITION SERVICE RESPONSIBILITIES.
6.1. Responsibilities of Service Recipient . Service Recipient shall:
(a) provide Service Provider with access to its facilities as is reasonably necessary for Service Provider to perform the Services it is obligated to provide hereunder;
(b) provide Service Provider with information and documentation reasonably necessary for Service Provider to perform the Services it is obligated to provide hereunder; and
(c) make available, as reasonably requested by Service Provider, reasonable access to resources and provide timely decisions in order that Service Provider may perform its obligations hereunder.
6.2. Mutual Responsibilities . The parties will use good faith efforts to cooperate with each other in all matters relating to the provision and receipt of Services. Such cooperation shall include:
(a) exchanging information relevant to the provision of Services hereunder;
(b) using good faith efforts to mitigate problems with the work environment that may be interfering with the Services; and
(c) each party requiring its personnel to obey any security regulations and other published policies of the other party while on the other partys premises.
7. INTELLECTUAL PROPERTY.
7.1. Existing Ownership Rights Unaffected . Except as expressly set out in this Section 7 , neither party will gain, by virtue of this Agreement, any rights of ownership or use of any Intellectual Property owned by the other party.
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7.2. Trademarks . Neither party is granted by virtue of this Agreement, any ownership in or license to the Trademarks of the other party.
7.3. Removal of Marks . The parties agree that neither party will remove any Copyright notices, proprietary markings, Trademarks or other indicia of ownership of the other party from any materials of the other party.
7.4. Ownership of Data . Service Recipient shall own all data and records created by Seller Representative or any of its Affiliates related exclusively to the Business and generated in connection with the performance of the Services (the Data ). Service Provider shall and hereby does, without further consideration, assign to Service Recipient any and all right, title or interest that Service Provider may possess in or to the Data. Upon Service Recipients request, Service Provider shall provide Service Recipient with copies of the Data in the format in which such Data is generated.
7.5. Limited License . Service Recipient hereby grants to Service Provider a non-exclusive, nontransferable, royalty-free, worldwide license to use its intellectual property for the limited purpose of and only to the extent necessary for the performance of the Services.
8. RELATIONSHIP BETWEEN THE PARTIES. The parties to this Agreement are and shall remain independent contractors and neither party is an employee, agent, partner, franchisee or joint venturer of or with the other. Each party will be solely responsible for any employment-related taxes, insurance premiums or other employment benefits respecting its employees. Neither party shall hold itself out as an agent of the other and neither party shall have the authority to bind the other.
9. AFFILIATE PERFORMANCE. Service Provider may engage one or more Affiliates to perform all or any portion of Service Providers duties under this Agreement; provided that Service Provider remains responsible for the performance of such Affiliates.
10. CONFIDENTIALITY.
10.1. Each party shall retain in strict confidence, and shall cause such partys representatives to retain in strict confidence, the terms and conditions of this Agreement and all information and data relating to the other party received pursuant to this Agreement, including information regarding its business, employees, development plans, programs, documentation, techniques, trade secrets, systems and know-how ( Confidential Information ) and shall not use such Confidential Information other than in connection with performance of this Agreement or, unless otherwise required by law, disclose such information to any third party without the other partys prior written consent, except for Confidential Information that:
(a) was in such partys possession on a non-confidential basis prior to the time of disclosure to such party by the disclosing party or its agents;
(b) in the case of Service Recipient, was included in the Purchased Assets;
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(c) was or becomes generally available to the public other than as a result of a disclosure by such party or its representatives; or
(d) becomes available to such party on a non-confidential basis from a source other than the disclosing party or its agents;
provided, in the case of (a) or (c), that the source of such information is not, to the knowledge of the receiving party, bound by a confidentiality agreement with the disclosing party or, to the receiving partys knowledge, otherwise prohibited from disclosing the information to the receiving party by a contractual, legal or fiduciary obligation.
10.2. In the event that the receiving party or any of its representatives are requested or required by judicial process to disclose any Confidential Information, the receiving party will provide the disclosing party with prompt written notice of any such request or requirement so that the disclosing party may seek an appropriate protective order or other appropriate remedy and/or waive compliance with the terms of this Agreement. In the event that such protective order or other remedy is not obtained, or that the disclosing party waives compliance with the terms hereof, the receiving party may disclose only that portion of the Confidential Information which is legally required and will exercise reasonable efforts to obtain assurance that confidential treatment will be accorded to such Confidential Information. The receiving party agrees not to oppose action taken by the disclosing party to obtain an appropriate protective order or other reliable assurance that confidential treatment will be accorded to the Confidential Information.
10.3. NEITHER PARTY MAKES ANY REPRESENTATIONS REGARDING THE ACCURACY OF CONFIDENTIAL INFORMATION.
10.4. It is understood and agreed that money damages may not be a sufficient remedy for any breach of this Section 10 , and that the disclosing party may be entitled to specific performance and injunctive or other equitable relief as a remedy for any such breach. Such remedy shall not be deemed to be the exclusive remedy for breach of this Section 10 , but shall be in addition to all other remedies available at law or equity to the disclosing party.
10.5. The obligations in this Section 10 shall survive any expiration or termination of this Agreement for three (3) years after the date of expiration or termination of this Agreement.
11. INDEMNIFICATION.
11.1. Each party will indemnify and hold harmless the other party and its Affiliates from and against any and all Losses which any such indemnitee may incur or suffer to the extent proximately caused by the gross negligence or wilful misconduct of the other party or as a result of a failure by a party to perform any covenant or obligation set forth in this Agreement. Notwithstanding anything to the contrary, the aggregate liability for which the Service Provider can be found liable under this Agreement is as set forth in Section 2.6 hereof.
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11.2. EXCEPT AS EXPRESSLY SET OUT IN THIS AGREEMENT, SERVICE PROVIDER MAKES NO WARRANTY OR REPRESENTATION REGARDING THE SERVICES, EXPRESS OR IMPLIED, INCLUDING, BUT NOT LIMITED TO, ANY WARRANTY AS TO MERCHANTABILITY, FITNESS FOR A PARTICULAR PURPOSE OR NON-INFRINGEMENT.
12. FORCE MAJEURE. Each party will be excused for any failure or delay in performing any of its obligations under this Agreement, other than the obligations of Service Recipient to make payments to Service Provider for Services already rendered, if such failure or delay is caused by any act of God, any accident, explosion, fire, act of terrorism, storm, earthquake, flood or any similar circumstance or event.
13. MISCELLANEOUS.
13.1. Interpretation . Except as otherwise explicitly specified to the contrary, (a) references to a Section or Transition Service Schedule mean a Section of or Transition Service Schedule to this Agreement, unless another agreement is specified, (b) the word including (in its various forms) means including without limitation, (c) references to a particular statute or regulation include all rules and regulations thereunder and any predecessor or successor statute, rules or regulation, in each case as amended or otherwise modified from time to time, (d) words in the singular or plural form include the plural and singular form, respectively, (e) references to a particular Person include such Persons successors and assigns to the extent not prohibited by this Agreement, (f) the headings contained in this Agreement and in any Transition Service Schedule hereto are for reference purposes only and shall not affect in any way the meaning or interpretation of this Agreement and (g) references to $ shall mean U.S. dollars.
13.2. Entire Agreement . This Agreement, including the other documents and agreements and Transition Service Schedules specifically referred to herein, constitutes the entire agreement between and among the parties hereto with regard to the subject matter hereof, and supersedes all prior agreements and understandings with regard to such subject matter. There are now no agreements, representations or warranties between or among the parties other than those set forth in the Asset Purchase Agreement or the documents and agreements contemplated in this Agreement and the Asset Purchase Agreement.
13.3. Amendment, Waivers and Consents . This Agreement shall not be changed or modified, in whole or in part, except by supplemental agreement or amendment signed by both parties. Any party may waive compliance by any other party with any of the covenants or conditions of this Agreement, but no waiver shall be binding unless executed in writing by the party making the waiver. No waiver of any provision of this Agreement shall be deemed, or shall constitute, a waiver of any other provision, whether or not similar, nor shall any waiver constitute a continuing waiver. Any consent under this Agreement shall be in writing and shall be effective only to the extent specifically set forth in such writing.
13.4. Successors and Assigns . Subject to the immediately following sentence, this Agreement will be binding upon and inure to the benefit of the parties and their respective successors and permitted assigns, each of which such successors and permitted assigns will
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be deemed to be a party hereto for all purposes hereof. Neither party may assign, delegate or otherwise transfer either this Agreement or any of its rights, interests or obligations hereunder without the prior written approval of the other party, and any attempt to do so will be null and void ab initio ; provided that (a) each party may assign this Agreement and any or all of its rights and interests hereunder to one or more of its Affiliates or designate one or more of its Affiliates to perform its obligations hereunder, in each case, so long as such party is not relieved of any liability or obligations hereunder, (b) each party may assign this Agreement and any or all of its rights and interest hereunder to any purchaser of all or substantially all of its assets or business related to this Agreement (whether by merger, stock purchase, asset purchase or otherwise) and (c) each party may collaterally assign any or all of its rights and obligations hereunder to any provider of debt financing to it or any of its Affiliates. In addition, Service Provider may use one or more subcontractors or other third parties to perform any of its obligations hereunder; provided that Service Provider shall remain responsible for each Service and liable hereunder for any such subcontractors failure to perform the obligations of Service Provider set forth in this Agreement.
13.5. Governing Law . The rights and obligations of the parties shall be governed by, and this Agreement shall be interpreted, construed and enforced in accordance with, the internal laws of the State of New York, excluding its conflict of laws rules to the extent such rules would apply the law of another jurisdiction.
13.6. Jurisdiction . Subject to Section 3.2 , any judicial proceeding brought against any of the parties to this Agreement or any dispute arising out of this Agreement or related hereto shall be brought in the courts of the State of New York, or in the U.S. District Court for the Southern District of New York, and, by execution and delivery of this Agreement, each of the parties to this Agreement accepts the exclusive jurisdiction of such courts, and irrevocably agrees to be bound by any judgment rendered thereby in connection with this Agreement. The foregoing consents to jurisdiction shall not constitute general consents to service of process in the State of New York for any purpose except as provided above and shall not be deemed to confer rights on any Person other than the parties to this Agreement. Each of the parties to this Agreement agree that service of any process, summons, notice or document by U.S. mail to such partys address for notice hereunder shall be effective service of process for any action, suit or proceeding in the State of New York with respect to any matters for which it has submitted to jurisdiction pursuant to this Section 13.6 .
13.7. Rules of Construction . The parties acknowledge that each party has read and negotiated the language used in this Agreement. The parties agree that, because all parties participated in negotiating and drafting this Agreement, no rule of construction shall apply to this Agreement which construes ambiguous language in favor of or against any party by reason of that partys role in drafting this Agreement.
13.8. Severability . If any provision of this Agreement, as applied to either party or to any circumstance, is declared by a court of competent jurisdiction to be illegal, unenforceable or void, this Agreement shall continue in full force and effect without said provision.
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13.9. Transition Service Schedules . All Transition Service Schedules attached hereto shall be deemed to be a part of this Agreement and are fully incorporated in this Agreement by this reference.
13.10. Notices . Any notice required or permitted to be given hereunder shall be sufficient if in writing and (a) delivered in person or by express delivery or courier service, (b) sent by facsimile or e-mail (with confirmation of transmission), or (c) deposited in the mail registered or certified first class, postage prepaid and return receipt requested (provided that any notice given pursuant to clause (b) is also confirmed by the means described in clause (a) or (c)) to such address or facsimile number of the party set forth below or to such other place or places as such party from time to time may designate in writing in compliance with the terms hereof. Each notice shall be deemed given when so delivered personally, or sent by facsimile transmission or e-mail, or, if sent by express delivery or courier service one (1) Business Day after being sent, or if mailed, five (5) Business Days after the date of deposit in the mail. A notice of change of address or facsimile number shall be effective only when given in accordance with this Section 13.10 .
To Service Recipient at: | Concordia Pharmaceuticals Inc. | |
Chancery House | ||
High Street | ||
Bridgetown, BB11128 | ||
Barbados, West Indies | ||
Attention: John McCleery | ||
Fax: +1 (246) 431-0076 | ||
Phone: +1 (246) 431-0070 | ||
E-mail: jmccleery@concordiarx.com | ||
With a copy to: | Concordia Healthcare Inc. | |
277 Lakeshore Road East, Suite 204 | ||
Oakville, Ontario, Canada | ||
L6J 1H9 | ||
Attention: Mark Thompson | ||
Fax: (416) 972-6208 | ||
Phone: (416) 453-9497 | ||
E-mail: mthompson@concordiarx.com | ||
To Service Provider at: | PBM Pharmaceuticals, Inc. | |
200 Garrett Street, Suite S | ||
Charlottesville, VA 22902 | ||
Attention: CEO | ||
Telephone: 1-434-980-8100 | ||
With a copy to: | PBM Pharmaceuticals, Inc. | |
200 Garrett Street, Suite S | ||
Charlottesville, VA 22902 | ||
Attention: CFO | ||
Telephone: 1-434-980-8100 |
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13.11. Rights of Parties . Except as provided in Section 11 with respect to the indemnified parties, nothing in this Agreement, whether express or implied, is intended to confer any rights or remedies under or by reason of this Agreement on any persons other than the parties to it and their respective successors and permitted assigns, nor is anything in this Agreement intended to relieve or discharge the obligation or liability of any third party to any party to this Agreement, nor shall any provision give any third party any right of subrogation or action over or against any party to this Agreement.
13.12. Counterparts . This Agreement may be signed in any number of counterparts, including facsimile copies thereof or electronic scan copies thereof delivered by electronic mail, each of which shall be deemed an original, and all of which will constitute one and the same instrument.
[Signatures Follow On Next Page]
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IN WITNESS WHEREOF , each of the parties has caused this Agreement to be executed on its behalf by their respective officers thereunto duly authorized as of the Effective Date.
CONCORDIA PHARMACEUTICALS INC. as Service Recipient |
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By: |
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Name: | ||
Title: | ||
PBM PHARMACEUTICALS, INC. as Service Provider |
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By: |
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Name: | ||
Title: |
[Signature Page to Transition Services Agreement]
Schedule A
Transition Service Schedule
Schedule completed as per Transition Services Agreement
Disclosure Schedules
Disclosure required as per Asset Purchase Agreement
SCHEDULE LIST
Schedule 1.1(a) | - | Assigned Contracts | ||
Schedule 1.1(b) | - | Knowledge | ||
Schedule 1.1(c) | - | Leased Real Property | ||
Schedule 1.1(d) | - | Leases | ||
Schedule 1.1(e) | - | NDAs | ||
Schedule 1.1(f) | - | Owned Real Property | ||
Schedule 1.1(g) | - | Product Domain Names | ||
Schedule 1.1(h) | - | Product Marks | ||
Schedule 1.1(i) | - | Product Trade Dress | ||
Schedule 1.1(j) | - | Promotional Materials | ||
Schedule 1.1(k) | - | Registrations | ||
Schedule 1.1(l) | - | Sales Training Modules | ||
Schedule 1.1(m) | - | Seller Brands | ||
Schedule 1.1(n) | - | Tangible Personal Property | ||
Schedule 1.1(o) | - | Tooling | ||
Schedule 2.6 | - | Wire Instructions | ||
Schedule 4.3 | - | No Conflicts | ||
Schedule 4.4.1 | - | Title of Assets | ||
Schedule 4.4.2 | - | Condition | ||
Schedule 4.5.1 | - | Product Intellectual Property Actions and Governmental Orders | ||
Schedule 4.5.2 | - | Material Intellectual Property Agreements | ||
Schedule 4.6 | - | Litigation | ||
Schedule 4.7 | - | Consents | ||
Schedule 4.9 | - | Adverse Notice | ||
Schedule 4.10.1 | - | Regulatory Status of Donnatal Elixir, Donnatal Tablets and Donnatal Capsules | ||
Schedule 4.10.2 | - | Regulatory Status of Donnatal Extentabs | ||
Schedule 4.10.3 | - | Manufacturing of Donnatal at IriSys under NOOH | ||
Schedule 4.10.4 | - | Seller and West-Ward Pharmaceuticals Inc. | ||
Schedule 4.10.5 | - | Drug Master Files | ||
Schedule 4.10.6 | - | Records | ||
Schedule 4.10.7 | - | Reimbursable Coverage of Donnatal | ||
Schedule 4.10.8 | - | Import Matter | ||
Schedule 4.10.9 | - | Existing Registrations | ||
Schedule 4.10.11 | - | Current Permits | ||
Schedule 4.12 | - | Inventory | ||
Schedule 4.14 | - | Certain Changes | ||
Schedule 4.15.1 | - | Material Contracts | ||
Schedule 4.16.1 | - | Material Customers | ||
Schedule 4.16.2 | - | Material Suppliers | ||
Schedule 4.17.1 | - | Employees, Independent Contractors and Consultants | ||
Schedule 4.17.3 | - | Employment Actions | ||
Schedule 4.19.2 | - | Environmental Permits | ||
Schedule 4.19.5 | - | Storage Tanks |
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Schedule 4.19.6 | - | Off-Site Hazardous Materials Treatment, Storage, or Disposal Facilities or Locations | ||
Schedule 4.27 | - | Related Party Transactions | ||
Schedule 6.1 | - | Conduct with Respect to the Product | ||
Schedule 6.5 | - | Employees | ||
Schedule 7.2.6 | - | Closing Consents | ||
Schedule 8.4.2 | - | Joint Notice |
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Schedule 1.1(a)
Assigned Contracts
Disclosure required as per Asset Purchase Agreement
Schedule 1.1(b)
Knowledge
Disclosure required as per Asset Purchase Agreement
Schedule 1.1(c)
Leased Real Property
Disclosure required as per Asset Purchase Agreement
Schedule 1.1(d)
Leases
Disclosure required as per Asset Purchase Agreement
Schedule 1.1(e)
NDAs
Disclosure required as per Asset Purchase Agreement
Schedule 1.1(f)
Owned Real Property
Disclosure required as per Asset Purchase Agreement
Schedule 1.1(g)
Product Domain Names
Disclosure required as per Asset Purchase Agreement
Schedule 1.1(h)
Product Marks
Disclosure required as per Asset Purchase Agreement
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Schedule 1.1(i)
Product Trade Dress
Disclosure required as per Asset Purchase Agreement
Schedule 1.1(j)
Promotional Materials
Disclosure required as per Asset Purchase Agreement
Schedule 1.1(k)
Registrations
Disclosure required as per Asset Purchase Agreement
Schedule 1.1(l)
Sales Training Modules
Disclosure required as per Asset Purchase Agreement
Schedule 1.1(m)
Seller Brands
Disclosure required as per Asset Purchase Agreement
Schedule 1.1(n)
Tangible Personal Property
Disclosure required as per Asset Purchase Agreement
Schedule 1.1(o)
Tooling
Disclosure required as per Asset Purchase Agreement
Schedule 2.6
Wire Instructions
Disclosure required as per Asset Purchase Agreement
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Schedule 4.3
No Conflicts
Disclosure required as per Asset Purchase Agreement
Schedule 4.4.1
Title of Assets
Disclosure required as per Asset Purchase Agreement
Schedule 4.4.2
Condition
Disclosure required as per Asset Purchase Agreement
Schedule 4.5.1
Product Intellectual Property Actions and Governmental Orders
Disclosure required as per Asset Purchase Agreement
Schedule 4.5.2
Material Intellectual Property Agreements
Disclosure required as per Asset Purchase Agreement
Schedule 4.6
Litigation
Disclosure required as per Asset Purchase Agreement
Schedule 4.7
Consents
Disclosure required as per Asset Purchase Agreement
Schedule 4.9
Adverse Notice
Disclosure required as per Asset Purchase Agreement
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Schedule 4.10.1
Regulatory Status of Donnatal Elixir, Donnatal Tablets, and Donnatal Capsules
Disclosure required as per Asset Purchase Agreement
Schedule 4.10.2
Regulatory Status of Donnatal Extentabs
Disclosure required as per Asset Purchase Agreement
Schedule 4.10.3
Manufacturing of Donnatal at IriSys under NOOH
Disclosure required as per Asset Purchase Agreement
Schedule 4.10.4
Seller and West-Ward Pharmaceuticals Inc.
Disclosure required as per Asset Purchase Agreement
Schedule 4.10.5
Drug Master Files
Disclosure required as per Asset Purchase Agreement
Schedule 4.10.6
Records
Disclosure required as per Asset Purchase Agreement
Schedule 4.10.7
Reimbursement Coverage of Donnatal
Disclosure required as per Asset Purchase Agreement
7
Schedule 4.10.8
Import Matter
Disclosure required as per Asset Purchase Agreement
Schedule 4.10.9
Existing Registrations
Disclosure required as per Asset Purchase Agreement
Schedule 4.10.11
Current Permits
Disclosure required as per Asset Purchase Agreement
Schedule 4.12
Inventory
Disclosure required as per Asset Purchase Agreement
Schedule 4.14
Certain Changes
Disclosure required as per Asset Purchase Agreement
Schedule 4.15.1
Material Contracts
Disclosure required as per Asset Purchase Agreement
Schedule 4.16.1
Material Customers
Disclosure required as per Asset Purchase Agreement
Schedule 4.16.2
Material Suppliers
Disclosure required as per Asset Purchase Agreement
8
Schedule 4.17.1
Employees, Independent Contractors and Consultants
Disclosure required as per Asset Purchase Agreement
Schedule 4.17.3
Employment Actions
Disclosure required as per Asset Purchase Agreement
Schedule 4.19.2
Environmental Permits
Disclosure required as per Asset Purchase Agreement
Schedule 4.19.5
Storage Tanks
Disclosure required as per Asset Purchase Agreement
Schedule 4.19.6
Off-Site Hazardous Materials Treatment, Storage, or Disposal Facilities or Locations
Disclosure required as per Asset Purchase Agreement
Schedule 4.27
Related Party Transactions
Disclosure required as per Asset Purchase Agreement
Schedule 6.1
Conduct with Respect to the Product
Disclosure required as per Asset Purchase Agreement
Schedule 6.5
Employees
Disclosure required as per Asset Purchase Agreement
9
Schedule 7.2.6
Closing Consents
Disclosure required as per Asset Purchase Agreement
Schedule 8.4.2
Joint Notice
Disclosure required as per Asset Purchase Agreement
10
Exhibit 99.13
Execution Copy
GUARANTEE
This Guarantee is made by Concordia Healthcare Corp., an Ontario corporation ( Guarantor ), in favor of Eisai Inc., a Delaware corporation ( Seller ), as of September 3, 2014 (this Guarantee ).
Capitalized terms used herein without definition have the meanings given to them in the Asset Purchase Agreement (as defined below). Section 1.2 of the Asset Purchase Agreement is incorporated herein by this reference mutatis mutandis .
1. Guarantee . To induce Seller to enter into the Asset Purchase Agreement of even date herewith (as amended, amended and restated, supplemented or otherwise modified from time to time, the Asset Purchase Agreement ), by and between Concordia Pharmaceuticals Inc., an international business company incorporated under the laws of Barbados ( Buyer ), and Seller, and the Ancillary Agreements (other than this Guarantee) to be entered into at the Closing, Guarantor hereby absolutely, unconditionally and irrevocably guarantees, as primary obligor and not merely as surety, the due and punctual payment, performance and discharge of Buyers payment and indemnification obligations under (a) the Asset Purchase Agreement and (b) each Ancillary Agreement other than this Guarantee which contains payment or indemnification obligations (collectively, the Obligations , and such agreements, the Guaranteed Agreements ).
2. Nature of Guarantee . Seller shall not be obligated to file any claim relating to the Obligations in the event that Buyer becomes subject to an Insolvency Event (as defined in Section 16 below), and the failure of Seller to so file shall not affect Guarantors obligations hereunder. In the event that any payment to Seller in respect of the Obligations is rescinded or must otherwise be returned for any reason whatsoever (the Returned Amounts ), Guarantor shall remain liable hereunder with respect to the Obligations as if such payment had not been made. This is an unconditional guarantee of payment and not of collectibility.
3. Changes in Obligations; Certain Waivers .
1.1. Guarantor agrees that its obligations hereunder shall not be released or discharged, in whole or in part, or otherwise affected by (i) the failure of Seller to assert any claim or demand or to enforce any right or remedy against Buyer (or any of its permitted assignees) or any other Person; (ii) any change in time, place or manner of payment of any of the Obligations or any rescission, waiver, compromise, consolidation or other amendment to or modification of any of the terms or provisions of any Guaranteed Agreement made in accordance with the terms thereof or any other agreement evidencing, securing or otherwise executed in connection with any of the Obligations; (iii) the addition, substitution or release of Buyer (or any of its permitted assignees) or any other Person; (iv) any change in the corporate existence, structure or ownership of Buyer (or any of its permitted assignees) or any other Person; (v) any Insolvency Event or other similar proceeding affecting Buyer (or any of its successors or permitted assigns) or any other Person; (vi) the existence of any claim, set-off or other right which the Guarantor may have at any time against Buyer or Seller or any of their respective Affiliates, whether in connection with the Obligations or otherwise; (vii) the adequacy of any other means Seller may have of obtaining repayment of
any of the Obligations; or (viii) the value, genuineness, validity, regularity, illegality or enforceability of any Guaranteed Agreement. To the fullest extent permitted by Law, Guarantor hereby expressly waives any and all rights or defenses arising by reason of any Law which would otherwise require any election of remedies by Seller. Guarantor waives promptness, diligence, notice of the acceptance of this Guarantee and of the Obligations, presentment, demand for payment, notice of non-performance, default, dishonor and protest, notice of die incurrence of any Obligations and all other notices of any kind, all defenses which may be available by virtue of any valuation, stay, moratorium law or other similar Law now or hereafter in effect, any right to require the marshalling of assets of Buyer or any other Person interested in the transactions contemplated by the Guaranteed Agreements, and all suretyship defenses generally. Notwithstanding anything to the contrary, (A) Guarantor shall be entitled to the benefit of and may assert any right, remedy, set-off, claim, counter-claim, limitation and defense against the payment of the Obligations that are available to Buyer under any applicable Guaranteed Agreement (other than any such rights, remedies, set-offs, claims, counter-claims, limitations and defenses arising out of, or due to, or as a result of, the insolvency or bankruptcy of Buyer (including the rejection of the applicable Guaranteed Agreement in an insolvency or bankruptcy of Buyer)); (B) Seller hereby agrees that to the extent Buyer is relieved of its obligations and liabilities under any Guaranteed Agreement (other than due to, in connection with, or as a result of, the insolvency or bankruptcy of Buyer (including the rejection of the applicable Guaranteed Agreement in an insolvency or bankruptcy of Buyer)), Guarantor shall be similarly relieved of the applicable Obligations under this Guarantee; and (C) Guarantor shall be entitled to the benefit of the defense of payment in full. Guarantor acknowledges that it will receive substantial direct and indirect benefits from the transactions contemplated by the Guaranteed Agreements and that the waivers set forth in this Guarantee are knowingly made in contemplation of such benefits.
1.2. Guarantor hereby covenants and agrees that it shall not institute, directly or indirectly, and shall cause its Affiliates not to institute, directly or indirectly, any Litigation asserting that this Guarantee is illegal, invalid or unenforceable in accordance with its terms. Guarantor hereby unconditionally and irrevocably agrees not to exercise any rights that it may now have or hereafter acquire against Buyer that arise from the existence, payment, performance, or enforcement of Guarantors obligations under or in respect of this Guarantee or any other agreement in connection with this Guarantee, including any right of subrogation, reimbursement, exoneration, contribution or indemnification and any right to participate in any claim or remedy of Seller against Buyer, whether or not such claim, remedy or right arises under applicable Law, whether at law or in equity, or under Contract, including the right to take or receive from Buyer, directly or indirectly, in cash or other property or by set-off or in any other manner, payment or security on account of such claim, remedy or right, in each case, unless and until all of the Obligations and all other amounts payable under this Guarantee shall have been paid in full in cash. If any amount shall be paid to Guarantor in violation of the immediately preceding sentence at any time prior to the payment in full of the Obligations and all other amounts payable under this Guarantee, an amount equal to the lesser of (i) the amount paid to Guarantor in violation of the immediately preceding sentence and (ii) all amounts payable under this Guarantee shall forthwith be paid or delivered to Seller in the same form as so received (with any necessary endorsement or assignment) to be credited and applied to the Obligations and all other amounts payable under this Guarantee, in accordance with the terms of each applicable Guaranteed
2
Agreement, whether matured or unmatured, or to be held as collateral for any of the Obligations or other amounts payable under this Guarantee thereafter arising.
2. Expenses . Guarantor agrees to pay on demand all reasonable out-of-pocket expenses (including reasonable fees of counsel) incurred by Seller in connection with the enforcement of its rights hereunder.
3. Representations and Warranties . Guarantor hereby represents and warrants to Seller that:
3.1. Guarantor is a corporation duly organized, validly existing and in good standing under the Laws of the Province of Ontario.
3.2. Guarantor has the requisite corporate power and authority to enter into this Guarantee, to perform its obligations hereunder and to consummate the transactions contemplated hereby. The execution and delivery of this Guarantee and the consummation of the transactions contemplated hereby have been duly authorized by the necessary corporate actions of Guarantor. This Guarantee constitutes the valid and legally binding obligation of Guarantor, enforceable against Guarantor in accordance with its terms.
3.3. The execution, delivery and performance by Guarantor of this Guarantee does not and will not (i) violate the certificate of incorporation or bylaws of Guarantor, (ii) violate in any material respect any Law or other restriction of any Governmental Authority applicable to Guarantor or (iii) materially violate, materially breach or constitute a material default under or result in the termination of any material Contract to which Guarantor is a party.
3.4. All consents, approvals, authorizations, permits of, filings with and notifications to, any Governmental Authority or other Person necessary for the due execution, delivery and performance of this Guarantee by Guarantor have been obtained or made and all conditions thereof have been duly complied with, and no other action by, and no notice to or filing with, any Governmental Authority or other Person is required in connection with its execution, delivery or performance of this Guarantee, except for the failure to obtain or make, as applicable, such consents, approvals, authorizations, permits, filings and notifications which would not have a material adverse effect on Guarantor.
3.5. Guarantor has the financial capacity to pay and perform its obligations under this Guarantee as of the date hereof, and all funds necessary for Guarantor to fulfill its obligations under this Guarantee are and shall be available to Guarantor (or its assignee pursuant to Section 5 hereof) for as long as this Guarantee shall remain in effect in accordance with Section 8 hereof.
3.6. Guarantor is fully aware of the financial condition of Buyer and is executing and delivering this Guarantee based solely upon Guarantors own independent investigation of all matters pertinent hereto and is not relying in any manner upon any representation or statement of Seller.
3
3.7. Guarantor has adequate means to obtain on a continuing basis (i) from Buyer, information concerning Buyer and Buyers financial condition and affairs, and (ii) from other reliable sources, such other information as it deems material in deciding to provide this Guarantee.
4. Indemnity . Guarantor shall indemnify, defend and hold harmless Seller, its Affiliates and its and their respective directors, officers, employees and agents from and against, and compensate and reimburse each of them for, any and all Losses incurred by any of them arising out of or related to (a) any breach by Guarantor of any of its representations, warranties or covenants hereunder; (b) any failure of Guarantor to perform any of its covenants, obligations or agreements contained in this Guarantee; or (c) any Returned Amounts. This Section 4 shall survive any termination, cancellation or discharge of this Guarantee or any of the Obligations for a period of one (1) year.
5. Assignment . Neither this Guarantee nor either partys rights or obligations hereunder may be assigned or delegated by such party without the prior written consent of the other party, and any attempted assignment or delegation of this Guarantee or any of such rights or obligations by either party without the prior written consent of the other party shall be void and of no effect; provided, that Seller may assign this Guarantee, in whole or in part, to any assignee or transferee of any of Sellers rights under any Guaranteed Agreement without the prior written consent of Guarantor. Notwithstanding the foregoing, the Guarantor shall be entitled to assign this Guarantee to a third party that acquires all or substantially all of the assets of the Guarantor without the prior written consent of the Seller.
6. Notices .
6.1. Notice Requirements . Any notice, request, demand, waiver, consent, approval or other communication permitted or required under this Guarantee (each, a Notice ) shall be in writing, shall refer specifically to this Guarantee and shall be deemed given only if delivered by hand or sent by facsimile transmission or by email of a PDF attachment (with transmission confirmed) or by overnight registered mail, courier or express delivery service that maintains records of delivery, addressed to the parties at their respective addresses specified in Section 6.2 or to such other address as the party to whom notice is to be given may have provided to the other party at least 10 days prior to such address taking effect in accordance with this Section 6.1. Such Notice shall be deemed to have been received: (a) as of the date delivered by hand or by overnight registered mail, courier or express delivery service; or (b) on the day sent by facsimile or email provided that the sender has received confirmation of transmission (by facsimile or email receipt confirmation or confirmation by telephone (with respect to facsimile only) or email) prior to 6:00 p.m. Eastern Time on such day (and if confirmation is received after 6:00 p.m. Eastern Time, such Notice shall be deemed to have been delivered on the following Business Day). Any Notice delivered by facsimile or email shall be confirmed by a hard copy delivered promptly thereafter.
6.2. Address for Notice .
If to Seller, to:
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Eisai Inc.
100 Tice Boulevard
Woodcliff Lake, NJ 07677
Facsimile: [REDACTED]
Email: [REDACTED]
Attention: General Counsel
with a copy (which shall not constitute notice) to:
Covington & Burling LLP
1201 Pennsylvania Avenue, N.W.
Washington, DC 20004
Facsimile: (202) 778-5168
Email: mriella@cov.com
Attention: Michael J. Riella
If to Guarantor, to:
Concordia Healthcare Corp.
277 Lakeshore Road East, Suite 302
Oakville, Ontario L6J 1H9
Facsimile: [REDACTED]
Email: [REDACTED]
Attention: Leith Tessy
with a copy (which shall not constitute notice) to:
Fasken Martineau DuMoulin LLP
333 Bay Street, Suite 2400
Bay Adelaide Centre, Box 20
Toronto, Ontario, Canada M5H 2T6
Facsimile: (416) 364-7813
Email: jholmstrom@fasken.com
Attention: Jon Holmstrom
- and to -
Dorsey & Whitney LLP
Suite 1500, 50 South Sixth Street
Minneapolis, MN 55402-1498
Facsimile: (612) 677-3361
Email: rauch.eric@dorsey.com
Attention: Eric Rauch
7. Waiver and Non-Exclusion of Remedies . Any term or condition of this Guarantee may be waived at any time by the party that is entitled to the benefit thereof, but no such waiver shall be effective unless set forth in a written instrument duly executed by or on behalf of the party waiving such term or condition. The waiver by any party of any right hereunder or of the failure to perform or of a breach by the other party shall not be deemed a
5
waiver of any other right hereunder or of any other breach or failure by said other party whether of a similar nature or otherwise. The rights and remedies provided herein are cumulative and do not exclude any other right or remedy provided by applicable Law or otherwise available except as expressly set forth herein.
8. Continuing Guarantee . This Guarantee shall remain in full force and effect and shall be binding on Guarantor and its successors and permitted assigns, and shall inure to the benefit of Seller and its successors and permitted assigns, until all of the Obligations and all amounts payable under this Guarantee have been indefeasibly paid, observed, performed or satisfied in full, except to the extent set forth herein.
9. Governing Law; Jurisdiction; Venue and Service .
9.1. Governing Law . This Guarantee shall be governed by and construed in accordance with the Laws of the State of Delaware, excluding any conflicts or choice of Law rule or principle that might otherwise refer construction or interpretation of this Guarantee to the substantive Law of another jurisdiction.
9.2. Jurisdiction . Subject to Section 10, the parties each hereby irrevocably and unconditionally consent to the exclusive jurisdiction of the courts of the State of Delaware and the United States District Court for the District of Delaware for any action, suit or proceeding (other than appeals therefrom) arising out of or relating to this Guarantee, and agree not to commence any action, suit or proceeding (other than appeals therefrom) related thereto except in such courts. The parties irrevocably and unconditionally waive their right to a jury trial.
9.3. Venue . The parties further hereby irrevocably and unconditionally waive any objection to the laying of venue of any action, suit or proceeding (other than appeals therefrom) arising out of or relating to this Guarantee in the courts of the State of Delaware or in the United States District Court for the District of Delaware, and hereby further irrevocably and unconditionally waive and agree not to plead or claim in any such court that any such action, suit or proceeding brought in any such court has been brought in an inconvenient forum.
9.4. Service . Each of Seller and Guarantor further agrees that service of any process, summons, notice or document by registered mail to its address set forth in Section 6 shall be effective service of process for any action, suit or proceeding brought against it under this Guarantee in any such court.
10. Equitable Relief . The Parties agree that irreparable damage would occur in the event that any of the provisions of this Guarantee were not performed in accordance with their specific terms or were otherwise breached. It is accordingly agreed that the parties shall be entitled to an injunction or injunctions to prevent breaches of this Guarantee and to enforce specifically the terms and provisions of this Guarantee in any court of the United States or any state having jurisdiction, this being in addition to any other remedy to which they are entitled at law or in equity. Each party hereby waives (a) any requirement that the other party post a bond
6
or other security as a condition for obtaining any such relief, and (b) any defenses in any action for specific performance, including the defense that a remedy at law would be adequate.
11. Counterparts . This Guarantee may be executed in any number of counterparts, and each such counterpart hereof shall be deemed to be an original instrument, but all such counterparts together shall constitute but one agreement. Delivery of an executed counterpart of a signature page of this Guarantee by facsimile or other electronic transmission shall be effective as delivery of a manually executed original counterpart of this Guarantee.
12. Amendment . This Guarantee may not be modified, amended, altered or supplemented except upon the execution and delivery of a written agreement executed by both parties.
13. Severability . If any provision of this Guarantee is held to be illegal, invalid or unenforceable under any present or future Law, and if the rights or obligations of either party under this Guarantee will not be materially and adversely affected thereby, (a) such provision shall be fully severable, (b) this Guarantee shall be construed and enforced as if such illegal, invalid or unenforceable provision had never comprised a part hereof, (c) the remaining provisions of this Guarantee shall remain in full force and effect and shall not be affected by the illegal, invalid or unenforceable provision or by its severance herefrom and (d) in lieu of such illegal, invalid or unenforceable provision, there shall be added automatically as a part of this Guarantee a legal, valid and enforceable provision as similar in terms to such illegal, invalid or unenforceable provision as may be possible and reasonably acceptable to the parties.
14. No Benefit to Third Parties . The covenants and agreements set forth in this Guarantee are for the sole benefit of the parties and their respective successors and permitted assigns, and, except for the rights of any third party indemnitees under Article 4, they shall not be construed as conferring any rights on any other Persons.
15. English Language . This Guarantee shall be written and executed in, and all other communications under or in connection with this Guarantee shall be in, the English language. Any translation into any other language shall not be an official version thereof, and in the event of any conflict in interpretation between the English version and such translation, the English version shall control.
16. Definitions . As used in this Guarantee,
16.1. Insolvency Event means, with respect to a Person:
16.1.1. a voluntary case or proceeding under any applicable bankruptcy, insolvency, or other similar Law is commenced by such Person, or such Person consents to the entry of an order for relief in an involuntary case or proceeding under any such Law or against such Person, or such Person consents to the appointment of or taking possession by a receiver, liquidator, assignee, trustee, custodian, sequestrator, conservator, supervisor, rehabilitator (or other similar official) of such Person or for any material portion of such Persons assets and properties, or such Person makes a general assignment for the benefit of creditors, or such Person fails generally to pay, or admits in writing its inability to pay, its debts as they become due or takes any entity action in
7
furtherance of the foregoing, and such case, proceeding or event is not dismissed or remedied within 60 days;
16.1.2. the commencement of an involuntaiy case or proceeding under any applicable bankruptcy, insolvency, or other similar Law against such Person, and such case or proceeding is not dismissed within 60 days;
16.1.3. the entry by a Governmental Authority having jurisdiction over such Person of a decree or order appointing a receiver, liquidator, assignee, custodian, trustee, sequestrator, conservator, supervisor, rehabilitator (or similar official) for such Person or for any material portion of such Persons assets and properties, or ordering the winding-up, supervision, or liquidation of such Persons affairs, and such decree or order is not dismissed within 60 days; or
16.1.4. the taking of any formal action by such Person, its board of directors (or similar governing body) or holders of its voting securities authorizing any of the foregoing.
17. Entire Agreement . This Guarantee contains the entire agreement between Guarantor and Seller with respect to the transactions contemplated hereby and supersede all prior agreements, understandings, promises and representations, whether written or oral, between Guarantor and Seller with respect to the subject matter hereof.
[ The remainder of this page is left blank intentionally .]
8
IN WITNESS WHEREOF, each of Guarantor and Seller has caused this Guarantee to be executed and delivered as of the date first written above.
GUARANTOR: |
||||
CONCORDIA HEALTHCARE CORP. |
||||
By: |
[REDACTED] |
|||
|
||||
Name: | Mark Thompson [REDACTED] | |||
Title: | CEO [REDACTED] | |||
SELLER: | ||||
EISAI INC. | ||||
By: |
|
|||
Name: | ||||
Title: |
[S IGNATURE P AGE TO G UARANTEE ]
IN WITNESS WHEREOF, each of Guarantor and Seller have executed this Guarantee as of the date first written above.
GUARANTOR : | ||||
CONCORDIA HEALTHCARE CORP. |
||||
By: |
|
|||
Name: | ||||
Title: | ||||
SELLER : | ||||
EISAI INC. | ||||
By: |
[REDACTED] |
|||
|
||||
Name: | Shaji Procida | |||
Title: | President & COO |
[S IGNATURE P AGE TO G UARANTEE ]
Exhibit 99.14
Execution Copy
ASSET PURCHASE AGREEMENT
By and between
EISAI INC.
and
CONCORDIA PHARMACEUTICALS INC.
Dated as of September 3, 2014
TABLE OF CONTENTS
ARTICLE 1 |
DEFINITIONS |
1 | ||||
1.1 |
Certain Defined Terms |
1 | ||||
1.2 |
Construction |
14 | ||||
ARTICLE 2 |
SALE AND PURCHASE OF ASSETS; LIABILITIES |
15 | ||||
2.1 |
Sale of Purchased Assets |
15 | ||||
2.2 |
Liabilities |
17 | ||||
2.3 |
Consideration |
17 | ||||
2.4 |
Closing |
20 | ||||
ARTICLE 3 |
REPRESENTATIONS AND WARRANTIES |
21 | ||||
3.1 |
Representations and Warranties of Seller |
21 | ||||
3.2 |
Representations and Warranties of Buyer |
29 | ||||
ARTICLE 4 |
PRE-CLOSING COVENANTS |
31 | ||||
4.1 |
Access and Information |
31 | ||||
4.2 |
Ordinary Course of Business |
32 | ||||
4.3 |
Obligation to Consummate the Transaction |
33 | ||||
4.4 |
Competition Filings |
34 | ||||
4.5 |
Notices |
35 | ||||
ARTICLE 5 |
ADDITIONAL COVENANTS |
35 | ||||
5.1 |
Cooperation in Litigation and Investigations |
35 | ||||
5.2 |
Further Assurances |
35 | ||||
5.3 |
Publicity |
37 | ||||
5.4 |
Confidentiality |
38 | ||||
5.5 |
Commercialization |
40 | ||||
5.6 |
Transitional Trademark License |
42 | ||||
5.7 |
Regulatory Responsibilities |
43 | ||||
5.8 |
Access to Regulatory Approvals and Documentation |
44 | ||||
5.9 |
Medical and Other Inquiries |
45 | ||||
5.10 |
Wrong Pockets |
45 | ||||
5.11 |
Accounts Receivable; Accounts Payable |
46 |
i
5.12 |
Non-Competition |
46 | ||||
5.13 |
Certain Tax Matters |
47 | ||||
5.14 |
Payment Claims; Government Price Reporting |
48 | ||||
5.15 |
Covenant Not to Sue |
53 | ||||
5.16 |
Ancillary Agreements |
53 | ||||
ARTICLE 6 |
CONDITIONS PRECEDENT |
53 | ||||
6.1 |
Conditions to Obligations of Buyer and Seller |
53 | ||||
6.2 |
Conditions to Obligations of Buyer |
54 | ||||
6.3 |
Conditions to Obligations of Seller |
54 | ||||
6.4 |
Frustration of Closing Conditions |
55 | ||||
ARTICLE 7 |
INDEMNIFICATION |
55 | ||||
7.1 |
Indemnification |
55 | ||||
7.2 |
Claim Procedure |
56 | ||||
7.3 |
Limitations on Indemnification |
59 | ||||
7.4 |
Tax Treatment of Indemnification Payments |
61 | ||||
7.5 |
Exclusive Remedy |
61 | ||||
7.6 |
Setoff Rights |
61 | ||||
ARTICLE 8 |
TERMINATION |
61 | ||||
8.1 |
Termination |
61 | ||||
8.2 |
Procedure and Effect of Termination |
62 | ||||
ARTICLE 9 |
MISCELLANEOUS |
63 | ||||
9.1 |
Governing Law, Jurisdiction, Venue and Service |
63 | ||||
9.2 |
Notices |
63 | ||||
9.3 |
No Benefit to Third Parties |
65 | ||||
9.4 |
Waiver and Non-Exclusion of Remedies |
65 | ||||
9.5 |
Expenses |
65 | ||||
9.6 |
Assignment |
65 | ||||
9.7 |
Amendment |
65 | ||||
9.8 |
Severability |
66 | ||||
9.9 |
Equitable Relief |
66 | ||||
9.10 |
English Language |
66 |
ii
9.11 |
Bulk Sales Statutes |
66 | ||||
9.12 |
Counterparts |
66 | ||||
9.13 |
Entire Agreement |
66 |
iii
EXHIBITS
Exhibit A | Form of Dainippon Assignment and Assumption Agreement | |
Exhibit B | Form of Supply Agreement | |
Exhibit C | Form of Transition Services Agreement |
SCHEDULES
Schedule 1.1.74 | Licensed Copyrights | |
Schedule 1.1.77 | Licensed Trademarks | |
Schedule 1.1.94 | Permitted Encumbrances | |
Schedule 1.1.108 | Purchased Domain Names | |
Schedule 1.1.124 | Seller Marks | |
Schedule 1.1.128 | Sellers Knowledge | |
Schedule 2.1.1(a) | Purchased Contracts | |
Schedule 2.3.1 | Purchased Inventory Value Calculation | |
Schedule 2.4.2(a)(iii) | Purchased Assets Delivery Schedule | |
Schedule 3.2.5 | Buyer Consents | |
Schedule 4.2.1 | Ordinary Course of Business Exceptions | |
Schedule 5.14.2(d) | Best Price and AMP |
iv
ASSET PURCHASE AGREEMENT
This Asset Purchase Agreement (this Agreement ) is made and executed as of September 3, 2014 (the Execution Date ), by and between Eisai Inc., a Delaware corporation ( Seller ), and Concordia Pharmaceuticals Inc., an international business company incorporated under the laws of Barbados ( Buyer ). Seller and Buyer are sometimes referred to herein individually as a Party and collectively as the Parties .
RECITALS
WHEREAS , Seller is engaged in the sourcing and Exploitation of the Product in the Buyer Territory (collectively, the Product Business );
WHEREAS , Seller wishes to sell to Buyer, and Buyer desires to purchase from Seller, certain assets and rights comprising or associated with the Product Business, upon the terms and conditions hereinafter set forth;
WHEREAS , concurrently with the Parties execution and delivery of this Agreement, Buyer Parent is executing and delivering to Seller the Guarantee; and
WHEREAS , at the Closing, Seller and Buyer intend to enter into the Dainippon Assignment and Assumption Agreement and the other Ancillary Agreements (other than the Guarantee).
NOW, THEREFORE , in consideration of the mutual benefits to be derived from this Agreement and of the representations, warranties, conditions, agreements and promises contained herein and other good and valuable consideration, the receipt and sufficiency of which are hereby acknowledged, the Parties, intending to be legally bound, hereby agree as follows:
ARTICLE 1
DEFINITIONS
1.1 Certain Defined Terms. As used herein, the following terms shall have the following meanings:
1.1.1 Accountants means Grant Thornton LLP or if Grant Thornton LLP is unable or refuses to act, an accounting firm of national reputation (excluding each of Sellers and Buyers respective regular outside accounting firms) as may be mutually acceptable to Seller and Buyer.
1.1.2 Accounts Receivable means all accounts receivable, notes receivable and other indebtedness due and owed by any Third Party to Seller or any of its Affiliates arising from sales of the Product by or on behalf of Seller or its Affiliates prior to the Closing Date.
1
1.1.3 Act means the United States Federal Food, Drug and Cosmetic Act.
1.1.4 Actual Closing Date Inventory Value has the meaning set forth in Section 2.3.2(a).
1.1.5 Affiliate means, with respect to a Person, any other Person that, directly or indirectly, through one or more intermediaries, controls, is controlled by or is under common control with such first Person. For purposes of this definition, control and, with correlative meanings, the terms controlled by and under common control with, means (a) the possession, directly or indirectly, of the power to direct the management or policies of a business entity, whether through the ownership of voting securities, by contract relating to voting rights or corporate governance, or otherwise or (b) the ownership, directly or indirectly, of more than 50% of the voting securities or other ownership interest of a business entity (or, with respect to a limited partnership or other similar entity, its general partner or controlling entity).
1.1.6 Agreed Amount has the meaning set forth in Section 7.2.1.
1.1.7 Agreement has the meaning set forth in the preamble hereto.
1.1.8 Allocation has the meaning set forth in Section 2.3.3(a).
1.1.9 AMP has the meaning set forth in Section 5.14.2(d).
1.1.10 Ancillary Agreements means the Bill of Sale, the Dainippon Assignment and Assumption Agreement, the Domain Name Assignment Agreement, the Guarantee, the License Agreement, the Quality Agreement, the Safety Data Exchange Agreement, the Supply Agreement and the Transition Services Agreement.
1.1.11 Apportioned Obligations has the meaning set forth in Section 5.13.1(b).
1.1.12 Assumed Liabilities has the meaning set forth in Section 2.2.1.
1.1.13 Authorization means any consent, approval, order, license, permit and other similar authorization of or from any Governmental Authority, together with any renewals, extensions, or modifications thereof and additions thereto.
1.1.14 Best Price has the meaning set forth in Section 5.14.2(d).
1.1.15 Bill of Sale means one or more Bill of Sale and Assignment and Assumption Agreements to be entered into by the Parties or their respective Affiliates at Closing.
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1.1.16 Business Day means any day other than Saturday, Sunday or a day on which banking institutions in New York, New York, the province of Ontario, Canada or Barbados are permitted or obligated by Law to remain closed.
1.1.17 Buyer has the meaning set forth in the preamble hereto.
1.1.18 Buyer Confidential Information has the meaning set forth in Section 5.4.2.
1.1.19 Buyer Indemnitees has the meaning set forth in Section 7.1.1.
1.1.20 Buyer Material Adverse Effect means any event, fact, condition, occurrence, change or effect that prevents or materially delays the consummation by Buyer of the Transactions.
1.1.21 Buyer Parent means Concordia Healthcare Corp.
1.1.22 Buyer Permitted Purpose has the meaning set forth in Section 5.4.3.
1.1.23 Buyer Regulatory Approvals and Documentation means any and all Regulatory Approvals and other Regulatory Documentation related to the Product or any Other Product, in each case, that are Controlled by Buyer or any of its Affiliates, licensees, sublicensees or distributors effective as of and following the Closing, including the U.S. Regulatory Approval and the Purchased Regulatory Documentation.
1.1.24 Buyer Territory means the United States of America, including Puerto Rico.
1.1.25 Canadian Securities Laws means, collectively, securities statutes in each of the Provinces of Canada (other than Quebec) and the respective rules and regulations made thereunder, together with applicable multilateral or national instruments, orders and rulings issued or adopted by the securities commissions or regulatory authorities of such Provinces.
1.1.26 cGMP means the then-current standards of good manufacturing practice for, the manufacture, processing, packaging, testing or holding of a medicinal product for human use to assure that such medicinal product meets the requirements of applicable Law and other requirements of the FDA or any other Governmental Authority as to safety, identity and strength, and meets the quality and purity characteristics that it purports or is represented to possess.
1.1.27 Chargeback Claims has the meaning set forth in Section 5.14.4(a).
1.1.28 Claim Notice has the meaning set forth in Section 7.2.2.
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1.1.29 Closing has the meaning set forth in Section 2.4.1.
1.1.30 Closing Date means the date on which the Closing occurs.
1.1.31 Closing Date Inventory Statement has the meaning set forth in Section 2.3.2(a).
1.1.32 Closing Payment has the meaning set forth in Section 2.3.1(a).
1.1.33 Code means the Internal Revenue Code of 1986.
1.1.34 Confidential Information has the meaning set forth in Section 5.4.1.
1.1.35 Confidentiality Agreement means that certain Confidentiality Agreement, dated as of June 4, 2014, between Buyer and Seller.
1.1.36 Contract means any written or oral contract, agreement, lease, sublease, license, sublicense, instrument, note, guaranty, deed, assignment, purchase order, or other legally binding commitment or arrangement.
1.1.37 Control means, with respect to any Regulatory Approval, Regulatory Documentation or Intellectual Property Rights, possession of the right, whether directly or indirectly, and whether by ownership, license or otherwise, to assign or grant a license, sublicense or other right to or under such Regulatory Approval, Regulatory Documentation or Intellectual Property Right as provided for herein or in any of the Ancillary Agreements without violating the terms of any Contract with any Third Party.
1.1.38 Controlling Party has the meaning set forth in Section 7.2.2.
1.1.39 Copyright means copyrights and rights in copyrightable works, copyright registrations, or any application therefor and all extensions, restorations, reversions and renewals of any of the foregoing, in each case, in the Buyer Territory.
1.1.40 Dainippon means Dainippon Sumitomo Pharma Co., Ltd.
1.1.41 Dainippon Assignment and Assumption Agreement means the Assignment and Assumption Agreement to be entered into by Dainippon, Seller and Buyer (or the Parties respective Affiliates) at or prior to Closing, substantially in the form attached as Exhibit A .
1.1.42 Dainippon License Agreement means the Distribution and License Agreement concerning zonisamide for the North America territory, dated March 21, 1997, among Eisai Co., Ltd., Seller and Dainippon, as amended, restated, replaced or supplemented from time to time.
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1.1.43 Disclosing Party has the meaning set forth in Section 5.4.1.
1.1.44 Disclosure Schedules means the disclosure schedules of Seller related to the representations and warranties of Seller set forth in Section 3.1.
1.1.45 Domain Name Assignment Agreement means the Domain Name Assignment Agreement to be entered into by the Parties or their respective Affiliates at Closing.
1.1.46 Domain Names means any and all Internet or global computing network addresses or locations, including all generic top-level domains ( gTLDs ) and country code top-level domains ( ccTLDs ).
1.1.47 Encumbrance means any charge, claim, community property interest, condition, equitable interest, mortgage, lien (statutory or other), license, pledge, option, security interest, right of first refusal, or other encumbrance or restriction of any kind, including any restriction on use or transfer, receipt of income or exercise of any other attribute of ownership.
1.1.48 End Date has the meaning set forth in Section 8.1.2.
1.1.49 Estimated Closing Date Inventory Value has the meaning set forth in Section 2.3.1(b).
1.1.50 Excluded Assets means all assets, property, rights and interests of Seller and its Affiliates other than the Purchased Assets, including (a) all rights with respect to the Product in the Seller Territory, (b) all tangible personal property of Seller or any of its Affiliates other than the Purchased Inventory and other tangible Purchased Assets, (c) all Intellectual Property Rights of Seller and its Affiliates other than the Purchased Domain Names and (d) all Manufacturing assets of Seller and its Affiliates.
1.1.51 Excluded Liabilities means all Liabilities (a) arising out of, or related to, (i) the Manufacture or Exploitation of the Product in the Buyer Territory before the Closing ( provided , however , that (x) with respect to this clause (i), a Liability will not be considered to arise prior to the Closing solely by virtue of the chemical structure or any inherent characteristic of zonisamide, the fact that zonisamide was first discovered prior to the Closing or any disclosure in any warning on the Product label or Product insert or packaging and (y) this clause (i) shall not include any Liabilities arising out of or related to any Product sold under the Supply Agreement), or (ii) the Manufacture or Exploitation of the Product or any Other Product in the Seller Territory, in each case, on, before, or after the Closing ( provided , however , that this clause (ii) shall not include (x) Liabilities arising out of or related to the Product or Other Product sold or distributed by or on behalf of Buyer or its Affiliates outside of the Buyer Territory in breach of this Agreement or the Ancillary Agreements or arising out of or related to the Manufacture of the Product or Other Product by or on behalf of Buyer or its Affiliates or (y) any Liabilities arising out of
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or related to any to any Product sold under the Supply Agreement); (b) arising out of, or related to, the Purchased Contracts prior to the Closing; and (c) of Seller or any of its Affiliates (i) for all Litigation arising prior to the Closing, (ii) arising from or relating to periods prior to the Closing ( provided , however , that (x) with respect to this clause (ii), a Liability will not be considered to arise prior to the Closing solely by virtue of the chemical structure or any inherent characteristic of zonisamide, the fact that zonisamide was first discovered prior to the Closing or any disclosure in any warning on the Product label or Product insert or packaging and (y) this clause (ii) shall not include any Liabilities arising out of or related to any Product sold under the Supply Agreement), (iii) for Excluded Assets, (iv) under any Purchased Contract or portion of any Purchased Contract which is not assigned to Buyer except to the extent the benefits of such Contract or portion thereof are provided to Buyer; and (v) any and all Taxes whatsoever relating to, or arising from or during, any Pre-Closing Tax Period.
1.1.52 Execution Date has the meaning set forth in the preamble hereto.
1.1.53 Exploit means to import, export, use, have made subject to the terms and conditions of the Dainippon License Agreement, have used, sell, offer for sale, have sold, research, develop, commercialize, hold or keep (whether for disposal or otherwise), transport, distribute, promote, market, or otherwise dispose of, but excludes to Manufacture.
1.1.54 FDA means the United States Food and Drug Administration and any successor agency thereto.
1.1.55 Final Closing Date Inventory Value has the meaning set forth in Section 2.3.2(b).
1.1.56 Financial Information has the meaning set forth in Section 3.1.12.
1.1.57 Fiscal Year means a 12-month period beginning on April 1 and ending on March 31 of the following calendar year
1.1.58 FSS means the Federal Supply Schedule administered by the United States Department of Veterans Affairs.
1.1.59 Fundamental Reps means the representations and warranties set forth in [REDACTED] and [REDACTED]
1.1.60 GAAP means generally accepted accounting principles, as applied in the United States.
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1.1.61 Governmental Authority means any supranational, international, nation, commonwealth, province, territory, county, municipality, district, federal, state or local court (or any arbitrator or other tribunal having competent jurisdiction), administrative agency or commission or other governmental authority, instrumentality, domestic or foreign, or political subdivision thereof, or any agency or instrumentality of such government or political subdivision, including the FDA, or any self-regulatory organization, or quasi-governmental authority.
1.1.62 Guarantee means the Guarantee entered into by Buyer Parent on the date hereof in favor of Seller.
1.1.63 Health Care Reform Fees or HCR Fees means the fees described in Section 9008 of the Patient Protection and Affordable Care Act, as amended by Section 1404 of the Health Care and Education Reconciliation Act of 2010.
1.1.64 HSR Act means the Hart-Scott-Rodino Antitrust Improvements Act of 1976.
1.1.65 Indemnification Certificate has the meaning set forth in Section 7.2.1.
1.1.66 Indemnified Party has the meaning set forth in Section 7.2.1.
1.1.67 Indemnifying Party has the meaning set forth in Section 7.2.1.
1.1.68 Infringement has the meaning set forth in Section 5.15.
1.1.69 Intellectual Property Rights means any and all of the following: Copyrights, Domain Names, Patent Rights, Trademarks, rights to protect confidential or proprietary information, and Trade Secrets.
1.1.70 Inventory Statement Objection Notice has the meaning set forth in Section 2.3.2(b).
1.1.71 Law means any statute, law, treaty, judgment, ordinance, constitution, rule, regulation, order, or any administrative interpretation or other requirement having the force of law, of any Governmental Authority.
1.1.72 Liabilities means any debts, liabilities, obligations, commitments, claims of complaints, whether accrued or unaccrued, asserted or unasserted, matured or, unmatured, known or unknown, fixed or contingent, determined or determinable and whether or not the same would be required to be reflected in financial statements or disclosed in the notes thereto.
1.1.73 License Agreement means the License Agreement to be entered into by the Parties or their respective Affiliates at Closing.
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1.1.74 Licensed Copyrights means all Copyrights in the Buyer Territory that are owned by Seller or any of Sellers Affiliates and that are (a) used or held for use exclusively or primarily in connection with the Product Business or (b) embodied in the Product Records and Product Promotional Materials, including those Copyrights listed on Schedule 1.1.74 .
1.1.75 Licensed Intellectual Property means the Licensed Copyrights and Licensed Trademarks.
1.1.76 Licensed Registered Product IP has the meaning set forth in Section 3.1.11(c).
1.1.77 Licensed Trademarks means the Trademarks listed on Schedule 1.1.77 .
1.1.78 Litigation means any claim, action, cause of action, demand, lawsuit, arbitration, mediation, hearing, inquiry, audit, notice of violation, proceeding, litigation, citation, summons, subpoena or investigation of any nature, suit, warning letter, finding of deficiency or non-compliance, notice of violation or request for recall (whether civil, criminal, administrative, regulatory, investigative, appellate or informal or otherwise, whether at law or in equity).
1.1.79 Loss or Losses means any losses, damages, judgments, fines, penalties, awards, Taxes, amounts paid in settlement, fees (including costs and expenses in connection with investigations, suits and proceedings, expert fees, accounting fees, advisory fees and reasonable legal fees), charges, costs or expenses, including any of the foregoing to the extent incurred enforcing any right to indemnification hereunder or complying with Section 7.3.3, including pursuing any insurance providers.
1.1.80 Manufacture and Manufacturing means all activities related to the production, manufacture, processing, filling, finishing, packaging, labeling, and shipping and holding (prior to distribution) of the Product or any intermediate thereof, including process development, process qualification and validation, scale-up, pre-clinical, clinical and commercial manufacture and analytic development, product characterization, stability testing, quality assurance and quality control.
1.1.81 Material Adverse Effect means an event, fact, condition, occurrence, circumstance, change or effect ( Effect ) that, considered together with all other Effects, (i) is, or would reasonably be expected to be, materially adverse to the business, results of operations and condition (financial or otherwise) of the Product Business, the Purchased Assets and the Assumed Liabilities, taken as a whole, or (ii) prevents or materially delays the consummation by Seller of any of the Transactions; provided , however , that, except as provided in the last sentence of this definition, none of the following, and no Effects resulting from the following, shall be deemed (individually or in combination) to constitute, or shall be taken into account in determining whether there
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has been, a Material Adverse Effect: (a) general political or economic conditions in the Buyer Territory or conditions affecting the capital or financial markets generally; (b) conditions generally affecting the pharmaceutical industry; (c) any change in accounting requirements or applicable Law or the enforcement or interpretation thereof; (d) any hostility, act of war, sabotage, terrorism or military actions, or any escalation or worsening of any of the foregoing; (e) any hurricane, flood, tornado, earthquake or other natural disaster or force majeure event; (f) the public announcement, execution or delivery of this Agreement or the pendency or consummation of the transactions contemplated hereby; (g) Sellers or any of its Affiliates actions to the extent both required by the terms and conditions of this Agreement and outside the Ordinary Course of Business of the Product Business, or any other action by Seller or any of its Affiliates (I) that Buyer has requested and not contemplated by this Agreement or (II) to which Buyer has consented in writing; (h) any decline in sales or revenue from sales of the Product in the Buyer Territory ( provided , that the underlying causes of such decline shall not be excluded); and (i) the failure of the Product Business to achieve any projections, predictions or forecasts (financial or otherwise) in and of itself ( provided , that the underlying causes of such failure shall not be excluded); except, in each of clauses (a) through (e), for those conditions that have a disproportionate effect on the Product Business, the Purchased Assets and the Assumed Liabilities, taken as a whole, relative to other Persons engaged in businesses similar to the Product Business in the Buyer Territory.
1.1.82 NDA means a New Drug Application, as defined in the Act.
1.1.83 NDC means National Drug Code, which is the eleven digit code registered by a company with the FDA with respect to a pharmaceutical product.
1.1.84 NFAMP means the non-federal average manufacturer price as defined in 38 U.S.C. §8126.
1.1.85 Non-Controlling Party has the meaning set forth in Section 7.2.2.
1.1.86 Non-Exclusive Information has the meaning set forth in Section 5.4.3.
1.1.87 Notice has the meaning set forth in Section 9.2.1.
1.1.88 Objection Notice has the meaning set forth in Section 7.2.1.
1.1.89 Ordinary Course of Business has the meaning set forth in Section 4.2.1
1.1.90 Other Product means any product, other than the Product, containing zonisamide or any pharmaceutically acceptable salts, isomers or metabolites, or other analogues of zonisamide as an active ingredient, whether alone or in combination with one or more other active ingredients. For the avoidance of doubt, any pharmaceutical
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product containing zonisamide and sold in the Seller Territory under the Trademark ZONEGRAN® shall constitute an Other Product.
1.1.91 Owned Registered Product IP has the meaning set forth in Section 3.1.11(b).
1.1.92 Party(ies) has the meaning set forth in the preamble hereto.
1.1.93 Patent Rights means all patents and filed patent applications, including provisional and non-provisional patent applications, design registrations, design registration applications, industrial designs, industrial design applications and industrial design registrations, and including any and all divisions, continuations, continuations in part, extensions, substitutions, renewals, registrations, revalidations, reversions, reexaminations, reissues or additions, of or to any of the foregoing items, and all rights and priorities afforded under any applicable Law with respect thereto.
1.1.94 Permitted Encumbrance means any (a) Encumbrance for Taxes not yet due and payable; (b) the rights retained by Seller under Section 2.1.4; and (c) any Encumbrance disclosed on Schedule 1.1.94 .
1.1.95 Person means any individual, partnership, limited partnership, limited liability company, joint venture, syndicate, sole proprietorship, corporation, unincorporated association, trust, trustee, executor, administrator or other legal personal representative, or any other legal entity, including a Governmental Authority.
1.1.96 Personal Information means any information the unauthorized acquisition, access, use, or disclosure of which would require Seller to notify affected individuals, a Governmental Authority, or the media under applicable Laws in the Buyer Territory relating to data breaches.
1.1.97 PHS 340B Program means the drug discount program, available to covered entities, that is administered by the Health Resources and Services Administration pursuant to 42 U.S.C. §256B.
1.1.98 Post-Closing Tax Period has the meaning set forth in Section 5.13.1(b).
1.1.99 Pre-Closing Period has the meaning set forth in Section 4.1.1.
1.1.100 Pre-Closing Tax Period has the meaning set forth in Section 5.13.1(b).
1.1.101 Product means any pharmaceutical product containing zonisamide approved by the FDA pursuant to the U.S. Regulatory Approval and commercialized in the Buyer Territory prior to the Closing by Seller under the Trademark ZONEGRAN®.
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1.1.102 Product Business has the meaning set forth in the first recital hereto.
1.1.103 Product Promotional Materials means the advertising, promotional and media materials, sales training materials (including related quizzes and answers, if any), existing customer lists, other marketing data and materials, trade show materials (including displays) and videos, including materials containing clinical data, if any, owned by Seller or any of its Affiliates and used exclusively or held for exclusive use for the commercialization of the Product in the Buyer Territory as of the Closing Date. For the avoidance of doubt, the Product Promotional Materials shall include all internet accessible content used by Seller or its Affiliates to promote the Product in the Buyer Territory at any time from August 25, 2014 through the Closing Date other than the Seller Marks and the Licensed Intellectual Property.
1.1.104 Product Records means all books and records, other than the Regulatory Documentation and Product Promotional Materials, either (i) relating exclusively to the Product in the Buyer Territory, including the Manufacture of the Product, or (ii) used exclusively to conduct the Product Business, as Exploited or conducted (as applicable) by Seller as of the Execution Date or in the prior calendar year, in each case, to the extent owned by Seller or any of its Affiliates, but excluding, in all cases, (a) all books, documents, records and files prepared in connection with or relating to the transactions contemplated under this Agreement, including strategic, financial or Tax analyses relating to the divestiture of the Purchased Assets, the Assumed Liabilities, the Product or the Product Business, (b) Trade Secrets of Third Parties not also constituting Trade Secrets of Seller, (c) any attorney work product, attorney-client communications and other items protected by established legal privilege, unless the books and records can be transferred without losing such privilege, (d) human resources and any other employee books and records, (e) any financial, Tax and accounting records to the extent not related to the Product and the Buyer Territory, and (f) any items to the extent applicable Law prohibits their transfer. For clarity, a particular book or record may include information that does not constitute Product Records as well as information that constitutes Product Records and Seller may redact the portion of such book or record that does not constitute Product Records before delivering to Buyer the portion of such book or record that constitutes Product Records.
1.1.105 Purchase Price means the sum of the Closing Payment and the Final Closing Date Inventory Value.
1.1.106 Purchased Assets has the meaning set forth in Section 2.1.1.
1.1.107 Purchased Contracts has the meaning set forth in Section 2.1.1(a).
1.1.108 Purchased Domain Names means the Domain Names listed on Schedule 1.1.108 .
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1.1.109 Purchased Inventory means all inventories of finished Product labeled and held for sale in the Buyer Territory that are owned by Seller or any of Sellers Affiliates and that have not been sold to a distributor or wholesaler.
1.1.110 Purchased Regulatory Documentation has the meaning set forth in Section 2.1.1(b).
1.1.111 Purchasing Affiliate has the meaning set forth in Section 3.2.1.
1.1.112 Quality Agreement means the Quality Agreement to be entered into by the Parties or their respective Affiliates at or, if agreed by the Parties, following Closing.
1.1.113 Rebate Tail Period has the meaning set forth in Section 5.14.2(a).
1.1.114 Receiving Party has the meaning set forth in Section 5.4.1.
1.1.115 Regulatory Approvals means, with respect to a product, any and all approvals, licenses, registrations (except manufacturing establishment registrations) or authorizations of any Governmental Authority in the Buyer Territory necessary to commercially distribute, sell or market such product in the Buyer Territory, including, where applicable, (a) NDAs, (b) pre- and post-approval marketing authorizations and (c) labeling approvals.
1.1.116 Regulatory Authority means any Governmental Authority that is concerned with the safety, efficacy, reliability, Manufacture, investigation or Exploitation of pharmaceutical products, medical products, biologics or biopharmaceuticals, including the FDA.
1.1.117 Regulatory Documentation means all (a) documentation comprising the Regulatory Approvals for the Product or any Other Product, (b) correspondence and reports necessary to, or otherwise describing the ability to, Exploit the Product or any Other Product submitted to or received from Governmental Authorities (including minutes and official contact reports relating to any communications with any Governmental Authority) and relevant supporting documents submitted to or received from Governmental Authorities with respect thereto, including all regulatory drug lists, final versions of advertising and promotion documents, adverse event files and complaint files, and (c) all data (including clinical and pre-clinical data) contained in any of the foregoing.
1.1.118 Representatives has the meaning set forth in Section 4.1.1.
1.1.119 Review Period has the meaning set forth in Section 2.3.2(b).
1.1.120 Safety Data Exchange Agreement means the Safety Data Exchange Agreement to be entered into by the Parties or their respective Affiliates at or, if agreed by the Parties, following Closing.
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1.1.121 Seller has the meaning set forth in the preamble hereto.
1.1.122 Seller Confidential Information has the meaning set forth in Section 5.4.3.
1.1.123 Seller Indemnitees has the meaning set forth in Section 7.12.
1.1.124 Seller Marks means the trade names, corporate names and corporate logos of Seller or Sellers Affiliates (other than, for clarity, the Licensed Trademarks) that are used by Seller in connection with the Product Business prior to or as of the Closing Date, but that are not used exclusively in connection with the Product Business, including those Trademarks listed on Schedule 1.1.124 .
1.1.125 Seller Permitted Purpose has the meaning set forth in Section 5.4.2.
1.1.126 Seller Regulatory Documentation means any and all Regulatory Documentation related to the Product or Other Product, in each case, Controlled by Seller or any of its Affiliates as of and following the Closing, excluding the Purchased Regulatory Documentation.
1.1.127 Seller Territory means worldwide, excluding the Buyer Territory.
1.1.128 Sellers Knowledge or Known to Seller means the collective actual knowledge, after reasonable inquiry in the course of their respective duties of the individuals listed on Schedule 1.1.128 .
1.1.129 Subject IP has the meaning set forth in Section 5.15.
1.1.130 Supply Agreement means the Supply Agreement to be entered into by the Parties or their respective Affiliates at Closing, substantially in the form attached as Exhibit B .
1.1.131 Tax Return means any return, declaration, report, claim for refund, information return or statement relating to Taxes, including any schedule or attachment thereto, filed or maintained, or required to be filed or maintained, in connection with the calculation, determination, assessment or collection of any Tax and includes any amended returns required as a result of examination adjustments made by the Internal Revenue Service or other Tax authority.
1.1.132 Taxes means all taxes of any kind including all U.S. federal, state, local or non-U.S. net income, capital gains, gross income, gross receipt, property, franchise, sales, use, excise, withholding, payroll, employment, social security, workers compensation, unemployment, occupation, capital stock, transfer, gains, windfall profits, net worth, asset, transaction and other taxes, and any interest, penalties or additions to tax with respect thereto, imposed upon any Person by any taxing authority or other
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Governmental Authority under applicable Law, including any obligations to indemnify or otherwise assume or succeed to the Tax liability of any other Person.
1.1.133 Third Party means any Person other than Seller, Buyer and their respective Affiliates and permitted successors and assigns.
1.1.134 Trade Secrets means information that derives independent economic value from not being generally known to, and not being readily ascertainable by proper means by other Persons who can obtain economic value from its disclosure or use.
1.1.135 Trademark means any word, name, symbol, color, product shape, designation or device or any combination thereof that functions as a source identifier, including any trademark, trade dress, brand mark, service mark, trade name, brand name, trade dress rights, slogans, product configuration, logo or business symbol, whether or not registered, and any registrations or applications for registration to use any of the foregoing.
1.1.136 Transactions means all of the transactions contemplated by this Agreement and each of the Ancillary Agreements.
1.1.137 Transfer Taxes has the meaning set forth in Section 5.13.1(a).
1.1.138 Transition Lots means those lots of a Product for which Product was partially sold prior to the Closing Date and partially sold on or following the Closing Date.
1.1.139 Transition Services Agreement means the Transition Services Agreement to be entered into by the Parties or their respective Affiliates at Closing, substantially in the form attached as Exhibit C .
1.1.140 U.S. Regulatory Approval means NDA [REDACTED]
1.1.141 UTSA means the Uniform Trade Secrets Act.
1.2 Construction. Except where the context otherwise requires, wherever used, the singular includes the plural, the plural the singular, the use of any gender shall be applicable to all genders and the word or is used in the inclusive sense (and/or). The captions of this Agreement are for convenience of reference only and in no way define, describe, extend or limit the scope or intent of this Agreement or the intent of any provision contained in this Agreement. The term including and include and variations thereof shall not be deemed to be terms of limitation, but rather shall be deemed to be followed by the words without limitation. The language of this Agreement shall be deemed to be the language mutually chosen by the Parties and no rule of strict construction shall be applied against any Party. Unless otherwise specified or where the context otherwise requires, (a) references in this Agreement to any Article, Section, Schedule or Exhibit are references to such Article, Section, Schedule or Exhibit of this Agreement; (b) references in any Section to any clause are references to such clause of such
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Section; (c) hereof hereto, hereby, herein and hereunder and words of similar import when used in this Agreement refer to this Agreement as a whole and not to any particular provision of this Agreement; (d) references to a Person are also to its permitted successors and assigns; (e) references to a Law include any amendment or modification to such Law and any rules or regulations issued thereunder, in each case, as in effect at the relevant time of reference thereto; (f) references to any agreement, instrument or other document in this Agreement refer to such agreement, instrument or other document as originally executed or, if subsequently amended, replaced or supplemented from time to time, as so amended, replaced or supplemented and in effect at the relevant time of reference thereto; (g) extent in the phrase to the extent means the degree to which a subject or other thing extends, and such phrase does not mean simply if and (h) references to monetary amounts are denominated in U.S. dollars.
ARTICLE 2
SALE AND PURCHASE OF ASSETS; LIABILITIES
2.1 Sale of Purchased Assets.
2.1.1 Purchase and Sale of Purchased Assets . Upon the terms and subject to the conditions of this Agreement, at and effective as of the Closing, Seller shall sell, transfer, convey, assign and deliver to Buyer (or one or more Affiliates of Buyer), and Buyer (or one or more Affiliates of Buyer) shall purchase and accept from Seller, free and clear of all Encumbrances other than Permitted Encumbrances, all right, title and interest of Seller in and to the following properties, rights, interests and assets, as existing as of the Closing (collectively, the Purchased Assets ):
(a) All Contracts to which Seller or any of Sellers Affiliates is a party and that are used or held for use exclusively in connection with the Product Business, including (i) all rights of Seller under the Contracts set forth on Schedule 2.1.1(a)(i) and (ii) those certain rights and interests of Seller under the Dainippon License Agreement listed on Schedule 2.1.1(a)(ii) , in the case of (i), as such Schedule may be updated by Seller, and approved by Buyer in its sole discretion, not less than five Business Days prior to the Closing Date to include rights and interests under any Contracts relating to the Product Business entered into by Seller during the Pre-Closing Period in accordance with Section 4.2, in each case, excluding all rights, claims or causes of action (including warranty claims and Accounts Receivable) of Seller thereunder related to Product supplied or services provided to Seller prior to the Closing that are not included in the Purchased Assets (the Purchased Contracts );
(b) all Regulatory Documentation to the extent relating to the Product in the Buyer Territory and in the Control of Seller or any of its Affiliates (the Purchased Regulatory Documentation );
(c) all Product Records to the extent in the possession or control of Seller or any of its Affiliates;
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(d) all Product Promotional Materials;
(e) all Purchased Domain Names;
(f) all prepaid expenses, credits, advance payments, claims, security, refunds, rights of recovery, rights of set-off, rights of recoupment, deposits, charges, sums and fees (including any such item relating to the payment of Taxes) to the extent related to a Purchased Contract, excluding all rights, claims or causes of action (including warranty claims and Accounts Receivable) of Seller thereunder related to Product supplied or services provided to Seller prior to the Closing that are not included in the Purchased Assets or the Assumed Liabilities;
(g) all rights to any Litigation of any nature available to or being pursued by Seller to the other Purchased Assets or the Assumed Liabilities in the Buyer Territory, whether arising by way of counterclaim or otherwise, excluding all rights, claims or causes of action (including warranty claims and Accounts Receivable) of Seller thereunder related to Product supplied or services provided to Seller prior to the Closing that are not included in the Purchased Assets or the Assumed Liabilities;
(h) all of Sellers or its Affiliates rights under warranties, indemnities and all similar rights against Third Parties to the extent arising out of any other Purchased Assets, excluding all rights, claims or causes of action (including warranty claims and Accounts Receivable) of Seller thereunder related to Product supplied or services provided to Seller prior to the Closing that are not included in the Purchased Assets or the Assumed Liabilities;
(i) all goodwill and the going concern value of the Product Business, other than any goodwill relating to the Licensed Trademarks; and
(j) all Purchased Inventory.
2.1.2 Excluded Assets . Buyer shall not acquire, pursuant to this Agreement or any Ancillary Agreement, and Seller shall retain following the Closing Date, the Excluded Assets.
2.1.3 No Rights in the Seller/Buyer Territory . Buyer acknowledges and agrees that Buyer shall not receive any rights by virtue of this Agreement or any Ancillary Agreement in the Seller Territory. From and after the Closing Date, (a) Buyer shall not. and shall cause its Affiliates, licensees, sublicensees and distributors not to, Exploit the Product outside of the Buyer Territory and (b) except to the extent contemplated in Section 2.1.4, Seller shall not, and shall cause its Affiliates, licensees, sublicensees and distributors not to Exploit the Product outside of the Seller Territory.
2.1.4 Retention of Rights . Notwithstanding anything to the contrary in this Agreement or any Ancillary Agreement, Seller retains, on behalf of itself and its
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Affiliates, licensees, sublicensees, licensors and distributors, such rights in and to the Purchased Assets, including a right of reference to the Purchased Regulatory Documentation, in each case, solely to the extent necessary or useful to (a) Exploit the Product or any Other Product in the Seller Territory, (b) exercise its rights or perform its obligations under this Agreement or any Ancillary Agreement, and (c) subject to the restrictions set forth in Section 5.12: Manufacture or have Manufactured the Product or any Other Product worldwide for Exploitation in the Seller Territory. Except as expressly granted herein or in any Ancillary Agreement, Seller grants no other right or license to any assets or rights, including Intellectual Property Rights, of Seller and its Affiliates.
2.2 Liabilities.
2.2.1 Assumed Liabilities . Upon the terms and subject to the conditions of this Agreement, at the Closing, Seller shall assign and Buyer or its Affiliates shall assume and agree to pay and discharge when due (a) all Liabilities of Seller and its Affiliates under or relating to the Purchased Assets first arising on or after the Closing, and (b) all Liabilities relating to the Manufacture or Exploitation of the Product first arising on or after the Closing in the Buyer Territory ((a) and (b), collectively, the Assumed Liabilities ); provided, however , (i) the Assumed Liabilities shall not include any Liability to the extent arising from or relating to any breach by Seller or its Affiliates of any Ancillary Agreement or this Agreement including any representation or warranty contained in Section 3.1 or such Ancillary Agreement [REDACTED] and [REDACTED] (ii) the first arising on or after the Closing limitations in the preceding clauses (a) and (b) shall not, in and of themselves, exclude from the Assumed Liabilities any ordinary course, ongoing or continuing obligations under the Purchased Assets to the extent related to the period from and after the Closing [REDACTED]
2.2.2 Excluded Liabilities . Notwithstanding anything to the contrary herein, neither Buyer nor any of its Affiliates shall assume any Liabilities under this Agreement (whether or not related to the Product Business) other than the Assumed Liabilities, and the Excluded Liabilities shall remain the sole obligation and responsibility of Seller and its Affiliates which shall pay and discharge such Excluded Liabilities when due.
2.3 Consideration.
2.3.1 Purchase Price .
(a) In consideration of the conveyances contemplated under Section 2.1, on the Closing Date Buyer shall pay to Seller the sum of (i) $90,000,000 (the Closing Payment ) plus (ii) the Estimated Closing Date Inventory Value by wire transfer
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of immediately available funds to the account designated by Seller by written notice to Buyer at least two days prior to the Closing Date.
(b) No more than five Business Days nor less than three Business Days prior to the Closing Date, Seller shall prepare and provide to Buyer a statement calculating in reasonable detail the estimated amount and value of the Purchased Inventory as of the Closing Date in accordance with GAAP as set forth in Schedule 2.3.1 (the Estimated Closing Date Inventory Value ). With respect to Purchased Inventory value shall mean Sellers standard cost for such Purchased Inventory.
23.2 Post-Closing Inventory Value Adjustment .
(a) As soon as practicable, but in no event later than 60 days following the Closing Date, Buyer shall cause to be prepared and delivered to Seller a statement calculating in reasonable detail the actual amount and value of the Purchased Inventory as of the Closing Date in accordance with GAAP as set forth in Schedule 2.3.1 (the Actual Closing Date Inventory Value ), together with supporting written documentation (the Closing Date Inventory Statement ).
(b) Seller shall have 30 days from the date on which the Closing Date Inventory Statement is delivered by Buyer to review the Closing Date Inventory Statement (the Review Period ). The Closing Date Inventory Statement (and the Actual Closing Date Inventory Value contained therein) shall become final and binding upon Seller and Buyer at the end of such Review Period, unless Seller objects that the calculation of the Actual Closing Date Inventory Value is not in accord with Schedule 2.3.1 , in which case Seller shall send written notice (the Inventory Statement Objection Notice ) to Buyer within such Review Period, setting forth in specific detail the basis for its objection and Sellers proposal for any adjustments to the Closing Date Inventory Statement. If a timely Inventory Statement Objection Notice is delivered to Buyer, then the Closing Date Inventory Statement (and the Actual Closing Date Inventory Value contained therein) shall become final and binding (except as provided below with respect to resolution of disputes) on Seller and Buyer on the first to occur of (i) the date on which Seller and Buyer resolve in writing any differences they have with respect to the matters specified in the Inventory Statement Objection Notice and (ii) the date on which all matters in dispute are finally resolved in writing by the Accountants, in each case as provided below. Seller and Buyer shall seek in good faith to reach agreement as to any such proposed adjustment or that no such adjustment is necessary within 15 days following delivery of the Inventory Statement Objection Notice. If agreement is reached in writing within such 15-day period as to all proposed adjustments, or that no adjustments are necessary, Seller and Buyer shall revise the Closing Date Inventory Statement accordingly. If Seller and Buyer are unable to reach agreement within 15 days following delivery of the Inventory Statement Objection Notice, then the Accountants shall be engaged at that time to review the Closing Date Inventory Statement, and shall make a determination as to the resolution of any adjustments. The determination of the Accountants regarding the Closing Date Inventory Statement (and the Actual Closing Date Inventory Value contained therein) shall be delivered as soon as practicable following
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engagement of the Accountants, but in no event more than 60 days thereafter, and shall be final, conclusive and binding upon Seller and Buyer, and the Parties shall revise the Closing Date Inventory Statement accordingly. The final value as of the Closing Date of the Purchased Inventory, as determined pursuant to this Section 2.3.2, is the Final Closing Date Inventory Value . Subject to the exercise by a Party of applicable rights of appeal under applicable Law, the Parties agree that judgment may be entered on such determination in any court having jurisdiction. Seller, on the one hand, and Buyer, on the other hand, shall each pay one-half of the cost of the Accountants.
(c) Within five Business Days after the date on which the Closing Date Inventory Statement (and the Actual Closing Date Inventory Value contained therein) becomes final and binding on Seller and Buyer in accordance with Section 2.3.2(b), (i) in the event that the Final Closing Date Inventory Value is less than the Estimated Closing Date Inventory Value, the Purchase Price shall be adjusted downward by the amount by which the Estimated Closing Date Inventory Value exceeds the Final Closing Date Inventory Value, and Seller shall pay the amount of such excess to Buyer and (ii) in the event that the Final Closing Date Inventory Value is greater than the Estimated Closing Date Inventory Value, the Purchase Price shall be adjusted upward by the amount by which the Final Closing Date Inventory Value exceeds the Estimated Closing Date Inventory Value, and Buyer shall pay the amount of such excess to Seller. All payments made pursuant to this Section 2.3.2(c) shall be made by wire transfer of immediately available funds to an account designated by the recipient in writing.
2.3.3 Allocation of Consideration .
(a) Buyer shall allocate the Purchase Price (including the Assumed Liabilities, to the extent properly taken into account under Section 1060 of the Code, but excluding the Final Closing Date Inventory Value and the Assumed Liabilities related to the Purchased Inventory) among the Purchased Assets other than the Purchased Inventory, and shall allocate the Final Closing Date Inventory Value (and the Assumed Liabilities related to the Purchased Inventory, to the extent properly taken into account under Section 1060 of the Code) among the Purchased Inventory, in accordance with Section 1060 of the Code (the Allocation ) prior to or within 60 days following the Closing, and shall deliver to Seller a copy of such Allocation (Internal Revenue Service Form 8594) promptly after such determination. Seller shall have the right to review and raise any objections in writing to the Allocation during the 10-day period after its receipt thereof. If Seller disagrees with respect to any item in the Allocation, the Parties shall negotiate in good faith to resolve the dispute. If the Parties are unable to agree on the Allocation within 30 days after the commencement of such good faith negotiations (or such longer period as Seller and Buyer may mutually agree in writing), then the Accountants shall be engaged at that time to review the Allocation, and shall make a determination as to the resolution of such Allocation. The determination of the Accountants regarding the Allocation shall be delivered as soon as practicable following engagement of the Accountants, but in no event more than 60 days thereafter, and shall be final, conclusive and binding upon Seller and Buyer, and Buyer shall revise the Allocation
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accordingly. Seller, on the one hand, and Buyer on the other hand, shall each pay one-half of the cost of the Accountants.
(b) Buyer and Seller shall report, act and file Tax Returns (including Internal Revenue Service Form 8594) in all respects and for all purposes consistent with such Allocation unless otherwise required by applicable Law. Neither Buyer nor Seller shall take any position (whether in audits, Tax Returns or otherwise) that is inconsistent with such Allocation unless required by applicable Law.
(c) The Allocation shall be adjusted in accordance with the procedure set forth in Section 2.3.3(a) to account for any adjustment to the Purchase Price pursuant to Section 2.3.2 or ARTICLE 7.
2.4 Closing.
2.4.1 Closing . Pursuant to the terms and subject to the conditions of this Agreement, the closing of the transactions contemplated hereby (the Closing) shall take place at the Washington, DC offices of Covington & Burling LLP, at 10:00 a.m., eastern time, on a Business Day following satisfaction of all conditions (other than those that by their terms are to be satisfied or taken at the Closing) set forth in ARTICLE 6 (or, to the extent permitted by applicable Law, waived by the Party entitled to the benefits thereof): (i) if such satisfaction occurs on or prior to September 26, 2014, then the earlier of the fifth Business Day after such satisfaction or September 30, 2014; (ii) if such satisfaction occurs after September 26, 2014, then the fifth Business Day after such satisfaction; or (iii) such other time and place as Buyer and Seller may agree to in writing. The Closing shall be deemed to have occurred at 12:00 a.m., eastern time, on the Closing Date.
2.4.2 Closing Deliveries .
(a) Except as otherwise indicated below, at the Closing, Seller shall deliver the following to Buyer:
(i) each of the Ancillary Agreements to which Seller is a party (other than the Guarantee and, if agreed upon by the Parties, the Quality Agreement and the Safety Data Exchange Agreement), executed by a duly authorized officer of Seller;
(ii) a certificate, executed by an officer of Seller and dated the Closing Date, confirming on behalf of Seller that the conditions set forth in Sections 6.2.1 and 6.2.2 have been satisfied; and
(iii) the Purchased Assets, including true and complete copies of all Purchased Contracts to the extent not already provided; provided , that (A) with respect to tangible Purchased Assets, including the Purchased Inventory, delivery shall, unless the Parties otherwise mutually agree, be in accordance with Schedule 2.4.2(a)(iii) , (B) the Product Records included among the Purchased Assets and the Purchased Regulatory Documentation will be
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transferred in the format in which they are maintained in the ordinary course of the Product Business, with respect to electronic documents, to the extent that Sellers and Buyers respective IT systems allow, and to the extent electronic documents cannot be transferred due to incompatibility such documents will be transferred in PDF format and (C) Seller may retain one copy of the Product Records included within the Purchased Assets, the Purchased Regulatory Documentation and the Purchased Contracts (and, for clarity, prior to delivering or making available any Purchased Contracts or any files, documents, instruments, papers, books and records containing Product Records to Buyer, Seller shall be entitled to redact from such files, documents, instruments, papers, books and records any information to the extent that it does not relate to the Product Business).
(b) At the Closing, Buyer shall deliver the following to Seller:
(i) the Closing Payment and the Estimated Closing Date Inventory Value, each in accordance with Section 2.3.1;
(ii) each of the Ancillary Agreements to which Buyer is a party (other than, if agreed upon by the Parties, the Quality Agreement and the Safety Data Exchange Agreement), executed by a duly authorized officer of Buyer; and
(iii) a certificate, executed by an officer of Buyer and dated the Closing Date, confirming on behalf of Buyer that the conditions set forth in Sections 6.3.1 and 6.3.2 have been satisfied.
The Parties acknowledge that Buyer shall not be required to initiate the wire transfer to Seller of the Closing Payment and the Estimated Closing Date Inventory Value until the instant when all other conditions set forth in ARTICLE 6 have been satisfied or, as applicable, waived.
ARTICLE 3
REPRESENTATIONS AND WARRANTIES
3.1 Representations and Warranties of Seller. Seller represents and warrants to Buyer as follows, with each such representation and warranty subject to such exceptions, if any, as are set forth in corresponding sections of the Disclosure Schedules. Disclosures in any section or paragraph or cross-referenced in the particular section of the Disclosure Schedules address the corresponding section or paragraph of this Agreement and other sections or paragraphs of this Agreement to the extent that it is reasonably apparent from the face of such disclosure that such disclosure is applicable to such other sections or paragraphs.
3.1.1 Corporate Status . Seller is a corporation duly organized, validly existing and in good standing under the Laws of the State of Delaware and has all requisite corporate power and authority to own, operate, lease or license the Purchased Assets now owned, operated, leased or licensed by it and to carry on the Product Business as now being conducted. Seller is duly licensed or qualified to do business and is in good standing in each jurisdiction in which the ownership of the Purchased Assets or the operation of the
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Product Business as currently conducted makes such licensing or qualification necessary, except where the failure to be duty licensed, qualified to do business or in good standing would not reasonably be expected to have a Material Adverse Effect.
3.1.2 Authority . Seller has the requisite corporate power and authority to enter into and deliver this Agreement and the Ancillary Agreements to which it is a party, to perform its obligations hereunder and thereunder and to consummate the Transactions. The execution and delivery of this Agreement and the Ancillary Agreements to which Seller is a party and the consummation by Seller of the Transactions have been duly authorized by all necessary corporate actions of Seller. This Agreement constitutes, and each Ancillary Agreement to which Seller is a party, when executed and delivered by Seller, will constitute, the valid and legally binding obligation of Seller.
3.1.3 Non-Contravention . The execution, delivery, consummation and performance by Seller of this Agreement and each Ancillary Agreement to which it is a party do not and will not (a) violate the certificate of incorporation or bylaws of Seller, (b) subject to compliance with the HSR Act, violate any Law in the Buyer Territory applicable to Seller, the Product Business or the Purchased Assets, or (c) subject to obtaining the consents, approvals and authorizations, making the filings and giving the notices referred to in Section 3.1.3 of the Disclosure Schedules and Section 3.1.5(b), (i) violate, breach or constitute a default under, or result in the termination of, or give rise to a right of termination, cancellation or acceleration of any right or obligation under, any Purchased Contract, (ii) violate any order or judgment of a Governmental Authority in the Buyer Territory to which Seller is subject relating primarily to the Product Business or (iii) result in the imposition or creation of any Encumbrance other than a Permitted Encumbrance upon any Purchased Asset, except, (x) in the case of (c)(i) or (c)(iii), for such violations, breaches, defaults, accelerations, terminations or Encumbrances that would not reasonably be expected to materially affect the Product Business, the Purchased Assets or the Assumed Liabilities (or any material portion of the Product Business, the Purchased Assets or the Assumed Liabilities) and (y) in the case of (b) and (c)(ii), for such violations, breaches, defaults, accelerations, cancellations, terminations or Encumbrances that would not reasonably be expected to have a Material Adverse Effect.
3.1.4 No Broker . There is no broker, finder, investment banker or financial advisor acting or who has acted on behalf of or based upon arrangements made by Seller, who is entitled to receive any brokerage or finders or other fee or commission in connection with the transactions contemplated by this Agreement.
3.1.5 No Litigation: Consents .
(a) (i) There is no Litigation (other than investigations or inquiries) pending or, to Sellers Knowledge, pending investigation or inquiry, or threatened Litigation of any nature whatsoever, against Seller relating primarily to the Product, the Product Business or the Purchased Assets, and (ii) there is no order or judgment of a Governmental Authority in the Buyer Territory to which Seller is subject relating to the Product, the Product
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conduct of the Product Business as it is currently conducted, except where the failure to possess or comply with any such Authorization would not reasonably be expected to materially affect the Product Business, the Purchased Assets or the Assumed Liabilities (or any material portion of the Product Business, the Purchased Assets or the Assumed Liabilities).
(c) With respect to interactions with healthcare professionals, the Seller follows, and during the [REDACTED] has followed, its corporate compliance program in the Buyer Territory, which complies with applicable Law and the Seller believes is the substantial equivalent of the PhRMA Code on Interactions with Healthcare Professionals.
3.1.9 Regulatory Matters .
(a) Seller possesses, or has a right of reference to, all material Regulatory Approvals necessary to conduct the Product Business as currently conducted in the Buyer Territory. The U.S. Regulatory Approval is in full force and effect. During the [REDACTED] Seller has not received any written communication from any Governmental Authority in the Buyer Territory threatening to revoke, withdraw, modify, suspend, cancel or terminate the U.S. Regulatory Approval. No proceeding is pending or, to Sellers Knowledge, threatened regarding the suspension or revocation of the U.S. Regulatory Approval. Seller is not, and during the [REDACTED] has not been, in violation of the terms of the U.S. Regulatory Approval. Seller has not previously sold, licensed, or transferred in any manner, in whole or in part, the U.S. Regulatory Approval.
(b) During the [REDACTED], with respect to the Product in the Buyer Territory, Seller has not and, to Sellers Knowledge, no Third Party contract manufacturer, packager, labeler, or other vendor that must list the Product with the FDA has, received or been subject to: (i) any Form 483s, warning letters or other written correspondence from the FDA with respect to the Product in which the FDA asserted that the operations of Seller or any such Third Party relating to the Product were not in compliance with applicable Law; or (ii) any warning letters or other written communication from any other Governmental Authority with respect to the Product in the Buyer Territory in which such other Governmental Authority asserted that the Product Business or operations of Seller or any such Third Party relating to the Product were not in compliance with applicable Law.
(c) During the [REDACTED] there has not been any product recall, dear doctor letter or market withdrawal or replacement conducted by or on behalf of Seller concerning the Product in the Buyer Territory or any product recall, dear doctor letter, market withdrawal or replacement conducted by or on behalf of any Third Party as a result of any alleged defect in the Product in the Buyer Territory. During the [REDACTED] Seller has not received any written notice that any Governmental Authority has commenced, or threatened to initiate, any action to request a recall of the Product in the Buyer Territory, or commenced, or threatened to initiate, any action to enjoin production at any facility at which the Product is Manufactured for distribution in the Buyer Territory. Seller has made
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available to Buyer true and correct summary reports regarding material complaints and notices of alleged defect or adverse reaction with respect to a Product in the Buyer Territory that have been received in writing by Seller during the [REDACTED] During the [REDACTED] Seller has not received any written notice that the FDA or any other Governmental Authority has (i) commenced, or threatened to initiate, any action to enjoin the Manufacture or Exploitation of the Product in the Buyer Territory or (ii) commenced, or threatened to initiate, any action to enjoin the Manufacture or Exploitation of the Product in the Buyer Territory.
(d) To the Knowledge of Seller, there are no existing circumstances which would reasonably be expected to furnish a basis for an action by FDA or any other Governmental Authority to revoke, suspend, cancel, modify or withdraw the U.S. Regulatory Approval.
(e) During the [REDACTED] the Product in the Buyer Territory has been Manufactured in compliance with applicable Law, including the Act and cGMP, and the U.S. Regulatory Approval. During the [REDACTED] neither Seller, nor, to Sellers Knowledge, any employee or agent of Seller, has made on behalf of Seller any material false statements or material omissions in any application or other submission to the FDA or other Governmental Authority in the Buyer Territory relating to the Product, the Product Business or the Purchased Assets.
(f) None of Seller or any employee or, to Sellers Knowledge, any consultant of Seller who has undertaken activities in connection with the Product Business in the [REDACTED], has been debarred, restricted, suspended or deemed subject to debarment by the FDA, nor, to Sellers Knowledge, are any such Persons the subject of a conviction described in, (i) Section 306 of the Act or (ii) 42 U.S.C. §1320a-7 or any similar debarment or ineligibility provisions applicable to any health care program of a Governmental Authority.
(g) Seller has not entered into any settlement agreement, corporate integrity agreement, or similar agreement with any Governmental Authority relating to the Product, the Purchased Assets or the Product Business that would be binding on the Buyer or under which the Buyer would have any payment, reporting, or other obligations to any Governmental Authority.
(h) Seller has not notified, either voluntarily or as required by applicable Law, any affected individual, any Governmental Authority, or the media of any breach of Personal Information. Seller has not suffered any unauthorized acquisition, access, use or disclosure of any Personal Information relating to the Product, the Product Business or the Purchased Assets that, individually or in the aggregate, materially compromises the security or privacy of such Personal Information.
(i) (i) There are no pending preclinical tests or clinical trials by or on behalf of Seller or any of its Affiliates associated with the Product and (ii) Seller has not
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received written notice of and, to Sellers Knowledge, there are no currently outstanding or unanswered questions from FDA regarding any pending clinical studies involving the Product.
3.1.10 Taxes .
(a) Seller does not have any Liability for Taxes for which Buyer would become liable or that would adversely affect (a) the interests to be acquired by Buyer hereunder and under the Ancillary Agreements or (b) Buyers right to use or enjoy (free and clear of any Encumbrances, other than Permitted Encumbrances) any Purchased Asset.
(b) Seller has timely filed all income and other material Tax Returns with regard to the Purchased Assets that it was required to file under applicable Laws. All such material Tax Returns were correct and complete in all material respects and were prepared in compliance in all material respects with all applicable Laws. There are no Encumbrances for Taxes upon any of the Purchased Assets other than Permitted Encumbrances.
(c) To Sellers Knowledge, there are no proceedings, investigations, audits or claims now pending or threatened against Seller with respect to Taxes related to the Purchased Assets or the Product Business.
3.1.11 Intellectual Property .
(a) Seller owns the Purchased Domain Names and owns or has pursuant to a Purchased Contract valid license rights to, all Licensed Intellectual Property.
(b) Section 3.1.11(b) of the Disclosure Schedules sets forth a true and complete list of all Purchased Domain Names and, in the Buyer Territory, all Licensed Intellectual Property, in each case, owned by Seller that has not expired or been abandoned and has issued, been registered or granted or that is the subject of an application for registration, issuance or grant ( Owned Registered Product IP ). All maintenance fees, annuity fees or renewal fees for such Owned Registered Product IP in the Buyer Territory that are due and payable have been paid and all associated filings needed to maintain such Owned Registered Product IP have been made.
(c) Section 3.1.11(c) of the Disclosure Schedules sets forth a true and complete list of all Licensed Intellectual Property that is licensed by Seller, has not expired or been abandoned and has issued, been registered or granted or that are the subject of an application for registration, issuance or grant in the Buyer Territory ( Licensed Registered Product IP ). To Sellers Knowledge, all maintenance fees, annuity fees or renewal fees for such Licensed Registered Product IP in the Buyer Territory that are due and payable have been paid and all associated filings needed to maintain such Licensed Registered Product IP have been made.
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(d) None of the Purchased Domain Names or Licensed Intellectual Property that constitute Owned Registered Product IP or Licensed Registered Product IP, or registrations or applications to use or register such items is involved in any cancellation, nullification, interference, concurrent use or opposition proceeding or other material Litigation (other than any investigation or inquiry) or, to Sellers Knowledge, any material investigation or inquiry.
(e) To Sellers Knowledge, the conduct of the Product Business as conducted as of the Execution Date does not infringe or misappropriate any Third Partys Intellectual Property Rights in the Buyer Territory. No Litigation (other than any investigation or inquiry) is pending or, to Sellers Knowledge, threatened, and to Sellers Knowledge, there is no investigation or inquiry pending or threatened, against Seller (i) based upon, challenging or seeking to deny or restrict the use of any of the Purchased Domain Names or any Licensed Registered Product IP or (ii) alleging that Sellers conduct of the Product Business infringes or misappropriates the Intellectual Property Rights of any Third Party.
(f) Seller has not granted any licenses, sublicenses or other rights in or with respect to any Purchased Domain Names or, in the Buyer Territory, any Licensed Intellectual Property, in each case, to any Third Parties. To Sellers Knowledge, no Third Party is engaging in any activity that infringes or misappropriates any Purchased Domain Name or any Licensed Registered Product IP in the Buyer Territory.
3.1.12 Product Financial Information . Section 3.1.12 of the Disclosure Schedules sets forth the annual gross sales and net sales (and certain components thereof) for the Product in the Buyer Territory for the Fiscal Years ended March 31, 2013 and 2014 and for the period through June 30, 2014 (the Financial Information ). The Financial Information has been prepared in accordance with GAAP from the books and records of Seller and fairly presents in all material respects the annual gross sales and net sales (and certain components thereof) for the Product in the Buyer Territory for the periods indicated. Seller maintains a system of accounting for the Product Business established and administered in accordance with GAAP.
3.1.13 Purchased Inventory . The Purchased Inventory is owned by Seller free and clear of all Encumbrances (other than Permitted Encumbrances). The Purchased Inventory was Manufactured in accordance with cGMP and the U.S. Regulatory Approval and is saleable in the ordinary course of the Product Business. All finished product included in the Purchased Inventory has, as of the Closing Date, a shelf life of at [REDACTED]
3.1.14 Customers and Suppliers .
(a) Section 3.1.14(a) of the Disclosure Schedules sets forth with respect to the Product Business each customer who has paid aggregate consideration to Seller for goods or services rendered in an amount greater than or equal to [REDACTED] for each of
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Sellers [REDACTED] (collectively, the Material Customers ). Seller has not received any written notice that any of the Material Customers has ceased, or intends to cease or otherwise terminate or materially reduce, after the Closing, purchasing the Product.
(b) Section 3.1.14(b) of the Disclosure Schedules, which shall be delivered by Seller to Buyer within 10 Business Days following the Execution Date, sets forth with respect to the Product Business each supplier of the active pharmaceutical ingredient and any excipients or other raw materials included in, and primary packaging components for, the Product to whom Seller has paid consideration for goods or services rendered in an amount greater than or equal to [REDACTED] for each of Sellers [REDACTED] (collectively, the Material Suppliers ). Seller has not received any written notice that any of the Material Suppliers has ceased, or intends to cease or otherwise terminate or materially reduce, after the Closing, to supply goods or services to the Product Business.
3.1.15 Exclusivity of Representations . SELLER ACKNOWLEDGES AND AGREES THAT, EXCEPT FOR THE EXPRESS REPRESENTATIONS AND WARRANTIES CONTAINED IN SECTION 3.2, THE ANCILLARY AGREEMENTS TO BE ENTERED INTO AT THE CLOSING AND THE CERTIFICATE DELIVERED BY BUYER PURSUANT TO SECTION 2.4.2(b)(iii), BUYER HAS MADE NO REPRESENTATION OR WARRANTY WHATSOEVER RELATED TO THE TRANSACTIONS, INCLUDING WITH RESPECT TO ANY INFORMATION, DOCUMENTS, OR MATERIALS FURNISHED TO OR FOR SELLER BY BUYER OR ANY OF ITS AFFILIATES OR ANY OF THEIR RESPECTIVE REPRESENTATIVES, INCLUDING ANY INFORMATION, DOCUMENTS, OR MATERIAL MADE AVAILABLE TO SELLER IN ANY MANAGEMENT PRESENTATION, OR ANY OTHER FORM IN CONNECTION WITH THE TRANSACTIONS, AND SELLER HAS NOT RELIED ON ANY REPRESENTATION OR WARRANTY, EXPRESS OR IMPLIED.
3.2 Representations and Warranties of Buyer. Buyer represents and warrants to Seller as follows:
3.2.1 Corporate Status . Buyer is an international business company incorporated, validly existing and in good standing under the Laws of Barbados. Each Affiliate of Buyer that is or will be a party to an Ancillary Agreement (each, a Purchasing Affiliate ) is a legal entity duly organized, validly existing and in good standing under the Laws of its jurisdiction of organization.
3.2.2 Authority .
(a) Buyer has the requisite corporate power and authority to enter into this Agreement and the Ancillary Agreements to which it is a party, to perform its obligations hereunder and thereunder and to consummate the Transactions. The execution and delivery of this Agreement and the Ancillary Agreements to which Buyer is a party and
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the consummation by Buyer of the Transactions have been duly authorized by the necessary corporate actions of Buyer. This Agreement constitutes and each Ancillary Agreement to which Buyer is a party, when executed and delivered by Buyer will constitute, the valid and legally binding obligation of Buyer, enforceable against Buyer in accordance with its terms.
(b) Each Purchasing Affiliate has the requisite entity power and authority to enter into each Ancillary Agreement to which it is a party, to perform its obligations thereunder and to consummate the Transactions. The execution and delivery of each Ancillary Agreement to which a Purchasing Affiliate is a party and the consummation by such Purchasing Affiliate of the Transactions have been duly authorized by the necessary entity actions of such Purchasing Affiliate. Each Ancillary Agreement to which a Purchasing Affiliate is a party, when executed and delivered by such Purchasing Affiliate, will constitute, the valid and legally binding obligation of such Purchasing Affiliate, enforceable against such Purchasing Affiliate in accordance with its terms.
3.2.3 Non-Contravention . The execution, delivery, consummation and performance by Buyer of this Agreement and each Ancillary Agreement to which Buyer is a party, and the execution, delivery, consummation and performance by each Purchasing Affiliate of each Ancillary Agreement to which such Purchasing Affiliate is a party, do not and will not (a) violate the certificate of incorporation or bylaws, or comparable organizational documents, of Buyer or any Purchasing Affiliate, (b) subject to compliance with the HSR Act, violate any Law or other restriction of any Governmental Authority applicable to Buyer or any Purchasing Affiliate or (c) subject to obtaining the Authorizations, making the filings and giving the notices referred to in Section 3.2.5(b), (i) violate, breach or constitute a default under or result in the termination of, or give rise to a right of termination, cancellation or acceleration of any right or obligation under, any material Contract to which Buyer or any Purchasing Affiliate is a party or (ii) violate any order or judgment of a Governmental Authority in the Buyer Territory to which Buyer or any Purchasing Affiliate is subject, except with respect to clauses (b) and (c), for violations, breaches, defaults, terminations, cancellations or accelerations that would not reasonably be expected to have a Buyer Material Adverse Effect.
3.2.4 No Broker . There is no broker, finder, financial advisor or other Person acting or who has acted on behalf of Buyer or its Affiliates other than Torreya Partners. No such entity acting on behalf of Buyer or its Affiliates is entitled to receive any brokerage or finders or financial advisory fee from Seller or any of its Affiliates in connection with the transactions contemplated by this Agreement.
3.2.5 Litigation; Consents .
(a) There is no (i), to the knowledge of Buyer, Litigation pending or threatened against Buyer or any of its Purchasing Affiliates by or before any Governmental Authority, or (ii) order or judgment of a Governmental Authority to which Buyer or any of its Purchasing Affiliates is subject, in each case, except for such Litigation,
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orders or judgments that would not reasonably be expected to have a Buyer Material Adverse Effect.
(b) Except for (i), if required, filings under the HSR Act and the expiration or termination of the waiting period thereunder, (ii) any filing with or Authorization of any stock exchange on which Buyers securities or those of its Purchasing Affiliates are listed, (iii) Authorizations that if not received, or declarations, filings or registrations that if not made, would not reasonably be expected to have a Buyer Material Adverse Effect, and (iv) items disclosed in Schedule 3.2.5 , no notice to, filing with or Authorization of, any Governmental Authority or other Person is required for Buyer to consummate the Transactions.
3.2.6 Financial Capacity . On the Closing Date, Buyer will have immediately available cash that is sufficient to enable it to consummate the Transactions and perform its obligations under this Agreement and the Ancillary Agreements.
3.2.7 Exclusivity of Representations . BUYER ACKNOWLEDGES AND AGREES THAT, EXCEPT FOR THE EXPRESS REPRESENTATIONS AND WARRANTIES CONTAINED IN SECTION 3.1, THE ANCILLARY AGREEMENTS AND THE CERTIFICATE DELIVERED BY SELLER PURSUANT TO SECTION 2.4.2(a)(ii), SELLER HAS MADE NO REPRESENTATION OR WARRANTY WHATSOEVER RELATED TO THE TRANSACTIONS, INCLUDING WITH RESPECT TO ANY INFORMATION, DOCUMENTS, OR MATERIALS FURNISHED TO OR FOR BUYER BY SELLER OR ANY OF ITS AFFILIATES OR ANY OF THEIR RESPECTIVE REPRESENTATIVES, INCLUDING ANY INFORMATION, DOCUMENTS, OR MATERIAL MADE AVAILABLE TO BUYER IN ANY DATA ROOM, MANAGEMENT PRESENTATION, OR ANY OTHER FORM IN CONNECTION WITH THE TRANSACTIONS, AND BUYER HAS NOT RELIED ON ANY REPRESENTATION OR WARRANTY, EXPRESS OR IMPLIED. WITHOUT LIMITING THE GENERALITY OF THE FOREGOING, BUYER ACKNOWLEDGES AND AGREES THAT, EXCEPT AS EXPRESSLY PROVIDED IN SECTION 3.1, THE ANCILLARY AGREEMENTS AND THE CERTIFICATE DELIVERED BY SELLER PURSUANT TO SECTION 2.4.2(a)(ii): BUYER IS ACQUIRING THE PURCHASED ASSETS AND LICENSING THE LICENSED INTELLECTUAL PROPERTY ON AN AS IS, WHERE IS BASIS WITHOUT ANY EXPRESS OR IMPLIED WARRANTIES, EITHER IN FACT OR BY OPERATION OF LAW, BY STATUTE OR OTHERWISE, INCLUDING ANY WARRANTY AS TO QUALITY, FITNESS FOR A PARTICULAR PURPOSE, MERCHANTABILITY, CONDITION OF ASSETS OR AS TO ANY OTHER MATTER.
ARTICLE 4
PRE-CLOSING COVENANTS
4.1 Access and Information.
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4.1.1 During the period commencing on the Execution Date and ending on the earlier to occur of (a) the Closing and (b) the termination of this Agreement in accordance with ARTICLE 8 (the Pre-Closing Period ), Seller shall afford Buyer and its officers, employees, agents, attorneys, consultants, advisors and other representatives (collectively, Representatives ), continued reasonable access to Seller and the Representatives and, through an electronic data room, the books and records, of Seller and its Affiliates, to the extent related to the Product, the Product Business, the Purchased Assets and the Assumed Liabilities, and during such period, shall provide to Buyer such information, books and records to the extent that they relate to the Product, the Product Business, the Purchased Assets and the Assumed Liabilities, as Buyer may reasonably request ( provided , that Seller shall only be required to use its commercially reasonable efforts to provide Buyer any such information, books and records that are in the possession or control of a Third Party), in each case for the purpose of enabling Buyer to verify the accuracy of Sellers representations and warranties contained in this Agreement, and to continue conducting due diligence in connection with the Transactions, and as may be agreed by Buyer and Seller as useful and allowable for post-Closing integration planning; provided, however , that such access shall not unreasonably disrupt Sellers ordinary course operations. Notwithstanding anything to the contrary contained in this Agreement, Seller shall not be required to disclose any information or provide any such access if such disclosure or access would reasonably be expected, in Sellers reasonable judgment, to (i) violate (A) applicable Law, including applicable antitrust Laws, or (B) any binding agreement entered into by Seller prior to the Closing Date, including any confidentiality agreement to which Seller is a party ( provided , that Seller shall use commercially reasonable efforts to obtain consent from any Third Party to any such binding agreement to enable Seller to disclose such information), (ii) jeopardize any attorney/client privilege or other established legal privilege, or (iii) disclose any Trade Secrets.
4.1.2 During the Pre-Closing Period, Buyer hereby agrees that, except as agreed upon by Seller, neither it nor any of its Affiliates or Representatives shall contact any licensor, competitor, supplier, distributor or customer of, or service provider to, Seller with respect to the Product, the Purchased Assets, the Product Business, this Agreement, the Ancillary Agreements or the Transactions.
4.2 Ordinary Course of Business.
4.2.1 During the Pre-Closing Period, except (i) as set forth in Schedule 4.2.1 or as otherwise contemplated by this Agreement or any Ancillary Agreement, (ii) as required by applicable Law, (iii) as required by the terms of any agreement binding upon Seller or its Affiliates, (iv) for any actions taken by Seller that are reasonably necessary to consummate the Transactions or (v) as Buyer shall otherwise consent in writing, which consent shall not be unreasonably withheld, conditioned or delayed, Seller and its Affiliates (x) shall conduct the Product Business in substantially the same manner as heretofore conducted and in the ordinary course (the Ordinary Course of Business ) except to the extent necessary to comply with Section 4.2.1(a) and (y) shall not:
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(a) [REDACTED]
(b) accelerate any rights or obligations under, terminate, materially modify or cancel any Purchased Contract, Contract that would be a Purchased Contract, but for such termination or acceleration, or the U.S. Regulatory Approval;
(c) make or commit to make material capital expenditures which would constitute Assumed Liabilities;
(d) sell, dispose of, transfer, lease, license or Encumber any assets that are (or would otherwise be) Purchased Assets, other than (i) sales of inventory in the Ordinary Course of Business, (ii) any disposition of inventory that does not comply with the representations and warranties in Section 3.1.13, or (iii) Permitted Encumbrances; or
(e) enter any Contract to do any of the foregoing ((a) through (d)), or take any action or omission that would result in any of the foregoing ((a) through (d)).
No action by Seller with respect to matters expressly addressed by subsections (b) through (e) above shall be deemed a breach of clause (x) of Section 4.2.1 unless such action would constitute a breach of any such specific subsection.
4.2.2 Nothing contained in this Agreement is intended to give Buyer or its Affiliates, directly or indirectly, the right to control or direct the Product Business prior to the Closing, and nothing contained in this Agreement is intended to give Seller or its Affiliates, directly or indirectly, the right to control or direct Buyers operations. Prior to the Closing, each of Buyer, on the one hand, and Seller and its Affiliates, on the other hand, shall exercise, consistent with the terms and conditions of this Agreement, complete control and supervision over its and its Affiliates respective operations.
4.3 Obligation to Consummate the Transaction. Each of the Parties agrees that, subject to this Section 4.3 and Section 4.4, it shall use its reasonable best efforts to take, or cause to be taken, all action, and to do, or cause to be done, all things necessary, proper or advisable to the extent permissible under applicable Law, to consummate and make effective the transactions contemplated by this Agreement and to ensure that the conditions set forth in ARTICLE 6 are satisfied, insofar as such matters are within the control of either of them. Without limiting the generality of the foregoing, as soon as reasonably practicable after the Execution Date, Seller shall use its commercially reasonable efforts (not requiring the payment of money, the commencement of any Litigation or offer or grant any accommodation (financial or otherwise) to any Third Party) to obtain the consents, permits and authorizations, make the filings and issue the notices disclosed in Section 3.1.5(b) of the Disclosure Schedules.
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4.4 Competition Filings.
4.4.1 If required pursuant to applicable Law, each of Buyer and Seller shall file or cause to be filed as soon as practicable, and in any event no later than 10 Business Days following the Execution Date, any notifications required under the HSR Act. Thereafter, each of Buyer and Seller shall use commercially reasonable efforts to respond as promptly as practicable to any inquiries or requests received from any Governmental Authority for additional information or documentation and to cause the waiting period under the HSR Act to terminate or expire at the earliest possible date after the date of filing.
4.4.2 Buyer and Seller shall cooperate with each other and shall (a) promptly prepare and file all necessary documentation and (b) effect all necessary applications, notices, petitions and filings and execute all agreements and documents, in each case, as required to comply with the HSR Act in connection with the Transactions. Each Party, acting solely through outside counsel, will promptly notify the other Party of any written communication with respect to the HSR Act to that Party from any Governmental Authority in the Buyer Territory, and, to the extent practicable, outside of the Buyer Territory, in each case, with respect to the Transactions, and, subject to applicable Law, if practicable, permit the other Party to review in advance any proposed written communication related to the HSR Act and the Transactions to any such Governmental Authority and incorporate the other Partys reasonable comments. Each Party also agrees not to participate in any substantive meeting or discussion related to the HSR Act with any such Governmental Authority in respect of any filing, investigation or inquiry concerning this Agreement or the Transactions unless it consults with the other Party in advance and, to the extent permitted by such Governmental Authority, gives the other Party the opportunity to attend. Each of Seller and Buyer further agrees, to the extent permitted by applicable Law, to furnish the other Party with copies of all correspondence, filings and written communications between it and its Affiliates and their respective Representatives on one hand, and any such Governmental Authority or its respective staff on the other hand, with respect to the HSR Act, this Agreement and the Transactions, except that any materials concerning either Partys valuation of the transaction, internal financial information, or competitively sensitive information may be redacted. Notwithstanding anything to the contrary herein, neither Buyer nor any of its Affiliates shall be required to agree to (i) sell, hold, divest, discontinue or limit, before or after the Closing Date, any assets, businesses or interests of Buyer or any of its Affiliates; (ii) any conditions relating to, or changes or restrictions in, the operations of any such assets, businesses or interests which, in either case, could reasonably be expected to result in a Material Adverse Effect or materially and adversely impact the economic or business benefits to Buyer of the Transactions and the other Ancillary Agreements; or (iii) any material modification or waiver of the terms and conditions of this Agreement
4.4.3 All filing fees under applicable competition laws, and all expenses (other than legal fees and expenses, which shall be borne by the Party incurring such
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expenses) in complying with any request for additional information or documentary material from any applicable Governmental Authority, shall be borne by Buyer.
4.5 Notices. Subject to Section 5.4, during the Pre-Closing Period, each Party shall give prompt written notice to the other Party of any Litigation, examination or audit in which such Party is involved as a party that concerns and would reasonably be expected to materially and adversely affect the Product, the Product Business or Purchased Assets or the other Partys rights in the same or that would otherwise (a) reasonably be expected to have a Material Adverse Effect or Buyer Material Adverse Effect, as applicable or (b) has resulted in, or would reasonably be expected to result in, the failure of any of the conditions set forth in ARTICLE 6 to be satisfied.
ARTICLE 5
ADDITIONAL COVENANTS
5.1 Cooperation in Litigation and Investigations. Subject to Section 5.4 and except as set forth in any Ancillary Agreement, from and after the Closing Date, Buyer and Seller shall fully cooperate with each other in the defense or prosecution of any Litigation, examination or audit instituted prior to the Closing or which may be instituted thereafter against or by either Party relating to or arising out of the conduct of the Product Business or the Manufacture of the Product in the Buyer Territory prior to or after the Closing (other than Litigation between Buyer and Seller or their respective Affiliates arising out of the Transactions). In connection therewith, and except as set forth in any Ancillary Agreement, from and after the Closing Date, each of Seller and Buyer shall make available to the other during normal business hours and upon reasonable prior written notice, but without unreasonably disrupting its business, all records relating exclusively to the Purchased Assets, the Assumed Liabilities and the Excluded Liabilities held by it and reasonably necessary to permit the defense or investigation of any such Litigation, examination or audit (other than Litigation between Buyer and Seller or their respective Affiliates arising out of the Transactions, with respect to which applicable rules of discovery shall apply), and shall preserve and retain all such records for the length of time contemplated by its standard record retention policies and schedules. Subject to, and not in derogation or limitation of, the Parties respective obligations under ARTICLE 7, the Party requesting such cooperation shall pay the reasonable costs and expenses of providing such cooperation (including legal fees and disbursements) incurred by the Party providing such cooperation and by its officers, directors, employees and agents, and any applicable Taxes in connection therewith.
5.2 Further Assurances.
5.2.1 Each of Seller and Buyer shall, at any time or from time to time after the Closing, at the request and expense of the other, execute and deliver to the other all such instruments and documents or further assurances as the other may reasonably request in order to (a) vest in Buyer all of the rights, title and interests of Seller in and to the Purchased Assets as contemplated hereby, (b) effectuate Buyers assumption of the Assumed Liabilities and (c) grant to each Party all rights contemplated herein to be granted
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to such Party under the Ancillary Agreements; provided , however , that after the Closing, apart from such customary further assurances, neither Seller nor Buyer shall have any other obligations except as specifically set forth and described herein or in the Ancillary Agreements. Without limitation of the foregoing, except as expressly set forth herein or in the Ancillary Agreements, Seller shall not have any obligation to assist or otherwise participate in the amendment or supplementation of any Regulatory Approval or otherwise to participate in any filings or other activities relating to any Regulatory Approval other than as necessary to effect the transfer of Sellers rights, title and interest with respect thereto to Buyer in connection with the Closing pursuant to this Agreement.
5.2.2 To the extent that Sellers rights under any Purchased Asset may not be assigned without the approval, consent or waiver of another Person and such approval, consent or waiver has not been obtained prior to the Closing, this Agreement shall not constitute an agreement to assign the same if an attempted assignment would constitute a breach thereof or be unlawful. If any such approval, consent or waiver shall not have been obtained prior to the Closing, Seller shall for a period of up to nine months after the Closing, (a) use its commercially reasonable efforts to obtain all necessary approvals, consents and waivers to the assignment and transfer thereof, and Buyer shall use its commercially reasonable efforts to assist and cooperate with Seller in connection therewith (in each case at the sole cost and expense of Seller); provided , that neither Seller nor any of its Affiliates shall be required to pay money to any Third Party, commence any Litigation or offer or grant any accommodation (financial or otherwise) to any Third Party in connection with such efforts; and (b) until any such approval, consent or waiver is obtained and the related Purchased Asset is transferred and assigned to Buyer or Buyers designee, use its commercially reasonable efforts to provide to Buyer substantially comparable benefits thereof and enforce, at the request of and for the account of Buyer, any rights of Seller arising under any such Purchased Asset against any Person. To the extent that Buyer is provided with benefits of any such Purchased Asset, Seller shall perform the obligations of Seller thereunder.
5.2.3 [REDACTED]
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5.2.4 Seller shall use its commercially reasonable efforts to provide to Buyer as soon as reasonably practicable after the date of the Closing, all information and documents related to the Purchased Assets (including the audited carve-out financial statements related to the Purchased Assets in respect of Sellers fiscal years ended March 31, 2014 and March 31, 2013 and unaudited interim carve-out financial statements) reasonably required by Buyer or its Affiliates in order to comply with its obligation to prepare and file within the time required under Canadian Securities Laws a business acquisition report (as contemplated in NI 51-102 Continuous Disclosure Obligations), and Seller shall use its commercially reasonable efforts to (a) cause its auditors to cooperate with Buyers or its Affiliates accounting professionals and auditors as is reasonably required and (b) make available to Buyer or its Affiliates and its auditors all financial information related to the Purchased Assets (including, if required, the Financial Information, carve-out financial statements related to the Purchased Assets in respect of Sellers fiscal years ended March 31, 2014 and March 31, 2013, and any required auditor consents) as may be reasonably required by Buyer, in each case, to comply with its obligations under Part 8 of NI 51-102; provided, however , that Seller shall be provided a reasonable opportunity to review and comment on any draft disclosure document containing Seller information to be publicly filed in connection with Buyers or its Affiliates obligations under Part 8 of NI 51-102 in advance of the filing or public disclosure thereof and Buyer will give good faith consideration to any comments of Seller thereon. Seller shall use its commercially reasonable efforts to provide to Buyer information of the type addressed above, including by submitting any necessary consents to, or otherwise causing, its auditors to provide Buyer with any such information in connection with any financing, public or private, with respect to securities of the Buyer or its Affiliates as may be required by Regulatory Authorities. Buyer shall be responsible for all costs and expenses incurred by Seller and its Affiliates in connection with this Section 5.2.3.
5.3 Publicity. No public announcement related to this Agreement or the transactions contemplated herein will be issued without the joint approval of Seller and Buyer, which approval shall not be unreasonably withheld, conditioned or delayed; except in any public disclosure which either Seller or Buyer, in its good faith judgment, believes is required by applicable Law or by any stock exchange on which its securities or those of its Affiliates are listed. If either Party, in its good faith judgment, believes such disclosure is required, such Party will use its commercially reasonable efforts to consult with the other Party and its Representatives, and to consider in good faith any revisions proposed by the other Party or its Representatives, as applicable, prior to making (or prior to any of its Affiliates making) such disclosure, and shall limit such disclosure to only that information which is legally required to be disclosed. Notwithstanding the foregoing, neither Seller nor Buyer shall issue or permit any of its Affiliates to issue any public announcement of the execution of this Agreement without the prior written consent of the other Party, which consent shall not be unreasonably withheld, delayed or conditioned; provided, however, that where Seller or Buyer, as the case may be, shall have received advice of counsel that it or its Affiliates is required to make an announcement or furnish a statement pursuant to the Laws of its jurisdiction of incorporation or any jurisdiction in
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which any of its securities are publicly traded or the rules of any stock exchange upon which its securities are listed or any registered securities quotation system on which such securities are traded (including in the case of Buyer or its Affiliates, Canadian Securities Laws), it shall be permitted, after providing the other Party with a copy of such announcement or statement at least five Business Days (or such shorter time as advised by counsel, but in no event less than two Business Days) prior to its proposed issuance or submission, and after discussing such announcement or statement with the other Party and considering in good faith the modifications to such announcement or statement proposed by the other Party, to do so even if it has not obtained the approval of the other Party.
5.4 Confidentiality.
5.4.1 Subject to Section 5.3, all Confidential Information provided by one Party (or its Representatives or Affiliates) (collectively, the Disclosing Party with respect to such information) to the other Party (or its Representatives or Affiliates) (collectively, the Receiving Party with respect to such information) shall be subject to and treated in accordance with the terms of this Section 5.4. As used in this Section 5.4, Confidential Information means, as to a Party (a) all information disclosed by such Party (or its Representatives or Affiliates) to the Receiving Party in connection with this Agreement, including all information with respect to the Disclosing Partys licensors, licensees or Affiliates, (b) all information disclosed to the Receiving Party by the Disclosing Party under the Confidentiality Agreement and (c) all memoranda, notes, analyses, compilations, studies and other materials prepared by or for the Receiving Party to the extent containing or reflecting the information in the preceding clause (a) or (b). Notwithstanding the foregoing, Confidential Information shall not include information that, in each case as demonstrated by competent written documentation:
(i) was already known to the Receiving Party, other than under an obligation of confidentiality, at the time of disclosure by the Disclosing Party;
(ii) was generally available to the public or otherwise part of the public domain at the time of its disclosure to the Receiving Party;
(iii) became generally available to the public or otherwise part of the public domain after its disclosure to the Receiving Party other than through any act or omission of the Receiving Party in breach of this Agreement or the Confidentiality Agreement;
(iv) is subsequently disclosed to the Receiving Party by a Third Party without obligations of confidentiality to the Disclosing Party with respect thereto; or
(v) is subsequently independently discovered or developed by the Receiving Party without the aid, application or use of Confidential Information of the Disclosing Party.
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5.4.2 (i) All Confidential Information obtained by Seller (or its Affiliates or Representatives) from Buyer (or its Affiliates or Representatives) and (ii) from and after the Closing, all Confidential Information to the extent relating to the Product Business, the Purchased Assets and the Assumed Liabilities ((i) and (ii), collectively, the Buyer Confidential Information ) shall be deemed to be Confidential Information disclosed by Buyer to Seller for purposes of this Section 5.4 and shall be used by Seller solely as required to (a) perform its obligations or exercise or enforce its rights under this Agreement (including Sellers exercise of the rights retained pursuant to Section 2.1.4) or any Ancillary Agreement, (b) operate the business of Seller and its Affiliates in the Seller Territory, and, with respect to Excluded Assets only, in the Buyer Territory (including the sale of such business), or (c) comply with applicable Law (each of (a) through (c), a Seller Permitted Purpose ), and for no other purpose. For a period of [REDAC TED ] years after the Closing Date (or, if the Closing does not occur, [REDACTED] years after the Execution Date), Seller shall not disclose, or permit the disclosure of, any of the Buyer Confidential Information to any Person except those Persons to whom such disclosure is necessary in connection with any Seller Permitted Purpose (and Seller shall be liable to Buyer for any disclosure of Confidential Information by such Persons which would be a breach of this Agreement if such disclosure was made by Seller itself) and Seller shall not use the Buyer Confidential Information except in connection with the Seller Permitted Purpose; provided, however , that with respect to any Buyer Confidential Information that is a Trade Secret, Seller shall not disclose, or permit the disclosure of, such information for the period of time that it is considered a Trade Secret under the UTSA, other than in compliance with the Confidentiality Agreement, for a Seller Permitted Purpose (to the extent reasonable measures are taken to preserve the confidentiality of such Trade Secret), or in accordance with Section 5.4.4. Seller shall treat, and will cause its Affiliates and the Representatives of Seller or any of its Affiliates to treat, the Buyer Confidential Information as confidential, using the same degree of care as Seller normally employs to safeguard its own confidential information from unauthorized use or disclosure, but in no event less than a reasonable degree of care.
5.4.3 All Buyer Confidential Information described in clause (ii) of Section 5.4.2 to the extent not solely related to the Product Business, the Purchased Assets or the Assumed Liabilities ( Non-Exclusive Information ) and all Confidential Information obtained by Buyer (or its Affiliates or Representatives) from Seller (or its Affiliates or Representatives) other than the Buyer Confidential Information (together with Non-Exclusive Information, the Seller Confidential Information ) shall be used by Buyer solely as required to (a) perform its obligations or exercise or enforce its rights under this Agreement or any Ancillary Agreement, (b) with respect to Non-Exclusive Information, operate the business of Buyer and its Affiliates in the Buyer Territory (including the sale of such business), or (c) comply with applicable Law (each of (a) and (b), a Buyer Permitted Purpose ), and for no other purpose. For a period of [REDACTED] years after the Closing Date (or, if the Closing does not occur, [REDACTED] years after the Execution Date), Buyer shall not disclose, or permit the disclosure of, any of the Seller Confidential Information to any Person except those Persons to whom such disclosure is necessary in
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connection with a Buyer Permitted Purpose (and Buyer shall be liable to Seller for any disclosure of Confidential Information by such Persons which would be a breach of this Agreement if such disclosure was made by Buyer itself) and Buyer shall not use, or permit the use of, the Seller Confidential Information, except in connection with a Buyer Permitted Purpose; provided, however, that with respect to any Seller Confidential Information that is a Trade Secret, Buyer shall not disclose, or permit the disclosure of, such information for the period of time that it is considered a Trade Secret under the UTSA, other than in compliance with the Confidentiality Agreement, for a Buyer Permitted Purpose (to the extent reasonable measures are taken to preserve the confidentiality of such Trade Secret), or in accordance with Section 5.4.4. Buyer shall treat, and will cause its Affiliates and the Representatives of Buyer or any of its Affiliates to treat, Seller Confidential Information as confidential, using the same degree of care as Buyer normally employs to safeguard its own confidential information from unauthorized use or disclosure, but in no event less than a reasonable degree of care.
5.4.4 In the event either Party is requested pursuant to, or required by, applicable Law to disclose any of the other Partys Confidential Information ( i.e ., Seller Confidential Information or Buyer Confidential Information, as applicable), it will notify the other Party in a timely manner so that such Party may seek a protective order or other appropriate remedy or, in such Partys sole discretion, waive compliance with the confidentiality provisions of this Agreement. Each Party will cooperate in all reasonable respects in connection with any reasonable actions to be taken for the foregoing purpose, at the sole cost and expense of the Party seeking such remedy or order. In any event, the Party requested or required to disclose such Confidential Information may furnish it as requested or required pursuant to applicable Law (subject to any such protective order or other appropriate remedy) without liability hereunder, provided that such Party furnishes only that portion of the Confidential Information which such Party is advised by its counsel is legally required, and if confidential treatment is available such Party exercises reasonable efforts to obtain reliable assurances that confidential treatment will be accorded to such Confidential Information, at the sole cost and expense of the other Party.
5.4.5 Nothing in this Section 5.4 shall be construed as preventing or in any way inhibiting either Party from complying with applicable Law governing activities and obligations undertaken pursuant to this Agreement or any Ancillary Agreement in any manner which it reasonably deems appropriate.
5.4.6 The Confidentiality Agreement shall automatically terminate upon the Closing.
5.5 Commercialization. Except to the extent otherwise provided in the Transition Services Agreement, from and after the Closing Date, (a) Buyer, at its own cost and expense, shall be responsible for and have sole discretion over the commercialization, marketing strategy, promotion, distribution and sale of the Product in the Buyer Territory and shall independently determine and set prices for the Product in the Buyer Territory, including the selling price, volume discounts, rebates and similar matters; (b) Buyer shall be responsible, at its own cost and
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expense, for all marketing, advertising and promotional materials related to the Product in the Buyer Territory; and (c) Buyer or its Affiliates shall be responsible for receiving and processing all orders, undertaking all invoicing, collection and receivables, and providing all customer service related to the sale of the Product in the Buyer Territory.
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5.6 Transitional Trademark License.
5.6.1 Effective as of the Closing Date until the date that Buyer sells or otherwise disposes the last of the Purchased Inventory (the Transitional License Period ), Seller hereby grants to Buyer, and Buyer hereby accepts, a non-exclusive, non- transferable, non-sublicensable (except to Buyers Affiliates responsible for operating the Product Business during the Transitional License Period), royalty-free, paid-up, license in the Buyer Territory under the Seller Marks, for use during such period solely in connection with (a) Buyers sale of the finished Product included in the Purchased Inventory in the Buyer Territory, and (b) the labeling on Product Manufactured by or on behalf of Buyer during the Transitional License Period (and the sale of such Product). Notwithstanding the foregoing, Buyer acknowledges and agrees that the license granted under this Section 5.6.1 is being granted solely for transitional purposes and Buyer shall use its commercially reasonable efforts to cease its use of the Seller Marks as soon as is reasonably practicable after the Closing, but in no event later than the termination of the Transitional License Period.
5.6.2 To the extent Buyer is utilizing the license granted by Seller in Section 5.6.1, Buyer shall, and shall cause its permitted sublicensees to, (a) comply with all Trademark usage guidelines as may be reasonably specified from time to time by Seller with respect to the manner of use of the Seller Marks; (b) except as required pursuant to the preceding clause (a), not add any other labels or marks to, or otherwise alter, the Seller Marks as used in the Product Business as of the Closing Date or change in any way the style of the Seller Marks as used in the Product Business as of the Closing Date, in each case in this clause (b), except as otherwise agreed to or directed by Seller; and (c) at Sellers request, furnish to Seller representative samples of all Product labeling and other materials bearing any of the Seller Marks for quality control purposes.
5.6.3 Buyer shall not, and it shall cause its permitted sublicensees not to, (a) directly or indirectly, at any time challenge Sellers rights, title or interest in and to the Seller Marks or in any registration or registration application therefor; (b) do or cause to be done or fail to do anything, the doing, causing or failing of which would contest or in any way impair or tend to impair Sellers rights in and to the Seller Marks or in any registrations or registration applications therefor; (c) represent to any Third Party that it has, in any jurisdiction, any ownership rights in or to the Seller Marks or any other rights in the Seller Marks other than the specific rights conferred by this Agreement; (d) register or attempt to register the Seller Marks or any confusingly similar Trademark as a Trademark with any Governmental Authority in its own name or in the name of any Third Party in any jurisdiction; or (e) do any act that endangers, destroys or adversely affects the Seller Marks or the value of the goodwill associated with the Seller Marks (for the avoidance of doubt, the sale of the Purchased Inventory in accordance with applicable Law and this Agreement and the Ancillary Agreements, or the consequences of such sale, shall not breach this provision or give rise to any Buyer liability hereunder).
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5.6.4 Buyer hereby acknowledges and agrees that (a) as between the Parties, Seller has exclusive right, title and interest in and to the Seller Marks and to any registration or registration application therefor, (b) nothing herein shall be construed to accord it any rights in the Seller Marks, except for the limited license right expressly conferred by Section 5.6.1, (c) no ownership rights are vested or created in the Seller Marks anywhere in the world by the license granted in Section 5.6.1, and (d) all use of the Seller Marks by Buyer, its Affiliates and its permitted sublicensees, and all goodwill generated in connection therewith, shall inure solely for and to the benefit of Seller.
5.7 Regulatory Responsibilities.
5.7.1 From and after the Closing, subject to the terms of Section 5.9, the Ancillary Agreements and except as required by a Party to comply with applicable Law or to exercise its rights and obligations hereunder or under any other Ancillary Agreement, in accordance with the terms and subject to the conditions of the Dainippon License Agreement, Buyer shall have the sole right and responsibility for (a) taking all actions, paying all fees and conducting all communications with applicable Governmental Authorities with respect to the U.S. Regulatory Approval, including preparing and filing all reports (including adverse drug experience reports) with applicable Governmental Authorities, (b) taking all actions and conducting all communications with Third Parties in respect of Product sold pursuant to the U.S. Regulatory Approval in the Buyer Territory, including responding to all complaints in respect thereof and (c) investigating all complaints and adverse drug experiences in respect of Product sold pursuant to the U.S. Regulatory Approval. Buyer shall consult Seller reasonably in advance of making any communications or filing any reports with any Governmental Authority with respect to adverse drug experiences relating to Product Manufactured prior to the Closing and consider in good faith any proposals by Seller with respect to such communications.
5.7.2 Subject to the terms of the Transition Services Agreement, from and after the Closing (a) Seller shall support Buyer, as may be reasonably necessary and practicable, at Buyers cost and expense, in preparing, obtaining and maintaining all Regulatory Approvals for the Product in the Buyer Territory, including providing necessary documents or other materials required by applicable Law for Buyer to obtain or maintain such Regulatory Approvals, in each case, in accordance with the terms and conditions of this Agreement; and (b) Buyer shall support Seller and its Affiliates, as may be reasonably necessary and practicable, at Sellers cost and expense, in preparing, obtaining and maintaining all Regulatory Approvals for the Product and any Other Product in the Seller Territory, including providing necessary documents or other materials required by applicable Law for Seller to obtain or maintain such Regulatory Approvals, in each case, in accordance with the terms and conditions of this Agreement.
5.7.3 Subject to the immediately following sentence and except to the extent otherwise provided in the Transition Services Agreement, from and after the Closing, (a) Buyer shall provide Seller with (i) copies of all written or electronic correspondence relating to the Product in the Buyer Territory, received by Buyer, its
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Affiliates, licensees, sublicensees or distributors from, or submitted by Buyer, its Affiliates, licensees, sublicensees or distributors to, Regulatory Authorities and (ii) copies of all meeting minutes and other similar summaries of all meetings, conferences and discussions held by Buyer with Regulatory Authorities to the extent relating solely to the Product, including copies of all contact reports produced by Buyer and its Affiliates, licensees, sublicensees and distributors, in each case ((i) and (ii)), within five Business Days after Buyers receipt, submission or production of the foregoing, as applicable; and (b) Seller shall provide Buyer with (i) copies of all written or electronic correspondence relating to the Product received by Seller, its Affiliates, licensees, sublicensees or distributors from, or submitted by Seller, its Affiliates, licensees, sublicensees or distributors to, Regulatory Authorities and (ii) copies of all meeting minutes and other similar summaries of all meetings, conferences and discussions held by Seller with Regulatory Authorities to the extent relating solely to the Product in the Seller Territory, including copies of all contact reports produced by Seller and its Affiliates, licensees, sublicensees and distributors, in each case ((i) and (ii)), within five Business Days after Sellers receipt, submission or production of the foregoing, as applicable.
5.7.4 Seller shall be solely responsible for all costs associated with, or required to address, any clinical findings or concerns regarding clinical data, in either case, regarding the Product, that were conveyed by FDA to Seller in writing prior to the Closing other than any such costs related to or arising out of data generated at or after the Closing.
5.8 Access to Regulatory Approvals and Documentation.
5.8.1 Effective from and after the Closing, Buyer hereby grants to Seller and its Affiliates, a perpetual, irrevocable, worldwide, exclusive, royalty-free and non- transferable license and right of reference (with a right to grant sublicenses and further rights of reference for purposes of conducting Sellers and its Affiliates business) to the Buyer Regulatory Approvals and Documentation as necessary to exercise the rights retained by Seller pursuant to Section 2.1.4 and otherwise Exploit and Manufacture or have Manufactured the Product or any Other Product in the Seller Territory. Effective from and after the Closing, Seller hereby grants to Buyer and its Affiliates, a perpetual, irrevocable, worldwide, exclusive, royalty-free and non-transferable license and right of reference (with a right to grant sublicenses and further rights of reference for purposes of conducting Buyers and its Affiliates business) to the Seller Regulatory Documentation, as necessary to Manufacture and Exploit the Product in the Buyer Territory.
5.8.2 From and after the Closing, upon Buyers reasonable request, Seller promptly shall (a) provide to Buyer, at Buyers cost and expense, copies of the Seller Regulatory Documentation as shall be reasonably requested by Buyer solely for purposes of Exploiting and Manufacturing or having Manufactured the Product in the Buyer Territory and (b) provide to Buyer and to any specified Governmental Authority in the Buyer Territory a letter, in the form reasonably requested by Buyer, acknowledging that Buyer has the right of reference to any Seller Regulatory Documentation as necessary to Exploit and Manufacture or have Manufactured the Product in the Buyer Territory.
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Notwithstanding anything to the contrary contained in this Agreement, Seller shall not be required to disclose any information or provide any such access if such disclosure or access would, (x) violate (i) applicable Law or (ii) any binding agreement entered into by Seller prior to the Closing Date, including any confidentiality agreement to which Seller is a party ( provided , that Seller shall use commercially reasonable efforts to obtain consent from any Third Party to any such binding agreement to enable Seller to disclose such information), (y) jeopardize any attorney/client privilege or other established legal privilege or (z) disclose any Trade Secrets.
5.8.3 From and after the Closing, upon Sellers reasonable request, Buyer promptly shall (a) provide to Seller or Sellers Affiliates, at Sellers cost and expense, copies of the Buyer Regulatory Approvals and Documentation as shall be reasonably requested by Seller or its applicable Affiliate solely for purposes of exercising the rights retained by Seller pursuant to Section 2.1.4 and otherwise Exploiting and Manufacturing or having Manufactured the Product or any Other Product in the Seller Territory and (b) provide to Seller or its applicable Affiliate and to any specified Governmental Authority in the Seller Territory a letter, in the form reasonably requested by Seller, acknowledging that Seller or its applicable Affiliate has the right of reference to any Buyer Regulatory Approvals and Documentation as necessary to Exploit the Product or, as applicable, any Other Product in the Seller Territory. Notwithstanding anything to the contrary contained in this Agreement, Buyer shall not be required to disclose any information or provide any such access if such disclosure or access would, (x) violate (i) applicable Law or (ii) any binding agreement entered into by Buyer prior to the Closing Date, including any confidentiality agreement to which Buyer is a party ( provided , that Buyer shall use commercially reasonable efforts to obtain consent from any Third Party to any such binding agreement to enable Buyer to disclose such information), (y) jeopardize any attorney/client privilege or other established legal privilege or (z) disclose any Trade Secrets.
5.9 Medical and Other Inquiries. Except to the extent otherwise provided in the Transition Services Agreement or the Safety Data Exchange Agreement, from and after the Closing Date, Buyer or its designee (a) shall be responsible for, and shall handle and respond to, all customer complaints and inquiries (including medical and non-medical inquiries) related to the Product in the Buyer Territory ( provided , that Buyer shall use commercially reasonable efforts to consult and coordinate with Seller prior to communicating with any Regulatory Authority in connection with any customer complaints and reported defects with respect to the Product in the Buyer Territory where such consultation and coordination does not interfere with the proper conduct of the Product Business), and (b) shall be responsible for, and shall conduct, all correspondence and communication with physicians and other health care professionals in the Buyer Territory relating to the Product. Buyer shall keep such records and make such reports as shall be reasonably necessary to document such communications in compliance with applicable Law.
5.10 Wrong Pockets. If either Buyer or Seller becomes aware that any of the Purchased Assets has not been transferred to Buyer or that any of the Excluded Assets has been
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transferred to Buyer, it shall promptly notify the other and the Parties shall, as soon as reasonably practicable, ensure that such property is transferred (except if such notification occurs more than six months after the Closing Date and such property is not reasonably obtainable; provided , however , that this limitation of the obligation to transfer shall not limit the Parties respective rights and obligations under ARTICLE 7), at the expense of [ REDACTED] and with any necessary prior Third Party consent or approval, to (a) Buyer, in the case of any Purchased Asset which was not transferred to Buyer at the Closing; or (b) Seller, in the case of any Excluded Asset which was transferred to Buyer at the Closing.
5.11 Accounts Receivable; Accounts Payable.
5.11.1 Accounts Receivable . The Parties acknowledge and agree that all Accounts Receivable outstanding on the Closing Date shall remain the property of Seller and shall be collected by Seller or its Affiliates subsequent to the Closing. In the event that, subsequent to the Closing, Buyer or an Affiliate of Buyer receives any payments from any obligor with respect to an Account Receivable, then Buyer shall, within 30 days after receipt of such payment, remit the full amount of such payment to Seller. In the case of the receipt by Buyer of any payment from any obligor of both Seller and Buyer then, unless otherwise specified by such obligor, such payment shall be applied first to amounts owed to Buyer with the excess, if any, remitted to Seller. In the event that, subsequent to the Closing, Seller or any of its Affiliates receives any payments from any obligor with respect to an account receivable, notes receivable or other indebtedness due and owed by any Third Party to Buyer or any of its Affiliates arising from sales of the Product by or on behalf of Buyer or its Affiliates for any period after the Closing Date, then Seller shall, within 30 days after receipt of such payment, remit the full amount of such payment to Buyer. In the case of the receipt by Seller of any payment from any obligor of both Seller and Buyer then, unless otherwise specified by such obligor, such payment shall be applied first to amounts owed to Seller with the excess, if any, remitted to Buyer.
5.11.2 Accounts Payable . In the event that, subsequent to the Closing, Buyer or an Affiliate of Buyer receives any invoices from any Third Party with respect to any account payable of the Product Business arising prior to the Closing, then Buyer shall, within 30 days after receipt of such invoice, provide such invoice to Seller. In the event that, subsequent to the Closing, Seller or any of its Affiliates receives any invoices from any Third Party with respect to any account payable of Buyer or any of its Affiliates with respect to the Product Business arising after the Closing, then Seller shall, within 30 days after receipt of such invoice, provide such invoice to Buyer.
5.12 Non-Competition. During the [REDACTED] following the Closing, except as provided in the Transition Services Agreement, Seller shall not, and shall cause each of its Affiliates not to, directly or indirectly, (a) market, promote, distribute, sell or accept orders for the sale of any product containing zonisamide, or any pharmaceutically acceptable salts, isomers or metabolites, or other analogues of zonisamide, as an active pharmaceutical ingredient for use in the treatment of epilepsy in the Buyer Territory or (b) assist or cooperate in any material way with any other Person in connection with the marketing, promotion, distribution, selling or
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acceptance of orders for the sale of any such product for the treatment of epilepsy in the Buyer Territory.
5.13 Certain Tax Matters.
5.13.1 Transfer Taxes and Apportioned Obligations .
(a) All amounts payable hereunder or under any Ancillary Agreement are exclusive of all recordation, transfer, documentary, excise, sales, value added, use, stamp, conveyance or other similar Taxes, duties or governmental charges, and all recording or filing fees or similar costs, imposed or levied by reason of, in connection with or attributable to this Agreement or the transactions contemplated hereby (collectively, Transfer Taxes ). [REDACTED] shall be responsible for the payment of the Transfer Taxes, and shall pay all amounts due and owing in respect of any Transfer Taxes at the rate in force at the due time for payment or such other time as is stipulated under applicable Law.
(b) All personal property and similar ad valorem obligations levied with respect to the Purchased Assets for a taxable period which includes (but does not end on) the Closing Date (collectively, the Apportioned Obligations ) shall be apportioned between Seller and Buyer based on the number of days of such taxable period ending on the day prior to the Closing Date (such portion of such taxable period, the Pre-Closing Tax Period ) and the number of days of such taxable period on and after the Closing Date (such portion of such taxable period, the Post-Closing Tax Period ). Seller shall be liable for the proportionate amount of such Apportioned Obligations that is attributable to the Pre-Closing Tax Period, and Buyer shall be liable for the proportionate amount of such Apportioned Obligations that is attributable to the Post-Closing Tax Period.
(c) Apportioned Obligations and Transfer Taxes shall be timely paid, and all applicable filings, reports and returns shall be filed, as provided by applicable Law. With respect to the Apportioned Obligations, the paying Party shall be entitled to reimbursement from the non-paying Party in accordance with Section 5.13.1(b). Upon payment of any such Apportioned Obligation, the paying Party shall present a statement to the non-paying Party setting forth the amount of reimbursement to which the paying Party is entitled under Section 5.13.1(b) together with such supporting evidence as is reasonably necessary to calculate the amount to be reimbursed. The non-paying Party shall make such reimbursement promptly but in no event later than 10 days after the presentation of such statement.
5.13.2 Cooperation and Exchange of Information . Each of Seller and Buyer shall (a) provide the other with such assistance as may reasonably be requested by the other in connection with the preparation of any Tax Return, audit or other examination by any taxing authority or judicial or administrative proceeding relating to Liability for Taxes in connection with the Product Business or the Purchased Assets, (b) retain and provide the other with any records or other information that may be relevant to such Tax Return, audit or examination, proceeding or determination and (c) inform the other of any final
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determination of any such audit or examination, proceeding or determination that affects any amount required to be shown on any Tax Return of the other for any period.
5.13.3 Survival of Covenants . The covenants contained in this Section 5.13 shall survive until 30 days after the expiration of the applicable statute of limitations (including extensions thereof).
5.14 Payment Claims; Government Price Reporting.
5.14.1 NDC Numbers; Returned Product .
(a) Promptly, but in no event later than 30 days, following the Closing Date, Buyer shall obtain its own NDC number for the Product and Buyer shall use, or caused to be used, its new NDC number on all invoices, orders, drug labels, and labeling and other communications with all customers and Governmental Authorities for Product other than the Purchased Inventory, for which Seller agrees Buyer shall be entitled to use Sellers NDC number pursuant to the Transition Services Agreement.
(b) All returns of Product following the Closing (including with respect to Product labeled with an NDC number of Seller or any of its Affiliates and Product labeled with an NDC number of Buyer or any of its Affiliates) that were sold in the Buyer Territory shall be sent to Buyer or its designee for processing. Returns will be processed by Buyer or its designee in accordance with its then-current returned goods policy, regardless of which Party made the corresponding original sale. Buyer shall be financially responsible for return reimbursement for all Product sold on or after the Closing Date in the Buyer Territory and Seller shall be financially responsible for return reimbursement for all Product sold prior to the Closing Date in the Buyer Territory. Notwithstanding the foregoing, Buyer and Seller shall be financially responsible for returns of Product included in Transition Lots on a proportional basis, based on the number of units of Product in such Transition Lot sold by Buyer on or after the Closing Date and on the number of units of Product in such Transition Lot sold by Seller prior to the Closing Date. The Parties respective financial responsibility for returns of Product included in a Transition Lot shall be determined as of the expiration date for such lot. Within 30 days following Sellers receipt of written notice from Buyer, Seller shall reimburse Buyer for all refunds paid by Buyer for (i) returns of Product sold by Seller in the Buyer Territory prior to the Closing Date and (ii) Sellers proportionate share of refunds for returns of Product included in Transition Lots. Buyer shall notify all customers of the Product Business in the Buyer Territory of the foregoing change in trade return procedures as soon as practicable after the Closing Date, with a reminder notification sent to all customers no later than 30 days following the Closing Date. All such notifications shall be provided to Seller within five days following communication to the customers.
(c) Buyer shall promptly destroy, or cause to be promptly destroyed, all such returned Product in a manner consistent with all applicable Law and Seller shall reimburse Buyer for all reasonable out-of-pocket costs of destruction of such Product that were sold prior to the Closing Date.
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(d) Neither Buyer nor Seller shall instruct, recommend or attempt to induce customers who have previously purchased Product in the Buyer Territory to (i) return such Product when that would not otherwise have been the case but for such Partys instructions, recommendations or inducement or (ii) delay the return of such Product.
5.14.2 Government Rebates .
(a) From and after the Closing, Seller shall be financially responsible for ail rebates pursuant to any government rebate programs with respect to Product dispensed to patients (i) on or prior to the Closing Date, or (ii) during the [REDACTED] day period following the Closing Date (such period, the Rebate Tail Period ). From and after the Closing, Buyer shall be financially responsible for all rebates pursuant to any government rebate programs with respect to Product dispensed to patients beginning on the date following the expiration of the Rebate Tail Period. After the Closing, Seller shall be administratively responsible for processing all such rebates for Product labeled with an NDC number of Seller. Buyer shall be administratively responsible for processing all such rebates for Product labeled with an NDC number of Buyer. Upon reasonable advance notice, Buyer will provide to Seller information relating to the Product labeled with an NDC number of Seller sold by Buyer that Seller reasonably needs in order to comply with applicable rules and regulations relating to government rebates.
(b) To the extent that information related to any government rebate programs with respect to Product is received with respect to the calendar quarter that includes the Rebate Tail Period following the end of such calendar quarter, and such information does not include a dispense date, (i) Seller shall be financially responsible for the amount of such rebates that is equal to the product of (A) a fraction, the numerator of which is the sum of the number of days in such calendar quarter included in the Rebate Tail Period plus the number of days in such calendar quarter prior to, and including, the Closing Date, and the denominator of which is the number of days in such calendar quarter, and (B) the amount of the rebate and (ii) Buyer shall be financially responsible for the amount of such rebates that is equal to the product of (A) one minus the fraction determined pursuant to clause (i) above and (B) the amount of the rebate.
(c) To the extent that Seller processes any government rebates that are the financial responsibility of Buyer, Buyer shall reimburse Seller within 30 days after receipt of invoices that describe the requested payments in reasonable detail and include reasonable supporting documentation. To the extent that Buyer processes any government rebates that are the financial responsibility of Seller, Seller shall reimburse Buyer within 30 days after receipt of invoices that describe the requested payments in reasonable detail and include reasonable supporting documentation.
(d) Schedule 5.14.2(d) sets forth the Best Price (as defined at 42 U.S.C. § 1396r-8(c)(1)(C)) and Average Manufacturers Price ( AMP ) (as defined at 42 U.S.C. § 1396r-8(k)(1)) reported by Seller for each Product for the two most recently ended calendar quarters prior to the Execution Date. Buyer shall be responsible for any notices to
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any Governmental Authorities with respect to any changes in the average wholesale price or weighted average costs of the Product following the Closing Date, in each case as may be required by applicable Law.
(e) From and after the Closing, Buyer shall conduct all federal and state government price reporting for the Product ( i.e . Best Price, AMP, NFAMP, annual NFAMP and state reporting) in accordance with all applicable Laws. Seller shall provide to Buyer such information relating to the Product labeled with an NDC number of Seller sold by Buyer that is reasonably necessary for Buyer to comply with applicable Law relating to government price reporting.
(f) Seller and Buyer shall work together to coordinate the addition of the Product to Buyers FSS and TriCare Retail Refund Pricing Agreement as soon as practicable following Closing Date and to coincide with Seller removing the Product from its FSS and TriCare Retail Refund Pricing Agreement; provided , that Seller shall be entitled to remove the Product from its FSS and TriCare Retail Pricing Agreement if the Product is not added to Buyers FSS and TriCare Retail Pricing Agreement by December 31, 2014. Notwithstanding the foregoing, as between the Parties, Buyer shall be solely responsible for adding the Product to its FSS and TriCare Retail Refund Pricing Agreement.
5.14.3 Commercial Rebates .
(a) From and after the Closing, Seller shall be financially responsible for all commercial rebates with respect to Product labeled with an NDC number of Seller and dispensed to patients prior to the expiration of the Rebate Tail Period. From and after the Closing, Buyer shall be financially responsible for all commercial rebates with respect to Product dispensed to patients beginning on the date following the expiration of the Rebate Tail Period. After the Closing, Seller shall be administratively responsible for processing all such rebates for Product labeled with an NDC number of Seller. Buyer shall be administratively responsible for processing all such rebates for Product labeled with an NDC number of Buyer.
(b) To the extent that any commercial rebates are invoiced on a calendar quarter basis, in the event that the Rebate Tail Period is not the last day of a calendar quarter, (i) Seller shall be financially responsible for the amount of such rebates that is equal to the product of (A) a fraction, the numerator of which is the sum of the number of days in such calendar quarter included in the Rebate Tail Period plus the number of days in such calendar quarter prior to, and including, the Closing Date, and the denominator of which is the number of days in such calendar quarter, and (B) the amount of the rebate and (ii) Buyer shall be financially responsible for the amount of such rebates that is equal to the product of (A) one minus the fraction determined pursuant to clause (i) above and (B) the amount of the rebate.
(c) Notwithstanding the foregoing, the Parties agree that (i) Seller shall not be responsible for credits or shelf stock adjustments to the extent resulting from
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price decreases initiated by Buyer on or after the Closing Date and (ii) any such commercial rebate payments by Seller shall be made on the terms and conditions equivalent to Sellers rebate obligations as of the Closing with respect to each commercial customer as set forth in Sellers terms of agreement with such customer.
(d) To the extent that Seller processes any commercial rebates that are the financial responsibility of Buyer, Buyer shall reimburse Seller within 30 days after receipt of invoices that describe the requested payments in reasonable detail and include reasonable supporting documentation. To the extent that Buyer processes any commercial rebates that are the financial responsibility of Seller, Seller shall reimburse Buyer within 30 days after receipt of invoices that describe the requested payments in reasonable detail and include reasonable supporting documentation.
5.14.4 Chargeback Claims .
(a) Seller shall be financially responsible for all chargeback claims (and associated administrative fees) (the Chargeback Claims ) related to Product sold by Seller prior to the Closing Date. Buyer shall be financially responsible for all other Chargeback Claims related to the Product in the Buyer Territory. Notwithstanding the foregoing, the Parties acknowledge that the VA National Acquisition Center must approve the removal of the Product from Sellers FSS before the responsibility of processing such rebates is transferred from Seller to Buyer. Until such approval is obtained (and the Parties agree that they shall each use commercially reasonable efforts to promptly facilitate such approval), Seller shall continue to be responsible for processing the FSS Chargeback Claims for which Buyer is financially responsible on Buyers behalf, and Buyer shall reimburse Seller for same as set forth below. The Parties agree that, upon Closing, Seller may immediately remove the Product from its agreement under the PHS 340B Program. Buyer and Seller agree that (i) Sellers financial liability for Chargeback Claims shall be limited to those customers with which Seller has chargeback obligations as of the Closing Date and (ii) any such Chargeback Claims issued by Seller shall be made on terms and conditions equivalent to Sellers obligations as of the Closing with respect to each customer as of the Closing Date.
(b) To the extent that Seller processes Chargeback Claims that are the financial responsibility of Buyer, Buyer shall reimburse Seller within 30 days after receipt of invoices that describe the requested payments in reasonable detail and include reasonable supporting documentation. To the extent that Buyer processes Chargeback Claims that are the financial responsibility of Seller, Seller shall reimburse Buyer within 30 days after receipt of invoices that describe the requested payments in reasonable detail and include reasonable supporting documentation.
5.14.5 Health Care Reform Fees .
(a) With respect to HCR Fees invoiced to Seller during 2015 based on sales in 2013 as an estimate of sales in 2014, Buyer shall be financially responsible for
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that portion of Sellers HCR Fees associated with the sale of the Product in 2013 that represents the portion of calendar year 2014 that follows the Closing Date.
(b) With respect to any adjustment in HCR Fees invoiced to either Party during 2016 based on actual sales in 2014, Buyer shall be financially responsible for that portion of the adjustment associated with the sale of the Product in 2014 that represents the portion of 2014 that follows the Closing Date.
(c) In the event that HCR Fees for the Product for 2014 or any adjustment thereto are invoiced to Seller, within 30 days following Sellers receipt of such invoice, Seller shall provide to Buyer an invoice that includes a calculation of the portion of such fees allocable to Buyer, as set forth above. In the event that HCR Fees for the Product for 2014 are invoiced to Buyer, within 30 days following Buyers receipt of such invoice, Buyer shall provide to Seller an invoice that includes a calculation of the portion of such fees allocable to Seller, as set forth above. Seller or Buyer, as applicable, shall pay to the other the amount of HCR Fees for which it is invoiced by the other Party under this Section 5.14.5(c) within 30 days after receipt of such invoice and reasonable supporting documentation. In the event that the United States Department of Treasury issues final regulations with respect to the determination of HCR Fees which mandates a mechanism the effect of which a party believes is materially and substantially different from that contemplated herein such that it would render the allocation method described herein impracticable or inequitable, it shall so notify the other party and propose an alternative allocation method, and the parties shall meet in good faith to discuss the alternative method.
5.14.6 Reconciliation . No later than June 30, 2015, Seller and Buyer shall reconcile expenses and other amounts reimbursable, payable or accountable by one Party to another (as of the end of the period ending six months after the Closing Date) as envisioned in this Section 5.14, and the Party owing money shall pay the other Party no later than July 31, 2015. To the extent that Seller continues to have obligations to pay rebates, Chargeback Claims or similar expenses on account of the sale of the Product, Seller and Buyer shall continue the financial reporting and reconciliation obligations of this Section 5.14 on a calendar quarter basis until all such obligations end. In such event, reconciliations shall occur within 45 days after the end of a calendar quarter and any payments due shall be paid within 75 days after the end of such calendar quarter.
5.14.7 Impact of Price Increases on Payment Claims . Notwithstanding anything in this Agreement to the contrary, Sellers financial responsibility for any rebate, Chargeback Claim, HCR Fee or other payment obligation under this Section 5.14 shall not take into account any price increases Buyer or its Affiliates may implement for the Product on or after the Closing Date. Buyer shall be financially responsible for the excess of the amount of any such payment obligation of Seller over the amount of such payment obligation without giving effect to price increases Buyer or its Affiliates may implement for the Product on or after the Closing Date.
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5.15 [REDACTED]
5.16 Ancillary Agreements . Promptly following the date hereof, Buyer and Seller shall commence good faith negotiations of the Ancillary Agreements other than the Dainippon Assignment and Assumption Agreement, Guarantee, the Supply Agreement and the Transition Services Agreement (and, if so agreed upon by the Parties, the Quality Agreement), and shall enter into the Ancillary Agreements (other than the Guarantee and, if so agreed upon by the Parties, the Quality Agreement) on the Closing Date.
ARTICLE 6
CONDITIONS PRECEDENT
6.1 Conditions to Obligations of Buyer and Seller . The obligations of Buyer and Seller to complete the transactions contemplated by this Agreement are subject to the satisfaction at or prior to the Closing of the following conditions:
6.1.1 No Adverse Law; No Injunction . No Law shall have been enacted, entered, promulgated or enforced by any Governmental Authority that prohibits the consummation of all or any part of the Transactions, and no order by any Governmental Authority restraining, enjoining or otherwise preventing the consummation of the transactions contemplated hereby shall be in effect; and
6.1.2 Governmental Approvals . All required Authorizations of, notifications to and filings with any Governmental Authority shall have been received or made, as applicable and any waiting period applicable to the transactions contemplated hereby under the HSR Act shall have expired or been terminated.
6.1.3 Required Consents and Authorizations . Seller shall have received all consents, Authorizations, orders and approvals from the Persons referred to in Section 3.1.3 of the Disclosure Schedules and Buyer shall have received all consents, Authorizations, orders and approvals from the Persons referred to in Section 3.2.3, in each case, in form
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and substance reasonably satisfactory to Buyer and Seller, and no such consent, authorization, order or approval shall have been revoked.
6.1.4 Ancillary Agreements . Each of the Ancillary Agreements (other than the Quality Agreement, if the Parties agree to enter into the Quality Agreement after the Closing), shall have been finalized in a form reasonably acceptable to each of the Parties.
6.2 Conditions to Obligations of Buyer. The obligation of Buyer to complete the transactions contemplated by this Agreement is subject to the satisfaction or waiver by Buyer at or prior to the Closing of the following additional conditions:
6.2.1 Representations and Warranties . The representations and warranties of Seller contained in Section 3.1, other than the Fundamental Reps contained in Section 3.1, shall be true and correct in all respects (disregarding all material, in all material respects and Material Adverse Effect qualifiers) at and as of the Execution Date and the Closing Date as if made at and as of such date (except that those representations and warranties that address matters only as of a particular date need only be true and correct as of such date), except for breaches of such representations and warranties that would not, individually or in the aggregate, with respect to the Execution Date, materially affect the Product Business, the Purchased Assets or the Assumed Liabilities (or any material portion of the Product Business, the Purchased Assets or the Assumed Liabilities) and, with respect to the Closing Date, have a Material Adverse Effect; and the Fundamental Reps contained in Section 3.1 shall be true and correct in all respects at and as of the Execution Date and the Closing Date as if made at and as of such date (except that those Fundamental Reps contained in Section 3.1 that address matters only as of a particular date need only be true and correct as of such date);
6.2.2 Covenants . Seller shall have performed and complied in all material respects with all covenants, agreements and obligations required to be performed or complied with on or prior to the Closing Date;
6.23 Material Adverse Effect . Since the Execution Date, there shall not have been a Material Adverse Effect; and
6.2.4 Closing Deliveries . Seller shall have delivered to Buyer each of the items listed in Section 2.4.2(a).
6.3 Conditions to Obligations of Seller. The obligation of Seller to complete the transactions contemplated by this Agreement is subject to the satisfaction or waiver by Seller at or prior to the Closing of the following additional conditions:
63.1 Representations and Warranties . The representations and warranties of Buyer contained in Section 3.2, other than the Fundamental Reps contained in Section 3.2, shall be true and correct in all respects (disregarding all material, in all material
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respects and Buyer Material Adverse Effect qualifiers) at and as of the Execution Date and the Closing Date as if made at and as of such date (except that those representations and warranties that address matters only as of a particular date need only be true and correct as of such date), except for breaches of such representations and warranties that would not, individually or in the aggregate, with respect to the Execution Date, materially affect Buyers ability to complete any material portion of the Transactions and, with respect to the Closing Date, have a Buyer Material Adverse Effect; and the Fundamental Reps contained in Section 32 shall be true and correct in all respects at and as of the Execution Date and the Closing Date as if made at and as of such date (except that those Fundamental Reps contained in Section 3.2 that address matters only as of a particular date need only be true and correct as of such date);
6.3.2 Covenants . Buyer shall have performed and complied in all material respects with all covenants, agreements and obligations required to be performed or complied with on or prior to the Closing Date; and
633 Closing Deliveries . Buyer shall have delivered to Seller each of the items listed in Section 2.4.2(b) (and, for clarity, Seller shall have received the Closing Payment and the Estimated Closing Date Inventory Value in Sellers bank account (the wire transfer for which shall be initiated as set forth in the last paragraph of Section 2.4.2(b)).
6.4 Frustration of Closing Conditions. With respect to the conditions to Buyers and Sellers respective obligations to consummate the transactions contemplated by this Agreement as provided hereunder and each Partys right to terminate this Agreement as provided in Section 8.1, neither Buyer nor Seller may rely on the failure of any condition set forth in this ARTICLE 6 to be satisfied if such failure was caused by such Partys failure to act in good faith or to use its reasonable best efforts to cause the condition to be satisfied to the extent required by Section 4.3.
ARTICLE 7
INDEMNIFICATION
7.1 Indemnification.
7.1.1 Indemnification by Seller . Following the Closing, but subject to the provisions of this ARTICLE 7, Seller shall indemnify, defend and hold harmless Buyer and its Affiliates, and their respective officers, directors, employees and agents (collectively, Buyer Indemnitees ) from and against, and compensate and reimburse the Buyer Indemnitees for, any and all Losses incurred by any Buyer Indemnitee arising out of or related to:
(a) (i) any breach as of the Execution Date or the Closing Date of any of the representations or warranties made by Seller in Section 3.1 (as if such representations or warranties were made both on the Execution Date and on the Closing
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Date) or (ii) any breach of any of the representations and warranties made by Seller in any Ancillary Agreement (to the extent such Ancillary Agreement does not contain indemnification provisions);
(b) any failure of Seller to perform or any breach by Seller of any of its covenants, agreements or obligations contained in this Agreement or in any Ancillary Agreement (to the extent such Ancillary Agreement does not include indemnification provisions);
(c) any Excluded Liability; or
(d) any failure of Seller to pay [REDACTED] Apportioned Obligations allocated to Seller under Section 5.13.1.
7.1.2 Indemnification by Buyer . Following the Closing, but subject to the provisions of this ARTICLE 7, Buyer shall indemnify and hold harmless Seller and its Affiliates, and their respective officers, directors, employees and agents (collectively, Seller Indemnitees ) from and against, and compensate and reimburse the Seller Indemnitees for, any and all Losses incurred by any Seller Indemnitee arising out of or related to:
(a) (i) any breach as of the Execution Date or the Closing Date of any of the representations or warranties made by Buyer in Section 3.2 (as if such representations or warranties were made both on the Execution Date and on the Closing Date) or (ii) any breach of any of the representations and warranties made by Buyer in any Ancillary Agreement (to the extent such Ancillary Agreement does not contain indemnification provisions);
(b) any failure of Buyer to perform or any breach by Buyer of any of its covenants, agreements or obligations contained in this Agreement or in any Ancillary Agreement (to the extent such Ancillary Agreement does not include indemnification provisions);
(c) except to the extent the Loss is indemnifiable by Seller under Section 7.1.1(a) or any Ancillary Agreement, any Assumed Liability; or
(d) any failure of Buyer to pay Apportioned Obligations allocated to Buyer under Section 5.13.1.
7.2 Claim Procedure.
7.2.1 Indemnification Claim Procedure . Except as provided in Section 7.2.2 with respect to Third Party claims, in the event of a claim made by a Buyer Indemnitee or a Seller Indemnitee (the Indemnified Party ), the Indemnified Party shall give reasonably prompt written notice to the other Party (the Indemnifying Party ),
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which notice (an Indemnification Certificate ) shall: (a) state that the Indemnified Party has paid or properly accrued or in good faith anticipates that it will have to pay or accrue Losses that are subject to indemnification by the Indemnifying Party pursuant to Section 7.1.1 or Section 7.1.2, as applicable, and (b) specify in reasonable detail the facts and circumstances supporting the Indemnified Partys claim for indemnification (to the extent known) and contain a non-binding preliminary, good faith estimate of the amount to which the Indemnified Party claims to be entitled (to the extent known); provided , however , that the failure to give, or delay in giving, reasonably prompt notice shall not relieve the applicable Indemnifying Party of its indemnification obligations under this Agreement except to the extent that the Indemnifying Party forfeits rights or defenses by reason of such delay or failure. In the event that the Indemnifying Party agrees to or is determined to have an obligation to indemnify or reimburse the Indemnified Party for Losses as provided in this ARTICLE 7 the Indemnifying Party shall, subject to the provisions of Section 7.2.2, promptly (but in any event, within 30 days of receipt of the Indemnification Certificate) pay such amount to the Indemnified Party by wire transfer of immediately available funds to the account specified in writing by the Indemnified Party. If the Indemnifying Party objects to all or a portion of the Indemnified Partys claim made in the Indemnification Certificate, the Indemnifying Party will notify the Indemnified Party of such objection by delivering a written statement (the Objection Notice ) to the Indemnifying Party within 30 days following receipt of the Indemnification Certificate. The Objection Notice shall indicate whether the Indemnifying Party objects to all or only a portion of the claim specified in the Indemnification Certificate and shall specify in reasonable detail the facts and circumstances supporting the Indemnifying Partys basis and reasons for such objection. An Indemnifying Partys failure to deliver an Objection Notice in accordance with the provisions of this Section 7.2.1 within such 30-day period to any claim set forth in an Indemnification Certificate shall be deemed to be the Indemnifying Partys acceptance of, and waiver of any objections to, such claim and the Indemnifying Party shall be deemed to have agreed that an amount equal to the full claimed amount specified in the Indemnification Certificate is owed to the Indemnified Party. If the Indemnifying Party in its Objection Notice objects only to a portion of the claim set forth in the Indemnification Certificate (the amount of Losses claimed in the Indemnification Certificate to which the Indemnifying Party does not object shall be referred to herein as the Agreed Amount ), then such Indemnifying Party shall, within 10 Business Days following the delivery of such Objection Notice pay the Agreed Amount to the Indemnified Party. If an Indemnifying Party shall provide an Objection Notice in accordance with the provisions of this Section 7.2.1, the Indemnifying Party and the Indemnified Party shall attempt in good faith for a period of 20 days following the Indemnified Partys receipt of the Objection Notice to agree upon the rights of the respective parties with respect to each of such claims. If no such agreement can be reached after such 20-day period of good faith negotiation, either the Indemnifying Party or the Indemnified Party may initiate Litigation for purposes of having the matter settled in accordance with the terms of this Agreement.
7.2.2 Third Party Claim Procedure . In the event an Indemnified Party becomes aware of a claim made by a Third Party (including any action or proceeding
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commenced or threatened to be commenced by any Third Party) that such Indemnified Party in good faith believes may result in an indemnification claim pursuant to Section 7.1, such Indemnified Party shall promptly (and in any event within 10 Business Days after receiving written notice of such claim) notify the Indemnifying Party in writing of such claim (such notice, the Claim Notice ). The Claim Notice shall be accompanied by reasonable supporting documentation submitted by the Third Party making such claim and shall describe in reasonable detail (to the extent known by the Indemnified Party) the facts constituting the basis for such claim and the amount of the claimed damages; provided , however , that no delay or failure on the part of the Indemnified Party in delivering a Claim Notice shall relieve the applicable Indemnifying Party of its indemnification obligations under this Agreement except to the extent that the Indemnifying Party forfeits rights or defenses by reason of such delay or failure. Within 30 days after receipt of any Claim Notice, the Indemnifying Party may, upon written notice thereof to the Indemnified Party, assume control of the defense of the claim referred to therein at the Indemnifying Partys sole cost and expense (which shall be subject to Section 7.3) with counsel reasonably satisfactory to the Indemnified Party so long as: [REDACTED] If the Indemnifying Party does not so assume control of the defense of such claim, the Indemnified Party shall control the defense of such claim. The party not controlling the defense of such claim (the Non-Controlling Party ) may participate therein at its own expense; provided , however , that if the Indemnifying Party assumes control of the defense of such claim and the Indemnifying Party and the Indemnified Party have materially conflicting interests or different defenses available with respect to such claim that cause the Indemnified Party to hire its own separate counsel with respect to such proceeding, the reasonable fees and expenses of a single counsel to the Indemnified Party shall be considered Losses for purposes of this Agreement. The party controlling the defense of such claim (the Controlling Party ) shall keep the Non-Controlling Party advised of the status of such claim and the defense thereof and shall consider in good faith recommendations made by the Non-Controlling Party with respect thereto. The Non-Controlling Party shall furnish the Controlling Party with such information as it may have with respect to such claim (including copies of any summons, complaint or other pleading that may have been served on such party and any written claim, demand, invoice, billing or other document evidencing or asserting the same) and shall otherwise cooperate with and assist the Controlling Party in the defense of such claim. Neither the Indemnified Party nor the Indemnifying Party shall agree to any settlement of, or the entry of any judgment arising from, any such claim without the prior written consent of the other Party, which consent shall not be unreasonably withheld, conditioned or delayed; provided , however , that the consent of the Indemnified Party shall not be required with respect to any such settlement or judgment if the Indemnifying Party agrees in writing to pay or cause to be paid any amounts payable pursuant to such settlement or judgment
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and such settlement or judgment includes no admission of liability by or other obligation on the part of the Indemnified Party and includes a complete release of the Indemnified Party from further Liability.
7.3 Limitations on Indemnification.
7.3.1 The provisions for indemnity under Section 7.1.1(a) or Section 7.1.2(a), as applicable, shall be effective only when the aggregate amount of all Losses for claims for which indemnification is sought from any Indemnifying Party exceeds [ REDACTED] provided , however , that the foregoing limitation shall not be applicable for breaches of any Fundamental Rep.
7.3.2 In no event shall any Indemnifying Party have liability for indemnification under Section 7.1.1(a) or Section 7.1.2(a), as applicable, for any amount exceeding, in the aggregate, [REDACTED] provided , that the foregoing limitation on indemnification described in this Section 7.3.2 shall not apply to breaches of any Fundamental Rep.
7.3.3 The Indemnified Party shall take all commercially reasonable steps to mitigate any Losses or Liabilities incurred by such party upon and after becoming aware of any event or condition that would reasonably be expected to give rise to any indemnification rights hereunder. The amount of Losses recovered by an Indemnified Party under Section 7.1.1 or Section 7.1.2, as applicable, shall be reduced by (a) any amounts actually recovered by the Indemnified Party from a Third Party in connection with such claim and (b) the amount of any insurance proceeds paid to the Indemnified Party relating to such claim net of any increase in premiums resulting from such claim (a Premium Increase ). If any amounts referenced in the preceding clauses (a) and (b) are received after payment by the Indemnifying Party of the full amount otherwise required to be paid to an Indemnified Party pursuant to this ARTICLE 7 the Indemnified Party shall repay to the Indemnifying Party, promptly after such receipt, any amount that the Indemnifying Party would not have had to pay pursuant to this ARTICLE 7 had such amounts been received prior to such payment. If any Premium Increase is paid by the Indemnified Party after payment by the Indemnifying Party of the full amount otherwise required to be paid to an Indemnified Party pursuant to this ARTICLE 7, the Indemnifying Party shall pay to the Indemnified Party the amount of the Premium Increase.
7.3.4 If the Indemnified Party receives any payment from an Indemnifying Party in respect of any Losses pursuant to Section 7.1.1 or Section 7.1.2 and the Indemnified Party could have recovered all or a part of such Losses from a Third Party based on the underlying claim asserted against the Indemnifying Party, the Indemnified Party shall assign such of its rights to proceed against such Third Party as are necessary to permit the Indemnifying Party to recover from the Third Party the amount of such payment; provided , however , that if the Indemnifying Party is the Seller and such Third Party is a customer, vendor or supplier of the Product Business, then Seller shall not pursue
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such underlying claim in a manner that is, or would reasonably expected to be, materially detrimental to the Product Business.
7.3.5 The representations and warranties of Seller and Buyer contained in this Agreement and any obligation of a Party to indemnify any Indemnified Party for such Partys failure to perform or breach of any covenant, agreement or obligation contained in ARTICLE 4 shall survive the Closing and continue in full force and effect thereafter through and including the [REDACTED] anniversary of the Closing Date; provided , that the Fundamental Reps shall remain in full force and effect and shall survive indefinitely or, if applicable, until 60 days following the expiration of the applicable statute of limitations [REDACTED] provided , further , that if a Claim Notice or Indemnification Certificate relating to the breach of any representation or warranty or the failure to perform or breach of any covenant, agreement or obligation contained in ARTICLE 4 is given to the Indemnifying Party on or prior to the date on which the applicable survival period described in this Section 7.3.5 expires, then, notwithstanding anything to the contrary contained in this Section 7.3.5, such Claim Notice or Indemnification Certificate, as applicable, shall not expire at the applicable expiration date, but rather shall remain in full force and effect until such time as the Claim Notice or the Indemnification Certificate has been fully and finally resolved.
7.3.6 [REDACTED]
7.3.7 For the avoidance of doubt, no Indemnified Party shall be entitled to indemnification under this ARTICLE 7 in respect of any Loss to the extent such Indemnified Party has been previously indemnified or reimbursed in respect of such Loss
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pursuant to any other provision of this Agreement or any provision of any Ancillary Agreement.
7.4 Tax Treatment of Indemnification Payments. All payments made pursuant to this ARTICLE 7 shall be treated as adjustments to the Purchase Price for all Tax purposes, unless otherwise required by applicable Law.
7.5 Exclusive Remedy. Except as expressly provided otherwise in this Agreement or any Ancillary Agreement and subject to Section 9.9, each Party acknowledges and agrees that, following the Closing, the remedies provided for in this ARTICLE 7 shall be the sole and exclusive remedies for claims and damages available to the Parties and their respective Affiliates arising out of or relating to this Agreement and the transactions contemplated hereby. Nothing herein shall limit the Liability of either Party for common law fraud or willful misconduct. Notwithstanding anything to the contrary contained in this Agreement, no breach of any representation, warranty, covenant or agreement contained herein shall, after the consummation of the transactions contemplated by this Agreement, give rise to any right on the part of Buyer, on the one hand, or Seller, on the other hand, to rescind this Agreement or any of the transactions contemplated hereby.
7.6 Setoff Rights. [REDACTED]
ARTICLE 8
TERMINATION
8.1 Termination. Prior to the Closing, this Agreement shall terminate on the earliest to occur of any of the following events:
8.1.1 the mutual written agreement of Buyer and Seller;
8.1.2 by written notice delivered by either Buyer or Seller to the other, if the Closing shall not have occurred on or prior to December 31, 2014 (the End Date ) (other than due to a breach of any representation or warranty hereunder of the Party seeking to terminate this Agreement or as a result of the failure on the part of such Party to comply with or perform any of its covenants, agreements or obligations under this Agreement);
8.1.3 by written notice delivered by Buyer to Seller, if (a) there has been a breach by Seller of a representation or Warranty of Seller contained in this Agreement or (b) there shall be a material breach by Seller of any covenant, agreement or obligation of Seller in this Agreement, and such failure or breach described in clause (a) or (b) would result in the failure of a condition set forth in Section 6.2.1 or Section 6.2.2 that has not
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been waived by Buyer, or in the case of a breach of any covenant or agreement, is not cured upon the earlier to occur of (i) the 30th day after written notice thereof is given by Buyer to Seller and (ii) the day that is five Business Days prior to the End Date; provided , that Buyer may not terminate this Agreement pursuant to this Section 8.1.3 if Buyer is in material breach of its agreements or covenants contained in this Agreement and such breach is the cause of Sellers breach;
8.1.4 by written notice delivered by Seller to Buyer, if (a) there has been a breach by Buyer of a representation or warranty of Buyer contained in this Agreement or (b) there shall be a material breach by Buyer of any covenant, agreement or obligation of Buyer in this Agreement, and such failure or breach described in clause (a) or clause (b) would result in the failure of a condition set forth in Section 6.3.1 or Section 6.3.2 and has not been waived by Seller, or in the case of a breach of any covenant or agreement, is not cured upon the earlier to occur of (i) the 30th day after written notice thereof is given by Seller to Buyer and (ii) the day that is five Business Days prior to the End Date; provided , that Seller may not terminate this Agreement pursuant to this Section 8.1.4 if Seller is in material breach of its agreements or covenants contained in this Agreement and such breach is the cause of Buyers breach; or
8.1.5 by written notice delivered by Seller to Buyer or by Buyer to Seller if the condition set forth in Section 6.1.1 cannot be satisfied prior to the End Date; provided , however, that the right to terminate this Agreement pursuant to this Section 8.1.5 shall not be available to a Party if the inability to satisfy the condition set forth in Section 6.1.1 is a result of the failure of such Party to perform any of its covenants, agreements or obligations under this Agreement.
8.2 Procedure and Effect of Termination.
8.2.1 Notice of Termination . Termination of this Agreement by either Buyer or Seller shall be by delivery of a written notice to the other. Such notice shall state the termination provision in this Agreement that such terminating Party is claiming provides a basis for termination of this Agreement. Termination of this Agreement pursuant to the provisions of Section 8.1 shall be effective upon and as of the date of delivery of such written notice as determined pursuant to Section 9.2.
8.2.2 Effect of Termination . In the event of the termination of this Agreement pursuant to Section 8.1 by Buyer or Seller, this Agreement shall be terminated and have no further effect, and there shall be no liability hereunder on the part of Seller, Buyer or any of their respective Affiliates, except that Sections 5.3 ( Publicity ), 5.4 ( Confidentiality ), 8.2.2 ( Effect of Termination ), 8.2.3 ( Withdrawal of Certain Filings ) and ARTICLE 9 ( Miscellaneous ) shall survive any termination of this Agreement. For clarity, in the event of termination of this Agreement pursuant to Section 8.1, the Parties shall not enter into any of the Ancillary Agreements not entered into on the Execution Date or have any obligations thereunder. Nothing in this Section 8.2.2 shall relieve any Party to this Agreement of liability for common law fraud or any material breach by such Party of any
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representation or warranty of such Party contained herein or any covenant or agreement of such Party contained herein.
8.2.3 Withdrawal of Certain Filings . As soon as practicable following a termination of this Agreement for any reason, but in no event less than 30 days after such termination, Buyer or Seller shall, to the extent practicable, withdraw all filings, applications and other submissions relating to the transactions contemplated by this Agreement filed or submitted by or on behalf of such Party, any Governmental Authority or other Person.
ARTICLE 9
MISCELLANEOUS
9.1 Governing Law, Jurisdiction, Venue and Service.
9.1.1 Governing Law . This Agreement shall he governed by and construed in accordance with the Laws of the State of Delaware, excluding any conflicts or choice of Law rule or principle that might otherwise refer construction or interpretation of this Agreement to the substantive Law of another jurisdiction.
9.1.2 Jurisdiction . Subject to Section 9.9, the Parties hereby irrevocably and unconditionally consent to the exclusive jurisdiction of the courts of the State of Delaware and the United States District Court for the District of Delaware for any action, suit or proceeding (other than appeals therefrom) arising out of or relating to this Agreement, and agree not to commence any action, suit or proceeding (other than appeals therefrom) related thereto except in such courts. The Parties irrevocably and unconditionally waive their right to a jury trial.
9.1.3 Venue . The Parties further hereby irrevocably and unconditionally waive any objection to the laying of venue of any action, suit or proceeding (other than appeals therefrom) arising out of or relating to this Agreement in the courts of the State of Delaware or in the United States District Court for the District of Delaware, and hereby further irrevocably and unconditionally waive and agree not to plead or claim in any such court that any such action, suit or proceeding brought in any such court has been brought in an inconvenient forum.
9.1.4 Service . Each Party further agrees that service of any process, summons, notice or document by registered mail to its address set forth in Section 9.2.2 shall be effective service of process for any action, suit or proceeding brought against it under this Agreement in any such court.
9.2 Notices.
9.2.1 Notice Requirements . Any notice, request, demand, waiver, consent, approval or other communication permitted or required under this Agreement (each, a
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Notice ) shall be in writing, shall refer specifically to this Agreement and shall be deemed given only if delivered by hand or sent by facsimile transmission or by email of a PDF attachment (with transmission confirmed) or by overnight registered mail, courier or express delivery service that maintains records of delivery, addressed to the Parties at their respective addresses specified in Section 9.2.2 or to such other address as the Party to whom notice is to be given may have provided to the other Party at least 10 days prior to such address taking effect in accordance with this Section 9.2. Such Notice shall be deemed to have been received: (a) as of the date delivered by hand or by overnight registered mail, courier or express delivery service; or (b) on the day sent by facsimile or email provided that the sender has received confirmation of transmission (by facsimile or email receipt confirmation or confirmation by telephone (with respect to facsimile only) or email) prior to 6:00 p.m. Eastern Time on such day (and if confirmation is received after 6:00 p.m. Eastern Time, such Notice shall be deemed to have been delivered on the following Business Day). Any Notice delivered by facsimile or email shall be confirmed by a hard copy delivered promptly thereafter.
9.2.2 Address for Notice .
If to Seller, to: |
Eisai Inc. |
100 Tice Boulevard |
Woodcliff Lake, NJ 07677 |
Facsimile: [REDACTED] |
Email: [REDACTED] |
Attention: General Counsel
with a copy (which shall not constitute notice) to: |
Covington & Burling LLP |
1201 Pennsylvania Avenue, N.W. |
Washington, DC 20004 |
Facsimile: (202) 778-5168 |
Email: mriella@cov.com |
Attention: Michael J. Riella |
If to Buyer, to: |
Concordia Pharmaceuticals Inc. |
Chancery House, High Street |
Bridgetown, St. Michael, BB11128, BARBADOS |
Attention: Managing Director |
Facsimile: [REDACTED] |
Email: [REDACTED] |
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with a copy (which shall not constitute notice) to:
Dorsey & Whitney LLP
TD Canada Trust Tower
Brookfield Place 161 Bay Street
Suite 4310
Toronto M5J 2S1
Canada
Facsimile: (416) 367-7370
Email: raymer.richard@dorsey.com
Attention: Richard Raymer
9.3 No Benefit to Third Parties. The covenants and agreements set forth in this Agreement are for the sole benefit of the Parties and their successors and permitted assigns, and, except for the rights of Buyer Indemnitees and Seller Indemnitees under ARTICLE 7, they shall not be construed as conferring any rights on any other Persons.
9.4 Waiver and Non-Exclusion of Remedies. Any term or condition of this Agreement may be waived at any time by the Party that is entitled to the benefit thereof, but no such waiver shall be effective unless set forth in a written instrument duly executed by or on behalf of the Party waiving such term or condition. The waiver by any Party of any right hereunder or of the failure to perform or of a breach by the other Party shall not be deemed a waiver of any other right hereunder or of any other breach or failure by said other Party whether of a similar nature or otherwise.
9.5 Expenses. Except as otherwise specified herein or in any Ancillary Agreement, and whether or not the Closing takes place, each Party shall bear any costs and expenses incurred by it with respect to the Transactions.
9.6 Assignment. Neither this Agreement nor either Partys rights or obligations hereunder may be assigned or delegated by such Party without the prior written consent of the other Party, and any attempted assignment or delegation of this Agreement or any of such rights or obligations by either Party without the prior written consent of the other Party shall be void and of no effect; provided , however , that either Party may assign or delegate any or all of its rights or obligations hereunder to an Affiliate without the prior written consent of the other Party; provided , further , that such assigning Party shall remain liable to fulfill its obligations hereunder from and after such assignment. Subject to the preceding sentence, this Agreement will be binding upon, inure to the benefit of, and be enforceable by, the Parties and their respective successors and permitted assigns.
9.7 Amendment. This Agreement may not be modified, amended, altered or supplemented except upon the execution and delivery of a written agreement executed by both Parties.
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9.8 Severability. If any provision of this Agreement is held to be illegal, invalid or unenforceable under any present or future Law, and if the rights or obligations of either Party under this Agreement will not be materially and adversely affected thereby, (a) such provision shall be fully severable, (b) this Agreement shall be construed and enforced as if such illegal, invalid or unenforceable provision had never comprised a part hereof, (c) the remaining provisions of this Agreement shall remain in full force and effect and shall not be affected by the illegal, invalid or unenforceable provision or by its severance herefrom and (d) in lieu of such illegal, invalid or unenforceable provision, there shall be added automatically as a part of this Agreement a legal, valid and enforceable provision as similar in terms to such illegal, invalid or unenforceable provision as may be possible and reasonably acceptable to the Parties.
9.9 Equitable Relief. The Parties agree that irreparable damage would occur in the event that any of the provisions of this Agreement were not performed in accordance with their specific terms or were otherwise breached. It is accordingly agreed that the Parties shall be entitled to an injunction or injunctions to prevent breaches of this Agreement and to enforce specifically the terms and provisions of this Agreement in any court of the United States or any state having jurisdiction, this being in addition to any other remedy to which they are entitled at law or in equity. Each Party hereby waives (a) any requirement that the other Party post a bond or other security as a condition for obtaining any such relief, and (b) any defenses in any action for specific performance, including the defense that a remedy at law would be adequate.
9.10 English Language. This Agreement shall be written and executed in, and all other communications under or in connection with this Agreement shall be in, the English language. Any translation into any other language shall not be an official version thereof, and in the event of any conflict in interpretation between the English version and such translation, the English version shall control.
9.11 Bulk Sales Statutes. Buyer hereby waives compliance by Seller with any applicable bulk sales statutes in any jurisdiction in connection with the transactions under this Agreement, it being understood that any Liabilities arising out of the failure of Seller to comply with any such bulk sales statute shall be Excluded Liabilities.
9.12 Counterparts. This Agreement may be executed in any number of counterparts, and each such counterpart hereof shall be deemed to be an original instrument, but all such counterparts together shall constitute but one agreement. Delivery of an executed counterpart of a signature page of this Agreement by facsimile or other electronic transmission shall be effective as delivery of a manually executed original counterpart of this Agreement.
9.13 Entire Agreement. This Agreement, together with the Schedules and Exhibits expressly contemplated hereby and attached hereto, the Disclosure Schedules, the Ancillary Agreements, the Confidentiality Agreement and the other agreements, certificates and documents delivered in connection herewith or therewith or otherwise in connection with the transactions contemplated hereby and thereby, contain the entire agreement between the Parties with respect to the transactions contemplated hereby or thereby and supersede all prior agreements, understandings, promises and representations, whether written or oral, between the Parties with
66
respect to the subject matter hereof and thereof. In the event of any inconsistency between any such Schedules and Exhibits and this Agreement, the terms of this Agreement shall govern.
[ Signature page follows ]
67
IN WITNESS WHEREOF , the Parties have executed this Agreement as of the Execution Date.
EISAI INC. | ||||
By: |
[REDACTED] |
|||
|
||||
Name: | Shaji Procida | |||
Title: | President & COO | |||
CONCORDIA PHARMACEUTICALS INC. | ||||
By: | ||||
|
||||
Name: | ||||
Title: |
[S IGNATURE P AGE TO A SSET P URCHASE A GREEMENT ]
IN WITNESS WHEREOF , the Parties have executed this Agreement as of the Execution Date.
EISAI INC. | ||||
By: | ||||
|
||||
Name: | ||||
Title: | ||||
CONCORDIA PHARMACEUTICALS INC. | ||||
By: |
[REDACTED] |
|||
|
||||
Name: | Ruairidh MacKenzie | |||
Title: | Controller |
[S IGNATURE P AGE TO A SSET P URCHASE A GREEMENT ]
Execution Copy
Confidential
Schedule 1.1.74
Licensed Copyrights
[REDACTED]
Schedule 1.1.77
Licensed Trademarks
Schedule of [REDACTED] Trademarks
Trademark Applications and Registrations:
Mark |
Country |
Status |
Appl. No. Appl. Date |
Reg. No. Reg. Date |
Owner |
|||||
[REDACTED] |
[REDACTED] |
[REDACTED] | [REDACTED] | [REDACTED] | [REDACTED] |
Copyright Registrations:
[REDACTED]
U.S. Customs and Border Protection Recordation:
[REDACTED]
Schedule of [REDACTED] Trademarks
Trademark Applications and Registrations:
Mark |
Country |
Status |
Appl. No. Appl. Date |
Reg. No. Reg. Date |
Owner |
|||||
[REDACTED] |
[REDACTED] |
[REDACTED] | [REDACTED] | [REDACTED] | [REDACTED] |
Copyright Registrations:
[REDACTED]
U.S. Customs and Border Protection Recordation:
[REDACTED]
2
Schedule 1.1.94
Permitted Encumbrances
[REDACTED]
3
Schedule 1.1.108
Purchased Domain Names
[REDACTED]
4
[REDACTED]
5
Schedule 1.1.124
Seller Marks
[REDACTED]
6
Schedule 1.1.128
Sellers Knowledge
[REDACTED]
7
Schedule 2.1.1(a)
Purchased Contracts
(i) |
[REDACTED]
(ii)
[REDACTED]
8
Schedule 2.3.1
Estimated Closing Date Inventory Value
SKU |
Description |
Std Cost/Unit (bottles) (A) |
Quantity (B) |
$ Value (A) x (B) |
||||||
(1) |
[REDACTED] |
[REDACTED] |
[REDACTED] |
[REDACTED] |
[REDACTED] |
|||||
(2) |
[REDACTED] |
[REDACTED] |
[REDACTED] |
[REDACTED] |
[REDACTED] |
9
Schedule 2.4.2(a)(iii)
Purchased Assets Delivery Schedule
Delivery of Purchased Assets as described in the below referenced subsections of Section 2.1.1:
(a) |
[REDACTED]
(b) |
[REDACTED]
(c) |
[REDACTED]
(d) |
[REDACTED]
(e) |
[REDACTED]
(f) |
[REDACTED]
(g) |
[REDACTED]
(h) |
[REDACTED]
(i) |
[REDACTED]
(j) |
[REDACTED]
10
Schedule 3.2.5
Buyer Consents
[REDACTED]
11
Schedule 4.2.1
Ordinary Course of Business Exceptions
[REDACTED]
12
Schedule 5.14.2(d)
Government Rebates
Zonegran Capsules (per capsule) |
||||||||
[REDACTED] |
||||||||
[REDACTED] |
[REDACTED] |
[REDACTED] |
||||||
[REDACTED] |
[REDACTED] |
[REDACTED] |
||||||
[REDACTED] |
[REDACTED] |
[REDACTED] |
||||||
[REDACTED] |
||||||||
[REDACTED] |
[REDACTED] |
[REDACTED] |
||||||
[REDACTED] |
[REDACTED] |
[REDACTED] |
||||||
[REDACTED] |
[REDACTED] |
[REDACTED] |
13
Exhibit 99.15
Execution Copy
SUPPLY AGREEMENT
between
Eisai Inc.
and
Concordia Pharmaceuticals Inc.
Dated as of September 30 , 2014
TABLE OF CONTENTS
ARTICLE 1 |
DEFINITIONS |
1 | ||||
1.1 |
Certain Defined Terms |
1 | ||||
1.2 |
Construction |
5 | ||||
ARTICLE 2 |
MANUFACTURE, PURCHASE AND SALE OF PRODUCT |
6 | ||||
2.1 |
Supply |
6 | ||||
2.2 |
Forecasts |
6 | ||||
2.3 |
Purchase Orders |
6 | ||||
2.4 |
Failure or Inability to Supply Supplied Product |
7 | ||||
2.5 |
Changes in Purchase Orders |
8 | ||||
2.6 |
Delivery |
8 | ||||
2.7 |
Rejected Goods/Shortages |
8 | ||||
2.8 |
Manufacturing Changes |
9 | ||||
2.9 |
Materials |
10 | ||||
2.10 |
Labeling |
11 | ||||
2.11 |
Seller Subcontracting of Manufacture |
11 | ||||
2.12 |
Technology Transfer |
11 | ||||
2.13 |
Limited License |
12 | ||||
2.14 |
Supply of 50mg Dosage Strength |
12 | ||||
ARTICLE 3 |
PRICING AND PAYMENT |
12 | ||||
3.1 |
Pricing |
12 | ||||
3.2 |
Payment |
13 | ||||
ARTICLE 4 |
QUALITY ASSURANCE, ACCESS AND REGULATORY MATTERS |
14 | ||||
4.1 |
Testing; Certificate of Analysis |
14 | ||||
4.2 |
Records |
14 | ||||
4.3 |
Regulatory Compliance |
14 | ||||
4.4 |
Access to Facilities |
15 | ||||
4.5 |
Quality Agreement |
15 | ||||
ARTICLE 5 |
PRODUCT RECALLS |
15 | ||||
5.1 |
Product Recalls |
15 | ||||
5.2 |
Disputes |
16 | ||||
ARTICLE 6 |
REPRESENTATIONS AND WARRANTIES |
16 | ||||
6.1 |
Warranties of Seller |
16 | ||||
6.2 |
Warranties of Buyer |
16 |
ARTICLE 7 |
CONFIDENTIALITY |
17 | ||||
7.1 |
Confidentiality Obligations |
17 | ||||
ARTICLE 8 |
LIMITATION OF LIABILITY, INDEMNIFICATION AND INSURANCE |
17 | ||||
8.1 |
Indemnification of Seller |
17 | ||||
8.2 |
Indemnification of Buyer |
17 | ||||
8.3 |
Indemnification Procedures |
18 | ||||
8.4 |
Limitation on Damages and Liability |
18 | ||||
8.5 |
Insurance |
19 | ||||
ARTICLE 9 |
TERM AND TERMINATION |
19 | ||||
9.1 |
Term |
19 | ||||
9.2 |
Early Termination |
19 | ||||
9.3 |
Consequences of Termination |
20 | ||||
9.4 |
Accrued Rights; Surviving Obligations |
20 | ||||
ARTICLE 10 |
CORPORATE NAMES |
21 | ||||
10.1 |
Grants |
21 | ||||
10.2 |
Markings |
21 | ||||
10.3 |
Use of the Corporate Names |
21 | ||||
10.4 |
Approval Procedures |
23 | ||||
10.5 |
Registration, Enforcement and Defense of Seller Corporate Names |
23 | ||||
10.6 |
Registration, Enforcement and Defense of Buyer Corporate Names |
23 | ||||
10.7 |
No Implied Rights |
24 | ||||
ARTICLE 11 |
MISCELLANEOUS |
24 | ||||
11.1 |
Force Majeure |
24 | ||||
11.2 |
Assignment |
24 | ||||
11.3 |
Severability |
25 | ||||
11.4 |
Dispute Resolution |
25 | ||||
11.5 |
Governing Law, Jurisdiction, Venue and Service |
25 | ||||
11.6 |
Notices |
26 | ||||
11.7 |
Amendment |
27 | ||||
11.8 |
English Language |
27 | ||||
11.9 |
Equitable Relief |
27 | ||||
11.10 |
Waiver and Non-Exclusion of Remedies |
28 | ||||
11.11 |
No Benefit to Third Parties |
28 | ||||
11.12 |
Expenses |
28 | ||||
11.13 |
Further Assurance |
28 | ||||
11.14 |
Relationship of the Parties |
28 | ||||
11.15 |
Counterparts |
28 | ||||
11.16 |
Entire Agreement |
28 |
- ii -
SCHEDULES
|
||
Schedule 1.1.9 | Buyer Corporate Names | |
Schedule 1.1.28 | Minimum Batch Quantities | |
Schedule 1.1.41 | Seller Corporate Names | |
Schedule 1.1.43 | Specifications | |
Schedule 3.1 | Purchase Price |
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SUPPLY AGREEMENT
This Supply Agreement (this Agreement ) is made and entered into effective as of September 30 , 2014 (the Effective Date ) by and between Eisai Inc., a Delaware corporation ( Seller ), and Concordia Pharmaceuticals Inc., an international business company incorporated under the Laws of Barbados ( Buyer ). Seller and Buyer are sometimes referred to herein individually as a Party and collectively as the Parties .
RECITALS
WHEREAS , Seller and Buyer are parties to that certain Asset Purchase Agreement, dated as of September 3, 2014 (the Asset Purchase Agreement ), pursuant to which Buyer is purchasing from Seller certain assets related to the Product (as defined in the Asset Purchase Agreement) in the Buyer Territory;
WHEREAS , Buyer desires to engage Seller to Manufacture the Supplied Product for Buyer on the terms and conditions set forth herein; and
WHEREAS , Seller wishes to Manufacture the Supplied Product for Buyer on the terms and conditions set forth herein.
AGREEMENT
NOW, THEREFORE, in consideration of the premises and the mutual promises and conditions hereinafter set forth, and other good and valuable consideration, the receipt and sufficiency of which are hereby acknowledged, the Parties, intending to be legally bound, do hereby agree as follows:
ARTICLE 1
DEFINITIONS
1.1 Certain Defined Terms. Unless otherwise specifically provided herein, the following terms shall have the meaning set forth in this Section 1.1. Capitalized terms not otherwise defined herein shall have the meanings ascribed thereto in the Asset Purchase Agreement.
1.1.1 Agreement has the meaning set forth in the preamble hereto.
1.1.2 API means the active pharmaceutical ingredient zonisamide.
1.1.3 API Purchase Price means, at any time, the price payable to Dainippon for API pursuant to the Dainippon License Agreement at such time.
1.1.4 Asset Purchase Agreement has the meaning set forth in the first recital hereto.
1.1.5 Breaching Party has the meaning set forth in Section 9.2.1.
1.1.6 Bulk Product means the Product in unfinished capsule form.
1.1.7 Bulk Product Purchase Price means the purchase price payable hereunder for Bulk Product, to be set forth in Schedule 3.1 upon the expiration of the Finished Product Term pursuant to the terms of this Agreement and adjusted from time to time in accordance with this Agreement.
1.1.8 Buyer has the meaning set forth in the preamble hereto.
1.1.9 Buyer Corporate Names means the corporate names and other Trademarks and logos identified on Schedule 1.1.9 and such other corporate names or other Trademarks and logos that Buyer uses to identify itself or any of its Affiliates as Buyer may designate to Seller in writing from time to time.
1.1.10 Buyer Intellectual Property means (a) any data, information and know-how that (i) is not generally known, (ii) is Controlled by Buyer or its Affiliates as of the Effective Date or during the Term, and (iii) is necessary or useful for Seller to Manufacture the Supplied Product hereunder; (b) all Trademarks Controlled by Buyer used in the Manufacture or Exploitation of the Product, including the Buyer Corporate Names; and (c) the Licensed Trademarks.
1.1.11 Complaining Party has the meaning set forth in Section 9.2.1.
1.1.12 Contract Year means the 12 month period during the Supply Term commencing on January 1 and ending on December 31 of each calendar year; provided, however that the first Contract Year shall be the period beginning on the Effective Date and ending on December 31st in the calendar year in which the Effective Date occurs and the last Contract Year shall be the period beginning on January 1 and ending on the effective date of expiration or termination of this Agreement.
1.1.13 Discretionary Manufacturing Changes has the meaning set forth in Section 2.8.3.
1.1.14 Dispute has the meaning set forth in Section 11.4.
1.1.15 Effective Date has the meaning set forth in the preamble hereto.
1.1.16 Finished Product means the Product in finished, packaged form.
1.1.17 Finished Product Purchase Price means the purchase price payable hereunder for Finished Product, as set forth in Schedule 3.1 and adjusted from time to time in accordance with this Agreement
1.1.18 Finished Product Term means the period beginning on the Effective Date and ending on the earliest to occur of (a) the third anniversary of the Effective Date, provided , that the Finished Product Term shall automatically renew for successive one- year periods unless terminated by either Party upon at least 12 months prior written notice to the other Party, (b) the termination of this Agreement pursuant to Section 9.2 and (c) the date that is
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six months following delivery of a Packaging Transfer Notice by Seller or Buyer to the other Party.
1.1.19 Firm Forecast has the meaning set forth in Section 2.2.
1.1.20 Forecast has the meaning set forth in Section 2.2.
1.1.21 Initial API Order means the first purchase order for API submitted by Seller after the Effective Date that covers API that will be used in Supplied Product.
1.1.22 Manufacturing Changes means Discretionary Manufacturing Changes and Required Manufacturing Changes.
1.1.23 Manufacturing Cost means the actual Manufacturing costs incurred by Seller for the applicable Supplied Product, including for packaging, labeling, material, labor, testing, process support, reprocessing, retesting, and Manufacturing overhead associated with such Supplied Product (as determined in accordance with Sellers accounting policies consistently applied).
1.1.24 Manufacturing Technology means any data, information and know-how that (a) is not generally known, (b) is Controlled by Seller or its Affiliates as of the Effective Date or during the Term, and (c) is necessary or useful for Seller to Manufacture the Supplied Product hereunder; provided , that if any such data, information or know-how included in Manufacturing Technology becomes publicly disclosed (other than as a result of any disclosure by Buyer in breach of its obligations under Section 5.4 of the Asset Purchase Agreement or Article 6 of the License Agreement), such data, information or know-how shall no longer be deemed Manufacturing Technology.
1.1.25 Manufacturing Technology Transfer Notice has the meaning set forth in Section 2.12.2.
1.1.26 Markings has the meaning set forth in Section 10.2.
1.1.27 Materials means all API, excipients, components, labeling and packaging materials and other materials required to Manufacture the Product.
1.1.28 Minimum Batch Quantity means Sellers then-current minimum batch size of one full lot quantity of Supplied Product, which as of the Effective Date is set forth on Schedule 1.1.287 .
1.1.29 Notice Period has the meaning set forth in Section 9.2.1.
1.1.30 Packaging Technology means the Manufacturing Technology that is necessary or useful for the packaging and labeling of the Product in bulk form into Finished Product.
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1.1.31 Packaging Technology Transfer Notice has the meaning set forth in Section 2.12.1.
1.1.32 Packaging Transfer Notice means a written notice by Seller or Buyer to the other Party stating the delivering Partys intention to terminate Sellers supply of Finished Product and commence Sellers supply of Bulk Product, in each case, pursuant to this Agreement.
1.1.33 Party and Parties each has the meaning set forth in the preamble hereto.
1.1.34 PPI means the Producer Price Index for Finished Goods, Pharmaceutical Preparations, as it appears in the periodical PPI Detailed Report as published by the Bureau of Labor Statistics of the United States Department of Labor and using the latest version of data published as of the date of adjustment.
1.1.35 Product means any pharmaceutical product containing zonisamide approved by the FDA pursuant to the U.S. Regulatory Approval and commercialized in the Buyer Territory prior to the Closing by Seller under the Trademark ZONEGRAN®.
1.1.36 Product Labeling means, with respect to the Buyer Territory, (a) the Governmental Authority-approved full prescribing information for the Product for such country, including any required patient information and (b) all labels and other written, printed or graphic matter upon any container, wrapper or any package insert utilized with or for the Product.
1.1.37 Product Purchase Price means the Bulk Product Price for Bulk Product and the Finished Product Purchase Price for Finished Product, as applicable.
1.1.38 Purchase Order means a written purchase order in a form agreed upon by the Parties and consistent with the terms of this Agreement, that sets forth, with respect to the period covered thereby, (a) the quantity (which shall be the applicable Minimum Batch Quantity or whole multiples thereof) and types of Supplied Product (including the applicable NDC) to be delivered by Seller to Buyer and (b) the required delivery dates therefor.
1.1.39 Required Manufacturing Changes has the meaning set forth in Section 2.8.2.
1.1.40 Seller has the meaning set forth in the preamble hereto.
1.1.41 Seller Corporate Names means the corporate names and other Trademarks and logos identified on Schedule 1.1.41 and such other corporate names or other Trademarks and logos that Seller uses to identify itself or any of its Affiliates as Seller may designate to Buyer in writing from time to time.
1.1.42 Seller Labeled Product means the Product sold or distributed prior to the Effective Date and the Purchased Inventory.
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1.1.43 Specifications means the written specifications (including labeling specifications) as set forth on Schedule 1.1.43 , and the quality control testing procedures for the Supplied Product, each as amended or supplemented in accordance with Section 2.8.
1.1.44 Sublicensee means a Third Party that is granted a sublicense by Buyer or Seller under a grant in Section 10.1, as provided in such Section.
1.1.45 Supplied Product means (a) during the Finished Product Term, Finished Product and (b) thereafter, Bulk Product.
1.1.46 Technology Recipient has the meaning set forth in Section 2.12.
1.1.47 Term has the meaning set forth in Section 9.1.
1.1.48 Testing Laboratory has the meaning set forth in Section 2.7.2.
1.1.49 Third Party means any Person other than Seller, Buyer and their respective Affiliates.
1.1.50 Third Party Claim has the meaning set forth in Section 8.1
1.2 Construction. Except where the context otherwise requires, wherever used, the singular includes the plural, the plural the singular, the use of any gender shall be applicable to all genders and the word or is used in the inclusive sense (and/or). The captions of this Agreement are for convenience of reference only and in no way define, describe, extend or limit the scope or intent of this Agreement or the intent of any provision contained in this Agreement. The term including and include and variations thereof shall not be deemed to be terms of limitation, but rather shall be deemed to be followed by the words without limitation. The language of this Agreement shall be deemed to be the language mutually chosen by the Parties and no rule of strict construction shall be applied against any Party. Unless otherwise specified or where the context otherwise requires, (a) references in this Agreement to any Article, Section or Schedule are references to such Article or Section of or Schedule to this Agreement; (b) references in any Section to any clause are references to such clause of such Section; (c) hereof, hereto, hereby, herein and hereunder and words of similar import when used in this Agreement refer to this Agreement as a whole and not to any particular provision of this Agreement; (d) references to a Person are also to its permitted successors and assigns; (e) references to a Law include any amendment or modification to such Law and any rules or regulations issued thereunder, in each case, as in effect at the relevant time of reference thereto; (f) references to any agreement, instrument or other document in this Agreement refer to such agreement, instrument or other document as originally executed or, if subsequently amended, replaced or supplemented from time to time, as so amended, replaced or supplemented and in effect at the relevant time of reference thereto; (g) extent in the phrase to the extent means the degree to which a subject or other thing extends, and such phrase does not mean simply if and (h) references to monetary amounts are denominated in U.S. dollars.
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ARTICLE 2
MANUFACTURE, PURCHASE AND SALE OF PRODUCT; ADDITIONAL SERVICES
2.1 Supply. Subject to the terms and conditions of this Agreement, during the Term, Seller agrees to Manufacture and sell to Buyer, and Buyer agrees to purchase from Seller, except as otherwise provided in Section 2.4.1, all of Buyers requirements for the Supplied Product for sale or distribution by Buyer solely in the Buyer Territory in accordance with the terms and conditions of the Asset Purchase Agreement and License Agreement. Buyer shall not purchase, or permit any Affiliate to purchase, the Product for (re)sale from any supplier other than Seller.
2.2 Forecasts. On the Effective Date, Buyer shall provide Seller with a written good faith forecast estimating Buyers monthly requirements for Supplied Product (in multiples of Sellers Minimum Batch Quantities) during the then-current calendar month and each of the succeeding 24 calendar months thereafter. Thereafter, not later than 30 days prior to the commencement of each subsequent calendar quarter during the Term, Buyer shall provide Seller with a rolling 24-calendar month forecast for the Supplied Product that covers the succeeding 24-calendar month period (or the period until the expiration of the Term, as applicable, if shorter), with the forecast for all 24 months to be provided on a monthly basis and further broken down by type of Supplied Product (including relevant NDC) and number of units of each type of Supplied Product (each such 24-calendar month forecast, a Forecast ). Each Forecast (and ultimate Purchase Order) shall not exceed the upper or lower quantities by more than the following: (a) for the first through sixth months of the applicable Forecast (and ultimate Purchase Orders), +/- 0%; (b) for the seventh through ninth months of the applicable Forecast: +/[REDACTED]; and (c) for the 10th through 24th months of the applicable Forecast: +/ [REDACTED]. The +/- [REDACTED] deviation allowance for the seventh through ninth month Forecast and the +/- [REDACTED] deviation allowance for the 10th through 24th month Forecast shall set out the ultimate limit for changes in subsequent Forecasts and Purchase Orders. The first six calendar months of each Forecast shall be a Firm Forecast and shall represent a binding commitment of Buyer to purchase the quantities and types of Supplied Product included therein. Otherwise, except as set forth in Section 2.3.1 and Section 2.3.2 with respect to Purchase Orders and Firm Forecasts, a Forecast shall not be binding on either Party.
2.3 Purchase Orders.
2.3.1 At least 180 days prior to the first day of each calendar month during the Term, Buyer shall submit to Seller via email ( [REDACTED]), facsimile ( [REDACTED]) or hard copy (Eisai Inc., [REDACTED], sent to the attention of Plant Planner, a Purchase Order for the Supplied Product to be delivered to Buyer during such calendar month; provided , that the initial Purchase Order shall (a) be submitted to Seller within 10 Business Days following the Effective Date, (b) cover the period from the Effective Date until six months thereafter, and (c) include in the Supplied Product ordered therein all Supplied Product to be produced by Seller during the six months following the Effective Date pursuant to Sellers manufacturing plan as of the Effective Date. All quantities of Supplied Product ordered by Buyer shall be in Minimum Batch Quantities or whole multiples thereof.
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2.3.2 The quantity of Supplied Product specified in any Purchase Order for delivery in any calendar month shall not be [REDACTED], of the quantities of the Supplied Product set forth in the Firm Forecast applicable for such calendar month (other than, as applicable, the initial Purchase Order contemplated under Section 2.3.1). If Buyer submits a Purchase Order that requires Seller to Manufacture more than [REDACTED] of the quantities of Supplied Product set forth in the most recent Firm Forecast Seller shall exercise commercially reasonable efforts to Manufacture such excess Supplied Product but shall not be liable for its inability to do so.
2.3.3 Except with respect to the initial Purchase Order, Buyer hereby acknowledges and agrees that the lead time on all Purchase Orders is at least 180 days. In the event of any change to the Product Labeling pursuant to Section 2.9, the lead time for any Purchase Orders for Supplied Product with such changed Product Labeling shall be 180 days after the date on which Buyer provides to Seller master labeling specification documents, electronic graphic files and hard-copy proofs of labeling, and other printed materials reflecting such change reasonably requested by Seller.
2.3.4 Subject to the terms hereof, Seller shall accept each submitted Purchase Order that complies with this Section 2.3 and Seller shall be obligated to Manufacture and deliver the specified types and quantities of Supplied Product in accordance with the delivery schedule set forth in each accepted Purchase Order; provided , that if Seller delivers at least [REDACTED] of the quantity of Supplied Product set forth in a Purchase Order within [REDACTED] Business Days of the required delivery date set forth therein, Seller shall be deemed to have fully performed its obligations with respect to such Purchase Order. In the event that the quantity of Supplied Product delivered by Seller differs from the quantity requested in the applicable Purchase Order, Buyer shall pay Seller for the quantity of Supplied Product delivered rather than the quantity requested in the Purchase Order to the extent that the quantity delivered is not less than [REDACTED] nor more than [REDACTED] of the quantity requested in the Purchase Order.
2.4 Failure or Inability to Supply Supplied Product.
2.4.1 Seller shall promptly notify Buyer in writing if at any time Seller has reason to believe that Seller will not be able to (a) fill a Purchase Order for Supplied Product in accordance with the delivery schedule specified therein by Buyer and pursuant to the terms and conditions of this Agreement and the Quality Agreement or (b) supply Supplied Product to Buyer in satisfaction of the most recent Firm Forecast, which notice in either case shall provide Buyer with information on the extent of the expected shortfall of supply. Upon such notice of a supply problem, or in any event upon Sellers failure to satisfy, within the delivery time frame specified by Buyer in a Purchase Order, a portion of the Supplied Product ordered by Buyer in compliance with this Agreement and the Quality Agreement, Buyer may procure replacement Product from a Third Party source.
2.4.2 Notwithstanding anything to the contrary herein, the remedies set forth in this Section 2.4 shall be Buyers sole and exclusive remedy with respect to any failure of Seller to supply Supplied Product in accordance with this Agreement.
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2.5 Changes in Purchase Orders. Purchase Orders may be amended only by mutual agreement of the Parties; provided , that Seller shall exercise its commercially reasonable efforts to comply with proposed amendments to Purchase Orders that Buyer may request after sending a Purchase Order to Seller; provided, further , that Seller shall not be liable in any way for its inability to do so.
2.6 Delivery. Seller shall deliver or arrange for delivery of Supplied Product purchased by Buyer to a carrier designated by Buyer in the applicable Purchase Order hereunder ( provided that such designated carrier shall be approved by Seller, such approval not to be unreasonably withheld, conditioned or delayed), [REDACTED] Sellers (or, as the case may be, its Affiliates or designated Third Partys) Manufacturing plant or warehouse. For the sake of clarity, (a) delivery shall occur [REDACTED], and (b) all shipping costs (including any and all related insurance costs and import taxes, duties and tariffs) associated with the delivery of Supplied Product hereunder (whether shipped from Sellers or, as the case may be, its Affiliates or designated Third Partys Manufacturing plant or warehouse) shall be paid by Buyer. Each delivery of Supplied Product shall be accompanied by a certificate of analysis as provided in Section 4.1 and such other documents as shall be required by the Quality Agreement.
2.7 Rejected Goods/Shortages.
2.7.1 Notice; Replacement . Buyer shall notify Seller in writing of (a) any claim relating to Supplied Product that, as of the time of delivery thereof, fails to conform to the applicable Specifications (excluding non-conformity relating to (i) Sellers incorporation of any change to the Specifications or Manufacturing Changes requested by Buyer or (ii) packaging or labeling of the Supplied Product supplied by or prepared at the direction of Buyer in accordance with Section 2.10), or (b) any shortage in quantity of any shipment of the Supplied Product, in each case as soon as reasonably practicable, but not later than [REDACTED] days following delivery of such Supplied Product in the case of patent defects and, in the case of latent defects, not later than [REDACTED] days from Buyers discovery of a latent defect that was not detectable through Buyers customary and reasonable inspection. If the Parties agree that the Supplied Product fails to conform to the applicable Specifications or that there is a shortage, then [REDACTED]
2.7.2 Disputes . If Seller disagrees with Buyers claim that any Supplied Product fails to meet the applicable Specifications as of the time of delivery, representatives of Seller and Buyer shall attempt to resolve such dispute in good faith. If the representatives cannot resolve such dispute within [ REDACTED] days, a sample of the applicable Supplied Product shall be submitted by Seller and Buyer to an independent testing laboratory or other appropriate expert mutually acceptable to the Parties (the Testing Laboratory ) for evaluation against the applicable Specifications and the test results obtained by the Testing Laboratory shall be final and controlling, absent manifest error. The fees and expenses of the Testing Laboratory shall be borne by Buyer if the Testing Laboratory confirms that the applicable Supplied Product
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conforms to the applicable Specifications and otherwise by Seller. [REDACTED]
2.7.3. Costs and Expenses: Disposal . [REDACTED]
2.7.4 Exclusive Remedy . Notwithstanding anything to the contrary herein but subject to Section 2.4 (if Seller providing nonconforming Supplied Product results in an inability to supply under Section 2.4) and Section 5.1, the provisions of this Section 2.7 shall be the sole and exclusive remedy available to Buyer with respect to nonconforming Supplied Product.
2.8 Manufacturing Changes.
2.8.1 Change to Specifications Generally . In the event of a proposed change by either Party in the Specifications during the Term with respect to the Supplied Product, the proposing Party shall promptly notify the other Party of the proposed change and shall provide the other Party with documentation in support of such proposed change. Within a period of 30 Business Days from receipt of such notice, the Parties shall initiate review and comment on such proposed change. Seller and Buyer shall cooperate in good faith to design a plan to resolve any Supplied Product supply issues that may result from changes in the Specifications, and no change will be made without the written mutual agreement of both Parties (such agreement not to be unreasonably withheld, conditioned or delayed) except as required by applicable Law.
2.8.2 Required Manufacturing Changes . Each Party shall give the other Party reasonable written notice prior to any changes to the process of Manufacturing Supplied Product for sale in the Buyer Territory that are required by cGMP or other applicable Law (collectively, Required Manufacturing Changes ). The Party required by cGMP or other applicable Law to make Required Manufacturing Changes shall use commercially reasonable efforts to carry out such Required Manufacturing Changes and the other Party shall, where required, reasonably assist in carrying out such changes.
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2.8.3 Discretionary Manufacturing Changes . Seller may, upon reasonable advanced notice to Buyer [REDACTED] make changes to the process of Manufacturing of Supplied Product other that Required Manufacturing Changes (collectively, Discretionary Manufacturing Changes ) [REDACTED] Buyer may request Discretionary Manufacturing Changes and if Seller agrees (in its reasonable discretion) to make any such Discretionary Manufacturing Changes, Seller will provide the estimated cost and time of implementing any such Discretionary Manufacturing Changes to Buyer along with the terms on which Seller would be willing to make such Discretionary Manufacturing Changes. Upon Buyers written acceptance of such cost and time estimate, the Parties shall cooperate in making such Discretionary Manufacturing Changes and Seller shall use commercially reasonable efforts to implement such Discretionary Manufacturing Changes as requested by Buyer.
2.8.4 Regulatory Approvals . If a change is made to the Specifications or Manufacturing process for the Supplied Product, then prior to the implementation of such change Buyer shall (a) submit all supplemental applications or reports to Governmental Authorities with respect to the Product, if required, to reflect such change, (b) obtain all approvals required by Governmental Authorities (including required Regulatory Approvals) with respect to such change and (c) promptly provide copies of the materials referenced in clauses (a) and (b) to Seller. Seller shall reasonably cooperate with Buyer in connection therewith. Buyer shall reasonably cooperate with Seller (including by providing relevant data and other information), to allow Seller to comply with all of its regulatory obligations in connection with any such change at Sellers sole cost and expense.
2.8.5 Costs of Manufacturing Changes . All costs and expenses (including FDA filings, write offs and other costs due to such changes associated with obsolete raw materials, work-in-process and finished product inventories, and all printed materials, including packaging and labeling materials) associated with any changes to the Specifications or other Manufacturing changes (including Required Manufacturing Changes and Discretionary Manufacturing Changes) shall be borne by Buyer, and Buyer shall promptly reimburse Seller upon invoice therefor, except for costs and expenses associated with any Discretionary Manufacturing Change initiated by Seller, in which case such costs and expenses shall be borne solely by Seller.
2.8.6 Changes from One Manufacturing Facility to Another . Notwithstanding anything to the contrary contained herein, Seller may change the Manufacturing facilities for the Supplied Product hereunder after giving Buyer at least [REDACTED] days prior written notice of such change. All costs and expenses associated with a change by Seller of its Manufacturing facilities for the Supplied Product shall be borne by Seller.
2.9 Materials. Seller shall obtain all Materials required for the Manufacture of the Product. Without limiting the generality of the foregoing, Seller shall be responsible for establishing order volumes for ordering and purchasing API from Dainippon under the Dainippon License Agreement.
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2.10 Labeling. Seller shall continue to incorporate on the Product the Product Labeling in place as of the Effective Date. Within [REDACTED] days after the Effective Date, Buyer shall initiate the necessary changes to the Product Labeling to reflect Buyers ownership of the Product, in the Buyer Territory. With respect to the change described in the immediately preceding sentence, and any other change to the Product Labeling in the Buyer Territory that Buyer desires to initiate during the Term, Buyer shall provide to Seller master labeling specification documents, electronic graphic files and hard-copy proofs of labeling, and other printed materials reflecting such changes reasonably requested by Seller. Buyer shall reimburse Seller for all reasonable internal and external costs and expenses incurred by Seller in connection with implementing such changed Product Labeling (including for obsolete Supplied Product) and Buyer warrants that all such changed Product Labeling will comply in all respects with all applicable Laws and the Regulatory Approvals for the Product. Buyer shall provide Seller written notice promptly following Buyers sale of the last of the Seller Labeled Product.
2.11 Seller Subcontracting of Manufacture. During the Term, Seller shall be entitled, at any time, [REDACTED] and subject to the terms and conditions of the Dainippon License Agreement, to subcontract to a Third Party its obligations to Manufacture and supply the Supplied Product; provided , however , that no such subcontract shall relieve Seller of any of its obligations or liabilities under this Agreement except to the extent any such obligation or liability has been performed by the subcontractor in full conformity with this Agreement.
2.12 Technology Transfer.
2.12.1 Packaging Technology Transfer . Within [REDACTED] months prior to the termination or expiration of the Finished Product Term, Buyer shall have the right to provide notice to Seller requesting transfer to Buyer or its designated Third Party manufacturer (the Technology Recipient ) of the Packaging Technology (the Packaging Technology Transfer Notice ). Promptly following Buyers delivery of such Packaging Technology Transfer Notice, the Parties shall work together to agree to a plan for transitioning the Packaging Technology to the Technology Recipient, and each Party shall use commercially reasonable efforts to perform its obligations under such plan in accordance with the timelines set out therein. Such plan shall provide for the transfer by Seller to the Technology Recipient, at Buyers cost and expense, of all Packaging Technology, the amounts payable by Buyer to Seller in connection therewith (which, for clarity, shall cover Sellers direct costs incurred in connection with such technology transfer) and the maximum number of hours Seller is required to devote to such technology transfer.
2.12.2 Manufacturing Technology Transfer . From and after the end of the [REDACTED] month following the Effective Date, promptly following the delivery of any notice pursuant to Section 9.1 or Section 9.2 terminating this Agreement or promptly following Buyers notice that it is exercising its right to procure replacement Product from a Third Party source pursuant to Section 2.4.1, Buyer shall have the right to provide notice to Seller requesting transfer to the Technology Recipient of the Manufacturing Technology (the Manufacturing Technology Transfer Notice ). Promptly following Buyers delivery of such Manufacturing Technology Transfer Notice, the Parties shall work together to agree to a plan for transitioning the Manufacturing Technology (other than any Packaging Technology that has been transferred pursuant to Section 2.12.1) to the Technology Recipient, and each Party shall use commercially
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reasonable efforts to perform its obligations under such plan in accordance with the timelines set out therein. Such plan shall provide for the transfer by Seller to the Technology Recipient, at Buyers cost and expense, of all Manufacturing Technology (other than any Packaging Technology that has been transferred pursuant to Section 2.12.1), the amounts payable by Buyer to Seller in connection therewith (which, for clarity, shall cover Sellers direct costs incurred in connection with such technology transfer) and the maximum number of hours Seller is required to devote to such technology transfer. Seller shall continue to supply Buyer with the Supplied Product until the technology transfer is completed. The Parties also acknowledge that upon Sellers receipt of a Manufacturing Technology Transfer Notice, the upper and lower quantities set forth in the most recent Forecast provided by Buyer shall not be applicable, and the Parties shall discuss in good faith the implementation of a modified Forecast taking into account the transfer of the Manufacturing Technology to the Technology Recipient.
2.12.3 Limitations . In no event shall Seller be required to transfer the Packaging Technology or the Manufacturing Technology to more than one Technology Recipient. Buyer (or the Technology Recipient at Buyers direction) shall obtain and make available such information, personnel, products, materials, services, facilities and other resources, and take such other actions, as are reasonably necessary or useful to enable Seller to transfer the Packaging Technology or the Manufacturing Technology, as applicable, to the Technology Recipient, including those set forth in the applicable technology transfer plan to be agreed to by the Parties. Buyer acknowledges that the timely and successful transfer of the Packaging Technology or the Manufacturing Technology, as applicable, to the Technology Recipient depends on the provision of information, personnel, products, materials, services, facilities and other resources by or on behalf of Buyer or the taking of certain actions by or on behalf of Buyer.
2.13 Limited License . Buyer, on behalf of itself and its Affiliates, hereby grants to Seller and its Affiliates a non-exclusive, royalty-free, fully paid-up, non-transferable (except as provided in Section 11.2) license under the Buyer Intellectual Property and a right of reference and use under the Buyer Regulatory Approvals and Documentation, with the right, to grant further licenses and sublicenses or rights of reference and use, in each case, to the extent necessary for Seller and its Affiliates to perform their obligations hereunder.
2.14 Supply of 50mg Dosage Strength . Buyer acknowledges that as of the Effective Date, the 50mg dosage strength of the Product is not a Supplied Product. Buyer shall notify Seller in writing if Buyer desires for Seller to supply Buyer with the 50mg dosage strength of the Product under this Agreement. Promptly following Sellers receipt of such notice, the Parties shall work together in good faith to agree upon a process and timeline for the testing, qualification and validation activities required for Seller to supply such dosage strength as a Supplied Product. Buyer shall be responsible for all costs and expenses incurred by Seller in connection with such activities.
ARTICLE 3
PRICING AND PAYMENT
3.1 Pricing.
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3.1.1 Initial Price . The initial Product Purchase Price for Supplied Product supplied under this Agreement is set forth in Schedule 3.1 . The Product Purchase Price is subject to adjustment as set forth in this Agreement.
3.1.2 Adjustments . On January 1, 2015 and each January 1 thereafter during the Term, the Product Purchase Price shall be subject to adjustment by Seller for inflation by a percentage less than or equal to the percentage increase in the PPl for the immediately preceding 12-month period. Additionally, the Product Purchase Price shall be subject to adjustment by Seller to pass through to Buyer any increases in Sellers Manufacturing Costs; provided , that Seller shall provide Buyer with reasonable documentation supporting the need for any such increase in the Product Purchase Price to the extent that the new Product Purchase Price is [REDACTED] or more than the Product Purchase Price prior to such increase. Seller shall notify Buyer of any increase in the Product Purchase Price effected pursuant to this Section 3.1.2.
3.2 Payment.
3.2.1 Purchase Price .
(a) Product Using Inventory API . Prior to the use of the API ordered in the Initial API Order ( provided , that Seller shall only use such API after exhausting all API held by Seller prior to the Effective Date), Seller shall invoice Buyer for the applicable Product Purchase Price for Supplied Product delivered pursuant to Section 2.6 promptly following delivery of such Supplied Product.
(b) Following Use of Initial API Order . Except as set forth in Section 3.2.1(a) above and, for clarity, including with respect to the Initial API Order, (i) Seller shall invoice Buyer for the then-applicable API Purchase Price for the API ordered by Seller from Dainippon (the amount of API ordered to be determined by mutual agreement of Buyer and Seller) promptly following Sellers submission of an order for API to Dainippon, and (ii) Seller separately shall invoice Buyer for the then-applicable Product Purchase Price for all Supplied Product delivered pursuant to Section 2.6, less the amount of the API Purchase Price already paid by Buyer for such Supplied Product, promptly following the delivery of such Supplied Product.
3.2.2 Terms . All payments to Seller under this Agreement shall be (a) paid in full by Buyer without any deduction or set-off, within 30 days from the date of any invoice delivered pursuant to Section 3.2.1 and (b) made by deposit of Dollars in the requisite amount to such bank account as Seller may from time to time designate by notice to Buyer. Any undisputed amounts under this Agreement that are not paid on or before the applicable due date shall bear interest at the rate of the lesser of [REDACTED] on the latest date prior to the payment due date on which such rate is available, and the maximum rate allowed by Law, calculated on a daily basis on the actual number of days elapsed from the payment due date to the date of actual payment. If Buyer disputes any portion of an invoice provided by Seller hereunder, it shall promptly pay the undisputed portion as provided in clause (a) above and shall provide Seller with written notice of the disputed portion and its reasons therefor, and Buyer shall not then be obligated to pay such disputed portion unless and
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until it is determined in accordance with Section 11.4 that such amount is owed by Buyer. The Parties shall use good faith efforts to resolve any such disputes promptly.
3.2.3 Default . Subject to Buyers right to dispute invoices as contemplated in Section 3.2.2, with respect to payment defaults not cured within [REDACTED] days after receipt of written notice from Seller to Buyer, Seller shall, in its sole discretion, and without prejudice to any other of its accrued rights, be entitled to suspend the supply of the Supplied Product, which suspension shall not result in or constitute a breach of any of Sellers obligations under this Agreement.
3.2.4 Taxes . To the extent not otherwise exempted as set forth herein, Buyer shall pay all Taxes arising under or in connection with this Agreement exclusive of Taxes based on Sellers employees, benefits plans, income or net worth. Official receipts indicating proof of payment of any such taxes shall be secured and made available to Seller upon request as evidence of payment.
ARTICLE 4
QUALITY ASSURANCE, ACCESS AND REGULATORY MATTERS
4.1 Testing; Certificate of Analysis. Seller shall perform, or cause to be performed, the tests required to be performed by Seller pursuant to the applicable Specifications or the Quality Agreement on each lot of Supplied Product Manufactured pursuant to this Agreement before delivery thereof to Buyer, Seller shall deliver a certificate of analysis and other documents required under the Quality Agreement with respect to each lot of Supplied Product concurrently with delivery thereof that sets forth the items tested, Specifications and test results, and that contains the other types of information that shall have been approved by mutual agreement of the Parties.
4.2 Records. Seller shall maintain or shall cause to be maintained all Manufacturing records, all records of shipment and all validation data relating to the Supplied Product to the extent, and for the time periods, required by applicable Laws with respect to the Supplied Product, in each case, in accordance with its customary procedures. Buyer shall bear all costs and expenses associated with translating any such records into the English language to the extent such records customarily are maintained by Seller or its Affiliates in a language other than English. Seller shall reasonably cooperate with Buyer, including by making reasonably available relevant Seller personnel, in connection with any such translation; provided , however , that Seller shall not have any obligation to perform any such translation or any Liability in connection with any such translation (including for the accuracy thereof).
4.3 Regulatory Compliance.
4.3.1 Seller shall (a) advise Buyer promptly if an authorized agent of the FDA (or other Governmental Authority) visits its Manufacturing facilities where the Supplied Product is being Manufactured or quality tested, and (b) furnish to Buyer all material information supplied by the FDA (or other Governmental Authority) in connection with such visit, including any Form 483 observations and responses and any establishment inspection reports within [REDACTED] days after its receipt of such information, in each case ((a) and (b)), to the extent that Seller
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determines after consultation with Buyer that the Supplied Product in the Buyer Territory would be affected by such information. [REDACTED]
4.3.2 From and after the Effective Date, Buyer shall receive, hold, store, ship and distribute the Supplied Product in accordance with (a) current cGMP, (b) all applicable Regulatory Approvals, (c) all applicable analytical methods and procedures, material specifications, master batch records and stability protocols, and, (d) all Law applicable to the receipt, holding, storage, shipment, and sale of the Product.
4.4 Access to Facilities. No more than once during any Contract Year (unless any such inspection reveals a material compliance issue, in which event Buyer shall have the right to conduct additional inspections to verify that such issue has been remediated), upon the reasonable prior written request of Buyer, Buyer shall have the right to inspect those portions of the facilities of Seller where the Supplied Product is being Manufactured, during regular business hours, to ascertain compliance with applicable Laws and the Specifications, subject to the reasonable rules and regulations of Seller, including any confidentiality restrictions.
4.5 Quality Agreement. Each Party shall perform its obligations under the Quality Agreement. To the extent any provision of the Quality Agreement conflicts with any provision of this Agreement with respect to any matter regarding the quality of the Supplied Product, the provisions of the Quality Agreement shall govern. Otherwise, the provisions of this Agreement shall govern.
ARTICLE 5
PRODUCT RECALLS
5.1 Product Recalls.
5.1.1 Subject to Section 5.1.2, any recalls or market withdrawals of the Product in the Buyer Territory shall be implemented by or under the direction of Buyer ( provided , that Buyer shall inform Seller and, to the extent possible, consult with Seller prior to initiating any recall or market withdrawal of the Product in the Buyer Territory) and Seller shall cooperate with Buyer as reasonably requested in effecting any such recall or market withdrawal of the Product in the Buyer Territory. Buyer shall be responsible for all costs of each recall or market withdrawal, including costs incurred by Seller [REDACTED]
5.1.2 Buyer shall not unreasonably object to a recall or market withdrawal requested in writing by Seller relating to Supplied Product or Seller Labeled Product. In the event Buyer elects not to initiate a recall or market withdrawal of the Product as requested by Seller under this Section 5.1.2, any costs and expenses related to Buyers failure to perform such recall or market withdrawal shall be borne by Buyer and Buyer shall indemnify Seller and the Seller Indemnitees in accordance with Section 8.1 for any Losses with respect thereto incurred by Seller or any Seller Indemnitee to the extent such Losses result from Buyers failure
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to perform such recall or market withdrawal. Seller shall reimburse Buyer for the reasonable and documented direct expenses and costs of conducting recalls relating to Product sold by or on behalf of Seller prior to the Closing, including the reasonable costs of notifying customers, the reasonable costs associated with shipment of such recalled Product and the reasonable price paid to reimburse customers for such Product. Buyer shall promptly notify Seller in the event that a recall of Product sold by Seller may be necessary. Seller shall fully reimburse Buyer the Product Purchase Price for each unit of recalled or withdrawn Supplied Product or Seller Labeled Product, in each case, resulting or related to a recall or market withdrawal requested by Seller.
5.2 Disputes. If there is any dispute concerning which Partys acts or omissions gave rise to any recall or market withdrawal of the Product, such dispute shall be referred for decision to an independent expert, acting as an expert and not as an arbitrator, to be appointed by agreement between Buyer and Seller. The decision of such independent expert shall be in writing and, except for manifest error on the face of the decision, shall be binding on both Buyer and Seller. The costs of such independent expert shall be borne by the Party who is found to be responsible for the recall or market withdrawal by the independent expert. After such determination, costs shall be paid by the responsible Party in accordance with Section 5.1.
ARTICLE 6
REPRESENTATIONS AND WARRANTIES
6.1 Warranties of Seller.
6.1.1 Supplied Product Warranty . Seller hereby warrants to Buyer that all Supplied Product delivered pursuant to the terms hereof by Seller (or any subcontractor thereof) to Buyer during the Term will, at the time of such delivery: (a) have been Manufactured in compliance with cGMP and, subject to Section 2.8, the Specifications and (b) not be adulterated or misbranded within the meaning of the Act; provided , in each case ((a) and (b)), that Buyer has complied [REDACTED] with its warranties under Section 2.10 and Section 6.2(a).
6.1.2 Exclusion of Other Warranties . EXCEPT AS EXPRESSLY SET FORTH IN THIS AGREEMENT, SELLER MAKES NO WARRANTY IN RESPECT OF THE SUPPLIED PRODUCT SUPPLIED HEREUNDER, WHETHER EXPRESS OR IMPLIED BY STATUTE, CUSTOM OF THE TRADE OR OTHERWISE, INCLUDING ANY WARRANTY RELATING TO THE DESCRIPTION OR QUALITY OF THE PRODUCT, ITS MERCHANTABILITY OR FITNESS FOR A PARTICULAR PURPOSE OR USE UNDER ANY CONDITIONS, AND ANY SUCH WARRANTY IS HEREBY EXCLUDED.
6.2 Warranties of Buyer. Buyer hereby warrants to Seller that: (a) any changes to the Specifications for the Supplied Product requested by Buyer will comply with the Regulatory Approvals for such Supplied Product and all applicable Laws; (b) Buyer shall at all times handle, take control of, warehouse, store, market, sell, import, export, distribute and otherwise dispose of the Supplied Product in compliance with all applicable Laws, including cGMP, Regulatory Approvals and Specifications; (c) Buyer has, or will obtain, all applicable licenses, registrations and permits necessary to handle, take control of, warehouse, store, market, sell, import, export, distribute and otherwise dispose of the Supplied Product in the Buyer
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Territory; (d) Buyer will make any filings with respect to the Supplied Product that are required to be made by it by any Governmental Authority; and (e) Buyer will not sell or distribute the Supplied Product in the Buyer Territory prior to receiving all necessary Regulatory Approvals.
ARTICLE 7
CONFIDENTIALITY
7.1 Confidentiality Obligations. The rights and obligations of the Parties with respect to Confidential Information disclosed hereunder (which shall constitute Non-Exclusive Information) shall be governed by the terms of Section 5.4 of the Asset Purchase Agreement; provided , that the term of the Parties respective confidentiality and non-use obligations shall continue for [REDACTED] years following the expiration or termination of this Agreement.
ARTICLE 8
LIMITATION OF LIABILITY, INDEMNIFICATION AND INSURANCE
8.1 Indemnification of Seller. Subject to this Article 8, Buyer shall indemnify, defend and hold harmless Seller, its Affiliates and its and their respective directors, officers, employees, and agents (the Seller Indemnitees ), from and against, and compensate and reimburse the Seller Indemnitees for, any and all Losses incurred by any Seller Indemnitee in connection with any and all suits, investigations, claims or demands of Third Parties (collectively, Third Party Claims ) arising from or occurring as a result of: (a) any breach by Buyer or its Affiliates of this Agreement or the Quality Agreement or the gross negligence or willful misconduct of Buyer or its Affiliates in the performance of its obligations hereunder or under the Quality Agreement, (b) the Exploitation of the Supplied Product in the Buyer Territory, (c) Buyers failure to perform a recall or market withdrawal of the Supplied Product requested by Seller under Section 5.1.2 or (d) any Third Party Claim alleging that the Manufacture or supply of the Supplied Product in accordance with the terms of this Agreement infringes, misappropriates or otherwise violates the Intellectual Property Rights of such Third Party [REDACTED], in each case ((a) through (d)), except to the extent of those Losses for which Seller has an obligation to indemnify Buyer or any Buyer Indemnitee pursuant to Section 8.2, as to which Losses each Party shall indemnify the other Party and the Seller Indemnitees or the Buyer Indemnitees, as applicable, to the extent of their respective liability for such Losses.
8.2 Indemnification of Buyer. Subject to Section 6.1.2 and this Article 8, Seller shall indemnify, defend and hold harmless Buyer, its Affiliates and its and their respective directors, officers, employees and agents (the Buyer Indemnitees ), from and against, and compensate and reimburse the Buyer Indemnitees for, any and all Losses incurred by any Buyer Indemnitee in connection with any and all Third Party Claims arising from or occurring as a result of: (a) any breach by Seller or its Affiliates of this Agreement or the Quality Agreement or the gross negligence or willful misconduct of Seller or its Affiliates in the performance of its obligations hereunder or under the Quality Agreement; (b) [REDACTED]
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[REDACTED] or (c) the cost of any API that is unusable for Finished Product as a result of Sellers or its Affiliates gross negligence or willful misconduct, and in all cases ((a) through (c)) except to the extent of those Losses for which Buyer has an obligation to indemnify Seller or any Seller Indemnitee pursuant to Section 8.1, as to which Losses each Party shall indemnify the other Party and the Seller Indemnitees or the Buyer Indemnitees, as applicable, to the extent of its liability for such Losses.
8.3 Indemnification Procedures. All indemnification claims in respect of Buyer or any Buyer Indemnitee shall be made solely by Buyer and all indemnification claims in respect of Seller or any Seller Indemnitee shall be made solely by Seller and, in each case, shall be governed by Section 7.2 of the Asset Purchase Agreement.
8.4 Limitation on Damages and Liability.
8.4.1 [REDACTED]
8.4.2 [REDACTED]
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8.5 Insurance. During the Term and for a period of not less than [REDACTED] years after its termination or expiration, each Party shall obtain or maintain, respectively, at its sole cost and expense, liability insurance not less than [REDACTED] per occurrence and [REDACTED] in the aggregate. Such liability insurance shall insure against any liability arising out of (a) with respect to Seller, Sellers actions under this Agreement, including personal injury arising out of the Manufacture of the Supplied Product and (b) with respect to Buyer, Buyers actions with respect to the Supplied Product, including personal injury arising out of the packaging, labeling, sale, distribution or marketing of Supplied Product. Each Party shall provide the other Party with written proof of the existence of such insurance (including copies of any relevant policies) upon reasonable request. Notwithstanding the foregoing, Seller may elect to self-insure all or part of the limits described above (including deductibles or retentions). For clarity, the foregoing insurance requirements shall not in any way limit a Partys liability with respect to its indemnification or other obligations under this Agreement.
ARTICLE 9
TERM AND TERMINATION
9.1 Term. Unless earlier terminated in accordance with Section 9.2, the term of this Agreement shall commence on the Effective Date and shall expire on the [REDACTED] anniversary of the Execution Date and shall automatically renew for successive [REDACTED] year periods (the Term ).
9.2 Early Termination. This Agreement may be terminated prior to the expiration of the Term as follows:
9.2.1 Mutual Agreement . This Agreement may be terminated upon the mutual written agreement of Buyer and Seller at any time.
9.2.2 Termination for Material Breach . In the event that either Party (the Breaching Party ) breaches any of its material obligations under this Agreement, the other Party (the Complaining Party ) may terminate this Agreement upon [REDACTED] days prior written notice (such [REDACTED] day period, the Notice Period ) to the Breaching Party, specifying the breach and its claim of right to terminate; provided , that the termination of this Agreement shall not become effective at the end of the Notice Period if (a) the Breaching Party cures such breach during the Notice Period or (b) such breach cannot be cured during the Notice Period and the Breaching Party commences and diligently pursues actions to cure such breach within the Notice Period, in which case the Breaching Party shall have an additional [REDACTED] day period to cure such breach before such termination becomes effective.
9.2.3 Termination for Insolvency . Either Party may terminate this Agreement immediately upon written notice to the other Party if the other Party: (a) Files in any court or with any other Governmental Authority, pursuant to any statute or regulation of any state or country, a petition in bankruptcy or insolvency or for reorganization or for an arrangement or for the appointment of a receiver or trustee of that Party or of its assets; (b) proposes a written agreement of composition or extension of its debts; (c) is served with an involuntary petition against it, filed in any insolvency proceeding, and such petition is not dismissed within 60 days after the filing thereof; (d) consents to the appointment or taking
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possession by a receiver, liquidator, assignee, custodian, trustee, sequestrator (or similar official) of such Party or for any substantial part of its property or makes any assignment for the benefit of creditors; (e) admits in writing its inability to pay its debts generally as they become due; or (f) has issued or levied against its property any judgment, writ, warrant of attachment or execution or similar process that represents a substantial portion of its property
9.2.4 Termination Following Withdrawal . Either Party may terminate this Agreement upon [REDACTED] days prior written notice to the other Party, in the event that Governmental Authorities cause the withdrawal of the Product from every jurisdiction in the Buyer Territory.
9.2.5 Termination for Force Majeure . Either Party may terminate this Agreement to the extent permitted pursuant to Section 11.1.
9.2.6 Termination for Convenience . Either Party may terminate this Agreement at any time during the Term upon at least [REDACTED] months prior written notice to the other Party.
9.3 Consequences of Termination.
9.3.1 Upon the expiration or earlier termination of this Agreement, (a) all unfilled Purchase Orders shall be cancelled and (b) Buyer promptly shall pay to Seller (i) all amounts outstanding and remaining to be paid for Supplied Product delivered prior to the expiration or termination; (ii) the costs of Sellers then existing inventory of Materials, including API (as to which the API Purchase Price shall apply), that cannot otherwise be used in the business of Seller or its Affiliates without additional cost; and (iii) the applicable Product Purchase Price for all work in process and Supplied Product Manufactured, but not then delivered, by Seller in accordance with Buyers then current Forecast; provided , that Buyers liability to reimburse for Materials, work in process and Supplied Product under this Section 9.3.1 shall be limited to levels of Materials, work in process and Supplied Product that were procured by Seller in reliance on Buyers then current Forecast, including any Forecast revised pursuant to Section 2.12.2. In addition, Seller shall assign to Buyer, and Buyer shall assume, all of Sellers non-cancellable contracts and orders with suppliers of Materials that cannot otherwise be used in the business of Seller or its Affiliates.
9.3.2 Unless this Agreement is terminated by Seller pursuant to Section 9.2.2 or Section 9.2.3 or by either Party pursuant to Section 9.2.4, the license granted by Seller to Buyer pursuant to Section 10.1 shall survive such termination until the earlier of [REDACTED] For clarity, in no event shall Buyer sell any of the Supplied Product purchased under this Agreement after the termination of the license granted in Section 10.1.
9.4 Accrued Rights; Surviving Obligations.
9.4.1 Accrued Rights . Termination or expiration of this Agreement for any reason shall be without prejudice to any rights that shall have accrued to the benefit of a Party prior to such termination or expiration. Such termination or expiration shall not relieve a
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Party from obligations that are expressly indicated to survive the termination or expiration of this Agreement.
9.4.2 Survival . Without limiting the foregoing, Sections 2.12, 3.2, 4.2, 6.1.2, 9.3, 9.4 and 10.1 (if and only to the extent provided in Section 9.3.2) and Article 5, 7, 8 and 11 of this Agreement shall survive the termination or expiration of this Agreement for any reason.
ARTICLE 10
CORPORATE NAMES
10.1 Grants. Subject to the terms and conditions of the Asset Purchase Agreement and the other Ancillary Agreements, each of Seller and Buyer (on behalf of itself and its Affiliates) hereby grants to the other Party and its Affiliates, subject to Section 10.2, Section 10.3, Section 10.4 and Section 10.5, a non-exclusive, royalty-free, non-transferable (except as provided in Section 11.2) license to use the Seller Corporate Names in the Buyer Territory and to use the Buyer Corporate Names in the Seller Territory, as applicable, solely as required to comply with Section 10.2 and for no other purpose.
10.2 Markings. To the extent required by applicable Law in a country in the Buyer Territory or the Seller Territory, the Product Labeling, Product packaging, Product inserts and advertising, marketing, promotional or other materials for the Product used by Buyer or Seller, respectively (and by Buyers or Sellers respective Affiliates, licensees, Sublicensees or distributors) in connection with the Supplied Product in such country shall contain the logo or corporate name of the manufacturer (collectively, the Markings ). During any period in which the Product is Manufactured by or on behalf of Seller pursuant to this Agreement, the manner in which the Markings are to be presented on the Product Labeling, Product packaging, Product inserts and advertising, marketing, promotional or other materials for the Product shall be subject to (a) prior review and approval by Seller (which approval shall not be unreasonably withheld, conditioned or delayed) and (b) Section 10.3, Section 10.4 and Section 10.5.
10.3 Use of the Corporate Names.
10.3.1 With respect to the Seller Corporate Names licensed to Buyer and the Buyer Corporate Names licensed to Seller under Section 10.1, Buyer and Seller, as applicable, shall, and shall cause its Affiliates, licensees, Sublicensees and distributors to, (a) comply with all trademark usage guidelines, quality standards, business practices, methodology, policies and procedures, and technical and operational specifications as may be reasonably specified from time to time by Buyer or Seller, as applicable, or as may be imposed by applicable Law with respect to the nature and quality of the Product and manner of use of the Buyer Corporate Names or Seller Corporate Names and (b) promptly make any changes to all Product Labeling, Product packaging, Product inserts and advertising, marketing, promotional or other materials bearing any of the Buyer Corporate Names or Seller Corporate Names as Buyer or Seller, respectively, may reasonably request to achieve compliance with the foregoing.
10.3.2 Each of Buyer and Seller shall, and shall cause its respective Affiliates, licensees, Sublicensees and distributors to, at the other Partys request, furnish to such other Party representative samples of all goods and all Product Labeling, Product packaging,
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Product inserts and advertising, marketing, promotional or other materials bearing any of the Buyer or Seller Corporate Names for quality control purposes, including web pages, brochures and stationery.
10.3.3 Neither Buyer nor Seller shall, and each shall cause its respective Affiliates not to, and shall use commercially reasonable efforts to cause its licensees, Sublicensees and distributors not to, (a) directly or indirectly, at any time challenge the other Partys rights, title or interest in and to the Buyer Corporate Names or Seller Corporate Names, as applicable, or in any registration or registration application therefor in any jurisdiction, (b) do or cause to be done or omit to do anything, the doing, causing or omitting of which would contest or in any way impair or tend to impair the rights of the other Party in and to the Buyer Corporate Names or Seller Corporate Names, as applicable, or in any registrations or registration applications therefor in any jurisdiction, (c) represent to any Third Party that it has, in any jurisdiction, any ownership rights in or to the Buyer Corporate Names or Seller Corporate Names, as applicable, or any other rights in the Buyer Corporate Names or Seller Corporate Names other than the specific rights conferred by this Agreement, or (d) register or attempt to register the Buyer Corporate Names or Seller Corporate Names, as applicable, or any confusingly similar Trademark (including any translation or transliteration of any of the Buyer Corporate Names or Seller Corporate Names or any colorable imitation thereof) as a Trademark with any Governmental Authority in its own name or in the name of any Third Party in any jurisdiction.
10.3.4 Neither Buyer nor Seller shall, and each shall cause its respective Affiliates not to, and shall use commercially reasonable efforts to cause its licensees, Sublicensees and distributors not to, do any act that reflects negatively on the other Party or that endangers, destroys or adversely affects, in any material respect, the Buyer Corporate Names or Seller Corporate Names, as applicable, or the value of the goodwill associated with the Buyer Corporate Names or Seller Corporate Names, as applicable.
10.3.5 Each of Buyer and Seller shall execute any documents required in the reasonable opinion of the other Party for such first Party to be entered as a registered user or recorded licensee of the Buyer Corporate Names or Seller Corporate Names, as applicable, or to be removed as registered user or licensee thereof.
10.3.6 Each of Buyer and Seller hereby acknowledges and agrees that (a) as between the Parties, (i) Seller has exclusive right, title and interest in and to the Seller Corporate Names and to any registration or registration application therefor and (ii) Buyer has exclusive right, title and interest in and to the Buyer Corporate Names and to any registration or registration application therefor, in each case ((i) and (ii)) together with all goodwill associated therewith, on a worldwide basis, (b) nothing herein shall be construed to accord it any rights in the Buyer Corporate Names or Seller Corporate Names, as applicable, except for the limited license right expressly conferred by this Agreement, (c) no ownership rights are vested or created in the Buyer Corporate Names or Seller Corporate Names, as applicable, anywhere in the world by the licenses and other rights granted in Section 10.1, (d) all use of the Seller Corporate Names by Buyer, its Affiliates, licensees, Sublicensees, and distributors and all goodwill generated in connection therewith, shall inure solely for and to the benefit of Seller and its Affiliates, and (e) all use of the Buyer Corporate Names by Seller, its Affiliates, licensees, Sublicensees, and
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distributors and all goodwill generated in connection therewith, shall inure solely for and to the benefit of Buyer and its Affiliates.
10.4 Approval Procedures. Buyer shall submit to Seller for review and prior approval any new Product Label, Product packaging, Product insert and advertising, marketing, promotional or other materials or any revisions to any existing Product Label, Product packaging, Product insert and advertising, marketing, promotional or other materials, in any case, bearing a Seller Corporate Name that Buyer wishes to use on or in connection with the Exploitation of the Product in the Buyer Territory. Seiler shall use commercially reasonable efforts to review and to respond to each such submission as soon as is reasonably practicable and to notify Buyer in writing no later than [REDACTED] Business Days of Sellers receipt of each such request for approval, whether Seller is approving or withholding its approval of such proposed new, or revisions to existing, Product Label, Product packaging, advertising, marketing, promotional or other materials bearing a Seller Corporate Name. If Seller fails to respond to a request for approval within such [REDACTED] Business Day period, the proposed new, or revisions to existing, Product Label, Product packaging, advertising, marketing, promotional or other materials bearing a Seller Corporate Name shall be deemed approved by Seller.
10.5 Registration, Enforcement and Defense of Seller Corporate Names. Seller shall have sole responsibility over the registration, enforcement and defense of the Seller Corporate Names worldwide. If (a) in the reasonable opinion of Seller after consultation with legal counsel, there exists a Trademark right of a Third Party in the Buyer Territory such that Buyer cannot use one or more of the Seller Corporate Names on or in connection with the Exploitation of the Product in the Buyer Territory without infringing such Third Partys Trademark right or (b) as a result of any claim made against Buyer or any of its Affiliates, licensees, Sublicensees or distributors alleging that the use of such Seller Corporate Names by Buyer or any of its Affiliates, licensees, Sublicensees or distributors infringes, misappropriates or otherwise violates any Trademark right of a Third Party in the Buyer Territory, a judgment is entered by a court of competent jurisdiction from which no appeal is taken within the time permitted for appeal or from which no further appeal is available, such that Buyer or its Affiliate, licensee, Sublicensee or distributor cannot use one or more of the Seller Corporate Names in the Buyer Territory without infringing the Trademark right of such Third Party, then in either case ((a) or (b)), Seller shall have the right to immediately terminate Buyers license right to use such Seller Corporate Name in the Buyer Territory and Buyer and its Affiliates, licensees, Sublicensees and distributors shall immediately cease all use of such Seller Corporate Name in the Buyer Territory.
10.6 Registration, Enforcement and Defense of Buyer Corporate Names. Buyer shall have sole responsibility over the registration, enforcement and defense of the Buyer Corporate Names worldwide. If (a) in the reasonable opinion of Buyer after consultation with legal counsel, there exists a Trademark right of a Third Party in any country within the Seller Territory such that Seller cannot use one or more of the Buyer Corporate Names on or in connection with the Exploitation of the Product in such country without infringing such Third Partys Trademark right or (b) as a result of any claim made against Seller or any of its Affiliates, licensees, Sublicensees or distributors alleging that the use of such Buyer Corporate Names by Seller or any of its Affiliates, licensees, Sublicensees or distributors infringes, misappropriates or otherwise violates any Trademark right of a Third Party in any country in the
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Seller Territory, a judgment is entered by a court of competent jurisdiction from which no appeal is taken within the time permitted for appeal or from which no further appeal is available, such that Seller or its Affiliate, licensee, Sublicensee or distributor cannot use one or more of the Buyer Corporate Names in such country without infringing the Trademark right of such Third Party, then in either case ((a) or (b)), Buyer shall have the right to immediately terminate Sellers license right to use such Buyer Corporate Name in that country and Seller and its Affiliates, licensees, Sublicensees and distributors shall immediately cease all use of such Buyer Corporate Name in such country within the Seller Territory.
10.7 No Implied Rights. Except as expressly provided in this Article 10, neither Buyer nor Seller shall have any right to register, maintain, prosecute, enforce, defend or use in any social media any of the Seller Corporate Names or Buyer Corporate Names, respectively.
ARTICLE 11
MISCELLANEOUS
11.1 Force Majeure. Neither Party shall be held liable or responsible to the other Party or be deemed to have defaulted under or breached this Agreement for failure or delay in fulfilling or performing any term of this Agreement (other than an obligation to make payments) when such failure or delay is caused by or results from events beyond the reasonable control of the non-performing Party, including fires, floods, earthquakes, hurricanes, embargoes, epidemics or pandemics, quarantines, war, acts of war (whether war be declared or not), terrorist acts, insurrections, riots, civil commotion, strikes, lockouts or other labor disturbances (whether involving the workforce of the non-performing Party or of any other Person), acts of God or acts, omissions or delays in acting by any Governmental Authority. The non-performing Party shall notify the other Party of such force majeure within [REDACTED] days after such occurrence by giving written notice to the other Party stating the nature of the event, its anticipated duration, and any action being taken to avoid or minimize its effect The suspension of performance shall be of no greater scope and no longer duration than is necessary and the non-performing Party shall use commercially reasonable efforts to remedy its inability to perform. Should the force majeure event last in excess of six consecutive months, the non-performing Party shall be entitled to terminate this Agreement.
11.2 Assignment. Subject to Section 2.11, neither this Agreement nor either Partys rights or obligations hereunder may be assigned or delegated by such Party without the prior written consent of the other Party, and any attempted assignment or delegation of this Agreement or any of such rights or obligations by either Party without the prior written consent of the other Party shall be void and of no effect; provided , however , that either Party may assign or delegate any or all of its rights or obligations hereunder to an Affiliate without the prior written consent of the other Party; provided further , that such assigning Party shall remain liable to fulfill its obligations hereunder from and after such assignment. [REDACTED] Subject to the preceding sentence, this Agreement will be binding upon, inure to the benefit of, and be enforceable by, the Parties and their respective successors and permitted assigns.
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11.3 Severability. If any provision of this Agreement is held to be illegal, invalid or unenforceable under any present or future Law, and if the rights or obligations of either Party under this Agreement will not be materially and adversely affected thereby, (a) such provision shall be fully severable, (b) this Agreement shall be construed and enforced as if such illegal, invalid or unenforceable provision had never comprised a part hereof, (c) the remaining provisions of this Agreement shall remain in full force and effect and shall not be affected by the illegal, invalid or unenforceable provision or by its severance herefrom and (d) in lieu of such illegal, invalid or unenforceable provision, there shall be added automatically as a part of this Agreement a legal, valid and enforceable provision as similar in terms to such illegal, invalid or unenforceable provision as may be possible and reasonably acceptable to the Parties.
11.4 Dispute Resolution. Except for disputes arising under Section 2.7.2 or Section 5.2, if a dispute arises between the Parties in connection with or relating to this Agreement or any document or instrument delivered in connection herewith (a Dispute ), it shall be resolved pursuant to this Section 11.4.
11.4.1 General . Either Party shall have the right to refer any Dispute to the President and Chief Executive Officer of Seller and the President and Chief Executive Officer of Buyer who shall confer on the resolution of the issue. Any final decision mutually agreed to by such officers shall be conclusive and binding on the Parties. If such officers are not able to agree on the resolution of any such issue within 15 Business Days after such Dispute is first referred to them, either Party may, by written notice to the other Party, elect to initiate litigation in accordance with Section 11.5 for purposes of having the matter settled.
11.4.2 Interim Relief and Tolling . Notwithstanding anything herein to the contrary, (a) any relevant time period related to a matter that is the subject of a Dispute shall be tolled during any dispute resolution proceeding under this Section 11.4 and (b) nothing in this Section 11.4 shall preclude either Party from seeking interim or provisional relief, including a temporary restraining order, preliminary injunction or other interim equitable relief concerning a Dispute, if necessary to protect the interests of such Party. This Section 11.4.2 shall be specifically enforceable.
11.5 Governing Law, Jurisdiction, Venue and Service.
11.5.1 Governing Law . This Agreement shall be governed by and construed in accordance with the Laws of the State of Delaware, excluding any conflicts or choice of law rule or principle that might otherwise refer construction or interpretation of this Agreement to the substantive Law of another jurisdiction. The Parties agree to exclude the application to this Agreement of the United Nations Convention on Contracts for the International Sale of Goods.
11.5.2 Jurisdiction . Subject to Section 11.9, the Parties hereby irrevocably and unconditionally consent to the exclusive jurisdiction of the courts of the State of Delaware and the United States District Court for the District of Delaware for any action, suit or proceeding (other than appeals therefrom) arising out of or relating to this Agreement, and agree not to commence any action, suit or proceeding (other than appeals therefrom) related thereto except in such courts. The Parties irrevocably and unconditionally waive their right to a jury trial.
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11.5.3 Venue . The Parties further hereby irrevocably and unconditionally waive any objection to the laying of venue of any action, suit or proceeding (other than appeals therefrom) arising out of or relating to this Agreement in the courts of the State of Delaware or in the United States District Court for the District of Delaware, and hereby further irrevocably and unconditionally waive and agree not to plead or claim in any such court that any such action, suit or proceeding brought in any such court has been brought in an inconvenient forum.
11.5.4 Service . Each Party further agrees that service of any process, summons, notice or document by registered mail to its address set forth in Section 11.6.2 shall be effective service of process for any action, suit or proceeding brought against it under this Agreement in any such court.
11.6 Notices.
11.6.1 Notice Requirements . Except as otherwise provided in Section 2.3.1, any notice, request, demand, waiver, consent, approval or other communication permitted or required under this Agreement (each, a Notice ) shall be in writing, shall refer specifically to this Agreement and shall be deemed given only if delivered by hand or sent by facsimile transmission or email of a PDF attachment (with such transmission confirmed) or by overnight registered mail, courier or express delivery service that maintains records of delivery, addressed to the Parties at their respective addresses specified in Section 11.6.2 or to such other address as the Party to whom notice is to be given may have provided to the other Party at least 10 days prior to such address taking effect in accordance with this Section 11.6. Such Notice shall be deemed to have been received: (a) as of the date delivered by hand or by overnight registered mail, courier or express delivery service; or (b) on the day sent by facsimile or email provided that the sender has received confirmation of transmission (by facsimile or email receipt confirmation or confirmation by telephone (with respect to facsimile only) or email) prior to 6:00 p.m. Eastern Time on such day (and if confirmation is received after 6:00 p.m. Eastern Time, such Notice shall be deemed to have been delivered on the following Business Day). Any Notice delivered by facsimile or email shall be confirmed by a hard copy delivered promptly thereafter.
11.6.2 Address for Notice .
If to Seller, to: |
Eisai Inc. |
100 Tice Blvd. |
Woodcliff Lake, New Jersey 07677 |
Facsimile: [REDACTED] |
Email: [REDACTED] |
Attention: General Counsel |
with a copy (which shall not constitute notice) to: |
Covington & Burling LLP |
1201 Pennsylvania Avenue, N.W. |
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Washington, DC 20004 |
Facsimile: (202) 778-5168 |
Email: mriella@cov.com |
Attention: Michael Riella |
If to Buyer, to: |
Concordia Pharmaceuticals Inc. |
Chancery House, High Street |
Bridgetown, St. Michael, BB11128, BARBADOS |
Attention: Managing Director |
Facsimile: [REDACTED] |
Email: [REDACTED] |
with a copy (which shall not constitute notice) to: |
Dorsey & Whitney LLP |
TD Canada Trust Tower |
Brookfield Place 161 Bay Street |
Suite 4310 |
Toronto M5J 2S1 |
Canada |
Facsimile: (416) 367-7370 |
Email: raymer.richard@dorsey.com |
Attention: Richard Raymer |
11.7 Amendment. No amendment, modification, release or discharge shall be binding upon the Parties unless in writing and duly executed by authorized representatives of both Buyer and Seller; provided , that Seller shall be entitled to update Schedule 3.1 to reflect the Bulk Product Purchase Price in accordance with the definition of such term.
11.8 English Language. This Agreement shall be written and executed in, and all other communications under or in connection with this Agreement shall be in, the English language. Any translation into any other language shall not be an official version thereof, and in the event of any conflict in interpretation between the English version and such translation, the English version shall control.
11.9 Equitable Relief. The Parties agree that irreparable damage would occur in the event that any of the provisions of Article 7 were not performed in accordance with their specific terms or were otherwise breached. It is accordingly agreed that the Parties shall be entitled to seek an injunction or injunctions to prevent breaches of Article 7 and to enforce specifically the terms and provisions of Article 7 in any court of the United States or any state having jurisdiction, this being in addition to any other remedy to which they are entitled at law or in equity. Each Party hereby waives (a) any requirement that the other Party post a bond or other security as a condition for obtaining any such relief, and (b) any defenses in any action for specific performance, including the defense that a remedy at law would be adequate. Nothing in
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this Section 11.9 is intended, or should be construed, to limit either Partys right to equitable relief or any other remedy for a breach of any other provision of this Agreement.
11.10 Waiver and Non-Exclusion of Remedies. Any term or condition of this Agreement may be waived at any time by the Party that is entitled to the benefit thereof, but no such waiver shall be effective unless set forth in a written instrument duly executed by or on behalf of the Party waiving such term or condition. The waiver by either Party hereto of any right hereunder or of the failure to perform or of a breach by the other Party shall not be deemed a waiver of any other right hereunder or of any other breach or failure by said other Party whether of a similar nature or otherwise. The rights and remedies provided for herein are cumulative and do not exclude any other right or remedy provided by applicable Law or otherwise available except as expressly set forth herein.
11.11 No Benefit to Third Parties. The covenants and agreements set forth in this Agreement are for the sole benefit of the Parties and their successors and permitted assigns, and, except for the rights of Buyer Indemnitees and Seller Indemnitees under Article 8, they shall not be construed as conferring any rights on any other Persons.
11.12 Expenses. Except as otherwise specified herein or in the Asset Purchase Agreement or in any other Ancillary Agreement, each Party shall bear any costs and expenses with respect to the transactions contemplated herein incurred by it.
11.13 Further Assurance. Each Party shall duly execute and deliver, or cause to be duly executed and delivered, such further instruments and do and cause to be done such further acts and things, including the filing of such assignments, agreements, documents and instruments, as may be necessary or as the other Party may reasonably request in connection with this Agreement or to carry out more effectively the provisions and purposes hereof, or to better assure and confirm unto such other Party its rights and remedies under this Agreement.
11.14 Relationship of the Parties. It is expressly agreed that Seller, on the one hand, and Buyer, on the other hand, shall be independent contractors and that the relationship between the two Parties shall not constitute a partnership, joint venture or agency. Neither Seller, on the one hand, nor Buyer, on the other hand, shall have the authority to make any statements, representations or commitments of any kind, or to take any action, which shall be binding on the other, without the prior written consent of the other Party to do so. 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.
11.15 Counterparts. This Agreement may be executed in any number of counterparts, and each such counterpart hereof shall be deemed to be an original instrument, but all such counterparts together shall constitute but one agreement. Delivery of an executed counterpart of a signature page of this Agreement by facsimile or other electronic transmission shall be effective as delivery of a manually executed original counterpart of this Agreement.
11.16 Entire Agreement. This Agreement, together with the Schedules expressly contemplated hereby and attached hereto, the Asset Purchase Agreement, the Ancillary
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Agreements, and the other agreements, certificates and documents expressly contemplated thereby and delivered in connection therewith contain the entire agreement among the Parties with respect to the transactions contemplated hereby and thereby and supersede all prior agreements, understandings, promises and representations, whether written or oral, among the Parties with respect to the subject matter hereof and thereof. In the event of any inconsistency between any such Schedules and this Agreement, the terms of this Agreement shall govern.
[ Signature page follows ]
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IN WITNESS WHEREOF , the Parties have executed this Agreement as of the Effective Date.
EISAI INC. | ||||
By: | [REDACTED] | |||
|
||||
Name: | [REDACTED] | |||
Title: | [REDACTED] | |||
CONCORDIA PHARMACEUTICALS INC. | ||||
By: | ||||
|
||||
Name: | ||||
Title: |
[S IGNATURE P AGE TO S UPPLY A GREEMENT ]
IN WITNESS WHEREOF , the Parties have executed this Agreement as of the Effective Date.
EISAI INC. | ||||
By: | ||||
|
||||
Name: | ||||
Title: | ||||
CONCORDIA PHARMACEUTICALS INC. | ||||
By: | [REDACTED] | |||
|
||||
Name: | [REDACTED] | |||
Title: | [REDACTED] |
[S IGNATURE P AGE TO S UPPLY A GREEMENT ]
Schedule 1.1.9
Buyer Corporate Names
[REDACTED]
Schedule 1.1.287
Minimum Batch Quantities
[REDACTED] (25mg) |
[REDACTED] (100mg) |
|||
Bulk Product: | [REDACTED] | [REDACTED] | ||
[REDACTED] | ||||
Finished Product: | [REDACTED] | [REDACTED] | ||
[REDACTED] |
Schedule 1.1.410
Seller Corporate Names
[REDACTED]
Schedule 1.1.432
Specifications
[REDACTED]
Schedule 3.1
Purchase Price
Product Purchase Price:
[REDACTED] (25mg) |
[REDACTED] (100mg) |
|||
Finished Product price per bottle: |
[REDACTED] | [REDACTED] |
Exhibit 99.16
Execution Copy
LICENSE AGREEMENT
between
Eisai Inc.
and
Concordia Pharmaceuticals Inc.
Dated as of September 30 , 2014
TABLE OF CONTENTS
ARTICLE 1 |
DEFINITIONS | 1 | ||||
1.1 |
Certain Defined Terms | 1 | ||||
1.2 |
Construction | 3 | ||||
ARTICLE 2 |
GRANT OF RIGHTS | 3 | ||||
2.1 |
Grants to Buyer | 3 | ||||
2.2 |
Retention of Rights by Seller | 3 | ||||
2.3 |
Sublicenses | 4 | ||||
2.4 |
No Implied Rights | 4 | ||||
ARTICLE 3 |
COMPLIANCE | 4 | ||||
3.1 |
Compliance with Legal Requirements | 4 | ||||
3.2 |
Compliance with Ethical Business Practices | 5 | ||||
3.3 |
Product Liability Claims | 5 | ||||
ARTICLE 4 |
UNAUTHORIZED SALES | 6 | ||||
4.1 |
Unauthorized Sales by Buyer | 6 | ||||
4.2 |
Unauthorized Sales by Seller | 6 | ||||
4.3 |
Incidental Crossover within Territories | 6 | ||||
ARTICLE 5 |
LICENSED TRADEMARKS | 7 | ||||
5.1 |
Use of Licensed Trademarks | 7 | ||||
5.2 |
Approval Procedures | 8 | ||||
5.3 |
Clearance, Registration, Prosecution and Maintenance of Licensed Trademarks | 9 | ||||
5.4 |
Enforcement of Licensed Trademarks and Licensed Copyrights | 10 | ||||
5.5 |
Redirect Web Traffic | 11 | ||||
5.6 |
No Implied Rights | 11 |
ARTICLE 6 |
CONFIDENTIALITY | 11 | ||||
6.1 |
Confidentiality | 11 | ||||
ARTICLE 7 |
DISCLAIMER OF WARRANTIES | 11 | ||||
ARTICLE 8 |
INDEMNITY | 12 | ||||
8.1 |
Indemnification of Seller | 12 | ||||
8.2 |
Indemnification of Buyer | 12 | ||||
8.3 |
Indemnification Procedures | 12 | ||||
8.4 |
Limitation on Damages and Liability | 12 | ||||
8.5 |
Insurance | 13 | ||||
8.6 |
Limitation on Breaches | 13 | ||||
ARTICLE 9 |
TERM AND TERMINATION | 13 | ||||
9.1 |
Term | 13 | ||||
9.2 |
Termination for Material Breach | 13 | ||||
9.3 |
Termination for Insolvency | 14 | ||||
9.4 |
Mutual Agreement | 14 | ||||
9.5 |
Consequences of Termination | 14 | ||||
9.6 |
Accrued Rights; Surviving Obligations | 15 | ||||
ARTICLE 10 |
MISCELLANEOUS | 15 | ||||
10.1 |
Force Majeure | 15 | ||||
10.2 |
Dispute Resolution | 15 | ||||
10.3 |
Governing Law, Jurisdiction, Venue and Service | 16 | ||||
10.4 |
Notices | 16 | ||||
10.5 |
No Benefit to Third Parties | 18 | ||||
10.6 |
Waiver and Non-Exclusion of Remedies | 18 | ||||
10.7 |
Expenses | 18 |
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10.8 |
Assignment | 18 | ||||
10.9 |
Amendment | 18 | ||||
10.10 |
Severability | 19 | ||||
10.11 |
Equitable Relief | 19 | ||||
10.12 |
English Language | 19 | ||||
10.13 |
Further Assurances | 19 | ||||
10.14 |
Relationship of the Parties | 19 | ||||
10.15 |
Counterparts | 20 | ||||
10.16 |
Entire Agreement | 20 |
SCHEDULE | ||
Schedule 1 | Dainippon Owned Trademarks | |
Schedule 2 | Licensed Copyrights | |
Schedule 3 | Licensed Trademarks |
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LICENSE AGREEMENT
This License Agreement (this Agreement ) is made and entered into effective as of September 30 , 2014 (the Effective Date ), by and between Eisai Inc., a Delaware corporation ( Seller ), and Concordia Pharmaceuticals Inc., an international business company incorporated under the laws of Barbados ( Buyer ). Seller and Buyer may each be referred to herein as a Party and collectively as the Parties.
RECITALS
WHEREAS, Seller and Buyer are parties to that certain Asset Purchase Agreement, dated as of September 3 , 2014 (the Asset Purchase Agreement ), pursuant to which, effective as of the Closing, Buyer is purchasing from Seller the Purchased Assets and assuming the Assumed Liabilities; and
WHEREAS, the Asset Purchase Agreement requires that Seller and Buyer enter into this Agreement at the Closing, pursuant to which Seller is granting to Buyer, and Buyer is accepting from Seller, the licenses and other rights set forth herein with respect to the Licensed Copyrights and Licensed Trademarks, subject to the terms and conditions of this Agreement.
NOW, THEREFORE, in consideration of the premises and the mutual promises and conditions hereinafter set forth and set forth in the Asset Purchase Agreement and the other Ancillary Agreements, and other good and valuable consideration, the receipt and sufficiency of which are hereby acknowledged, the Parties, intending to be legally bound, do hereby agree as follows:
ARTICLE 1
DEFINITIONS
1.1 Certain Defined Terms. Unless otherwise specifically provided herein, the following terms shall have the meanings set forth in this Section 1.1. Capitalized terms not otherwise defined herein shall have the respective meanings ascribed thereto in the Asset Purchase Agreement.
1.1.1 Agreement has the meaning set forth in the preamble hereto.
1.1.2 Asset Purchase Agreement has the meaning set forth in the first recital hereto.
1.1.3 Breaching Party has the meaning set forth in Section 9.2.
1.1.4 Buyer has the meaning set forth in the preamble hereto.
1.1.5 Buyer Indemnitees has the meaning set forth in Section 8.2.
1.1.6 Complaining Party has the meaning set forth in Section 9.2.
1.1.7 Dainippon Owned Trademarks means the Trademarks listed on Schedule 1 .
1.1.8 Effective Date has the meaning set forth in the preamble hereto.
1.1.9 Licensed Copyrights means all Copyrights in the Buyer Territory that are owned by Seller or any of Sellers Affiliates and that are (a) used or held for use exclusively or primarily in connection with the Product Business or (b) embodied in the Product Records and Product Promotional Materials, including those Copyrights listed on Schedule 1.1.74 of the Asset Purchase Agreement, reproduced as Schedule 2 hereto .
1.1.10 Licensed Trademarks means (a) the Trademarks listed on Schedule 1.1.77 of the Asset Purchase Agreement, reproduced as Schedule 3 hereto and (b) any other Trademarks, including, for clarity, any trade dress, that the Parties develop under this Agreement for use on or in connection with the Product Business in the Buyer Territory in accordance with the procedures set forth in Section 5.1. For clarity, the Licensed Trademarks include the Dainippon Owned Trademarks.
1.1.11 Notice has the meaning set forth in Section 10.3.4.
1.1.12 Notice Period has the meaning set forth in Section 9.2.
1.1.13 Officials has the meaning set forth in Section 3.2.1
1.1.14 Party and Parties each has the meaning set forth in the preamble hereto.
1.1.15 Payment has the meaning set forth in Section 3.2.1
1.1.16 Product Label means, with respect to the Product in the Buyer Territory, (a) the Regulatory Authority-approved full prescribing information for the Product, including any required patient information and (b) all labels and other written, printed or graphic matter upon a container, wrapper or any package insert utilized with or for the Product in the Buyer Territory.
1.1.17 Seller Indemnitees has the meaning set forth in Section 8.1.
1.1.18 Sublicensee means a Third Party that is granted a sublicense by Buyer under the grant in Section 2.1, as provided in Section 2.3.
1.1.19 Term has the meaning set forth in Section 9.1.
1.1.20 Territory means the Seller Territory or the Buyer Territory, as applicable.
1.1.21 UDRP has the meaning set forth in Section 10.3.2.
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1.2 Construction. Except where the context otherwise requires, wherever used, the singular includes the plural, the plural the singular, the use of any gender shall be applicable to all genders and the word or is used in the inclusive sense (and/or). The captions of this Agreement are for convenience of reference only and in no way define, describe, extend or limit the scope or intent of this Agreement or the intent of any provision contained in this Agreement. The term including and include and variations thereof shall not be deemed to be terms of limitation, but rather shall be deemed to be followed by the words without limitation. The language of this Agreement shall be deemed to be the language mutually chosen by the Parties and no rule of strict construction shall be applied against any Party. Unless otherwise specified or where the context otherwise requires, (a) references in this Agreement to any Article, Section or Schedule are references to such Article, Section or Schedule of this Agreement; (b) references in any Section to any clause are references to such clause of such Section; (c) hereof, hereto, hereby, herein and hereunder and words of similar import when used in this Agreement refer to this Agreement as a whole and not to any particular provision of this Agreement; (d) references to a Person are also to its permitted successors and assigns; (e) references to a Law include any amendment or modification to such Law and any rules or regulations issued thereunder, in each case, as in effect at the relevant time of reference thereto; (f) references to any agreement, instrument or other document in this Agreement refer to such agreement, instrument or other document as originally executed or, if subsequently amended, replaced or supplemented from time to time, as so amended, replaced or supplemented and in effect at the relevant time of reference thereto; (g) extent in the phrase to the extent means the degree to which a subject or other thing extends, and such phrase does not mean simply if and (h) references to monetary amounts are denominated in U.S. dollars.
ARTICLE 2
GRANT OF RIGHTS
2.1 Grants to Buyer. Subject to the terms and conditions of this Agreement, Seller (on behalf of itself and its Affiliates) hereby grants to Buyer and its Affiliates:
2.1.1 subject to Section 5.4, a royalty-free, non-transferable (except as provided in Section 10.8) license, with the right to grant sublicenses in accordance with Section 2.3, to the Licensed Copyrights solely in the Buyer Territory and solely in order to Manufacture and Exploit the Product in the Buyer Territory, which license shall be exclusive as to the Licensed Copyrights that are used or held for use exclusively in connection with the Product Business and non-exclusive as to all other Licensed Copyrights; and
2.1.2 subject to Article 5, an exclusive, royalty-free, non-transferable (except as provided in Section 10.8) license, with the right to grant sublicenses in accordance with Section 2.3, to the Licensed Trademarks solely in the Buyer Territory and solely in order to Manufacture and Exploit the Product in the Buyer Territory.
2.2 Retention of Rights by Seller. Notwithstanding anything to the contrary in this Agreement, Seller retains, on behalf of itself and its Affiliates, licensees, Sublicensees and distributors, (a) all rights with respect to Exploiting or granting any Person the right to Exploit the Licensed Copyrights outside of the Product Business and (b) such rights in and to the Licensed Copyrights and Licensed Trademarks solely to the extent necessary or useful to
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(i) Exploit the Product or any Other Product in the Seller Territory, (ii) exercise its rights or perform its obligations under this Agreement or any Ancillary Agreement, and (iii) Manufacture or have Manufactured the Product or any Other Product worldwide for Exploitation in the Seller Territory, subject to the terms and conditions of the Asset Purchase Agreement. Except as expressly granted herein, in the Asset Purchase Agreement or in the Supply Agreement, Seller grants no other right or license to any Intellectual Property Rights of Seller and its Affiliates, including any rights or licenses to the Licensed Copyrights or the Licensed Trademarks.
2.3 Sublicenses. Subject to Section 4 of the Dainippon Assignment and Assumption Agreement, Buyer shall have the right to grant sublicenses under the licenses granted in Section 2.1 through multiple tiers of Sublicensees; provided , that Buyer shall (a) remain jointly and severally liable for the performance or non-performance of any such Sublicensee and (b) provide to Seller a written notice setting forth in reasonable detail the nature of such sublicense and the identity of the Sublicensee (which written notice shall include a copy of any such proposed sublicense agreement ( provided , that the financial terms of any such sublicense agreement may be redacted to the extent not pertinent to an understanding of Buyers obligations under this Agreement)). All sublicenses granted hereunder shall be consistent with the terms and conditions set forth in this Agreement. Moreover, the grant of any such sublicense shall not relieve Buyer of its obligations under this Agreement, except to the extent such obligations are performed by such Sublicensee, and any such sublicense shall at all times be subject to the terms of this Agreement. A copy of any sublicense agreement executed by Buyer pursuant to this Section 2.3 (with financial terms redacted) shall be provided to Seller within 14 days after its execution by Buyer and the applicable Sublicensee.
2.4 No Implied Rights. For the avoidance of doubt, Buyer and its Affiliates, licensees, Sublicensees and distributors shall have no right, express or implied, with respect to the Licensed Copyrights or the Licensed Trademarks except as expressly provided in Section 2.1. For clarity, except for the licenses granted to Buyer under the Licensed Trademarks, nothing herein grants Buyer or any of its Affiliates the right to use or to register any Domain Name (including both gTLDs and ccTLDs) or any social media name, tag or handle or similar identifier that incorporates in whole or in part any of the Seller Marks or any of the Licensed Trademarks, except for the Purchased Domain Names or a variant thereof in which only the com, biz or similar TLD component is changed, which use shall be permitted.
ARTICLE 3
COMPLIANCE
3.1 Compliance with Legal Requirements.
3.1.1 Buyer shall conduct, and shall ensure that its Affiliates, Sublicensees, and Third Party subcontractors and distributors conduct, all activities concerning the Product (including the Exploitation thereof), the Licensed Copyrights and the Licensed Trademarks in compliance with all applicable Laws, including cGMP, as applicable, except for such noncompliance that would not reasonably be expected to materially affect the Licensed Intellectual Property (or any material portion thereof).
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3.1.2 Buyer shall not at any time, from and after the Effective Date, retain or use in any capacity in connection with the marketing, sale or distribution of the Product any Person who (a) has been debarred pursuant to (i) Section 306 of the Act or (ii) 42 U.S.C. §1320a7 or (b) is the subject of a conviction described in such sections. From and after the Effective Date, Buyer shall promptly inform Seller in writing if Buyer, any of its Affiliates or any other Person connected with the marketing, sale or distribution of the Product in the Buyer Territory is debarred or is the subject of a conviction described in Section 306 of the Act or in 42 U.S.C. §1320a7, or if any Litigation or investigation is pending or, to Buyers knowledge, is threatened, relating to the debarment or conviction of Buyer or any such Person.
3.2 Compliance with Ethical Business Practices.
3.2.1 Governments and International Public Organizations . Without limitation of the foregoing, Buyer warrants that none of its employees, officers or other members of its management (or any employees, officers or other members of management of any of its Affiliates) or, to its knowledge after reasonable inquiry, its agents (or those of its Affiliates) are officials, officers, agents, representatives of any Governmental Authority or international public organization. Buyer shall not make any payment, shall ensure that its Affiliates, and shall use commercially reasonably efforts to ensure that its Sublicensees, and Third Party contractors and distributors, do not make any payment, either directly or indirectly, of money or other assets, including to the compensation Buyer derives from this Agreement (collectively, a Payment ), to government or political party officials, officials of international public organizations, candidates for public office, or representatives of other businesses or persons acting on behalf of any of the foregoing (collectively, Officials) where such Payment would constitute a violation of any applicable Law. Buyer acknowledges that no employee of Seller or its Affiliates has the authority to waive compliance by Buyer with this Section 3.2.1.
3.2.2 Exclusions List . Buyer shall not use (and shall cause its Affiliates not to use) any Person (including any employee, officer, director, Sublicensee or Third Party contractor or distributor) who is (or has been) on the Exclusions List of the Office of Inspector General, U.S. Department of Health & Human Services, or who is or has been in violation of the terms hereof in connection with the performance of any activities hereunder. Buyer certifies to Seller that, as of the Effective Date, Buyer has screened itself, its officers and directors, and its Affiliates, Sublicensees and Third Party contractors and distributors and their respective officers and directors, against the Exclusions List of the Office of Inspector General, U.S. Department of Health & Human Services and that it has informed Seller whether Buyer or any such other Person has been in violation of the terms hereof in connection with the performance of any activities hereunder. Buyer shall promptly notify Seller in writing if any such violation occurs or comes to its attention during the Term.
3.3 Product Liability Claims. As soon as it becomes aware, each Party shall give the other Party prompt written notice of any defect or alleged defect in the Product, any injury alleged to have occurred as a result of the use or application of the Product, and any circumstances that may give rise to Litigation relating to the Product, recall or market withdrawal of the Product or regulatory action that may affect the Exploitation of the Product, specifying, to the extent the Party has such information, the time, place and circumstances thereof and the names and addresses of the Persons involved. Each Party also shall furnish
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promptly to the other Party copies of all documents received in respect of any Litigation arising out of such alleged defect, injury or regulatory action; provided , that neither Party shall be required to furnish such documents if such disclosure could, in such Partys reasonable discretion, (x) violate (i) applicable Law or (ii) any binding agreement entered into by such Party, including any confidentiality agreement to which such Party is a party ( provided , that such Party shall use commercially reasonable efforts to obtain consent from any Third Party to any such binding agreement to enable such Party to disclose such information), (y) jeopardize any attorney/client privilege or other established legal privilege or (z) disclose any Trade Secrets.
ARTICLE 4
UNAUTHORIZED SALES
4.1 Unauthorized Sales by Buyer. Buyer (a) shall, and shall cause its Affiliates, licensees, Sublicensees and distributors to, distribute, market, promote, offer for sale and sell the Product only in the Buyer Territory, and (b) shall not, and shall not permit its Affiliates, licensees, Sublicensees or distributors to, distribute, market, promote, offer for sale or sell the Product directly or indirectly (i) to any Person in the Seller Territory or (ii) to any Person inside the Buyer Territory that is reasonably likely to directly or indirectly distribute, market, promote, offer for sale or sell the Product in the Seller Territory or assist another Person to do so. If Buyer or any of its Affiliates receives or becomes aware of receipt by a licensee, Sublicensee or distributor of any orders for the Product for the Seller Territory, such Person shall refer such orders to Seller. Buyer shall cause its Affiliates, licensees, Sublicensees and distributors to notify Buyer of any receipt of any orders for the Product in the Seller Territory.
4.2 Unauthorized Sales by Seller. Seller (a) shall, and shall cause its Affiliates, licensees, Sublicensees and distributors to, distribute, market, promote, offer for sale and sell the Product or any Other Product (except to the extent Seller is not prohibited from Exploiting such Other Product in the Buyer Territory pursuant to the Asset Purchase Agreement) only in the Seller Territory, and (b) shall not, and shall not permit its Affiliates, licensees, Sublicensees or distributors to, distribute, market, promote, offer for sale or sell the Product or any Other Product directly or indirectly (i) to any Person in the Buyer Territory (except with respect to any Other Product, to the extent Seller is not prohibited from Exploiting such Other Product in the Buyer Territory pursuant to the Asset Purchase Agreement) or (ii) to any Person inside the Seller Territory that is reasonably likely to directly or indirectly distribute, market, promote, offer for sale or sell the Product or any Other Product (except to the extent Seller is not prohibited from Exploiting such Other Product in the Buyer Territory pursuant to the Asset Purchase Agreement) in the Buyer Territory or assist another Person to do so. If Seller or any of its Affiliates receives or becomes aware of the receipt by a licensee, Sublicensee or distributor of any orders for the Product for the Buyer Territory, Seller shall refer such orders to Buyer. Seller shall cause its Affiliates, licensees, Sublicensees and distributors to notify Seller of any receipt of any orders for the Product in the Buyer Territory.
4.3 Incidental Crossover within Territories. Notwithstanding anything in this Agreement to the contrary, each Party acknowledges and agrees that certain advertising, promotion or marketing of the Product by the other Party, including the advertising, promotion and marketing of the Product through the use of the internet and pan-regional print advertisements and at conferences and seminars held outside the other Partys Territory, may
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reach Persons in the other Partys Territory, and that the other Party shall not be in breach of this Agreement for such activities so long as (a) the objective of such advertising, promotion or marketing of such other Party is to reach Persons within the other Partys Territory or otherwise to promote sales of the Product (as applicable) in the other Partys Territory, and (b) the receipt by Persons located inside its Territory of such advertising, promotion or marketing with respect to the Product is merely incidental to the objectives of such advertising, promotion or marketing. Further, each Party acknowledges that Product sold by the other Party to distributors outside of its Territory and intended for resale to end users outside of its Territory may end up being resold (through, for example, an internet sales channel) to end users in its Territory, and that the other Party shall not be in breach of this Agreement based on such resales so long as such other Party or any of its Affiliates, licensee, Sublicensees or distributors does not authorize such resales into the other Partys Territory and complies with its obligations set forth in this Article 4; provided , however , that in the event of a resale of its Product involving crossover into the Territory of the other Party, each Party agrees to take commercially reasonable steps to identify the channel and parties involved in such resale and to prevent additional sales involving crossover into the Territory of the other Party by the same parties and the same or a similar channel.
ARTICLE 5
LICENSED TRADEMARKS
5.1 Use of Licensed Trademarks.
5.1.1 Buyer hereby acknowledges Sellers (and, with respect to the Dainippon Owned Trademarks, Sellers and its licensors) assertion of exclusive right, title and interest in and to the Licensed Trademarks, together with all goodwill associated therewith and all registrations and registration applications therefor, on a worldwide basis and acknowledges that nothing herein shall be construed to accord to Buyer any rights in the Licensed Trademarks except for the license right expressly conferred by this Agreement.
5.1.2 Buyer shall, and shall cause its Affiliates, licensees, Sublicensees and distributors to, (a) comply with all trademark usage guidelines, quality standards, business practices, methodology, policies and procedures and technical and operational specifications as may be reasonably specified by Seller from time to time in writing or as may be imposed by applicable Law with respect to the nature and quality of the Product and the manner of use of the Licensed Trademarks and (b) promptly make any changes to all Product Labeling, Product packaging and advertising, marketing, promotional or other materials bearing any of the Licensed Trademarks as Seller may reasonably request, and at Sellers sole expense, to achieve compliance with clause (a).
5.1.3 Buyer shall not, and shall cause its Affiliates, licensees, Sublicensees and distributors not to, (a) use in their respective businesses, any Trademark that is confusingly similar to or a colorable imitation of, misleading or deceptive with respect to or that dilutes any (or any part) of the Licensed Trademarks, (b) take any action that reflects negatively on Seller or its licensor or that endangers, destroys or similarly affects, in any material respect, the Licensed Trademarks or the value of the goodwill associated with the Licensed Trademarks, (c) directly or indirectly, at any time challenge Sellers (or, with respect to the Dainippon Owned Trademarks, Sellers and its licensors) rights, title or interest in and to the Licensed Trademarks
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or in any registration or registration application therefor in any jurisdiction, (d) do or cause to be done or fail to do anything, the doing, causing or failing of which would contest or in any way impair or tend to impair the rights of Seller in and to the Licensed Trademarks or in any registrations or registration applications therefor in any jurisdiction, (e) represent to any Third Party that it has, in any jurisdiction, any ownership rights in or to the Licensed Trademarks or in any registration or registration application therefor or any other rights in the Licensed Trademarks other than the specific license rights conferred by this Agreement, or (f) register or attempt to register the Licensed Trademarks or any confusingly similar Trademark (including any translation or transliteration of any of the Licensed Trademarks or any colorable imitation thereof) as a Trademark with any Governmental Authority in its own name or in the name of any of its Affiliate or any Third Party in any jurisdiction.
5.1.4 [REDACTED]
5.1.5 Buyer acknowledges and agrees that no ownership rights are vested or created in the Licensed Trademarks anywhere in the world by the licenses and other rights granted in this Agreement (including, for clarity, Section 2.1) and that all use of the Licensed Trademarks by Buyer, its Affiliates, licensees, Sublicensees, and distributors and all goodwill generated in connection therewith, shall inure solely for and to the benefit of Seller. Seller acknowledges and agrees that use of the Purchased Domain Names and exercise of rights under the Domain Name Assignment Agreement under are not a violation of Section 5.1.3.
5.2 Approval Procedures.
5.2.1 Buyer shall submit to Seller for review and prior approval (which approval shall not be unreasonably withheld, conditioned, or delayed) any new, or any revisions to any existing, Product Label, Product packaging and advertising, marketing, promotional or other materials, in each case, bearing a Licensed Trademark, that Buyer wishes to use on or in connection with the Exploitation of the Product in the Buyer Territory. Seller shall use commercially reasonable efforts to review and to respond to each such submission as soon as is reasonably practicable and to notify Buyer in writing no later than [REDACTED] Business Days of Sellers
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receipt of each such request for approval, whether Seller is approving or withholding its approval of such proposed new, or revisions to existing, Product Label, Product packaging, advertising, marketing, promotional or other materials bearing a Licensed Trademark, and the basis for any withholding of approval (including guidance for alternatives or revisions that will be acceptable [REDACTED]
5.2.2 During the Term, and after Buyer has complied with its Trademark clearance and consultation obligations set forth in Section 5.3, Buyer shall submit to Seller for review and prior approval any new Trademark, including, for clarity, any trade dress, logo or other Trademark, or any variation or derivative of an existing Licensed Trademark, that Buyer wishes to use on or in connection with the Exploitation of the Product in the Buyer Territory, which Trademarks (other than Buyers corporate name, trade name and corporate logo), upon approval (which approval shall not be unreasonably withheld, conditioned, or delayed) by Seller, shall be deemed Licensed Trademarks under this Agreement and subject to the terms hereof. Seller shall use commercially reasonable efforts to review and to respond to each such submission as soon as is reasonably practicable and to notify Buyer in writing no later than [REDACTED]. Business Days of Sellers receipt of each such request for approval, whether Seller is approving or withholding its approval of such proposed new Licensed Trademark, and the basis for any withholding of approval [REDACTED]. At Sellers reasonable request, Buyer shall, and shall cause its Affiliates, licensees, Sublicensees and distributors to, furnish to Seller representative samples of all goods and all Product Labeling, Product packaging, Product inserts and advertising, marketing, promotional or other materials bearing any of the Licensed Trademarks for quality control purposes, including web pages, brochures and stationery.
5.3 Clearance, Registration, Prosecution and Maintenance of Licensed Trademarks. Buyer acknowledges that, pursuant to the Dainippon License Agreement, Dainippon has all rights with respect to the registration, prosecution and maintenance of the Dainippon Owned Trademarks in the Buyer Territory. As between Seller and Buyer, Seller shall be responsible for the registration, prosecution and maintenance of the Licensed Trademarks in the Buyer Territory. To the extent that a particular Licensed Trademark is not already in use and registered for a Product in the Buyer Territory, prior to any use of, or efforts to register, any such Licensed Trademarks (including the Dainippon Owned Trademarks) or any derivative or variant thereof that becomes an approved Licensed Mark, Buyer shall (a) be solely responsible for conducting commercially reasonable trademark clearance searches and for assessing the availability of such Licensed Trademark for use on, and registration for, such Product in the Buyer Territory and (b) consult with Seller with respect to whether to proceed with the use or registration of each such Licensed Trademark. Except for the Dainippon Owned Trademarks and any derivative or variation thereof approved in accordance with the procedures set forth in Section 5.2.2, all registrations and applications for the other Licensed Trademarks shall be filed, prosecuted, registered and maintained in the name, and for the benefit, of Seller. All registrations and applications for the Dainippon Owned Trademarks and any derivative or variation thereof approved in accordance with the procedures set forth in Section 5.2.2 shall be
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filed, prosecuted, registered and maintained by, and in the name of, and for the benefit of Dainippon. All reasonable costs and expenses of, maintaining [REDACTED] clearing, registering and prosecuting, the Licensed Trademarks in the Buyer Territory shall be borne solely by Buyer.
5.4 Enforcement of Licensed Trademarks and Licensed Copyrights . As between Seller and Buyer, Seller shall have the right, but not the obligation, to enforce and defend the Licensed Trademarks and Licensed Copyrights in the Buyer Territory, including (a) defending against any alleged, threatened or actual claim by a Third Party that the use of the Licensed Trademarks or Licensed Copyrights in the Buyer Territory infringes, dilutes, misappropriates or otherwise violates any Trademark or Copyright of that Third Party or constitutes unfair trade practices or any other like offense, or any other claims as may be brought by a Third Party against a Party in connection with the use of or relating to the Licensed Trademarks or Licensed Copyrights with respect to the Product in the Buyer Territory and (b) taking such action as Seller deems necessary against a Third Party based on any alleged, threatened or actual infringement, dilution, misappropriation or other violation of, or unfair trade practices or any other like offense relating to, the Licensed Trademarks or Licensed Copyrights by a Third Party in the Buyer Territory; provided , that if Seller plans to cease, or ceases, any action with respect to the enforcement or defense of any of the Licensed Trademarks or Licensed Copyrights in the Buyer Territory, Seller shall notify Buyer of such plans in writing [REDACTED]. Seller agrees to consult with Buyer about actions to enable Buyer to make a claim in the event Seller does not take any action against a Third Party that is causing material injury to the Product Business by infringement, dilution, misappropriation or other violation of, or unfair trade practices or any other like offense relating to, any such Licensed Trademarks or Licensed Copyrights. [REDACTED] Buyer shall bear all costs and expenses relating to any enforcement action or defense commenced pursuant to this Section 5.4 and any settlements and judgments with respect thereto. Any damages or other amounts recovered in any such proceeding and payable to Seller [REDACTED], less Sellers costs and expenses incurred in connection with any such proceeding, shall be paid to Buyer. Seller shall bear all costs and expenses relating to any enforcement action or defense commenced at its own initiative and not at Buyers request and shall have all rights to any damages or other amounts recovered in any such proceeding and payable to it [REDACTED]. Buyer shall provide to Seller all reasonable assistance requested by Seller in connection with any such action, defense, claim or suit under this Section 5.4, at Sellers cost and expense, unless Buyer has requested the action, defense, claim or suit.
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5.5 Redirect Web Traffic. Buyer shall place a hyperlink on the home page of any website associated with [REDACTED] and on the home page of its principal website for promoting the Products within the Buyer Territory, if different, which hyperlinks shall be placed in a manner, form and style mutually agreeable to the Parties, each acting reasonably, to direct Internet users originating from the Seller Territory to such website or websites as Seller may designate in writing. Seller shall place a hyperlink on the home page of any website associated with [REDACTED] and on the home page of its principal website for promoting the Products within the Seller Territory, if different, which hyperlinks shall be placed in a manner, form and style mutually agreeable to the Parties, each acting reasonably, to direct Internet users originating from the Buyer Territory to such website or websites as Buyer may designate in writing.
5.6 No Implied Rights. Buyer shall have no right to register, maintain, prosecute, enforce or defend the Licensed Trademarks except as set forth herein.
ARTICLE 6
CONFIDENTIALITY
6.1 Confidentiality. The rights and obligations of the Parties with respect to information disclosed hereunder (which shall constitute Non-Exclusive Information) shall be governed by the terms of Section 5.4 of the Asset Purchase Agreement; provided , that the term of the Parties respective confidentiality and non-use obligations shall continue for [REDACTED] years following the expiration or termination of this Agreement. The Confidentiality Agreement shall hereby be void and have no further force or effect.
ARTICLE 7
DISCLAIMER OF WARRANTIES
SELLER REPRESENTS AND WARRANTS TO BUYER THAT SELLER HAS THE RIGHT TO GRANT ALL LICENSE RIGHTS GRANTED IN THIS AGREEMENT. BUYER ACKNOWLEDGES AND AGREES THAT, EXCEPT FOR THE PRECEDING SENTENCE AND THE EXPRESS REPRESENTATIONS AND WARRANTIES CONTAINED IN SECTION 3.1 OF THE ASSET PURCHASE AGREEMENT, SELLER HAS MADE NO REPRESENTATION OR WARRANTY WHATSOEVER REGARDING THE LICENSED COPYRIGHTS OR THE LICENSED TRADEMARKS AND BUYER HAS NOT RELIED ON ANY REPRESENTATION OR WARRANTY, EXPRESS OR IMPLIED. WITHOUT LIMITING THE GENERALITY OF THE FOREGOING, BUYER ACKNOWLEDGES AND AGREES THAT, EXCEPT AS EXPRESSLY PROVIDED IN SECTION 3.1 OF THE ASSET PURCHASE AGREEMENT, BUYER IS LICENSING THE RIGHTS GRANTED HEREUNDER ON AN AS IS, WHERE IS BASIS WITHOUT ANY EXPRESS OR IMPLIED WARRANTIES, EITHER IN FACT OR BY OPERATION OF LAW, BY STATUTE OR OTHERWISE, INCLUDING ANY WARRANTY OF QUALITY, THE FITNESS FOR A PARTICULAR PURPOSE, MERCHANTABILITY, CONDITION OF THE ASSETS, AS TO THE NON-INFRINGEMENT OF ANY INTELLECTUAL PROPERTY RIGHTS OF ANY PERSON OR AS TO ANY OTHER MATTER.
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ARTICLE 8
INDEMNITY
8.1 Indemnification of Seller. Buyer shall indemnify, defend and hold harmless Seller and its Affiliates, and their respective officers, directors, employees and agents (collectively, Seller Indemnitees ) from and against, and compensate and reimburse the Seller Indemnitees for, any and all Losses suffered by them arising from or occurring as a result of: (a) any breach by Buyer of any term of this Agreement, (b) the fraud, gross negligence or willful misconduct on the part of any Buyer Indemnitee in the performance of Buyers obligations under this Agreement or (c) the Manufacture or Exploitation of the Product by or on behalf of Buyer, its Affiliates, licensees, Sublicensees or distributors (but excluding the Manufacture of the Product by or on behalf of Seller pursuant to the Supply Agreement), except, (i) in each case ((a), (b) and (c)), to the extent of those Losses for which Seller has an obligation to indemnify any Buyer Indemnitees pursuant to Section 8.2, as to which Losses each Party shall indemnify the other Party and the Seller Indemnitees or the Buyer Indemnitees, as applicable, to the extent of its liability for such Losses, and (ii) in the case of clause (i), to the extent the Loss is indemnifiable by Seller under the Supply Agreement.
8.2 Indemnification of Buyer. Seller shall indemnify, defend and hold harmless Buyer and its Affiliates, and their respective officers, directors, employees and agents (collectively, Buyer Indemnitees ) from and against, and compensate and reimburse the Buyer Indemnitees for, any and all Losses suffered by them arising from or occurring as a result of: (a) any breach by Seller of any term of this Agreement, (b) the fraud, gross negligence or willful misconduct on the part of any Seller Indemnitee in the performance of Sellers obligations under this Agreement or (c) the Manufacture or Exploitation of the Product in the Seller Territory or the Other Product by or on behalf of the Seller, its Affiliates, licensees, sublicensees or distributors (but excluding the Manufacture of the Product by or on behalf of Seller pursuant to the Supply Agreement and the Manufacture or Exploitation of the Product or any Other Product by or on behalf of Buyer, its Affiliates, licensees, Sublicensees or distributors), except, in each case ((a), (b) and (c)), for those Losses for which Buyer has an obligation to indemnify any Seller Indemnitee pursuant to Section 8.1, as to which Losses each Party shall indemnify the other Party and the Seller Indemnitees or the Buyer Indemnitees, as applicable, to the extent of its liability for such Losses.
8.3 Indemnification Procedures. All indemnification claims in respect of Buyer or any Buyer Indemnitee shall be made solely by Buyer and all indemnification claims in respect of Seller or any Seller Indemnitee shall be made solely by Seller and, in each case, shall be governed by Section 7.2 of the Asset Purchase Agreement. Notwithstanding anything herein to the contrary, the Parties respective indemnification obligations under this Article 8 shall not apply to any Losses for which such Party is entitled to indemnification under the Asset Purchase Agreement (excluding for this purpose application of the limitations in Section 7.3 of the Asset Purchase Agreement).
8.4 Limitation on Damages and Liability. [REDACTED]
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[REDACTED]
8.5 Insurance. As of the Effective Date, Buyer shall have and maintain adequate insurance coverage, which policies shall be in effect during the Term and shall include products liability coverage and comprehensive general liability insurance of not less than $[REDACTED] provided , that if any such policy is held on a claims-made basis, such policy shall be maintained throughout the Term [REDACTED]. All insurers providing such policies shall have an AM Best (A-) or higher rating. Upon Sellers reasonable request, Buyer shall provide Seller with certificates of insurance evidencing that the policies required to be maintained by Buyer hereunder are in full force and effect. Should any of the policies be cancelled, terminated or otherwise materially altered before the expiration date thereof, notice will be delivered in accordance with the policy provisions in writing to Seller.
8.6 Limitation on Breaches. [REDACTED]
ARTICLE 9
TERM AND TERMINATION
9.1 Term. The term of this Agreement shall commence on the Effective Date and shall continue in full force and effect until terminated in accordance with this Article 9 (such period, the Term ).
9.2 Termination for Material Breach. In the event that either Party (the Breaching Party ) breaches any of its material obligations under this Agreement, the other Party (the Complaining Party ) may terminate this Agreement upon [REDACTED] days prior written notice (such [REDACTED] day period, the Notice Period ) to the Breaching Party, specifying the breach and its claim of right to terminate; provided , that the termination of this Agreement shall not become effective at the end of the Notice Period if (a) the Breaching Party cures such breach during the Notice Period or (b) such breach cannot be cured during the Notice Period and the Breaching Party commences and diligently pursues actions to cure such breach within the Notice
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Period, in which case the Breaching Party shall have an additional [REDACTED] day period to cure such breach before such termination becomes effective. [REDACTED]
9.3 Termination for Insolvency. Either Party may terminate this Agreement immediately upon written notice to the other Party if the other Party: (a) files in any court or with any other Governmental Authority, pursuant to any statute or regulation of any state or country, a petition in bankruptcy or insolvency or for reorganization or for an arrangement or for the appointment of a receiver or trustee of that Party or of its assets; (b) proposes a written agreement of composition or extension of its debts; (c) is served with an involuntary petition against it, filed in any insolvency proceeding, and such petition is not dismissed within 60 days after the filing thereof; (d) consents to the appointment or taking possession by a receiver, liquidator, assignee, custodian, trustee, sequestrator (or similar official) of such Party or for any substantial part of its property or makes any assignment for the benefit of creditors; (e) admits in writing its inability to pay its debts generally as they become due; or (f) has issued or levied against its property any judgment, writ, warrant of attachment or execution or similar process that represents a substantial portion of its property.
9.4 Mutual Agreement . This Agreement may be terminated upon the mutual written agreement of Buyer and Seller at any time.
9.5 Consequences of Termination.
9.5.1 Termination of Agreement . Upon any termination of this Agreement pursuant to Section 9.2, Section 9.3 or Section 9.4, the licenses granted by Seller to Buyer under Sections 2.1.1 and 2.1.2, and any sublicenses related thereto entered into by Buyer pursuant to Section 2.4, shall terminate in their entirety.
9.5.2 Discontinued Use of Licensed Copyrights and Licensed Trademarks . Upon any termination described in Section 9.5.1, Buyer shall, and shall cause its Affiliates, licensees, Sublicensees and distributors to discontinue all use of the Licensed Copyrights and the Licensed Trademarks (including in connection with all Product Labels, packaging with respect to the Product and advertising, marketing, promotional or other materials bearing any of the Licensed Trademarks), but in any event, within [REDACTED] days, after any such termination [REDACTED].
9.5.3 Assignment of Domain Names and Social Media Identifiers Relating to Licensed Trademarks . Upon any termination described in Section 9.5.1, Buyer shall, and shall cause its Affiliates, licensees, Sublicensees and distributors to, assign and transfer to
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Seller all of its and their rights, title and interest in and to, and all control over, any and all other domain names (both gTLDs and ccTLDs) and social media tags, handles and other identifiers (and any accounts relating thereto) consisting of, or incorporating, in whole or in part, any of the Licensed Trademarks, other than the Purchased Domain Names.
9.6 Accrued Rights; Surviving Obligations.
9.6.1 Accrued Rights . The termination or expiration of this Agreement for any reason shall be without prejudice to any rights that shall have accrued to the benefit of a Party prior to such termination or expiration. Such termination or expiration shall not relieve a Party from obligations that are expressly indicated to survive the termination or expiration of this Agreement.
9.6.2 Survival . Without limiting the foregoing, Sections 2.4, 9.5 and 9.6 and Article 3, Article 4, Article 6, Article 8 and Article 10 shall survive the termination or expiration of this Agreement for any reason.
ARTICLE 10
MISCELLANEOUS
10.1 Force Majeure. Neither Party shall be held liable or responsible to the other Party or be deemed to have defaulted under or breached this Agreement for failure or delay in fulfilling or performing any term of this Agreement when such failure or delay is caused by or results from events beyond the reasonable control of the non-performing Party, including fires, floods, earthquakes, hurricanes, embargoes, epidemics or pandemics, quarantines, war, acts of war (whether war be declared or not), terrorist acts, insurrections, riots, civil commotion, strikes, lockouts or other labor disturbances (whether involving the workforce of the non-performing Party or of any other Person), acts of God or acts, omissions or delays in acting by any Governmental Authority. The non-performing Party shall notify the other Party of such force majeure within 15 days after such occurrence by giving written notice to the other Party stating the nature of the event, its anticipated duration, and any action being taken to avoid or minimize its effect. The suspension of performance shall be of no greater scope and no longer duration than is necessary and the non-performing Party shall use commercially reasonable efforts to remedy its inability to perform.
10.2 Dispute Resolution. If a dispute arises between the Parties in connection with or relating to this Agreement or any document or instrument delivered in connection herewith (a Dispute ), it shall be resolved pursuant to this Section 10.2.
10.2.1 General . Either Party shall have the right to refer any Dispute to the President and Chief Executive Officer of Seller and the President and Chief Executive Officer of Buyer who shall confer on the resolution of the issue. Any final decision mutually agreed to by such officers shall be conclusive and binding on the Parties. If such officers are not able to agree on the resolution of any such issue within [REDACTED] Business Days after such Dispute is first referred to them, either Party may, by written notice to the other Party, elect to initiate litigation in accordance with Section 10.3 for purposes of having the matter settled.
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10.2.2 Interim Relief and Tolling . Notwithstanding anything herein to the contrary, (a) any relevant time period related to a matter that is the subject of a Dispute shall be tolled during any dispute resolution proceeding under this Section 10.2 and (b) nothing in this Section 10.2 shall preclude either Party from seeking interim or provisional relief, including a temporary restraining order, preliminary injunction or other interim equitable relief concerning a Dispute, if necessary to protect the interests of such Party. This Section 10.2.2 shall be specifically enforceable.
10.3 Governing Law, Jurisdiction, Venue and Service.
10.3.1 Governing Law . This Agreement shall be governed by and construed in accordance with the Laws of the State of Delaware, excluding any conflicts or choice of Law rule or principle that might otherwise refer construction or interpretation of this Agreement to the substantive Law of another jurisdiction.
10.3.2 Jurisdiction . Subject to Section 10.11, the Parties hereby irrevocably and unconditionally consent to the exclusive jurisdiction of the courts of the State of Delaware and the United States District Court for the District of Delaware for any action, suit or proceeding (other than appeals therefrom) arising out of or relating to this Agreement, and agree not to commence any action, suit or proceeding (other than appeals therefrom) related thereto except in such courts. The Parties irrevocably and unconditionally waive their right to a jury trial. Notwithstanding the foregoing, the Parties agree that Disputes relating to the Licensed Trademarks or Purchased Domain Names to the extent suitable for resolution under the Uniform Domain-Name Dispute-Resolution Policy (the UDRP ) may be brought before the World Intellectual Property Organization or other providers of UDRP authorized by the Internet Corporation for Assigned Names and Numbers.
10.3.3 Venue . The Parties further hereby irrevocably and unconditionally waive any objection to the laying of venue of any action, suit or proceeding (other than appeals therefrom) arising out of or relating to this Agreement in the courts of the State of Delaware or in the United States District Court for the District of Delaware, and hereby further irrevocably and unconditionally waive and agree not to plead or claim in any such court that any such action, suit or proceeding brought in any such court has been brought in an inconvenient forum.
10.3.4 Service . Each Party further agrees that service of any process, summons, notice or document by registered mail to its address set forth in Section 10.4.2 shall be effective service of process for any action, suit or proceeding brought against it under this Agreement in any such court.
10.4 Notices.
10.4.1 Notice Requirements . Any notice, request, demand, waiver, consent, approval or other communication permitted or required under this Agreement (each, a Notice ) shall be in writing, shall refer specifically to this Agreement and shall be deemed given only if delivered by hand or sent by facsimile transmission or by email of a PDF attachment (with transmission confirmed) or by internationally recognized overnight delivery service that maintains records of delivery, addressed to the Parties at their respective addresses
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specified in Section 10.4.2 or to such other address as the Party to whom notice is to be given may have provided to the other Party at least 10 days prior to such address taking effect in accordance with this Section 10.4. Such Notice shall be deemed to have been given as of the date delivered by hand or internationally recognized overnight delivery service or confirmed that it was received by facsimile or by email (with receipt confirmed by telephone or email). Any Notice delivered by facsimile or email shall be confirmed by a hard copy delivered as soon as practicable thereafter.
10.4.2 Address for Notice.
If to Seller, to:
Eisai Inc.
100 Tice Blvd.
Woodcliff Lake, New Jersey 07677
Facsimile: [REDACTED]
Email: [REDACTED]
Attention: General Counsel
with a copy (which shall not constitute notice) to:
Covington & Burling LLP
1201 Pennsylvania Avenue, N.W.
Washington, DC 20004
Facsimile: (202) 778-5168
Email: mriella@cov.com
Attention: Michael J. Riella
If to Buyer, to:
Concordia Pharmaceuticals Inc.
Chancery House, High Street
Bridgetown, St. Michael, BB11128, BARBADOS
Attention: Managing Director
Facsimile: [REDACTED]
Email: [REDACTED]
with a copy (which shall not constitute notice) to:
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Dorsey & Whitney LLP
TD Canada Trust Tower
Brookfield Place 161 Bay Street
Suite 4310
Toronto M5J 2S1
Canada
Facsimile: (416) 367-7370
Email: raymer.richard@dorsey.com
Attention: Richard Raymer
10.5 No Benefit to Third Parties. The covenants and agreements set forth in this Agreement are for the sole benefit of the Parties and their successors and permitted assigns, and, except for the rights of Buyer Indemnitees and Seller Indemnitees under Article 8, they shall not be construed as conferring any rights on any other Persons.
10.6 Waiver and Non-Exclusion of Remedies. Any term or condition of this Agreement may be waived at any time by the Party that is entitled to the benefit thereof, but no such waiver shall be effective unless set forth in a written instrument duly executed by or on behalf of the Party waiving such term or condition. The waiver by any Party of any right hereunder or of the failure to perform or of a breach by the other Party shall not be deemed a waiver of any other right hereunder or of any other breach or failure by said other Party whether of a similar nature or otherwise. The rights and remedies provided herein are cumulative and do not exclude any other right or remedy provided by applicable Law or otherwise available except as expressly set forth herein.
10.7 Expenses. Except as otherwise specified herein or in the Asset Purchase Agreement or in any other Ancillary Agreement, each Party shall bear any costs and expenses with respect to the transactions contemplated herein incurred by it.
10.8 Assignment. Neither this Agreement nor either Partys rights or obligations hereunder may be assigned or delegated by such Party without the prior written consent of the other Party, and any attempted assignment or delegation of this Agreement or any of such rights or obligations by either Party without the prior written consent of the other Party shall be void and of no effect; provided , however , that either Party may assign or delegate any or all of its rights or obligations hereunder to an Affiliate without the prior written consent of the other Party; provided, further , that such assigning Party shall remain liable to fulfill its obligations hereunder from and after such assignment. Notwithstanding the foregoing, Buyer may, without the prior written consent of Seller (but upon notice to Seller), assign this Agreement to a third party that acquires all or substantially all of the assets of Buyer. Subject to the preceding sentence, this Agreement will be binding upon, inure to the benefit of, and be enforceable by, the Parties and their respective successors and assigns.
10.9 Amendment. This Agreement may not be modified, amended, altered or supplemented except upon the execution and delivery of a written agreement executed by both Parties.
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10.10 Severability. If any provision of this Agreement is held to be illegal, invalid or unenforceable under any present or future Law, and if the rights or obligations of either Party under this Agreement will not be materially and adversely affected thereby, (a) such provision shall be fully severable, (b) this Agreement shall be construed and enforced as if such illegal, invalid or unenforceable provision had never comprised a part hereof, (c) the remaining provisions of this Agreement shall remain in full force and effect and shall not be affected by the illegal, invalid or unenforceable provision or by its severance herefrom and (d) in lieu of such illegal, invalid or unenforceable provision, there shall be added automatically as a part of this Agreement a legal, valid and enforceable provision as similar in terms to such illegal, invalid or unenforceable provision as may be possible and reasonably acceptable to the Parties.
10.11 Equitable Relief. The Parties agree that irreparable damage would occur in the event that any of the provisions of this Agreement were not performed in accordance with their specific terms or were otherwise breached. It is accordingly agreed that the Parties shall be entitled to an injunction or injunctions to prevent breaches of this Agreement and to enforce specifically the terms and provisions of this Agreement in any court of the United States or any state having jurisdiction, this being in addition to any other remedy to which they are entitled at law or in equity. Each Party hereby waives any requirement that the other Party post a bond or other security as a condition for obtaining any such relief.
10.12 English Language. This Agreement shall be written and executed in, and all other communications under or in connection with this Agreement shall be in, the English language. Any translation into any other language shall not be an official version thereof, and in the event of any conflict in interpretation between the English version and such translation, the English version shall control.
10.13 Further Assurances. Each Party shall duly execute and deliver, or cause to be duly executed and delivered, such further instruments and do and cause to be done such further acts and things, including the filing of such assignments, agreements, documents and instruments, as may be necessary or as the other Party may reasonably request in connection with this Agreement or to carry out more effectively the provisions and purposes hereof, or to better assure and confirm unto such other Party its rights and remedies under this Agreement. Buyer acknowledges and agrees, and shall provide Seller with such assistance as Seller may reasonably request, to record this Agreement, or to register or record Buyer and its Sublicensees as registered users of or licensees of the Licensed Trademarks, with any trademark office or other Governmental Agency in the Buyer Territory as Seller may deem necessary or desirable, at Sellers cost and expense.
10.14 Relationship of the Parties. It is expressly agreed that Seller, on the one hand, and Buyer, on the other hand, shall be independent contractors and that the relationship between the two Parties shall not constitute a partnership, joint venture or agency. Neither Seller, on the one hand, nor Buyer, on the other hand, shall have the authority to make any statements, representations or commitments of any kind, or to take any action, which shall be binding on the other, without the prior written consent of the other Party to do so. 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.
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10.15 Counterparts. This Agreement may be executed in any number of counterparts, and each such counterpart hereof shall be deemed to be an original instrument, but all such counterparts together shall constitute but one agreement. Delivery of an executed counterpart of a signature page of this Agreement by facsimile or other electronic transmission shall be effective as delivery of a manually executed original counterpart of this Agreement.
10.16 Entire Agreement. This Agreement, together with the Schedules expressly contemplated hereby and attached hereto, the Asset Purchase Agreement, the other Ancillary Agreements and the other agreements, certificates and documents expressly contemplated thereby and delivered in connection therewith contain the entire agreement among the Parties with respect to the transactions contemplated hereby and thereby and supersede all prior agreements, understandings, promises and representations, whether written or oral, among the Parties with respect to the subject matter hereof and thereof.
[ Signature page follows ]
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IN WITNESS WHEREOF , the Parties have executed this Agreement as of the Effective Date.
EISAI INC. | ||
By: | [REDACTED] | |
Name: [REDACTED] | ||
Title: [REDACTED] | ||
CONCORDIA PHARMACEUTICALS INC. | ||
By: | ||
Name: | ||
Title: |
[S IGNATURE P AGE TO L ICENSE A GREEMENT ]
IN WITNESS WHEREOF , the Parties have executed this Agreement as of the Effective Date.
EISAI INC. | ||||
By: | ||||
Name: | ||||
Title: | ||||
CONCORDIA PHARMACEUTICALS INC. | ||||
By: |
[REDACTED] |
|||
Name: |
[REDACTED] |
|||
Title: |
[REDACTED] |
[S IGNATURE P AGE TO L ICENSE A GREEMENT ]
Schedule 1
Dainippon Owned Trademarks
Mark |
Country |
Status |
Appl. No.
Appl. Date |
Reg. No.
Reg. Date |
Owner | |||||
[REDACTED] |
[REDACTED] |
[REDACTED] | [REDACTED] | [REDACTED] | [REDACTED] |
S-1
Schedule 2
Licensed Copyrights
[REDACTED]
S-2
Schedule 3
Licensed Trademarks
Mark |
Country |
Status |
Appl. No.
Appl. Date |
Reg. No.
Reg. Date |
Owner | |||||
[REDACTED] |
[REDACTED] |
[REDACTED] | [REDACTED] | [REDACTED] | [REDACTED] | |||||
[REDACTED] |
[REDACTED] |
[REDACTED] | [REDACTED] | [REDACTED] | [REDACTED] |
S-3
Exhibit 99.17
Execution Copy
SUMITOMO ASSIGNMENT AND ASSUMPTION AGREEMENT
This Sumitomo Assignment and Assumption Agreement (this Agreement ) is entered into this 17 th day of September, 2014, by and among Eisai Co., Ltd., a Japanese limited company ( ECL ), Eisai Inc., a Delaware corporation ( ESI , and together with ECL, the Eisai Companies ), Concordia Pharmaceuticals Inc., an international business company incorporated under the laws of Barbados ( Concordia ), and Sumitomo Dainippon Pharma Co., Ltd., a company organized under the laws of Japan ( Sumitomo ). The Eisai Companies, Concordia and Sumitomo may each be referred to herein as a Party and collectively as the Parties . This Agreement is entered into in connection with the execution and delivery of the Asset Purchase Agreement, dated as of September 3, 2014, by and between ESI and Concordia (the Asset Purchase Agreement ). Additional definitions are listed in Annex A. Capitalized terms used but not defined herein shall have the respective meanings assigned to them in the North American Agreement (as defined in Annex A).
WHEREAS, the Eisai Companies and Sumitomo are parties to the following agreements: (I) a Consolidation Agreement, dated as of December 16,2003 (the Consolidation Agreement ), (2) the North American Agreement, (3) the European Agreement (as defined in Annex A), and (4) the Other Agreements (as defined in Annex A) (the Consolidation Agreement, the North American Agreement, the European Agreement and the Other Agreements collectively, the Sumitomo Agreements );
WHEREAS, ESI and Concordia have entered into the Asset Purchase Agreement, which provides, among other things, for the sale by ESI to Concordia of assets relating to the pharmaceutical product containing zonisamide that was approved by the U.S. Food and Drug Administration pursuant to NDA [REDACTED] and commercialized in the United States of America, including Puerto Rico (the U .S. Territory ), prior to the closing of the transactions contemplated by the Asset Purchase Agreement (the Closing ) by ESI under the trademark ZONEGRAN® (such product, the U.S. Product ), as such assets and business exist immediately prior to the Closing, including certain rights of ESI under the Sumitomo Agreements with respect to the U.S. Territory more fully described herein;
WHEREAS, under the terms of the Asset Purchase Agreement, (1) ESI has agreed to assign, and Concordia has agreed to assume, in each case, at the Closing, certain rights, liabilities and obligations of ESI under or pursuant to the North American Agreement with respect to the U.S. Territory, all as more fully described herein, that arise on or after the Closing Date (as defined in Annex A), and (2) ESI has agreed to license to Concordia certain trademarks related to the U.S. Product in the U.S. Territory and sublicense to Concordia ESIs rights under the North American Agreement with respect to the Trademark in the U.S. Territory;
WHEREAS, Sumitomo desires to consent to ESIs assignment of the Assigned U.S. Rights (as defined below) and Concordias assumption of the Assumed U.S. Obligations (as defined below) and ESIs sublicense to Concordia of ESIs rights under the North American Agreement with respect to the Trademark in the U.S. Territory, in each case, on the terms and conditions set forth herein; and
WHEREAS, in connection with ESIs assignment of the Assigned U.S. Rights and Concordias assumption of the Assumed U.S. Obligations, Sumitomo and the Eisai Companies desire to terminate the Consolidation Agreement, with such termination to be effective immediately prior to the Closing.
NOW, THEREFORE, for good and valuable consideration, the receipt and sufficiency of which is hereby acknowledged, and subject to the terms and conditions set forth herein, the Parties hereto agree as follows:
1. Termination of Consolidation Agreement. [REDACTED] (a) ESI and Sumitodmo shall be the parties to the North American Agreement and, as a result thereof, (i) all rights, obligations and liabilities of the Eisai Companies thereunder shall be the rights, obligations and liabilities, respectively, of only ESI, (ii) Sumitomo shall not have any recourse against ECL or under the European Agreement with respect to any obligations or liabilities of any Eisai Company under the North American Agreement, regardless of when such obligations or liabilities arose, and (iii) ESI shall not have any recourse against Sumitomo or under the European Agreement with respect to any obligations or liabilities of Sumitomo under the North American Agreement, regardless of when such obligations or liabilities arose; and (b) ECL and Sumitomo shall be the parties to the European Agreement and, as a result thereof, (i) all rights, obligations and liabilities of the Eisai Companies thereunder shall be the rights, obligations and liabilities, respectively, of only ECL, (ii) Sumitomo shall not have any recourse against ESI or under the North American Agreement with respect to any obligations or liabilities of any Eisai Company under the European Agreement, regardless of when such obligations or liabilities arose, and (iii) ECL shall not have any recourse against Sumitomo or under the North American Agreement with respect to any obligations or liabilities of Sumitomo under the European Agreement, regardless of when such obligations or liabilities arose.
2. Assignment of Assigned U.S. Rights . In accordance with terms and conditions of the Asset Purchase Agreement and Article 29, and notwithstanding Clause 2.03, of the North American Agreement, ESI hereby assigns to Concordia, effective upon the Closing, the Assigned U.S. Rights. For purposes of this Agreement, the Assigned U.S. Rights means all of ESIs rights, title and interest in and to the North American Agreement from and after the Closing to the extent related to or arising out of the U.S. Territory (including, but not limited to, the marketing, distribution, manufacture and sale of the Product and all regulatory rights to act as U.S. representative and authorized agent of Sumitomo with respect to the Product), but excluding any and all of ESIs rights and interest in the Trademark. Notwithstanding the foregoing, (a) ESI retains, and the Assigned U.S. Rights do not include, all rights granted under Clause 2.02 of the North American Agreement with respect to the Trademark and the Information as such Information relates to Canada and Mexico only, (b) ESI retains the right to make and have made the Product in the U.S. Territory for sale outside of the U.S. Territory, and (c) ESI retains a right to receive Dainippon Clinical Data and Dainippon Funded Zonisamide Information and a right and license to use the Dainippon Clinical Data and the Dainippon Funded Zonisamide Information throughout Canada and Mexico, in each case, in accordance with Clause 4.04(a) and Clause 4.04(b), respectively, of the North American Agreement.
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3. Assumption of Assumed U.S. Obligations. In accordance with terms and conditions of the Asset Purchase Agreement and Article 29, and notwithstanding Clause 2.03, of the North American Agreement, Concordia hereby assumes, effective upon the Closing, all obligations and liabilities of ESI under the North American Agreement to the extent related to or arising out of the Assigned U.S. Rights on or after the Closing Date (the Assumed U.S. Obligations ). Except for the Assumed U.S. Obligations, the Parties agree and acknowledge that Concordia shall not assume and shall not be liable or responsible in any manner for any other obligation of ESI pursuant to the North American Agreement.
4. Sumitomo Consent. Sumitomo hereby irrevocably and, except as expressly provided herein, unconditionally, consents to (a) the assignment by ESI to Concordia of the Assigned U.S. Rights and the assumption by Concordia of the Assumed U.S. Obligations and (b) from and after the Closing, the sublicense by ESI to Concordia (with right to grant further sublicenses through multiple tiers only to Affiliates of Concordia and only for so long as they remain Affiliates of Concordia) of ESIs rights in and to the Trademark solely in the U.S. Territory and solely in order to distribute, commercialize, market, manufacture, or otherwise exploit in any way the Product in the U.S. Territory. Sumitomo shall not exercise, and does hereby waive, its right to terminate the North American Agreement under Clause 28.01d) thereof as a result of the assignment and assumption contemplated by this Agreement. Without limiting the generality of the foregoing, from and after the Closing, Sumitomo shall look only to (i) Concordia for the performance of the Assumed U.S. Obligations and ESI shall have no obligation to Sumitomo with respect thereto and (ii) ESI for the performance of all other obligations under the North American Agreement and Concordia shall have no obligation to Sumitomo with respect thereto.
5. Retention of Pre-Closing Rights and Obligations. ESI and Sumitomo retain all of their respective rights, liabilities and obligations, as between each other, pursuant to the North American Agreement solely to the extent that any such rights, liabilities or obligations arise out of facts, events or circumstances occurring prior to the Closing Date, including under Article 23 of the North American Agreement. Except as set forth in this Agreement, the Parties agree and acknowledge that all other rights and obligations between ESI and Sumitomo, as between each other, under the North American Agreement with respect to the U.S. Territory (but not with respect to the Trademark) are hereby terminated in their entirety effective as of the Closing.
6. Transition Period. It is understood that a transition period shall commence on the Closing Date and continue for a period of [REDACTED] days, which period may be extended by mutual agreement of ESI and Concordia, for the purpose of providing a smooth and expeditious transition of the Assigned U.S. Rights and the Assumed U.S. Obligations and business and operational activities related to the Product in the U.S. Territory. [REDACTED] While both ESI and Concordia will be performing activities during the transition period with respect to the U.S. Territory, as between Concordia and Sumitomo, Concordia shall be responsible to Sumitomo for ensuring full performance of the Assumed U.S. Obligations and shall not assert any failure by ESI as a defense. It is
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further agreed that the following persons have been designated by ESI and Concordia, respectively, as the contact person for such Party for the purposes of the transition period:
For ESI:
[REDACTED]
Eisai Inc.
100 Tice Boulevard
Woodcliff Lake, NJ 07677
Facsimile: [REDACTED]
Email: [REDACTED]
For Concordia:
[REDACTED]
Concordia Pharmaceuticals Inc.
Chancery House, High Street
Bridgetown, St. Michael, BB11128, BARBADOS
Facsimile: [REDACTED]
Email: [REDACTED]
7. Modifications to North American Agreement. Effective upon the Closing, the North American Agreement is hereby modified as follows:
(a) Concordia Designations . Concordia proposes and Sumitomo consents to the designation pursuant to Clause 2.03 and Clause 10.06 of the North American Agreement by Concordia of the following parties, as subcontractors, to carry out Concordias rights and obligations under the North American Agreement for and on behalf of Concordia, in each case, only to the extent and for so long as Concordia chooses in its sole discretion, with respect to the U.S. Territory, as follows, provided that such designations will not limit, waive or affect Concordias obligations under the North American Agreement or the Other Agreements, except to the extent that such obligations are performed by the applicable designee:
(i) [REDACTED]
(ii) [REDACTED]
(iii) [REDACTED]
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(iv) [REDACTED]
(v) [REDACTED]
For the avoidance of doubt this provision shall not give rise to any rights of the Eisai Companies, Eisai Ltd. or any of their Affiliates exercisable against Concordia or Sumitomo, or any obligations of Sumitomo or Concordia to the Eisai Companies, Eisai Ltd. or any of their Affiliates.
In the event that any of the designations in Section 7(a) are terminated, ESI or its applicable Affiliate shall assign and Concordia or its applicable Affiliate shall assume, each Other Agreement that is related to the obligations that Concordia (or its future designee) will perform as a result of such termination.
(b) Supply Price and Payment Terms . Clause 11.05 of the North American Agreement shall be deleted in its entirety and replaced with the following: Title to and risk of loss for the Compound shall pass to Concordia when the Compound is delivered by Dainippon to [REDACTED] or another location designated by Concordia.
(c) Set-off Rights . Sumitomo shall not have any right to set-off any amount owed by Sumitomo under the North American Agreement, whether under Clause 11.06 thereof or otherwise, with respect to (i) the U.S. Territory against any amount owed to Sumitomo by ESI with respect to Canada, Mexico or the Trademark or (ii) Canada, Mexico or the Trademark against any amount owed to Sumitomo by Concordia with respect to the U.S. Territory.
(d) Report . Concordia shall be required to prepare and deliver to Sumitomo the reports described in Clause 15.01 of the North American Agreement and keep the records described in Clause 15.02 of the North American Agreement solely with respect to the U.S. Territory and ESI shall be required to prepare and deliver to Sumitomo the reports described in Clause 15.01 of the North American Agreement and keep the records described in Clause 15.02 of the North American Agreement solely with respect to Canada and Mexico.
(e) Performance by Affiliate and Designee . Notwithstanding anything to the contrary in the North American Agreement, including without limitation Clause 21.01, Concordia shall not be required to guarantee the performance by any Eisai Company or any Affiliate or designee of such entities under the North American Agreement or pursuant to the designations under Section 7(a) above.
(f) Secrecy . The language in Clause 25.01 of the North American Agreement through the end of subclause i) thereof shall be deleted in its entirety and replaced with the following:
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During the term of this Agreement and for [REDACTED] thereafter, Concordia, Eisai and Sumitomo shall each maintain confidential the Information or any other confidential or proprietary information received from any other party under this Agreement, except for or to the extent of the Information or such other information:
i) which must be disclosed by the recipient to any Registration Body to the extent the same is necessary to enable the attainment of the purpose of this Agreement; or
(g) Term of Agreement . For clarity, (i) only Concordia and Sumitomo shall have the right to terminate the North American Agreement with respect to the U.S. Territory pursuant to Clause 26.02 thereof and (ii) only ESI and Sumitomo shall have the right to terminate the North American Agreement with respect to Canada and Mexico pursuant to Clause 26.03 thereof.
(h) Termination .
(i) Sumitomo shall be permitted to terminate the North American Agreement pursuant to Clause 28.01a) only with respect to Concordia if Concordia notifies Sumitomo in writing of its determination to discontinue sale of the Product in the U.S. Territory and only with respect to Eisai if ESI notifies Sumitomo in writing of its determination to discontinue sale of the Product in Canada and Mexico.
(ii) No termination of the North American Agreement by Sumitomo pursuant to Clause 28.01b) or Clause 28.01c) thereof as a result of any breach of the North American Agreement by Concordia or ESI or the suffering by Concordia or ESI of any event specified in Clause 28.01c), respectively, shall result in the termination of the North American Agreement with respect to the other such Party and its territory. No termination of the North American Agreement by Concordia or ESI pursuant to Clause 28.01b) or Clause 28.01c) thereof shall result in the termination of the North American Agreement with respect to the other such Party and its territory.
(iii) Article 27 of the North American Agreement shall apply to Concordia or ESI only to the extent the North American Agreement is terminated with respect to such Party and its territory in accordance with the preceding clauses (i) and (ii).
(iv) Clause 26.04 of the North American Agreement is hereby deleted in its entirety and shall have no further force or effect.
(i) Marketing and Minimums . Article 13 and Schedule C of the North American Agreement, are hereby deleted in their entirety and shall have no further force or effect. Notwithstanding anything to the contrary in the North American Agreement, Concordia shall only be required to provide the following information with respect to the Product in the U.S. Territory under Article 15 of the North American Agreement: (1) monthly gross and net sales in both unit and value, (2) selling price and (5) current inventory levels.
8. Regulatory Matters .
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(a) Effective from and after the Closing, Sumitomo hereby grants to ESI and its Affiliates (so long as they remain Affiliates of ESI), a revocable (upon the termination for any reason of the North American Agreement with respect to Eisai), non-exclusive, fully-paid, royalty-free, non-sublicensable (provided that the lack of a sublicense shall not be used by a Party to challenge the manufacture, sale or distribution of products by third party manufacturers, wholesalers and distributors of ESI and its Affiliates in Canada and Mexico) and non-transferable license and right of reference to the US Registration and all Information related thereto in order for ESI to exercise its rights and perform its obligations under the North American Agreement with respect to Canada and Mexico.
(b) In furtherance of the grants in Section 8(a) above, from and after the Closing, upon ESIs reasonable request, Sumitomo shall, (i) provide to ESI or ESIs Affiliates, at ESIs cost and expense, copies of the US Registration owned by Sumitomo and all Information related thereto as shall be reasonably requested by ESI or its applicable Affiliate solely for purposes of exercising ESIs rights or performing ESIs obligations under the North American Agreement with respect to Canada and Mexico and (ii) provide to ESI or its applicable Affiliate and to any specified Canadian Authority or Mexican Authority a letter, in the form reasonably requested by ESI, acknowledging that ESI or its applicable Affiliate has the right of reference to the US Registration and all Information related thereto in order to exercise its rights and perform its obligations under the North American Agreement with respect to Canada and Mexico.
(c) Effective from and after the Closing, Sumitomo hereby grants to Concordia and its Affiliates (so long as they remain Affiliates of Concordia), a revocable (upon the termination for any reason of the North American Agreement with respect to Concordia), non-exclusive, fully-paid, royalty-free, non-sublicensable (provided that the lack of a sublicense shall not be used by a Party to challenge the manufacture, sale or distribution of U.S. Products by third party manufacturers, wholesalers and distributors of Concordia and its Affiliates in the U.S. Territory) and non-transferable license and right of reference in the U.S. Territory to any Registration owned by Sumitomo, other than the U.S. Registration, and all Information related thereto in order for Concordia to exercise its rights and perform its obligations under the North American Agreement with respect to the U.S. Territory.
(d) In furtherance of the grants in Section 8(c) above, from and after the Closing, upon Concordias reasonable request, Sumitomo shall, (i) provide to Concordia or Concordias Affiliates, at Concordias cost and expense, copies of the Registration owned by Sumitomo, other than the U.S. Registration, and all Information related thereto as shall be reasonably requested by Concordia or its applicable Affiliate solely for purposes of exercising Concordias rights or performing Concordias obligations under the North American Agreement with respect to the U.S. Territory and (ii) provide to Concordia or its applicable Affiliate and to any specified U.S. governmental authority a letter, in the form reasonably requested by Concordia, acknowledging that Concordia or its applicable Affiliate has the right of reference to such Registration and all Information related thereto in order to exercise its rights and perform its obligations under the North American Agreement with respect to the U.S. Territory.
9. Notices . From and after the Closing, (a) all notices provided under the North American Agreement relating solely to the U.S. Territory shall be sent to Concordia or Sumitomo, as applicable, (b) all notices provided under the North American Agreement relating solely to Canada or Mexico shall be sent to ESI or Sumitomo, as applicable, and
- 7 -
(c) all notices provided under the North American Agreement under Clause 26 or Clause 28 thereof or the Trademark or relating to both the U.S. Territory and to (i) Canada or Mexico or (ii) the Trademark shall be sent to Concordia, ESI and Sumitomo. Any notices to be sent to Concordia pursuant to Article 34 of the North American Agreement shall be sent to Concordia as follows:
Concordia Pharmaceuticals Inc.
Chancery House, High Street
Bridgetown, St. Michael, BB11128, BARBADOS
Attention: Managing Director
Facsimile: [REDACTED]
Email: [REDACTED]
with a copy (which shall not constitute notice) to:
Dorsey & Whitney LLP
TD Canada Trust Tower
Brookfield Place 161 Bay Street
Suite 4310
Toronto M5J 2S1
Canada
Facsimile: (416)367-7370
Email: raymer.richard@dorsey.com
Attention: Richard Raymer
10. No Other Amendments . Except as expressly amended hereby, the Sumitomo Agreements are not amended, modified or affected by this Agreement, and the Sumitomo Agreements and all terms and provisions thereof shall remain in full force and effect.
11. Effectiveness; Termination . The Parties agree and acknowledge that this Agreement shall become effective upon the Closing.
12. Representations and Warranties . Each Party represents and warrants to the other Parties that (i) such Party is duly organized, validly existing and, where applicable, in good standing under the laws of such Partys jurisdiction of organization, (ii) this Agreement has been duly and validly authorized, executed and delivered by such Party and, when executed and delivered by the other Parties, will constitute a legal valid and binding obligation of such Party enforceable against it in accordance with its terms, and (iii) neither the execution and delivery by such Party of this Agreement nor the consummation of the transactions contemplated by this Agreement will (A) violate any applicable law to which such Party is subject or any provision of its organizational documents, or (B) conflict with, result in a breach of, constitute a default under, result in the acceleration of, create in any Party the right to accelerate, terminate, modify or cancel, or require any notice under, or the consent of any other Party to, any material contract, lease, sublease, license, franchise, permit, indenture, agreement for borrowed money, instrument of indebtedness, lien or other arrangement to which such Party is bound or to which any of such Partys assets are subject.
13. Further Assurances . Each Party agrees, from and after the Closing, upon the reasonable request of another Party, and at the expense of the requesting Party, to make, execute and deliver any or all documents or instruments of any kind or character, and to
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perform all such other actions, that may be necessary or proper and reasonable to effectuate, confirm, perform or carry out the terms and provisions of this Agreement.
14. Governing Law, Arbitration .
(a) Governing Law . This Agreement shall be governed by and construed in accordance with the laws of the State of Delaware, excluding any conflicts or choice of law rule or principle that might otherwise refer construction or interpretation of this Agreement to the substantive law of another jurisdiction.
(b) Arbitration . All disputes arising out of or in connection with this Agreement or the Sumitomo Agreements, notwithstanding any other provisions therein, shall be finally settled under the Rules of Arbitration of the International Chamber of Commerce (the ICC Rules ) by one or more arbitrators appointed in accordance with the ICC Rules. The arbitration shall be held in New York, New York, and shall be conducted in English. The decision and award of the arbitrators in any arbitration proceeding between the Parties shall be: (a) in writing, stating the reasons for such decision, (b) final and binding upon the Parties hereto; and (c) enforceable in any court of competent jurisdiction. The arbitrators shall have no authority to award punitive or any other type of damages not measured by a Partys compensatory damages.
15. Construction . Except where the context otherwise requires, wherever used, the singular includes the plural, the plural the singular, the use of any gender shall be applicable to all genders and the word or is used in the inclusive sense (and/or). The captions of this Agreement are for convenience of reference only and in no way define, describe, extend or limit the scope or intent of this Agreement or the intent of any provision contained in this Agreement. The term including and include and variations thereof shall not be deemed to be terms of limitation, but rather shall be deemed to be followed by the words without limitation. The language of this Agreement shall be deemed to be the language mutually chosen by the Parties and no rule of strict construction shall be applied against any Party. Unless otherwise specified or where the context otherwise requires, extent in the phrase to the extent means the degree to which a subject or other thing extends, and such phrase does not mean simply if.
16. Counterparts . This Agreement may be executed in any number of counterparts, each of which when so executed shall be deemed to be an original and all of which taken together shall constitute but one and the same agreement. Delivery of an executed counterpart of a signature page of this Agreement by facsimile or other electronic transmission shall be effective as delivery of a manually executed original counterpart of this Agreement.
[SIGNATURE PAGE TO FOLLOW]
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IN WITNESS WHEREOF, the Parties have executed this Agreement as of the day and year first written above.
[SIGNATURE PAGE TO SUMITOMO ASSIGNMENT AND ASSUMPTION
AGREEMENT]
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IN WITNESS WHEREOF, the Parties have executed this Agreement as of the day and year first written above.
SUMITOMO DAINIPPON PHARMA CO., LTD. |
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By: |
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Name: |
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Title: |
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EISAI CO., LTD |
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By: |
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Name: |
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Title: |
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EISAI INC. |
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By: |
[REDACTED] | |
Name: |
[REDACTED] | |
Title: |
[REDACTED] |
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CONCORDIA PHARMACEUTICALS INC. |
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By: |
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Name: |
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Title: |
[SIGNATURE PAGE TO SUMITOMO ASSIGNMENT AND ASSUMPTION
AGREEMENT]
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IN WITNESS WHEREOF, the Parties have executed this Agreement as of the day and year first written above.
SUMITOMO DAINIPPON PHARMA CO., LTD. |
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By: |
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Name: |
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Title: |
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EISAI CO., LTD |
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By: |
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Name: |
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Title: |
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EISAI INC. |
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By: |
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Name: |
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Title: |
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CONCORDIA PHARMACEUTICALS INC. |
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By: |
[REDACTED] |
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Name: |
[REDACTED] |
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Title: |
[REDACTED] |
[SIGNATURE PAGE TO SUMITOMO ASSIGNMENT AND ASSUMPTION
AGREEMENT]
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ANNEX A
ADDITIONAL DEFINITIONS
North American Agreement means
1. [REDACTED]
2. [REDACTED]
3. [REDACTED]
4. [REDACTED]
5. [REDACTED]
6. [REDACTED]
7. [REDACTED]
8. [REDACTED]
9. [REDACTED]
Other Agreements means
1. [REDACTED]
2. [REDACTED]
European Agreement means
1. [REDACTED]
2. [REDACTED]
3. [REDACTED]
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4. [REDACTED]
5. [REDACTED]
6. [REDACTED]
7. [REDACTED]
8. [REDACTED]
9. [REDACTED]
10. [REDACTED]
11. [REDACTED]
12. [REDACTED]
13. [REDACTED]
14. [REDACTED]
15. [REDACTED]
16. [REDACTED]
17. [REDACTED]
18. [REDACTED]
19. [REDACTED]
20. [REDACTED]
21. [REDACTED]
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22. [REDACTED]
23. [REDACTED]
24. [REDACTED]
25. [REDACTED]
26. [REDACTED]
27. [REDACTED]
28. [REDACTED]
29. [REDACTED]
Closing Date means the date on which the Closing occurs.
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Exhibit 99.18
EXECUTION VERSION
ASSET PURCHASE AGREEMENT
between
COVIS PHARMA S.À.R.L., ZUG BRANCH,
COVIS INJECTABLES S.À.R.L., ZUG BRANCH,
CONCORDIA PHARMACEUTICALS INC.,
CONCORDIA HEALTHCARE CORP.
(solely with respect to Section 6.10 , Section 10.18 and the applicable provisions of Article X ),
and
COVIS PHARMA HOLDINGS S.À.R.L.
(solely with respect to Section 10.19 and the applicable provisions of Article X ),
DATED AS OF MARCH 9, 2015
TABLE OF CONTENTS
Page | ||||||
ARTICLE I DEFINITIONS AND TERMS |
1 | |||||
Section 1.1. |
Definitions |
1 | ||||
Section 1.2. |
Other Definitional Provisions |
17 | ||||
ARTICLE II PURCHASE AND SALE |
17 | |||||
Section 2.1. |
Purchase and Sale of Assets |
17 | ||||
Section 2.2. |
Non-assignable Assets |
18 | ||||
Section 2.3. |
Excluded Assets |
19 | ||||
Section 2.4. |
Assumption of Liabilities |
20 | ||||
Section 2.5. |
Retained Liabilities |
21 | ||||
Section 2.6. |
Purchase Price |
22 | ||||
ARTICLE III CLOSING |
23 | |||||
Section 3.1. |
Closing |
23 | ||||
ARTICLE IV REPRESENTATIONS AND WARRANTIES OF SELLERS |
24 | |||||
Section 4.1. |
Organization |
24 | ||||
Section 4.2. |
Authority; Binding Effect |
24 | ||||
Section 4.3. |
No Conflicts; Consents |
25 | ||||
Section 4.4. |
Governmental Authorization |
25 | ||||
Section 4.5. |
Absence of Material Changes |
26 | ||||
Section 4.6. |
Litigation |
26 | ||||
Section 4.7. |
Compliance with Laws |
27 | ||||
Section 4.8. |
Product Registrations; Regulatory Compliance |
28 | ||||
Section 4.9. |
Intellectual Property |
30 | ||||
Section 4.10. |
Assets |
31 | ||||
Section 4.11. |
Taxes |
31 | ||||
Section 4.12. |
Contracts |
32 | ||||
Section 4.13. |
Financial Data |
34 | ||||
Section 4.14. |
Brokers |
34 | ||||
Section 4.15. |
Inventory |
34 | ||||
Section 4.16. |
Product Distribution Practices |
35 | ||||
Section 4.17. |
Product Liability |
35 | ||||
Section 4.18. |
Insurance |
35 | ||||
Section 4.19. |
Chief Executive Office |
35 | ||||
Section 4.20. |
No Other Representations or Warranties |
35 | ||||
ARTICLE V REPRESENTATIONS AND WARRANTIES OF PURCHASER |
36 | |||||
Section 5.1. |
Organization |
36 | ||||
Section 5.2. |
Authority; Binding Effect |
36 | ||||
Section 5.3. |
No Conflicts; Consents |
37 | ||||
Section 5.4. |
Governmental Authorization |
37 | ||||
Section 5.5. |
Financing |
37 |
-i-
Section 5.6. |
Litigation |
38 | ||||
Section 5.7. |
Brokers |
38 | ||||
Section 5.8. |
Solvency |
38 | ||||
Section 5.9. |
No Other Representations or Warranties |
39 | ||||
ARTICLE VI COVENANTS |
39 | |||||
Section 6.1. |
Information and Documents |
39 | ||||
Section 6.2. |
Conduct |
40 | ||||
Section 6.3. |
Regulatory Approvals |
42 | ||||
Section 6.4. |
Efforts to Consummate Generally |
43 | ||||
Section 6.5. |
Bulk Transfer Laws |
44 | ||||
Section 6.6. |
Insurance |
44 | ||||
Section 6.7. |
Trade Notification |
44 | ||||
Section 6.8. |
Seller-Labeled Products |
45 | ||||
Section 6.9. |
NDC Numbers |
45 | ||||
Section 6.10. |
Financing |
46 | ||||
Section 6.11. |
Existing Debt |
49 | ||||
Section 6.12. |
Non-Solicitation |
50 | ||||
Section 6.13. |
No-Shop |
50 | ||||
Section 6.14. |
Transfer of Product Registrations, Related Applications and Dossiers |
51 | ||||
Section 6.15. |
Confidentiality |
52 | ||||
Section 6.16. |
Shared Contracts |
52 | ||||
Section 6.17. |
Product Returns, Rebates and Chargebacks |
53 | ||||
Section 6.18. |
Know-How License |
56 | ||||
Section 6.19. |
Ancillary Agreements |
56 | ||||
Section 6.20. |
Correspondence |
57 | ||||
Section 6.21. |
Escrow Account |
57 | ||||
ARTICLE VII CONDITIONS TO CLOSING |
57 | |||||
Section 7.1. |
Conditions to the Obligations of Purchaser and Sellers |
57 | ||||
Section 7.2. |
Conditions to the Obligations of Purchaser |
58 | ||||
Section 7.3. |
Conditions to the Obligations of Sellers |
59 | ||||
Section 7.4. |
Frustration of Closing Conditions |
59 | ||||
ARTICLE VIII INDEMNIFICATION |
59 | |||||
Section 8.1. |
Indemnification by Sellers |
59 | ||||
Section 8.2. |
Indemnification by Purchaser |
60 | ||||
Section 8.3. |
Notice of Third-Party Claims |
60 | ||||
Section 8.4. |
Expiration |
62 | ||||
Section 8.5. |
Limitations on Indemnification |
63 | ||||
Section 8.6. |
Reimbursement |
65 | ||||
Section 8.7. |
Sole Remedy/Waiver |
65 | ||||
Section 8.8. |
Security for Indemnification Obligations |
65 | ||||
ARTICLE IX TERMINATION |
65 | |||||
Section 9.1. |
Termination |
65 |
-ii-
Section 9.2. |
Effect of Termination |
66 | ||||
Section 9.3. |
Termination Fee |
67 | ||||
ARTICLE X MISCELLANEOUS |
68 | |||||
Section 10.1. |
Notices |
68 | ||||
Section 10.2. |
Amendment; Waiver |
69 | ||||
Section 10.3. |
Assignment |
70 | ||||
Section 10.4. |
Entire Agreement |
70 | ||||
Section 10.5. |
Parties in Interest |
70 | ||||
Section 10.6. |
Public Disclosure |
70 | ||||
Section 10.7. |
Return of Information |
70 | ||||
Section 10.8. |
Expenses, Transfer Taxes and Property Taxes |
71 | ||||
Section 10.9. |
Schedules |
71 | ||||
Section 10.10. |
Governing Law; Jurisdiction |
71 | ||||
Section 10.11. |
WAIVER OF JURY TRIAL |
72 | ||||
Section 10.12. |
Counterparts |
73 | ||||
Section 10.13. |
Headings |
73 | ||||
Section 10.14. |
Severability |
73 | ||||
Section 10.15. |
Specific Performance |
73 | ||||
Section 10.16. |
Non-Recourse |
74 | ||||
Section 10.17. |
Mutual Drafting |
75 | ||||
Section 10.18. |
Purchaser Parent |
75 | ||||
Section 10.19. |
Seller Parent |
75 | ||||
SCHEDULES OTHER THAN DISCLOSURE SCHEDULES
|
||||||
1.1(a) |
Excluded Contracts |
|||||
1.1(b) |
Intellectual Property Licenses |
|||||
1.1(d) |
Knowledge of Purchaser |
|||||
1.1(e) |
Knowledge of Sellers |
|||||
1.1(f) |
Products |
|||||
1.1(g) |
Retained Products |
|||||
1.1(h) |
[REDACTED] |
|||||
4.11 |
Tax Matters |
|||||
EXHIBITS
|
||||||
EXHIBIT A |
List of instruments and documents to be provided by Sellers |
|||||
EXHIBIT B |
List of instruments and documents to be provided by Purchaser |
|||||
EXHIBIT C |
Transition Services Agreement Term Sheet |
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ASSET PURCHASE AGREEMENT
This Asset Purchase Agreement is made and entered into as of the 9 th day of March 2015, by and between Covis Pharma S.à.r.l., Zug Branch, a limited liability company organized under the Laws of Luxembourg ( Covis Pharma ), Covis Injectables S.à.r.l., Zug Branch, a limited liability company organized under the Laws of Luxembourg ( Covis Injectables ; each of Covis Pharma and Covis Injectables is referred to individually as a Seller and, collectively, Covis Pharma and Covis Injectables are referred to as the Sellers ), Concordia Pharmaceuticals Inc., an international business company organized under the Laws of Barbados ( Purchaser ), Concordia Healthcare Corp., a corporation organized under the Laws of the province of Ontario ( Purchaser Parent ) (solely with respect to Section 6.10 , Section 10.18 and the applicable provisions of Article X ) and Covis Pharma Holdings S.à.r.l., a limited liability company organized under the Laws of Luxembourg ( Seller Parent ) (solely with respect to Section 10.19 and the applicable provisions of Article X ).
W I T N E S S E T H:
WHEREAS , Sellers desire to sell, transfer and assign to Purchaser, and Purchaser desires to acquire and assume from Sellers, all of the Purchased Assets and Assumed Liabilities, all as more specifically provided herein.
NOW, THEREFORE , in consideration of the foregoing and the representations, warranties, covenants and agreements contained herein, and for other good and valuable consideration, the receipt and sufficiency of which are hereby acknowledged, the parties hereby agree as follows:
ARTICLE I
DEFINITIONS AND TERMS
Section 1.1. Definitions . As used in this Agreement, the following terms shall have the meanings set forth or as referenced below:
Accounts Receivable means all trade accounts and notes receivable and other miscellaneous receivables of the Business as of the Closing arising out of the sale or other disposition of goods or services of the Business.
Acquisition Proposal shall have the meaning set forth in Section 6.13(a) .
Additional Ancillary Agreement shall have the meaning set forth in Section 6.19(a) .
Affiliate means with respect to any Person, any other Person directly or indirectly controlling, controlled by, or under common control with, such Person at any time during the period for which the determination of affiliation is being made. For purposes of this definition, the term control (including the correlative meanings of the terms controlled by and under common control with ), as used with respect to any Person, means the possession,
directly or indirectly, of the power to direct or cause the direction of the management policies of such Person, whether through the ownership of voting securities or by contract or otherwise.
AG Distribution Contract means authorized generic distribution contracts, including: (i) the Supply & Distribution Agreement, dated May 23, 2013, by and between Covis Pharma S.à.r.l. and Rising Pharmaceuticals Inc.; (ii) the Supply & Distribution Agreement, dated December 2013, by and between Covis Pharma S.à.r.l. and Par Pharmaceutical, Inc.; and (iii) the Supply & Distribution Agreement, dated as of October 10, 2014, by and between Covis Pharma S.à.r.l. and Prasco, LLC.
Agreement means this Agreement, as the same may be amended or supplemented from time to time in accordance with the terms hereof.
Ancillary Agreements means, collectively, the Assignment and Assumption Agreement, the Bill of Sale, the Escrow Agreement, the Intellectual Property Assignment Agreement, the Transition Services Agreement and any Additional Ancillary Agreement.
Antitrust Laws means all statutes, rules, regulations, orders, decrees, administrative and judicial doctrines, and other Laws of any jurisdiction applicable to Purchaser or any Seller that are designed or intended to prohibit, restrict or regulate actions having the purpose or effect of monopolization or restraint of trade, or the creation or strengthening of a dominant position, or the substantial lessening of competition, including the HSR Act and the regulations of any applicable foreign jurisdiction.
Assignment and Assumption Agreement means an assignment and assumption agreement, the definitive form of which will be executed and delivered by each of the Sellers and Purchaser at Closing, containing such reasonable and customary terms and conditions as mutually agreed to by Sellers and Purchaser, in connection with the assignment by Sellers to Purchaser of all rights, benefits and interests under the Assumed Contracts and all rights, benefits and interests to be assigned to Purchaser under the Shared Contracts, and the assumption by Purchaser of the Assumed Liabilities, in each case in accordance with, and subject to, the terms of this Agreement.
Assumed Contracts means all Contracts (other than this Agreement, the Ancillary Agreements and the Excluded Contracts) that are Related to the Business as of the Closing, whether written or oral, including Intellectual Property Licenses and Contracts set forth on Section 4.12(a)(i) of the Sellers Disclosure Schedules.
Assumed Liability shall have the meaning set forth in Section 2.4 .
Bill of Sale means a bill of sale, the definitive form of which will be executed and delivered by each of the Sellers and Purchaser at Closing, containing such reasonable and customary terms and conditions as mutually agreed to by Sellers and Purchaser, in connection with the conveyance by Sellers to Purchaser of all right, title and interest to, in and under the Purchased Assets, in each case in accordance with, and subject to, the terms of this Agreement.
Books and Records means financial, accounting, operating data and records, including (a) inventory records, product specifications, customer lists, cost and pricing
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information, supplier lists, customer literature, quality control records and manuals; (b) product development files, and records and stability and clinical studies; (c) data relevant to the manufacturing of a Product; (d) Regulatory Documentation, (e) Registration Information and (e) Promotional Materials, in each case to the extent Related to the Business (including all data and other information stored on discs, tapes or other media); provided , however , that Sellers may retain a copy of (A) all such business and financial records, (B) any other books and records to the extent necessary for reporting, regulatory, Tax, accounting or litigation purposes and (C) any correspondence to, with or from any Person in connection with the Business, related to the Excluded Assets, the Retained Liabilities or as otherwise required by Law.
Business means the operations of Sellers in respect of the Products, consisting of commercializing, manufacturing, Labeling, packaging, marketing, promoting, storage, selling, distributing and transporting of the Products as conducted, directly or indirectly through third parties, by Sellers; it being understood that (i) the term Business is intended to describe the operations of Sellers in respect of the Products, based on the assets, rights and benefits held and exercised by Sellers, and shall not be understood to enlarge upon such operations and (ii) Sellers only commercialize, sell and distribute the Products, directly or indirectly through third parties, within the United States, with the sole exception of any of the foregoing actions as they relate to Dibenzyline, which are conducted in Australia under a temporary license.
Business Day means any day other than a Saturday, a Sunday or a day on which commercial banks in New York City, Toronto, Ontario, the parish of St. Michael, Barbados or the Grand Duchy of Luxembourg are authorized or obligated by applicable Law or executive order to close.
Business Disclosure shall have the meaning set forth within the definition of Required Information.
Cap shall have the meaning set forth in Section 8.5(b) .
Chargeback Claims shall have the meaning set forth in Section 6.17(c) .
Closing means the closing of the transactions contemplated by this Agreement pursuant to the terms of this Agreement.
Closing Date shall have the meaning set forth in Section 3.1(a) .
Closing Purchase Price shall have the meaning set forth in Section 2.6(a) .
Code means the Internal Revenue Code of 1986, as amended, from time to time.
Commercial Rebates shall have the meaning set forth in Section 6.17(b) .
Commitment Letter shall have the meaning set forth in Section 5.5(a) .
Compliant means, without giving effect to any supplements or updates, (a) the Business Disclosure does not contain any untrue statement of a material fact or omit to state any
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material fact, in each case with respect to the Business or the Sellers in relation to the Business, necessary in order to make such Business Disclosure, in light of the circumstances under which the statements contained in the Business Disclosure were made, not misleading, (b) to the extent that the financial statements and other financial information prepared by the Sellers and included in such Required Information consists of the type of financial information with respect to which independent auditors customarily provide comfort letters, such financial statements and financial information are, and remain throughout the Marketing Period sufficient to permit the Financing Sources (including underwriters, placement agents or initial purchasers) to receive customary comfort letters from Sellers independent auditors with respect to such financial statements and financial information (including customary negative assurance comfort with respect to periods following the end of the latest fiscal year and fiscal quarter for which historical financial statements are included) as contemplated by the definition of Required Information on any date during the Marketing Period.
Confidentiality Agreement means the Confidentiality Agreement between Seller Parent and Purchaser Parent dated June 23, 2014, as amended or supplemented from time to time.
Consideration shall have the meaning set forth in Section 2.6(c) .
Contract means any binding written or oral contract, agreement, commitment, franchise, indenture, lease, license, note, bond or mortgage.
Copyright Rights means all rights, anywhere in the world, in or to published and unpublished works of authorship, whether copyrightable or not (including software, data, databases and other complications of information), copyrights, copyright registrations and applications, and renewals, extensions, restorations and reversions thereof.
Covis Injectables shall have the meaning set forth in the preamble to this Agreement.
Covis Pharma shall have the meaning set forth in the preamble to this Agreement.
CPI means Covis Pharmaceuticals, Inc., a Delaware corporation.
CPI Distribution Contracts means, collectively, (i) the CPI/Covis Pharma Distribution Contract, and (ii) the CPI/Covis Injectables Distribution Contract.
CPI/Covis Pharma Distribution Contract means the Second Amended and restated Supply & Distribution Agreement, between Covis Pharma and CPI, dated as of March 31, 2014.
CPI/Covis Injectables Distribution Contract means the Supply & Distribution Agreement, between Covis Injectables and CPI, dated as of March 31, 2014.
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Credit Facility means the Credit Agreement, dated April 4, 2013, by and among Covis Pharma Holdings S.à.r.l., Covis Holdings L.P., the guarantors party thereto, Credit Suisse AG, Credit Suisse Securities (USA) LLC and Morgan Stanley Senior Funding, Inc.
Definitive Agreements shall have the meaning set forth in Section 6.10(a) .
Disclosure Schedule and Disclosure Schedules mean (i), with respect to Sellers, the disclosure schedules attached hereto and delivered by Sellers pursuant to Article IV and Section 6.2 and that relate to such Sections of this Agreement and (ii), with respect to Purchaser, the disclosure schedules attached hereto delivered by Purchaser pursuant to Article V and that relate to such Sections of this Agreement.
Distribution Activities shall have the meaning set forth in Section 6.9(c) .
Escrow Account means the account established under the Escrow Agreement.
Escrow Agent means the Person mutually selected by the Sellers and Purchaser to serve as escrow agent under the Escrow Agreement.
Escrow Agreement means an escrow agreement, the definitive form of which will be executed and delivered by the applicable parties at Closing on the terms and conditions contemplated by Section 6.21 and Article VIII , and containing such other terms and conditions as mutually agreed to by the Escrow Agent, Sellers and Purchaser.
Escrow Amount [REDACTED]
Escrow Funds means, at any given time, the portion of the Escrow Amount then remaining in the Escrow Account.
Excluded Assets shall have the meaning set forth in Section 23(a) .
Excluded Claim or Excluded Claims shall have the meaning set forth in Section 8.5(a) .
Excluded Contracts means all Contracts other than the Assumed Contracts, including (i) those Contracts listed on Schedule 1.1(a) , (ii) except as provided in Section 6.2(d) in respect of the CPI/Covis Injectables Distribution Contract or as otherwise agreed to by the Parties in writing, those Contracts between a Seller and any of its Affiliates, and (iii) all Contracts related exclusively to Excluded Assets or Retained Liabilities.
Existing Debt means the Credit Facility.
Export and Sanctions Regulations means the relevant sanctions and export control Laws and regulations, including the U.S. International Traffic in Arms Regulations, the Export Administration Regulations, and U.S. sanctions Laws and regulations administered by the Department of the Treasurys Office of Foreign Assets Control.
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FCPA means the U.S. Foreign Corrupt Practices Act of 1977, as amended.
FDA means the U.S. Food and Drug Administration or a successor thereto.
FDCA means the Federal Food, Drug and Cosmetic Act of 1938, as amended.
Final Determination shall have the meaning set forth in Section 8.5(e) .
Financial Statements shall have the meaning set forth in Section 4.13(a) .
Financing shall have the meaning set forth in Section 5.5(a) .
Financing Period shall have the meaning set forth in Section 9.1(f) .
Financing Source shall mean each Person (including each agent and arranger) (other than Purchaser or any of its Affiliates) that has committed to provide the Financing in connection with the transactions contemplated hereby, pursuant to the terms of the Commitment Letter and the fee letter contemplated therein, engagement letters, underwriting or agency agreements, purchase agreements, credit agreements, loan agreements or indentures relating thereto, together with each Affiliate thereof and each Representative (other than its lenders) of each such Person or Affiliate and their respective successors and assigns to the extent permitted pursuant to Section 6.10 .
First Date shall have the meaning set forth in Section 9.1(f) .
[REDACTED]
Fixtures and Equipment means all furniture, furnishings, vehicles, equipment, computers, tools and other tangible personal property (other than Inventory) to the extent Related to the Business, wherever located, including any of the foregoing purchased subject to any conditional sales or title retention agreement in favor of any other Person.
GAAP means United States generally accepted accounting principles consistently applied.
Government Official shall have the meaning set forth in Section 4.7(c) .
Government Rebates shall have the meaning set forth in Section 6.17(b) .
Governmental Authority means any supranational, national, federal, state, commonwealth, province, territory, county or municipality, or judicial, legislative, executive or regulatory authority, or any court, administrative body or other governmental or quasi- governmental entity of any nature including any multinational organization or body, or any instrumentality or subdivision thereof.
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Governmental Authorizations means all licenses, permits, certificates, franchises, consents, clearances and other authorizations and approvals granted or otherwise made available by or under the applicable Laws of any Governmental Authority.
Governmental Order means any order, writ, judgment, injunction, decree, stipulation, determination or award enacted, issued, promulgated, enforced or entered by or with any Governmental Authority.
Health Care Laws means all applicable health care Laws and Governmental Orders, including the federal Anti-Kickback Statute, 42 U.S.C. § 1320a-7b(b), the AntiInducement Law, 42 U.S.C. § 1320a-7a(a)(5), the civil False Claims Act, 31 U.S.C. §§ 3729 et seq., the administrative False Claims Law, 42 U.S.C. § 1320a-7b(a), the Health Insurance Portability and Accountability Act of 1996, 42 U.S.C. §§ 1320d et seq., as amended by the Health Information Technology for Economic and Clinical Health Act, 42 U.S.C. §§ 17921 et seq., the exclusion Laws, 42 U.S.C. § 1320a-7, the FDCA and related FDA regulations, the Public Health Service Act, the Controlled Substances Act, Medicare, Title XVIII of the Social Security Act, and Medicaid, Title XIX of the Social Security Act.
HSR Act means the Hart-Scott-Rodino Antitrust Improvements Act of 1976, as amended.
IFRS means the International Financial Reporting Standards, as developed and issued by the International Accounting Standards Board, as utilized in preparing Purchaser Parents Annual Information Form for the year ended December 31, 2014.
IND means an Investigational New Drug Application pursuant to 21 C.F.R. Part 312.
Indemnified Party shall have the meaning set forth in Section 8.3(a) .
Indemnifying Party shall have the meaning set forth in Section 8.3(a) .
[REDACTED]
Indemnity Threshold shall have the meaning set forth in Section 8.5(a) .
Independent Accountant shall have the meaning set forth in Section 2.6(c) .
Intellectual Property means all rights anywhere in the world in or to: (i) Copyright Rights, (ii) Patent Rights, (iii) Trademark Rights, (iv) Trade Secret Rights and (v) all other intellectual property or similar rights.
Intellectual Property Assignment Agreement means an intellectual property assignment agreement, the definitive form of which will be executed and delivered by each of the Sellers at Closing, containing such reasonable and customary terms and conditions as mutually agreed to by Sellers and Purchaser, in connection with the assignment by Sellers to Purchaser of all right, title and interest to, in and under the Purchased Intellectual Property in accordance with and subject to the terms of this Agreement.
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Intellectual Property Licenses means the Contracts set forth on Schedule 1.1(b) .
Intracompany Payables means all account, note or loan payables recorded on the books of Seller or any Affiliate for goods or services purchased by or provided to the Business, or advances (cash or otherwise) or any other extensions of credit to the Business from Seller or any Affiliate, including amounts recorded on the Financial Statements as due to Parent, whether current or non-current.
Intracompany Receivables means all account, note or loan receivables recorded on the books of the Sellers or any of their respective Affiliates for goods or services sold or provided by the Business to any of the Sellers or any of their respective Affiliates or advances (cash or otherwise) or any other extensions of credit made by the Business to any of the Sellers or any of their respective Affiliates, including amounts recorded on the Financial Statements as due from Parent, whether current or non-current.
Inventory means (a) all raw materials, active pharmaceutical ingredients, excipients, intermediaries, reagents, supplies, packaging, work in progress and finished goods owned by Sellers and (b) finished goods of the Business, whether imported, procured from contract manufacturers, or otherwise, that are located at or in transit to third-party distribution sites or from such sites in transit to Sellers, in each case, as of the Closing Date and that are Related to the Business; provided that, Inventory shall not include authorized generic products that were sold to distributors prior to the Closing pursuant to the AG Distribution Contracts.
Knowledge of Purchaser means the actual knowledge, together with the knowledge that such individuals would have had after reasonable inquiry and investigation in the ordinary course within the scope of their respective employment and responsibility, of any of the individuals listed on Schedule 1.1(d) .
Knowledge of Sellers means the actual knowledge, together with the knowledge that such individuals would have had after reasonable inquiry and investigation in the ordinary course within the scope of their respective employment and responsibility, of any of the individuals listed on Schedule 1.1(e) .
Labeling (and the correlative terms Label and Labeled ) shall be as defined in Section 201(m) of the FDCA (21 U.S.C. § 321(m)) and other comparable foreign Law relating to the subject matter thereof, including the applicable Products label, packaging and package inserts accompanying such Product, and any other written, printed, or graphic materials accompanying such Product, including patient instructions or patient indication guides.
Laws means any federal, state, foreign or local law, common law, statute, ordinance, rule, regulation, code, Governmental Order or other requirements of similar effect of any Governmental Authority.
Liabilities means any and all Losses, debts, liabilities, commitments and obligations of any kind, whether accrued or unaccrued, fixed, asserted or not asserted, known or unknown, absolute or contingent, liquidated or unliquidated, matured or unmatured, determined, determinable or otherwise, whenever or however arising (including those arising under any Law, those arising under any Contract, instrument, permit, franchise or undertaking and those arising
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as a result of any action or omission) and whether or not required by GAAP to be reflected in financial statements or disclosed in the notes thereto.
Licensed Intellectual Property shall have the meaning set forth in Section 4.9(a) .
Licensed Know-How shall mean all Trade Secret Rights that are (a) owned or licensable by any of Sellers immediately after the Closing and (b) used in or necessary for the conduct of the Business.
Liens means any lien, pledge, security interest, hypothecation, pledge, option, mortgage, license, lease, easement, covenant, deed of trust, right of first refusal, conditional sale agreement, title retention agreement, transfer restriction, defect of (or restriction on) title or other claim, charge or encumbrance of any nature whatsoever, including any restriction on the use, voting, receipt of income or other exercise of any attributes of ownership.
Loss or Losses means all claims, losses, Liabilities, damages, actions, causes of action, awards, proceedings, payments, judgments, settlements, assessments, deficiencies, Taxes, interest, penalties, costs and expenses, including reasonable attorneys fees and disbursements, provided , that for purposes of computing Losses imposed on, incurred by or asserted against such Purchaser Indemnified Party or Seller Indemnified Party, as applicable, there shall be deducted an amount equal to the amount of any insurance proceeds, indemnification payments, contribution payments and reimbursements actually received by such Purchaser Indemnified Party or Seller Indemnified Party, as applicable, in connection with the Losses or the circumstances giving rise thereto.
Marketing Period means the first period of fifteen (15) consecutive Business Days commencing on or after April 10, 2015 plus the three (3) consecutive Business Days thereafter throughout which and on the first and last day of which (a) Sellers shall have provided the Purchaser with the Required Information (provided that if Sellers shall in good faith reasonably believe they have provided the Required Information, Sellers may deliver to Purchaser a written notice to that effect (stating when they believe they completed such delivery), in which case the Sellers shall be deemed to have provided the Required Information on the date specified in the notice (which date shall not be earlier than the date of such notice) unless Purchaser in good faith reasonably believes the Sellers have not completed the delivery of the Required Information and not later than 5:00 p.m. (Eastern Time) two (2) Business Days following the date of the delivery of such notice by Sellers delivers a written notice to the Sellers to that effect (stating which Required Information has not been delivered)) and (b) the conditions set forth in Section 7.1 shall have been satisfied or waived. Notwithstanding the foregoing, the Marketing Period shall not commence and shall be deemed not to have commenced if, on or prior to the completion of such fifteen (15) consecutive Business Day period Sellers independent registered accounting firm shall have withdrawn its authorization letter or audit opinion with respect to any financial statements contained in the Required Information, in which case the Marketing Period shall not be deemed to commence until the time at which, as applicable, a new authorization letter or audit opinion (in a form customary for carve-out financial statements) is issued with respect to the financial statements for the applicable periods by Sellers independent registered accounting firm or another independent registered accounting
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firm reasonably acceptable to Purchaser. If the Required Information is not Compliant throughout and on the first and the last day of such period, then a new fifteen (15) consecutive Business Day period shall commence upon Purchaser receiving updated Required Information that is Compliant.
Material Adverse Effect means any event, state of facts, occurrence, circumstance, development or change that, individually or in combination with any other event, state of facts, occurrence, circumstance, development or change, is or would reasonably be expected to have a materially adverse effect on the business, results of operations or financial condition of the Business, taken as a whole, other than states of fact, occurrences, circumstances, developments or changes to the extent resulting from the following: (a) changes or effects that are generally applicable in the economy (including changes in interest or exchange rates) of any country in which the Business has substantial operations, or in the securities, syndicated loan, credit or financial markets of any such country; (b) changes in political or economic conditions affecting the Business in general; (c) changes in GAAP or applicable Law; (d) changes or effects that arise out of or are attributable to the commencement, occurrence, continuation or intensification or reduction or cessation of any war (whether or not declared), sabotage, armed hostilities or acts of terrorism; (e) changes or effects that arise out of or are attributable to earthquakes, hurricanes or other natural disasters, epidemics or other outbreaks of disease; (f) changes or effects that relate to any failure by a Seller to meet internal projections or forecasts for any period (including with respect to the Business); provided , that the exclusion from the definition of Material Adverse Effect set forth in this clause (f), shall not preclude the determination that any event, state of facts, occurrence, circumstance, development or change underlying any such failure has contributed to or would reasonably be expected to have a Material Adverse Effect; (g) changes or effects that arise out of or are attributable to market conditions with respect to the Products, including pricing dynamics, sales results, the availability of generic alternatives or alternative therapies and treatments or the availability of Patent Rights; (h) changes or effects that arise out of the execution or public announcement of this Agreement, including such changes or effects on relationships, contractual or otherwise, with customers, suppliers, manufacturers, distributors, partners or employees, proximately caused thereby; provided , that the exclusion from the definition of Material Adverse Effect set forth in this clause (h) shall not preclude the determination that any such change or effect that is also a breach of any representations, warranties or covenants the purpose of which is to address such changes or events has contributed to or would reasonably be expected to have a Material Adverse Effect; (i) any action taken by a Seller as expressly required by this Agreement or with Purchasers written consent; or (j) changes or effects that arise out of or are attributable to the Excluded Assets or Retained Liabilities (including but not limited to the commencement or material development of any Proceeding with respect to the Excluded Assets or Retained Liabilities; provided , however , that any event, state of facts, occurrence, circumstance, development or change set forth in the foregoing clauses (a), (b), (c), (d), (e) and (g) shall be taken into account in determining whether a Material Adverse Effect has occurred, or would reasonably be expected to occur, if such event, state of facts, occurrence, circumstance, development or change has a disproportionate adverse effect on the business, results of operations or condition (financial or otherwise) of the Business, taken as a whole, relative to other Persons engaged in similarly situated businesses to the Business, in the industries in which the Business operates.
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NDA means any new drug application filed pursuant to the requirements of the FDA, as more fully defined in 21 C.F.R. Part 314 et seq., and any foreign equivalent application filed with any Governmental Authority.
NDC Number . means the unique identifying number assigned to a drug product, including the labeler code, product code and package code, in connection with the drug listing requirements of Section 510(j) of the FDCA and applicable FDA rules and regulations.
Non-assignable Asset Event shall have the meaning set forth in Section 2.2 .
Non-Responsible Party shall have the meaning set forth in Section 6.17(d)(i) .
Notice Period shall have the meaning set forth in Section 8.3(a) .
Offering Documentation shall have the meaning set forth in Section 6.10(d) .
Outside Date shall have the meaning set forth in Section 9.1(b) .
Party means Purchaser and each Seller, Covis Pharma and Covis Injectables.
Patent Rights means all rights, anywhere in the world, in or to patents and patent applications, together with any extensions, supplemental protection certificates, reexaminations, reissues, renewals, divisions and continuations and foreign counterparts claiming priority to any of the foregoing.
Permitted Encumbrances means (i) statutory Liens arising by operation of Law with respect to a Liability incurred in the ordinary course of business consistent with past practices and which is not delinquent; (ii) Liens for Taxes not yet due or payable or that are being contested in good faith by appropriate proceedings and for which appropriate reserves have been established in the Financial Statements; (iii) mechanics, materialmens, carriers, workmens, warehousemens, repairmens, landlords or other like Liens and security obligations that are incurred in the ordinary course of business and are not delinquent; and (iv) Liens that will be released and, as appropriate, removed of record, at or prior to the Closing Date in accordance with the terms of this Agreement.
Person means an individual, a limited liability company, joint venture, a corporation, a partnership, an association, a trust, a division or operating group of any of the foregoing or any other entity or organization.
Post-Closing Tax Period means any Tax period (or portion thereof) beginning after the Closing Date.
Pre-Closing Tax Period means any Tax period (or portion thereof) ending on or before the Closing Date.
Proceeding shall have the meaning set forth in Section 10.10(b) .
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Product Registrations means all Governmental Authorizations (including NDAs and INDs) and comparable regulatory filings granted to Sellers by, or applications therefor pending with, any Governmental Authority (including applications that are in the process of being prepared by Sellers) required to manufacture, commercialize, develop, package, Label, store, use, market, import, export, distribute and/or sell any of the Products.
Products means the products listed on Schedule 1.1(f) .
Promotional Materials means, collectively, all marketing materials, marketing research data, customer and sales information, product literature, promotional materials and data, advertising and display materials (including all underlying designs, samples, charts, diagrams, photos and electronic files related to the foregoing) and all training materials, in each case in whatever form or medium (e.g., audio, visual, digital or print), to the extent Related to the Business and that are in Sellers physical possession or under its control or that are located at or in transit to or from third-party distribution sites, in each case, as of the Closing Date.
Property Taxes shall have the meaning set forth in Section 10.8(b) .
Purchase Price shall have the meaning set forth in Section 2.6(a) .
Purchased Assets shall have the meaning set forth in Section 2.1(a) ; it being understood that the Purchased Assets do not include the Excluded Assets.
Purchased Intellectual Property means all Intellectual Property owned by any of the Sellers that is Related to the Business, including the Intellectual Property set forth on Schedule 4.9(a) of the Disclosure Schedules.
Purchaser has the meaning set forth in the preamble to this Agreement.
Purchaser Indemnified Parties shall have the meaning set forth in Section 8.1(a) .
Purchaser Parent shall have the meaning set forth in the preamble to this Agreement.
Purchasers Fundamental Representations shall have the meaning set forth in Section 7.3(a) .
Purchaser Termination Fee shall have the meaning set forth in Section 9.3(a) .
Rebates shall have the meaning set forth in Section 6.17(b) .
Rebate Tail Period shall have the meaning set forth in Section 6.17(b)(i) .
Registered means issued by, registered with, renewed by or the subject of a pending application before any Governmental Authority or Internet domain name registrar.
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Registered Intellectual Property shall have the meaning set forth in Section 4.9(a) .
Registration Information means any and all original Product Registrations, together with all Regulatory Documentation.
Regulatory Documentation means (a) all regulatory filings and supporting documents (including copies of all correspondence between any of Sellers and the applicable Governmental Authority), chemistry, manufacturing and controls data and documentation, preclinical and clinical studies and tests, (b) the NDA and all regulatory files and foreign equivalents related thereto, current approved packaging and any other existing files and dossiers, including the underlying data or information used to support, maintain or obtain marketing authorization of the underlying Product, (c) all records maintained under record keeping or reporting Laws of the FDA or any other Governmental Authority including all IND applications, IND annual and safety reports, drug master files, FDA warning letters, FDA notices of adverse finding letters, FDA audit reports (including any responses to such reports), any correspondence with the Office of Prescription Drug Promotion, periodic safety update reports, complaint files, and annual product quality reviews, (d) the complete complaint, adverse event and medical inquiry filings with respect to the Products as required by applicable Laws and Related to the Business, including the Product Registrations and (e) all equivalent, comparable or analogous documentation with respect to any other country outside the United States.
Related to the Business means required for or used primarily in connection with the Business as conducted by the Sellers.
Representatives means, with respect to any Person, the directors, officers, managers, employees, attorneys, accountants, representatives, financial advisors, lenders, agents or consultants of such Person.
Required Information means, as of any date:
(i) (1) the audited carve-out financial statements of Sellers related to the Business, prepared in accordance with GAAP, which shall be comprised of (A) a consolidated statement of comprehensive income, a consolidated statement of changes in equity and a consolidated statement of cash flows in respect of Sellers fiscal years ended December 31, 2014 and December 31, 2013 and (B) a consolidated statement of financial position or balance sheet as at December 31, 2014 and December 31, 2013;
(2) if the Closing Date does not occur before May 15, 2015, unaudited interim carve-out financial statements of Sellers related to the Business, prepared in accordance with GAAP, which shall be comprised of a (A) consolidated statement of comprehensive income, a consolidated statement of changes in equity and a consolidated statement of cash flows for each fiscal quarter following December 31, 2014 ended at least forty-five (45) days prior to the Closing Date and the comparable fiscal quarter(s) in the preceding fiscal year and (B) consolidated statement of financial position or balance sheet as of the end of the most recent fiscal quarter following December 31, 2014 that ended at least forty-five (45) days prior to the Closing Date and the comparable fiscal quarter in the preceding fiscal year (which shall have
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been reviewed by the independent auditors for the Sellers as provided in the procedures specified by the American Institute of Certified Public Accountants AU-C Section 930);
(3) customary draft consent letters of the independent auditors of Sellers (which shall be addressed to the Canadian securities regulatory authorities), in form and substance consistent with Canadian securities Law and as are required in connection with the use of a short form prospectus for an offering of equity securities in accordance with Canadian securities Law that can be provided in customary final form on the filing date of a short-form final prospectus of Purchaser and/or Purchaser Parent);
(ii) information regarding the Business that would customarily be included in information memoranda and prospectuses for securities offerings and syndication materials for revolving and term loan facilities similar to those contemplated in the Financing (including any equity financing), consisting solely of (x) Sellers managements discussion and analysis of financial performance for Sellers fiscal years ended December 31, 2014 and December 31, 2013 and, if applicable, for each fiscal quarter following December 31, 2014 ended at least forty-five (45) days prior to the Closing Date and the comparable fiscal quarter(s) in the preceding fiscal year), (y) Sellers description of the Business (the information referred to in clauses (ii)(x) and (ii)(y), the Business Disclosure) and (z) such financial information of the Business for the fiscal years ended December 31, 2014 and December 31, 2013 (or, if applicable, the fiscal quarter(s) following December 31, 2014) as is necessary for Purchaser to prepare such pro forma financial statements as are required by Canadian securities Law to be included in any prospectus used in the Financing (including any equity financing) (including information as reasonably required to prepare pro forma financial information in accordance with IFRS); and
(iii) draft comfort letters in customary form to be provided by the independent auditors of Sellers solely in respect of the financial information set forth in the financial statements referred to in clauses (i)(1) and (i)(2) and financial information contained in clause (ii) above (including customary negative assurance comfort; provided, that, for the avoidance of doubt, such comfort letters and negative assurance comfort shall only be required in respect of financial information to the extent it consists of the type of financial information with respect to which independent auditors customarily provide comfort or negative assurance comfort, as applicable) as of the commencement of the Marketing Period that can be provided in customary final form on any date during the Marketing Period (provided, however, that such comfort letters shall be provided in final form prior to the filing of any short-form final prospectus or the pricing of any offering related to the Financing (including any equity financing) by Purchaser and/or any of its Affiliates and a customary bring-down comfort letter shall be provided by the independent auditors of Sellers at the closing of such short-form prospectus offering or the Financing).
Responsible Party shall have the meaning set forth in Section 6.17(d)(i) .
Retained Liabilities shall have the meaning set forth in Section 2.5 .
Retained Products means the products set forth on Schedule 1.1(g) .
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[REDACTED]
Seller and Sellers has the meaning set forth in the preamble to this Agreement.
Seller Indemnified Parties shall have the meaning set forth in Section 8.2(a) .
Seller-Labeled Products shall have the meaning set forth in Section 6.8(a) .
Seller Parent shall have the meaning set forth in the preamble to this Agreement.
Sellers Fundamental Representations shall have the meaning set forth in Section 7.2(a) .
Shared Contracts means any Contract that relates both to the Business and to the Retained Products including those set forth in Section 4.12(a)(i) of the Sellers Disclosure Schedule.
Solvent , when used with respect to any Person, means that, as of any date of determination, on a consolidated basis, (a) the amount of the fair saleable value of the assets of such Person on a going concern basis will, as of such date, exceed (i) the value of all liabilities of such Person, including contingent and other liabilities as of such date, as such quoted terms are generally determined in accordance with applicable United States federal laws governing determinations of the insolvency of debtors and (ii) the amount that will be required to pay the probable liabilities of such Person on its existing debts (including contingent liabilities) as such debts become absolute and matured, (b) such Person will not have, as of such date, an unreasonably small amount of capital for the operation of the businesses in which it is engaged or proposed to be engaged following such date and (c) such Person will be able to pay its liabilities, including contingent and other liabilities, as they mature. For purposes of this definition, each of the phrases not have an unreasonably small amount of capital for the operation of the businesses in which it is engaged or proposed to be engaged and able to pay its liabilities, including contingent and other liabilities, as they mature means that such Person will be able to generate enough cash from operations, asset dispositions or refinancing, or a combination thereof, to meet its obligations as they become due.
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Specified Termination shall have the meaning set forth in Section 9.3(a) .
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Subsidiary means, with respect to any Person, any corporation or other organization, whether incorporated or unincorporated, (a) of which such Person or any other Subsidiary of such Person is a general partner (excluding partnerships, the general partnership interests of which held by such Person or any Subsidiary of such Person do not have a majority of the voting interests in such partnership), or (b) of which such Person (or one or more of such Persons Subsidiaries, or such Person together with one or more of such Persons Subsidiaries) holds or controls at least a majority of the securities or other interests that have by their terms ordinary voting power to elect a majority of the board of directors or others performing similar functions with respect to such corporation or other organization.
Tax or Taxes means all domestic or foreign, federal, state, county, local, provincial, territorial or municipal taxes, levies, duties, assessments, deductions, withholdings or other similar charges, including income, excise, property, sales or use, value added, ad valorem, goods and services, service, gross receipts, business, escheat, profits, license, payroll, employment, unemployment, severance, net worth, capital gains, transfer, stamp, customs, social security, environmental, occupation and franchise taxes, imposed by any Taxing Authority, and including any interest, penalties and additions attributable thereto, and any obligation to pay any such amounts as a result of transferee or successor liability, or as a result of being a member of an affiliated, consolidated, combined or unitary group.
Tax Indemnification means any claim for indemnification in respect of any Retained Liability described in Section 2.5(f) , any breach of any representation or warranty contained in Section 4.11 ( Taxes ), any breach of covenant contained in Section 6.5 or any Transfer Taxes for which Sellers are responsible pursuant to Section 10.8(a) .
Tax Return or Tax Returns means any return, report, declaration, information return, statement or other document filed or required to be filed with any Taxing Authority, in connection with the determination, assessment or collection of any Tax or the administration of any Laws relating to any Tax.
Taxing Authority means any Governmental Authority, body or instrumentality exercising any authority to impose, regulate or administer the imposition of Taxes.
Third-Party Claim shall have the meaning set forth in Section 8.3(a) .
Third Party Consents means the consents and approvals set forth on Schedule 4.3 of the Sellers Disclosure Schedule subject to the provisions of Section 6.4 .
Trade Secret Rights means all rights, anywhere in the world, in or to trade secrets, inventions, discoveries, formulae, know-how, ideas, processes, designs, data, databases and other proprietary information, in each case, whether or not patentable or copyrightable.
Trademark Rights means all rights, anywhere in the world, in or to trademarks, service marks, brand names, certification marks, collective marks, d/b/as, Internet domain names, logos, symbols, trade dress, trade names, and other indicia of origin, all registrations and applications for any of the foregoing, including extensions, modifications, divisions or renewals of such registrations or applications, and including the goodwill associated with or symbolized by any of the foregoing.
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Transfer Taxes means any sales, use, transfer, value added, conveyance, documentary transfer, stamp, recording, registration or other similar Tax (including any notarial fee) imposed in connection with, or otherwise relating to, the transactions contemplated by this Agreement or the recording of any sale, transfer or assignment of property (or any interest therein) effected pursuant to this Agreement.
Transition Lots means those lots of a Product for which Product was partially sold prior to the Closing and partially sold on or following the Closing.
Transition Services Agreement means a transition services agreement for which a summary of principal terms is set forth on Exhibit C hereto, the definitive form of which will be executed and delivered by the applicable parties at Closing on the terms and conditions set forth in such Exhibit and containing such other terms and conditions as are mutually agreed to by the Sellers and Purchaser.
Section 1.2. Other Definitional Provisions . (a) The words hereof, herein, hereto and hereunder and words of similar import, when used in this Agreement, shall refer to this Agreement as a whole and not to any particular provision of this Agreement.
(b) The terms defined in the singular shall have a comparable meaning when used in the plural, and vice versa.
(c) The terms dollars and $ shall mean United States of America dollars.
(d) The term including shall mean including, without limitation.
(e) When a reference is made in this Agreement to an Article, a Section, an Exhibit or a Schedule, such reference shall be to an Article of, a Section of, an Exhibit to or a Schedule to, this Agreement unless otherwise indicated.
ARTICLE II
PURCHASE AND SALE
Section 2.1. Purchase and Sale of Assets .
(a) Upon the terms and subject to the conditions set forth herein and subject to Section 2.2 , at the Closing, Sellers shall sell, convey, assign, transfer and deliver to Purchaser, and Purchaser shall purchase, acquire and accept from Sellers, free and clear of all Liens, other than Permitted Encumbrances, all of Sellers right, title and interest, as of the Closing, in, to and under the assets of Sellers Related to the Business, whether tangible or intangible, real, personal or mixed, other than the Excluded Assets (the Purchased Assets ), including all of such right, title and interest in and to the following (whether or not subsumed within the foregoing):
(i) all rights, benefits and interests under the Assumed Contracts and the Shared Contracts;
(ii) all Purchased Intellectual Property;
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(iii) all Product Registrations and the Registration Information (including applications that are in the process of being prepared by Sellers for Product Registrations);
(iv) to the extent their transfer is permitted by Law, all Governmental Authorizations (and all applications therefor) to the extent Related to the Business;
(v) all Inventory, including all rights of Sellers to quantities of Product pursuant to the CPI Distribution Contracts as of the Closing ( it being understood that no adjustment or additional purchase notice shall be payable by Purchaser therefor);
(vi) Books and Records;
(vii) all causes of action, lawsuits, judgments, claims, demands and legal privileges of any nature available to or being pursued by or on behalf of either Seller to the extent related to other Purchased Assets enumerated in this Section 2.1 (a) , whether arising by way of counterclaim or otherwise;
(viii) all goodwill and going concern value to the extent Related to the Business;
(ix) all credits, prepaid expenses, deferred charges, advance payments, refunds, rights of set-off, rights of recovery, security deposits, prepaid items and duties to the extent related to other Purchased Assets enumerated in this Section 2.1(a) ;
(x) all guaranties, express or implied warranties, indemnities and similar rights in favor of a Seller to the extent Related to the Business;
(xi) an electronic copy of all of the materials in the electronic dataroom Related to the Business on compact disc media;
(xii) all refunds for Taxes relating to the Purchased Assets or Related to the Business, in each case with respect to a Post-Closing Tax Period; and
(xiii) all rights that accrue to Purchaser under this Agreement and the Ancillary Agreements.
(b) After the Closing Date, Sellers shall take all actions reasonably requested by Purchaser to effect the provisions of this Section 2.1 .
Section 2.2. Non-assignable Assets . To the extent that the sale, assignment, sublease, transfer, conveyance or delivery or attempted sale, assignment, sublease, transfer, conveyance or delivery to Purchaser of any asset that would be a Purchased Asset or any claim or right or any benefit arising thereunder or resulting therefrom is prohibited by any applicable Law or would require any Governmental Authorizations or third-party authorizations or other approvals, consents or waivers, and such authorizations, approvals, consents or waivers shall not have been obtained prior to the Closing, the Closing shall proceed without the sale, assignment, sublease, transfer, conveyance or delivery of such asset, unless such failure causes or would be reasonably likely to cause (assuming compliance with applicable Law and rights of third parties)
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a net negative impact on the consolidated annual revenues of the Business (excluding all revenues attributable to any of the Contracts set forth as items 3, 4, 9, 10, 11, 13, 14, 20 of Section 4.3(ii) of the Sellers Disclosure Schedules) in excess of 10% as measured against the consolidated revenues of the Business (excluding all revenues attributable to any of the Contracts set forth as items 3, 4, 9, 10, 11, 13, 14, 20 of Section 4.3(ii) of the Sellers Disclosure Schedules) (the Non-assignable Asset Event ), taken as a whole, for fiscal year 2014 contained in the financial statements for Sellers included in the Required Information, in which event the Closing shall proceed only if the Non-assignable Asset Event is cured prior to the Outside Date, including by enforcement of any rights on behalf of Purchaser, and/or by entry into suitable arrangements (including subleasing, sublicensing or subcontracting) to provide to Purchaser the economic (taking into account Tax costs and benefits) and operational equivalent (for the duration or useful life of such asset) prior to the Closing. In the event that the Closing proceeds without the transfer, sublease or assignment of any such asset, then following the Closing, the parties shall use their respective commercially reasonable best efforts, and cooperate with each other, to obtain promptly such authorizations, approvals, consents or waivers to effectuate the sale, assignment, sublease, transfer, conveyance or delivery of any asset that is not sold, assigned, subleased, transferred, conveyed or delivered at the Closing. Pending such third-party authorization, approval, consent or waiver, the parties shall cooperate with each other in any mutually agreeable, reasonable and lawful arrangements designed to provide to Purchaser the benefits of use of such asset and the benefits, including any indemnities, that it would have obtained had the asset been conveyed at the Closing. Once authorization, approval, consent or waiver for the sale, assignment, sublease, transfer, conveyance or delivery of any such asset not sold, assigned, subleased, transferred, conveyed or delivered at the Closing is obtained, Sellers shall assign, transfer, convey and deliver such asset to Purchaser at no additional cost. To the extent that any such asset cannot be transferred or the full benefits of use of any such asset cannot be provided to Purchaser following the Closing pursuant to this Section 2.2 , then Purchaser and Sellers shall enter into such arrangements (including subleasing, sublicensing or subcontracting) to provide to the parties the economic (taking into account Tax costs and benefits) and operational equivalent (for the duration or useful life of such asset had it been transferred at the Closing) of obtaining such authorization, approval, consent or waiver and the performance by Purchaser of the obligations thereunder. Sellers shall hold in trust for and pay to Purchaser promptly upon receipt thereof, all income, proceeds and other monies received by Sellers in connection with its use of any asset (net of any Taxes and any other costs imposed upon Sellers) in connection with the arrangements under this Section 2.2 . In no event shall either Seller or Purchaser or any of their respective Affiliates be required to pay any consideration to any third parties or give anything of value to obtain any such third partys authorization, approval, consent or waiver to effectuate the sale, assignment, sublease, transfer, conveyance of delivery of any such asset pursuant to the foregoing, other than filing, recordation or similar fees which shall be shared equally by Sellers and Purchaser.
Section 2.3. Excluded Assets . (a) Nothing herein contained shall be deemed to sell, transfer, assign or convey the Excluded Assets to Purchaser, and the applicable Seller shall retain all right, title and interest to, in and under the Excluded Assets. Excluded Assets means any right, title or interest in, to or under any of the following assets:
(i) the Retained Products;
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(ii) the Excluded Contracts;
(iii) any Intellectual Property of Sellers other than (A) the Purchased Intellectual Property, (B) Sellers rights in or to Licensed Intellectual Property and (C) the licenses granted to Purchaser pursuant to Section 6.8 or Section 6.18 of this Agreement;
(iv) all cash and cash equivalents, bank deposits or similar cash items and Accounts Receivable;
(v) all insurance policies and rights thereunder;
(vi) the Fixtures and Equipment;
(vii) all software and information technology systems;
(viii) all insurance proceeds that Sellers have a right to receive as of the Closing that relate to events, circumstances or occurrences prior to the Closing;
(ix) all Tax Returns and financial statements of a Seller and all records (including working papers) related thereto;
(x) all refunds for Taxes other than those described in Section 2.1(a)(xii) ;
(xi) all telephone or facsimile numbers and all rights to receive mail and other communications addressed to Sellers;
(xii) all credits, prepaid expenses, deferred charges, advance payments, refunds, rights of set-off, rights of recovery, security deposits, prepaid items and duties except to the extent such credit or other item is a Purchased Asset;
(xiii) all Intracompany Receivables;
(xiv) the capital stock of, membership interests in and other equity or ownership interests in each Seller;
(xv) all rights in respect of real property, including leasehold interests; and
(xvi) all rights that accrue to Sellers under this Agreement and the Ancillary Agreements.
(b) After the Closing Date, Purchaser shall take all actions (or shall cause its Affiliates to take all actions) reasonably requested by either Seller to effect the provisions of this Section 2.3 , including the return of any Excluded Assets.
Section 2.4. Assumption of Liabilities . Upon the terms and subject to the conditions of this Agreement, Purchaser agrees, effective at the Closing, to assume, satisfy and discharge when due the Assumed Liabilities. Purchaser will not assume or have any responsibility of any nature with respect to any Liability that is not an Assumed Liability. For
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the purposes of this Agreement, the term Assumed Liability excludes the Retained Liabilities and means only the following:
(i) all Liabilities to the extent arising out of or resulting from the operation or ownership of the Business, the Products or the Purchased Assets from and after the Closing, including Liabilities in respect of returns, rebates and chargebacks of Products from and after the Closing Date (but not including any Liabilities arising out of or relating to any Product sold prior to the Closing Date, except as expressly provided in clauses (iv) and (v) below);
(ii) all Liabilities for Taxes relating to the Purchased Assets or Related to the Business, in each case with respect to a Post-Closing Tax Period allocated in accordance with Section 10.8(b) ;
(iii) all Liabilities for (A) payment of the purchase price in respect of Inventory ordered in the ordinary course of business that remains unpaid for reasons other than delay or delinquency on normal payment terms as of the Closing and (B) materials and services, to the extent Related to the Business, contracted for in the ordinary course of business consistent with past practice prior to the Closing, but scheduled to be delivered or provided thereafter;
(iv) all Liabilities to customers under purchase orders for Products with respect to which payment has not yet been made and which is not an Excluded Asset and that have not yet been shipped at Closing;
(v) all Liabilities of the Business under Assumed Contracts, other than any Liability arising out of, or resulting from, Liabilities incurred, or any event, state of facts, occurrence, circumstance, development or change that arose or existed, at or prior to the Closing (other than the Liabilities described in clause (iii) and clause (iv) above); and
(vi) all Liabilities arising pursuant to Section 14.1 of the CPI Distribution Contracts with respect to the purchase of Products following the termination of the CPI Distribution Contracts, but only to the extent the Inventory is of a quality and quantity useable and saleable in the ordinary course of business.
Section 2.5. Retained Liabilities . Notwithstanding any provision in this Agreement, Sellers shall retain and be responsible for all Liabilities of Sellers other than the Assumed Liabilities (the Retained Liabilities ), including the following (whether or not subsumed within the foregoing):
(a) all Liabilities to the extent related to the Excluded Assets;
(b) all Liabilities arising out of or resulting from the operation or ownership of the Business, the Products or the Purchased Assets prior to the Closing, including Liabilities in respect of returns, rebates and chargebacks of Products as further provided in this Agreement, but excluding the Assumed Liabilities referred to in Section 2.4(iv) and (v) ;
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(c) all Liabilities in respect of any Proceeding (whether class, individual or otherwise in nature, in law or in equity) arising out of or to the extent relating to or otherwise in any way relating to the Business, the Products or the Purchased Assets or the ownership or operation thereof prior to the Closing;
(d) all Liabilities for materials and services Related to the Business, the Products or the Purchased Assets that were delivered or provided to a Seller prior to Closing;
(e) all Liabilities arising out of the employment or other services or termination of such employment or services of any Person at any time, including all Liabilities related to any compensation and benefit plans, programs, agreements and arrangements sponsored or maintained by any Seller or any of their respective Affiliates and any severance benefits (including statutory severance and benefits related to any acquired rights or similar protections under applicable Law), retention benefits, change in control benefits and any other bonus or incentives;
(f) all Liabilities for Taxes other than those described in Section 2.4(ii) ;
(g) all Liabilities arising pursuant to the CPI Distribution Contracts, including as a result of the termination of the CPI Distribution Contracts;
(h) all Intracompany Payables;
(i) [REDACTED]
(j) all Liabilities relating to or arising from authorized generic products that were sold to distributors prior to the Closing pursuant to the AG Distribution Contracts; and
(k) any Liabilities under any Purchased Asset or portion of a Purchased Asset which is not assigned to Purchaser except to the extent the full benefits of such Purchased Asset or portion thereof are provided to Purchaser.
Section 2.6. Purchase Price .
(a) On the terms and subject to the conditions set forth herein, in consideration of the sale and transfer of the Purchased Assets, at the Closing, in addition to the assumption of the Assumed Liabilities, Purchaser shall pay (i) to an account designated in writing by the Escrow Agent not less than two (2) Business Days prior to the Closing, an amount in cash equal to the Escrow Amount and (ii) to the account(s) designated in writing by Sellers not less than two (2) Business Days prior to the Closing, an amount in cash equal to $1,200,000,000 less the Escrow Amount (the Closing Purchase Price and together with the Escrow Amount, the Purchase Price ). The Purchase Price shall be paid in immediately available funds by wire transfer, the wire instructions for which shall be specified in written instructions given by Sellers to Purchaser not less than two (2) Business Days prior to the Closing.
(b) To the extent that Purchaser is required under any provision of Law to deduct and withhold Taxes on any payment hereunder, Purchaser shall withhold and deduct from
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the Purchase Price such required amounts and such withheld amounts shall be treated for all purposes of this Agreement as having been paid to the Persons in respect of which such deductions and withholdings were made; provided , however , that Purchaser may deduct such amounts only if Purchaser shall (i) give Sellers reasonable advance notice of the intention to make such deduction or withholding; (ii) explain the basis for such deduction or withholding, and (iii) cooperate with Sellers to the extent reasonably requested to obtain any applicable reduction of or relief from such deduction or withholding.
(c) The Parties to this Agreement agree that the amount of the total consideration transferred by Purchaser to Sellers pursuant to this Agreement (the Consideration ) and the allocation of the Consideration in accordance with the fair market value of the assets and Liabilities transferred shall be proposed by Purchaser prior to or within ninety (90) days following the Closing. Purchaser shall deliver to Sellers a copy of such allocation promptly after its determination of the proposed allocation, and Sellers shall have the right to review and raise any objections in writing to the proposed allocation during the ten (10) day period after Sellers receipt thereof. If Sellers do not notify Purchaser of a disagreement with the proposed allocation during such ten (10) day period, the proposed allocation shall become final. If Sellers disagree with respect to any item in the allocation, the Parties shall negotiate in good faith to resolve the dispute. If the Parties are unable to agree on the allocation within thirty (30) days after the commencement of such good faith negotiations (or such longer period as Sellers and Purchaser may mutually agree in writing), then the parties shall refer such dispute to an independent internationally recognized accounting firm ( Independent Accountant ) at that time to review the allocation, and make a determination as to the resolution of such allocation. The determination of the Independent Accountant regarding the allocation shall be delivered as soon as practicable following engagement of the Independent Accountant, but in no event more than sixty (60) days thereafter, and shall be final, conclusive and binding upon Sellers and Purchaser, and Purchaser shall revise the allocation accordingly. Sellers, on the one hand, and Purchaser on the other hand, shall each pay one-half of the cost of the Independent Accountant. The finalized allocation shall be binding on Sellers and Purchaser for all Tax reporting purposes and Sellers and Purchaser agree to refrain from taking any position inconsistent therewith unless required by applicable Law or a final determination of a Taxing Authority.
(d) Sellers and Purchaser agree to treat all payments made either to or for the benefit of the other Party under this Agreement as adjustments to the Purchase Price for Tax purposes to the extent permitted under applicable Tax Law.
ARTICLE III
CLOSING
Section 3.1. Closing . (a) The Closing shall take place at the offices of Lowenstein Sandler LLP, located at 1251 Avenue of the Americas, New York, New York 10020, (a) at 10:00 A.M., New York time on the second (2 nd ) Business Day following the satisfaction (or, to the extent permitted hereby and by applicable Law, waiver) of all of the conditions set forth in Article VII (other than the conditions that by their nature are to be satisfied by actions to be taken on the Closing Date, but subject to the waiver or satisfaction of such conditions) or (b) at such other time and place as the Parties may mutually agree in writing; provided that if the
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Marketing Period has not ended at the time of the satisfaction or waiver of the conditions set forth in Article VII (other than those conditions that by their nature are to be satisfied by actions to be taken at the Closing, but subject to the satisfaction or waiver of such conditions), the Closing shall occur on the earlier of (x) a date during the Marketing Period specified by Purchaser in writing on no fewer than two (2) Business Days notice to Sellers and (y) the first Business Day immediately following the last day of the Marketing Period. The date on which the Closing occurs is called the Closing Date . The Closing shall be deemed to occur and be effective as of the opening of business on the Closing Date.
(b) At the Closing, Sellers shall deliver or cause to be delivered to Purchaser the instruments and documents set forth in Exhibit A , in each case, in form and substance reasonably acceptable to Purchaser.
(c) At the Closing, Purchaser shall deliver or cause to be delivered to Sellers, the following: (i) the Closing Purchase Price, as provided in Section 2.6(a) , and (ii) the instruments and documents set forth in Exhibit B , in each case, in form and substance reasonably acceptable to Sellers.
(d) At the Closing, Purchaser shall deliver or cause to be delivered to the Escrow Agent the Escrow Amount pursuant to the Escrow Agreement, as provided in Section 2.6(a) .
ARTICLE IV
REPRESENTATIONS AND WARRANTIES OF SELLERS
Except as set forth on the Disclosure Schedule attached hereto that relates to such Section of this Agreement or in another Disclosure Schedule to the extent that it is reasonably apparent on its face that such disclosure is applicable to such Section of this Agreement, Sellers hereby, jointly and severally, represent and warrant to Purchaser as follows:
Section 4.1. Organization . Each Seller (i) is a limited liability company duly organized, validly existing and in good standing under the Laws of Luxembourg and (ii) is duly qualified or licensed to do business and is in good standing in each jurisdiction in which such qualification or licensing is necessary under applicable Laws or where the ownership or operation of the Products or the Purchased Assets or the conduct of the Business requires such qualification. Each Seller has no Subsidiaries.
Section 4.2. Authority; Binding Effect . (a) Each Seller has all requisite corporate power and authority to own, lease and operate its properties and assets, to carry on its business as it is now being conducted (including the Business) and to execute and deliver this Agreement and each Ancillary Agreement to which it will be a party and to perform its obligations hereunder and thereunder. The execution and delivery by each Seller of this Agreement and each Ancillary Agreement to which it will be a party and the performance by any Seller of its obligations hereunder and thereunder have been duly authorized by all requisite corporate action on the part of any of the Sellers, as applicable, including any requisite resolution duly adopted and not subsequently rescinded or modified in any way by the board of managers
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of any of the Sellers approving the execution, delivery and performance by such Seller of this Agreement and each Ancillary Agreement to which it will be a party. No approval of Seller Parent or any of its Affiliates, nor any of their respective shareholders or holders of capital stock, is necessary for either Seller to execute and deliver this Agreement and each Ancillary Agreement to which it will be a party or perform the transactions contemplated hereby or thereby, other than any such approval that has been obtained and remains in full force and effect.
(b) This Agreement has been duly executed and delivered by each Seller and, assuming the valid execution and delivery by Purchaser, constitutes a legal, valid and binding obligation of such Seller, and each Ancillary Agreement will be, prior to the Closing, duly executed and delivered by each Seller and will, from and after the Closing, assuming the valid execution and delivery by Purchaser, constitute a legal, valid and binding obligation of such Seller, in each case enforceable against such Seller in accordance with its terms, except as enforcement may be limited by bankruptcy, insolvency, reorganization, fraudulent conveyance, moratorium or similar Laws affecting creditors rights generally or by general principles of equity (regardless of whether enforcement is sought in a proceeding in equity or law).
Section 4.3. No Conflicts; Consents . The execution, delivery and performance of this Agreement and each of the Ancillary Agreements by each Seller and the consummation of the transactions contemplated hereby and thereby do not and will not (i) violate any of the terms, conditions or provisions of the organizational documents of such Seller; (ii) conflict with, or result in the breach of, constitute a default under, result in the suspension, termination, cancellation or acceleration (whether after the giving of notice or the lapse of time or both) of any right or obligation of a Seller under, or to a loss of any benefit of the Business to which a Seller is entitled under, any Purchased Asset or Assumed Contract or lease of real estate to which such Seller is a party or to which its properties or assets are subject, as applicable, or result in the creation of any Lien (other than Permitted Encumbrances) upon any of the Purchased Assets; or (iii) assuming that all consents, approvals and authorizations contemplated by Section 4.4 have been obtained and all filings described therein have been made, violate or result in a breach of or constitute a default under any applicable Law or other restriction of any Governmental Authority to which such Seller is subject; except, with respect to clauses (ii) and (iii), for any violations, breaches, conflicts, defaults, terminations, cancellations or accelerations as would not, individually or in the aggregate, reasonably be expected to result in a Material Adverse Effect. No consent, approval, waiver, authorization, notice or filing is required to be obtained by either Seller or any of their respective Affiliates from, or to be given by either Seller or any of their respective Affiliates to, or either Seller or any of their respective Affiliates with, any Person that is not a Governmental Authority in connection with the execution, delivery and performance by either Seller or any of their respective Affiliates of this Agreement and the Ancillary Agreements other than any such consent, approval, waiver, authorization, notice or filing that has been obtained and remains in full force and effect.
Section 4.4. Governmental Authorization . The execution, delivery and performance of this Agreement by each Seller and the consummation of the transactions contemplated hereby, do not require any consent or approval of any Governmental Authority except for (i) expiration or early termination of the waiting period under the HSR Act and (ii) consents or approvals, the failure of which to obtain would not, individually or in the aggregate, reasonably be expected to result in a Material Adverse Effect.
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Section 4.5. Absence of Material Changes . Since December 31, 2014:
(a) Sellers have operated the Business in the ordinary course in a manner consistent with past practice in all material respects; and
(b) there has not been:
(i) any event, state of facts, occurrence, circumstance, development or change that, individually or in the aggregate, has had or would reasonably be expected to result in a Material Adverse Effect;
(ii) any sale, lease, license, abandonment or other disposition by any Seller of any material assets used solely in the Business or Related to the Business, except (i) in the ordinary course of business consistent with past practice, (ii) to a Seller or (iii) in connection with the transactions contemplated hereby;
(iii) any acquisition of any material properties or assets that constitute Purchased Assets, other than (A) in the ordinary course of business consistent with past practice or (B) for Purchased Assets that would not reasonably be expected to result in any material Assumed Liabilities;
(iv) any settlement of any material litigation or material claim or waiver of any material claims or rights of material value in a manner that constitutes an Assumed Liability.
(v) any termination, cancellation, material amendment, material waiver or modification of any Governmental Authorizations Related to the Business or any Product Registrations;
(vi) any termination, amendment or waiver of, or material modification to, any Assumed Contract or Shared Contract outside of the ordinary course of business;
(vii) any abandonment, cancellation or other expiration or lapse of any of the Purchased Intellectual Property;
(viii) any settlement of or compromise of any material Tax Liability, change in any material respect of any Tax election or Tax method of accounting, any new material Tax election or adoption of any material new Tax method of accounting that would affect the Tax treatment of any Purchased Asset on or after the Closing;
(ix) any material change in the manner of billing of, or the credit lines made available to, any customers of the Business; or
(x) any agreement or commitment to take any action described in this Section 4.5 .
Section 4.6. Litigation . (a) There is no civil, criminal or administrative Proceeding, hearing or other investigation that (i) is material to the Business, taken as a whole,
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(ii) would be reasonably expected to enjoin, restrict or prohibit the transfer of all or any part of the Purchased Assets or the performance by Sellers contemplated by this Agreement or the Ancillary Agreements or (iii) would be reasonably expected to impose any material limitation on the ability of Sellers to operate the Business as currently conducted, in each case, pending or, to the Knowledge of Sellers, expressly threatened in writing, against any of the Sellers as of the date hereof.
(b) No Seller and none of the Purchased Assets are subject to any Governmental Order or arbitration award that is material to the Business, taken as a whole, or that imposes any material limitation on the ability of any Seller to operate the Business as currently conducted.
Section 4.7. Compliance with Laws . Except with respect to Product Registrations, which are the subject of Section 4.8:
(a) Each Seller is, and has been, since January 1, 2012, in compliance in all material respects with all Laws applicable to the ownership of the Purchased Assets or operation of the Business. Neither Seller has, since January 1, 2012, received any written notice alleging any violation under any applicable Law, except for any such violation that would not be material to the Business.
(b) Each Seller possesses, and is in compliance with, all Governmental Authorizations that are material to the conduct of the Business as it is currently conducted.
(c) Sellers (i) have instituted policies and procedures designed to ensure compliance with the FCPA and other anti-bribery, anti-corruption and anti-money laundering Laws in each jurisdiction in which Sellers operate and (ii) have maintained and will maintain such policies and procedures in force. Sellers, and to the Knowledge of Sellers, their owners and respective Representatives are in compliance, and since January 1, 2012 have complied, in all material respects with: (i) the FCPA, as if its foreign payments provisions were fully applicable to Sellers, their owners and respective Representatives, and (ii) the provisions of all anti-bribery, anti-corruption and anti-money laundering Laws of each jurisdiction in which the Business is operated or has been operated and in which any Representative thereof is conducting or has conducted business involving Sellers. Since January 1, 2012, Sellers and, to the Knowledge of Sellers, their owners and respective Representatives have not paid, offered or promised to pay, or authorized or ratified the payment, directly or indirectly, of any monies or anything of value to any national, provincial, municipal or other Government Official or any political party or candidate for political office for the purpose of corruptly influencing any act or decision of such official or of the government to obtain or retain business, or direct business to any Person or to secure any other improper benefit or advantage in each case in violation in any material respect of the FCPA and any Laws described in clause (ii). For purposes of this provision, Government Official means any official, officer, employee, or representative of, or any Person acting in an official capacity for or on behalf of, any Governmental Authority, and includes any official or employee of any directly or indirectly government owned or controlled entity, and any officer or employee of a public international organization, as well as any Person acting in an official capacity for or on behalf of any such government or department, agency, or instrumentality, or for or on behalf of any such public international organization.
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(d) Sellers (i) have instituted policies and procedures designed to ensure compliance with the Export and Sanctions Regulations in each jurisdiction in which Sellers operate or are otherwise subject to jurisdiction and (ii) have maintained and will maintain such policies and procedures in force. Each Seller is and has, since January 1, 2012, been in compliance in all material respects with Export and Sanctions Regulation where the Business is operated or it or the Purchased Assets are otherwise subject to jurisdiction. No licenses or other authorizations are required under the Export and Sanctions Regulations for the operation of the Business in any jurisdiction in which it or the Purchased Assets are subject to jurisdiction.
Section 4.8. Product Registrations; Regulatory Compliance .
(a) A true and complete list of Product Registrations is set forth on Schedule 4.8(a) of the Disclosure Schedules. Sellers are in compliance in all material respects with all Health Care Laws applicable to the conduct of the Business as currently conducted. No Seller has received any notification of any pending or, to Knowledge of Sellers, threatened, Proceeding, hearing, enforcement, audit, inquiry, investigation, arbitration or other action from any Governmental Authority, including, without limitation, the FDA, the Centers for Medicare & Medicaid Services, and the U.S. Department of Health and Human Services Office of Inspector General, alleging potential or actual non-compliance by, or liability of, Sellers under any Health Care Law, except as would not, individually or in the aggregate, be material to the Business. All Products sold under the Product Registrations are, and at all times since January 1, 2012, have been, manufactured and marketed in all material respects in compliance with the specifications and standards contained in such Product Registrations and in compliance with all applicable Health Care Laws.
(b) A Seller is the sole and exclusive owner of the Product Registrations, free and clear of any Liens, and no right of reference has been granted to any Person with respect to any of the Product Registrations.
(c) Sellers hold all Product Registrations required for the conduct of the Business as currently conducted, and such Product Registrations are valid and in full force and effect. Sellers have fulfilled and performed, and are performing, all of their obligations with respect to the Product Registrations, and no event has occurred that allows, or after notice or lapse of time would allow, revocation or termination thereof or result in any other impairment of the rights of the holder of any Product Registration. Sellers have not received any notice, letters or other correspondence from the FDA, or any other Governmental Authority or Person (i) contesting any of their Product Registrations or (ii) otherwise alleging any violation of Health Care Laws by Sellers. There are no civil, criminal or administrative Proceedings, hearings or other investigations pending or, to the Knowledge of Sellers, threatened, and no event has occurred that could result in a penalty under or the revocation, cancellation, suspension, nonrenewal or adverse modification of any Product Registration.
(d) To Knowledge of Sellers (which for this purpose shall be limited to the actual knowledge of the individuals listed in Schedule 1.1(e) ), the clinical and pre-clinical studies, whether or not conducted under an IND, submitted to the FDA in support of the Product Registrations were, and if still pending, are being conducted in accordance with standard medical and scientific research procedures and all applicable Health Care Laws, including, but not
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limited to, the FDCA and its applicable implementing regulations at 21 C.F.R. Parts 50, 54, 56, 58 and 312, except as would not, individually or in the aggregate, be material to the Business.
(e) There are no pending requirements to conduct any Phase IV or other clinical studies with respect to any Product in the United States for any approved indication.
(f) None of the Sellers has received any written information from the FDA which would reasonably be expected to lead to the denial of any application for marketing approval or other Product Registration currently pending before the FDA.
(g) Each Seller has completed and filed all reports, documents, claims, permits and notices required by any Governmental Authority in order to maintain the Product Registrations, including drug registration and listing submissions to the FDA. To Knowledge of Sellers, no director, officer, employee, or agent of Sellers has made an untrue statement of a material fact or fraudulent statement to the FDA or any other Governmental Authority, failed to disclose a material fact required to be disclosed to the FDA or any other Governmental Authority, or committed an act, made a statement, or failed to make a statement that, at the time such disclosure was made, would reasonably be expected to provide a basis for the FDA or any other Governmental Authority to invoke its policy respecting Fraud, Untrue Statements of Material Facts, Bribery, and Illegal Gratuities, set forth in 56 Fed. Reg. 46191 (Sept. 10, 1991) or any similar policy. To Knowledge of Sellers, no director, officer, employee, or agent of Sellers has engaged in any conduct that has resulted, or would reasonably be expected to result, in debarments under 21 U.S.C. § 335a(a) or any similar Laws. With respect to the Business, neither Seller nor any of their respective officers, employees, agents or distributors has been convicted of any crime or engaged in any conduct for which such Person could be excluded from participating in any federal health care programs under Section 1128 of the Social Security Act of 1935, as amended, or any similar Law or program.
(h) Since January 1, 2012, neither Seller has voluntarily or involuntarily initiated, conducted or issued, or caused to be initiated, conducted or issued, nor is either Seller aware of any circumstances reasonably likely to give rise to, any recall, field alerts, field corrections, market withdrawal or replacement, safety alert, warning, dear doctor letter, investigator notice, safety alert, or other notice or action relating to an alleged lack of safety, efficacy or regulatory compliance of any Product.
(i) Since January 1, 2012, neither of the Sellers has received any written notice that any Governmental Authority has (i) commenced, or threatened to initiate, any action to request the recall of any Product sold or intended to be sold by Sellers or alleging any violations of any federal, state or local or any payor fraud and abuse, consumer protection and false claims statutes and regulations or any pricing or rebate reporting requirements, (ii) commenced, or threatened to initiate, any action to enjoin manufacture or distribution of any Product sold or intended to be sold by Sellers, (iii) issued any demand letter, finding of deficiency or non-compliance or adverse inspection report in respect of any Product or the Business.
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Section 4.9. Intellectual Property .
(a) Schedule 4.9(a) of the Disclosure Schedules set forth a true and correct list of all Purchased Intellectual Property that is Registered ( Registered Intellectual Property ). All Registered Intellectual Property is subsisting, valid, and, to the actual Knowledge of Sellers (which for this purpose shall be limited to the actual knowledge of the individuals listed in Schedule 1.1(e)) , enforceable. There is no, and since January 1, 2012 there has been no, Proceeding or notice of any objection or claim asserted in writing or, to the Knowledge of Sellers, threatened by any Person, with respect to or challenging the ownership, validity or enforceability of any Registered Intellectual Property (or, to the Knowledge of Sellers, any Intellectual Property licensed, or subject to a covenant not to sue or other grant, to Sellers pursuant to any Intellectual Property License ( Licensed Intellectual Property )).
(b) Sellers solely and exclusively own all Purchased Intellectual Property, and no other Person has any joint ownership interest in any Purchased Intellectual Property. The Purchased Intellectual Property and the rights of Sellers under the Licensed Intellectual Property are free and clear of any Liens, other than Permitted Encumbrances. None of the Purchased Intellectual Property (nor, to the Knowledge of Sellers, any Licensed Intellectual Property) has been or is the subject of (i) any pending (or, to the Knowledge of Sellers, threatened) material adverse claim, judgment, injunction, order, decree or agreement restricting (A) its use or other exploitation in connection with any Product or (B) assignment thereof by Sellers as contemplated hereunder, or (ii) any other pending (or, to the Knowledge of Sellers, threatened) material litigation or claim of infringement.
(c) The Licensed Intellectual Property constitutes all of the material Intellectual Property that is licensed, or subject to a covenant not to sue or other grant, by Sellers from any Person that is used in connection with or necessary for the conduct of the Business as of the date of this Agreement.
(d) The Purchased Intellectual Property and the Licensed Intellectual Property, together with the Intellectual Property licensed to Purchaser under Section 6.8 and Section 6.18 of this Agreement, collectively, constitute (i) all of the Intellectual Property owned by or licensed, or subject to a covenant not to sue or other grant, to Sellers that is material to the conduct of the Business as conducted as of the date of this Agreement, and (ii) all of the material Intellectual Property that is used in or necessary for the conduct of the Business as conducted as of the date of this Agreement. Other than the Purchased Intellectual Property and any Intellectual Property licensed to Purchaser under Section 6.8 and Section 6.18 of this Agreement, Sellers do not own (and to the Knowledge of Sellers, none of their Affiliates own) any material Intellectual Property that is used in or necessary for the conduct of the Business.
(e) (i) Neither any of the Products, nor the conduct of the Business, infringes, misappropriates or otherwise violates, or since January 1, 2012, has infringed, misappropriated or otherwise violated, any Intellectual Property or proprietary right of any Person, (ii) to the Knowledge of Sellers, no Person is infringing, misappropriating or otherwise violating any Purchased Intellectual Property or Licensed Intellectual Property, and no such infringement, misappropriation or other violation has occurred since January 1, 2012, and (iii) Sellers have not
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sent or received any written notice alleging any infringement, misappropriation or other violation that would be covered by the foregoing Section 4.9(e)(i) or 4.9(e)(ii) .
(f) Neither of the Sellers has granted any license, covenant not to sue, option or other rights with respect to any of the Purchased Intellectual Property or, solely with respect to the Products, any rights of any of the Sellers under any Licensed Intellectual Property to any other Person.
(g) Sellers have paid in full all registration, application, filing, recordation and maintenance fees related to the Registered Intellectual Property that are due and payable prior to the Closing Date.
(h) The assignment of the Assumed Contracts and the Shared Contracts to Purchaser and the consummation of the transactions contemplated hereby will not create or result in the grant of a license, covenant not to sue, option or other right under any Intellectual Property of Purchaser or any of its Affiliates, other than the Purchased Intellectual Property.
Section 4.10. Assets .
(a) Each Seller owns or has the legal right to use all of the Purchased Assets. Each Seller has good title to all its Purchased Assets free and clear of all Liens, except for Permitted Encumbrances. The Purchased Assets collectively generated 90% of all of the revenue recorded in Seller Parents consolidated financial statements for the fiscal year ended December 31, 2014, excluding any revenue generated by Excluded Assets and regular turnover of Inventory. No Affiliate of Seller has any rights, licenses, assets or Government Authorizations that have been used or were necessary to generate any of the revenues contained in Seller Parents consolidated financial statements for the fiscal year ended December 31, 2014, other than the rights of CPI under the CPI Distribution Contracts.
(b) The Purchased Assets (including the Inventory) and Purchasers rights under this Agreement will constitute all of the rights, assets and licenses that are and have been used by Sellers in conducting the Business over the twelve (12) month period ended on the date hereof and will permit Purchaser, immediately following the Closing, to conduct the Business in a substantially similar manner as the Business was operated by Sellers and their Affiliates as of the date hereof, except in each case, (i) as set forth on Schedule 4.10(b) of the Disclosure Schedules, (ii) for the exclusion of the Excluded Assets described in Section 2.3 , (iii) for services contemplated to be provided by the Transition Services Agreement, (iv) for the Shared Contracts to the extent not Related to the Business and (v) impediments arising out of circumstances affecting Purchaser as compared to any other Person acquiring the Business. In the event this representation and warranty is breached because any Seller has in good faith failed to identify any assets used in the Business, such breach shall be deemed cured if such Seller promptly transfers such assets to Purchaser (or otherwise transfers the benefits and burdens of such assets) at no additional cost or expense to Purchaser. The Sellers, together, are in possession of all Books and Records.
Section 4.11. Taxes . (i) Each Seller has duly and timely filed, including extensions, (or caused to be filed) with the appropriate Taxing Authorities all Tax Returns
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relating to the Purchased Assets or Related to the Business required to be filed; (ii) each Seller has paid (or caused to be paid) all Taxes relating to the Purchased Assets or Related to the Business due and payable (whether or not shown on any Tax Return) on or prior to the Closing Date; (iii) each Seller has withheld or collected (or caused to be withheld or collected) all Taxes relating to the Purchased Assets or Related to the Business required to be withheld or collected; (iv) there are no Liens for Taxes nor is any Taxing Authority in the process of imposing any Lien on any of the Purchased Assets, other than for Permitted Encumbrances set forth in paragraph (ii) of such definition; (v) there exists no claimed or proposed assessment, deficiency or other adjustment for Taxes against any Seller which, if not satisfied or resolved, would result in a Lien on the Purchased Assets that would survive the Closing Date or in liability of Purchaser or its Affiliates as a transferee of or successor to the Purchased Assets or the Business; (vi) no Seller has waived any statute of limitations, agreed to any extension of time, or entered into any written agreement in respect of Taxes the nonpayment or underpayment of which would result in a Lien on the Purchased Assets that would survive the Closing Date or in Liability of Purchaser or its Affiliates as a transferee of or successor to the Purchased Assets or the Business; (vii) no claim has ever been made in writing by a Taxing Authority in any jurisdiction where a Seller does not file Tax Returns that any such Seller is or may be subject to taxation by that jurisdiction as a result of such Sellers operation, ownership or use of the Purchased Assets or the Business; (viii) no Seller has recorded a reserve for Tax Liabilities for financial accounting purposes due to (A) the factors set forth on Schedule 4.11 , or (B) possible permanent establishment in a jurisdiction outside the United States, in which such Seller has not filed Tax Returns as a result of the operation, ownership or use of the Purchased Assets or the Business; and (ix) no Seller is transferring an ownership interest in a United States real property interest (within the meaning of Section 897 of the Code) to Purchaser pursuant to this Agreement.
Section 4.12. Contracts .
(a) Schedule 4.12(a)(i) and Schedule 4.12(a)(ii) of the Disclosure Schedules respectively set forth, as of the date of this Agreement, a true, correct and complete list of all of the Assumed Contracts and Shared Contracts (including all amendments or modifications thereto), to which any Seller is a party or by which any of the Purchased Assets are bound, including:
(i) Any Contract that, in accordance with its terms, requires aggregate payments of $250,000 or more within the twelve (12) month period following the date hereof and that is not cancelable without Liability on ninety (90) or fewer days notice to the other party thereto;
(ii) Any Contract with each of (A) the ten (10) largest customers, (B) the ten (10) largest suppliers or service providers (measured by dollar volume of purchases or sales, respectively) during the fiscal year ended December 31, 2014 and (C) any supplier that constitutes a sole source of supply to the Business;
(iii) Any Contracts or agreements relating to or evidencing indebtedness in excess of $250,000, any Contracts related to any guarantee or assumption of obligations of any third party or reimbursement of any maker of a letter of credit and any Contract relating to any hedging, derivative or similar Contract or arrangement;
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(iv) Any Contracts that contain any non-compete or exclusivity provisions (or obligates Purchaser or any of its Affiliates to enter into any non-compete or exclusivity arrangements following the Closing) with respect to any line of business or geographic area;
(v) Any Contract that requires (or would require upon the happening of a contingency) the disposition of any assets or line of business of Sellers prior to Closing, or by Purchaser or any of its Affiliates following the Closing;
(vi) Any Contract that grants a contractual counterparty most favored nation or similar status;
(vii) Any Contract that restricts the conduct of any line of business (including the ability to research, develop, distribute, sell, supply, market or manufacture any product (including products under development) for any indication in any product market, therapeutic area or geographic area) by Purchaser or any of its Affiliates following the Closing;
(viii) Any Contract that requires or obligates Purchaser or any of its Affiliates to purchase specified minimum amounts of any product or material or to perform or conduct research, clinical trials or development for the benefit of any Person other than Purchaser or any of its Affiliates;
(ix) Any Contract that prohibits or limits in any material respect the right of any of Sellers prior to Closing, or Purchaser or any of its Affiliates following the Closing, to make, sell or distribute any products or services or use, transfer, license, distribute or enforce any of their respective Intellectual Property;
(x) Any Contract that could reasonably be expected to account for aggregate revenue of $1,000,000 or more during the fiscal year ending December 31, 2014;
(xi) Any Contract that is a settlement agreement, other than (i) releases or separation agreements entered into with former employees or current or former independent contractors and (ii) settlement agreements under which there are no continuing obligations, Liabilities or rights (excluding releases);
(xii) Any Intellectual Property License, and any Contract pursuant to which any of the Sellers grant a license, covenant not to sue, option or other right with respect to any Purchased Intellectual Property; and
(xiii) Any Contract that contains any liability or obligation to indemnify any Person against any Tax Liability or to share any Tax Liability with any Person.
(b) Each Seller has made available to Purchaser true, complete and correct copies of (i) all Assumed Contracts and (ii) all Shared Contracts, in each case including any and all amendments, supplements or modifications thereto, or detailed descriptions of any oral Assumed Contracts. Each Assumed Contract and each Shared Contract is a legal, valid and binding obligation enforceable against the Seller that is a party thereto and, to the Knowledge of
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Sellers, the other party thereto, and is in full force and effect, subject to bankruptcy, insolvency, reorganization, fraudulent conveyance, moratorium or similar Laws affecting creditors rights generally or by general principles of equity (regardless of whether enforcement is sought in a Proceeding in equity or law). Neither Seller, nor, to the Knowledge of Sellers, any other party thereto (i) is in breach or violation of, or default under, or has delivered a notice of termination of, any Assumed Contract or Shared Contract, and no event has occurred that, with the giving of notice or lapse of time or both, would constitute a breach or default of any Assumed Contract or Shared Contract, (ii) has not communicated any intention or threat to Sellers, to reduce the prices it will pay to Sellers pursuant thereto, to terminate or to cancel any Assumed Contract or Shared Contract or has failed to renew or extend the term of any Assumed Contract or Shared Contract upon the expiration of any such term.
Section 4.13. Financial Data .
(a) Schedule 4.13(a) of the Disclosure Schedules sets forth Sellers audited, consolidated balance sheet, statement of income and statement of cash flows as of and for the fiscal years ended on December 31, 2014, 2013 and 2012 (the Financial Statements ). The Financial Statements have been prepared in accordance with GAAP applied on a basis consistent with each prior period, and, fairly present, in all material respects, the consolidated financial position and statements of operations, equity and cash flow of Sellers as of the respective dates thereof and for the periods referred to therein. There are no material off balance sheet transactions, arrangements, obligations or relationships attributable to the Business or to which any Seller is a party that would be materially adverse to the financial condition, results of operations, liquidity or capital resources of the Business. Each Seller maintains systems of internal accounting controls designed to provide reasonable assurances to such Seller for purposes of preparing its audited financial statements that: (i) transactions are executed in accordance with managements general or specific authorization; (ii) transactions are recorded as necessary to permit the preparation of financial statements in conformity with GAAP and to maintain accountability for assets; (iii) access to assets or authorization of expenditures is permitted only in accordance with managements general or specific authorization; and (iv) the recorded accountability for assets is compared with the actual levels at reasonable intervals and appropriate action is taken with respect to any differences.
(b) The Assumed Liabilities do not include any Liabilities which, if known, would be required to be reflected or reserved against on a consolidated balance sheet prepared in accordance with GAAP or the notes thereto, except Liabilities (a) that are reflected in the Financial Statements, (b) incurred in the ordinary course of business consistent with past practices since December 31, 2014, (c) as expressly required by this Agreement or (d) under the terms of the Assumed Contracts.
Section 4.14. Brokers . No broker, finder or investment banker is entitled to any brokerage, finders or other fee or commission in connection with the transactions contemplated by this Agreement based upon arrangements made by or on behalf of either Seller.
Section 4.15. Inventory . The Inventory, when delivered or transferred to Purchaser, (i) shall comply with all applicable specifications in all material respects, (ii) shall have been manufactured in all material respects in accordance with current Good Manufacturing
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Practices, as set forth in the United States Code of Federal Regulations and the Product Registrations, (iii) shall not be misbranded or adulterated, within the meaning of the FDCA, (iv) shall be saleable in the ordinary course of business and fit for the purpose for which it was procured or manufactured and (v) to the extent the Inventory contains raw materials and work-in- process, such raw materials and work-in-process shall have been manufactured, handled, maintained, packaged and stored at all times and in all material respects in compliance with applicable Laws.
Section 4.16. Product Distribution Practices . Since January 1, 2014, (a) Sellers have (i) shipped and sold the Products in quantities that are substantially consistent with then- current market demand, and (ii) priced all Products in the ordinary course of business, consistent with past practices; and (b) Sellers have not (w) stopped or slowed the shipping of any of the Products; (x) loaded sales of any of the Products; (y) encouraged or required customers to buy in any of the Products; or (z) taken any similar actions outside the ordinary course of business or inconsistent with past practices that would reasonably be expected to adversely impact Purchasers anticipated sales of any of the Products or the Business following the Closing.
Section 4.17. Product Liability . Since January 1, 2012, no Proceedings or arbitrations related to product liability, including those for consumer fraud and economic loss, have been initiated against Sellers and, to the Knowledge of Sellers, no such Proceedings or arbitrations have been threatened or filed against either Seller relating to any of the Products or product candidates developed, tested, manufactured, marketed, distributed or sold by Sellers.
Section 4.18. Insurance . Schedule 4.18 of the Disclosure Schedules sets forth a complete and correct list of all policies of products liability insurance maintained by Sellers relating to the Business, including the type of coverage, the insurer, the policy limit and the expiration date of such policies.
Section 4.19. Chief Executive Office . Sellers place of business and chief executive office (both within the meaning of Article 6 of the Uniform Commercial Code) is located at Bahnhofstrasse 11, CH- 6300 Zug, Switzerland.
Section 4.20. No Other Representations or Warranties . EXCEPT FOR THE REPRESENTATIONS AND WARRANTIES EXPRESSLY CONTAINED IN THIS ARTICLE IV (AS MODIFIED BY THE DISCLOSURE SCHEDULES), NEITHER SELLER NOR ANY OTHER PERSON MAKES ANY OTHER EXPRESS OR IMPLIED REPRESENTATION OR WARRANTY WITH RESPECT TO SELLERS, THE PURCHASED ASSETS, OR THE TRANSACTIONS CONTEMPLATED BY THIS AGREEMENT, THE ASSUMED LIABILITIES AND ANY OTHER RIGHTS OR OBLIGATIONS TO BE TRANSFERRED HEREUNDER OR PURSUANT HERETO, AND SELLERS DISCLAIM ANY OTHER REPRESENTATIONS OR WARRANTIES, WHETHER MADE BY A SELLER OR ANY OF ITS AFFILIATES, OFFICERS, DIRECTORS, EMPLOYEES, AGENTS OR REPRESENTATIVES. EXCEPT FOR THE REPRESENTATIONS AND WARRANTIES EXPRESSLY CONTAINED IN THIS ARTICLE IV (AS MODIFIED BY THE DISCLOSURE SCHEDULES) OR IN THE ANCILLARY AGREEMENTS, SELLERS HEREBY DISCLAIM ALL LIABILITY AND RESPONSIBILITY FOR ANY REPRESENTATION, WARRANTY,
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PROJECTION, FORECAST, STATEMENT, OR INFORMATION MADE, COMMUNICATED OR FURNISHED (ORALLY OR IN WRITING) TO PURCHASER OR ITS AFFILIATES OR REPRESENTATIVES (INCLUDING ANY OPINION, INFORMATION, PROJECTION OR ADVICE THAT MAY HAVE BEEN OR MAY BE PROVIDED TO PURCHASER BY ANY DIRECTOR, OFFICER, EMPLOYEE, AGENT, CONSULTANT OR REPRESENTATIVE OF A SELLER OR ANY OF ITS AFFILIATES). SELLERS MAKE NO REPRESENTATIONS OR WARRANTIES TO PURCHASER REGARDING THE PROBABLE SUCCESS OR PROFITABILITY OF THE PURCHASED ASSETS OR THE PRODUCTS.
ARTICLE V
REPRESENTATIONS AND WARRANTIES OF PURCHASER
Except as set forth on the Disclosure Schedule attached hereto that relates to such Section of this Agreement or in another Disclosure Schedule to the extent that it is reasonably apparent on the face of such disclosure that such disclosure is applicable to such Section of this Agreement, Purchaser hereby represents and warrants to Sellers as follows:
Section 5.1. Organization . Purchaser (i) is a corporation duly organized, validly existing and in good standing under the Laws of the jurisdiction of its incorporation and (ii) is duly qualified or licensed to do business and is in good standing in each jurisdiction in which such qualification or licensing is necessary under applicable Law.
Section 5.2. Authority; Binding Effect .
(a) No vote of holders of capital stock of Purchaser or Purchaser Parent is necessary to approve this Agreement, the transactions contemplated by this Agreement or the Financing. Purchaser has all requisite corporate power and authority to own, lease and operate its properties and assets, to carry on its business as it is now being conducted and to execute and deliver this Agreement and each Ancillary Agreement to which it will be a party and to perform its obligations hereunder and thereunder. The execution and delivery by Purchaser of this Agreement and each Ancillary Agreement to which it will be a party and the performance by Purchaser of its obligations hereunder and thereunder have been duly authorized by all requisite corporate action on the part of Purchaser, including any requisite resolution duly adopted and not subsequently rescinded or modified in any way by the board of directors of Purchaser approving the execution, delivery and performance by Purchaser of this Agreement and each Ancillary Agreement to which it will be a party.
(b) This Agreement has been duly executed and delivered by Purchaser and, assuming the valid execution and delivery by Sellers, constitutes a legal, valid and binding obligation of Purchaser, and each Ancillary Agreement will be, prior to the Closing, duly executed and delivered by Purchaser and will, from and after the Closing, assuming the valid execution and delivery by Sellers and Seller Parent, as applicable, constitute a legal, valid and binding obligation of Purchaser, in each case enforceable against Purchaser in accordance with its terms, except as enforcement may be limited by bankruptcy, insolvency, reorganization, fraudulent conveyance, moratorium or similar Laws affecting creditors rights generally or by
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general principles of equity (regardless of whether enforcement is sought in a proceeding in equity or law).
Section 5.3. No Conflicts; Consents . The execution, delivery and performance of this Agreement and each of the Ancillary Agreements by Purchaser and the consummation of the transactions contemplated hereby and thereby do not and will not (i) violate any provision of the organizational documents of Purchaser; (ii) subject to obtaining the consents referred to in Schedule 5.3 of the Disclosure Schedules, conflict with, or result in the breach of, constitute a default under, result in the termination, cancellation or acceleration (whether after the giving of notice or the lapse of time or both) of any right or obligation of Purchaser under, or to a loss of any benefit to which Purchaser is entitled under, any Contract or lease of real estate to which Purchaser is a party or to which its properties or assets are subject; or (iii) assuming that all consents, approvals and authorizations contemplated by Section 5.4 have been obtained and all filings described therein have been made, violate or result in a breach of or constitute a default under any applicable Law or other restriction of any Governmental Authority to which Purchaser is subject; except, with respect to clause (ii), and (iii) for any violations, breaches, conflicts, defaults, terminations, cancellations or accelerations as would not, individually or in the aggregate, prevent, materially delay or materially impair Purchasers ability to effect the Closing.
Section 5.4. Governmental Authorization . The execution and delivery of this Agreement by Purchaser and the consummation of the transactions contemplated hereby, do not require any consent or approval of, or any notice to or other filing with, any Governmental Authority except for (i) expiration or early termination of the waiting period under the HSR Act, (ii)the consents or approvals set forth in Schedule 5.4 of the Disclosure Schedules, and (iii) consents or approvals, the failure of which to obtain, would not, individually or in the aggregate, prevent, materially delay or materially impair Purchasers ability to effect the Closing.
Section 5.5. Financing .
(a) Purchaser has delivered to Sellers true, correct and complete copies of the executed (i) commitment letter, dated as of March 9, 2015, in favor of Purchaser Parent from the Financing Sources and (ii) fee letter related thereto subject to redaction of fee amounts, pricing caps (including pricing caps in any securities demand provisions), economic flex terms and other economic provisions that are customarily redacted in connection with acquisition agreements of this type ((i) and (ii), together with all exhibits, annexes, schedules and attachments thereto, the Commitment Letter )), pursuant to which the Financing Sources have committed, subject to the terms and conditions of the Commitment Letter, to lend to Purchaser Parent, the amounts set forth therein (the Financing ) for the purpose of funding the transactions contemplated by this Agreement.
(b) Except as expressly set forth in the Commitment Letter, there are no conditions precedent to the obligations of the Financing Sources to provide the Financing or any contingencies that would permit the Financing Sources to reduce the total amount of the Financing. As of the date of this Agreement, assuming the satisfaction or waiver of the conditions set forth in Section 7.2(a) and Section 7.2(b) , Purchaser does not have any reason to believe that it and Purchaser Parent will be unable to satisfy on a timely basis all terms and conditions to be satisfied by it in the Commitment Letter on or prior to the Closing Date, nor
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does Purchaser have knowledge as of the date of this Agreement that any of the Financing Sources will not perform its obligations thereunder, including the funding of the Financing on the Closing Date.
(c) Assuming the satisfaction or waiver of the conditions set forth in Section 7.2(a) and Section 7.2(b) , the Financing, when funded in accordance with the Commitment Letter, together with any cash and marketable securities on Purchasers and Purchaser Parents balance sheets, shall provide Purchaser with funds sufficient to pay the Purchase Price and any fees and expenses of or payable by Purchaser pursuant to this Agreement and the Commitment Letter.
(d) The Commitment Letter is (i) a legal, valid and binding obligation of Purchaser Parent and, to the Knowledge of Purchaser, of each of the other parties thereto and (ii) as of the date hereof, in full force and effect, in each case subject to bankruptcy, insolvency, reorganization and other Laws of general applicability relating to or affecting creditors rights and to general equity principles. Assuming there is no breach of any representation or warranty of Sellers contained in this Agreement such that the condition set forth in Section 7.2(a) could not be satisfied, as of the date of this Agreement, to the Knowledge of Purchaser, no event has occurred that, with or without notice, lapse of time, or both, would reasonably be expected to constitute a default or breach or a failure to satisfy a condition precedent on the part of Purchaser Parent under the terms and conditions of the Commitment Letter. Purchaser Parent has paid in full any and all commitment fees or other fees required to be paid by Purchaser Parent pursuant to the terms of the Commitment Letter on or before the date of this Agreement, and shall pay in full any such amounts arising under the Commitment Letter as and when they become payable. As of the date of this Agreement, Purchaser Parent has taken all actions required by the Commitment Letter to consummate the Financing. The Commitment Letter has not been modified, amended or altered as of the date hereof and none of the commitments under the Commitment Letter have been withdrawn or rescinded in any respect.
(e) In no event shall the receipt or availability of any funds or financing (including the Financing) by Purchaser Parent, Purchaser or any Affiliate be a condition to any of Purchasers or Purchaser Parents obligations hereunder.
Section 5.6. Litigation . There is no civil, criminal or administrative Proceeding, hearing or other investigation that seeks to delay or prevent the consummation of the transactions contemplated by this Agreement or the Financing or would, if successful, materially and adversely affect the ability of Purchaser to consummate the transactions contemplated by this Agreement or the Financing.
Section 5.7. Brokers . Except for RBC Dominion Securities Inc., no broker, finder or investment banker is entitled to any brokerage, finders or other fee or commission in connection with the transactions contemplated by this Agreement based upon arrangements made by or on behalf of Purchaser. Purchaser is solely responsible for the fees and expenses of RBC Dominion Securities Inc.
Section 5.8. Solvency. Immediately after the Closing, and after giving effect to the transactions contemplated by this Agreement and the Financing, Purchaser will be Solvent.
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Section 5.9. No Other Representations or Warranties . Notwithstanding anything contained in this Agreement to the contrary, Purchaser acknowledges and agrees that Sellers and Seller Parent are not making any representations or warranties whatsoever, express or implied, beyond those expressly given by Sellers in Article IV hereof (as modified by the Disclosure Schedules), and Purchaser acknowledges and agrees that, except for the representations and warranties contained therein, the Purchased Assets and the Business are being transferred on a WHERE IS and, as to condition, AS IS basis. Any claims Purchaser may have for breach of representation or warranty shall be based solely on the representations and warranties of Sellers set forth in Article IV hereof (as modified by the Disclosure Schedules). Purchaser further represents that neither Sellers nor any of their Affiliates nor any other Person has made any representation or warranty, express or implied, as to the accuracy or completeness of any information regarding Sellers or the Business not expressly set forth in this Agreement, and none of Sellers, any of their Affiliates or any other Person will have or be subject to any liability to Purchaser or any other Person resulting from the distribution to Purchaser or its Representatives or Purchasers use of, any such information.
ARTICLE VI
COVENANTS
Section 6.1. Information and Documents .
(a) From and after the date hereof and pending Closing, upon reasonable advance notice, to the extent permitted by applicable Law, Sellers shall (i) permit Purchaser and its Representatives (including Representatives of the Financing Sources) to have reasonable access, during regular business hours to all offices and facilities, and the assets, books, records, agreements, documents, data, files and personnel of, and such other information relating to the Business (including the Books and Records), (ii) furnish, or cause to be furnished, to Purchaser any financial and operating data and other information that is available with respect to the Business as Purchaser from time to time reasonably requests and (iii) instruct the personnel, and their counsels and financial advisors to cooperate with Purchaser in its investigation of the Business, including instructing its accountants to give Purchaser access to their work papers; provided , however , that no such access shall unreasonably interfere in any material respect with Sellers operation of business; and provided further that Sellers may restrict the foregoing access to the extent that (A) in the reasonable judgment of Sellers, any applicable Law requires Sellers to restrict or prohibit access to any information, (B) in the reasonable judgment of Sellers, the information is subject to confidentiality obligations to a third party, or (C) disclosure of any such information or document could result in the loss or waiver of the attorney-client or other applicable privilege. If Sellers seek to withhold information from Purchaser for any reason permitted by this Section 6.1 , Sellers and Purchaser shall cooperate in good faith to implement appropriate and mutually agreeable measures to permit the disclosure of such information in a manner to remove the basis for the objection, including by arrangement of appropriate clean room procedures, redaction or entry into a customary joint defense agreement with respect to any information to be so provided. It is further agreed that, prior to Closing, except as contemplated by Section 6.7 , Purchaser and its Representatives shall not make any announcements or statements targeted at, or otherwise communicate directly with, any of the customers, manufacturers or suppliers of Sellers, in connection with the transactions contemplated by this
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Agreement, whether in person or by telephone, mail or other means of communication, without the specific prior authorization by Sellers, which authorization shall not be unreasonably withheld, conditioned or delayed.
(b) All information received by Purchaser and given by or on behalf of Sellers in connection with this Agreement and the transactions contemplated hereby shall be held by Purchaser and its Affiliates, agents and Representatives as Evaluation Material, as defined in, and pursuant to the terms of, the Confidentiality Agreement.
(c) No information or access provided to a Party or its Representatives pursuant to this Section 6.1 , or any other investigation made by or on behalf of such Party, shall affect or be deemed to modify any of the representations or warranties of the other Party contained in this Agreement, the Ancillary Agreements or any agreement or certificate delivered in connection herewith and therewith, any covenants or agreements by such other Party hereunder or thereunder, or the conditions hereunder to the obligations of such Party.
(d) Each Party hereto shall give prompt written notice to the other Party hereto, of any event, state of facts, occurrence, circumstance, development or change that, individually or in combination with any other event, state of facts, occurrence, circumstance, development or change, individually or in the aggregate, with respect to Sellers, is or would reasonably be expected to have a Material Adverse Effect or, with respect to either Party, is or would reasonably be expected to cause any failure of any of the conditions hereunder to the obligations of either Party.
Section 6.2. Conduct .
(a) From and after the date hereof until the Closing, except (i) as set forth on Schedule 6.2 of the Disclosure Schedules or as otherwise expressly contemplated by this Agreement or (ii) as Purchaser shall otherwise consent in writing, which consent shall not be unreasonably withheld, Sellers agree that they shall conduct the Business in the ordinary course consistent with past practice, and to the extent consistent therewith, use commercially reasonable efforts to (w) maintain the assets of the Business in all material respects, (x) preserve intact the Business and the current relationships and goodwill of the Business with customers, suppliers and others having business dealings with the Business, (y) maintain the Books and Records in the usual, regular and ordinary manner, on a basis consistent with past practice and (z) comply in all material respects with applicable Law. From and after the date hereof until the Closing, except (i) as set forth on Schedule 6.2 of the Disclosure Schedules or as otherwise contemplated by this Agreement, or (ii) as Purchaser shall otherwise consent in writing, which consent shall not be unreasonably withheld, Sellers covenant and agree that, with respect to the Business, they shall:
(i) not incur, create or assume any Lien, other than Permitted Encumbrances;
(ii) not incur or suffer to exist any indebtedness except (A) for working capital borrowings incurred in the ordinary course of business, (B) incurrence of trade payables in the ordinary course of business consistent with past practice or (C) indebtedness
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incurred in the ordinary course of business pursuant to the Credit Facility or (D) indebtedness incurred solely in connection with Retained Liabilities or Excluded Assets;
(iii) not amend, modify or terminate any material term of, or waive any material right under, any Assumed Contract or Shared Contract except in the ordinary course of business;
(iv) not enter into any Contract, agreement or commitment that would constitute an Assumed Contract or a Shared Contract if it were in effect on the date of this Agreement;
(v) not divest, sell, assign, license, transfer, abandon, cancel, convey, lease or otherwise dispose of any assets that would constitute Purchased Assets;
(vi) not adopt a plan or agreement of complete or partial liquidation, dissolution, merger, consolidation, restructuring, recapitalization or other material reorganization of Sellers;
(vii) not change the accounting policies or procedures of the Business except to the extent required to conform with GAAP;
(viii) except in the ordinary course of business and consistent with past practice in all material respects, not (a) encourage contractual counterparties to make payments earlier than would otherwise reasonably be expected (based on historical patterns) to be made, (b) agree to payment terms or conditions with respect to the Business that are less favorable to the Business, (c) make any material change in the promotion, marketing, selling, distribution, advertising, terms of sale or collection practices, or (d) engage in the process of positioning Inventory with distributors, wholesalers, retailers or customers in excess of requirements or initiate or engage in any program, activity or other action (including any rebate, discount, chargeback or refund policy or practice) that could reasonably be expected to result, directly or indirectly, in sales or profits in excess of purchasing patterns that have been normal for the Business;
(ix) manage Inventory consistent with past practice over the past two (2) years in all material respects and in line with expected demand over the next twelve (12) months;
(x) not settle any Proceeding (i) that would (A) materially affect the conduct of operations of the Business with respect to any Product or (B) result in the Business being subject to any Governmental Order or other equitable relief or admission of wrongdoing or (ii) for an amount, individually or in the aggregate, exceeding $1,000,000; provided , that the foregoing shall not apply to any Proceeding that is solely related to a Retained Liability;
(xi) not withdraw, amend, modify or terminate any Product Registrations;
(xii) submit all adverse event reports required to be submitted to any Governmental Authority under any Law;
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(xiii) not dispose of or permit to expire, terminate or otherwise lapse any rights in, to or for the use of any Purchased Intellectual Property or the subject of any Intellectual Property License, or disclose to any Person any Purchased Intellectual Property or the subject of any Intellectual Property License not heretofore a matter of public knowledge, except pursuant to judicial or administrative process;
(xiv) not grant any license, covenant not to sue or other right under any Purchased Intellectual Property, or cancel, abandon or allow to lapse or expire any Purchased Intellectual Property;
(xv) not authorize, agree or resolve or consent to any of the foregoing.
(b) Nothing contained in this Agreement is intended to give Purchaser, directly or indirectly, the right to control or direct any of Sellers or their respective Affiliates businesses or operations prior to the consummation of the transactions contemplated by this Agreement. Prior to the consummation of the transactions contemplated by this Agreement, Sellers and Purchaser shall exercise, consistent with the terms and conditions of this Agreement, complete control and supervision over their and their Subsidiaries respective operations.
(c) Sellers and Seller Parent shall use their reasonable best efforts to take, or cause to be taken, all actions, and do, or cause to be done, all things necessary, proper or advisable to have Covis Pharma listed, as soon as possible after the date hereof and in any event no later than on the Closing Date, as the current owner of the Plaquenil ® ( Hydroxychloroquine Sulfate ) [REDACTED] (tablet) on the FDAs Orange Book and Drugs@FDA.gov websites.
(d) Sellers shall: (i) cause the CPI/Covis Injectables Distribution Contract to continue after Closing, notwithstanding any rights in favor of CPI therein to terminate such Contract in connection with the consummation of the transactions contemplated hereby; (ii) notwithstanding the provisions of this Section 6.2(d) , cause the specific provisions of the CPI/Covis Injectables Distribution Contract that relate to Lanoxin IV (Digoxin) to be terminated as of Closing; and (iii) at Closing, shall assign to Purchaser all of Sellers remaining rights and obligations under the CPI/Covis Injectables Distribution Contract.
Section 6.3. Regulatory Approvals .
(a) Subject to Section 6.3(b) and Section 6.3(c) and the terms and conditions set forth in this Agreement, each of Purchaser and Sellers shall cooperate with the other and use their respective reasonable best efforts to (i) prepare and file as promptly as practicable, and in any event within the time prescribed by any applicable Law or Antitrust Law, all documentation to effect all necessary notices, reports and other filings and to obtain as promptly as practicable all consents, registrations, approvals, permits and authorizations necessary or advisable to be obtained from, or renewed with, any Governmental Authority, in each case in order to consummate as promptly as practicable the transactions contemplated by this Agreement, (ii) furnish as promptly as practicable all information to any Governmental Authority as may be required by such Governmental Authority in connection with the foregoing and (iii) obtain all consents, registrations, approvals, permits and authorizations necessary, proper or advisable to be obtained from, or renewed with, any other Person, in each case in order to consummate as
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promptly as practicable the transactions contemplated by this Agreement; provided that under no circumstances shall Purchaser or Sellers be required to make any payment to any Person to secure such Persons consent. Notwithstanding the foregoing and without limiting the generality thereof, the Parties shall (a) prepare and file a notification with respect to the transactions contemplated by this Agreement pursuant to the HSR Act with the Federal Trade Commission and the Antitrust Division of the United States Department of Justice within ten (10) Business Days from the date hereof, and (b) seek early termination of any waiting periods under the HSR Act.
(b) Subject to appropriate confidentiality protections, each Party shall furnish to the other such necessary information and assistance as the other Party may reasonably request in connection with the preparation of any necessary filings or submissions for any Governmental Authority, and will keep the other Party reasonably informed with respect to any consent, authorization, order, approval, or exemption that is sought or received from any Governmental Authority in connection with this Agreement and the transactions contemplated hereby. Except as required by Law, each Party or its attorneys shall provide the other Party or its attorneys the opportunity to review and make copies of all correspondence, filings, communications or memoranda setting forth the substance thereof between such Party or its Representatives, on the one hand, and any Governmental Authority, on the other hand, with respect to this Agreement or the transactions contemplated in this Agreement (omitting any information that constitutes a competitively sensitive business secret of either Party). Each Party shall give sufficient notice to the other Party with respect to any meeting, discussion, appearance or contact with any Governmental Authority or the staff or regulators of any Governmental Authority in order to provide the other Party with the opportunity to attend and participate in such meeting, discussion, appearance or contact.
(c) Purchaser shall pay all filing fees in connection with any filings in connection with approvals of Governmental Authorities to the transactions contemplated hereby.
Section 6.4. Efforts to Consummate Generally . Subject to the terms and conditions of this Agreement (and without limiting the requirements of Section 6.3 ), each Party shall use its reasonable best efforts to cause the Closing to occur as soon as possible after the date hereof, including (i) satisfying the conditions precedent set forth in Article VII within the control of such Party, (ii) securing as promptly as practicable all consents, approvals, waivers and authorizations required in connection with the transactions contemplated hereby, (iii) effecting all registrations, filings and transfers (to the extent transferable) of Governmental Authorizations Related to the Business in a manner consistent with the operation of the Business during the one (1) year period immediately prior to the Closing and (iv) drafting, negotiating, executing and delivering to each other in good faith such other agreements, documents, instruments and/or certificates, and doing such other acts and things, as may be reasonably necessary or desirable for the implementation of this Agreement and the Ancillary Agreements and the consummation of the transactions contemplated hereby and thereby. In addition, Sellers shall use reasonable best efforts to give all notices to, make all filings with and obtain all third party consents, including the Third Party Consents, necessary or advisable to be obtained from any Persons (other than Governmental Authorities), necessary to consummate the transactions contemplated hereby and by the Ancillary Agreements without resulting in any breach or violation of, a default under, or an acceleration of any obligations or the creation of a Lien on the
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Business, the Products or the Purchased Assets (without the expenditure of any funds therefor other than filing, recordation or similar fees, which shall be shared equally by Sellers and Purchaser, as provided by Section 2.2 and except as contemplated by Section 6.11 concerning the Sellers obligation to repay and discharge all Existing Debt). In furtherance of the foregoing, promptly following the date of this Agreement and, in any event, within five (5) Business Days, Sellers and Purchaser shall agree upon a plan with respect to the Third Party Consents. Sellers and Purchaser agree to use their reasonable best efforts to obtain each such consent, and shall promptly consult with each other and provide to the other Party any information reasonably requested with respect thereto, and, following adequate notice of such meetings or discussions, permit the other to participate, to the extent legally permissible, in all meetings or discussions with any such third party in connection with this Agreement and the transactions contemplated by this Agreement. Sellers shall use their reasonable best effort to obtain, not later than thirty (30) days after the date of this Agreement, and shall thereafter promptly deliver, all Third Party Consents without any material change in the respective terms of the related Contracts, unless such changes are acceptable to Purchaser (it being understood that any such modification or amendment is not in the ordinary course of business as contemplated by Section 6.2(a)(iii) ). Purchaser shall use reasonable best efforts to assist Sellers in obtaining such Third Party Consents, including through the provision of such information regarding Purchaser as such third party may reasonably request in connection with obtaining such consent, but in no event shall any party or any of their respective Affiliates be required to pay any consideration to any third parties or to give anything of value in connection with Sellers efforts to obtain such Third Party Consents. To the extent any such Third Party Consent relates to a Contract is a Shared Contract, Sellers and Purchaser shall seek a partial assignment consistent with Section 6.16 of this Agreement, failing which, such Shared Contract, and any Assumed Contract the consent to assignment of which shall not have been obtained by the Closing, shall be deemed a non- assignable asset governed by Section 2.2 .
Section 6.5. Bulk Transfer Laws . Purchaser hereby waives compliance by Sellers with the requirements and provisions of any bulk transfer Laws applicable to trade creditors of any jurisdiction that may otherwise be applicable with respect to the sale of any or all of the Business, the Products or the Purchased Assets to Purchaser. Each Party acknowledges and agrees that the foregoing waiver shall not limit either Partys indemnity obligations in respect of Taxes, as provided in Article VIII .
Section 6.6. Insurance . As of the Closing Date, the coverage under all insurance policies Related to the Business shall continue in force only for the benefit of Sellers and not for the benefit of Purchaser or any of its Affiliates. Purchaser agrees to arrange for its own insurance policies with respect to the Purchased Assets covering all periods and agrees not to seek to benefit from any of Sellers insurance policies that may provide coverage for claims relating in any way to the Purchased Assets prior to the Closing.
Section 6.7. Trade Notification . Subject to the provisions of Section 6.4 concerning the Parties obligations with respect to Third Party Consents, Sellers and Purchaser shall mutually agree on the method and content of written notifications to manufacturers, distributors, suppliers, customers and other third parties of the sale of the Purchased Assets to Purchaser and prior to the Closing, Purchaser may communicate with manufacturers, suppliers, distributors and customers of the Business with the prior consent of the Chief Executive Officer
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of either Seller, in accordance with Section 6.1 ; provided , however , that a Representative of Seller must be present during any such communication. Sellers and Purchaser agree that said notifications are to provide sufficient advance notice to customers of the sale and the plans associated therewith, so as to provide a smooth transition of the Business from Sellers to Purchaser.
Section 6.8. Seller-Labeled Products .
(a) From and after Closing, Purchaser and its Affiliates may use, reproduce and display, and Sellers hereby grant (effective upon Closing) to Purchaser and its Affiliates a non-exclusive, paid-up and royalty-free right and license to use, reproduce and display, the Trademark Rights and trade dress of Sellers, and shall use their reasonable best efforts to cause CPI to grant (effective upon Closing) to Purchaser such right in respect of the NDC Numbers, Trademark Rights and trade dress related to the Products to the extent CPI owns such rights, solely to the extent the foregoing are affixed to (i) the Inventory of finished, packaged Products that are included in the Purchased Assets and/or (ii) quantities of finished, packaged Products that are manufactured, within six (6) months after the Closing Date, for or on behalf of Purchaser or its Affiliates (Products subject to subsection (ii), the Seller-Labeled Products ); provided that (a) except for any Seller-Labeled Products and the Inventory, as of the date that is six (6) months after the Closing Date, Purchaser and its Affiliates shall cease and discontinue all use of such Trademark Rights, trade dress and NDC Numbers of Sellers or CPI, provided further that, with respect to any Seller-Labeled Products and the Inventory, the license set forth in this Section 6.8(a) shall continue until Purchaser and its Affiliates have disposed of all such Seller- Labeled Products and Inventory and (b) Purchaser shall provide Sellers, within a reasonable time, with written notice of the date and expiration date of the last lot of each Product sold that is included within the Seller-Labeled Products.
(b) Except as set forth in Section 6.8(a) and except for the NDC Numbers, the Trademark Rights that will be licensed to Purchaser under the Transition Services Agreement, and the Trademark Rights that are included in the Purchased Assets, Purchaser and its Affiliates shall have no right under this Agreement to use any of the trademarks, service marks, brand names, certification marks, trade dress, logos or domain names containing Covis, or any word or expression confusingly similar thereto or constituting an abbreviation or extension thereof or any logos containing or comprising the foregoing or any NDC Numbers of Sellers.
Section 6.9. NDC Numbers .
(a) Purchaser shall fully reimburse Sellers for any increased cost or Liability (including any returns, Rebates or Chargeback Claims) associated with any changes in pricing, including any changes in wholesale acquisition cost, made by Purchaser or any of its Affiliates to any Product that bears an NDC Number of Sellers or CPI. Purchaser shall notify Sellers immediately of any such changes in pricing to a Product that bears an NDC Number of Sellers or CPI.
(b) Purchaser shall fully cooperate with Sellers and CPI by providing whatever assistance, product sales and other information and access as may be required by Sellers or CPI to comply with any reporting obligations that arise as a result of the sale by
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Purchaser of Product bearing an NDC Number of Sellers or CPI, and to audit the Books and Records of Purchaser and its Affiliates with respect to any such sales (provided that such audit takes place upon reasonable advance written notice to Purchaser, during normal business hours of Purchaser and does not materially interfere with Purchasers business). Purchaser represents and warrants that all Product sales and other information provided to Sellers in connection with the foregoing shall be accurate and complete in all material respects, and shall be calculated in accordance with applicable Laws and regulatory guidance.
(c) Subject to appropriate confidentiality protection, after the Closing Date and for a period of ten (10) years thereafter (except with respect to government claims not subject to a statute of limitations, such as Medicaid rebate claims, which shall continue as long as there is potential for a claim), Purchaser and its Affiliates shall cooperate with Sellers and their Representatives, subject to confidentiality protections reasonably satisfactory to Purchaser, during normal business hours and upon reasonable advance notice, to provide reasonable access to records maintained by Purchaser and its Affiliates relating to Purchaser and its Affiliates distribution of Seller-Labeled Products or related regulatory filing and reporting requirements and activities with respect to Seller-Labeled Products, including, without limitation, government price reporting ( Distribution Activities ), to provide reports reasonably requested by Sellers regarding such records and information, and to permit copying at the expense of Sellers or, where reasonably necessary, to loan original documents relating to the same for the purposes of (i) any financial reporting or Tax matters relating to Distribution Activities, (ii) any claims or litigation involving Distribution Activities or (iii) any investigation being conducted by any federal, state or local Governmental Authority relating to Distribution Activities.
Section 6.10. Financing .
(a) Purchaser and Purchaser Parent shall use their reasonable best efforts to take, or cause to be taken, all actions, and do, or cause to be done, all things necessary, proper or advisable to obtain the proceeds of the Financing on the terms and conditions described herein and in the Commitment Letter prior to the Outside Date, including (i) maintaining in effect the Commitment Letter, (ii) negotiating definitive agreements with respect to the Financing (the Definitive Agreements ) consistent with the terms and conditions contained therein (including, as necessary, the flex provisions contained in any related fee letter) or, if available, on other terms that are acceptable to Purchaser and Purchaser Parent and not materially less favorable, taken as a whole to Purchaser or Purchaser Parent than the terms set forth in the Commitment Letter and would not adversely affect (including with respect to timing) the ability of Purchaser to consummate the transactions contemplated herein and (iii) satisfying on a timely basis all conditions applicable to Purchaser Parent, Purchaser and their respective Subsidiaries in the Commitment Letter and the Definitive Agreements. Each of Purchaser and Purchaser Parent shall use its reasonable best efforts to comply with its obligations, and shall enforce its rights under the Commitment Letter and Definitive Agreements, including by seeking specific performance, in each case in a timely and diligent manner.
(b) Each of Purchaser and Purchaser Parent shall not, without the prior written consent of Sellers, (i) permit any amendment or modification to, or any waiver of any provision or remedy under, the Commitment Letter if such amendment, modification or waiver would reasonably be expected to (A) prevent or delay the Closing Date from occurring, (B) reduce the
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aggregate amount of the Financing, (C) adversely affect the ability of Purchaser or Purchaser Parent to enforce its rights against other parties to the Commitment Letter or the Definitive Agreements as so amended or modified, relative to the ability of Purchaser or Purchaser Parent to enforce its rights against such other parties to the Commitment Letter as in effect on the date hereof or in the Definitive Agreements or (D) make the funding of the Financing materially less likely to occur, other than (x) a waiver of any closing conditions by Financing Sources or their agents or (y) to add Financing Sources, lead arrangers, bookrunners syndication agents or similar entities that have not executed the Commitment Letter as of the date hereof; or (ii) release, terminate or consent to the release or termination of the obligations of any Financing Sources or other Persons under the Commitment Letter. Purchaser and Purchaser Parent shall promptly (but in any event within two (2) days of receipt of any such proposed amendment, modification, waiver, release, termination or consent, or notice thereof) deliver to Sellers copies of any such proposed amendment, modification, waiver, release, termination or consent.
(c) In the event that any portion of the Financing becomes unavailable, regardless of the reason therefor, each of Purchaser and Purchaser Parent shall (i) use its reasonable best efforts to obtain alternative debt financing (in an amount sufficient, when taken together with Purchasers and Purchaser Parents cash and marketable securities on hand and the available portion of the Financing, to consummate the transactions contemplated by this Agreement and to pay related fees and expenses) from the same or other sources and which do not include any conditions to the consummation of such alternative debt financing that are more onerous to Purchaser and Purchaser Parent than the conditions set forth in the Financing and are otherwise on terms no less favorable to Purchaser and Purchaser Parent than such unavailable Financing (including the flex provisions) and (ii) promptly (but in any event within two (2) days of receipt of notice of the unavailability of all or any portion of the Financing) notify Sellers of such unavailability and, to Purchasers knowledge, the reason therefor. For the purposes of this Section 6.10 , the term Commitment Letter shall be deemed to include any commitment letter (or similar agreement) with respect to any alternative financing arranged in compliance herewith (and any Commitment Letter remaining in effect at the time in question) and the term Financing shall be deemed to include any financing contemplated by any commitment letter as permitted by this Section 6.10 to be amended or modified or replaced by any alternative financing arranged in compliance herewith. Purchaser and Purchaser Parent shall provide Sellers with prompt (but in any event within two (2) days of receipt of notice regarding any of the items hereinafter set forth) written notice if (A) to the Knowledge of Purchaser, there exists any breach or default by any party to the Commitment Letter, any letter or agreement related thereto or the Definitive Agreements or any termination of the obligations of any Financing Sources or other Persons under the Commitment Letter, (B) Purchaser or Purchaser Parent receives any written notice or other written communication from any Financing Source or other source with respect to any actual or threatened breach, default, termination or repudiation by any party to any Commitment Letter or the Definitive Agreements of any provision thereof or (C) for any reason, Purchaser or Purchaser Parent no longer believes in good faith that it will be able to obtain all or any portion of the Financing contemplated by the Commitment Letter on the terms described therein. Purchaser and Purchaser Parent shall keep Sellers reasonably informed of the status of its efforts to consummate the Financing.
(d) Prior to the Closing, Sellers shall use their reasonable best efforts to provide, and to cause their respective Representatives (other than their lenders) to use their
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reasonable best efforts to provide, upon reasonable notice from Purchaser and at reasonable times, all customary cooperation in connection with the arrangement, syndication and consummation of the Financing (including any equity financing) contemplated by the Commitment Letter, which shall be limited to the following: (i) using their reasonable best efforts to furnish to Purchaser, Purchaser Parent and Financing Sources, as promptly as practicable, the Required Information; (ii) participating in a reasonable number of meetings (including conference calls with the parties acting as agents, lead arrangers, lead bookrunners for the Financing (including any equity financing) and senior management and the employees, investment bankers, attorneys, accountants and other Representatives of Purchaser or Purchaser Parent), drafting sessions, due diligence sessions and sessions with ratings agencies, in each case that are customary for financings of a type similar to the Financing (including any equity financing), in each case, at times and locations mutually agreed upon and upon reasonable advance notice; (iii) assisting in a commercially reasonable manner Purchaser, Purchaser Parent and their Financing Sources in the preparation of any offering documents, prospectus, syndication documents and materials, including confidential information memoranda, private placement memoranda, offering memoranda, lender and investor presentations, bank information memoranda, rating agency materials and similar documents contemplated therein as reasonably requested by Purchaser or Purchaser Parent and customary for financings of a type similar to the Financing (including any equity financing) (collectively, the Offering Documentation ); (iv) reasonably cooperating with the marketing efforts of Purchaser, Purchaser Parent and Financing Sources for any of such Financing (including any equity financing); (v) subject to the occurrence of the Closing, executing and delivering any customary representation and authorization letters to accountants and auditors, customary closing certificates and any other certificates, letters and documents, in each case as may be reasonably requested by Purchaser or Purchaser Parent and customary for financings of a type similar to the Financing (including any equity financing); (vi) using reasonable best efforts to facilitate the obtaining of (A) audit reports, authorization letters and consents of accountants and auditors with respect to financial statements and other financial information for the Purchased Assets, in each case as may be reasonably requested by Purchaser and customary for financings of a type similar to the Financing (including any equity financing), for inclusion in any Offering Documentation, and (B) subject to the occurrence of the Closing, legal opinions of internal and local legal counsel, in each case as reasonably requested by Purchaser and customary for financings similar to the Financing; (vii) subject to the occurrence of the Closing, otherwise reasonably facilitating the granting of a security interest (and perfection thereof) in collateral, the pay-off of Existing Debt and the release of related Liens, guarantees and other security interests, in each case as may be reasonably requested by Purchaser and customary for financings of a type similar to the Financing; (viii) at times and locations mutually agreed upon and upon reasonable advance notice, permitting the Financing Sources and lenders involved in the Financing to conduct due diligence, collateral audits and appraisals and evaluate the Purchased Assets for the purposes of consummating the Financing and establishing collateral arrangements as of the Closing (and providing all relevant information or documentation, in each case as may be reasonably requested and customary for financings of a type similar to the Financing); (ix) subject to the occurrence of the Closing, using commercially reasonable efforts to obtain waivers, consents, estoppels, approvals, authorizations and instruments, in each case as may be reasonably requested by Purchaser or Purchaser Parent and customary for financings of a type similar to the Financing (including any equity financing); and (x) taking all corporate actions, subject to the
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occurrence of the Closing, necessary and reasonably requested by Purchaser or Purchaser Parent to permit the consummation of the Financing on the Closing Date to consummate the transactions contemplated by this Agreement; provided , that (A) all material, non-public information regarding the Purchased Assets and Sellers and their Affiliates provided to Purchaser, Purchaser Parent, any lender or Financing Source or any other Person pursuant to this Section 6.10 that is not disclosed in the Offering Documentation shall be kept confidential by them in accordance with the terms of the Confidentiality Agreement, in the case of Purchaser or Purchaser Parent, or a confidentiality agreement on terms substantially identical to those set forth in the Confidentiality Agreement or customarily used in connection with financing transactions similar to the Financing, in the case of any other Person, and (B) none of any Seller or any of its Affiliates shall be required to (i) commit to take any action that is not contingent upon the Closing (including the entry into any agreement) or that would be effective prior to the Closing that would otherwise subject any of them to actual or potential Liability or fee, cost or expense in connection with the Financing or (ii) take any action to the extent that it would, in Sellers reasonable, good faith judgment, (x) unreasonably interfere with the business or operations of Sellers or their Affiliates, (y) violate any applicable Law or (z) be reasonably likely to result in the waiver of any attorney-client privilege, the unauthorized disclosure of any trade secrets of third parties or the breach of any applicable confidentiality obligations; provided , further , that Purchaser and Purchaser Parent shall promptly upon request by Sellers (but in any event within two (2) days of receipt of such request), reimburse Sellers for all reasonable and documented out-of-pocket third-party costs and expenses (including reasonable attorneys fees) incurred by Sellers and their Affiliates and each of their respective officers, directors, member of management, employees and other Representatives in connection with the cooperation contemplated by this Section 6.10 . Purchaser and Purchaser Parent shall indemnify and hold harmless the Seller Indemnified Parties from and against any and all Losses suffered or incurred by any of them in connection with the arrangement of the Financing, including any action taken in accordance with this Section 6.10 , and any information utilized in connection therewith (other than such Losses solely relating to or arising out of the gross negligence or willful misconduct of Sellers as determined by the final non-appealable judgment of a court of competent jurisdiction).
(e) Notwithstanding anything in this Agreement to the contrary, the Parties acknowledge and agree that Purchasers obligation to consummate the transactions contemplated by this Agreement shall not be conditioned on Purchasers or Purchaser Parents receipt of the proceeds of the Financing or any other financing undertaken in connection therewith and Purchaser and Purchaser Parent reaffirm their obligations to consummate the transactions contemplated by this Agreement on the terms and subject to the conditions set forth herein, regardless of the availability of, or the ability to obtain, the Financing or the compliance by Sellers with the provisions of this Section 6.10 .
Section 6.11. Existing Debt .
(a) At or prior to the Closing, Sellers shall, and shall cause their respective Affiliates where relevant to, have (a) repaid and discharged all Existing Debt (including all interest accrued thereon and all fees, charges or premiums or other ancillary obligations, which are then due and payable therewith) (other than unsecured contingent liabilities which by the terms of the Existing Debt survive termination) and (b) caused all commitments related to such Existing Debt to be terminated without any Liability to Purchaser.
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(b) Sellers shall deliver to Purchaser at or immediately prior to the Closing Date customary pay-off letters, in form and substance reasonably acceptable to Purchaser, from the administrative agent under the Existing Debt, and shall make arrangements for the release of all Liens on the Purchased Assets securing its obligations under the Existing Debt, together with the return of any collateral in the possession of the administrative agent, at or immediately prior to the Closing Date.
Section 6.12. Non-Solicitation .
(a) For a period of one (1) year commencing on the Closing Date, neither Purchaser, on the one hand, nor Sellers, on the other hand, shall solicit (or cause to be solicited) any officer, management employee or key technical employee of Sellers and their Affiliates or of Purchaser and its Affiliates, respectively, who is at the time of such solicitation an officer, management employee or key technical employee of such Party; provided that the foregoing restriction shall not apply to (i) generalized searches by use of advertising placed in publicly available media, including any such Partys website, through attendance at trade or industry conferences or recruiting efforts (including the use of search firms) which are not specifically targeted at any such officer, management employee or key technical employee or (ii) the recruitment of any such officer, management employee or key technical employee whose employment has been terminated by such Party prior to such recruitment.
(b) It is the intention of the Parties that this Section 6.12 be enforced to the fullest extent permissible, and shall be deemed subject to automatic modification, to the extent necessary to remain enforceable. The unenforceability (or the modification to conform to applicable Law) of any aspect of this Section 6.12 shall not render unenforceable or impair, the remainder of this Section 6.12 . Accordingly, if any aspect of this Section 6.12 shall be determined to be invalid or unenforceable, such invalidity or unenforceability shall be deemed to apply only with respect to the operation of such aspect of this Section 6.12 in the particular jurisdiction in which such determination is made and not with respect to any other aspect of this Section 6.12 or any other jurisdiction.
Section 6.13. No-Shop .
(a) From the date hereof until the Closing or earlier termination of this Agreement, Sellers and their Affiliates shall not, and shall not authorize or permit any of their Representatives to, directly or indirectly, (i) knowingly encourage, solicit, initiate, facilitate or continue inquiries regarding an Acquisition Proposal; (ii) enter into discussions or negotiations with, or provide any information to, any Person concerning a possible Acquisition Proposal other than to state that Sellers, their Affiliates and each of their Representatives are restricted from entering into, continuing or participating in such discussions or negotiations pursuant to the terms of this Section 6.13 ; or (iii) enter into any agreements or other instruments (whether or not binding) regarding an Acquisition Proposal. Sellers and their Affiliates shall immediately cease and cause to be terminated, and shall cause their Representatives to immediately cease and cause to be terminated, all existing discussions or negotiations with any Persons conducted heretofore with respect to, or that could reasonably be expected to lead to, an Acquisition Proposal and shall revoke all access in favor of any Person (other than Purchaser, Purchaser Parent and their respective Representatives and Purchasers Financing Sources and their respective
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Representatives) to any virtual data room established for the purposes of evaluating a potential acquisition of all or a part of the Business and will promptly request each Person that has heretofore executed a confidentiality agreement in connection with such Persons consideration of an acquisition of all or part of the Business return or destroy all confidential information heretofore furnished to such Person by or on behalf of Sellers, their Affiliates or any of their respective Representatives. For purposes of this Section 6.13 , Acquisition Proposal shall mean any inquiry, proposal or offer from any Person (other than Purchaser or any of its Affiliates) concerning (i) the direct or indirect disposition, whether by sale, merger or otherwise, of all or any portion of the Business to any Person other than Purchaser or Purchaser Parent; or (ii) the disclosure, directly or indirectly, to any Person of any confidential information or data concerning the Business except as necessary to conduct the Business in the ordinary course consistent with past practice.
(b) Each Seller agrees that the rights and remedies for noncompliance with this Section 6.13 shall include having such provision specifically enforced by any court having equity jurisdiction, it being acknowledged and agreed that any such breach or threatened breach shall cause irreparable injury to Purchaser and that money damages would not provide an adequate remedy to Purchaser.
Section 6.14. Transfer of Product Registrations, Related Applications and Dossiers .
(a) On the Closing Date, each Seller shall deliver a letter to the FDA transferring the rights to the Product Registrations to Purchaser (or its designee). On the Closing Date, Purchaser shall deliver a letter to the FDA assuming responsibility for the Product Registrations from Sellers. As soon as practical after the Closing Date and in no event more than sixty (60) calendar days following the Closing Date, each Seller shall deliver to Purchaser, or its Affiliate as directed by Purchaser, in physical and electronic form, the Registration Information and Regulatory Documentation.
(b) Promptly after the Closing and in any event within thirty (30) calendar days after the Closing, Sellers and Purchaser shall make all appropriate filings and submissions with Governmental Authorities, including the Centers for Medicare & Medicaid Services and the FDA to register the NDC Numbers in the name of Purchaser and transfer all regulatory responsibilities, excluding all Retained Liabilities and except as contemplated by Section 6.9 and Section 6.17 , attaching thereto of each Product, from Sellers to Purchaser.
(c) Without limiting the Parties respective obligations under Section 6.14(a) with respect to any Product that is marketed in the United States on the basis of an existing Product Registration, (i) each Seller shall use all commercially reasonable efforts to complete the transfer of the corresponding Product Registrations as promptly as practicable after the Closing Date to the benefit of Purchaser or its Affiliates as directed by Purchaser in accordance with this Section 6.14(c) and (ii) Purchaser or its Affiliates shall use all commercially reasonable efforts to assist Sellers in the transfer of such Product Registrations, accept the transfer of the corresponding Product Registrations and formalize with Sellers and any applicable Governmental Authority, as promptly as practicable after the Closing Date, all necessary
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documents. Following the transfer of the Product Registration, Sellers shall retain no rights in the Product Registration or Registration Information, including any rights to use or reference.
Section 6.15. Confidentiality . From and after the Closing:
(a) the Confidentiality Agreement will terminate without further action by the parties thereto.
(b) each Seller and Seller Parent shall treat as confidential and shall safeguard any and all information, knowledge and data included in the Purchased Assets (including with respect to the Business, the Products and the Assumed Liability) by using the same degree of care, but no less than a reasonable standard of care, to prevent the unauthorized use, dissemination or disclosure of such information, knowledge and data as any Seller or its Affiliates used with respect thereto prior to the execution of this Agreement.
(c) Purchaser and Purchaser Parent shall treat as confidential and shall safeguard any and all information, knowledge or data included in any information relating to the business of Sellers, other than the Business, the Products, the Purchased Assets or the Assumed Liabilities, and except as otherwise agreed to by Sellers in writing; provided , however , that nothing in this Section 6.15(c) shall prevent the disclosure of any such information, knowledge or data to any directors, officers or employees of Purchaser or Purchaser Parent to whom such disclosure is necessary or desirable in the conduct of the Business if such Persons are informed by Purchaser of the confidential nature of such information and are directed by Purchaser to comply with the provisions of this Section 6.15(c) .
(d) Purchaser, Purchaser Parent, Sellers and Seller Parent acknowledge that the confidentiality obligations set forth herein shall not extend to information, knowledge and data that is publicly available or becomes publicly available through no act or omission of the Party owing a duty of confidentiality, or becomes available on a non-confidential basis from a source other than the Party owing a duty of confidentiality so long as such source is not known by such Party to be bound by a confidentiality agreement with or other obligations of secrecy to the other Party.
(e) In the event of a breach of the obligations hereunder by Purchaser, Purchaser Parent, Sellers or Seller Parent, the non-breaching party, in addition to all other available remedies, will be entitled to injunctive relief to enforce the provisions of this Section 6.15 in any court of competent jurisdiction.
Section 6.16. Shared Contracts . Prior to the Closing, each Seller shall notify, or cause to be notified, the counterparties of the Shared Contracts of the impending transaction in order to effect the partial assignment of the Shared Contracts, to the extent they are Related to the Business, to Purchaser, by such Seller to Purchaser or to use its commercially reasonable efforts to obtain the prior consent of the counterparties to the partial assignment of such Shared Contracts, to the extent such consent is required under any Shared Contract. In no event shall either Seller or Purchaser or any of their respective Affiliates be required to pay any consideration to any third parties to obtain any such third partys authorization, approval, consent or waiver to effectuate such assignment pursuant to the foregoing, other than filing, recordation
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or similar fees which shall be shared equally by Sellers and Purchaser. Purchaser and Sellers shall act in good faith and reasonably cooperate in connection with the arrangement of the partial assignment or any other appropriate arrangement (including the jointly determined allocation of Sellers and Purchasers respective rights and obligations thereunder) in connection with the Shared Contracts. In the event that the Parties are unable to effect a partial assignment of such Shared Contracts to Sellers and to Purchaser at the Closing but may effect an assignment of such Shared Contract as a whole to Purchaser as contemplated by Section 2.1 , the parties will cooperate in good faith to provide suitable arrangements pursuant to which Purchaser shall in good faith pass through to Sellers the substantial equivalent of Sellers rights, benefits and obligations pursuant to such Shared Contract, to the extent such rights, benefits and obligations of the Shared Contract are not Related to the Business but relate solely to the Excluded Assets, following Purchasers acquisition of the Shared Contract pursuant to Section 2.1 . To the extent any such consent cannot be obtained, such Shared Contract shall be deemed a non-assignable asset governed by Section 2.2 .
Section 6.17. Product Returns, Rebates and Chargebacks .
(a) Product Returns . Except to the extent otherwise provided pursuant to the terms of the Transition Services Agreement:
(i) Prior to the Closing Date, all returns of Products, other than Products sold pursuant to AG Distribution Contracts, from lots that were sold entirely prior to Closing shall continue to be sent to Sellers designated return processor. All returns from lots that are sold entirely after Closing shall be sent to Purchaser and all returns of Transition Lots shall be sent to Purchaser. Returns will be processed in accordance with the then-current returned goods policy of the Party that made the corresponding original sale (which policies shall be provided to the other Party prior to the Closing Date).
(ii) From and after the Closing Date, Purchaser shall, or shall cause its distributor to, process and be financially responsible for all returns of Product that are from lots sold entirely after Closing. Sellers shall process and be financially responsible for all returns of Product, other than Products sold pursuant to AG Distribution Contracts, from lots sold entirely prior to the Closing Date. Purchaser and Sellers shall both be financially responsible for returns of the Transition Lots, on a proportional basis equal to the proportion of Product in such Transition Lots sold prior to and on or after the Closing Date (for example, if 40% of the Products in the Transition Lots were sold prior to the Closing Date and the remaining 60% were sold on or after the Closing Date, then Sellers shall be responsible for 40% of the costs and expenses associated with the returns of the Transition Lots and Purchaser shall be responsible for the remaining 60% of such costs and expenses).
(iii) For any Product that is returned to one Party but is the processing responsibility of the other Party, the Party receiving the return will destroy, or cause to be destroyed, all such Product and by the tenth (10 th ) Business Day of each month, provide the other Party a reporting of such Product returned, including documentation sufficient to determine any appropriate customer reimbursement or credit, which shall be processed according to the then-current returned goods policy of the Party that made the
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corresponding original sale. Each Party shall destroy, or cause to be destroyed, all such returned Product in a manner consistent with applicable Law and the costs of such destruction shall not be reimbursed.
(b) Rebates . Sellers and Purchaser to cooperate reasonably in the analysis of dispensing data relating to Rebates and will agree in a reasonable example allocation to assist the parties to calculate the Rebates in accordance with these provisions. Responsibility for rebates pursuant to any government rebate programs with respect to government claims for Products ( Government Rebates ) and for commercial rebates with respect to Products ( Commercial Rebates , collectively with Government Rebates, Rebates ) shall be allocated between Sellers and Purchaser as follows:
(i) Subject to Section 6.9(a) and Section 6.17(b)(iv) , Sellers shall be responsible for payment of any and all Rebates with respect to Products dispensed to patients on or prior to the Closing Date and any and all Rebates with respect to Products dispensed to patients on or before the forty-fifth (45 th ) day following the Closing Date (such period, the Rebate Tail Period ).
(ii) Purchaser shall be responsible for payment of any and all Rebates with respect to Products dispensed to patients beginning on the day following the expiration of the Rebate Tail Period.
(iii) With respect to Government Rebates, Purchaser shall have the right to request through Sellers any claims level data (dispense data) contained in any report from a state rebate program which shall be used for purposes of determining the date of such claim or for state rebate dispute purposes. In the event Purchaser determines an invoice or claim for a Government Rebate should be disputed, Sellers shall cooperate with Purchaser to dispute such claim or invoice.
(iv) Purchaser and Sellers further agree that (A) Sellers financial liability for Rebates shall be limited to those customers with which the Business has a rebate obligation as of the Closing Date, and (B) any payments by Sellers shall be made in accordance with Sellers rebate obligations on the Closing Date with respect to each customer and shall be solely based on the terms and conditions of Sellers agreements with the respective customer, as such terms and conditions existed as of the Closing Date.
(c) Chargeback Claims . Sellers shall be financially and legally responsible for all chargeback claims ( Chargeback Claims ) related to Products sold by the wholesaler or distributor prior to the Closing Date and during the thirty (30) day period following the Closing Date. Purchaser shall process and be financially and legally responsible for all Chargeback Claims related to Products sold on or after such period, but only to the extent such Chargeback Claims do not exceed $200,000 in the aggregate. If after the thirty (30) day period following the Closing Date such Chargeback Claims related to the Products exceed $200,000 in the aggregate the Parties shall determine, in accordance with this Section 6.17(c) , whether any such Chargeback Claim relates to Products sold before or after the Closing Date, with the Sellers assuming financial and legal responsibility for those Chargeback Claims which relate to sales occurring prior to the Closing Date and during the thirty (30) day period following the Closing
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Date, and the Purchaser assuming financial and legal responsibility for those Chargeback Claims which relate to sales occurring after the Closing Date. For the purposes of this Section 6.17(c) , the date on which Products shall be deemed to have been sold shall be the date on which it was shipped by the applicable wholesaler. Notwithstanding the foregoing, the Parties acknowledge that the removal of Products from CPIs Federal Supply Schedule must be approved before the responsibility of processing such claims is transferred from Sellers to Purchaser. Sellers will use reasonable best efforts to obtain such approval as promptly as possible after the Closing Date. Until such approval is obtained, Sellers shall continue to be responsible for processing the Federal Supply Schedule Chargeback Claims on Purchasers behalf, and Purchaser shall reimburse Sellers for same as set forth below. Purchaser and Sellers agree that (A) Sellers financial liability for the Chargeback Claims shall be limited to those commercial customers with which Sellers or CPI have chargeback obligations as of the Closing Date, and (B) any such Chargeback Claims issued by Sellers shall be made in accordance with terms and conditions of Sellers obligations as of the Closing Date with respect to each customer and shall be solely based on the terms and conditions of Sellers or CPIs agreements with the respective customer, as such terms and conditions existed as of the Closing Date. Sellers shall utilize records from third-party rebate administrators to demonstrate which chargebacks relate to Products sold by the wholesaler or distributor prior to or during the thirty (30) day period following the Closing Date for purposes of determining Sellers obligation. The foregoing provisions of this Section 6.17(c) shall apply except to the extent otherwise provided pursuant to the terms of the Transition Services Agreement.
(d) Reimbursement .
(i) If either Party (the Non-Responsible Party ) receives (y) an invoice with respect to any of the Rebates or (z) a Chargeback Claim, in each case that is the responsibility of the other Party (the Responsible Party ), such Non-Responsible Party shall promptly provide a copy of such invoice or Chargeback Claim, as applicable, to the Responsible Party and such Responsible Party shall have fifteen (15) calendar days following receipt of such invoice or Chargeback Claim, as applicable, to notify the Non-Responsible Party that it intends to dispute such invoice or Chargeback Claim, as applicable. If the Responsible Party does not so notify the Non-Responsible Party within such fifteen (15) calendar day period, such Non-Responsible Party shall be permitted to remit payment in respect of such invoice or Chargeback Claim, as applicable, on the Responsible Partys behalf and the Responsible Party shall reimburse the Non-Responsible Party for such payment pursuant to the terms of Section 6.17(d)(ii) below. If the Responsible Party provides such notice to the Non-Responsible Party within such fifteen (15) calendar day period then the Responsible Party shall promptly initiate a dispute of such invoice or Chargeback Claim, as applicable, at its sole cost and expense and shall be liable for all reasonable costs and expenses (including reasonable attorney fees) of the Non-Responsible Party required to prosecute the disputed invoice or Chargeback Claim, as applicable. In the event that an invoice or Chargeback Claim, as applicable, is disputed under this Section 6.17(d)(i) by the Responsible Party, the Non-Responsible Party shall not remit payment in respect of such invoice without the Responsible Partys prior written consent; provided , that any late fees, interest or other penalties that are ultimately owing due to delayed payment on such invoice or Chargeback Claim, as applicable, shall be satisfied by the Responsible Party and
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provided , further , that notwithstanding the foregoing, the Non-Responsible Party may, in its sole discretion, pay any such disputed invoice or Chargeback Claim, as applicable, without the consent of the Responsible Party, but in such case the Non-Responsible Party shall be entitled to reimbursement by the Responsible Party only with respect to amounts if any, that are finally owing following settlement of the related dispute.
(ii) Subject to Section 6.17(d)(i) , to the extent that a Non-Responsible Party (y) remits payment in respect of any of the Rebates or (z) processes Chargeback Claims which are payable by or the responsibility of, as applicable, the Responsible Party, the Responsible Party shall reimburse the other Party on or before the date that is thirty (30) calendar days following receipt of such invoices by such Non-Responsible Party, provided , that such invoices describe in reasonable detail the payments made by such Non-Responsible Party.
Section 6.18. Know-How License . Effective as of the Closing, each Seller hereby grants to Purchaser a perpetual, irrevocable, transferable (as set forth in this Section 6.18 ), sublicensable (as set forth in this Section 6.18 ), non-exclusive, paid-up, royalty-free, worldwide right and license to use and otherwise exploit the Licensed Know-How of such Seller in developing, commercializing, manufacturing, using, packaging, marketing, promoting, importing, exporting, researching, transporting, selling and distributing the Products. Purchaser may (but it is not obligated to) transfer the foregoing license, and/or grant sublicenses thereunder, to (a) any of its Affiliates, and (b) any acquirer of any of the assets or business of Purchaser and its Affiliates relating to any of the Products.
Section 6.19. Ancillary Agreements .
(a) As soon as reasonably practicable after the date hereof and prior to the Closing, each of the Purchaser and Sellers shall, and shall cause each of their respective Affiliates where relevant to, cooperate promptly and in good faith (i) to finalize in definitive form each of the Ancillary Agreements, (ii) to negotiate and reach agreement on a definitive form of each of such other agreements, documents, instruments and/or certificates that may be reasonably necessary or desirable for the implementation of this Agreement and the Ancillary Agreements and the consummation of the transactions contemplated hereby and thereby ( Additional Ancillary Agreement ). With respect to each Ancillary Agreement for which a summary of principal terms is included as a covenant in this Agreement, or for which a term sheet is attached to this Agreement as an Exhibit, the definitive form of such Ancillary Agreement to be executed and delivered by the applicable parties at Closing shall be on the terms and conditions set forth in such covenant or Exhibit as applicable and shall contain such other customary terms and conditions as are reasonably agreed between the Parties or required by applicable Law; provided , that if either Party proposes a modification to an Ancillary Agreement that is not included in the principal terms included in this Agreement and to which the other Parties do not agree as of the Closing (after cooperating in good faith as required by this Section 6.19 ), the Parties shall execute the Ancillary Agreement on the basis of the principal terms included in this Agreement.
(b) To the extent that, notwithstanding such good faith efforts, the Parties are unable to reach agreement on a material term or condition of an Ancillary Agreement or of an
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Additional Ancillary Agreement, then each Party shall designate a senior personnel for the functional area to which the services relate to handle such dispute and the Parties shall cause such designees to meet as promptly as practicable and use their respective reasonable best efforts to resolve such dispute within a reasonable period of time.
(c) At the Closing, Sellers and Purchaser shall, and shall cause each of their respective Affiliates where relevant to, execute the Ancillary Agreements and, as the case may be, the Additional Ancillary Agreements.
Section 6.20. Correspondence . Each Seller authorizes Purchaser on and after the Closing Date to receive and open all mail and other communications received by Purchaser relating to the Business and to deal with the contents of such communications in good faith and in a proper manner. Each Seller shall use commercially reasonable efforts to promptly deliver, or cause to be delivered, to Purchaser any mail or other communications received by any Seller from any Person (including the FDA) intended for the Business (including any mail or other communications in respect of the Products, the subject matter of this Agreement and the Ancillary Agreements).
Section 6.21. Escrow Account .
(a) At or prior to the Closing, Purchaser, each Seller and the Escrow Agent shall enter into the Escrow Agreement. Any distributions to Purchaser Indemnified Parties from the Escrow Account shall be made pursuant to joint written instructions of Purchaser and Sellers to the Escrow Agent instructing the Escrow Agent to make such distributions in accordance with the terms of the Escrow Agreement.
(b) Any Escrow Funds as of the twelfth (12 th ) month anniversary of the Closing Date (minus the aggregate amount reserved in respect of claims made, but not yet resolved prior to such date, in favor of Purchaser Indemnified Parties pursuant to this Agreement) shall be automatically released to Sellers in accordance with the terms of the Escrow Agreement. At any time following the twelfth (12 th ) month anniversary of the Closing Date, to the extent the Escrow Funds reserved in respect of unresolved claims exceed the aggregate amount claimed by the Purchaser Indemnified Parties pursuant to claims as of such date not yet resolved but made prior to such twelfth (12 th ) month anniversary of the Closing Date, the excess funds shall be promptly released to Sellers in accordance with the terms of the Escrow Agreement.
ARTICLE VII
CONDITIONS TO CLOSING
Section 7.1. Conditions to the Obligations of Purchaser and Sellers . The respective obligations of each of the Parties to consummate the transactions contemplated by this Agreement shall be subject to the satisfaction (or waiver to the extent legally permissible) prior to the Closing of the following conditions precedent:
(a) No Injunction . There shall be no Governmental Order or Law in existence that prohibits or restrains the transactions contemplated by this Agreement or the Ancillary
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Agreements, and there shall be no Proceeding pending by any Governmental Authority seeking such a Governmental Order;
(a) HSR and Other Required Approvals . The waiting periods required under the HSR Act, including any extensions thereof, shall have expired or been terminated.
Section 7.2. Conditions to the Obligations of Purchaser . The obligation of Purchaser to consummate the transactions contemplated by this Agreement shall be subject to the satisfaction (or waiver) at or prior to the Closing of the following conditions precedent:
(a) Representations and Warranties . The representations and warranties of Sellers set forth in Section 4.1 ( Organization ), Section 4.2 ( Authority; Binding Effect ), Section 4.5(a)(i) ( Absence of Material Changes ), Section 4.7(a) ( Compliance with Laws ), Section 4.8(b) ( Product Registrations; Regulatory Compliance ), Section 4.10 ( Assets ), Section 4.14 ( Brokers ) and Section 4.19 ( Chief Executive Office ) (collectively, the Sellers Fundamental Representations ), shall each be true and correct in all material respects as of the date hereof and as of the Closing Date as though made on and as of such date and time (or, for representations and warranties that refer specifically to an earlier date, shall have been true and correct, as of such specified date). Each other representation and warranty of Sellers contained in Article IV hereof (other than the Sellers Fundamental Representations) shall be true and correct (disregarding all material, materially, materiality, Material Adverse Effect or other similar materiality qualification) as of the date hereof and as of the Closing Date as though made on and as of such date and time (or, for such of these representations and warranties that refer specifically to an earlier date, shall have been true and correct, as of such specified date), except where the failure of any such representation and warranty to be so true and correct, individually or in the aggregate, would not reasonably be expected to result in a Material Adverse Effect. Purchaser shall have received a certificate of Sellers, dated as of the Closing Date and signed by a duly authorized executive officer of each Seller in such capacity, certifying as to the fulfillment of the foregoing.
(b) Performance . Each Seller shall have performed and complied in all material respects with all agreements and obligations contained in this Agreement required to be performed by it at or before the Closing. Purchaser shall have received a certificate of Sellers, dated as of the Closing Date and signed by a duly authorized executive officer of each Seller in such capacity, certifying as to the fulfillment of the foregoing.
(c) Indebtedness . At the Closing, the Existing Debt (including all principal, interest, fees, prepayment premiums and penalties, if any) and all Liabilities thereto shall have been repaid and discharged in full, all Liens in or upon any of the Products or Purchased Assets arising from or in connection with such Existing Debt shall have been satisfied, released and discharged and Purchaser shall have received copies of customary pay-off letter(s) from each such creditor and copies of any and all releases of creditors Liens evidencing same.
(d) Closing Deliverables . Sellers shall have made or caused to be made delivery to Purchaser of the items required by Section 3.1(b) .
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Section 7.3. Conditions to the Obligations of Sellers . The obligation of Sellers to consummate the transactions contemplated by this Agreement shall be subject to the satisfaction (or waiver) at or prior to the Closing of the following conditions precedent:
(a) Representations and Warranties . The representations and warranties of Purchaser set forth in Section 5.1 ( Organization ), Section 5.2 ( Authority; Binding Effect ) and Section 5.7 ( Brokers ) (collectively, the Purchasers Fundamental Representations), shall each be true and correct in all material respects as of the date hereof and as of the Closing Date as though made on and as of such date and time (or, for representations and warranties that refer specifically to an earlier date, shall have been true and correct in all respects as of such specified date). Each representation and warranty of Purchaser contained in Article V hereof (other than the Purchasers Fundamental Representations) shall be true and correct as of the date hereof and as of the Closing Date as though made on and as of such date and time (or, for representations and warranties that refer specifically to an earlier date, shall have been true and correct, as of such specified date), except where the failure of any such representations and warranties to be so true and correct, individually or in the aggregate, would not prevent, materially delay or materially impair Purchasers ability to effect the Closing. Sellers shall have received a certificate of Purchaser, dated as of the Closing Date and signed by a duly authorized executive officer of Purchaser in such capacity, certifying as to the fulfillment of the foregoing.
(b) Performance . Purchaser shall have performed and complied in all material respects with all agreements and obligations contained in this Agreement required to be performed by it at or before the Closing. Sellers shall have received a certificate of Purchaser, dated as of the Closing Date and signed by a duly authorized executive officer of Purchaser in such capacity, certifying as to the fulfillment of the foregoing.
(c) Closing Deliverables . Purchaser shall have made or caused to be made delivery to Sellers of the items required by Section 3.1(c) .
Section 7.4. Frustration of Closing Conditions . None of the Sellers or Purchaser may rely on the failure of any condition set forth in this Article VII to be satisfied if such failure was caused by such Partys (or in the case of Purchaser, Purchaser Parent, or in the case of Seller, Seller Parent) failure to act in good faith or to use its reasonable best efforts to cause the Closing to occur, as required by Section 6.4 .
ARTICLE VIII
INDEMNIFICATION
Section 8.1. Indemnification by Sellers .
(a) Subject to the provisions of this Article VIII , from and after the Closing, Sellers agree to defend, indemnify and hold harmless Purchaser and its Affiliates, and, if applicable, their respective directors, officers, agents, employees, successors and assigns, each in their capacity as such (collectively, the Purchaser Indemnified Parties ) from and against any and all Losses to the extent arising or resulting from (i) any Retained Liability other than a [REDACTED], (ii) any breach by a Seller of any of its covenants or agreements
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contained in this Agreement, (iii) any breach of any representation or warranty of Sellers contained in this Agreement as of the date of this Agreement or as of the Closing Date (or for any representation or warranty specifically made as of an earlier date, as of such earlier date), (iv) any Transfer Taxes for which Sellers are responsible pursuant to Section 10.8(a) or (v) [REDACTED]).
(b) For purposes of determining whether there has been any breach or inaccuracy in respect of any representation or warranty of Sellers entitling a Purchaser Indemnified Party to indemnification for Losses pursuant to this Section 8.1 , and for purposes of calculating the amount of any Losses to which a Purchaser Indemnified Party is entitled as a result of any such breach or inaccuracy, such representation or warranty shall not be deemed qualified or limited by any material, materially, materiality, Material Adverse Effect or other similar materiality qualification or limitation, including references to dollar amounts.
Section 8.2. Indemnification by Purchaser .
(a) Subject to the provisions of this Article VIII , from and after the Closing, Purchaser agrees to defend, indemnify and hold harmless Sellers and their Affiliates, and, if applicable, their respective directors, officers, agents, employees, successors and assigns, each in their capacity as such (collectively, the Seller Indemnified Parties ) from and against any and all Losses to the extent arising or resulting from (i) any Assumed Liability, (ii) any breach by Purchaser of any of its covenants or agreements in this Agreement or (iii) any breach of any representation or warranty of Purchaser contained in this Agreement as of the date of this Agreement or as of the Closing Date (or for any representation or warranty specifically made as of an earlier date, as of such earlier date).
(b) For purposes of determining whether there has been any breach or inaccuracy in respect of any representation or warranty of Purchaser entitling Seller Indemnified Parties to indemnification for Losses pursuant to this Section 8.2 , and for purposes of calculating the amount of any Losses to which a Purchaser Indemnified Party is entitled as a result of any such breach or inaccuracy, such representation or warranty shall not be deemed qualified or limited by any material, materially, materiality, material adverse effect or other similar materiality qualification or limitation, including references to dollar amounts.
Section 8.3. Notice of Third-Party Claims .
(a) In the event any claim or demand for which any Seller Indemnified Party or Purchaser Indemnified Party (the Indemnified Party ) may have liability is asserted against or sought to be collected from any Indemnified Party by a third party (a Third-Party Claim ), such Indemnified Party shall promptly notify the Party responsible for providing indemnification therefor under this Agreement (the Indemnifying Party ) in writing describing such Third-Party Claim, the basis for indemnification hereunder, the amount or estimated amount of such Loss, if known or reasonably capable of estimation, and the method of computation of such amount or estimated amount, all with reasonable particularity and containing a reference to the provisions of this Agreement in respect of which such Loss shall have occurred. If any action at law or suit in equity is instituted by or against a third party with respect to which the Indemnified Party intends to seek indemnity under this Article VIII , the Indemnified Party shall promptly notify the
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Indemnifying Party of such action or suit. A failure by the Indemnified Party to give notice and to tender the conduct or defense of the action or suit in a timely manner pursuant to this Section 8.3 shall not limit the obligation of the Indemnifying Party under this Article VIII , except (i) to the extent such Indemnifying Party is actually and materially prejudiced by failure to give such notice, and (ii) to the extent notice of the claim has not been given pursuant to this Section 8.3(a) prior to the expiration of the applicable period provided in Section 8.4 . The Indemnifying Party shall have thirty (30) calendar days (or such lesser number of days as set forth in the notice of the claim as may be required by court proceeding in the event of a litigated matter) after receipt of the notice of the claim (the Notice Period ) to notify the Indemnified Party that it desires to defend the Indemnified Party against such Third-Party Claim.
(b) In the event that the Indemnifying Party notifies the Indemnified Party within the Notice Period that it desires to defend the Indemnified Party against a Third-Party Claim, the Indemnifying Party shall have the sole and absolute right after the receipt of notice, at its option and at its own expense, to be represented by counsel of its choice and to control, defend against, negotiate, settle or otherwise deal with such Third-Party Claim; provided , however , that the Indemnified Party may participate in any such Proceeding with counsel of its choice and at its expense; provided further , however , that the Indemnifying Party shall not be entitled to assume or continue control of the defense of any Third-Party Claim if (i) the Third-Party Claim relates to or arises in connection with any criminal or regulatory Proceeding, (ii) based on the advice of outside legal counsel to the Indemnified Party, a conflict (including the availability of different or additional defenses) exists between the Indemnified Party and the Indemnifying Party in connection with such Third-Party Claim or conduct of claim by the Indemnifying Party would compromise any legal privilege or similar doctrine with respect to the Indemnified Party or any of its Affiliates or (iii) the Third-Party Claim seeks (A) an injunction against the Indemnified Party or (B) where the Indemnified Party is a Purchaser Indemnified Party, equitable relief requiring the taking of action or the refraining from taking actions by Purchaser or (iv) with respect to a Purchaser Indemnified Party, the Purchaser Indemnified Party shall have reasonably concluded in good faith that the relevant Third-Party Claim relates to the matters that could adversely affect in any material respect the Business, including any regulatory matters relating thereto. By assuming the defense of any such Third-Party Claim, the Indemnifying Party shall thereby conclusively acknowledge for all purposes of this Agreement its obligation to indemnify the Indemnified Party in respect of such matter pursuant to and in accordance with (and, for the avoidance of doubt, subject to the limitations set forth in) this Article VIII , except as otherwise provided in Section 8.3(c) .
(c) To the extent the Indemnifying Party (i) elects not to assume the defense of such matter, whether by not giving the Indemnified Party timely notice of its desire to so defend or otherwise or (ii) after assuming the defense of a Third-Party Claim, fails to take reasonable steps necessary to defend diligently such Third-Party Claim within ten (10) calendar days after receiving written notice from the Indemnified Party to the effect that the Indemnifying Party has so failed, then the Indemnified Party may retain counsel at the expense of the Indemnifying Party, which counsel shall be reasonably acceptable to the Indemnifying Party, and control the defense of such Proceeding; provided , however , that the Indemnifying Party shall be obligated pursuant to this Section 8.3(c) to pay for only one firm of counsel for all Indemnified Parties in addition to any local counsel who may need to be retained; and it being understood that
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the Indemnified Partys right to indemnification for a Third-Party Claim shall not be adversely affected by assuming the defense of such Third-Party Claim pursuant to this Section 8.3(c) .
(d) If the Indemnifying Party has the right and does elect to defend any Third-Party Claim, the Indemnifying Party shall conduct the defense of such Third-Party Claim with reasonable diligence and promptly inform the Indemnified Party of the status of the claim, including all settlement negotiations, and all material developments with respect to such Third-Party Claim, and the Indemnified Party shall be entitled to participate in any discussions relating to the litigation strategy implemented with respect to the defense of such Third-Party Claim. The Indemnifying Party shall not, without the prior written consent of the Indemnified Party (which shall not be unreasonably withheld, conditioned or delayed), settle, compromise or offer to settle or compromise any pending or threatened Third-Party Claim on a basis that would not include an unconditional release of the Indemnified Party and would (i) exceed the balance of the Indemnifying Partys indemnity obligations hereunder (and, in the case of any Purchaser Indemnified Party, exceed the Escrow Fund), (ii) result in the imposition of a consent order, injunction or decree that would restrict the future activity or conduct of the Indemnified Party or any of its Affiliates, (iii) result in a finding or admission of a violation of requirements of Laws or violation of the rights of any Person by the Indemnified Party or any of its Affiliates or (iv) impose ongoing obligations on the Indemnified Party following the date of such settlement or compromise.
(e) The Parties shall cooperate reasonably in good faith in connection with the defense, negotiation or settlement of any Third-Party Claim, with such cooperation to include (i) the retention and the provision of the Indemnifying Party records and information that are reasonably relevant to such Third-Party Claim, and (ii) making employees available on a mutually convenient basis to provide additional information and explanation of any material provided hereunder. The Indemnified Party and the Indemnifying Party shall use reasonable best efforts to avoid production or other disclosure of confidential information (consistent with applicable Laws), and to cause all communications among employees, counsel and others representing any party to a Third-Party Claim to be made so as to preserve any applicable attorney-client or work-product privileges.
(f) The procedures in this Section 8.3 (other than the obligation to provide notice in Section 8.3(a) ) shall not apply to direct claims by Seller Indemnified Parties or Purchaser Indemnified Parties.
Section 8.4. Expiration . Each Partys obligation to indemnify any Indemnified Party under this Article VIII shall not expire, and the representations, warranties and covenants, as applicable, shall survive, until they terminate on the following dates, unless a claim therefor is asserted in writing prior to the applicable survival date (in which case such obligation to indemnify shall continue until such claim is resolved in accordance with this Article VIII ), failing which such claim shall be waived and extinguished: (i) on the date that is the [REDACTED] anniversary of the Closing Date with respect to breaches of representations and warranties other than breaches of Sellers Fundamental Representations and Purchasers Fundamental Representations, (ii) [REDACTED] (iii) on the date that is the [REDACTED] anniversary of the Closing with respect to Tax Indemnification and all other claims.
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Section 8.5. Limitations on Indemnification .
(a) Threshold . Other than for any Excluded Claim, Sellers shall not be liable, pursuant to Section 8.1 , for any Losses suffered by any Purchaser Indemnified Party unless the aggregate of all Losses suffered by the Purchaser Indemnified Parties exceeds, on a cumulative basis, an amount equal to [REDACTED] of the Purchase Price (the Indemnity Threshold ), and then Sellers shall only be liable to the extent of any such excess. Other than for any Excluded Claim, Purchaser shall not be liable, pursuant to Section 8.2 , for any Losses suffered by the Seller Indemnified Parties unless the aggregate of all Losses suffered by the Seller Indemnified Parties exceeds, on a cumulative basis, the Indemnity Threshold, and then Purchaser shall only be liable to the extent of any such excess. Notwithstanding any other provision of this Agreement to the contrary, other than for any Excluded Claim, no Indemnifying Party shall be required to indemnify, defend or hold harmless any Indemnified Party pursuant to this Article VIII against, or reimburse any Indemnified Party for, any Losses with respect to any individual claims unless such claim involves Losses in excess of [REDACTED] (nor shall such item be applied to or considered for purposes of calculating the Indemnity Threshold). For the purposes of this Agreement, Excluded Claims means, with respect to any Purchaser Indemnified Party, claims for (i) Tax Indemnification, (ii) indemnification pursuant to Section 8.1(a)(i) in connection with the Retained Liabilities other than [REDACTED] (iii) indemnification pursuant to Section 8.1(a)(iii) in connection with breaches of Sellers Fundamental Representations, (iv) indemnification pursuant to Section 8.1(a)(v) in connection with [REDACTED] (v) indemnification pursuant to Section 8.1(a)(ii) and (vi) fraud or willful and intentional breach, and with respect to any Seller Indemnified Party, claims for (i) indemnification pursuant to Section 8.2(a)(i) in connection with any Assumed Liability, (ii) indemnification pursuant to Section 8.2(a)(iii) in connection with breaches of Purchasers Fundamental Representations, (iii) indemnification pursuant to Section 8.2(a)(ii) or (iv) fraud or willful and intentional breach (each, an Excluded Claim ).
(b) Cap; [REDACTED] In no event shall Sellers be liable to indemnify the Purchaser Indemnified Parties pursuant to Section 8.1 for Losses in the aggregate in excess of an amount equal to [REDACTED] of the Purchase Price (the Cap ), other than for any Losses related to the [REDACTED], in which event Sellers shall be liable to indemnify Purchaser Indemnified Parties pursuant to Section 8.1 for all such Losses in an aggregate amount not to exceed the [REDACTED] In no event shall Purchaser be liable to indemnify the Seller Indemnified Parties pursuant to Section 8.2 for Losses in the aggregate in excess of the Cap.
(c) Mitigation . The Parties shall cooperate with each other to resolve any matter with respect to which an Indemnifying Party is obligated to indemnify an Indemnified Party hereunder, including by using such efforts as are required by applicable Law to mitigate damages after becoming aware of any event or condition that would reasonably be expected to give rise to any Losses that are indemnifiable hereunder.
(d) Other Limitations . Notwithstanding anything in this Agreement to the contrary, no Indemnified Party shall be indemnified or reimbursed for any Loss to the extent that such Loss is attributable to any failure by such Indemnified Party to comply with applicable Law from and after the Closing. If a Party is conducting any defense against a Third-Party Claim for
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which the other Party has sought indemnification pursuant to Section 8.1 or Section 8.2 , as applicable, fees and expenses incurred during the defense against such Third-Party Claim, including legal costs and expenses, shall constitute Losses for purposes of determining the amount subject to the Cap pursuant to Section 8.5(b) .
(e) Payments . The Indemnifying Party shall pay all amounts payable pursuant to this Article VIII , in immediately available funds, to an account specified by the Indemnified Party following receipt from an Indemnified Party of a bill, together with all accompanying reasonably detailed supporting documentation, for a Loss that is the subject of indemnification hereunder, unless the Indemnifying Party in good faith disputes the Loss, in which event it shall so notify the Indemnified Party. In any event, the Indemnifying Party shall pay to the Indemnified Party the amount of any Loss for which it is liable hereunder, in immediately available funds, to an account specified by the Indemnified Party no later than three (3) days following any Final Determination of such Loss and the Indemnifying Partys liability therefor. A Final Determination shall exist when (a) the parties to the dispute have reached an agreement in writing, (b) a court of competent jurisdiction shall have entered a final and non-appealable Governmental Order or judgment or (c) an arbitration or like panel shall have rendered a final non-appealable determination with respect to disputes the parties have agreed to submit thereto. Any amounts for which any Seller may be liable under Section 8.1 shall be payable first from the Escrow Amount; following such time when there are no amounts remaining in the Escrow Amount, any amounts for which any Seller may be liable hereunder shall be payable directly by such Seller.
(f) Exclusion of Certain Damages . NOTWITHSTANDING ANYTHING IN THIS AGREEMENT TO THE CONTRARY, NEITHER PARTY NOR ITS AFFILIATES SHALL BE LIABLE FOR ANY INDIRECT, INCIDENTAL, REMOTE, SPECIAL, CONSEQUENTIAL, EXEMPLARY, OPPORTUNITY COST, PUNITIVE DAMAGES OR DAMAGES FOR, MEASURED BY OR BASED ON LOST PROFITS, LOSS OF REVENUE OR INCOME, OR OTHER SIMILAR MEASURES OR FOR ANY LOSS OF BUSINESS REPUTATION OR OPPORTUNITY THAT ARISES OUT OF OR RELATES TO THIS AGREEMENT, EXCEPT IN EACH CASE TO THE EXTENT ANY SUCH DAMAGE OR LOSS WAS A REASONABLY FORESEEABLE CONSEQUENCE OF THE BREACH; PROVIDED , FURTHER , HOWEVER , THAT THE FOREGOING LIMITATION ON DAMAGES SHALL NOT APPLY TO (I) ANY SUCH DAMAGES THAT ARE ACTUALLY AWARDED TO A THIRD PARTY PURSUANT TO A THIRD-PARTY CLAIM OR (II) RESULTING FROM FRAUD OR WILLFUL AND INTENTIONAL BREACH OF THE INDEMNIFYING PARTY.
(g) Effect of Investigation . The representations, warranties and covenants of the Indemnifying Party, and the Indemnified Partys right to indemnification with respect thereto, shall not be affected or deemed waived by reason of any investigation made by or on behalf of the Indemnified Party (including by any of its Representatives) or by reason of the fact that the Indemnified Party or any of its Representatives knew or should have known that any such representation or warranty is, was or might be inaccurate or by reason of the Indemnified Partys waiver of any condition set forth in Article VII .
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Section 8.6. Reimbursement . If an Indemnified Party recovers an amount from a third party in respect of a Loss that is the subject of indemnification hereunder after all or a portion of such Loss has been paid by an Indemnifying Party pursuant to this Article VIII , the Indemnified Party shall promptly remit to the Indemnifying Party the amount received from the third party in respect thereof.
Section 8.7. Sole Remedy/Waiver . Should the Closing occur, the remedies provided for in this Article VIII shall be the sole and exclusive remedies of any Indemnified Party in respect of this Agreement, the Ancillary Agreements, the Purchased Assets, the Products, the Excluded Assets, the Assumed Liabilities, the Retained Liabilities or the transactions contemplated hereby or by the Ancillary Agreements, other than (i) for actions for specific performance or other equitable remedies or (ii) under the terms of the Transition Services Agreement. In furtherance of the foregoing, each Party hereby waives (on behalf of itself and the relevant Indemnified Parties) any provision of applicable Law to the extent that it would limit or restrict the agreement contained in this Section 8.7 , and each Party (on behalf of itself and the relevant Indemnified Parties) hereby waives for periods following the Closing any and all other rights, claims or causes of action it or its Affiliates or relevant Indemnified Parties may have against the other Party or its Affiliates or Representatives now or in the future arising under or based upon this Agreement, any Ancillary Agreement, or any document or certificate delivered in connection herewith.
Section 8.8. [REDACTED]
ARTICLE IX
TERMINATION
Section 9.1. Termination . This Agreement may be terminated at any time prior to the Closing:
(a) by written agreement of Purchaser and Sellers;
(b) by either the Sellers or Purchaser, by giving written notice of such termination to the other Party, if (i) the Closing shall not have occurred on or before the day that is the 180 day anniversary of the date of this Agreement (the Outside Date ) and (ii) the party seeking to terminate this Agreement pursuant to this Section 9.1(b) (x) shall not have breached any obligation under this Agreement such that the breach is a principal cause of, or has resulted in, the failure of the Closing to occur prior to the Outside Date and (y) shall have used such efforts as may be required by Section 6.4 to cause the Closing to occur on or before such date;
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(c) by Sellers, by giving written notice of such termination to Purchaser, if (i) there exists a breach of any representation or warranty of Purchaser contained in this Agreement such that the condition set forth in Section 7.3(a) could not be satisfied or (ii) Purchaser shall have breached any of the covenants or agreements contained in this Agreement to be complied with by it such that the condition set forth in Section 7.3(b) could not be satisfied, and, in the case of either (i) or (ii), such breach is incapable of being cured or not cured within thirty (30) days after written notice thereof from Sellers detailing the nature of such breach;
(d) by Purchaser, by giving written notice of such termination to Sellers, if (i) there exists a breach of any representation or warranty of Sellers contained in this Agreement such that the condition set forth in Section 7.2(a) could not be satisfied or (ii) either Seller shall have breached any of the covenants or agreements contained in this Agreement to be complied with by it such that the condition set forth in Section 7.2(b) could not be satisfied, and, in the case of either (i) or (ii), such breach is incapable of being cured or not cured within thirty (30) days after written notice thereof from Purchaser detailing the nature of such breach;
(e) by either Sellers or Purchaser, by giving written notice of such termination, if any court of competent jurisdiction or other competent Governmental Authority shall have issued a Governmental Order or taken any other action permanently restraining, enjoining or otherwise prohibiting the transactions contemplated by this Agreement and such Governmental Order or other action shall have become final and non-appealable; or
(f) by Sellers, by giving written notice of such termination, if (i) all of the conditions set forth in Section 7.1 and Section 7.2 have been satisfied (other than those conditions that are to be satisfied at Closing and other than those conditions that are incapable of being satisfied as a result of Purchasers breach of any of its obligations under this Agreement) and (ii) the Marketing Period has ended (the first Business Day immediately following the date on which clauses (i) and (ii) have both been satisfied, the First Date ) and Purchaser fails to consummate the Closing on or prior to the third Business Day following the First Date (the Financing Period ); provided that, Sellers are ready, willing and able to consummate the Closing and have provided written notice to Purchaser confirming such fact at least one (1) Business Day prior to the First Date.
Section 9.2. Effect of Termination . (a) In the event of the termination of this Agreement in accordance with Section 9.1 hereof, this Agreement shall thereafter become void and have no effect, and no Party shall have any liability to the other Party or their respective Affiliates, directors, officers or employees; provided that (i) no such termination shall relieve Purchaser of its obligation to pay the Purchaser Termination Fee, if, as and when required pursuant to Section 9.3 , (ii) the obligations of the Parties contained in this Section 9.2 and in Section 6.1(b) ( Information and Documents ), Section 10.1 ( Notices ), Section 10.6 ( Public Disclosure ), Section 10.7 ( Return of Information ), Section 10.8(a) ( Expenses, Transfer Taxes and Property Taxes ), Section 10.10 ( Governing Law; Jurisdiction ), Section 10.11 ( Waiver of Jury Trial ) and Section 10.16 ( Non-Recourse ) of this Agreement shall survive notwithstanding any such termination and (iii) except as provided in Section 9.3 , nothing herein shall relieve any Party from Liability for fraud or any willful and intentional breach of this Agreement prior to such termination.
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Section 9.3. Termination Fee .
(a) If this Agreement (x) is terminated by Sellers pursuant to Section 9.1(f) or (y) is terminated by either Party pursuant to Section 9.1(b) and at such time Sellers either (I) could have terminated under Section 9.1(f) or (II) shall have previously provided the Required Information that was Compliant as of the commencement of a Marketing Period and the Marketing Period shall not have been completed as a result of an event, change, circumstance, state of facts or development first arising after the date of the commencement of the Marketing Period that caused the Business Disclosure to fail to be Compliant pursuant to clause (a) of the definition of Compliant (each of (x) and (y), a Specified Termination ), then in each case of (x) and (y), Purchaser shall pay, by wire transfer of immediately available funds to the account(s) designated in writing by Sellers not less than two (2) Business Days prior to such payment, within three (3) Business Days after the date on which this Agreement is so terminated, to Sellers the fee of $75,000,000.00 in cash (the Purchaser Termination Fee ). If Purchaser fails to promptly pay any amount due pursuant to this Section 9.3(a) , Purchaser shall pay (or cause to be paid) to Sellers all fees, costs and expenses of enforcement (including attorneys fees as well as expenses) incurred in connection with any action initiated by Sellers to collect payment of the Purchaser Termination Fee, together with interest on the amount of the Purchaser Termination Fee at the prime lending rate prevailing during such period as published in the Wall Street Journal , calculated on a daily basis from the date the Purchaser Termination Fee was required to be paid until the date of actual payment.
(b) The Parties acknowledge that the Purchaser Termination Fee shall not constitute a penalty but is liquidated damages, in a reasonable amount that will compensate Sellers in the circumstances in which it is payable for the efforts and resources expended and opportunities foregone while negotiating this Agreement and in reliance on this Agreement and on the expectation of the consummation of the transactions contemplated hereby, which amount would otherwise be impossible to calculate with precision. Purchaser acknowledges that until the Purchaser Termination Fee is paid in full as provided in this Section 9.3(b) the right of Sellers to receive the Purchaser Termination Fee shall not limit or otherwise affect Sellers right to specific performance to the extent set forth in Section 10.15 ; provided that Sellers shall not be entitled under any circumstances to both (i) receive the Purchaser Termination Fee and (ii) such specific performance of Purchasers obligation to effect the Closing in accordance with Articles II and III ; and provided further , if, and only if, (x) a Specified Termination has occurred and (y) Purchaser has paid the Purchaser Termination Fee to Sellers in full, then Sellers shall have no right to seek additional remedies or recoveries beyond the Purchaser Termination Fee (including specific performance) for any Losses suffered as a result of the failure of the Closing to occur or for a breach or failure to perform hereunder (whether intentionally, willfully or otherwise) (and, effective upon the occurrence of such Specified Termination and receipt by the Sellers of the Purchaser Termination Fee, each Seller and their respective Representatives hereby expressly and irrevocably waives, discharges and releases and agrees to waive, discharge and release any and all other rights, claims or causes of action for any monetary, injunctive or other relief it or its Representatives may have against Purchaser, its Affiliates or any of their respective Representatives now or in the future under any Law or otherwise with respect thereto), and neither Purchaser nor any of its Affiliates or the Financing Source, or any of their respective Representatives shall have any further Liability relating to or arising out of this Agreement, the payment of such Purchaser Termination Fee being the sole and exclusive remedy against
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Purchaser, any of its Affiliates, the Financing Source or any of their respective Representatives for any Loss suffered by the Sellers, their respective Affiliates, and their respective Representatives in connection with this Agreement and the transactions contemplated by this Agreement, as a result of any breach of any covenant or agreement in this Agreement or the failure of the transactions contemplated by this Agreement to be consummated. In no event shall Purchaser and its Affiliates be required to pay the Purchaser Termination Fee on more than one occasion. For the avoidance of doubt, this Section 9.3 shall not limit the right of the Sellers to specific performance of this Agreement prior to termination to the extent provided in Section 10.15 .
(c) The Parties each acknowledge that the agreements contained in this Section 9.3 are an integral part of this Agreement and that, without this Section 9.3 , the Parties would not have entered into this Agreement.
ARTICLE X
MISCELLANEOUS
Section 10.1. Notices . All notices or other communications hereunder shall be deemed to have been duly given and made if in writing and if served by personal delivery upon the Party for whom it is intended, if delivered by registered or certified mail, return receipt requested, or by a national courier service, or if sent by facsimile, provided that the facsimile is promptly confirmed by telephone confirmation thereof, to the Person at the address set forth below, or such other address as may be designated in writing hereafter, in the same manner, by such Person:
To either Seller:
Covis Pharma S.à.r.l. and Covis Injectables S.à.r.l
[REDACTED]
To Seller Parent:
Covis Pharma Holdings S.à.r.l.
[REDACTED]
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with a copy (which shall not constitute notice) to:
Lowenstein Sandler LLP
1251 Avenue of the Americas
New York, NY 10020
Telephone: 212-262-6700
Facsimile: 212-262-7402
Attn: Robert G. Minion and Ethan A. Skerry
and a copy (which shall not constitute notice) to:
[REDACTED]
to Purchaser or Purchaser Parent:
[REDACTED]
In the case of either Purchaser or Purchaser Parent with a copy (which shall not constitute notice) to:
Sullivan & Cromwell LLP
125 Broad Street
New York, New York 10004
Telephone: 212-558-7931
Facsimile: 212-291-9519
Attn: Matthew G. Hurd and Krishna Veeraraghavan
Section 10.2. Amendment; Waiver . Any provision of this Agreement may be amended or waived if, and only if, such amendment or waiver is in writing and signed, in the case of an amendment, by Purchaser and Sellers, or in the case of a waiver, by the party against whom the waiver is to be effective. To the extent any amendment, modification or supplement to Section 9.3 , Section 10.5 , Section 10.10 , Section 10.11 , Section 10.16 or this Section 10.2 is sought which is adverse to the rights of the Financing Sources, the prior written consent of the Financing Sources shall be required before such amendment, modification or supplement is rendered effective. No failure or delay by any Party in exercising any right, power or privilege hereunder shall operate as a waiver thereof nor shall any single or partial exercise thereof preclude any other or further exercise thereof or the exercise of any other right, power or privilege.
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Section 10.3. Assignment . No Party to this Agreement may assign any of its rights or obligations under this Agreement without the prior written consent of the other Parties; provided , that nothing in the foregoing shall prohibit Purchaser from making any assignment (i) to any of its Affiliates so long as such Affiliate agrees in writing to be bound by all of the terms, conditions and provisions contained in this Agreement provided , further , no such assignment shall release Purchaser from its obligations under this Agreement; and (ii) to any successors to all or substantially all of the business and assets of Purchaser, whether in a merger, consolidation, sale of substantially all assets or other similar transaction. Any purported assignment, hypothecation or transfer in breach of this Section 10.3 shall be null and void. This Agreement shall be binding upon, and shall inure to the benefit of, and be enforceable by the Parties hereto and their successors and permitted assigns.
Section 10.4. Entire Agreement . This Agreement and the Ancillary Agreements (in each case, including all Schedules and Exhibits hereto and thereto) contain the entire agreement between the parties with respect to the subject matter hereof and supersede all prior agreements and understandings, oral or written, with respect to such matters, except for (i) subject to Section 6.15(a) , the Confidentiality Agreement which will remain in full force and effect for the term provided for therein and (ii) any written agreement of the Parties that expressly provides that it is not superseded by this Agreement.
Section 10.5. Parties in Interest . This Agreement shall inure to the benefit of and be binding upon the Parties and their respective successors and permitted assigns. Nothing in this Agreement, express or implied, is intended to confer upon any Person other than Purchaser, Sellers, or their successors or permitted assigns, any rights or remedies under or by reason of this Agreement, provided , that (i) the provisions of Article VIII shall inure to the benefit of the Purchaser Indemnified Parties, and Seller Indemnified Parties, as applicable, (ii) the provisions of Section 10.16 shall inure to the benefit of the Persons referenced therein and (iii) the provisions of Section 9.3 , Section 10.2 , Section 10.10 , Section 10.11 , Section 10.16 and this Section 10.5 , to the extent they apply to the Financing Sources, shall inure to the benefit of the Financing Sources.
Section 10.6. Public Disclosure . Notwithstanding anything herein to the contrary, each of the Parties to this Agreement agrees that, except as may be required to comply with the requirements of any applicable Laws, and the rules and regulations of any stock exchange to which any Party or its controlling Affiliate is subject, if any, no press release or similar public announcement or communication shall, if prior to the Closing, be made or caused to be made concerning the execution or performance of this Agreement or the transactions contemplated by this Agreement unless the Parties shall have consulted in advance with respect thereto, it being understood that the Parties intend to issue a joint press release in connection with the signing of this Agreement.
Section 10.7. Return of Information . If the transactions contemplated by this Agreement are terminated as provided herein:
(a) notwithstanding anything in the Confidentiality Agreement to the contrary, each Party shall return to the other Party or destroy all documents and other material
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received by such Party, its Affiliates and its and their respective Representatives, relating to the transactions contemplated hereby, whether so obtained before or after the execution hereof; and
(b) all confidential information received or made available by either Party, its respective Affiliates and its and their respective Representatives from or on behalf of the other Party shall be treated in accordance with the Confidentiality Agreement, which shall remain in full force and effect in accordance with its terms notwithstanding the termination of this Agreement.
Section 10.8. Expenses, Transfer Taxes and Property Taxes . (a) Except as otherwise expressly provided in this Agreement (including all filing fees in connection with the filings made pursuant to Section 6.3 ), whether or not the transactions contemplated by this Agreement are consummated, all costs and expenses incurred in connection with this Agreement and the transactions contemplated hereby shall be borne by the Party incurring such expenses. Notwithstanding the foregoing, all Transfer Taxes shall be paid by Sellers.
(b) In the case of any taxable period that includes (but does not end on) the Closing Date, (i) real, personal and intangible property Taxes and similar Taxes imposed with respect to the Purchased Assets or Related to the Business ( Property Taxes ) shall be allocated between the Pre-Closing Tax Period and the Post-Closing Tax Period on a per diem basis, and (ii) all other Taxes imposed with respect to the Purchased Assets or Related to the Business (other than Transfer Taxes which shall be borne by Sellers as provided in Section 10.8(a) ) shall be allocated between the Pre-Closing Tax Period and the Post-Closing Tax Period as though the taxable period terminated as of the effective time of the Closing. Sellers and Purchaser shall promptly reimburse each other in accordance with such allocation for any such Taxes which any Party is required to pay under applicable Law.
Section 10.9. Schedules . The disclosure of any matter in any Schedule to this Agreement shall be deemed to be a disclosure with respect to any other section or subsection of this Agreement with respect to which its relevance is reasonably apparent on its face for all purposes of this Agreement, but shall expressly not be deemed to constitute an admission by a Seller or Purchaser, or to otherwise imply, that any such matter is material for the purposes of this Agreement.
Section 10.10. Governing Law; Jurisdiction . (a) This Agreement and its negotiation, execution, performance or non-performance, interpretation, termination, construction and all claims or causes of action (whether in contract, in tort, at law or otherwise) that may be based upon, arise out of, or relate to this Agreement, or the transactions contemplated hereby (including any claim or cause of action based upon, arising out of or related to any representation or warranty made in connection with this Agreement or as an inducement to enter this Agreement), shall be exclusively governed by, and construed in accordance with, the Laws of the State of Delaware regardless of Laws that might otherwise govern under any applicable conflict of Laws principles. Notwithstanding anything in this Agreement to the contrary, the Parties agree that any claim, controversy or dispute of any kind or nature (whether based upon contract, tort or otherwise) involving a Financing Source that is based upon, arises out of, or relates to this Agreement or any of the transactions contemplated by this Agreement, including any dispute arising out of or relating in any way to the Financing or the Commitment
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Letter shall be governed by, and construed in accordance with, the Laws of the State of New York.
(b) Any claim, demand, suit, action, cause of action, or proceeding (whether in contract, in tort, at law, or otherwise) (each, a Proceeding ) based upon, arising out of, or related to this Agreement and its negotiation, execution, performance, non-performance, interpretation, termination, construction or the transactions contemplated hereby shall be heard and determined in the Court of Chancery in the City of Wilmington, New Castle County, Delaware or, in the event such court lacks subject matter jurisdiction, the United States District Court sitting in Wilmington, Delaware or, in the event such federal district court lacks subject matter jurisdiction, then in the Superior Court in the City of Wilmington, New Castle County, Delaware. Notwithstanding the foregoing, each Party hereby agrees that it will not bring or support any action, cause of action, claim, cross-claim or third-party claim of any kind or description, whether in law or in equity, whether in contract or in tort or otherwise, against the Financing Sources in any way relating to this Agreement, the Commitment Letter, or any of the transactions contemplated hereby or thereby, including, without limitation, any dispute arising out of or relating in any way to the Financing or the performance thereof, in any forum other than the Supreme Court of the State of New York, County of New York, or, if under applicable Law exclusive jurisdiction is vested in the federal courts, the United States District Court for the Southern District of New York (and the appellate courts thereof), and that the provisions of Section 10.11 relating to the waiver of jury trial shall apply to any such action, cause of action, claim, cross-claim or third-party claim. The Parties hereby irrevocably submit to the exclusive jurisdiction and venue of such courts in any such Proceeding and irrevocably and unconditionally waive the defense of an inconvenient forum, or lack of jurisdiction to the maintenance of any such Proceeding. The consents to jurisdiction and venue set forth herein shall not constitute general consents to service of process in the State of Delaware and shall have no effect for any purpose except as provided in this Section 10.10 and shall not be deemed to confer rights on any Person other than the Parties. Each Party agrees that the service of process upon such Party in any Proceeding arising out of or relating to this Agreement shall be effective if notice is given by overnight courier at the address set forth in Section 10.1 . Each of the Parties also agrees that any final, non-appealable judgment against a Party in connection with any Proceeding arising out of or relating to this Agreement shall be conclusive and binding on such Party and that such award or judgment may be enforced in any court of competent jurisdiction, either within or outside of the United States. A certified or exemplified copy of such award or judgment shall be conclusive evidence of the fact and amount of such award or judgment.
Section 10.11. WAIVER OF JURY TRIAL . TO THE FULLEST EXTENT PERMITTED BY LAW, THE PARTIES HEREBY WAIVE THEIR RESPECTIVE RIGHTS TO A JURY TRIAL OF ANY PROCEEDING (WHETHER IN CONTRACT, IN TORT, AT LAW OR OTHERWISE) BASED UPON, ARISING OUT OF, OR RELATED TO THIS AGREEMENT, ANY OF THE TRANSACTIONS CONTEMPLATED BY THIS AGREEMENT OR ARISING OUT OF OR RELATING TO THE FINANCING OR ANY OF THE TRANSACTIONS CONTEMPLATED THEREBY, INCLUDING IN ANY ACTION, PROCEEDING OR COUNTERCLAIM AGAINST ANY FINANCING SOURCE. THE SCOPE OF THIS WAIVER IS INTENDED TO BE ALL-ENCOMPASSING OF ANY AND ALL DISPUTES THAT MAY BE FILED IN ANY COURT AND THAT RELATE TO THE SUBJECT MATTER OF THIS AGREEMENT, INCLUDING WITHOUT LIMITATION,
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CONTRACT CLAIMS, TORT CLAIMS, BREACH OF DUTY CLAIMS AND ALL OTHER COMMON LAW AND STATUTORY CLAIMS. THE PARTIES ACKNOWLEDGE THAT THIS WAIVER IS A MATERIAL INDUCEMENT TO ENTER INTO A BUSINESS RELATIONSHIP, THAT EACH HAS ALREADY RELIED ON THE WAIVER IN ENTERING INTO THIS AGREEMENT AND THAT EACH WILL CONTINUE TO RELY ON THE WAIVER IN THEIR RELATED FUTURE DEALINGS. THE PARTIES FURTHER WARRANT AND REPRESENT THAT EACH HAS REVIEWED THIS WAIVER WITH ITS LEGAL COUNSEL, AND THAT EACH KNOWINGLY AND VOLUNTARILY WAIVES ITS JURY TRIAL RIGHTS FOLLOWING CONSULTATION WITH LEGAL COUNSEL. THIS WAIVER IS IRREVOCABLE, MEANING THAT IT MAY NOT BE MODIFIED EITHER ORALLY OR IN WRITING, AND THIS WAIVER SHALL APPLY TO ANY SUBSEQUENT AMENDMENTS, RENEWALS, SUPPLEMENTS OR MODIFICATIONS TO THIS AGREEMENT OR TO ANY OTHER DOCUMENTS OR AGREEMENTS RELATING TO THE TRANSACTIONS CONTEMPLATED HEREBY. IN THE EVENT OF LITIGATION, THIS AGREEMENT MAY BE FILED AS A WRITTEN CONSENT TO A TRIAL BY THE COURT.
Section 10.12. Counterparts . This Agreement may be executed in one or more counterparts (including by facsimile or electronic .pdf submission), each of which shall be deemed an original, and all of which shall constitute one and the same agreement and shall become effective when one or more counterparts have been signed by each of the Parties and delivered (by telecopy or otherwise) to the other Party, it being understood that both Parties need not sign the same counterpart.
Section 10.13. Headings . The heading references herein and the table of contents hereto are for convenience purposes only, do not constitute a part of this Agreement and shall not be deemed to limit or affect any of the provisions hereof.
Section 10.14. Severability . The provisions of this Agreement shall be deemed severable and the invalidity or unenforceability of any provision shall not affect the validity or enforceability of the other provisions hereof. If any term or other provision of this Agreement, or the application thereof to any Person or any circumstance, is invalid, illegal or unenforceable, (a) a suitable and equitable provision shall be substituted therefor in order to carry out, so far as may be valid and enforceable, the intent and purpose of such invalid or unenforceable provision and (b) the remainder of this Agreement and the application of such provision to other Persons, entities or circumstances shall not be affected by such invalidity, illegality or unenforceability, nor shall such invalidity, illegality or unenforceability affect the validity or enforceability of such provision, or the application thereof, in any other jurisdiction.
Section 10.15. Specific Performance .
(a) The Parties agree that irreparable damage would occur in the event that any of the provisions of this Agreement were not performed in accordance with their specific terms or were otherwise breached. Accordingly, each Party agrees that, subject to Section 9.3 and Section 10.15(b) , in the event of any breach or threatened breach by any other Party of any covenant or obligation contained in this Agreement, the non-breaching Party shall be entitled (in addition to any other remedy that may be available to it, whether in law or equity) to obtain (i) a
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decree or order of specific performance to enforce the observance and performance of such covenant or obligation, and (ii) an injunction restraining such breach or threatened breach. Each of the Parties agrees that, subject to Section 9.3 and Section 10.15(b) , it shall not oppose the granting of an injunction, specific performance and other equitable relief on the basis that any other Party has an adequate remedy at law or that any award of specific performance is not an appropriate remedy for any reason at law or in equity. Subject to Section 9.3 and Section 10.15(b) , any Party seeking an injunction or injunctions to prevent breaches of this Agreement or the Financing and to enforce specifically the terms and provisions of this Agreement or the Financing shall not be required to provide any bond or other security in connection with any such order or injunction.
(b) The Parties agree that the Sellers shall be entitled to specific performance against Purchaser and, as applicable, Purchaser Parent (A) of Purchasers and Purchaser Parents obligations under Section 6.10 , including Purchasers and Purchaser Parents obligation to cause each Financing Source to fund its respective committed portion of the Financing required to consummate the transactions contemplated hereby and to pay related fees and expenses on the Closing Date in accordance with the terms of the Commitment Letter and to enforce its rights under the Commitment Letter as contemplated by Section 6.10 , (B) to enforce Purchasers obligations under Section 6.3 and Section 6.4 , and to prevent any breach by Purchaser of its covenants under this Agreement, (C) to enforce Purchasers obligations to pay the Purchaser Termination Fee pursuant to the terms and conditions of Section 9.3 and (D) to cause Purchaser to consummate the transactions contemplated by this Agreement in accordance with the terms of this Agreement; provided, that Sellers will only have the right to specific performance in the case of clause (D) only to the extent each of the following conditions is satisfied: (x) the Marketing Period has ended and all conditions in Section 7.1 and Section 7.2 were satisfied (other than those conditions that can only be satisfied on the Closing Date and which were, at the time Closing would have been required to occur pursuant to Section 3.1 , capable of being satisfied) at the time when the Closing would have been required to occur pursuant to Section 3.1 , but for the failure of the Financing to be funded and (y) Sellers have irrevocably confirmed that if specific performance is granted, then the transactions contemplated by this Agreement will be consummated. To the extent any party to this Agreement brings a Proceeding to enforce specifically the performance of the terms and provisions of this Agreement when expressly available to such party pursuant to the terms of this Agreement, the Outside Date shall automatically be extended by the duration of time during which such Proceeding is actively pending before a court with jurisdiction pursuant to Section 10.10 of this Agreement.
Section 10.16. Non-Recourse .
(a) This Agreement may only be enforced against, and any claim or cause of action based upon, arising out of or related to this Agreement may only be brought against the entities that are expressly named as Parties and then only with respect to the specific obligations set forth herein with respect to such Party. For the purposes of this Section 10.16 . the term Party shall include Seller Parent and Purchaser Parent. Except to the extent a named Party to this Agreement (and then only to the extent of the specific obligations undertaken by such named Party in this Agreement), no past, present or future director, officer, employee, incorporator, member, partner, stockholder, Affiliate, agent, attorney or other Representative of any Party or of any Financing Source shall have any Liability (whether in contract or in tort, in law or in equity,
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or based upon any theory that seeks to impose Liability of an entity party against its owners or Affiliates) for any obligations or Liabilities of any Party under this Agreement or for any claim based on, in respect of, or by reason of, the transactions contemplated hereby or in respect of any oral representations made or alleged to have been made in connection herewith.
(b) The provisions of this Section 10.16 are intended to be for the benefit of, and enforceable by, the directors, officers, employees, incorporators, members, partners, stockholders, Affiliates, agents, attorneys and other Representatives of the Parties, and each such Person shall be a third-party beneficiary of this Section 10.16 .
Section 10.17. Mutual Drafting . The Parties are sophisticated and have been represented by lawyers throughout the transactions contemplated hereby who have carefully negotiated the provisions hereof. As a consequence, the Parties do not intend that the presumptions set forth in Laws or rules relating to the interpretation of contracts against the drafter of any particular clause should be applied to this Agreement or any Schedule or Exhibit hereto, and therefore, waive their effects.
Section 10.18. Purchaser Parent . Purchaser Parent is executing this Agreement to guaranty, and hereby does guaranty, unconditionally and as a primary obligation, the due and punctual performance by Purchaser of Purchasers obligations under this Agreement, including (i) all of Purchasers obligations pursuant to Section 6.10 . (ii) all of Purchasers payment obligations pursuant to Section 2.6 and Section 8.2 and (iii) in the event of a Specified Termination, Purchasers obligation to pay the Purchaser Termination Fee pursuant to Section 9.3 (and, in such circumstances, payment of the Purchaser Termination Fee shall be in full satisfaction of all obligations of Purchaser, Parent Purchaser and their respective Affiliates and Representatives, who shall thereafter have no liability to Seller Parent, either Seller or any of their respective Affiliates and Representatives, for monetary, injunctive or other relief of any kind as more fully provided in Section 9.3 ), and further agrees that it shall not be necessary to institute or exhaust remedies or causes of action against Purchaser as a condition of the obligations of Purchaser Parent pursuant to this provision. Purchaser Parent represents and warrants as of the date hereof and as of the Closing Date, those representations and warranties contained in Section 5.1 ( Organization ), Section 5.2 ( Authority; Binding Effect ), Section 5.3 ( No Conflicts; Consents ), Section 5.4 ( Governmental Authorization ), Section 5.5 ( Financing ) and Section 5.6 ( Litigation ), substituting as applicable, the term Purchaser Parent therein, mutatis mutandi , for references to the term Purchaser.
Section 10.19. Seller Parent . Seller Parent is executing this Agreement to (A) agree, and hereby does agree, to cause Sellers to perform the obligations set forth in Article II and (B) guaranty, and hereby does guaranty, unconditionally and as a primary obligation, the due and punctual performance of Sellers obligations under this Agreement, including the obligations to (i) perform all their obligations and assume all their Liabilities as provided by this Agreement, the Ancillary Agreements and any other agreement or instrument executed pursuant to this Agreement, including Sellers obligations pursuant to Article II , regardless of any alternations, waivers or extensions to any such agreement or instrument, and further agrees that it shall not be necessary to institute or exhaust remedies or causes of action against Sellers as a condition of the obligations of Seller Parent pursuant to this provision. Seller Parent represents and warrants as of the date hereof and as of the Closing Date, those representations and
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warranties contained in Section 4.1 ( Organization ), Section 4.2 ( Authority; Binding Effect ), Section 4.3 ( No Conflicts; Consents ), Section 4.4 ( Governmental Authorization ) and Section 4.6 ( Litigation ), substituting the term Seller Parent therein, mutatis mutandi , for references to the term Seller or Sellers.
[ Remainder of Page Intentionally Left Blank ]
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IN WITNESS WHEREOF , the Parties have executed or caused this Agreement to be executed as of the date first written above.
[Signature Page to Asset Purchase Agreement]
IN WITNESS WHEREOF , the Parties have executed or caused this Agreement to be executed as of the date first written above.
[Signature Page to Asset Purchase Agreement]
[Signature Page to Asset Purchase Agreement]
[Signature Page to Asset Purchase Agreement]
Schedule 1.1(a)
Excluded Contracts
[REDACTED]
[REDACTED]
[REDACTED]
Schedule 1.1(b)
Intellectual Property Licenses
| Trademark License Agreement, dated December 22, 2011, by and among Glaxo Group Limited, GlaxoSmithKline LLC and Covis Pharma S.à.r.l. |
| Trademark License Agreement, dated December 22, 2011, by and between Glaxo Group Limited and Covis Pharma S.à.r.l. |
| Manufacturing Know-How License Agreement, dated December 22, 2011, by and between Glaxo Group Limited and Covis Pharma S.à.r.l. |
| Manufacturing Know-How License Agreement, dated December 22, 2011, by and between GlaxoSmithKline LLC and Covis Pharma S.à.r.l. |
| Manufacturing Know-How License Agreement, dated December 22, 2011, by and among Glaxo Group Limited, Glaxo Wellcome Manufacturing Pte. Ltd. and Covis Pharma S.à.r.l. |
| License Agreement, dated February 28, 2014, by and between AstraZeneca AB and Covis Pharma S.à.r.l. |
| Intellectual Property Agreement, dated April 4, 2013, by and among sanofi-aventis U.S. LLC, sanofi and Covis Pharma S.à.r.l. |
| Transition Services Agreement, dated October 3, 2014, between Covis Pharma, S.à.r.l. and WellSpring Pharmaceutical Corporation. |
Schedule 1.1(d)
Knowledge of Purchaser
| John A.R. McCleery, Managing Director |
Schedule 1.1(e)
Knowledge of Sellers
| Jack Davis, Chief Executive Officer |
| Michael Porter, Chief Operating Officer |
| Fabio Fazio, Vice President & Head of Quality Assurance |
| Aziza Johnson, Vice President & Head of Regulatory Affairs |
Schedule 1.1(f)
Products
Product |
Scientific Name |
NDA
|
AG Available |
|||
Lanoxin ® 1 |
Digoxin |
[REDACTED] |
||||
Parnate ® | Tranylcypromine sulfate | |||||
Zantac ® Zantac ® In Plastic Container |
Ranitidine hydrochloride | |||||
Fortaz ® Fortaz ® In Plastic Container |
Ceftazidime | |||||
Zinacef ® Zinacef ® In Plastic Container |
Cefuroxime sodium | |||||
Nilandron ® | Nilutamide | |||||
Plaquenil ® | Hydroxychloroquine sulfate | |||||
Kayexalate ® | Sodium polystyrene sulfonate | |||||
Uroxatral ® | Alfuzosin hydrochloride | |||||
DuToprol ® | Hydrochlorothiazide; metoprolol succinate | |||||
Dibenzyline ® | Phenoxybenzamine hydrochloride | |||||
Dyrenium ® | Triamterene | |||||
|
1 | For the avoidance of doubt, this product is limited to the tablet form, and does not include Lanoxin IV, (otherwise referred to as the Lanoxin injection or the pediatric injection). Note also that the following SKUs of Lanoxin shall not be considered Products for purposes of the Agreement (but shall instead be considered Retained Products under the Agreement [REDACTED] |
Schedule 1.1(g)
Retained Products
Product |
Scientific Name |
NDA
|
AG Available |
|||
Rilutek® Lanoxin IV® Betapace ® Betapace AF ® |
Riluzole Digoxin Sotalol hydrochloride Sotalol hydrochloride |
[REDACTED] |
||||
The following SKUs of Lanox in shall not be considered Products for purposes of the Agreement (but shall instead be considered Retained Products under the Agreement):
Lanoxin Government PL SKUs
NDC |
Package |
|||
[REDACTED] |
Schedule 1.1(h)
[REDACTED]
[REDACTED]
Schedule 4.11
Taxes
Notwithstanding anything to the contrary in the Agreement, including the introductory paragraph of Article IV , this disclosure item serves the sole function of supplying the meaning of the factors referred to in Section 4.11 , it being understood that it is not an exception to, nor is it intended to, nor shall it be deemed to, in any other way, expand, enlarge or modify the representations and warranties given by Sellers in the Agreement.
1. | [REDACTED] |
EXHIBIT A
LIST OF INSTRUMENTS AND DOCUMENTS TO BE PROVIDED BY SELLERS
(a) | a receipt for payment of the Purchase Price at Closing; |
(b) | evidence of termination of the CPI Distribution Contracts in accordance with the terms and conditions thereof; |
(c) | the Transition Services Agreement, duly executed by an authorized officer of each of the Sellers; |
(d) | the Intellectual Property Assignment Agreement, duly executed by an authorized officer of each of the Sellers; |
(e) | the Assignment and Assumption Agreement, duly executed by an authorized officer of each of the Sellers; |
(f) | the Bill of Sale, duly executed by an authorized officer of each of the Sellers; |
(g) | The Escrow Agreement, duly executed by an authorized officer of each of the Sellers; |
(h) | the certificates referred to in Section 7.2(a) and Section 7.2(b) ; |
(i) | executed assignments of Assumed Contracts; and |
(j) | such other bills of sale or certificates of title, and such other instruments of transfer, as may be required to transfer to Purchaser all of Sellers right, title and interest in and to the Purchased Assets at the Closing and in the case of each of (a) (1), dated the Closing Date. |
EXHIBIT B
LIST OF INSTRUMENTS AND DOCUMENTS
TO BE PROVIDED BY PURCHASER
(a) | the Transition Services Agreement, duly executed by an authorized officer of Purchaser; |
(b) | the Intellectual Property Assignment Agreement, duly executed by an authorized officer of Purchaser; |
(d) | the Assignment and Assumption Agreement, duly executed by an authorized officer of Purchaser; |
(e) | the Bill of Sale, duly executed by an authorized officer of Purchaser; |
(f) | the Escrow Agreement, duly executed by an authorized officer of Purchaser; |
(g) | the certificates referred to in Section 7.3(a) and Section 7.3(b) ; |
(h) | any federal, state, local or foreign Tax forms, certificates, instruments or other documents requested by Sellers or otherwise required to be provided by Purchaser in connection with the consummation of the transactions contemplated by this Agreement; and |
(i) | such other bills of sale or certificates of title, and such other instruments of transfer, as may be required to transfer to Purchaser all of Sellers right, title and interest in and to the Purchased Assets at the Closing and in the case of each of (a) (i), dated the Closing Date. |
EXHIBIT C
TRANSITION SERVICES AGREEMENT TERM SHEET
Reference is made to the Asset Purchase Agreement dated the 9 th day of March 2015, by and between Covis Pharma S.à.r.l., Zug Branch, a limited liability company organized under the Laws of Luxembourg ( Covis Pharma ), Covis Injectables S.à.r.l., Zug Branch, a limited liability company organized under the Laws of Luxembourg ( Covis Injectables : each of Covis Pharma and Covis Injectables is referred to individually as a Seller and, collectively, Covis Pharma and Covis Injectables are referred to as the Sellers ). Concordia Pharmaceuticals Inc., an international business company organized under the Laws of Barbados ( Purchaser ), Concordia Healthcare Corp., a corporation organized under the Laws of the province of Ontario ( Purchaser Parent ) (solely with respect to Section 6.10 , Section 10.18 and the applicable provisions of Article X ) and Covis Pharma Holdings S.à.r.l., a limited liability company organized under the Laws of Luxembourg ( Seller Parent ) (solely with respect to Section 10.19 and the applicable provisions of Article X ) (as amended, modified or supplemented from time to time in accordance with its terms, the Purchase Agreement ).
Capitalized terms used but not defined in this Transition Services Agreement Term Sheet ( Term Sheet ) have the respective meanings given to them in the Purchase Agreement unless otherwise specified.
1. | Covis Pharmaceuticals Inc . Upon Purchasers request, Sellers shall, and shall cause their respective third party contractors to, provide or cause to be provided to Purchaser or any of its Affiliates and/or third party contractors, the services set forth below, as applicable. The parties contemplate that CPI may be a party to the Transition Services Agreement with respect to the services to be provided by CPI. |
2. | Rebates and Chargebacks . Parties agree to negotiate in good faith and reach agreement on the process for handling rebates and chargebacks (including a sample calculation representing the reimbursements), which process shall be consistent with Section 6.17(b) and Section 6.17(c) of the Purchase Agreement. |
3. | Returns . [REDACTED] |
4. | GPO Contracts . [REDACTED] |
5. | Commercial |
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a. | Marketing : |
i. | Continue to provide the services with respect to the commercialization of Nilandron under the CPI/Covis Pharma Distribution Contract until June 30, 2015 in a manner substantially consistent with the manner in which such services were provided as of the date of the Purchase Agreement, and subject to the parties agreeing on fees in the Transition Services Agreement to be paid to CPI with respect to such services. Such services may be extended beyond June 30, 2015 if agreed upon by the parties. |
ii. | Until June 30, 2015, provide reasonable access to the Product Manager(s) responsible for the Products. Such services may be extended beyond June 30, 2015 if agreed upon by the parties. |
iii. | Until June 30, 2015, provide reasonable access to the employees of each Seller and of their respective Affiliates involved in the commercialization of Nilandron ® . Such services may be extended beyond June 30, 2015 if agreed upon by the parties. |
b. | Trade : |
i. | Provide a list of all entities to which CPI directly or indirectly sold Products during the twelve (12) months ended on the execution date of the Purchase Agreement ( Customers ). |
ii. | Notify Customers that all orders for the Products are to be placed with Purchaser or its designee. |
iii. | If, after Closing, any orders for the Products are placed with CPI despite notification to the trade, each Seller will forward such orders to Purchaser or its designee within two (2) Business Days of receipt of same. |
iv. | CPI will work with Purchaser to notify customers and pricing services of any change in the price of the Products. |
v. | CPI to cooperate with Purchaser to transfer the Dibenzylene coupon programs to Purchaser at the Closing Date. CPI will be responsible for any costs of any Product coupon redemptions up to the Closing Date. |
6. | Medical Affairs . |
a. | Adverse Event Data . |
i. | Within thirty (30) days after the Closing Date, provide with an electronic copy of all Adverse Event data that was collected prior to Closing with respect to the Products. |
ii. | For a period of three (3) months following the Closing Date, continue to collect and manage Adverse Event information with respect to the Products in accordance with applicable FDA requirements, and provide such information to Purchaser. Purchaser shall be responsible for reporting such information to the FDA (together with any other Adverse Event information received directly by Purchaser), in accordance with applicable FDA requirements. |
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iii. | At all times after the date that is three (3) months following the Closing Date (the Cutover Date ), Purchaser shall be responsible for the collection, management and reporting of Adverse Event information received with respect to the Products. |
| Following the Cutover Date, Sellers will provide Purchaser with all Serious Adverse Event information received by Sellers for any Product within one (1) day of receipt by Sellers, in .pdf or verbatim text format. |
| Following the Cutover Date, Sellers will provide Purchaser with all Adverse Event information (other than Serious Adverse Event information) received by Sellers for any Product within ten (10) days of receipt by Sellers. |
b. | Medical Inquiries . |
i. | Within thirty (30) days after the Closing Date, provide an electronic copy of legacy data related to medical inquiries and responses with respect to the Products. |
ii. | From and after the Closing Date, refer all questions raised by health care professionals relating to the Products sold by Purchaser to Purchaser for response. |
iii. | From and after the Closing Date, Purchaser shall be responsible for and shall conduct all correspondence and communication with physicians and other health care professionals relating to the Products in the United States, including medical inquiries and responses thereto. |
c. | Provide copies of drug safety/medical information. |
d. | As promptly as practicable following the Closing Date, CPI will send a mutually agreed-upon letter to all patients enrolled the Patient Assistance Programs. |
7. | Regulatory / Quality |
a. | For a period of six (6) months following the Closing Date, provide (i) reasonable support for regulatory responsibilities and commitments for the Products, (ii) Purchaser with timely assistance in responding to specific questions posed by Purchaser and (iii) assist Purchaser in its compliance with regulatory matters related to the Products. |
b. | Seller shall use its commercially reasonable efforts to provide to Purchaser as soon as reasonably practicable after the Closing Date, (i) information and documents related to the Business reasonably required by Purchaser or its Affiliates to prepare and file a business acquisition report (as required by Canadian securities Laws) and (ii) such assistance as may reasonably be required by Purchaser in connection therewith. |
c. | Assistance With Preparation of FDA Reports : |
i. |
Provide a list of all Annual Reports, Periodic Safety Update Reports, Periodic Adverse Drug Experience Reports and other reports to the FDA or any other Governmental Authorities that are due to be submitted to the FDA on or |
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before April 30, 2016. |
ii. | Prepare, and provide to Purchaser for submission to the FDA, all FDA Annual Reports and any Periodic Safety Update Reports relating to the Products that are due to be submitted to the FDA on or before the date that is the three (3) month anniversary of the Closing Date. Purchaser will be responsible for submitting such reports to the FDA. |
iii. | From and after the date that is the three (3) month anniversary of the Closing Date, Purchaser shall have full responsibility for preparing and submitting, and shall prepare and submit, all FDA Annual Reports, Periodic Safety Update Reports and any other reports required by the FDA or any other Government Authority in the Territory with respect to the Products. |
d. | For a period of six (6) months following the Closing Date, provide reasonable, limited access to Sellers and/or any of their Affiliates Regulatory and Quality personnel that are responsible for the regulatory and quality function related to the Products. |
e. | During the six (6) month period following the Closing Date, each Party will provide the other Party with reasonably requested cooperation and responses to information requested resulting from audits, investigations or claims against one another by customers, regulatory agencies or governments related to activities performed. |
8. | Finance / Accounting |
a. | For a period of six (6) months following the Closing Date, provide (i) reasonable access to finance and accounting personnel that are responsible for the finance and accounting function related to the Products and (ii) such other financial- and accounting-related services as are agreed upon by the parties in the Transition Services Agreement. |
9. | Supply Chain |
a. | During the ninety (90) day period following the Closing Date, provide reasonable access to Sellers supply chain personnel that are responsible for the supply chain function related to the Products. |
b. | During the ninety (90) day period following the Closing Date, promptly meet to discuss logistics with respect to the Products. |
c. | During the ninety (90) day period following the Closing Date, provide Purchaser with reasonable assistance to support Purchasers demand and supply planning activities with respect to the Products. |
d. | Sellers to work with Purchaser to assume and/or cancel open Product purchase orders and to issue replacement purchase orders with contract manufacturers. Purchaser shall be responsible for any cancellation payments incurred as a result of the foregoing. |
10. | Government and PHS Contracts |
[REDACTED]
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[REDACTED]
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Exhibit 99.19
EXECUTION VERSION
CONCORDIA HEALTHCARE CORP.
$735,000,000 7.000% Senior Notes due 2023
Purchase Agreement
April 13, 2015
RBC Capital Markets, LLC
as Representative of the
several Initial Purchasers listed
in Schedule 1 hereto
c/o RBC Capital Markets, LLC
3 World Financial Center
200 Vesey Street, 8th Floor
New York, New York 10281
Ladies and Gentlemen:
Concordia Healthcare Corp., a corporation organized under the laws of the province of Ontario (the Company ), proposes to issue and sell to the several initial purchasers listed in Schedule 1 hereto (the Initial Purchasers ), for whom RBC Capital Markets, LLC is acting as the representative (the Representative ), $735,000,000 principal amount of its 7.000% Senior Notes due 2023 (the Notes ). The Notes will be issued pursuant to an Indenture to be dated as of April 21, 2015 (the Indenture ) among the Company, the guarantors listed in Schedule 2 hereto (the Guarantors and, together with the Company, the Issuers ) and U.S. Bank National Association, as trustee (the Trustee ), and will be guaranteed on a senior unsecured basis by each of the Guarantors (the Guarantees and, together with the Notes, the Securities ).
The Securities are being issued and sold in connection with the acquisition (the Acquisition ) by the Company of certain assets of Covis Pharma S.à.r.l., Zug Branch, a limited liability company organized under the Laws of Luxembourg ( Covis Pharma ), and Covis Injectables S.à.r.l., Zug Branch, a limited liability company organized under the Laws of Luxembourg ( Covis Injectables , and together with Covis Pharma, the Sellers ), pursuant to that certain Asset Purchase Agreement, dated as of March 9,2015 (the Asset Purchase Agreement ), among the Sellers, Concordia Pharmaceuticals Inc., an international business company incorporated under the Laws of Barbados (the Buyer ), the Company, as the indirect parent of the Buyer, and Covis Pharma Holdings S.à.r.l., as the parent of the Sellers (together with the Ancillary Agreements (as defined in the Asset Purchase Agreement), the Acquisition Documents ).
In connection with the Acquisition, (i) the Company and each of the Guarantors signatories thereto will enter into a senior secured credit facility, dated on or about April 21,
2015 (the Credit Facility , and, together with all other documents related to such facility, the Credit Documents ), with Royal Bank of Canada, as administrative agent, and the lenders party thereto, (ii) the Company has issued 3,764,720 subscription receipts (each, a Subscription Receipt ) at a price of $85.00 per Subscription Receipt (the Equity Offering ) pursuant to an underwriting agreement, dated as of March 23,2015, among the Company, RBC Dominion Securities Inc., GMP Securities L.P. and TD Securities Inc., as underwriters and (iii) all or substantially all existing indebtedness of the Company and its Subsidiaries (as defined below) (other than indebtedness secured by purchase money security interests or other similar security or pursuant to capital leases or trade payables and other indebtedness incurred in the ordinary course of business) will be repaid, all as described in the Time of Sale Information (as defined below).
The Securities will be sold to the Initial Purchasers without being registered under the Securities Act of 1933, as amended (the Securities Act ), in reliance upon an exemption therefrom and to non-U.S. persons in the Canadian Offering Jurisdictions (as defined below) in accordance with NI 45-106 (as defined below) pursuant to exemptions from the prospectus requirements under Canadian Securities Laws (as defined below) (the Offering ). The Issuers have prepared a preliminary offering memorandum dated April 6, 2015 (the Preliminary Offering Memorandum ), and will prepare an offering memorandum dated the date hereof (the Offering Memorandum ) setting forth information concerning the Company and the Securities. For the purposes hereof, any reference to the Preliminary Offering Memorandum includes the Canadian offering memorandum dated April 6, 2015 of the Company regarding the offer for sale of the Notes being made in Canada (the Canadian Preliminary Offering Memorandum ), to the extent applicable, and any reference to the Offering Memorandum includes the Canadian offering memorandum dated the date hereof of the Company regarding the offer for sale of the Notes being made in Canada (the Canadian Offering Memorandum ), to the extent applicable.
Copies of the Preliminary Offering Memorandum have been, and copies of the Offering Memorandum will be, delivered by the Company to the Initial Purchasers pursuant to the terms of this Agreement. The Company hereby confirms that it has authorized the use of the Preliminary Offering Memorandum, the other Time of Sale Information and the Offering Memorandum in connection with the offering and resale of the Securities by the Initial Purchasers in the manner contemplated by this Agreement. Capitalized terms used but not defined herein shall have the meanings given to such terms in the Preliminary Offering Memorandum.
At or prior to the time when sales of the Securities were first made (the Time of Sale ), the Preliminary Offering Memorandum, as supplemented and amended by the written communications listed on Annex A hereto (collectively, the Time of Sale Information ), shall have been prepared.
The issuance and sale of the Notes (including the execution and delivery of the Guarantees), the Acquisition, the entry by the Company and the Guarantors into the Credit Facility and the other Credit Documents and the initial extensions of credit thereunder, if any, on the Closing Date, and the payment of transaction costs are referred to herein collectively, as the Transactions .
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The Company hereby confirms its agreement with the several Initial Purchasers concerning the purchase and resale of the Securities, as follows:
Definitions . Unless otherwise defined herein, the following words and terms shall have the meanings ascribed below:
Canadian Offering Jurisdictions means the provinces of Alberta, British Columbia, Manitoba, Ontario and Quebec.
Canadian Securities Laws means, collectively, securities laws in each of the Canadian Offering Jurisdictions applicable in connection with the offer for sale of the Notes being made in the Canadian Offering Jurisdictions and the respective rules and regulations made thereunder, together with applicable multilateral or national instruments, and published orders and rulings issued or adopted by each of the Securities Regulators.
CMS means The Centers for Medicare and Medicaid Services, a division of the United States Department of Health and Human Services, or any successor agency thereto.
Company Option Plan means the stock option plan of the Company, as amended from time to time.
DOJ means the United States Department of Justice.
FDA means the U.S. Food and Drug Administration of the U.S., Department of Health & Human Services.
Federal Health Care Program has the meaning specified in Section 1128B(f) of the Social Security Act and includes the Medicare, Medicaid and TRICARE programs.
Governmental Authority means any federal, provincial, state, municipal, local or other governmental or public department, commission, board, bureau, agency, instrumentality or body, domestic or foreign (including, without limitation, any stock exchange, securities regulatory authority, central bank, fiscal or monetary authority or authority regulating banks), any subdivision or authority of any of the foregoing or any quasi-governmental, self-regulatory organization or private body exercising any regulatory, expropriation or taxing authority under or for the account of its members or any of the foregoing.
Health Care Laws means the following statutes, regulations, guidelines, ordinances, orders, standards, requirements, approvals, or consents, to the extent applicable to the business of the Company: Title XVIII of the Social Security Act, 42 U.S.C. §§ 1395-1395, including specifically and without limitation, the DMEPOS standards and conditions for Medicare payment, 42 C.F.R. § 424.57 and the Ethics in Patient Referrals Act, as amended, 42 U.S.C. § 1395nn; Title XIX of the Social Security Act, 42 U.S.C. §§ 1396 1396w-5v; the Federal Anti-Kickback Statute, 42 U.S.C. § 1320a-7b(b); the False Claims Act, 31 U.S.C. §§ 3729-3733 (as amended); the Program Fraud Civil Remedies Act, 31 U.S.C. §§ 3801-3812; the Anti-Kickback Act, 41 U.S.C. §§ 8701-8707; the Civil Monetary Penalties Law, 42 U.S.C. § 1320a-7a; the Criminal Penalties for Acts Involving Federal Health Care Programs, 42 U.S.C. § 1320a-7b; Mail and Wire Fraud, 18 U.S.C. §§ 1341-1343; False Statements Relating to Health Care Matters, 18 U.S.C. § 1035; Health Care
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Fraud, 18 U.S.C. § 1347; the Exclusion Laws, 42 U.S.C. § 1320a-7; Title II, Subtitle F of the Health Insurance Portability and Accountability Act of 1996, 42 U.S.C. §§ 1320d-1329d-9, as amended by Subtitle D of the Health Information Technology for Economic and Clinical Health (HITECH) Act as incorporated in the American Recovery and Reinvestment Act of 2009,42 U.S.C. §§17921-17953; Supplemental Medical Insurance Benefit regulations, 42 C.F.R. Part 410; the Transparency Reports and Reporting of Physician Ownership or Investment Interests Law (the Sunshine Act ). 42 U.S.C. § 1320a-7h; The Food, Drug, and Cosmetic Act, 21 U.S.C. §§ 301-399f (including the Orphan Drug Act), and any implementing regulations pursuant to any of the foregoing.
LTIP means the long-term incentive plan of the Company.
NI 45-106 means National Instrument 45-106 Prospectus and Registration Exemptions of the Canadian Securities Administrators.
OIG means the United States Department of Health and Human Services Office of Inspector General.
Permitted Encumbrances means (i) any validly perfected security interest given by the Company in respect of any indebtedness; (ii) any other security given by the Company in connection with the operation of the business of the Company; (iii) liens against the Company or its assets for taxes, assessments or governmental charges or levies not due and delinquent; (iv) undetermined or inchoate liens and charges incidental to the current operations of the Company which have not been filed pursuant to law or which relate to obligations not due or delinquent; and (v) those otherwise disclosed in the Transaction Documents, including in connection with the Credit Facility.
Person means any individual, partnership, limited partnership, limited liability partnership, limited liability corporation, limited liability company, joint venture, syndicate, sole proprietorship, company or corporation with or without share capital, unincorporated association, trust, trustee, executor, administrator or other legal personal representative or other entity however designated or constituted.
Products means the pharmaceutical products currently sold by the Company or any of its Subsidiaries.
Purchaser means any Person who shall purchase Notes pursuant to the Offering.
Regulatory Authority means any Governmental Authority or other body authorized by applicable law, exercising regulatory authority for the purpose of protecting or promoting public health and safety, over the testing, development, marketing, manufacturing, or distribution of any drug or medical device intended for use in human beings, including without limitation, the FDA.
Securities Regulators means the applicable securities commissions or regulatory authorities in each of the Canadian Offering Jurisdictions.
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1. Purchase and Resale of the Notes .
(a) The Issuers agree to issue and sell the Securities to the several Initial Purchasers as provided in this Agreement, and each Initial Purchaser, on the basis of the representations, warranties and agreements set forth herein and subject to the conditions set forth herein, agrees, severally and not jointly, to purchase from the Company the respective principal amount of Notes (including the Guarantees) set forth opposite such Initial Purchasers name in Schedule 1 hereto at [REDACTED] plus accrued interest, if any, from April 21, 2015 to the Closing Date. The Issuers will not be obligated to deliver any of the Notes (including the Guarantees) except upon payment for all the Notes (including the Guarantees) to be purchased as provided herein.
(b) The Issuers understand that the Initial Purchasers intend to offer the Securities for resale on the terms set forth in the Time of Sale Information and this Agreement. Each Initial Purchaser, severally and not jointly, represents, warrants and agrees that:
(i) it is a qualified institutional buyer within the meaning of Rule 144A under the Securities Act (a QIB ) and an accredited investor within the meaning of Rule 501(a) under the Securities Act;
(ii) it has not solicited offers for, or offered or sold, and will not solicit offers for, or offer or sell, the Securities by means of any form of general solicitation or general advertising within the meaning of Rule 502(c) of Regulation D under the Securities Act ( Regulation D ) or in any manner involving a public offering within the meaning of Section 4(a)(2) of the Securities Act; and
(iii) it has not solicited offers for, or offered or sold, and will not solicit offers for, or offer or sell, the Securities as part of their initial offering except:
(A) within the United States to persons whom it reasonably believes to be QIBs or, if any such person is buying for one or more institutional accounts for which such person is acting as fiduciary or agent, only when such person has represented to the Initial Purchasers that such account is a QIB, to whom notice has been given that such sale or delivery is being made in reliance on Rule 144A under the Securities Act ( Rule 144A ), and in each case, in transactions under Rule 144A; or
(B) in accordance with the restrictions set forth in Annex C hereto.
(c) Each Initial Purchaser acknowledges and agrees that the Issuers and, for purposes of the opinions to be delivered to the Initial Purchasers pursuant to Sections 6(f) and 6(g), counsel for the Issuers and counsel for the Initial Purchasers, respectively, may rely upon the accuracy of the representations and warranties of the Initial Purchasers, and compliance by the Initial Purchasers with their agreements, contained in paragraph
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(b) above (including Annex C hereto), and each Initial Purchaser hereby consents to such reliance.
(d) The Issuers acknowledge and agree that the Initial Purchasers may offer and sell Securities to or through any affiliate of an Initial Purchaser in the manner contemplated by the Time of Sale Information and the Offering Memorandum and that any such affiliate may offer and sell Securities purchased by it to or through any Initial Purchaser.
(e) The Issuers acknowledge and agree that the Initial Purchasers and the Representative are acting solely in the capacity of an arms length contractual counterparty to the Issuers with respect to the offering of Securities contemplated hereby (including in connection with determining the terms of the Offering) and not as financial advisors or fiduciaries to, or agents of, the Company, the Guarantors or any other person. Additionally, neither the Representative nor any other Initial Purchaser is advising the Company, the Guarantors or any other person as to any legal, tax, investment, accounting or regulatory matters in any jurisdiction in connection with the offering of Securities. The Company and the Guarantors shall consult with their own advisors concerning such matters and shall be responsible for making their own independent investigation and appraisal of the transactions contemplated hereby, and neither the Representative nor any other Initial Purchaser shall have any responsibility or liability to the Issuers with respect thereto. Any review by the Representative or any Initial Purchaser of the Company, the Guarantors, and the transactions contemplated hereby or other matters relating to such transactions will be performed solely for the benefit of the Representative or such Initial Purchaser, as the case may be, and shall not be on behalf of the Company, the Guarantors or any other person.
(f) The Initial Purchasers will use all commercially reasonable efforts to complete the distribution of the Notes as soon as possible and the Representative shall promptly notify the Company when, in their good faith opinion, the Initial Purchasers have ceased distribution of the Notes.
(g) The Company will file or cause to be filed all documents required to be filed by the Company in connection with the transactions contemplated by this Agreement so that the offer for sale of the Notes being made in the Canadian Offering Jurisdictions may be effected in a manner exempt from the prospectus requirements of Canadian Securities Laws, including filing within 10 days after the Closing Date a Form 45-106F1 and/or a Form 45-106F6, as applicable, pursuant to NI 45-106. Each Initial Purchaser shall deliver to the Company, as soon as practicable and, in any event, in sufficient time to allow the Company to comply with all Canadian Securities Laws and other regulatory requirements applicable in any Canadian Offering Jurisdiction (including in order to enable the Company to make the filings referenced in the prior sentence), all necessary information to allow the Company to file all required forms with the relevant Securities Regulators in Canada including the full name, residential address, telephone number, corporate account number, and the name and registered representative number of the Initial Purchaser responsible for the purchase of Notes by, and the aggregate principal amount of Notes purchased by, each Purchaser in a Canadian Offering Jurisdiction to
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whom such Initial Purchaser has sold Notes, as well as, in respect of any distributions in British Columbia (as described in Form 45-106F6) of the Notes, confirmation as to whether the relevant Purchasers have indicated to the Initial Purchaser that they are insiders of the Company or registrants and the name and telephone number of a contact person for each non individual Purchaser.
(h) None of the Company, the Initial Purchasers nor any of their respective affiliates shall provide to prospective Purchasers in any Canadian Offering Jurisdiction any document or other material that would constitute an offering memorandum within the meaning of Canadian Securities Laws other than the Canadian Preliminary Offering Memorandum or the Canadian Offering Memorandum, or other documents agreed upon in writing by the Company and the Initial Purchasers, and the offer for sale of the Notes being made in the Canadian Offering Jurisdictions will not be advertised in any newspaper, magazine, printed media or similar medium of general and regular paid circulation, broadcast over radio or television or by means of the internet and no seminar or meeting relating to the offer for sale of the Notes being made in the Canadian Offering Jurisdictions whose attendees have been invited by general solicitation or advertising will be conducted.
2. Payment and Delivery .
(a) Payment for and delivery of the Securities will be made at the offices of Sullivan & Cromwell LLP, 125 Broad Street, New York, New York 10004 at 10:00 A.M., New York City time, on April 21, 2015 or at such other time or place on the same or such other date, as the Representative and the Company may agree upon in writing. The time and date of such payment and delivery is referred to herein as the Closing Date .
(b) Payment for the Securities shall be made by wire transfer in immediately available funds to the account(s) specified by the Company to the Representative against delivery to the nominee of The Depository Trust Company, for the account of the Initial Purchasers, of one or more global notes representing the Notes (collectively, the Global Note), with any transfer taxes payable in connection with the sale of the Securities duly paid by the Company. The Global Note will be made available for inspection by the Representative not later than 1:00 P.M., New York City time, on the business day prior to the Closing Date.
3. Representations and Warranties of the Company and the Guarantors . The Company and each Guarantor jointly and severally represent and warrant to each Initial Purchaser that:
(a) Preliminary Offering Memorandum, Time of Sale Information and Offering Memorandum. The Preliminary Offering Memorandum, as of its date, did not, the Time of Sale Information, at the Time of Sale, did not, and at the Closing Date, will not, and the Offering Memorandum, as of its date (as amended or supplemented in accordance with Section 4(b), as applicable) and as of the Closing Date, will not, contain any untrue statement of a material fact or omit to state a material fact necessary in order to make the statements therein, in the light of the circumstances under which they were made, not misleading, and the Canadian Preliminary Offering Memorandum, as of its date, did not,
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and the Canadian Offering Memorandum, as of the Time of Sale and as of the Closing Date, will not, contain a misrepresentation (as defined under Canadian Securities Laws); provided that the Company and the Guarantors make no representation or warranty with respect to any statements or omissions made solely in reliance upon and in conformity with information relating to any Initial Purchaser furnished to the Company in writing by such Initial Purchaser through the Representative expressly for use in the Preliminary Offering Memorandum, the Canadian Preliminary Offering Memorandum, the Time of Sale Information, the Offering Memorandum or the Canadian Offering Memorandum.
(b) Additional Written Communications. The Issuers (including their agents and representatives, other than the Initial Purchasers in their capacity as such) have not prepared, made, used, authorized, approved or referred to and will not prepare, make, use, authorize, approve or refer to any written communication that constitutes an offer to sell or solicitation of an offer to buy the Securities (each such communication by the Issuers or their agents and representatives (other than a communication referred to in clauses (i), (ii), (iii) and (iv) below) an Issuer Written Communication ) other than (i) the Preliminary Offering Memorandum, (ii) the Offering Memorandum, (iii) the documents listed on Annex A hereto, including a term sheet substantially in the form of Annex B hereto, which constitute part of the Time of Sale Information, and (iv) any electronic road show or other written communications, in each case used in accordance with Section 4(c). Each such Issuer Written Communication, when taken together with the Time of Sale Information, did not, and at the Closing Date will not, contain (i) any untrue statement of a material fact or omit to state a material fact necessary in order to make the statements therein, in light of the circumstances under which they were made, not misleading and (ii) any information that conflicted, conflicts or will conflict with the information contained in this Agreement; provided that the Company makes no representation and warranty with respect to any statements or omissions made in each such Issuer Written Communication solely in reliance upon and in conformity with information relating to any Initial Purchaser furnished to the Company in writing by such Initial Purchaser through the Representative expressly for use in any Issuer Written Communication.
(c) Eligible for Resale. The Securities are eligible for resale pursuant to Rule 144A and there are no securities of the Issuers that are listed on a national securities exchange registered under Section 6 of the Securities Exchange Act of 1934, as amended (the Exchange Act ) or that are quoted in a United States automated interdealer quotation system of the same class within the meaning of Rule 144A as the Securities.
(d) Financial Statements .
(i) The financial statements of the Company and the related notes thereto included in each of the Preliminary Offering Memorandum, the Time of Sale Information and the Offering Memorandum present fairly, in all material respects, the consolidated financial position of the Company as of the dates indicated and its financial performance and cash flows for the periods specified, and there has been no change in accounting policies or practices of the Company since January 1, 2014, except as disclosed in the Companys financial statements, Managements Discussion and Analysis or the Preliminary Offering
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Memorandum, the Time of Sale Information or the Offering Memorandum; such financial statements have been prepared in accordance with International Financial Reporting Standards ( IFRS ) as issued by the International Accounting Standards Board applied on a consistent basis throughout the periods covered; the other financial information of the Company included in each of the Preliminary Offering Memorandum, the Time of Sale Information and the Offering Memorandum has been derived from the accounting or other records of the Company and its Subsidiaries and presents fairly, in all material respects, the information shown thereby. Except as set out in the Companys financial statements or as not otherwise required to be reported in accordance with IFRS, the Company does not have any outstanding indebtedness or any liabilities or obligations including any unfunded obligation under any employee plan, whether accrued, absolute, contingent or otherwise as of the date of such financial statements.
(ii) To the Companys knowledge, the carve-out financial statements in respect of the Covis Portfolio (as defined below) and the related notes thereto included in each of the Preliminary Offering Memorandum, the Time of Sale Information and the Offering Memorandum present fairly the financial position of the portfolio of Sellers products to be acquired by the Buyer in the Acquisition (the Covis Portfolio ) as of the dates indicated and for the periods specified, and such financial statements have been prepared in conformity with U.S. generally accepted accounting principles ( GAAP ) applied on a consistent basis throughout the periods covered.
(iii) To the Companys knowledge, the carve-out financial statements in respect of the Donnatal Acquisition (as defined below) and the related notes thereto included in each of the Preliminary Offering Memorandum, the Time of Sale Information and the Offering Memorandum present fairly the financial position of the acquisition described in the Companys business acquisition report dated June 9, 2014 (the Donnatal Acquisition ) as of the dates indicated and for the periods specified, and such financial statements have been prepared in conformity with GAAP applied on a consistent basis throughout the periods covered.
(iv) To the Companys knowledge, the carve-out financial statements in respect of the Zonegran Acquisition (as defined below) and the related notes thereto included in each of the Preliminary Offering Memorandum, the Time of Sale Information and the Offering Memorandum present fairly the financial position of the acquisition described in the Companys business acquisition report dated December 12,2014 (the Zonegran Acquisition ) as of the dates indicated and for the periods specified, and such financial statements have been prepared in conformity with GAAP applied on a consistent basis throughout the periods covered.
(v) The unaudited pro forma financial statements (including the notes thereto) or other pro forma financial information included in each of the
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Preliminary Offering Memorandum, the Time of Sale Information and the Offering Memorandum have been properly computed and presented based on the assumptions described therein. The assumptions used in the preparation of the unaudited pro forma financial statements and the other pro forma and adjusted financial information included in the Offering Memorandum (including Adjusted EBITDA ) are reasonable, and the adjustments used therein are appropriate to give effect to the transactions or circumstances referred to therein.
(e) No Material Adverse Change. Since the date of the most recent statement of financial position of the Company included in each of the Time of Sale Information and the Offering Memorandum, or except as otherwise disclosed therein, (i) other than the Transactions and the Equity Offering and other than in connection with the sale of Intellectual Property (as defined, below) from Pinnacle Biologies, Inc. to Concordia Laboratories Inc., there has not been any material change in the capital stock or long-term debt of the Company and any of its Subsidiaries taken as a whole, or any dividend or distribution of any kind declared, set aside for payment, paid or made by the Company on any class of capital stock, other than in accordance with the Companys current dividend policy, or any material adverse change, or any development involving a prospective material adverse change, in or affecting the business, properties, rights, assets, financial position or results of operations of the Company and its Subsidiaries taken as a whole; (ii) other than in connection with the Transactions and the Equity Offering, neither the Company nor any of its Subsidiaries has entered into any transaction or agreement that is material to the Company and its Subsidiaries taken as a whole, or other than in the ordinary course of business, incurred any liability or obligation, direct or contingent, that is material to the Company and its Subsidiaries taken as a whole; (iii) neither the Company nor any of its Subsidiaries has sustained any material loss or interference with its business from fire, explosion, flood or other calamity, whether or not covered by insurance, or from any labor disturbance or dispute or any action, order or decree of any court or arbitrator or governmental or regulatory authority and (iv) there has not been any material adverse change in the ability of the Company or its Subsidiaries to consummate any of the Transactions on a timely basis, except in each case as otherwise disclosed in the Time of Sale Information.
(f) Organization and Good Standing. Attached as Exhibit A is a true and complete list of each entity in which the Company has a direct or indirect majority equity or voting interest (each, a Subsidiary and, together, the Subsidiaries ), their jurisdictions of organization or incorporation, name of its equityholder(s) and percentage held by each equityholder. The Company does not own or control, directly or indirectly, any corporation, association or other entity other than the Subsidiaries. The Company and each of the Guarantors have been duly organized or incorporated and are validly existing and in good standing under the laws of their respective jurisdictions of organization or incorporation, are duly qualified to do business and, to the extent applicable, are in good standing in each jurisdiction in which their respective ownership or lease of property or the conduct of their respective businesses requires such qualification, and have all power and authority necessary to own or hold their respective properties and to conduct the businesses in which they are engaged, except where the failure to be so qualified, in good standing or have such power or authority would not, individually or in the aggregate,
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reasonably be expected to have a material adverse effect on the business, properties, rights, assets, financial position, results of operations of the Company and its Subsidiaries taken as a whole or on the performance by the Company and the Guarantors of their obligations under the Securities (a Material Adverse Effect ).
(g) Capitalization. The Company has an authorized capitalization as set forth in each of the Time of Sale Information and the Offering Memorandum under the heading Capitalization. The Company legally and beneficially owns, directly or indirectly, all of the issued and outstanding shares in the capital of each of its Subsidiaries (other than Pinnacle Oncology LLC, which is 87.5% indirectly owned by the Company) and all shares of such Subsidiaries are held free and clear of all liens, claims, charges, encumbrances or demands of any and kind whatsoever other than Permitted Encumbrances. All of the issued and outstanding equity interests of each Guarantor have been duly and validly authorized and issued; are fully paid and nonassessable (except as such nonassessability may be affected by provisions of such jurisdictions statutory rules); have been issued in compliance with the applicable U.S. federal or state securities laws, Canadian federal or provincial securities laws or, in the case of an interest in an entity formed under the laws of another foreign jurisdiction, similar laws of such jurisdiction; were not issued in violation of any preemptive, right of first refusal, or similar right and, except as set forth in the Offering Memorandum; are owned, directly or indirectly through Subsidiaries, by the Company free and clear of all liens other than Permitted Encumbrances. Except as set forth in the Offering Memorandum (including pursuant to the Equity Offering) or the Companys annual information form dated March 19,2015, there are no outstanding options, warrants or other rights to acquire or purchase, or instruments convertible into or exchangeable for, any equity interests of the Company or any of the Guarantors.
(h) Due Authorization. The Company and each of the Guarantors have all requisite corporate power, capacity and authority to execute and deliver this Agreement, the Notes, the Indenture (including each Guarantee set forth therein) and the Credit Documents (collectively, the Transaction Documents ) and to perform their respective obligations hereunder and thereunder; and all action required to be taken for the due and proper authorization, execution and delivery of each of the Transaction Documents and the consummation of the transactions contemplated thereby has been duly and validly taken.
(i) The Indenture. The Indenture has been duly authorized by the Company and each of the Guarantors and, when duly executed and delivered in accordance with its terms by each of the parties thereto, will constitute a valid and legally binding agreement of the Company and each of the Guarantors enforceable against the Company and each of the Guarantors in accordance with its terms by the other parties thereto, except as enforceability may be limited by applicable bankruptcy, insolvency or similar laws affecting the enforcement of creditors rights generally or by equitable principles relating to enforceability (collectively, the Enforceability Exceptions ). The Indenture, when executed and delivered, will conform in all material respects to the description thereof in the Offering Memorandum.
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(j) The Notes. The Notes have been duly and validly authorized for issuance and sale to the Initial Purchasers by the Company, and when issued, authenticated and delivered by the Company against payment therefor by the Initial Purchasers in accordance with the terms of this Agreement and the Indenture, the Notes will be in the form contemplated by the Indenture and will be legally binding and valid obligations of the Company, entitled to the benefits of the Indenture and enforceable against the Company in accordance with their terms, except as the enforcement thereof may be limited by the Enforceability Exceptions. The Notes, when issued, authenticated and delivered, will conform in all material respects to the description thereof in the Offering Memorandum.
(k) The Guarantees. The Guarantees have been duly and validly authorized by each of the Guarantors and, when the Notes are issued, authenticated by the Trustee and delivered by the Company against payment by the Initial Purchasers in accordance with the terms of this Agreement and the Indenture, will be in the form contemplated by the Indenture and will be legally binding and valid obligations of the Guarantors, entitled to the benefits of the Indenture, enforceable against each of them in accordance with their terms, except that enforceability thereof may be limited by the Enforceability Exceptions. The Guarantees, when issued, authenticated and delivered, will conform in all material respects to the description thereof in the Offering Memorandum.
(l) Purchase Agreement. This Agreement has been duly authorized, executed and delivered by the Company and each of the Guarantors.
(m) Descriptions of Certain Documents. Each Transaction Document and the Asset Purchase Agreement conforms in all material respects to the description thereof contained in each of the Time of Sale Information and the Offering Memorandum.
(n) No Violation or Default. None of the Company or any of the Guarantors is (i) in violation of its charter or by-laws or similar organizational documents; (ii) in default, and no event has occurred that, with notice or lapse of time or both, would constitute such a default, in the due performance or observance of any term, covenant or condition contained in any indenture, mortgage, deed of trust, loan agreement or other agreement or instrument to which the Company or any of the Guarantors is a party or by which the Company or any of the Guarantors is bound or to which any of the properties, rights or assets of the Company or any of the Guarantors is subject; or (iii) in violation of any law or statute or any judgment, order, proceeding, rule or regulation of any court or arbitrator or governmental or regulatory authority that is binding on the Company or any of the Guarantors, except, in the case of clauses (ii) and (iii) above, for any such default or violation that would not, individually or in the aggregate, reasonably be expected to have a Material Adverse Effect.
(o) No Conflicts. None of the execution, delivery and performance by the Company and each of the Guarantors of each of the Transaction Documents to which each is a party, the issuance and sale of the Securities (including the Guarantees), compliance by the Company and each of the Guarantors with the terms thereof and the consummation of each of the transactions contemplated by the Transaction Documents will (i) result in a
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breach or violation of any of the terms or provisions of, or constitute a default under any indenture, mortgage, deed of trust, loan agreement or other agreement or instrument to which the Company or any of the Guarantors is a party or by which the Company or any of the Guarantors is bound or to which any of the properties, rights or assets of the Company or any of the Guarantors is subject, (ii) result in any violation of the provisions of the charter or by-laws or similar organizational documents of the Company or any of the Guarantors, which are in effect as of the date hereof, in any material respect or (iii) result in the violation of any law, statute or regulation applicable to the Company or any of the Guarantors or any judgment, order or rule of any court or arbitrator or governmental or regulatory authority that is binding on the Company or any of the Guarantors, except, in the case of clauses (i) and (iii) above, for any such breach, violation or default that would not, individually or in the aggregate, reasonably be expected to have a Material Adverse Effect.
(p) No Consents Required. Assuming the accuracy of the representations and warranties of the Initial Purchasers in Section 1(b) of this Agreement, no consent, approval, authorization, order, registration or qualification of or with any court or arbitrator or governmental or regulatory authority is required for the execution, delivery and performance by the Company and each of the Guarantors of each of the Transaction Documents to which each is a party, the issuance and sale of the Notes (including the Guarantees) and each of the transactions contemplated by the Transaction Documents, except for such consents, approvals, authorizations, orders and registrations or qualifications (i) as may be required under applicable state securities laws in connection with the purchase and resale of the Securities by the Initial Purchasers and the filing of certain notices and payment of filing fees, if any, required by Canadian Securities Laws, including filing a report or reports of exempt distribution under NI 45-106 with payment of applicable filing fees and the filing of the Canadian Offering Memorandum, if applicable, (ii) that have been obtained or (iii) the absence of which would not, individually or in the aggregate, reasonably be expected to have a Material Adverse Effect.
(q) Legal Proceedings. Other than as disclosed in each of the Time of Sale Information and the Offering Memorandum or otherwise set forth herein, or except as would not reasonably be expected to have a Material Adverse Effect, there are no legal, governmental or regulatory investigations, actions, suits or proceedings pending to which the Company or any of its Subsidiaries is or may be a party or, to the knowledge of the Company, to which any property of the Company or any of its Subsidiaries is or may be the subject that, individually or in the aggregate, if determined adversely to the Company or any of its Subsidiaries, would reasonably be expected to have a Material Adverse Effect; and no such investigations, actions, suits or proceedings are threatened or, to the knowledge of the Company, contemplated by any governmental or regulatory authority or by others.
(r) Independent Accountant .
(i) To the knowledge of the Company, Collins Barrow Toronto LLP, who has certified (i) certain financial statements of the Company and its
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Subsidiaries and (ii) certain financial statements relating to Zonegran and the Zonegran Acquisition, is independent with respect to the Company within the meaning of Section 152 of the Business Corporations Act (Ontario) and there has never been a reportable event (within the meaning of National Instrument 51-102 - Continuous Disclosure Obligations) between the Company and Collins Barrow Toronto LLP, and the Companys audit committees composition complies and the Companys audit committees responsibilities comply in all material respects with National Instrument 52-110 Audit Committees.
(ii) To the knowledge of the Company, Keiter, Certified Public Accountants, who has certified certain financial statements relating to Donnatal and the Donnatal Acquisition, is an independent public accountant with respect to the Company within the meaning of Rule 101 of the Code of Professional Conduct of the American Institute of Certified Public Accountants and its interpretations and rulings thereunder.
(iii) To the knowledge of the Company, Crowe Horwath LLP, who has certified certain financial statements relating to the Covis Portfolio, is an independent public accountant with respect to the Company within the meaning of Rule 101 of the Code of Professional Conduct of the American Institute of Certified Public Accountants and its interpretations and rulings thereunder.
(s) Title to Real and Personal Property. Neither the Company nor any of the Guarantors owns real property (excluding, for certainty, leaseholds) and each of them has good and marketable title to all personal property free and clear of all liens, encumbrances and claims other than Permitted Encumbrances. With respect to each premises of the Company or any of the Guarantors, which is material to the business of the Company and the Guarantors taken as a whole and which the Company or a Guarantor occupies as tenant (the Leased Premises ), the Company or any of the Guarantors occupies the Leased Premises and has the exclusive right to occupy and use the Leased Premises and each of the leases pursuant to which the Company or a Guarantor occupies the Leased Premises is in good standing and in full force and effect in all material respects.
(t) Title to Intellectual Property, (i) The Company and the Guarantors own or possess adequate rights or licenses to use, and have taken all commercially reasonable steps to protect and maintain (other than in the case of third party Intellectual Property) all material patents, patent applications, trademarks, service marks, trade names, trademark, trade name, and service mark registrations and applications thereof, copyrights, domain names, licenses and know-how (including trade secrets and other unpatented and/or unpatentable proprietary or confidential information, systems or procedures) and all other U.S. and foreign intellectual property rights (collectively, Intellectual Property ) which are material to their respective businesses; (ii) to the knowledge of the Company, the conduct of its business does not infringe, misappropriate, or otherwise violate in any material respect any Intellectual Property rights of others; (iii) the Company and the Guarantors have not received any written notice alleging or threatening any claim of infringement, misappropriation, or other violation of any Intellectual Property rights of others; and (iv) to the knowledge of the Company, the Intellectual Property owned by the
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Company and the Guarantors that is material to their respective businesses is not being infringed, misappropriated or otherwise violated by any third party, except where such infringement, misappropriation or violation would not reasonably be expected to have a Material Adverse Effect.
(u) Investment Company Act. None of the Company or any of its Guarantors is, and after giving effect to the offering and sale of the Securities and the application of the proceeds thereof as described in each of the Time of Sale Information and the Offering Memorandum none of them will be, an investment company or an entity controlled by an investment company within the meaning of the Investment Company Act of 1940, as amended, and the rules and regulations of the Commission thereunder (collectively, the Investment Company Act ).
(v) No Event of Default. None of the Company or any Guarantor is in default or breach of any material contract to which the Company or a Guarantor is a party or by which the Company or any Guarantor is bound, except to the extent such default or breach would not reasonably be expect to have a Material Adverse Effect, and except as set forth in the Preliminary Offering Memorandum, the Time of Sale Information and the Offering Memorandum, to the knowledge of the Company, there exists no condition, event or act which with the giving of notice or the lapse of time or both would constitute a default or breach under any such contract which would give a right of termination on the part of any other party to such contract; except in any case as would not, individually or in the aggregate, reasonably be expected to have a Material Adverse Effect.
(w) Taxes. Each of the Company and the Guarantors has paid all U.S. federal, state and local, Canadian federal, provincial and local, and other non-U.S. taxes and any related or similar assessment, fine, interest or penalty required to be paid by it, and filed all tax returns required to be filed by it; and there is no tax deficiency that has been, or, to the knowledge of the Company, would reasonably be expected to be, asserted against the Company or any of the Guarantors or any of their respective properties or assets, except such failure to pay or file or deficiencies that would not, individually or in the aggregate, reasonably be expected to result in a Material Adverse Effect. There are no audits or investigations in progress or, to the knowledge of the Company, pending or threatened, against the Company or the Guarantors, and there are no outstanding assessments or reassessments of the Company or the Guarantors, in respect of taxes that would be reasonably expected to have a Material Adverse Effect. The Company has made adequate charges, accruals and reserves in accordance with applicable accounting standards in its consolidated financial statements for the year ended December 31,2014 in respect of all U.S. federal, state and local, Canadian federal, provincial and local, and other non-U.S. taxes, including such taxes that are not yet required to be paid.
(x) Stamp Taxes. To the knowledge of the Company, as at the Closing Date, there are no stamp or other issuance or transfer taxes or duties or other similar taxes, fees or charges required to be paid by or on behalf of the Initial Purchasers in Canada or to a taxing authority thereof in connection with the execution and delivery of the Transaction Documents or the creation, issuance, sale or delivery to the Initial Purchasers of the Securities or the resale of the Securities by the Initial Purchasers.
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(y) No Withholding Tax. On the date hereof, no payments to be made by the Company or the Guarantors to holders or beneficial owners of Notes who are non-residents of Canada for purposes of the Income Tax Act (Canada) on or under the Notes or the Guarantees in respect of interest, principal or premium will be subject to withholding or deduction in Canada or any political subdivision or taxing authority thereof or therein (except where (i) such holder or beneficial owner does not deal at arms length with the Company or a Guarantor for purposes of the Income Tax Act (Canada), (ii) such holder or beneficial owner is a specified shareholder of the Company or does not deal at arms length with a specified shareholder of the Company, in each case, within the meaning of and for purposes of the Income Tax Act (Canada), or (iii) interest is paid or payable in respect of a debt or other obligation to pay an amount to a person with whom the Company or a Guarantor is not dealing at arms length).
(z) Licenses and Permits.
(i) The Company and the Guarantors possess all licenses, sub-licenses, certificates, permits and other authorizations issued by, and have made all declarations and filings with, the appropriate federal, state, local or foreign governmental or regulatory authorities that are necessary or required to conduct their respective businesses as described in each of the Time of Sale Information and the Offering Memorandum, except where the failure to possess or make the same would not, individually or in the aggregate, reasonably be expected to have a Material Adverse Effect; and to the knowledge of the Company, neither the Company nor any of the Guarantors has received written notice of any revocation or modification of any such license, sublicense, certificate, permit or authorization or has any reason to believe that any such license, certificate, permit or authorization will not be renewed in the ordinary course, including with respect to any license, certificate, permit or authorization issued by FDA, and to the knowledge of the Company, neither the FDA nor any Governmental Authority or Regulatory Authority is considering such action.
(ii) To the knowledge of the Company, and upon completion of the Acquisition and in accordance with the terms of the Asset Purchase Agreement, the other Acquisition Documents and ancillary agreements related thereto, the Company and the Guarantors, as applicable, will possess all licenses, sub-licenses, certificates, permits and other authorizations that are necessary or required in respect of the Covis Portfolio for the Company and the Guarantors to conduct the business of the Covis Portfolio in the manner described in each of the Preliminary Offering Memorandum, the Time of Sale Information or the Offering Memorandum in each jurisdiction where such business is expected to be carried on that are reasonably expected to be material to the conduct of the business of the Covis Portfolio.
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(aa) Other Regulatory and Related Items.
(i) There is no false or misleading information or significant omission in any product application or other submission to the FDA or any comparable Regulatory Authority.
(ii) All Products developed, tested, investigated, manufactured, stored, distributed, marketed, or sold by or on behalf of the Company or the Guarantors that are subject to the jurisdiction of the FDA or any comparable Regulatory Authority have been and are being developed, tested, investigated, manufactured, stored, distributed, marketed, and sold in material compliance with FDA legal requirements or any other applicable legal requirement, including those regarding non-clinical testing, clinical research, establishment registration, device listing, pre-market notification, good manufacturing practices, labeling, advertising, record-keeping, adverse event reporting and reporting of corrections and removals; provided, however that such representation is limited to the actual knowledge of the Company with respect to the period prior to the time a Product was purchased or in-licensed by the Company or a Subsidiary, as applicable.
(iii) The clinical, pre-clinical and other studies and tests conducted by or on behalf of or sponsored by the Company or the Guarantors that are described or referred to in the Preliminary Offering Memorandum, the Time of Sale Information or the Offering Memorandum (collectively, the Clinical Trials ) were and, if still pending, are being conducted, in all material respects, in accordance with all experimental protocols, procedures and controls, accepted professional scientific standards, and applicable laws, including applicable laws administered by Regulatory Authorities; provided, however that such representation is limited to the actual knowledge of the Company with respect to the period prior to the time a Product was purchased or in-licensed by the Company or a Subsidiary, as applicable. Neither the Company nor any of the Guarantors has received any written notices or written correspondence from any Governmental Authority or Regulatory Authority with respect to any Clinical Trial requesting information about or requiring the termination or suspension of such Clinical Trial.
(iv) Each of the Company and the Guarantors has filed with the applicable Regulatory Authority all material filings, declarations, listings, registrations, reports, updates and submissions that are required to be so filed. All such filings were in compliance in all material respects with applicable laws when filed and no deficiencies have been asserted by any Regulatory Authority with respect to any such filings, declarations, listings, registrations, reports, updates or submissions.
(v) Except as would not reasonably be expected to have a Material Adverse Effect or except as disclosed in the Preliminary Offering Memorandum, the Time of Sale Information or the Offering Memorandum, neither the Company nor the Guarantors have received any Form FDA-483, notice of adverse finding,
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FDA warning letters, notice of violation or untitled letters, or notice of FDA action for import detentions or refusals or any other written correspondence from any Regulatory Authority alleging or asserting noncompliance with any applicable legal requirements or registrations. Except as would not reasonably be expected to have a Material Adverse Effect, neither the Company nor the Guarantors are subject to any obligation arising under an administrative or regulatory action, inspection, warning letter, notice of violation letter, or other written notice, response or commitment made to or with any Regulatory Authority, and, to the knowledge of the Company, no such proceedings have been threatened. The Company and the Guarantors have made all material notifications, submissions and reports required by FDA legal requirements.
(vi) Other than in respect of certain Intellectual Property licence agreements entered into in the ordinary course, certain intellectual property license agreements entered into in connection with the acquisition of the Products and certain distribution agreements relating to the Products, copies of which distribution agreements and such material Intellectual Property license agreements have been made available to the Initial Purchasers, the Company and the Guarantors are the sole legal and beneficial owners of, have good and marketable title to, and own all right, title and interest in the Products or otherwise acquired and own the exclusive rights to and in the Products, except to the extent that the failure to hold such title, right or interest would not reasonably be expected to have a Material Adverse Effect, and upon completion of the Acquisition in accordance with the terms of the Asset Purchase Agreement, the Company or its Subsidiaries, as applicable, will have the rights, title and interest to the Covis Portfolio as set forth in the Asset Purchase Agreement.
(vii) There has not been, nor, to the knowledge of the Company, is there currently under consideration by the Company, any of the Guarantors, or any Governmental Authority or Regulatory Authority, any material seizure, withdrawal, recall, field, notification, detention, field correction, safety alert, or suspension of manufacturing relating to any Product; a material change in safety-related labeling of any such Product; or a termination, seizure, or suspension of marketing of any such Product; provided, however that such representation is limited to the actual knowledge of the Company with respect to the period prior to the time a Product was purchased or in-licensed by the Company or any of the Guarantors, as applicable.
(viii) Other than with respect to the FDA warning letter in 2014 relating to the marketing of Kapvay ® , the Companys ongoing implementation of internal compliance processes with respect to the Specialty Healthcare Distribution Division lead generation process and other than disclosed in the Preliminary Offering Memorandum, the Time of Sale Information or the Offering Memorandum, the Company, the Guarantors and their respective officers, directors, and employees, and to the knowledge of the Company, their representatives, contractors, and agents, have been and are currently in compliance in all material respects with all applicable Health Care Laws in
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relation to the Products including, without limitation, the Companys and all of the Guarantors actions regarding coupon programs, discount programs, co-pay assistance programs, lead generation programs, marketing efforts, and requirements pertaining to mail-order pharmacies such as change of ownership requirements, licensing requirements, inspection requirements, and generic substitution laws, and, to the knowledge of the Company, neither the Company or any of the Guarantors nor their officers, directors, or employees, have engaged in any act or omission that violates or would violate any Health Care Laws in any material respect including, without limitation, misbranding, adulteration, or off-label promotion.
(ix) Other than as disclosed in the Preliminary Offering Memorandum, the Time of Sale Information or the Offering Memorandum and other than the Settlement Agreement dated October 17, 2013 with the United States of America, acting through the DOJ and the OIG, pursuant to which the Company is obligated to make certain payments to the United States, the Company, the Guarantors and their respective officers, directors, and employees (a) are not and have not been a party to, or bound by, any order, individual integrity agreement, corporate integrity agreement or other formal agreement with any Governmental Authority concerning compliance with Health Care Laws; (b) have not made any filings pursuant to the OIG or CMS self-disclosure protocol; (c) have not been a defendant in any action, or received a threat of any action, brought under a federal or state whistleblower statute, including without limitation the False Claims Act of 1863 (31 U.S.C. § 3729 et seq.); and (d) have not been served with or received any written search warrant, subpoena (other than those related to actions against third parties), civil investigative demand or contact letter from a Governmental Authority or Regulatory Authority.
(x) Neither the Company nor any of the Guarantors have presented or caused to be presented to any government or any other Person any claim for payment for an item or service in violation of, or that would be the basis for liability under, the False Claims Act, 31 U.S.C. § 3729 3733, any similar state false claims act, the Civil Monetary Penalties Law, 42 U.S.C. §§ 1320a-7a and 1320a-7b, the Program Fraud Civil Remedies Act, 31 U.S.C. §§ 3801-3812, any other Health Care Laws, or the common law or administrative theories of recoupment, payment by mistake, unjust enrichment, disgorgement, conversion, breach of contract, or fraud. The Company and each of the Guarantors has submitted all claims for reimbursement to Federal Health Care Programs in accordance with all applicable Health Care Laws.
(xi) Other than as disclosed in the Preliminary Offering Memorandum, the Time of Sale Information or the Offering Memorandum, neither the Company nor any of the Guarantors has received notice of any action by any Governmental Authority or Regulatory Authority to terminate, suspend, limit, withdraw, or forfeit the participation of the Company or any of the Guarantors in any Federal Health Care Program.
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(xii) Other than as disclosed in the Preliminary Offering Memorandum, the Time of Sale Information or the Offering Memorandum, the Company has no knowledge of any current inquiry or investigation relating to any Federal Health Care Program-related offense of which the Company or any of the Guarantors is a target or subject, or any other actual or threatened enforcement actions by any Governmental Authority or Regulatory Authority.
(xiii) To the knowledge of the Company, neither the Company nor any Guarantor has presented to any Federal Health Care Program or any other Person any claim for payment for an item or service provided or performed pursuant to: (A) the federal anti-kickback statute, 42 U.S.C. § 1320a-7b(b) or similar state anti-kickback statute; or (B) a prohibited referral under 42 U.S.C, § 1395nn or the regulations promulgated thereunder at 42 C.F.R. § 411.351 411.389.
(xiv) To the knowledge of the Company, neither the Company nor any Guarantor has (A) offered, authorized, promised, made or agreed to make gifts of money, other property, other value or similar benefits or contributions to, or entered into any fee-splitting arrangement with, any actual or potential patient, health care provider, actual or potential business partner, governmental employee, or other Person in a position to assist or hinder the Company or any Guarantor in connection with any actual or proposed transaction, or to any political party, political party official or candidate for federal, state or local public office in violation of any applicable law or (B) maintained any unrecorded fund or asset of the Company or any Guarantor for any improper purpose or made any false entries on its books and records for any reason.
(xv) Neither the Company nor any Guarantor has any material liability for any refund, overpayment, discount, or adjustment under any Federal Health Care Program, other than adjustments made lawfully in the normal course of business.
(xvi) To the knowledge of the Company, no Persons who have engaged in any activity that is in violation of, or have been convicted of, charged with, or investigated for, a felony or a criminal offense under any Health Care Law, or who are excluded, suspended, debarred, prohibited from providing services under, or otherwise ineligible to participate in any government program, or who have committed any act or have engaged in any activity that is permissive or mandatory grounds for exclusion, debarment, suspension, or other ineligibility to participate, or to the actual knowledge of the Company, who have been threatened with exclusion, debarment or being or otherwise ineligible to participate ,in any government program, are either employed by, under a consulting contract with, or agents of the Company or any Guarantor or provide items or services on behalf of the Company or any Guarantor.
(xvii) Except in respect of certain materials inadvertently delivered to a business partner of the Company, neither the Company nor any Guarantor has ever notified, either voluntarily or as required by a Health Care Law or other
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applicable law, any affected individual, any Governmental Authority, or the media about, or is otherwise aware of, any breach or unauthorized acquisition, access, use, or disclosure of protected health information or any other breach in violation of the Health Insurance Portability and Accountability Act of 1996 (HIPAA), 42 U.S.C. §§ 1320d-1329d-8; Health Information Technology for Economic and Clinical Health Act (HITECH); or implementing regulations; including a breach of any business associate agreement (within the meaning of HIPAA); nor, to the knowledge of the Company, is the Company aware of any investigation by any Governmental Authority for a violation of HIPAA, HITECH, or any other legal requirement applicable to the Company or any Guarantors use and dissemination of any personally-identifiable information concerning individuals, including receiving any written notices from the United States Department of Health and Human Services Office of Civil Rights relating to any such violations.
(xviii) The Company and the Guarantors have recorded all of the information required to be recorded under the Sunshine Act.
(xix) The Company and the Guarantors, in conducting the business of the Company, do not participate in, directly or, to the knowledge of the Company, through any broker, distributor or similar party, any arrangement pursuant to which customers of the business receive, directly or indirectly, a reduction in the purchase price or other benefits, monetary or otherwise, other than normal and legal customary trade practices and incidental business-related entertainment.
(xx) The Company and the Guarantors billing practices to all third party payors, including private insurance companies, have been true, current, and complete in all material respects and in compliance in all material respects with all applicable laws and the policies of those third party payors;
(xxi) To the extent the Company or any Guarantor provides to customers or others reimbursement coding or billing advice regarding products offered for sale by any Company or Guarantor and procedures related thereto, such advice is: (a) true, accurate and complete in all material respects, and (b) in compliance in all material respects applicable all Health Care Laws;
(xxii) Except as set forth in (ix) and (xvii) above, the Company and the Guarantors maintain and operate in material compliance with a compliance program in accordance with the criteria established by the OIG; the current U.S. Federal Sentencing Guidelines standards for effective compliance programs; the code of the Pharmaceutical Research and Manufacturers of America on Interactions with Health Care Professionals; and other similar laws.
(bb) No Labor Disputes. No labor disturbance by or dispute with employees of the Company or any of the Guarantors exists or, to the knowledge of the Company, is contemplated or threatened, and the Company is not aware of any existing or imminent labor disturbance by, or dispute with, the employees of any of the Companys or any of
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the Guarantors principal suppliers, contractors or customers, except as would not reasonably be expected to have a Material Adverse Effect; other than settlement agreements entered into with former employees or consultants of the Company and the Guarantors, which settlement amounts are not material, there has not been in the last two years and there is not currently any material labor disruption or dispute with the employees of the Company or any of the Guarantors, and no material labor disruption or dispute, to the knowledge of the Company, is imminent.
(cc) Compliance With Environmental Laws, (i) Except as referenced in each of the Time of Sale Information and the Offering Memorandum: the Company and the Guarantors (x) to the knowledge of the Company, are, and at all prior times were, in compliance, in all material respects, with any and all federal, state, local and foreign laws, rules, regulations, requirements, decisions and orders relating to the protection of human health or safety, the environment, natural resources, hazardous or toxic substances or wastes, pollutants or contaminants (collectively, Environmental Laws ), (y) have received and are in compliance, in all material respects, with all material permits, licenses, certificates or other authorizations or approvals required of them under applicable Environmental Laws to conduct their respective businesses, and (z) have not received written notice of any actual or potential liability under or relating to any Environmental Laws, including for the investigation or remediation of any disposal or release of hazardous or toxic substances or wastes, pollutants or contaminants, and the Company has no knowledge of any event or condition that would reasonably be expected to result in any such notice, and (ii) there are no costs or liabilities associated with Environmental Laws of or relating to the Company or the Guarantors, except in the case of each of (i) and (ii) above, for any such failure to comply, or failure to receive required permits, licenses, certificates, authorizations or approvals, or cost or liability, as would not, individually or in the aggregate, reasonably be expected to have a Material Adverse Effect; and (iii) except as referenced in each of the Time of Sale Information and the Offering Memorandum, there are no proceedings that are pending, or to the knowledge of the Company, contemplated, against the Company under any Environmental Laws in which a governmental entity is also a party. The Initial Purchasers acknowledge that this representation is limited to the actual knowledge of the Company with respect to the period prior to the time a Product or business was purchased or in-licensed, as applicable, by the Company or a Subsidiary, as applicable.
(dd) Compliance With Laws Governing Employment And Employee Plans.
(i) Neither the Company nor any Guarantor is a party to or bound by any collective agreement and is not currently conducting negotiations with any labor union or employee association.
(ii) The Company and each Guarantor is in compliance in all material respects with all laws respecting employment and employment practices, terms and conditions of employment, pay equity and wages and has not and is not engaged in any unfair labor practice.
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(iii) The Company and certain of the Guarantors have agreements, plans or practices relating to the payment of management, consulting, service or other fees or bonuses, pensions, share of profits or retirement allowance, insurance, health or other employee benefits or for retirement, stock purchase, profit sharing, stock option (including the Company Option Plan), equity plans (including the LTIP), deferred compensation, severance or termination pay, insurance, medical, hospital, dental, vision care, drug, sick leave, disability, salary continuation, legal benefits, unemployment benefits, vacation, incentive or otherwise contributed to, or required to be contributed to, by the Company or any of the Guarantors for the benefit of any current or former director, officer, employee or consultant of a Concordia Entity (each an Employee Plan ). The Company has made available to the Initial Purchasers the opportunity to review true and complete copies of documents, contracts and arrangements relating to each such Employee Plan, other than standard medical and dental benefit plans. Each Employee Plan has been established, operated in the ordinary course and administered in all material respects in accordance with their terms and applicable laws.
(iv) Except as disclosed in the Preliminary Offering Memorandum, the Time of Sale Information or the Offering Memorandum, since January 1,2014, none of the directors, officers or employees of the Company, the Guarantors or any associate or affiliate of any of the foregoing has any interest, direct or indirect, in any transaction with the Company or any Guarantor that materially affects, is material to or will materially affect the Company and the Guarantors taken as a whole.
(v) Except for wages, salaries and other compensation-related payments in the ordinary course and except for such other amounts as would not be material, neither the Company nor any Guarantor is indebted to: (i) any director or officer of the Company or a Guarantor; (ii) any individual related to any of the foregoing by blood, marriage or adoption; or (iii) any corporation controlled, directly or indirectly, by any one or more of those individuals referred to in this Subsection (v). None of those Persons referred to in this Subsection (v) is indebted to the Company or a Guarantor in a material amount. Neither the Company nor a Guarantor is currently a party to any material contract, agreement or understanding with any officer, director, employee, or any other Person not dealing at arms length with the Company or the Guarantors other than employment and consulting agreements.
(ee) Insurance. Except as described in each of the Preliminary Offering Memorandum, Time of Sale Information and the Offering Memorandum, the Company and the Guarantors have adequate insurance covering their respective properties, operations, personnel and businesses, including business interruption insurance, liability and product liability insurance, which insurance is in amounts and insures against such material losses and risks as are adequate to protect the Company and the Guarantors and their respective businesses; and none of the Company or any of the Guarantors has (i) received written notice from any insurer or agent of such insurer that capital
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improvements or other expenditures are required or necessary to be made in order to continue such insurance or (ii) any reason to believe that it will not be able to renew its existing insurance coverage as and when such coverage expires or to obtain similar coverage at reasonable cost from similar insurers as may be necessary to continue its business.
(ff) No Unlawful Payments. None of the Company or any of the Guarantors nor, to the knowledge of the Company, any director, officer, agent, employee or other person acting on behalf of the Company or any of the Guarantors has (i) used any corporate funds for any unlawful contribution, gift, entertainment or other unlawful expense relating to political activity; (ii) made any direct or indirect unlawful payment to any foreign or domestic government official or employee from corporate funds; (iii) violated or is in violation of any provision of the Corruption of Foreign Public Officials Act (Canada) or the Foreign Corrupt Practices Act of 1977 or similar law of a jurisdiction in which the Company or its Subsidiaries conduct their business and to which they are lawfully subject; or (iv) made any bribe, rebate, payoff, influence payment, kickback or other unlawful payment.
(gg) Compliance with Money Laundering Laws. The operations of the Company and the Guarantors are and have been conducted at all times in material compliance with applicable financial recordkeeping and reporting requirements of the Currency and Foreign Transactions Reporting Act of 1970, as amended, or similar law of a jurisdiction in which the Company or its Subsidiaries conduct their business and to which they are lawfully subject (collectively, the Money Laundering Laws ), and no action, suit or proceeding by or before any court or governmental agency, authority or body or any arbitrator involving the Company or any of the Guarantors with respect to the Money Laundering Laws is pending or, to the knowledge of the Company, threatened.
(hh) Compliance with OFAC. None of the Company or any of the Guarantors or, to the knowledge of the Company, none of the Company or any director, officer, agent, employee or affiliate of the Company or any of the Guarantors is currently subject to any U.S. sanctions administered by the Office of Foreign Assets Control of the U.S. Department of the Treasury or similar law of a jurisdiction in which the Company or its Subsidiaries conduct their business and to which they are lawfully subject (collectively, Sanctions ): and the Company will not directly or indirectly use the proceeds of the offering of the Securities hereunder, or lend, contribute or otherwise make available such proceeds to any Subsidiary, joint venture partner or other person or entity, for the purpose of financing the activities of any person currently subject to any such Sanctions.
(ii) Solvency. On and immediately after the Closing Date, the Company and the Guarantors (after giving effect to the Transactions and the other transactions related thereto as described in each of the Time of Sale Information and the Offering Memorandum) will be Solvent. As used in this paragraph, the term Solvent means, with respect to a particular date, that on such date (i) the present fair market value (or present fair saleable value) of the assets of the Company and the Guarantors is not less than the total amount required to pay the liabilities of the Company and the Guarantors on their total existing debts and liabilities (including contingent liabilities) as they become absolute
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and matured; and (ii) assuming consummation of the issuance of the Securities as contemplated by this Agreement, the Time of Sale Information and the Offering Memorandum, the Company and the Guarantors is not incurring debts or liabilities beyond its ability to pay as such debts and liabilities mature.
(jj) No Restrictions on Guarantors. No Guarantor of the Company is currently prohibited, directly or indirectly, under any agreement or other instrument to which it is a party or is subject, from paying any dividends to its shareholders, from making any other distribution on such Guarantors capital stock, from repaying to the Company any loans or advances to such Guarantor from the Company or from transferring any of such Guarantors properties or assets to the Company or any other Subsidiary of the Company, except for any such restrictions that will be permitted by the Indenture or except for restrictions imposed by applicable laws.
(kk) No Brokers Fees. Neither the Company or the Guarantors is a party to any contract, agreement or understanding with any person (other than this Agreement) that would give rise to a valid claim against any of them or any Initial Purchaser for a brokerage commission, finders fee or like payment in connection with the Offering.
(11) Rule 144A Eligibility. The Securities are eligible for resale pursuant to Rule 144A and on the Closing Date, the Securities will not be of the same class as securities listed on a national securities exchange registered under Section 6 of the Exchange Act or quoted in an automated inter-dealer quotation system; and each of the Preliminary Offering Memorandum, the Time of Sale Information and the Offering Memorandum, as of its respective date, contains or will contain all the information in all material respects that, if requested by a prospective purchaser of the Securities, would be required to be provided to such prospective purchaser pursuant to Rule 144A(d)(4) under the Securities Act.
(mm) No Integration. None of the Company or any of the Guarantors (as defined in Rule 501(b) of Regulation D) has, directly or through any agent, sold, offered for sale, solicited offers to buy or otherwise negotiated in respect of, any security (as defined in the Securities Act), that is or will be integrated with the sale of the Securities in a manner that would require registration of the Securities under the Securities Act.
(nn) No General Solicitation or Directed Selling Efforts. None of the Company, the Guarantors or any of its affiliates or any other Person acting on its or their behalf (other than the Initial Purchasers, as to which no representation is made) has (i) solicited offers for, or offered or sold, the Securities by means of any form of general solicitation or general advertising within the meaning of Rule 502(c) of Regulation D or in any manner involving a public offering within the meaning of Section 4(a)(2) of the Securities Act or (ii) engaged in any directed selling efforts within the meaning of Regulation S under the Securities Act ( Regulation S ). and all such Persons have complied with the offering restrictions requirement of Regulation S. Neither the Company nor any of its affiliates has entered into, or will enter into, any contractual arrangement with respect to the distribution of the Securities except for this Agreement.
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(oo) Securities Law Exemptions. Assuming the accuracy of the representations and warranties of the Initial Purchasers contained in Section 1(b) (including Annex C hereto) and their compliance with their agreements set forth therein, it is not necessary, in connection with the issuance and sale of the Securities to the Initial Purchasers and the offer, resale and delivery of the Securities by the Initial Purchasers in the manner contemplated by this Agreement, the Time of Sale Information and the Offering Memorandum, to register the Securities under the Securities Act or to qualify the Indenture under the Trust Indenture Act.
(pp) No Stabilization. Neither the Company nor any of the Guarantors has taken, directly or indirectly, any action designed to or that could reasonably be expected to cause or result in any stabilization or manipulation of the price of the Securities.
(qq) Margin Rules. Neither the issuance, sale and delivery of the Securities nor the application of the proceeds thereof by the Company as described in each of the Time of Sale Information and the Offering Memorandum will violate Regulation T, U or X of the Board of Governors of the Federal Reserve System or any other regulation of such Board of Governors.
(rr) Forward-Looking Statements. All forward-looking statements of the Company described under the caption Cautionary Note Regarding Forward-Looking Statements in the Offering Memorandum and the assumptions underlying such information and statements, subject to any qualifications contained therein, including any forecasts and estimates, expressions of opinion, intention and expectation, as at the time they were or will be made, were or will be made based on assumptions that are reasonable.
(ss) Statistical and Market Data. The statistical, industry and market related data included in the Offering Memorandum are derived from sources which the Company reasonably believes to be accurate, reasonable and reliable, and such data agrees in all material respects with the sources from which it was derived.
(tt) Accounting Controls. The Company has established and maintains a system of disclosure controls and procedures and internal control over financial reporting, and has: (i) designed such disclosure controls and procedures, or caused them to be designed under managements supervision, to provide reasonable assurance that material information relating to each of the Company and the Guarantors is made known to management by others, particularly during the period in which the financial statements are being prepared; and (ii) designed such internal control over financial reporting, or caused it to be designed under managements supervision, to provide reasonable assurance regarding the reliability of financial reporting and the preparation of financial statements for external purposes in accordance with IFRS.
(uu) Regulation S. The Company, the Guarantors and their respective affiliates and all persons acting on their behalf (other than the Initial Purchasers, as to whom the Company and the Guarantors make no such representation) have complied with and will comply with the offering restrictions requirements of Regulation S in connection with the offering of the Securities outside the United States and, in connection therewith, the Time
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of Sale Information and the Offering Memorandum will contain the disclosures required by Rule 902. The Company is a foreign issuer, as defined in Rule 902 under the Securities Act.
4. Further Agreements of the Company and the Guarantors . The Company and each of the Guarantors jointly and severally covenant and agree with each Initial Purchaser that:
(a) Delivery of Copies. The Company will provide, without charge, to the Initial Purchasers and counsel to the Initial Purchasers as many copies of the Preliminary Offering Memorandum, any other Time of Sale Information, any Issuer Written Communication and the Offering Memorandum (including all amendments and supplements thereto) as the Representative may reasonably request.
(b) Offering Memorandum, Amendments or Supplements. Before finalizing the Time of Sale Information and the Offering Memorandum or making or distributing any amendment or supplement to any of the Time of Sale Information or the Offering Memorandum, the Company will furnish to the Representative and counsel for the Initial Purchasers a copy of the proposed Time of Sale Information and Offering Memorandum or such amendment or supplement for review, and will not distribute any such proposed Time of Sale Information and Offering Memorandum, amendment or supplement to which the Representative reasonably objects.
(c) Additional Written Communications. Before making, preparing, using, authorizing, approving or referring to any Issuer Written Communication, the Company will furnish to the Representative and counsel for the Initial Purchasers a copy of such written communication for review and will not make, prepare, use, authorize, approve or refer to any such written communication to which the Representative reasonably objects.
(d) Notice to the Representative. The Company will advise the Representative promptly, and confirm such advice in writing, (i) of the issuance by any Governmental Authority or Regulatory Authority of any order preventing or suspending the use of any of the Time of Sale Information, any Issuer Written Communication or the Offering Memorandum or the initiation or threatening of any proceeding for that purpose; (ii) of the occurrence of any event at any time prior to the completion of the initial offering of the Securities as a result of which any of the Time of Sale Information, any Issuer Written Communication or the Offering Memorandum as then amended or supplemented would include any untrue statement of a material fact or omit to state a material fact necessary in order to make the statements therein, in the light of the circumstances existing when such Time of Sale Information, Issuer Written Communication or the Offering Memorandum is delivered to a purchaser, not misleading; and (iii) of the receipt by the Company or any of the Guarantors of any notice with respect to any suspension of the distribution of the Securities for offer and sale in any jurisdiction or the initiation or threatening of any proceeding for such purpose; and the Company and the Guarantors will use its reasonable best efforts to prevent the issuance of any such order preventing or suspending the use of any of the Time of Sale Information, any Issuer Written Communication or the Offering Memorandum or suspending any such distribution of the Securities and, if any such order is issued, will obtain as soon as possible the withdrawal thereof.
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(e) Time of Sale Information. If at any time prior to the Closing Date (i) any event shall occur or condition shall exist as a result of which any of the Time of Sale Information as then amended or supplemented would include any untrue statement of a material fact or omit to state any material fact necessary in order to make the statements therein, in the light of the circumstances under which they were made, not misleading or (ii) it is necessary to amend or supplement any of the Time of Sale Information to comply with applicable law, the Company will immediately notify the Initial Purchasers thereof and forthwith prepare and, subject to paragraph (b) above, furnish to the Initial Purchasers such amendments or supplements to any of the Time of Sale Information as may be necessary so that the statements in any of the Time of Sale Information as so amended or supplemented will not, in light of the circumstances under which they were made, be misleading or so that any of the Time of Sale Information will comply with law.
(f) Ongoing Compliance of the Offering Memorandum. If at any time prior to the completion of the initial offering of the Securities (i) any event shall occur or condition shall exist as a result of which the Offering Memorandum as then amended or supplemented would include any untrue statement of a material fact or omit to state any material fact necessary in order to make the statements therein, in the light of the circumstances existing when the Offering Memorandum is delivered to a purchaser, not misleading or (ii) it is necessary to amend or supplement the Offering Memorandum to comply with applicable law, the Company will promptly notify the Initial Purchasers thereof and forthwith prepare and, subject to paragraph (b) above, furnish to the Initial Purchasers such amendments or supplements to the Offering Memorandum as may be necessary so that the statements in the Offering Memorandum as so amended or supplemented will not, in the light of the circumstances existing when the Offering Memorandum is delivered to a purchaser, be misleading or so that the Offering Memorandum will comply with law.
(g) Blue Sky Compliance. The Company will qualify the Securities for offer and sale under the securities or Blue Sky laws of such jurisdictions as the Representative shall reasonably request and will continue such qualifications in effect so long as required for the offering and resale of the Securities; provided that neither the Company nor any of the Guarantors shall be required to (i) qualify as a foreign corporation or other entity or as a dealer in securities in any such jurisdiction where it would not otherwise be required to so qualify, (ii) file any general consent to service of process in any such jurisdiction or (iii) subject itself to taxation in any such jurisdiction if it is not otherwise so subject.
(h) Clear Market. During the period from the date hereof through and including the date that is 90 days after the date hereof, the Company and each of the Guarantors will not, without the prior written consent of the Representative, directly or indirectly, offer, sell, contract to sell, grant any option to purchase, issue any instrument convertible into or exchangeable for, or otherwise transfer or dispose of (or enter into any transaction or devise that is designed to, or could be expected to, result in the disposition in the future of) any debt securities issued or guaranteed by the Company or any of the Guarantors, other than those contemplated by the Transactions.
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(i) Use of Proceeds. The Company will apply the net proceeds from the sale of the Securities as described in each of the Time of Sale Information and the Offering Memorandum under the heading Use of Proceeds.
(j) Supplying Information. While the Securities remain outstanding and are restricted securities within the meaning of Rule 144(a)(3) under the Securities Act, the Company and each of the Guarantors will, during any period in which the Company is not subject to and in compliance with Section 13 or 15(d) of the Exchange Act, furnish to holders of the Securities and prospective purchasers of the Securities designated by such holders, upon the request of such holders or such prospective purchasers, the information required to be delivered pursuant to Rule 144A(d)(4) under the Securities Act.
(k) DTC. The Company will use its commercially reasonably efforts to assist the Initial Purchasers in arranging for the Securities to be eligible for clearance and settlement through The Depository Trust Company ( DTC ).
(1) No Resales by the Company. The Company will not, and will not permit any of its affiliates (as defined in Rule 144 under the Securities Act) to, resell any of the Securities that have been acquired by any of them, except for Securities purchased by the Company or any of its affiliates and resold in a transaction registered under the Securities Act.
(m) No Integration. Neither the Company nor any of its affiliates (as defined in Rule 501(b) of Regulation D) will, directly or through any agent, sell, offer for sale, solicit offers to buy or otherwise negotiate in respect of, any security (as defined in the Securities Act), that is or will be integrated with the sale of the Securities in a manner that would require registration of the Securities under the Securities Act.
(n) No General Solicitation or Directed Selling Efforts. None of the Company or any of its affiliates or any other person acting on its or their behalf (other than the Initial Purchasers, as to which no covenant is given) will (i) solicit offers for, or offer or sell, the Securities by means of any form of general solicitation or general advertising within the meaning of Rule 502(c) of Regulation D or in any manner involving a public offering within the meaning of Section 4(a)(2) of the Securities Act or (ii) engage in any directed selling efforts within the meaning of Regulation S, and all such persons will comply with the offering restrictions requirement of Regulation S.
(o) No Stabilization. None of the Company or any of its affiliates or any other person acting on its or their behalf (other than the Initial Purchasers, as to which no covenant is given) will take, directly or indirectly, any action designed to or that could reasonably be expected to cause or result in any stabilization or manipulation of the price of the Securities.
5. Certain Agreements of the Initial Purchasers .
(a) Each Initial Purchaser, severally and not jointly, hereby represents and agrees with the Issuer that:
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(i) it has not and will not use, authorize use of, refer to, or participate in the planning for use of, any written communication that constitutes an offer to sell or the solicitation of an offer to buy the Securities other than (A) the Time of Sale Information, the Preliminary Offering Memorandum and the Offering Memorandum, (B) a written communication that contains no issuer information (as defined in Rule 433(h)(2) under the Securities Act) that was not included (including through incorporation by reference) in the Time of Sale Information, the Preliminary Offering Memorandum or the Offering Memorandum, (C) any written communication listed on Annex A or prepared pursuant to Section 4(c) above (including any electronic road show presentation), (D) any written communication prepared by such Initial Purchaser and approved by the Company in advance in writing or (E) any written communication relating to or that contains the terms of the Securities and/or other information that was included (including through incorporation by reference) in the Time of Sale Information, the Preliminary Offering Memorandum or the Offering Memorandum;
(ii) it (or its Canadian affiliate(s) selling Notes in the Canadian Offering Jurisdictions) is duly registered in the Canadian Offering Jurisdictions, or is exempt from the dealer registration requirements under Canadian Securities Laws, in order to offer the Notes for sale in the Canadian Offering Jurisdictions as contemplated by this Agreement;
(iii) it will conduct activities in connection with arranging for the sale and distribution of the Notes upon the terms and conditions set forth in this Agreement, in the Time of Sale Information and the Offering Memorandum (including, for greater certainty, the Canadian Offering Memorandum); and
(iv) it will offer the Notes in Canada in compliance with Canadian Securities Laws only in the Canadian Offering Jurisdictions and only to such Purchasers and in such a manner that the sale of the Notes will be exempt from the prospectus requirements of Canadian Securities Laws. For greater certainty, each Purchaser in a Canadian Offering Jurisdiction shall purchase the Notes on the basis of the exemption available under Section 2.3 of NI 45-106 and each Initial Purchaser has not solicited offers for, or offered or sold and will not solicit offers, or offer or sell the Notes as part of their distribution of the Notes except in accordance with the requirements set out in the Canadian Offering Memorandum and Canadian Securities Laws.
(b) Each Initial Purchaser acknowledges that (i) the Securities have not been registered or qualified for distribution in any Canadian province, and are not eligible for resale in Canada for a period ending four (4) months plus one day from the Closing Date, and (ii) any certificate representing the Securities will bear, or if the Securities are entered into a direct registration or other electronic book-entry system then each Initial Purchaser acknowledges notice of such Securities being subject to, the legend set forth below:
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UNLESS PERMITTED UNDER SECURITIES LEGISLATION, THE HOLDER OF THIS SECURITY MUST NOT TRADE THE SECURITY BEFORE [insert four months plus 1 day from the Closing Date].
6. Conditions of Initial Purchasers Obligations . The obligation of each Initial Purchaser to purchase Securities on the Closing Date as provided herein is subject to the performance by the Company and each of the Guarantors of their respective covenants and other obligations hereunder and to the following additional conditions:
(a) Representations and Warranties. The representations and warranties of the Company and the Guarantors contained herein shall be true and correct (subject to all materiality and other qualifications contained therein) on the date hereof and on and as of the Closing Date (other than such representations and warranties that are made as of a specified date, which shall be true and correct as of such date); and the statements of the Company, the Guarantors and their respective officers made in any certificates delivered pursuant to this Agreement shall be true and correct (subject to all materiality and other qualifications contained therein) on and as of the Closing Date (other than such statements that are made as of a specified date, which shall be true and correct as of such date).
(b) No Downgrade. Subsequent to the earlier of (A) the Time of Sale and (B) the execution and delivery of this Agreement, (i) no downgrading shall have occurred in the rating accorded the Securities by any nationally recognized statistical rating organization, as such term is defined by the Commission for purposes of Section 3(a)(62) of the Exchange Act; and (ii) no such organization shall have publicly announced that it has under surveillance or review, or has changed its outlook with respect to, its rating of the Securities (other than an announcement with positive implications of a possible upgrading).
(c) No Material Adverse Change. No event or condition of a type described in Section 3(e) hereof shall have occurred or shall exist, which event or condition is not described in each of the Time of Sale Information (excluding any amendment or supplement thereto) and the Offering Memorandum (excluding any amendment or supplement thereto) the effect of which in the reasonable judgment of the Representative makes it impracticable or inadvisable to proceed with the offering, sale or delivery of the Securities on the terms and in the manner contemplated by this Agreement, the Time of Sale Information and the Offering Memorandum.
(d) Officers Certificates and Management Comfort Certificate.
(i) The Representative shall have received on and as of the Closing Date a certificate of the chief executive officer and the chief financial officer of the Company and of an executive officer of each Guarantor who has specific knowledge of the Companys or such Guarantors financial matters and is satisfactory to the Representative, on behalf of the Company or such Guarantor, without personal liability, (i) confirming that such officer has carefully reviewed the Time of Sale Information and the Offering Memorandum and, to the knowledge of such officer, the representations set forth in Sections 3(a) and
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3(b) hereof are true and correct, (ii) confirming that the other representations and warranties of the Company and the Guarantors in this Agreement are true and correct in all material respects and that the Company and the Guarantors have complied in all material respects with all agreements and satisfied all conditions on their part to be performed or satisfied hereunder at or prior to the Closing Date and (iii) to the effect set forth in paragraphs (b) and (c) above.
(ii) The Company shall have furnished to the Initial Purchasers a certificate, dated the date hereof and as of the Closing Date, of its chief financial officer with respect to certain financial data contained in the Time of Sale Information and the Offering Memorandum, providing management comfort with respect to such information, in form and substance satisfactory to the Representative.
(iii) The Representative shall have received on and as of the Closing Date a certificate dated the Closing Date of the secretary of the Company and a certificate of a senior officer of each of the Guarantors, on behalf of the Company or such Guarantor, without personal liability, each such certificate addressed to the Initial Purchasers and counsel to the Initial Purchasers, in each case, with respect to: (A) the constating documents and the by-laws (or equivalent) of the Company or the relevant Guarantor, as applicable; (B) all resolutions of the board of directors of the Company or the relevant Guarantor, as applicable, relating to the transactions contemplated hereby; and (C) the incumbency and specimen signatures of the signing officers relating to this Agreement and the Indenture, as applicable.
(e) Comfort Letters.
(i) On the date of this Agreement and on the Closing Date, Collins Barrow Toronto LLP with respect to (i) the Company and its Subsidiaries and (ii) Zonegran and the Zonegran Acquisition shall have furnished to the Initial Purchasers, at the request of the Company, letters, dated the respective dates of delivery thereof and addressed to the Initial Purchasers, in form and substance reasonably satisfactory to the Initial Purchasers, containing statements and information of the type customarily included in auditors comfort letters to underwriters with respect to the financial statements and certain financial information contained in each of the Time of Sale Information and the Offering Memorandum; provided that the letter delivered on the Closing Date shall use a cut-off date no more than three business days prior to the Closing Date.
(ii) On the date of this Agreement and on the Closing Date, Crowe Horwath LLP with respect to the Covis Portfolio shall have furnished to the Initial Purchasers, at the request of the Company, letters, dated the respective dates of delivery thereof and addressed to the Initial Purchasers, in form and substance reasonably satisfactory to the Initial Purchasers, containing statements and information of the type customarily included in auditors comfort letters to underwriters with respect to the financial statements and certain financial
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information contained in each of the Time of Sale Information and the Offering Memorandum; provided that the letter delivered on the Closing Date shall use a cut-off date no more than three business days prior to the Closing Date.
(iii) On the date of this Agreement and on the Closing Date, Keiter, Certified Public Accountants with respect to Donnatal and the Donnatal Acquisition shall have furnished to the Initial Purchasers, at the request of the Company, letters, dated the respective dates of delivery thereof and addressed to the Initial Purchasers, in form and substance reasonably satisfactory to the Initial Purchasers, containing statements and information of the type customarily included in auditors comfort letters to underwriters with respect to the financial statements and certain financial information contained in each of the Time of Sale Information and the Offering Memorandum; provided that the letter delivered on the Closing Date shall use a cut-off date no more than three business days prior to the Closing Date.
(f) Opinion and 10b-5 Statement of Counsel for the Company and the Guarantors.
(i) Sullivan & Cromwell LLP, United States counsel for the Company and the Guarantors, shall have furnished to the Initial Purchasers, at the request of the Company, their written opinion and disclosure letter, dated the Closing Date and addressed to the Initial Purchasers, in form and substance reasonably satisfactory to the Initial Purchasers.
(ii) Fasken Martineau DuMoulin LLP, Canadian counsel for the Company, shall have furnished to the Initial Purchasers, at the request of the Company, their written opinion, dated the Closing Date and addressed to the Initial Purchasers, in form and substance reasonably satisfactory to the Initial Purchasers.
(iii) Lewis, Rice & Fingersh, L.C., Missouri counsel for the Company, shall have furnished to the Initial Purchasers, at the request of the Company, their written opinion, dated the Closing Date and addressed to the Initial Purchasers, in form and substance reasonably satisfactory to the Initial Purchasers.
(iv) Chancery Chambers, Barbados counsel for the Company, shall have furnished to the Initial Purchasers, at the request of the Company, their written opinion, dated the Closing Date and addressed to the Initial Purchasers, in form and substance reasonably satisfactory to the Initial Purchasers.
(g) Opinion and 10b-5 Statement of Counsel for the Initial Purchasers.
(i) The Initial Purchasers shall have received on and as of the Closing Date an opinion and 10b-5 statement of Paul Hastings LLP, counsel for the Initial Purchasers, with respect to such matters as the Initial Purchasers may reasonably request, and such counsel shall have received such documents and information as they may reasonably request to enable them to pass upon such matters.
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(ii) The Initial Purchasers shall have received on and as of the Closing Date an opinion of Blake, Cassels & Graydon LLP, Canadian counsel for the Initial Purchasers, with respect to such matters as the Initial Purchasers may reasonably request, and such counsel shall have received such documents and information as they may reasonably request to enable them to pass upon such matters.
(h) No Legal Impediment to Issuance. No action shall have been taken and no statute, rule, regulation or order shall have been enacted, adopted or issued by any federal, state or foreign governmental or regulatory authority that would, as of the Closing Date, prevent the issuance or sale of the Notes or the issuance of the Guarantees; and no injunction or order of any federal, state or foreign court shall have been issued that would, as of the Closing Date, prevent the issuance or sale of the Notes or the issuance of the Guarantees.
(i) Good Standing. The Representative shall have received on the Closing Date a certificate of status or similar certificate, as applicable, dated as of a recent date, with respect to the jurisdictions in which the Company and the Guarantors are established or incorporated, as the case may be.
(j) DTC. The Securities shall be eligible for clearance and settlement through DTC.
(k) Indenture. The Issuers and the Trustee shall have executed and delivered the Indenture in form and substance satisfactory to the Initial Purchasers and the Initial Purchasers shall have received copies thereof.
(1) Credit Facility and Credit Documents. On the Closing Date, the Company and the Guarantors shall have entered into the Credit Facility and the Credit Documents, on the terms described in Time of Sale Information, substantially simultaneously with the issuance and sale of the Notes.
(m) Acquisition. On or prior to the Closing Date, the Representative shall have received satisfactory evidence that the conditions to the closing of the Acquisition as set forth in the Asset Purchase Agreement and any other Acquisition Document (other than payment of purchase price consideration) have been satisfied or will be satisfied substantially simultaneously with the issuance and sale of the Notes.
All opinions, letters, certificates and evidence mentioned above or elsewhere in this Agreement shall be deemed to be in compliance with the provisions hereof only if they are in form and substance reasonably satisfactory to counsel for the Initial Purchasers.
7. Indemnification and Contribution.
(a) Indemnification of the Initial Purchasers. The Company and each of the Guarantors jointly and severally agree to indemnify and hold harmless each Initial Purchaser, its affiliates, directors, officers and employees and each person, if any, who controls such Initial Purchaser within the meaning of Section 15 of the Securities Act or
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Section 20 of the Exchange Act, from and against any and all losses (other than loss of profits), claims, damages, liabilities and expenses (including, without limitation, reasonable and documented fees and disbursements of counsel and other expenses incurred in connection with investigating, defending, settling, compromising or paying any such loss, claim, damage, liability, expense or action), joint or several, that arise out of, or are based upon: any untrue statement or alleged untrue statement of a material fact contained in the Preliminary Offering Memorandum, any of the other Time of Sale Information, any Issuer Written Communication or the Offering Memorandum (or any amendment or supplement thereto) or any omission or alleged omission to state therein a material fact necessary in order to make the statements therein, in the light of the circumstances under which they were made, not misleading; provided, however, that the foregoing indemnity agreement shall not apply, with respect to an Initial Purchaser, to any loss, claim, damage, liability or expense to the extent, but only to the extent, arising out of or based upon any untrue statement or alleged untrue statement or omission or alleged omission made in reliance upon and in conformity with written information furnished to the Company by such Initial Purchaser through the Representative expressly for use in the Preliminary Offering Memorandum, the Time of Sale Information, any Issuer Written Communication or the Final Offering Memorandum (or any amendment or supplement thereto; and to reimburse each Initial Purchaser and each such affiliate, director, officer, employee or controlling person for any and all expenses (including the reasonable and documented fees and disbursements of counsel chosen by RBC Capital Markets, LLC) as such expenses are reasonably incurred by such Initial Purchaser or such affiliate, director, officer, employee or controlling person in connection with investigating, defending, settling, compromising or paying any such loss, claim, damage, liability, expense or action.
(b) Indemnification of the Company and the Guarantors. Each Initial Purchaser agrees, severally and not jointly, to indemnify and hold harmless the Company, each of the Guarantors, each of their respective affiliates, directors, officers and employees and each person, if any, who controls the Company or any of the Guarantors within the meaning of Section 15 of the Securities Act or Section 20 of the Exchange Act to the same extent as the indemnity set forth in paragraph (a) above, but only with respect to any losses, claims, damages or liabilities and expenses (including, without limitation, reasonable and documented fees and disbursements of counsel and other expenses incurred in connection with investigating, defending, settling, compromising or paying any such loss, claim, damage, liability, expense or action) that arise out of, or are based upon, any untrue statement or omission or alleged untrue statement or omission made in reliance upon and in conformity with any information relating to such Initial Purchaser furnished to the Company in writing by such Initial Purchaser through the Representative expressly for use in the Preliminary Offering Memorandum, any of the other Time of Sale Information, any Issuer Written Communication or the Offering Memorandum (or any amendment or supplement thereto), it being understood and agreed that the only such information consists of the information set forth under (a) the first sentence of the third paragraph, (b) the first sentence of the fifth paragraph, and (c) the third, fourth and fifth sentences of the thirteenth paragraph under the heading Plan of Distribution in the Preliminary Offering Memorandum and the Offering Memorandum.
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(c) Notice and Procedures. If any suit, action, proceeding (including any governmental or regulatory investigation), claim or demand shall be brought or asserted against any person in respect of which indemnification may be sought pursuant to either paragraph (a) or (b) above, such person (the Indemnified Person ) shall promptly notify the person against whom such indemnification may be sought (the Indemnifying Person ) in writing; provided that the failure to notify the Indemnifying Person shall not relieve it from any liability that it may have under this Section 7 except to the extent that it has been prejudiced (through the forfeiture of substantive rights or defenses) by such failure; and provided , further , that the failure to notify the Indemnifying Person shall not relieve it from any liability that it may have to an Indemnified Person otherwise than under this Section 7. If any such proceeding shall be brought or asserted against an Indemnified Person and it shall have notified the Indemnifying Person thereof, the Indemnifying Person shall retain counsel reasonably satisfactory to the Indemnified Person (who shall not, without the consent of the Indemnified Person, be counsel to the Indemnifying Person) to represent the Indemnified Person and any others entitled to indemnification pursuant to this Section 7 that the Indemnifying Person may designate in such proceeding and shall pay the reasonable and documented fees and expenses of such proceeding and shall pay the reasonable and documented fees and expenses of such counsel related to such proceeding, as incurred. In any such proceeding, any Indemnified Person shall have the right to retain its own counsel, but the fees and expenses of such counsel shall be at the expense of such Indemnified Person unless (i) the Indemnifying Person and the Indemnified Person shall have mutually agreed to the contrary; (ii) the Indemnifying Person has failed within a reasonable time to retain counsel reasonably satisfactory to the Indemnified Person; (iii) the Indemnified Person shall have reasonably concluded that there may be legal defenses available to it that are different from or in addition to those available to the Indemnifying Person; or (iv) the named parties in any such proceeding (including any impleaded parties) include both the Indemnifying Person and the Indemnified Person and representation of both parties by the same counsel would be inappropriate due to actual or potential differing interests between them. It is understood and agreed that the Indemnifying Person shall not, in connection with any proceeding or related proceeding in the same jurisdiction, be liable for the fees and expenses of more than one separate firm (in addition to any local counsel) for all Indemnified Persons, and that all such fees and expenses shall be reimbursed as they are incurred. Any such separate firm for any Initial Purchaser, its affiliates, directors and officers and any control persons of such Initial Purchaser shall be designated in writing by RBC Capital Markets, LLC, and any such separate firm for the Company, the Guarantors, their respective affiliates, directors and officers and any control persons of the Company and the Guarantors shall be designated in writing by the Company. The Indemnifying Person shall not be liable for any settlement of any proceeding effected without its written consent, but if settled with such consent or if there be a final judgment for the plaintiff, the Indemnifying Person agrees to indemnify each Indemnified Person from and against any loss or liability by reason of such settlement or judgment. Notwithstanding the foregoing sentence, if at any time an Indemnified Person shall have requested that an Indemnifying Person reimburse the Indemnified Person for the reasonable and documented fees and expenses of counsel as contemplated by this paragraph, the Indemnifying Person shall be liable for any settlement of any proceeding effected without its written consent if (i) such
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settlement is entered into more than 60 days after receipt by the Indemnifying Person of such request and (ii) the Indemnifying Person shall not have reimbursed the Indemnified Person in accordance with such request or contested such reimbursement in good faith prior to the date of such settlement. No Indemnifying Person shall, without the written consent of the Indemnified Person, effect any settlement of any pending or threatened proceeding in respect of which any Indemnified Person is or could have been a party and indemnification could have been sought hereunder by such Indemnified Person, unless such settlement (x) includes an unconditional release of such Indemnified Person, in form and substance reasonably satisfactory to such Indemnified Person, from all liability on claims that are the subject matter of such proceeding and (y) does not include any statement as to or any admission of fault, culpability or a failure to act by or on behalf of any Indemnified Person.
(d) Contribution. If the indemnification provided for in paragraphs (a) and (b) above is unavailable to an Indemnified Person or insufficient in respect of any losses, claims, damages, liabilities or expenses referred to therein, then each Indemnifying Person under such paragraph, in lieu of indemnifying such Indemnified Person thereunder, shall contribute to the amount paid or payable by such Indemnified Person as a result of such losses, claims, damages, liabilities or expenses (i) in such proportion as is appropriate to reflect the relative benefits received by the Indemnifying Person on the one hand and the Indemnified Person on the other from the offering of the Securities or (ii) if the allocation provided by clause (i) is not permitted by applicable law, in such proportion as is appropriate to reflect not only the relative benefits referred to in clause (i) but also the relative fault of the Indemnifying Person on the one hand and the Indemnified Person on the other in connection with the statements or omissions that resulted in such losses, claims, damages, liabilities or expenses, as well as any other relevant equitable considerations. The relative benefits received by the Company and the Guarantors on the one hand and the Initial Purchasers on the other shall be deemed to be in the same respective proportions as the net proceeds (before deducting expenses) received by the Company from the sale of the Securities and the total discounts and commissions received by the Initial Purchasers in connection therewith, as provided in this Agreement, bear to the aggregate offering price of the Securities. The relative fault of the parties shall be determined by reference to, among other things, whether the untrue or alleged untrue statement of a material fact or the omission or alleged omission to state a material fact relates to information supplied by the Company or by the Initial Purchasers and the parties relative intent, knowledge, access to information and opportunity to correct or prevent such statement or omission.
(e) Limitation on Liability. The Company, the Guarantors and the Initial Purchasers agree that it would not be just and equitable if contribution pursuant to this Section 7 were determined by pro rata allocation (even if the Initial Purchasers were treated as one entity for such purpose) or by any other method of allocation that does not take account of the equitable considerations referred to in paragraph (d) above. The amount paid or payable by an Indemnified Person as a result of the losses, claims, damages, liabilities or expenses referred to in paragraph (d) above shall be deemed to include, subject to the limitations set forth above, any legal or other expenses incurred by such Indemnified Person in connection with any such action or claim. Notwithstanding
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the provisions of this Section 7, in no event shall an Initial Purchaser be required to contribute any amount in excess of the amount by which the total discounts and commissions received by such Initial Purchaser with respect to the offering of the Securities exceeds the amount of any damages that such Initial Purchaser has otherwise been required to pay by reason of an untrue or alleged untrue statement or omission or alleged omission. No person guilty of fraudulent misrepresentation (within the meaning of Section 11 (f) of the Securities Act) shall be entitled to contribution from any person who was not guilty of such fraudulent misrepresentation. The Initial Purchasers obligations to contribute pursuant to this Section 7 are several in proportion to their respective purchase obligations hereunder and not joint.
(f) Non-Exclusive Remedies. The remedies provided for in this Section 7 are not exclusive and shall not limit any rights or remedies that may otherwise be available to any Indemnified Person at law or in equity.
8. Termination . This Agreement may be terminated in the absolute discretion of the Representative, by notice to the Company, if after the execution and delivery of this Agreement and on or prior to the Closing Date (i) the Company shall have failed, refused or been unable to perform any agreement on its part to be performed under this Agreement when and as required; (ii) any other condition to the obligations of the Initial Purchasers under this Agreement to be fulfilled by the Company and each of the Guarantors pursuant to Section 7 is not fulfilled when and as required in any material respect; (iii) trading in any securities of the Company shall be suspended or limited by the Ontario Securities Commission, any other Canadian securities regulator whose jurisdiction the Company is subject to, the Toronto Stock Exchange, OTCQX, or the Commission; (iv) trading in securities generally on either the Nasdaq Stock Market or the New York Stock Exchange shall have been suspended or materially limited, or minimum prices shall have been established thereon by the Commission, FINRA, or by such exchange or other regulatory body or governmental authority having jurisdiction; (v) a general moratorium shall have been declared by either federal or New York State authorities or a material disruption in commercial banking or securities settlement or clearance services in the United States shall have occurred; (vi) there is an outbreak or escalation of hostilities or national or international calamity or crisis in any case involving the United States, on or after the date of this Agreement, or if there has been a declaration by the United States of a national emergency or war or other national or international calamity or crisis (economic, political, financial or otherwise) which affects the U.S. and international financial markets, that, in the judgment of the Representative (acting reasonably), is material and adverse and makes it impracticable or inadvisable to proceed with the offering, sale or delivery of the Securities on the terms and in the manner contemplated by this Agreement, the Time of Sale Information and the Offering Memorandum; or (vii) there shall have been such a material adverse change in general economic, political or financial conditions or the effect (or potential effect if the financial markets in the United States or Canada have not yet opened) of international conditions on the financial markets in the United States or Canada shall be such that, in the judgment of the Representative (acting reasonably), makes it impracticable or inadvisable to proceed with the offering, sale or delivery of the Securities on the terms and in the manner contemplated by this Agreement, the Time of Sale Information and the Offering Memorandum.
9. Defaulting Initial Purchaser .
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(a) If, on the Closing Date, any Initial Purchaser defaults on its obligation to purchase the Securities that it has agreed to purchase hereunder, the non-defaulting Initial Purchasers may in their discretion arrange for the purchase of such Securities by other persons satisfactory to the Company on the terms contained in this Agreement. If, within 48 hours after any such default by any Initial Purchaser, the non-defaulting Initial Purchasers do not arrange for the purchase of such Securities, then the Company shall be entitled to a further period of 48 hours within which to procure other persons satisfactory to the non-defaulting Initial Purchasers to purchase such Securities on such terms. If other persons become obligated or agree to purchase the Securities of a defaulting Initial Purchaser, either the non-defaulting Initial Purchasers or the Company may postpone the Closing Date for up to five full business days in order to effect any changes that in the opinion of counsel for the Company or counsel for the Initial Purchasers may be necessary in the Time of Sale Information, the Offering Memorandum or in any other document or arrangement, and the Company agrees to promptly prepare any amendment or supplement to the Time of Sale Information or the Offering Memorandum that effects any such changes. As used in this Agreement, the term Initial Purchaser includes, for all purposes of this Agreement unless the context otherwise requires, any person not listed in Schedule 1 hereto that, pursuant to this Section 9, purchases Securities that a defaulting Initial Purchaser agreed but failed to purchase.
(b) If, after giving effect to any arrangements for the purchase of the Securities of a defaulting Initial Purchaser or Initial Purchasers by the non-defaulting Initial Purchasers and the Company as provided in paragraph (a) above, the aggregate principal amount of such Securities that remains unpurchased does not exceed one-eleventh of the aggregate principal amount of all the Securities, then the Company shall have the right to require each non-defaulting Initial Purchaser to purchase the principal amount of Securities that such Initial Purchaser agreed to purchase hereunder plus such Initial Purchasers pro rata share (based on the principal amount of Securities that such Initial Purchaser agreed to purchase hereunder) of the Securities of such defaulting Initial Purchaser or Initial Purchasers for which such arrangements have not been made.
(c) If, after giving effect to any arrangements for the purchase of the Securities of a defaulting Initial Purchaser or Initial Purchasers by the non-defaulting Initial Purchasers and the Company as provided in paragraph (a) above, the aggregate principal amount of such Securities that remains unpurchased exceeds one-eleventh of the aggregate principal amount of all the Securities, or if the Company shall not exercise the right described in paragraph (b) above, then this Agreement shall terminate without liability on the part of the non-defaulting Initial Purchasers and the Company and the Guarantors. Any termination of this Agreement pursuant to this Section 9 shall be without liability on the part of the Company or the Guarantors, except that the Company and each of the Guarantors will continue to be liable for the payment of expenses as set forth in Section 10 hereof (except for any such expenses of a defaulting Initial Purchaser) and except that the provisions of Section 7 hereof shall not terminate and shall remain in effect.
(d) Nothing contained herein shall relieve a defaulting Initial Purchaser of any liability it may have to the Company, the Guarantors or any non-defaulting Initial Purchaser for damages caused by its default.
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10. Payment of Expenses .
(a) Whether or not the transactions contemplated by this Agreement are consummated or this Agreement is terminated, the Company and each of the Guarantors jointly and severally agree to pay or cause to be paid all reasonable costs and expenses incident to the performance of their respective obligations hereunder, including without limitation, (i) the costs incident to the authorization, issuance, sale, preparation and delivery of the Securities and any taxes payable in that connection; (ii) the costs incident to the preparation and printing of the Preliminary Offering Memorandum, any other Time of Sale Information, any Issuer Written Communication and the Offering Memorandum (including any amendment or supplement thereto) and the distribution thereof; (iii) the costs of reproducing and distributing each of the Transaction Documents; (iv) the reasonable fees and expenses of the Companys and the Guarantors counsel (including local and special counsel) and independent accountants; (v) the fees and expenses incurred in connection with the registration or qualification and determination of eligibility for investment of the Securities under the laws of such jurisdictions as the Representative may designate and the preparation, printing and distribution of a Blue Sky Memorandum (including the related, reasonable and documented fees and expenses of counsel for the Initial Purchasers); (vi) any fees charged by rating agencies for rating the Securities; (vii) the fees and expenses of the Trustee and any paying agent (including related fees and expenses of any counsel to such parties); (viii) all expenses and application fees incurred in connection with the approval of the Securities for book-entry transfer by DTC; (ix) all expenses incurred by the Company in connection with any road show presentation to potential investors including, without limitation, expenses associated with the preparation or dissemination of any electronic road show presentation, expenses associated with production of road show slides and graphics, and, with the prior written approval of the Company, reasonable and documented fees and expenses of any consultants engaged in connection with the road show presentations, and travel and lodging expenses of the representatives and officers of the Company and any such consultants.
(b) If (i) this Agreement is terminated pursuant to Section 8, (ii) the Company for any reason fails to tender the Securities for delivery to the Initial Purchasers (other than pursuant to Section 9) or (iii) the Initial Purchasers decline to purchase the Securities for any reason permitted under this Agreement, the Company and each of the Guarantors jointly and severally agrees to reimburse the Initial Purchasers for all reasonable and documented out- of-pocket costs and expenses (including the reasonable and documented fees and expenses of their counsel) reasonably incurred by the Initial Purchasers in connection with this Agreement and the offering contemplated hereby subject to [REDACTED]
11. Persons Entitled to Benefit of Agreement . This Agreement shall inure to the benefit of and be binding upon the parties hereto and their respective successors and any controlling persons referred to herein, and the affiliates, officers and directors of each Initial Purchaser referred to in Section 7 hereof. Nothing in this Agreement is intended or shall be construed to give any other person any legal or equitable right, remedy or claim under or in respect of this Agreement or any provision contained herein. No purchaser of Securities from any Initial Purchaser shall be deemed to be a successor merely by reason of such purchase.
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12. Survival . The respective indemnities, rights of contribution, representations, warranties and agreements of the Company, the Guarantors and the Initial Purchasers contained in this Agreement or made by or on behalf of the Company, the Guarantors or the Initial Purchasers pursuant to this Agreement or any certificate delivered pursuant hereto shall survive the delivery of and payment for the Securities and shall remain in full force and effect, regardless of any termination of this Agreement or any investigation made by or on behalf of the Company, the Guarantors or the Initial Purchasers.
13. Certain Defined Terms . For purposes of this Agreement, (a) except where otherwise expressly provided, the term affiliate has the meaning set forth in Rule 405 under the Securities Act; (b) the term business day means any day other than a day on which banks are permitted or required to be closed in New York City; (c) the term subsidiary has the meaning set forth in Rule 405 under the Securities Act; and (d) the term written communication has the meaning set forth in Rule 405 under the Securities Act.
14. Miscellaneous .
(a) Authority of the Representative. Any action by the Initial Purchasers hereunder may be taken by RBC Capital Markets, LLC on behalf of the Initial Purchasers, and any such action taken by RBC Capital Markets, LLC shall be binding upon the Initial Purchasers.
(b) Partial Unenforceability. The invalidity or unenforceability of any section, paragraph or provision of this Agreement shall not affect the validity or enforceability of any other section, paragraph or provision hereof. If any section, paragraph or provision of this Agreement is for any reason determined to be invalid or unenforceable, there shall be deemed to be made such minor changes (and only such minor changes) as are necessary to make it valid and enforceable.
(c) Notices. All notices and other communications hereunder shall be in writing and shall be deemed to have been duly given if mailed or transmitted and confirmed by any standard form of telecommunication. Notices to the Initial Purchasers shall be given to the Representative c/o RBC Capital Markets, LLC, 3 World Financial Center, 200 Vesey Street, 8th Floor, New York, New York 10281 (fax: 212-618-2210); Attention: High Yield Capital Markets (with a copy to Paul Hastings LLP, 75 East 55th Street, New York, New York 10022, Attention: William Schwitter). Notices to the Company and the Guarantors shall be given to them at Concordia Healthcare Corp., 227 Lakeshore Road East, Suite 302, Oakville, Ontario L6J1H9, (fax: 905-842-5154); Attention: Mark Thompson, Chief Executive Officer.
In accordance with the requirements of the USA Patriot Act (Title III of Pub. L. 107-56 (signed into law October 26,2001)), the Initial Purchasers are required to obtain, verify and record information that identifies their respective clients, including the Company and the Guarantors, which information may include the name and address of their respective clients, as well as other information that will allow the Initial Purchasers to properly identify their respective clients.
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(d) Governing Law. THIS AGREEMENT SHALL BE GOVERNED BY AND CONSTRUED IN ACCORDANCE WITH THE INTERNAL LAWS OF THE STATE OF NEW YORK APPLICABLE TO AGREEMENTS MADE AND TO BE PERFORMED IN SUCH STATE WITHOUT REGARD TO CONFLICTS OF LAW PRINCIPLES THEREOF.
(e) Submission to Jurisdiction; Waiver of Jury Trial. The Company agrees that any suit, action or proceeding against the Company brought by any Initial Purchaser, the directors, officers, employees and agents of any Initial Purchaser, or by any person who controls any Initial Purchaser, arising out of or based upon this Agreement or the transactions contemplated hereby may be instituted in the courts of the State of New York located in the City and County of New York or in the United States District Court for the Southern District of New York and waives any objection which it may now or hereafter have to the laying of venue of any such proceeding, and irrevocably submits to the non-exclusive jurisdiction of such courts in any suit, action or proceeding. The Issuers hereby waive all right to trial by jury in any proceeding (whether based upon contract, tort or otherwise) in any way arising out of or relating to this Agreement. The Issuers agree that a final judgment in any such proceeding brought in any such court shall be conclusive and binding upon the Issuers and may be enforced in any other courts in the jurisdiction of which the Issuers are or may be subject, by suit upon such judgment.
(f) Waiver of Immunity. With respect to any proceeding related to this Agreement or the transactions contemplated hereby, each party irrevocably waives, to the fullest extent permitted by applicable law, all immunity (whether on the basis of sovereignty or otherwise) from jurisdiction, service of process, attachment (both before and after judgment) and execution to which it might otherwise be entitled in the courts of the State of New York located in the City and County of New York or in the United States District Court for the Southern District of New York, and with respect to any suits, actions, or proceedings instituted in regard to the enforcement of a judgment of any such proceeding brought in any such court, each party waives any such immunity in any such court or any other court of competent jurisdiction, and will not raise or claim or cause to be pleaded any such immunity at or in respect of any such proceeding or enforcement of a judgment, including, without limitation, any immunity pursuant to the United States Foreign Sovereign Immunities Act of 1976, as amended. Each Issuer hereby designates, appoints and empowers CT Corporation System, 11 Eighth Avenue, New York, NY (and any successor thereto, the Agent of Service ) as its designee, appointee and agent to receive, accept and acknowledge for and on its behalf, and its properties, assets and revenues, service of any and all legal process, summons, notices and documents that may be served in any action, suits or proceedings brought against it in any courts of the State of New York located in the City and County of New York or in the United States District Court for the Southern District of New York with respect to any proceeding related to this Agreement or the transactions contemplated hereby. Each Issuer further hereby irrevocably consents and agrees to the service of any and all legal process, summons, notices and documents that may be served in any action, suits or proceedings brought against it by serving a copy thereof upon the Agent of Service. The Issuers agree that the failure of the Agent of Service to give any notice of such service to them shall not impair
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or affect in any way the validity of such service or any judgment rendered in any action or proceeding based thereon.
(g) Judgment Currency. If for the purposes of obtaining judgment in any court it is necessary to convert a sum due hereunder into any currency other than U.S. dollars, the parties hereto agree, to the fullest extent that they may effectively do so, that the rate of exchange used shall be the rate at which in accordance with normal banking procedures the Initial Purchasers could purchase U.S. dollars with such other currency in the City of New York on the business day preceding that on which final judgment is given. The obligations of the Issuers in respect of any sum due from them to the Initial Purchasers shall, notwithstanding any judgment in any currency other than U.S. dollars, not be discharged until the first business day, following receipt by the Initial Purchasers of any sum adjudged to be so due in such other currency, on which (and only to the extent that) the Initial Purchasers may in accordance with normal banking procedures purchase U.S. dollars with such other currency; if the U.S. dollars so purchased are less than the sum originally due to the Initial Purchasers hereunder, the Issuers agree, as a separate obligation and notwithstanding any such judgment, to indemnify the Initial Purchasers against such loss. If the U.S. dollars so purchased are greater than the sum originally due to such Initial Purchasers hereunder, the Initial Purchasers agree to pay to the Issuers (but without duplication) an amount equal to the excess of the U.S. dollars so purchased over the sum originally due to the Initial Purchasers hereunder.
(h) Counterparts. This Agreement may be signed in counterparts (which may include counterparts delivered by any standard form of telecommunication), each of which shall be an original and all of which together shall constitute one and the same instrument.
(i) Amendments or Waivers. No amendment or waiver of any provision of this Agreement, nor any consent or approval to any departure therefrom, shall in any event be effective unless the same shall be in writing and signed by the parties hereto.
(j) Headings. The headings herein are included for convenience of reference only and are not intended to be part of, or to affect the meaning or interpretation of, this Agreement.
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If the foregoing is in accordance with your understanding, please indicate your acceptance of this Agreement by signing in the space provided below.
Very truly yours, |
CONCORDIA HEALTHCARE CORP., as Issuer |
(Signed) Mark Thompson CEO and President |
CONCORDIA HEALTHCARE INC., as Guarantor |
(Signed) Mark Thompson CEO and President |
CONCORDIA HEALTHCARE (USA) INC., as Guarantor |
(Signed) Leith Tessey CFO |
COMPLETE MEDICAL HOMECARE, INC., as Guarantor |
(Signed) Leith Tessey CFO |
[Signature Page to Purchase Agreement]
CONCORDIA LABS INC., as Guarantor |
(Signed) Mark Thompson President |
PINNACLE BIOLOGICS, INC., as Guarantor |
(Signed) Mark Thompson CEO |
CONCORDIA PHARMACEUTICALS INC., as Guarantor |
(Signed) John A. R. McCleery Managing Director and CFO |
CONCORDIA LABORATORIES INC., as Guarantor |
(Signed) John A. R. McCleery Managing Director and CFO |
[Signature Page to Purchase Agreement]
[Signature Page to Purchase Agreement]
Schedule 1
Initial Purchaser |
Principal Amount | |||||||
RBC Capital Markets, LLC |
$ | [REDACTED | ] | |||||
Morgan Stanley & Co. LLC |
$ | [REDACTED | ] | |||||
TD Securities (USA) LLC |
$ | [REDACTED | ] | |||||
Total |
$ | 735,000,000 |
Schedule 2
Guarantors
| Concordia Healthcare Inc., an Ontario Corporation |
| Concordia Healthcare (USA) Inc., a Delaware Corporation |
| Complete Medical Homecare, Inc., a Missouri Corporation |
| Concordia Labs Inc., a Delaware Corporation |
| Pinnacle Biologies, Inc., a Delaware Corporation |
| Concordia Pharmaceuticals Inc., a Barbados International Business Company |
| Concordia Laboratories Inc., a Barbados International Business Company |
ANNEX A
Time of Sale Information
1. Term sheet containing the terms of the securities, substantially in the form of Annex B.
ANNEX B
Form of Pricing Term Sheet
ANNEX C
Restrictions on Offers and Sales Outside the United States
In connection with offers and sales of Securities outside the United States:
(a) Each Initial Purchaser acknowledges that the Securities have not been registered under the Securities Act and may not be offered or sold within the United States or to, or for the account or benefit of, U.S. persons except pursuant to an exemption from, or in transactions not subject to, the registration requirements of the Securities Act.
(b) Each Initial Purchaser, severally and not jointly, represents, warrants and agrees that:
(i) Such Initial Purchaser has offered and sold the Securities, and will offer and sell the Securities, (A) as part of their distribution at any time and (B) otherwise until 40 days after the later of the commencement of the offering of the Securities and the Closing Date, only in accordance with Regulation S under the Securities Act ( Regulation S ) or Rule 144A or any other available exemption from registration under the Securities Act.
(ii) None of such Initial Purchaser or any of its affiliates or any other person acting on its or their behalf has engaged or will engage in any directed selling efforts with respect to the Securities, and all such persons have complied and will comply with the offering restrictions requirement of Regulation S.
(iii) At or prior to the confirmation of sale of any Securities sold in reliance on Regulation S, such Initial Purchaser will have sent to each distributor, dealer or other person receiving a selling concession, fee or other remuneration that purchases Securities from it during the distribution compliance period a confirmation or notice to substantially the following effect:
The Securities covered hereby have not been registered under the U.S. Securities Act of 1933, as amended (the Securities Act ), and may not be offered or sold within the United States or to, or for the account or benefit of, U.S. persons (i) as part of their distribution at any time or (ii) otherwise until 40 days after the later of the commencement of the offering of the Securities and the date of original issuance of the Securities, except in accordance with Regulation S or Rule 144A or any other available exemption from registration under the Securities Act. Terms used above have the meanings given to them by Regulation S.
(iv) Such Initial Purchaser has not and will not enter into any contractual arrangement with any distributor with respect to the distribution of the Securities, except with its affiliates or with the prior written consent of the Company.
ANNEX C
Terms used in paragraph (a) and this paragraph (b) and not otherwise defined in this Agreement have the meanings given to them by Regulation S.
(c) Each Initial Purchaser acknowledges that no action has been or will be taken by the Company that would permit a public offering of the Securities, or possession or distribution of any of the Preliminary Offering Memorandum, the Time of Sale Information, the Offering Memorandum, any Issuer Written Communication or any other offering or publicity material relating to the Securities, in any country or jurisdiction where action for that purpose is required.
EXHIBIT A
Subsidiary |
Jurisdiction |
Equityholder (% interest) |
||
Concordia Healthcare Inc. | Ontario, Canada | Concordia Healthcare Corp. (100%) | ||
Concordia Healthcare (USA) Inc. | Delaware, USA | Concordia Healthcare Inc. (100%) | ||
Concordia Labs Inc. | Delaware, USA | Concordia Healthcare Inc. (100%) | ||
Concordia Laboratories Inc. | Barbados | Concordia Healthcare Inc. (100%) | ||
Concordia Pharmaceuticals Inc. | Barbados | Concordia Healthcare Corp. (~50%) | ||
Concordia Healthcare Inc. (~50%) | ||||
Hawthorn Drug Group, Inc. | Delaware, USA | Concordia Healthcare (USA) Inc. | ||
(100%) | ||||
Complete Medical Homecare, Inc. | Missouri, USA | Concordia Healthcare (USA) Inc. | ||
(100%) | ||||
Pinnacle Biologies, Inc. | Delaware, USA | Concordia Labs Inc. (100%) | ||
Pinnacle Oncology LLC | Delaware, USA | Pinnacle Biologies, Inc. (87.5%) | ||
The University of Chicago [REDACTED] | ||||
[REDACTED] (12.5%) | ||||
Pinnacle Biologies B.V. | The Netherlands | Pinnacle Biologies, Inc. (100%) | ||
Compagnie Biologiques Pinnacle | Quebec, Canada | Pinnacle Biologies, Inc. (100%) | ||
Pinnacle Biopharma India Private | India | Pinnacle Biologies, Inc. (99%) | ||
Limited | [REDACTED] (1%) |
Exhibit 99.20
EXECUTION VERSION
ASSIGNMENT AND ASSUMPTION AGREEMENT
This Assignment and Assumption Agreement (this Agreement ) is made and entered into as of the 21 st day of April 2015, by and among Covis Pharma S.à.r.l., Zug Branch, a limited liability company organized under the Laws of Luxembourg ( Covis Pharma ), Covis Injectables S.à.r.l., Zug Branch, a limited liability company organized under the Laws of Luxembourg ( Covis Injectables , and collectively with Covis Pharma, Sellers ) and Concordia Pharmaceuticals Inc., an international business company organized under the Laws of Barbados ( Purchaser ). Capitalized terms used but not otherwise defined herein shall have the meanings ascribed to such terms in the Asset Purchase Agreement, dated as of the 9 th day of March 2015, among Sellers, Purchaser, Concordia Healthcare Corp., a corporation organized under the Laws of the province of Ontario ( Purchaser Parent ) (solely with respect to Section 6.10 , Section 10.18 and the applicable provisions of Article X thereof), and Covis Pharma Holdings S.à.r.l., a limited liability company organized under the Laws of Luxembourg ( Seller Parent ) (solely with respect to Section 10.19 and the applicable provisions of Article X thereof) (as amended, modified or supplemented from time to time in accordance with its terms, the Purchase Agreement ).
W I T N E S S E T H :
WHEREAS , pursuant to the Purchase Agreement, Sellers have agreed to sell, convey, assign, transfer and deliver to Purchaser, and Purchaser has agreed to purchase, acquire and accept from Sellers, for the consideration and upon the terms and subject to the conditions set forth in the Purchase Agreement, all of Sellers right, title and interest in, to and under the Purchased Assets, as more particularly set forth therein; and
WHEREAS , pursuant to the Purchase Agreement, Purchaser has agreed to assume, satisfy and discharge when due the Assumed Liabilities, as more particularly set forth therein.
NOW, THEREFORE , in consideration of the foregoing and the representations, warranties, covenants and agreements contained in the Purchase Agreement, and for other good and valuable consideration, the receipt and sufficiency of which are hereby acknowledged, the Parties, intending to be legally bound hereby, agree as follows:
1. Assignment . In accordance with and subject to the terms of the Purchase Agreement, Sellers hereby sell, convey, assign, transfer and deliver to Purchaser, and Purchaser hereby purchases, acquires and accepts from Sellers, free and clear of all Liens, other than Permitted Encumbrances, all of Sellers right, title and interest, as of the Closing, in, to and under the Purchased Assets, including the Assumed Contracts; it being understood that (i) certain Assumed Contracts and Shared Contracts are the subject of arrangements set forth in Appendix A-4 to the Transition Services Agreement, dated as of the date hereof, by and among Purchaser, Sellers and CPI, as contemplated by Section 2.2 of the Purchase Agreement, (ii) Sellers rights pursuant to the Shared Contracts listed on Schedule I will be conveyed, assigned and transferred to Purchaser to the extent related to the Products and Sellers will retain their rights thereunder solely to the extent related to
the Retained Products and solely for the term remaining under the applicable Shared Contract, and (iii) Sellers rights pursuant to the Shared Contracts listed on Schedule II will be terminated effective as of the Closing and Sellers will be parties, as applicable, to new contracts relating to the Excluded Assets with the counterparties of, and upon the same terms as, the Shared Contracts. Notwithstanding anything to the contrary herein, Sellers, as applicable, have not, and shall not be deemed to have hereunder sold, assigned, transferred, conveyed or delivered to Purchaser any portion of the Excluded Assets, and Sellers, as applicable, retain all right, title and interest to, in and under the Excluded Assets.
2. Assumption . In accordance with and subject to the terms of the Purchase Agreement in all respects (i) Purchaser hereby assumes, undertakes and agrees to satisfy and discharge when due the Assumed Liabilities, and (ii) Sellers acknowledge that (A) except as expressly set forth in the Purchase Agreement, Purchaser is not assuming or having any responsibility of any nature with respect to any Liability that is not an Assumed Liability and (B) Sellers will continue to be liable for all matters arising out of or relating to (1) the Shared Contracts prior to Closing and (2) the Excluded Assets.
3. Entire Agreement; Conflicting Terms . This Agreement and the Purchase Agreement (in each case, including all Schedules and Exhibits hereto and thereto) contain the entire agreement between the Parties with respect to the subject matter hereof and supersede all prior agreements and understandings, oral or written, with respect to such matters, except for (i) subject to Section 6.15(a) of the Purchase Agreement, the Confidentiality Agreement which will remain in full force and effect for the term provided for therein and (ii) any written agreement of the Parties that expressly provides that it is not superseded by this Agreement or the Purchase Agreement. Nothing herein shall be deemed to limit the rights, duties and obligations of the Parties under the Purchase Agreement and, to the extent of any conflict between the terms and conditions of this Agreement and the terms and conditions of the Purchase Agreement, the terms and conditions of the Purchase Agreement shall govern, supersede and prevail.
4. Notices . All notices, requests and other communications to any Party hereunder shall be made in accordance with Section 10.1 of the Purchase Agreement.
5. Amendment; Waiver . Any provision of this Agreement may be amended or waived if, and only if, such amendment or waiver is in writing and signed, in the case of an amendment, by Purchaser and Sellers, or in the case of a waiver, by the Party against whom the waiver is to be effective. To the extent any amendment, modification or supplement to Section 8 , Section 9 or this Section 5 is sought which is adverse to the rights of the Financing Sources, the prior written consent of the Financing Sources shall be required before such amendment, modification or supplement is rendered effective. No failure or delay by any Party in exercising any right, power or privilege hereunder shall operate as a waiver thereof nor shall any single or partial exercise thereof preclude any other or further exercise thereof or the exercise of any other right, power or privilege.
6. Assignment . No Party to this Agreement may assign any of its rights or obligations under this Agreement without the prior written consent of the other Parties;
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provided, that nothing in the foregoing shall prohibit Purchaser from making any assignment (i) to any of its Affiliates so long as such Affiliate agrees in writing to be bound by all of the terms, conditions and provisions contained in this Agreement provided, further, no such assignment shall release Purchaser from its obligations under this Agreement; and (ii) to any successors to all or substantially all of the business and assets of Purchaser, whether in a merger, consolidation, sale of substantially all assets or other similar transaction. Any purported assignment, hypothecation or transfer in breach of this Section 6 shall be null and void. This Agreement shall be binding upon, and shall inure to the benefit of, and be enforceable by the Parties hereto and their successors and permitted assigns.
7. Parties in Interest . This Agreement shall inure to the benefit of and be binding upon the Parties and their respective successors and permitted assigns. Nothing in this Agreement, express or implied, is intended to confer upon any Person other than Purchaser, Sellers, or their successors or permitted assigns, any rights or remedies under or by reason of this Agreement.
8. Governing Law; Jurisdiction .
(a) | This Agreement and its negotiation, execution, performance or non-performance, interpretation, termination, construction and all claims or causes of action (whether in contract, in tort, at law or otherwise) that may be based upon, arise out of, or relate to this Agreement, or the transactions contemplated hereby (including any claim or cause of action based upon, arising out of or related to any representation or warranty made in connection with this Agreement or as an inducement to enter this Agreement), shall be exclusively governed by, and construed in accordance with, the Laws of the State of Delaware regardless of Laws that might otherwise govern under any applicable conflict of Laws principles. Notwithstanding anything in this Agreement to the contrary, the Parties agree that any claim, controversy or dispute of any kind or nature (whether based upon contract, tort or otherwise) involving a Financing Source that is based upon, arises out of, or relates to this Agreement or any of the transactions contemplated by this Agreement, including any dispute arising out of or relating in any way to the Financing or the Commitment Letter shall be governed by, and construed in accordance with, the Laws of the State of New York. |
(b) |
Any claim, demand, suit, action, cause of action, or proceeding (whether in contract, in tort, at law, or otherwise) (each, a Proceeding ) based upon, arising out of, or related to this Agreement and its negotiation, execution, performance, non-performance, interpretation, termination, construction or the transactions contemplated hereby shall be heard and determined in the Court of Chancery in the City of Wilmington, New Castle County, Delaware or, in the event such court lacks subject matter jurisdiction, the United States District Court sitting in Wilmington, Delaware or, in the event such federal district court lacks subject matter jurisdiction, then in the Superior Court in the City of Wilmington, New Castle County, Delaware. Notwithstanding the foregoing, each Party hereby agrees that it will not bring or support any action, cause of action, claim, cross- |
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claim or third-party claim of any kind or description, whether in law or in equity, whether in contract or in tort or otherwise, against the Financing Sources in any way relating to this Agreement, the Commitment Letter, or any of the transactions contemplated hereby or thereby, including, without limitation, any dispute arising out of or relating in any way to the Financing or the performance thereof, in any forum other than the Supreme Court of the State of New York, County of New York, or, if under applicable Law exclusive jurisdiction is vested in the federal courts, the United States District Court for the Southern District of New York (and the appellate courts thereof), and that the provisions of Section 8 relating to the waiver of jury trial shall apply to any such action, cause of action, claim, cross-claim or third-party claim. The Parties hereby irrevocably submit to the exclusive jurisdiction and venue of such courts in any such Proceeding and irrevocably and unconditionally waive the defense of an inconvenient forum, or lack of jurisdiction to the maintenance of any such Proceeding. The consents to jurisdiction and venue set forth herein shall not constitute general consents to service of process in the State of Delaware and shall have no effect for any purpose except as provided in this Section 8 and shall not be deemed to confer rights on any Person other than the Parties. Each Party agrees that the service of process upon such Party in any Proceeding arising out of or relating to this Agreement shall be effective if notice is given by overnight courier at the address set forth in Section 4 . Each of the Parties also agrees that any final, non-appealable judgment against a Party in connection with any Proceeding arising out of or relating to this Agreement shall be conclusive and binding on such Party and that such award or judgment may be enforced in any court of competent jurisdiction, either within or outside of the United States. A certified or exemplified copy of such award or judgment shall be conclusive evidence of the fact and amount of such award or judgment. |
9. WAIVER OF JURY TRIAL . TO THE FULLEST EXTENT PERMITTED BY LAW, THE PARTIES HEREBY WAIVE THEIR RESPECTIVE RIGHTS TO A JURY TRIAL OF ANY PROCEEDING (WHETHER IN CONTRACT, IN TORT, AT LAW OR OTHERWISE) BASED UPON, ARISING OUT OF, OR RELATED TO THIS AGREEMENT, ANY OF THE TRANSACTIONS CONTEMPLATED BY THIS AGREEMENT OR ARISING OUT OF OR RELATING TO THE FINANCING OR ANY OF THE TRANSACTIONS CONTEMPLATED THEREBY, INCLUDING IN ANY ACTION, PROCEEDING OR COUNTERCLAIM AGAINST ANY FINANCING SOURCE. THE SCOPE OF THIS WAIVER IS INTENDED TO BE ALL-ENCOMPASSING OF ANY AND ALL DISPUTES THAT MAY BE FILED IN ANY COURT AND THAT RELATE TO THE SUBJECT MATTER OF THIS AGREEMENT, INCLUDING WITHOUT LIMITATION, CONTRACT CLAIMS, TORT CLAIMS, BREACH OF DUTY CLAIMS AND ALL OTHER COMMON LAW AND STATUTORY CLAIMS. THE PARTIES ACKNOWLEDGE THAT THIS WAIVER IS A MATERIAL INDUCEMENT TO ENTER INTO A BUSINESS RELATIONSHIP, THAT EACH HAS ALREADY RELIED ON THE WAIVER IN ENTERING INTO THIS AGREEMENT AND THAT EACH WILL CONTINUE TO RELY ON THE WAIVER IN THEIR RELATED FUTURE DEALINGS. THE PARTIES FURTHER WARRANT AND REPRESENT THAT EACH HAS
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REVIEWED THIS WAIVER WITH ITS LEGAL COUNSEL, AND THAT EACH KNOWINGLY AND VOLUNTARILY WAIVES ITS JURY TRIAL RIGHTS FOLLOWING CONSULTATION WITH LEGAL COUNSEL. THIS WAIVER IS IRREVOCABLE, MEANING THAT IT MAY NOT BE MODIFIED EITHER ORALLY OR IN WRITING, AND THIS WAIVER SHALL APPLY TO ANY SUBSEQUENT AMENDMENTS, RENEWALS, SUPPLEMENTS OR MODIFICATIONS TO THIS AGREEMENT OR TO ANY OTHER DOCUMENTS OR AGREEMENTS RELATING TO THE TRANSACTIONS CONTEMPLATED HEREBY. IN THE EVENT OF LITIGATION, THIS AGREEMENT MAY BE FILED AS A WRITTEN CONSENT TO A TRIAL BY THE COURT.
10. Counterparts . This Agreement may be executed in one or more counterparts (including by facsimile or electronic .pdf submission), each of which shall be deemed an original, and all of which shall constitute one and the same agreement and shall become effective when one or more counterparts have been signed by each of the Parties and delivered (by telecopy or otherwise) to the other Party, it being understood that both Parties need not sign the same counterpart.
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IN WITNESS WHEREOF , the Parties have duly executed and delivered this Agreement as of the date first written above.
SELLERS: | ||
COVIS PHARMA S.À.R.L., Acting through its Zug Branch |
||
By: |
[REDACTED personal information] |
|
[REDACTED personal information] | ||
[REDACTED personal information] | ||
COVIS INJECTABLES S.À.R.L., Acting through its Zug Branch |
||
By: |
[REDACTED personal information] |
|
[REDACTED personal information] | ||
[REDACTED personal information] | ||
PURCHASER: | ||
CONCORDIA PHARMACEUTICALS INC. | ||
By: |
[REDACTED personal information] |
|
[REDACTED personal information] | ||
[REDACTED personal information] |
[ Signature Page to Assignment and Assumption Agreement ]
Schedule I
[REDACTED commercially sensitive information.]
Schedule II
[REDACTED commercially sensitive information.]
Exhibit 99.21
EXECUTION VERSION
BILL OF SALE
This Bill of Sale (this Bill of Sale ) is made and entered into as of the 21 st day of April 2015, by and among Covis Pharma S.à.r.l., Zug Branch, a limited liability company organized under the Laws of Luxembourg ( Covis Pharma ), Covis Injectables S.à.r.l., Zug Branch, a limited liability company organized under the Laws of Luxembourg ( Covis Injectables , and collectively with Covis Pharma, Sellers ), and Concordia Pharmaceuticals Inc., an international business company organized under the Laws of Barbados ( Purchaser ). Capitalized terms used but not otherwise defined herein shall have the meanings ascribed to such terms in the Asset Purchase Agreement, dated as of the 9 th day of March 2015, among Sellers, Purchaser, Concordia Healthcare Corp., a corporation organized under the Laws of the province of Ontario (solely with respect to Section 6.10 , Section 10.18 and the applicable provisions of Article X thereof) and Covis Pharma Holdings S.à.r.l., a limited liability company organized under the Laws of Luxembourg (solely with respect to Section 10.19 and the applicable provisions of Article X thereof) (as amended, modified or supplemented from time to time in accordance with its terms, the Purchase Agreement ).
W I T N E S S E T H :
WHEREAS , pursuant to the Purchase Agreement, Sellers have agreed to sell, convey, assign, transfer and deliver to Purchaser, and Purchaser has agreed to purchase, acquire and accept from Sellers, for the consideration and upon the terms and subject to the conditions set forth in the Purchase Agreement, all of Sellers right, title and interest in, to and under the Purchased Assets, as more particularly set forth therein.
NOW, THEREFORE , in consideration of the foregoing and the representations, warranties, covenants and agreements contained in the Purchase Agreement, and for other good and valuable consideration, the receipt and sufficiency of which are hereby acknowledged, the Parties, intending to be legally bound hereby, agree as follows:
1. In accordance with and subject to the terms of the Purchase Agreement, Sellers hereby sell, convey, assign, transfer and deliver to Purchaser, and Purchaser hereby purchases, acquires and accepts from Sellers, free and clear of all Liens, other than Permitted Encumbrances, all of Sellers right, title and interest, as of the Closing, in, to and under the tangible personal property included in the Purchased Assets. Notwithstanding anything to the contrary, Sellers, as applicable, have not, and shall not be deemed to have hereunder sold, assigned, transferred, conveyed or delivered to Purchaser any portion of the Excluded Assets, and Sellers, as applicable, retain all right, title and interest to, in and under the Excluded Assets.
2. This Bill of Sale is executed for the purpose of evidencing and confirming the transfer of the tangible personal property included in the Purchased Assets from Sellers to Purchaser, upon the terms and subject to the conditions set forth in the Purchase Agreement.
3. This Bill of Sale and the Purchase Agreement (in each case, including all Schedules and Exhibits hereto and thereto) contain the entire agreement between the parties with respect to the subject matter hereof and supersede all prior agreements and understandings, oral or written, with respect to such matters, except for (i) subject to Section 6.15(a) of the Purchase Agreement,
the Confidentiality Agreement which will remain in full force and effect for the term provided for therein and (ii) any written agreement of the Parties that expressly provides that it is not superseded by this Bill of Sale or the Purchase Agreement. Nothing herein shall be deemed to limit the rights, duties and obligations of the Parties under the Purchase Agreement and, to the extent of any conflict between the terms and conditions of this Bill of Sale and the terms and conditions of the Purchase Agreement, the terms and conditions of the Purchase Agreement shall govern, supersede and prevail.
4. The following provisions of the Purchase Agreement are hereby incorporated by reference, substituting, in each such section, the term Bill of Sale as defined herein for the term Agreement as defined in the Purchase Agreement: Section 10.1 ( Notices ); Section 10.2 ( Amendment; Waiver ); Section 10.3 ( Assignment ); Section 10.5 ( Parties in Interest ) (other than the proviso); Section 10.10 ( Governing Law; Jurisdiction ); Section 10.11 ( Waiver of Jury Trial ) and Section 10.12 ( Counterparts ).
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IN WITNESS WHEREOF, the Parties have duly executed and delivered this Bill of Sale as of the date first written above.
SELLERS: | ||||
COVIS PHARMA S.À.R.L., Acting through its Zug Branch |
||||
By: |
/s/ [REDACTED Personal Information] |
|||
Name: | [REDACTED Personal Information] | |||
Title: | [REDACTED Personal Information] | |||
COVIS INJECTABLES S.À.R.L., Acting through its Zug Branch |
||||
By: |
/s/ [REDACTED Personal Information] |
|||
Name: | [REDACTED Personal Information] | |||
Title: | [REDACTED Personal Information] | |||
PURCHASER: | ||||
CONCORDIA PHARMACEUTICALS INC. | ||||
By: |
/s/ [REDACTED Personal Information] |
|||
Name: | [REDACTED Personal Information] | |||
Title: | [REDACTED Personal Information] |
[ Signature Page to Bill of Sale ]
Exhibit 99.22
EXECUTION VERSION
ESCROW AGREEMENT
This ESCROW AGREEMENT , dated as of April 21, 2015 (this Agreement ), is by and among COVIS PHARMA S.À.R.L., Zug Branch, a limited liability company organized under the Laws of Luxembourg ( Covis Pharma ), COVIS INJECTABLES S.À.R.L., Zug Branch, a limited liability company organized under the Laws of Luxembourg ( Covis Injectables , and collectively with Covis Pharma, Sellers ), CONCORDIA PHARMACEUTICALS INC., an international business company organized under the Laws of Barbados ( Purchaser ) and U.S. BANK NATIONAL ASSOCIATION, a national banking association, as escrow agent hereunder ( Escrow Agent ). All terms used but not otherwise defined herein shall have the meanings ascribed to them in the Purchase Agreement (as defined below).
RECITALS
WHEREAS , pursuant to that certain Asset Purchase Agreement, dated as of the 9 th day of March 2015, among Sellers, Purchaser, Concordia Healthcare Corp., a corporation organized under the Laws of the province of Ontario ( Purchaser Parent ) (solely with respect to Section 6.10 , Section 10.18 and the applicable provisions of Article X thereof), and Covis Pharma Holdings S.à.r.l., a limited liability company organized under the Laws of Luxembourg ( Seller Parent ) (solely with respect to Section 10.19 and the applicable provisions of Article X thereof) (as amended, modified or supplemented from time to time in accordance with its terms, the Purchase Agreement ), Sellers have agreed to sell, convey, assign, transfer and deliver to Purchaser, and Purchaser has agreed to purchase, acquire and accept from Sellers, for the consideration and upon the terms and subject to the conditions set forth in the Purchase Agreement, all of Sellers right, title and interest in, to and under the Purchased Assets, and Purchaser has agreed to assume, satisfy and discharge when due the Assumed Liabilities, in each case, subject to and in accordance with the terms of the Purchase Agreement;
WHEREAS , pursuant to Section 2.6 of the Purchase Agreement, Purchaser has agreed to deposit $[REDACTED Commercially Sensitive Information] (the Escrow Amount ) to an account that has been designated in writing by Escrow Agent not less than one (1) Business Day prior to the Closing to satisfy amounts payable by Sellers to Purchaser pursuant to the provisions of Article VIII of the Purchase Agreement and in accordance with the terms of Section 6.21 of the Purchase Agreement;
WHEREAS , Purchaser and Sellers agree that this Agreement is intended to be the Escrow Agreement as defined in the Purchase Agreement and desire to appoint Escrow Agent, acting as provided herein, to serve as Escrow Agent for the purposes of, and as defined in, the Purchase Agreement; and
WHEREAS , Escrow Agent desires to accept such appointment and to hold, invest, administer and distribute the funds and deposits in accordance with the terms of this Agreement.
NOW THEREFORE , for good and valuable consideration, the receipt and sufficiency of which are hereby acknowledged, the parties hereto, hereby agree as follows:
1. Definitions . The following terms shall have the meanings set forth or referenced
below when used in this Agreement:
Act has the meaning set forth in Section 18(a) of this Agreement.
Agreement has the meaning set forth in the preamble to this Agreement.
Claim has the meaning set forth in Section 5 of this Agreement.
Covis Injectables has the meaning set forth in the preamble to this Agreement.
Covis Pharma has the meaning set forth in the preamble to this Agreement.
Deposit Amount has the meaning set forth in Section 3(a)(ii) of this Agreement.
Eligible Investments has the meaning set forth in Section 8(a) of this Agreement.
Eligible Payment has the meaning set forth in Section 4 of this Agreement.
Escrow Account has the meaning set forth in Section 2 of this Agreement.
Escrow Account Balance has the meaning set forth in Section 4 of this Agreement.
Escrow Agent has the meaning set forth in the preamble to this Agreement.
Escrow Agent Losses has the meaning set forth in Section 13(a) of this Agreement.
Escrow Amount has the meaning set forth in the Recitals.
Escrow Confidential Information has the meaning set forth in Section 16 of this Agreement.
Escrow Funds has the meaning set forth in Section 2 of this Agreement.
Estimated Reserve Amount has the meaning set forth in Section 5 of this Agreement.
Excess Reserve Amount has the meaning set forth in Section 6(d) of this Agreement.
Final Determination has the meaning ascribed to such term in the Purchase Agreement.
Indemnified Party has the meaning set forth in Section 13(a) of this Agreement.
Joint Written Direction has the meaning set forth in Section 6(a) of this Agreement.
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Money Market Account has the meaning set forth in Section 8(c) of this Agreement.
Notice of Claim has the meaning set forth in Section 5 of this Agreement.
Payment Amount has the meaning set forth in Section 6(b) of this Agreement.
Purchaser has the meaning set forth in the preamble to this Agreement.
Purchaser Parent has the meaning set forth in the Recitals.
Purchase Agreement has the meaning set forth in the Recitals.
Release Date has the meaning set forth in Section 6(c) of this Agreement.
Seller Parent has the meaning set forth in the Recitals.
Sellers has the meaning set forth in the preamble to this Agreement.
Unresolved Claims has the meaning set forth in Section 6(c) of this Agreement.
Updated Notice of Claim has the meaning set forth in Section 5 of this Agreement.
2. Appointment of and Acceptance by Escrow Agent . Purchaser and Sellers hereby appoint Escrow Agent to act as such in accordance with the terms and conditions set forth in this Agreement. Escrow Agent hereby accepts such appointment and, upon receipt by wire transfer of the Escrow Amount in accordance with Section 3 of this Agreement, agrees to hold the Escrow Amount, together with any interest or other income earned thereon (the Escrow Funds ), in a segregated account established for such purpose (the Escrow Account ) by Escrow Agent for the exclusive benefit of Purchaser and Sellers as set forth in the Purchase Agreement, and no other Person shall have any right, title or interest therein. Escrow Agent shall administer, invest and disburse the Escrow Funds and the Deposit Amount solely in accordance with the terms of this Agreement. Upon receipt by wire transfer of the Deposit Amount in accordance with Section 3 of this Agreement, Escrow Agent agrees to disburse the Deposit Amount in accordance with Section 3 of this Agreement.
3. Deposit of the Escrow Amount and the Deposit Amount .
(a) Purchaser has agreed to deposit by wire transfer of immediately available funds, or to cause to be so deposited, with Escrow Agent at the Closing to the Escrow Account as designated in writing by Escrow Agent not less than one (1) Business Day prior to the Closing:
(i) an amount in cash equal to the Escrow Amount to be held in accordance with the terms of this Agreement; and
(ii) an amount in cash equal to [REDACTED commercially sensitive information], solely on behalf of, and for the sole and exclusive benefit of, Sellers and to which
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no other Person shall have any right, title or interest (the Deposit Amount ).
(b) Upon receipt of the Deposit Amount and the Escrow Amount, Escrow Agent shall promptly acknowledge such receipt in writing to Purchaser and Sellers. Furthermore, and notwithstanding anything to the contrary herein or otherwise, immediately upon receipt of the Deposit Amount, Escrow Agent shall automatically, and without any further action from Sellers, disburse the Deposit Amount in full and without deduction to Sellers by wire transfer of immediately available funds to the accounts designated by Sellers as specifically set forth in the wire transfer instructions included in the memorandum attached hereto as Exhibit A . For all purposes hereunder and otherwise and notwithstanding any provision herein to the contrary, the Deposit Amount shall not be deemed to constitute (i) Escrow Funds, or (ii) any part or portion of either the Escrow Amount or Escrow Account Balance, and Escrow Agent shall disburse the Deposit Amount solely in accordance with the terms of this Section 3 . Notwithstanding anything to the contrary herein or otherwise, Escrow Agent shall not withhold or make any similar deduction on any portion of the Deposit Amount disbursed to Sellers pursuant to this Section 3 .
4. Claims Against Escrow Amount . Purchaser may, from time to time during the term of this Agreement, make claims to the Escrow Funds from the Escrow Account (which, for the avoidance of doubt, shall not include the Deposit Amount) for payment of any amounts due and payable to any Purchaser Indemnified Party pursuant to, and subject to the terms and conditions of, Article VIII of the Purchase Agreement (in each case, an Eligible Payment ). The Escrow Funds may be reduced from time to time by payments made to Purchaser or to Sellers in accordance with the provisions of this Agreement. The balance of Escrow Funds in the Escrow Account from time to time during the term of this Agreement is referred to herein as the Escrow Account Balance .
5. Reserve of Escrow Funds . If any Purchaser Indemnified Party makes a claim for an Eligible Payment pursuant to, and subject to the terms and conditions of, the Purchase Agreement (each, a Claim ), then Purchaser shall promptly provide written notice (a Notice of Claim ) to Escrow Agent and Sellers setting forth (a) a description of such Claim in reasonable detail, (b) the basis for indemnification under the Purchase Agreement and references to the applicable provisions thereof, and (c) such Purchaser Indemnified Partys good faith estimate, and method of computation, of the amount that such Purchaser Indemnified Party is entitled to recover under the Purchase Agreement in respect of such Eligible Payment (each, an Estimated Reserve Amount ). If Purchaser receives additional information regarding the amount of any Claim for which an Estimated Reserve Amount has been established, subject to the immediately succeeding sentence, Purchaser may update such Estimated Reserve Amount by providing an updated Notice of Claim (an Updated Notice of Claim ) to Escrow Agent and Sellers, which notice shall set forth the basis for the update in reasonable detail and shall include an updated good faith estimate, and method of computation, of the aggregate Eligible Payment in respect of such Claim.
6. Escrow Funds .
(a) Escrow Agent shall retain custody of the Escrow Funds and, except in accordance with this Section 6 , shall make no payments or other dispositions of the Escrow Funds from the Escrow Account unless and until it is authorized and directed to do so pursuant to instructions in
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writing duly executed by Purchaser and each Seller, including any necessary wire transfer or other instructions for payment (a Joint Written Direction ).
(b) Following delivery to Escrow Agent at any time and from time to time of a Joint Written Direction setting forth the amount of the payment to be made to Purchaser (the Payment Amount ), Escrow Agent shall disburse to Purchaser from the Escrow Funds an amount in cash equal to the Payment Amount in accordance with the terms of such Joint Written Direction within three (3) calendar days of delivery of such Joint Written Direction.
(c) On the date that is the twelve (12) month anniversary of the Closing Date, or if such date is not a Business Day, the first Business Day after such date (the Release Date ), Escrow Agent shall automatically release from the Escrow Funds in the Escrow Account to Sellers an amount in cash equal to (i) the Escrow Amount minus (ii) the aggregate amount of payments made to Purchaser or any Purchaser Indemnified Party prior to the Release Date, minus (iii) the aggregate Estimated Reserve Amounts of all Claims notified to Sellers and Escrow Agent pursuant to Section 5 that remain unresolved and unpaid prior to the Release Date (each, an Unresolved Claim ); provided , however , that if the foregoing formula produces zero or a negative number then no release from the Escrow Account shall be made pursuant to this Section 6 .
(d) After the Release Date, if an Unresolved Claim reaches a Final Determination, following delivery to Escrow Agent at any time and from time to time of a Joint Written Direction setting forth (i) the Payment Amount required to be paid to Purchaser pursuant to such Final Determination in accordance with Section 6(b) above and (ii) the amount (if any) by which the Estimated Reserve Amount exceeded the Payment Amount with respect to such Claim (the Excess Reserve Amount ), Escrow Agent will disburse to Purchaser an amount equal to the Payment Amount, and shall release to Sellers an amount in cash equal to the Excess Reserve Amount (if any), within three (3) calendar days of delivery.
(e) Promptly after a Final Determination has occurred with respect to all Unresolved Claims and all Payment Amounts in respect of all such Claims shall have been paid in full, Escrow Agent shall automatically release to Sellers the remaining Escrow Account Balance.
7. Termination . This Agreement shall terminate on the first to occur of (i) the date specified for such termination in a Joint Written Direction delivered to Escrow Agent, (ii) the Release Date in the event there remain no Unresolved Claims for which there are Estimated Reserve Amounts at such time, or (iii) upon the automatic release by the Escrow Agent of the Escrow Account Balance in accordance with the provisions of Section 6(e) of this Agreement. Except with respect to the obligations set forth in Section 16 , Escrow Agent shall thereafter have no further obligation or liability whatsoever with respect to this Agreement or the Escrow Funds.
8. Investment of Funds .
(a) Initially, Escrow Agent is directed to invest the Escrow Funds in Eligible Investments (as defined below), and, during the term of the Agreement, in such Eligible Investments as Sellers and Purchaser shall direct Escrow Agent from time to time in a Joint Written Direction. As used in this Agreement, Eligible Investments means: (a) direct
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obligations of the United States of America or obligations the principal of and the interest on which are unconditionally guaranteed by the United State of America, in each case, with a maturity of ninety (90) days or less, (b) interest bearing deposits with maturity dates of ninety (90) days or less of any bank or trust company located within the United States that has capital and surplus of at least [REDACTED commercially sensitive information], including Escrow Agent (c) certificates of deposit with maturity dates of ninety (90) days or less issued by any bank or trust company located in the United States that has capital and surplus of at least [REDACTED commercially sensitive information], including Escrow Agent; and/or (d) any money market fund substantially invested in the categories described above, including the U.S. Bank Money Market Account described in Schedule B attached hereto. Purchaser and Sellers acknowledge that Escrow Agent does not have a duty nor will it undertake any duty to provide investment advice.
(b) All investments shall be made in the name of Escrow Agent. Escrow Agent shall refrain from so investing or reinvesting the Escrow Funds or portion thereof to the extent necessary or advisable to provide the funds necessary to make the required payment under the terms and conditions of this Agreement, however, Escrow Agent may, without notice to Purchaser and Sellers, sell or liquidate any such Eligible Investments at any time for any disbursement of Escrow Funds permitted or required hereunder. All earnings (including income, interest and gains) shall become part of the Escrow Funds and all losses as a result of investment in such Eligible Investments shall be charged against the Escrow Funds. Escrow Agent shall not be liable or responsible for loss in the value of any investment made pursuant to this Agreement, or for any loss, cost or penalty resulting from any sale or liquidation of the Escrow Funds. With respect to any Escrow Funds received by Escrow Agent after twelve oclock, p.m., Central Standard Time, Escrow Agent shall not be required to invest such funds or to effect any investment instruction until the next day upon which banks in Dallas, Texas and the New York Stock Exchange are open for business.
(c) If the Escrow Agent does not receive a Joint Written Direction with respect to the investment of the Escrow Funds, the Escrow Agent is instructed to invest the Funds and any interest thereon in the U.S Bank National Association Money Market Account as provided in Schedule B attached hereto (the Money Market Account ). The Escrow Funds shall remain invested in the Money Market Account until it receives a Joint Written Direction instructing the Escrow Agent to invest the Escrow Funds in another Eligible Investment. The Buyer and the Seller shall be responsible for qualifying an investment as an Eligible Investment.
9. Statements . Delivery of notices of Estimated Reserve Amounts and delivery of Joint Written Direction and the amounts of any Estimated Claim Amount or payment to Purchaser or Sellers in accordance with the terms of this Agreement shall be recorded in the internal account records maintained by Escrow Agent relating to the Escrow Account. Escrow Agent shall provide monthly statements of account with respect to the Escrow Account to Purchaser and the Sellers. Escrow Agent will also furnish Purchaser and Sellers periodic transaction statements that include detail for all investment transactions made by Escrow Agent.
10. Resignation and Removal of Escrow Agent .
(a) Escrow Agent may resign and be discharged from the performance of its duties
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hereunder at any time by giving thirty (30) days prior written notice to each of the Purchaser and Sellers specifying a date when such resignation shall take effect. Upon any such notice of resignation, Purchaser and Sellers will jointly appoint a banking corporation or trust company having capital and surplus in excess of [REDACTED commercially sensitive information], and organized under the laws of the United States or of a state of the United States, to become Escrow Agent under this Agreement. If Purchaser and Sellers fail to appoint a successor Escrow Agent within such thirty (30) day period, Escrow Agent shall have the right to petition a court of competent jurisdiction to appoint a successor Escrow Agent, and all reasonable and documented out-of-pocket costs and expenses (including reasonable attorneys fees) related to such petition shall be paid one half by Purchaser and one half by Sellers upon receipt of an invoice therefor from Escrow Agent. The retiring Escrow Agent shall transmit all records pertaining to the Escrow Funds (after making copies of such records as the retiring Escrow Agent deems necessary or prudent in order to comply with applicable Law and its bona fide internal document retention policies, which shall remain subject to the provisions of Section 16 , notwithstanding any termination hereof) and shall pay all Escrow Funds to the successor Escrow Agent. After any retiring Escrow Agents resignation, the provisions of this Agreement shall inure to its benefit as to any actions taken or omitted to be taken by it while it was Escrow Agent under this Agreement.
(b) Escrow Agent may be removed by Purchaser and Sellers, with or without cause, at any time upon ten (10) days joint written notice of removal from Purchaser and Sellers. Promptly upon the expiration of such ten (10) day period, Escrow Agent shall transfer the Escrow Account Balance in accordance with the instructions provided by Purchaser and Sellers in the joint written notice of removal.
Business Combinations . Any entity into which Escrow Agent consolidates, merges or converts into, or transfers all or substantially all of its corporate trust business (including the escrow contemplated by this Agreement) to, shall be Escrow Agent under this Agreement without any further action by the parties, provided that such entity is a banking corporation or trust company having capital and surplus in excess of [REDACTED commercially sensitive information] and organized under the laws of the United States or of a state of the United States.
11. Liability of Escrow Agent . Escrow Agent undertakes to perform only such duties as are expressly set forth herein and no duties shall be implied. Escrow Agent has no fiduciary or discretionary duties of any kind. Escrow Agent shall have no liability under and no duty to inquire as to the provisions of any agreement other than this Agreement, including without limitation any other agreement between any or all of the parties hereto or any other persons even though reference thereto may be made herein. Escrow Agent shall not be liable for any action taken or omitted by it in good faith in accordance with the terms of this Agreement except to the extent that a court of competent jurisdiction determines that Escrow Agents fraud, bad faith, gross negligence or willful misconduct was the cause of any loss to Purchaser or Sellers. Escrow Agents sole responsibility shall be for the safekeeping and disbursement of the Escrow Funds and the Deposit Amount in accordance with the terms of this Agreement. Escrow Agent shall not be charged with knowledge or notice of any fact or circumstance not specifically set forth herein. Escrow Agent may rely upon any notice, instruction, request or other instrument, not only as to its due execution, validity and effectiveness, but also as to the truth and accuracy of
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any information contained therein, which Escrow Agent shall believe to be genuine and to have been signed or presented by the Person or parties purporting to sign the same. In no event shall Escrow Agent be liable for incidental, indirect, special, consequential or punitive damages or penalties (including, but not limited to lost profits), even if Escrow Agent has been advised of the likelihood of such damages or penalty and regardless of the form of action. Escrow Agent shall not be responsible for delays or failures in performance of its obligations under this Agreement resulting from acts beyond its control, including without limitation acts of God, strikes, lockouts, riots, acts of war or terror, epidemics, governmental regulations, fire, communication line failures, computer viruses, power failures, earthquakes or other disasters; it being understood that Escrow Agent shall use commercially reasonable efforts that are consistent with accepted practices in the banking industry to resume performances as soon as reasonably practicable under the circumstances. Escrow Agent shall not be obligated to take any legal action or commence any proceeding in connection with the Escrow Funds, any account in which Escrow Funds are deposited, this Agreement or the Purchase Agreement, or to appear in, prosecute or defend any such legal action or proceeding. Escrow Agent may consult legal counsel selected by it in the event of any dispute or question as to the construction of any of the provisions of this Agreement or of any other agreement or of its duties hereunder, or relating to any dispute involving any party hereto.
12. Indemnification of Escrow Agent .
(a) Purchaser, on the one hand, and Sellers, on the other hand, each on its own behalf, will indemnify and hold harmless Escrow Agent and each director, officer, employee, attorney, agent and affiliate of Escrow Agent (each, in its capacity as such, an Indemnified Party ), to the extent that Purchaser, on the one hand, and any Seller, on the other hand, is adjudicated liable for any losses, damages, liabilities, expense and penalties of any nature incurred by the Escrow Agent, including reasonable and documented attorneys fees and out-of-pocket expenses arising out of or in connection with this Agreement or with Escrow Agents exercise or performance of its duties pursuant to the terms of this Agreement (collectively Escrow Agent Losses ), except to the extent that such Escrow Agent Losses are adjudicated to have been the result of the fraud, bad faith, willful misconduct or gross negligence or material breach of this Agreement by any Indemnified Party. The cost of any indemnification under this Section 13(a) will be paid by the party at fault in proportion to such partys fault. Notwithstanding anything in this Agreement to the contrary, in no event shall Purchaser or Sellers be liable for special, incidental, punitive, indirect or consequential loss or damage of any kind whatsoever. The obligations of Purchaser and Sellers under this Section 13 shall survive any termination of this Agreement and the resignation or removal of Escrow Agent.
(b) The parties agree that neither the payment by Purchaser or Sellers of any claim by Escrow Agent for indemnification hereunder nor the disbursement of any amounts to Escrow Agent from the Escrow Funds in respect of a claim by Escrow Agent for indemnification shall impair, limit, modify, or affect, as between Purchaser and Sellers, the respective rights and obligations of Purchaser and Sellers under the Purchase Agreement.
13. Disagreements . If any dispute arises between, among, or involving any of the Parties concerning the meaning or validity of any provision hereunder or concerning any other matter relating to this Agreement, the Escrow Agent may, at its option following receipt of
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notice of such dispute, retain the Escrow Funds until the dispute is resolved and the Escrow Agent receives a Final Determination or a written agreement executed by each of the parties involved in such disagreement or dispute directing delivery of the Escrow Funds, in which event the Escrow Agent shall be authorized to disburse the Escrow Funds in accordance with such Final Determination or agreement. The Escrow Agent shall be entitled to act on any such Final Determination without further question, inquiry, or consent.
14. Attachment of Escrow Funds . In the event that any Escrow Funds shall be attached, garnished or levied upon by any court order or the delivery thereof shall be stayed or enjoined by a court order, the Escrow Agent is hereby expressly authorized, in its reasonable discretion, to respond as it deems appropriate or to comply with all court orders so entered or issued, or which it is advised by legal counsel of its own choosing is binding upon it, whether with or without jurisdiction. In the event that the Escrow Agent obeys or complies with any such court order it shall not be liable to any of the Parties or to any other Person, firm or corporation, should, by reason of such compliance notwithstanding, such court order be subsequently reversed, modified, annulled, set aside or vacated.
15. Confidential Information . Escrow Agent shall not disclose, transfer, share or make available any information provided or made available to Escrow Agent by or on behalf of Purchaser or Sellers or any related documents (the Escrow Confidential Information ) to any third party, without the prior written consent of Purchaser and Sellers, except that Escrow Agent may disclose Escrow Confidential Information without Purchasers and Sellers prior written consent (a) to its directors, officers, employees, attorneys and accountants as may be required in connection with the performance and administration of Escrow Agents services hereunder and (b) as required (i) to comply with the request of a regulatory agency or any authorized government agency or in connection with an examination of such Escrow Agent or its directors, officers, employees, attorneys and accountants by bank examiners or other regulatory authorities; (ii) to comply with a subpoena, summons, order or other judicial or governmental process; or (iii) to comply with other applicable law; provided that Escrow Agent will provide prompt prior written notice to Purchaser and Sellers of such requirement for disclosure pursuant to the foregoing clause (ii) and shall provide Purchaser and Sellers with a reasonable opportunity to obtain a protective order or seek other preventive remedies.
16. Compensation of Escrow Agent . Purchaser and Seller agree to compensate Escrow Agent on demand for its services hereunder in accordance with Schedule A attached hereto and the provisions hereof. Purchaser, on the one hand, and Seller, on the other hand, will each pay one-half of Escrow Agents fees and reasonable and documented out-of-pocket expenses as set forth on Schedule A attached hereto, payable in accordance with the terms of an invoice sent by Escrow Agent to Purchaser and Sellers, respectively. In the event that the Escrow Agent is authorized to make distributions of Escrow Funds to any party to this Agreement pursuant to and in accordance with the terms of this Agreement, and expenses and disbursements are due and payable to the Escrow Agent pursuant to the terms of this Agreement by the party receiving such distribution, the Escrow Agent is authorized to offset such amounts due and payable to it against such disbursement to that party. Escrow Agent hereby waives any other right of set-off against the Escrow Account. The fee agreed upon for the services rendered hereunder is intended as full compensation for the Escrow Agents services as contemplated by this Escrow Agreement; provided, however, that in the event that the conditions for the
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disbursement of funds under this Escrow Agreement are not fulfilled, or the Escrow Agent renders any service not contemplated in this Escrow Agreement, or there is any assignment of interest in the subject matter of this Escrow Agreement, or any material modification hereof, or if any material controversy arises hereunder, or the Escrow Agent is made a party to any litigation pertaining to this Escrow Agreement or the subject matter hereof, then the Escrow Agent shall be compensated for such extraordinary services and reimbursed for all reasonable and documented out-of-pocket costs and expenses incurred by it, including reasonable attorneys fees and expenses, occasioned by any such delay, controversy, litigation or event. If any amount due to the Escrow Agent hereunder is not paid within thirty (30) days of the date due, the Escrow Agent in its sole discretion may charge interest on such amount up to the highest rate permitted by applicable law. The obligations of Purchaser and Seller under this Section 17 shall survive any termination of this Agreement and the resignation of Escrow Agent.
17. Miscellaneous .
(a) USA Patriot Act Compliance . To help the government fight the funding of terrorism and money laundering activities, federal law requires all financial institutions to obtain, verify, and record information that identifies each person who opens an account. For a non-individual person such as a business entity, a charity, a trust, or other legal entity, Escrow Agent requires documentation to verify its formation and existence as a legal entity. Escrow Agent may also ask to see financial statements, licenses, identification and authorization documents from individuals claiming authority to represent the entity or other relevant documentation. The parties acknowledge that a portion of the identifying information set forth herein is being requested by Escrow Agent in connection with the USA Patriot Act, Pub.L.107-56 (the Act ), and each agrees to provide all such information and documentation as to themselves as reasonably requested by Escrow Agent to ensure compliance with federal law.
(b) Notices . All notices or other communications hereunder shall be deemed to have been duly given and made if in writing and if served by personal delivery upon the party for whom it is intended, if delivered by registered or certified mail, return receipt requested, or by a national courier service, or if sent by facsimile, provided that the facsimile is promptly confirmed by telephone confirmation thereof, or via email by way of a PDF attachment thereto of a manually executed document, provided that the email is promptly confirmed by telephone confirmation thereof to the Person at the address set forth below, or such other address as may be designated in writing hereafter, in the same manner, by such Person:
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If to Purchaser, to:
[REDACTED personal information] | ||
with a copy (which shall not constitute notice) to: | ||
[REDACTED personal information] | ||
If to Sellers, to: | ||
[REDACTED personal information] | ||
with a copy (which shall not constitute notice) to: | ||
[REDACTED personal information] | ||
and a copy (which shall not constitute notice) to: | ||
[REDACTED personal information] | ||
If to Escrow Agent, to: | ||
[REDACTED personal information] | ||
with a copy to Purchaser and to Sellers, respectively. |
(c) Amendment and Waiver . Any provision of this Agreement may be amended or waived if, and only if, such amendment or waiver is in writing and signed, in the case of an amendment, by each party to this Agreement, or in the case of a waiver, by the party against whom the waiver is to be effective. No failure or delay by any Party in exercising any right, power or privilege hereunder shall operate as a waiver thereof nor shall any single or partial exercise thereof preclude any other or further exercise thereof or the exercise of any other right, power or privilege.
(d) Successors and Assigns . No party to this Agreement may assign any of its rights or obligations under this Agreement without the prior written consent of the other parties; provided , that nothing in the foregoing shall prohibit Purchaser or Sellers from making any assignment (i) to any of such assigning partys creditworthy Affiliates so long as such creditworthy Affiliate agrees in writing to be bound by all of the terms, conditions and provisions contained in this Agreement; provided , further , no such assignment shall release the assigning party from its obligations under this Agreement; and (ii) to any successors to all or substantially all of the business and assets of such assigning party, whether in a merger, consolidation, sale of substantially all assets or other similar transaction so long as such successor agrees in writing to be bound by all of the terms, conditions and provisions contained in this Agreement. Any purported assignment, hypothecation or transfer in breach of this Section 18(d) shall be null and void. This Agreement shall be binding upon, and shall inure to the benefit of, and be enforceable by the parties hereto and their successors and permitted assigns.
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(e) Nothing in this Agreement, express or implied, is intended to confer upon any Person other than Escrow Agent, Purchaser, Sellers, or their successors or permitted assigns, any rights or remedies under or by reason of this Agreement.
(f) Severability . The provisions of this Agreement shall be deemed severable and the invalidity or unenforceability of any provision shall not affect the validity or enforceability of the other provisions of this Agreement. If any term or other provision of this Agreement, or the application thereof to any Person or any circumstance, is invalid, illegal or unenforceable, (i) a suitable and equitable provision shall be substituted therefor in order to carry out, so far as may be valid and enforceable, the intent and purpose of such invalid or unenforceable provision and (ii) the remainder of this Agreement and the application of such provision to other Persons, entities or circumstances shall not be affected by such invalidity, illegality or unenforceability, nor shall such invalidity, illegality or unenforceability affect the validity or enforceability of such provision, or the application thereof, in any other jurisdiction.
(g) Governing Law; Jurisdiction; Waiver of Jury Trial . This Agreement and its negotiation, execution, performance or non-performance, interpretation, termination, construction and all claims or causes of action (whether in contract, in tort, at law or otherwise) that may be based upon, arise out of, or relate to this Agreement, or the transactions contemplated hereby (including any claim or cause of action based upon, arising out of or related to any representation or warranty made in connection with this Agreement or as an inducement to enter this Agreement), shall be exclusively governed by, and construed in accordance with, the Laws of the State of Delaware regardless of Laws that might otherwise govern under any applicable conflict of Laws principles. Any Proceeding based upon, arising out of, or related to this Agreement and its negotiation, execution, performance, non-performance, interpretation, termination, construction or the transactions contemplated hereby shall be heard and determined in the Court of Chancery in the City of Wilmington, New Castle County, Delaware or, in the event such court lacks subject matter jurisdiction, the United States District Court sitting in Wilmington, Delaware or, in the event such federal district court lacks subject matter jurisdiction, then in the Superior Court in the City of Wilmington, New Castle County, Delaware. The parties hereby irrevocably submit to the exclusive jurisdiction and venue of such courts in any such Proceeding and irrevocably and unconditionally waive the defense of an inconvenient forum, or lack of jurisdiction to the maintenance of any such Proceeding. The consents to jurisdiction and venue set forth herein shall not constitute general consents to service of process in the State of Delaware and shall have no effect for any purpose except as provided in this Section 18 and shall not be deemed to confer rights on any Person other than the parties. Each party agrees that the service of process upon such party in any Proceeding arising out of or relating to this Agreement shall be effective if notice is given by overnight courier at the address set forth in Section 18(b) . Each of the parties also agrees that any final, non-appealable judgment against a party in connection with any Proceeding arising out of or relating to this Agreement shall be conclusive and binding on such party and that such award or judgment may be enforced in any court of competent jurisdiction, either within or outside of the United States. A certified or exemplified copy of such award or judgment shall be conclusive evidence of the fact and amount of such award or judgment. TO THE FULLEST EXTENT PERMITTED BY LAW, THE PARTIES HEREBY WAIVE THEIR RESPECTIVE RIGHTS TO A JURY TRIAL OF ANY PROCEEDING (WHETHER IN CONTRACT, IN TORT, AT LAW OR OTHERWISE) BASED UPON, ARISING OUT OF, OR RELATED TO THIS AGREEMENT
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OR ANY OF THE TRANSACTIONS CONTEMPLATED BY THIS AGREEMENT. THE SCOPE OF THIS WAIVER IS INTENDED TO BE ALL-ENCOMPASSING OF ANY AND ALL DISPUTES THAT MAY BE FILED IN ANY COURT AND THAT RELATE TO THE SUBJECT MATTER OF THIS AGREEMENT, INCLUDING WITHOUT LIMITATION, CONTRACT CLAIMS, TORT CLAIMS, BREACH OF DUTY CLAIMS AND ALL OTHER COMMON LAW AND STATUTORY CLAIMS. THE PARTIES ACKNOWLEDGE THAT THIS WAIVER IS A MATERIAL INDUCEMENT TO ENTER INTO A BUSINESS RELATIONSHIP, THAT EACH HAS ALREADY RELIED ON THE WAIVER IN ENTERING INTO THIS AGREEMENT AND THAT EACH WILL CONTINUE TO RELY ON THE WAIVER IN THEIR RELATED FUTURE DEALINGS. THE PARTIES FURTHER WARRANT AND REPRESENT THAT EACH HAS REVIEWED THIS WAIVER WITH ITS LEGAL COUNSEL, AND THAT EACH KNOWINGLY AND VOLUNTARILY WAIVES ITS JURY TRIAL RIGHTS FOLLOWING CONSULTATION WITH LEGAL COUNSEL. THIS WAIVER IS IRREVOCABLE, MEANING THAT IT MAY NOT BE MODIFIED EITHER ORALLY OR IN WRITING, AND THIS WAIVER SHALL APPLY TO ANY SUBSEQUENT AMENDMENTS, RENEWALS, SUPPLEMENTS OR MODIFICATIONS TO THIS AGREEMENT OR TO ANY OTHER DOCUMENTS OR AGREEMENTS RELATING TO THE TRANSACTIONS CONTEMPLATED HEREBY. IN THE EVENT OF LITIGATION, THIS AGREEMENT MAY BE FILED AS A WRITTEN CONSENT TO A TRIAL BY THE COURT.
(h) Entire Agreement . This Agreement and the Purchase Agreement (in each case, including all Schedules and Exhibits hereto and thereto) contain the entire agreement among the parties with respect to the subject matter hereof and supersede all prior agreements and understandings, oral or written, with respect to such matters.
(i) Execution in Counterparts, Facsimiles . This Agreement and any Joint Written Direction may be executed in one or more counterparts (including by facsimile or electronic .pdf submission), each of which shall be deemed an original, and all of which shall constitute one and the same agreement and shall become effective when one or more counterparts have been signed by each of the parties and delivered (by telecopy or otherwise) to the other parties, it being understood that the parties need not sign the same counterpart.
(j) Dealings . Nothing herein shall preclude Escrow Agent from acting in any other capacity for Purchaser or for Sellers or for any other entity.
(k) Tax Reporting . Escrow Agent shall have no responsibility for the tax consequences of this Agreement and Purchaser and Seller shall consult with independent counsel concerning any and all tax matters. Purchaser and Sellers shall provide Escrow Agent with a Form W-9 or an original Form W-8, as applicable, for each payee, together with any other documentation and information reasonably requested by Escrow Agent in connection with Escrow Agents reporting obligations under applicable IRS regulations. If such tax documentation is not so provided, Escrow Agent shall withhold taxes as required by the IRS. Purchaser and Sellers have determined that any interest or income on Escrow Funds shall be reported on an accrual basis and deemed to be for the account of Purchaser. Purchaser shall be entitled to a disbursement from the Escrow Funds in the amount of 30% of interest or income earned on the Escrow Funds during any year in which interest or income is reported and
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Purchaser is subject to U.S. tax on such amounts during the term of this Agreement, such amount to be disbursed by the Escrow Agent to Purchaser automatically (i) on December 31, 2015 and each anniversary of such date thereafter during the term of this Agreement in accordance with payment instructions delivered three (3) Business Days prior to such anniversary date or (ii) prior to the Final Release or the termination of this Agreement in accordance with its terms if such Final Release or termination of this Agreement occurs prior to the annual payment referred to in the foregoing clause (i), with a copy to Sellers in accordance with the notice provisions hereof. In addition, Purchaser and Sellers further agree that:
(i) Escrow Agent IRS Reporting . Purchaser and Sellers shall accurately provide the Escrow Agent with all information reasonably requested by the Escrow Agent in connection with the preparation of all applicable Form 1099 and Form 1042-S documents with respect to all distributions as well as in the performance of Escrow Agents reporting obligations under the Foreign Account Tax Compliance Act and Foreign Investment in Real Property Tax Act or other applicable Law.
(l) Publicity . No party will (a) use any other partys proprietary indicia, trademarks, service marks, trade names, logos, symbols, or brand names, or (b) otherwise refer to or identify any other party in advertising, publicity releases, or promotional or marketing publications, or correspondence to third parties without, in each case, securing the prior written consent of such other party.
(m) Further Assurances . Each of the parties will execute and deliver such additional instruments and other documents and will take such further actions as may be necessary or appropriate to effectuate, carry out and comply with all of the terms of this Agreement.
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IN WITNESS WHEREOF , the parties hereto have caused this Agreement to be executed under seal as of the date first above written.
CONCORDIA PHARMACEUTICALS INC. | ||||
By: |
[REDACTED personal information] |
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Name: | [REDACTED personal information] | |||
Title: | [REDACTED personal information] | |||
COVIS PHARMA S.À.R.L., Acting through its Zug Branch |
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By: |
[REDACTED personal information] |
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Name: | [REDACTED personal information] | |||
Title: | [REDACTED personal information] | |||
COVIS INJECTABLES S.À.R.L., Acting through its Zug Branch |
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By: |
[REDACTED personal information] |
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Name: | [REDACTED personal information] | |||
Title: | [REDACTED personal information] | |||
U.S. BANK NATIONAL ASSOCIATION | ||||
By: |
[REDACTED personal information] |
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Name: | [REDACTED personal information] | |||
Title: | [REDACTED personal information] |
[ Signature Page to Escrow Agreement ]
EXHIBIT A
FUNDS FLOW MEMORANDUM
Funds Flow Memorandum
This memorandum sets forth the flow of funds to occur on April 21, 2015 (the Closing Date ), in connection with the purchase of certain assets and the assumption of certain liabilities of Covis Pharma S.à.r.l., Zug Branch ( Covis Pharma ) and Covis Injectables S.à.r.l., Zug Branch ( Covis Injectables , and together with Covis Pharma, the Sellers ) pursuant to the Asset Purchase Agreement, dated as of March 9, 2015 (the APA ), among the Sellers, Concordia Pharmaceuticals Inc., Concordia Healthcare Corp. (the Company ) and Covis Pharma Holdings S.à.r.l. Capitalized terms used but not otherwise defined herein shall have the meanings ascribed to such terms in the Purchase Agreement.
Unless otherwise indicated, all dollar amounts and references to $ are to U.S. dollars and any references to CDN $ are to Canadian dollars.
[REDACTED commercially sensitive information]
SCHEDULE A
Schedule of Fees for Services as Escrow Agent
01010 | Acceptance Fee | [REDACTED commercially sensitive information] | ||||
The acceptance fee includes the administrative review of documents, initial set-up of the account, and other reasonably required services up to and including the closing. This is a one-time fee, payable at closing. | ||||||
U.S. Bank Corporate Trust Services reserves the right to refer any or all escrow documents for legal review before execution. Legal fees (billed on an hourly basis) and expenses for this service will be billed to, and paid by, the customer. If appropriate and upon request by the customer, U.S. Bank Corporate Trust Services will provide advance estimates of these legal fees. | ||||||
04460 | Escrow Agent | [REDACTED commercially sensitive information] | ||||
Annual administration fee for performance of the routine duties of Escrow Agent associated with the management of the account. Administration fees are payable in advance. (includes up to 12 wire transfers per year at no additional cost). $25 per wire transfer after the first 12. | ||||||
U.S. Bank Corporate Trust Services reserves the right to refer any or all escrow documents for legal review before execution. With advance notice (including a reasonable advance estimate of fees) to Purchase and Sellers, respectively, the reasonable and documented out-of-pocket legal fees (billed on an hourly basis) and expenses for this service will be billed to, and such bill shall be paid one-half of by Purchaser and one half by Sellers, in accordance with an invoice submitted by U.S. Bank Corporate Trust Services to Purchaser and Sellers, respectively. | ||||||
Direct Out of Pocket Expenses | ||||||
Reimbursement of reasonable and documented out-of-pocket expenses associated with the performance of our duties, including but not limited to publications, legal counsel after the initial close, travel expenses and filing fees, up to $[●], reasonable and documented out-of-pocket expenses in excess of which shall require express prior authorization by Purchaser and by Sellers. | [REDACTED commercially sensitive information] | |||||
Extraordinary Services | ||||||
Extraordinary services are duties or responsibilities of an unusual nature, including termination, but not provided for in the governing documents or otherwise set forth in this Schedule A . With express prior approval including an estimate of fees therefor, a reasonable charge may be assessed based on the nature of the service and the responsibility involved in an invoice with reasonable supporting documentation. At our option, these charges will be billed at a flat fee or at our hourly rate then in effect. |
Account approval is subject to review and qualification. Fees paid in advance will not be prorated. The fees set forth above and any subsequent modifications thereof are part of your agreement. Finalization of the transaction constitutes agreement to the above fee schedule, including agreement to any reasonable subsequent changes upon proper prior written notice. In the event your transaction is not finalized, any related actual out-of-pocket expenses will be billed to Purchaser and to Seller directly as provided above. Payment of fees constitutes acceptance of the terms and conditions set forth.
IMPORTANT INFORMATION ABOUT PROCEDURES FOR OPENING A NEW ACCOUNT:
To help the government fight the funding of terrorism and money laundering activities, Federal law requires all financial institutions to obtain, verify and record information that identifies each person who opens an account. For a non-individual person such as a business entity, a charity, a Trust or other legal entity we will ask for documentation to verify its formation and existence as a legal entity. We
may also ask to see financial statements, licenses, identification and authorization documents from individuals claiming authority to represent the entity or other relevant documentation.
SCHEDULE B
U.S. BANK NATIONAL ASSOCIATION
MONEY MARKET ACCOUNT AUTHORIZATION FORM
DESCRIPTION AND TERMS
The U.S. Bank Money Market is a U.S. Bank National Association ( U.S. Bank ) interest-bearing money market deposit account designed to meet the needs of U.S. Banks Corporate Trust Services Escrow Group and other Corporate Trust customers of U.S. Bank. Selection of this investment includes authorization to place the funds on deposit and invest with U.S. Bank.
U.S. Bank uses the daily balance method to calculate interest on this account (actual/365 or 366). This method applies a daily periodic rate to the principal balance in the account each day. Interest is accrued daily and credited monthly to the account. Interest rates are determined at U.S. Banks discretion, and may be tiered by customer deposit amount.
The owner of the account is U.S. Bank as Agent for its trust customers. U.S. Banks trust department performs all account deposits and withdrawals. Deposit accounts are FDIC insured per depositor, as determined under FDIC Regulations, up to applicable FDIC limits.
AUTOMATIC AUTHORIZATION
In the absence of specific Joint Written Direction to the contrary, U.S. Bank is hereby directed to invest and reinvest proceeds and other available moneys in the U.S. Bank Money Market Account. The U.S. Bank Money Market Account is a permitted investment under the operative documents and this authorization is the permanent direction for investment of the moneys until notified in writing of alternate instructions.
SCHEDULE C
Each of the following person(s) is authorized to execute documents and direct Escrow Agent as to all matters, including fund transfers, address changes and contact information changes, on Purchasers behalf (only one signature required):
[REDACTED personal information] | [REDACTED personal information] |
Name | Specimen signature | Telephone No. | ||||||
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Name | Specimen signature | Telephone No | ||||||
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Name | Specimen signature | Telephone No |
(Note: if only one person is identified above, please add the following language:)
The following person not listed above is authorized for call-back confirmations:
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Name | Telephone Number |
Each of the following person(s) is authorized to execute documents and direct Escrow Agent as to all matters, including fund transfers, address changes and contact information changes, on Sellers behalf (only one signature required):
[REDACTED personal information] | [REDACTED personal information] |
Name | Specimen signature | Telephone No | ||||||
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Name | Specimen signature | Telephone No | ||||||
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Name | Specimen signature | Telephone No |
(Note: if only one person is identified above, please add the following language:)
The following person not listed above is authorized for call-back confirmations:
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Name | Telephone Number |
Exhibit 99.23
EXECUTION VERSION
INTELLECTUAL PROPERTY ASSIGNMENT AGREEMENT
This Intellectual Property Assignment Agreement (this IP Assignment Agreement ) is made and entered into as of the 21 st day of April 2015 (the Effective Date ), by and among Covis Pharma S.à.r.l., Zug Branch, a limited liability company organized under the laws of Luxembourg ( Covis Pharma ), Covis Pharma Holdings S.à.r.l., Zug Branch, a limited liability company organized under the laws of Luxembourg ( Covis Holdings ), Covis Injectables S.à.r.l., Zug Branch, a limited liability company organized under the laws of Luxembourg ( Covis Injectables , and collectively with Covis Pharma and Covis Holdings, Sellers ) and Concordia Pharmaceuticals Inc., an international business company organized under the laws of Barbados ( Purchaser ) (Sellers and Purchaser each a Party or together Parties ).
W I T N E S S E T H :
WHEREAS , Sellers own the trademarks registered in the United States of America as set forth in Schedule A attached hereto (hereinafter, the Trademarks );
WHEREAS , Sellers own the patent registered in the United States of America as set forth in Schedule B attached hereto (hereinafter, the Patent );
WHEREAS , pursuant to that certain Asset Purchase Agreement among Sellers, Purchaser and other parties thereto, dated as of the 9 th day of March 2015 (the Purchase Agreement ), Sellers have agreed to sell, convey, assign, transfer and deliver to Purchaser, and Purchaser has agreed to purchase, acquire and accept from Sellers, for the consideration and upon the terms and subject to the conditions set forth in the Purchase Agreement, all of Sellers right, title and interest in, to and under certain assets, including the Trademarks and the Patent.
NOW, THEREFORE , in consideration of the foregoing and the representations, warranties, covenants and agreements contained in the Purchase Agreement, and for other good and valuable consideration, the receipt and sufficiency of which are hereby acknowledged, the Parties, intending to be legally bound hereby, agree as follows:
1. Assignment of IP . Sellers hereby sell, convey, assign, transfer and deliver to Purchaser, and Purchaser hereby purchases, acquires and accepts from Sellers (A) all of Sellers right, title and interest, as of the Effective Date, in and to the Trademarks, including renewals of registration and the goodwill associated with or symbolized by the Trademarks, and all claims, causes of action and enforcement rights of any kind, and all rights to sue or otherwise bring actions for past, present or future infringement or other misappropriation or violation of any of the Trademarks; and (B) all of Sellers right, title and interest, as of the Effective Date, in and to the Patent, any extensions, supplemental protection certificates, reexaminations, reissues, divisions and continuations, with all claims, causes of action and enforcement rights of any kind, and all rights to sue or otherwise bring actions for past, present or future infringement of the Patent. The foregoing assignment in this Section 1 includes all rights to (i) apply for, file, register, maintain, extend, or renew the Trademarks or the Patent, and to transfer same and grant licenses and other rights with respect thereto, and (ii) collect royalties and other payments under or on account of any of the Trademarks or the Patent.
2. Recording . The Parties hereby authorize the relevant authority at the United States Patent and Trademark Office or any foreign equivalent thereto to record this assignment.
3. Entire Agreement; Conflicting Terms . This IP Assignment Agreement and the Purchase Agreement (in each case, including all Schedules and Exhibits hereto and thereto) contain the entire agreement between the Parties with respect to the subject matter hereof and supersede all prior agreements and understandings, oral or written, with respect to such matters, except for (i) subject to Section 6.15(a) of the Purchase Agreement, the Confidentiality Agreement which will remain in full force and effect for the term provided for therein and (ii) any written agreement of the Parties that expressly provides that it is not superseded by this IP Assignment Agreement or the Purchase Agreement. Nothing herein shall be deemed to limit the rights, duties and obligations of the Parties under the Purchase Agreement and, to the extent of any conflict between the terms and conditions of this IP Assignment Agreement and the terms and conditions of the Purchase Agreement, the terms and conditions of the Purchase Agreement shall govern, supersede and prevail.
4. Notices . All notices or other communications hereunder shall be deemed to have been duly given and made if in writing and if served by personal delivery upon the Party for whom it is intended, if delivered by registered or certified mail, return receipt requested, or by a national courier service, or if sent by facsimile, provided that the facsimile is promptly confirmed by telephone confirmation thereof, to the person at the address set forth below, or such other address as may be designated in writing hereafter, in the same manner, by such person:
To either Seller: | ||
Covis Pharma S.à.r.l. and Covis Injectables S.à.r.l [REDACTED personal information] Telephone: [REDACTED personal information] Attn: [REDACTED personal information] |
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with a copy (which shall not constitute notice) to: | ||
Lowenstein Sandler LLP [REDACTED personal information] Telephone: [REDACTED personal information] Facsimile: [REDACTED personal information] Attn: [REDACTED personal information] |
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and a copy (which shall not constitute notice) to: | ||
Cerberus Capital Management, L.P. [REDACTED personal information] Facsimile: [REDACTED personal information] Attn: [REDACTED personal information] |
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to Purchaser: | ||
Concordia Pharmaceuticals Inc. [REDACTED personal information] Telephone: [REDACTED personal information] Facsimile: [REDACTED personal information] Attn: [REDACTED personal information] |
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with a copy (which shall not constitute notice) to: | ||
Sullivan & Cromwell LLP [REDACTED personal information] Telephone: [REDACTED personal information] Facsimile: [REDACTED personal information] Attn: [REDACTED personal information] |
5. Amendment; Waiver . Any provision of this IP Assignment Agreement may be amended or waived if, and only if, such amendment or waiver is in writing and signed, in the case of an amendment, by Purchaser and Sellers, or in the case of a waiver, by the Party against whom the waiver is to be effective. No failure or delay by any Party in exercising any right, power or privilege hereunder shall operate as a waiver thereof nor shall any single or partial exercise thereof preclude any other or further exercise thereof or the exercise of any other right, power or privilege.
6. Assignment . No Party to this IP Assignment Agreement may assign any of its rights or obligations under this IP Assignment Agreement without the prior written consent of the other Parties; provided, that nothing in the foregoing shall prohibit Purchaser from making any assignment (i) to any other person directly or indirectly controlling, controlled by, or under common control with, Purchaser at any time during the period for which the determination of affiliation is being made ( Affiliates ) so long as such Affiliate agrees in writing to be bound by all of the terms, conditions and provisions contained in this IP Assignment Agreement provided, further, no such assignment shall release Purchaser from its obligations under this IP Assignment Agreement; and (ii) to any successors to all or substantially all of the business and assets of Purchaser, whether in a merger, consolidation, sale of substantially all assets or other similar transaction. Any purported assignment, hypothecation or transfer in breach of this Section 6 shall be null and void. This IP Assignment Agreement shall be binding upon, and shall inure to the benefit of, and be enforceable by the Parties hereto and their successors and permitted assigns.
7. Parties in Interest . This IP Assignment Agreement shall inure to the benefit of and be binding upon the Parties and their respective successors and permitted assigns. Nothing in this IP Assignment Agreement, express or implied, is intended to confer upon any person other than Purchaser, Sellers, or their successors or permitted assigns, any rights or remedies under or by reason of this IP Assignment Agreement.
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8. Governing Law; Jurisdiction .
(a) | This IP Assignment Agreement and its negotiation, execution, performance or non-performance, interpretation, termination, construction and all claims or causes of action (whether in contract, in tort, at law or otherwise) that may be based upon, arise out of, or relate to this IP Assignment Agreement, or the transactions contemplated hereby (including any claim or cause of action based upon, arising out of or related to any representation or warranty made in connection with this IP Assignment Agreement or as an inducement to enter this IP Assignment Agreement), shall be exclusively governed by, and construed in accordance with, the laws of the State of Delaware regardless of any laws that might otherwise govern under any applicable conflict of laws principles. |
(b) | Any claim, demand, suit, action, cause of action, or proceeding (whether in contract, in tort, at law, or otherwise) (each, a Proceeding ) based upon, arising out of, or related to this IP Assignment Agreement and its negotiation, execution, performance, non-performance, interpretation, termination, construction or the transactions contemplated hereby shall be heard and determined in the Court of Chancery in the City of Wilmington, New Castle County, Delaware or, in the event such court lacks subject matter jurisdiction, the United States District Court sitting in Wilmington, Delaware or, in the event such federal district court lacks subject matter jurisdiction, then in the Superior Court in the City of Wilmington, New Castle County, Delaware. The Parties hereby irrevocably submit to the exclusive jurisdiction and venue of such courts in any such Proceeding and irrevocably and unconditionally waive the defense of an inconvenient forum, or lack of jurisdiction to the maintenance of any such Proceeding. The consents to jurisdiction and venue set forth herein shall not constitute general consents to service of process in the State of Delaware and shall have no effect for any purpose except as provided in this Section 8 and shall not be deemed to confer rights on any person other than the Parties. Each Party agrees that the service of process upon such Party in any Proceeding arising out of or relating to this IP Assignment Agreement shall be effective if notice is given by overnight courier at the address set forth in Section 4 . Each of the Parties also agrees that any final, non-appealable judgment against a Party in connection with any Proceeding arising out of or relating to this IP Assignment Agreement shall be conclusive and binding on such Party and that such award or judgment may be enforced in any court of competent jurisdiction, either within or outside of the United States. A certified or exemplified copy of such award or judgment shall be conclusive evidence of the fact and amount of such award or judgment. |
9. WAIVER OF JURY TRIAL . TO THE FULLEST EXTENT PERMITTED BY LAW, THE PARTIES HEREBY WAIVE THEIR RESPECTIVE RIGHTS TO A JURY TRIAL OF ANY PROCEEDING (WHETHER IN CONTRACT, IN TORT, AT LAW OR
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OTHERWISE) BASED UPON, ARISING OUT OF, OR RELATED TO THIS IP ASSIGNMENT AGREEMENT, ANY OF THE TRANSACTIONS CONTEMPLATED BY THIS IP ASSIGNMENT AGREEMENT. THE SCOPE OF THIS WAIVER IS INTENDED TO BE ALL-ENCOMPASSING OF ANY AND ALL DISPUTES THAT MAY BE FILED IN ANY COURT AND THAT RELATE TO THE SUBJECT MATTER OF THIS IP ASSIGNMENT AGREEMENT, INCLUDING WITHOUT LIMITATION, CONTRACT CLAIMS, TORT CLAIMS, BREACH OF DUTY CLAIMS AND ALL OTHER COMMON LAW AND STATUTORY CLAIMS. THE PARTIES ACKNOWLEDGE THAT THIS WAIVER IS A MATERIAL INDUCEMENT TO ENTER INTO A BUSINESS RELATIONSHIP, THAT EACH HAS ALREADY RELIED ON THE WAIVER IN ENTERING INTO THIS IP ASSIGNMENT AGREEMENT AND THAT EACH WILL CONTINUE TO RELY ON THE WAIVER IN THEIR RELATED FUTURE DEALINGS. THE PARTIES FURTHER WARRANT AND REPRESENT THAT EACH HAS REVIEWED THIS WAIVER WITH ITS LEGAL COUNSEL, AND THAT EACH KNOWINGLY AND VOLUNTARILY WAIVES ITS JURY TRIAL RIGHTS FOLLOWING CONSULTATION WITH LEGAL COUNSEL. THIS WAIVER IS IRREVOCABLE, MEANING THAT IT MAY NOT BE MODIFIED EITHER ORALLY OR IN WRITING, AND THIS WAIVER SHALL APPLY TO ANY SUBSEQUENT AMENDMENTS, RENEWALS, SUPPLEMENTS OR MODIFICATIONS TO THIS IP ASSIGNMENT AGREEMENT OR TO ANY OTHER DOCUMENTS OR AGREEMENTS RELATING TO THE TRANSACTIONS CONTEMPLATED HEREBY. IN THE EVENT OF LITIGATION, THIS IP ASSIGNMENT AGREEMENT MAY BE FILED AS A WRITTEN CONSENT TO A TRIAL BY THE COURT.
10. Counterparts . This IP Assignment Agreement may be executed in one or more counterparts (including by facsimile or electronic .pdf submission), each of which shall be deemed an original, and all of which shall constitute one and the same agreement and shall become effective when one or more counterparts have been signed by each of the Parties and delivered (by telecopy or otherwise) to the other Party, it being understood that both Parties need not sign the same counterpart.
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IN WITNESS WHEREOF , the Parties have duly executed and delivered this IP Assignment Agreement as of the date first written above.
SELLERS: | ||||
COVIS PHARMA S.À.R.L., Acting through its Zug Branch |
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By: |
[REDACTED personal information] |
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Name: | [REDACTED personal information] | |||
Title: | [REDACTED personal information] | |||
COVIS INJECTABLES S.À.R.L., Acting through its Zug Branch |
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By: |
[REDACTED personal information] |
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Name: | [REDACTED personal information] | |||
Title: | [REDACTED personal information] | |||
COVIS PHARMA HOLDINGS S.À.R.L. | ||||
By: |
[REDACTED personal information] |
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Name: | [REDACTED personal information] | |||
Title: | [REDACTED personal information] | |||
PURCHASER: | ||||
CONCORDIA PHARMACEUTICALS INC. | ||||
By: |
[REDACTED personal information] |
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Name: | [REDACTED personal information] | |||
Title: | [REDACTED personal information] |
[ Signature Page to IP Assignment Agreement ]
SCHEDULE A
TRADEMARKS
[REDACTED commercially sensitive information]
SCHEDULE B
PATENT
[REDACTED commercially sensitive information]
Exhibit 99.24
EXECUTION VERSION
TRANSITION SERVICES AGREEMENT
This Transition Services Agreement (this Agreement ) is made and entered into effective as of the 21 st day of April 2015 (the Effective Date ), by and among Covis Pharma S.à.r.l., Zug Branch, a limited liability company organized under the Laws of Luxembourg ( Covis Pharma ), Covis Injectables S.à.r.l., Zug Branch, a limited liability company organized under the Laws of Luxembourg ( Covis Injectables , and collectively with Covis Pharma, Sellers ), Covis Pharmaceuticals, Inc., a Delaware corporation ( CPI ) and Concordia Pharmaceuticals Inc., an international business company organized under the Laws of Barbados ( Purchaser ).
W I T N E S S E T H :
WHEREAS, pursuant to that certain Asset Purchase Agreement, dated as of the 9 th day of March 2015, among Sellers, Purchaser, Concordia Healthcare Corp., a corporation organized under the Laws of the province of Ontario ( Purchaser Parent ) (solely with respect to Section 6.10 , Section 10.18 and the applicable provisions of Article X thereof), and Covis Pharma Holdings S.à.r.l., a limited liability company organized under the Laws of Luxembourg ( Seller Parent ) (solely with respect to Section 10.19 and the applicable provisions of Article X thereof) (as amended, modified or supplemented from time to time in accordance with its terms, the Purchase Agreement ), Sellers have agreed to sell, convey, assign, transfer and deliver to Purchaser, and Purchaser has agreed to purchase, acquire and accept from Sellers, for the consideration and upon the terms and subject to the conditions set forth in the Purchase Agreement, all of Sellers right, title and interest in, to and under the Purchased Assets (as defined in the Purchase Agreement), and Purchaser has agreed to assume, satisfy and discharge when due the Assumed Liabilities (as defined in the Purchase Agreement), in each case, subject to and in accordance with the terms of the Purchase Agreement; and
WHEREAS, the applicable Service Provider (as defined below) wishes to provide Purchaser with certain services and other assistance on a transitional basis in accordance with the terms and subject to the conditions set forth herein.
NOW, THEREFORE, in consideration of the foregoing and the representations, warranties, covenants and agreements contained in the Purchase Agreement, and for other good and valuable consideration, the receipt and sufficiency of which are hereby acknowledged, the Parties (as defined below), intending to be legally bound hereby, agree as follows:
ARTICLE I
DEFINITIONS
Section 1.1 Certain Defined Terms .
(a) Unless otherwise defined herein, all capitalized terms used herein shall have the same meanings as set forth in the Purchase Agreement.
(b) The following capitalized terms used in this Agreement shall have the meanings set forth below:
Additional Services shall have the meaning set forth in Section 2.1(d) .
Adverse Drug Experience shall mean any adverse event associated with the use of a drug in humans, whether or not considered drug related, including the following: An adverse event occurring in the course of the use of a drug product in professional practice; an adverse event occurring from drug overdose whether accidental or intentional; an adverse event occurring from drug abuse; an adverse event occurring from drug withdrawal; and any failure of expected pharmacological action.
Agreement shall have the meaning set forth in the Preamble.
Confidential Information shall have the meaning set forth in Section 6.1(a) .
Customer Notice Letter shall have the meaning set forth in Appendix A .
Dispute shall have the meaning set forth in Section 6.7 .
Effective Date shall have the meaning set forth in the Preamble.
Force Majeure means, with respect to a Party, any of the following events beyond the reasonable control of such Party (or any Person acting on its behalf): acts of God, storms, floods, riots, fires, earthquakes, sabotage, civil commotion or civil unrest, interference by civil or military authorities, riots, insurrections or other hostilities, embargo, fuel or energy shortage, acts of war (declared or undeclared) or armed hostilities or other national or international calamity or one or more acts of terrorism or failure or interruption of networks or energy sources.
GPO shall have the meaning set forth in Appendix A .
Licensee shall have the meaning set forth in Section 2.9(a) .
Parties means Purchaser, each Seller and CPI, collectively.
Party means, individually, Purchaser, each Seller and CPI.
Paying Party shall have the meaning set forth in Section 2.2(c) .
Payee shall have the meaning set forth in Section 2.2(c) .
Proceeding shall have the meaning set forth in Section 6.8(b) .
Purchase Agreement shall have the meaning set forth in the Recitals.
Purchaser shall have the meaning set forth in the Preamble.
Purchaser Contract Manager shall have the meaning set forth in Section 2.10(a)(i) .
Purchaser Designees shall have the meaning set forth in Section 2.5 .
Purchaser Parent shall have the meaning set forth in the Preamble.
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Required Technology shall have the meaning set forth in Section 2.8(a) .
Seller and Sellers shall have the meanings set forth in the Preamble.
Seller Parent shall have the meaning set forth in the Preamble.
Serious Adverse Experience means any [REDACTED commercially sensitive information].
Service means each individual service set forth on Appendix A .
Service Fees shall have the meaning set forth in Section 2.2(a) .
Service Provider means, with respect to a particular Service, the Party ( i.e . , either the Sellers or CPI) that is identified on Appendix A as being the Party that is responsible for providing such Service.
Service Provider Contract Manager shall have the meaning set forth in Section 2.10(a)(ii) .
Services Standard shall have the meaning set forth in Section 2.4 .
Territory shall mean the United States of America, including Puerto Rico.
Third Party Provider means any Person that is not a Party and that a Service Provider causes to provide to the Purchaser a Service in accordance with the terms of this Agreement (but only in such Persons capacity as the provider of such Service under this Agreement, and not in such Persons capacity as a service provider to Purchaser under any other agreement between such Person and Purchaser).
Virus(es) means any malicious computer code or instructions that have a material adverse effect on the operation, security or integrity of (a) a computing, telecommunications or other electronic operating or processing system or environment, (b) software programs, data, databases or other computer files or libraries or (c) computer hardware, networking devices or telecommunications equipment, including (i) viruses, Trojan horses, time bombs, back door devices, worms or any other software routine or hardware component designed to permit unauthorized access, disable, erase or otherwise harm software, hardware or data or perform any other such harmful or unauthorized actions and (ii) similar malicious code or data.
Section 1.2 Other Definitional Provisions . (a) The words hereof, herein, hereto and hereunder and words of similar import, when used in this Agreement, shall refer to this Agreement as a whole and not to any particular provision of this Agreement.
(c) The terms defined in the singular shall have a comparable meaning when used in the plural, and vice versa.
(d) The terms dollars and $ shall mean United States of America dollars.
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(e) The term including shall mean including, without limitation.
(f) When a reference is made in this Agreement to an Article, a Section, or an Appendix, such reference shall be to an Article of, a Section of, or an Appendix to, this Agreement unless otherwise indicated.
ARTICLE II
SERVICES
Section 2.1 Services .
(a) Subject to the terms and conditions of this Agreement: (i) Sellers will provide (or cause a Third Party Provider to provide) to Purchaser each Service for which Sellers are identified on Appendix A as being the Service Provider and (ii) CPI will provide (or cause a Third Party Provider to provide) to Purchaser each Service for which CPI is identified on Appendix A as being the Service Provider.
(b) The Parties acknowledge and agree that, notwithstanding anything to the contrary: (i) Sellers shall be responsible and liable (to the extent provided herein) to Purchaser solely with respect to the Services for which Sellers are identified on Appendix A (as it may be amended pursuant to the provisions of Section 2.1(d) ) as being the Service Provider (and not with respect to any Services for which CPI is the Service Provider) and (ii) CPI shall be responsible and liable (to the extent provided herein) to Purchaser solely with respect to the Services for which CPI is identified on Appendix A (as it may be amended pursuant to the provisions of Section 2.1(d) ) as being the Service Provider (and not with respect to any Services for which Sellers are the Service Provider).
(c) Each Party will comply with its obligations set forth on Appendix A related to the Services; it being understood that if a task or activity contemplated by Appendix A remains in process and has not been completed as of the date that a Service set forth in Appendix A otherwise terminates, the Service Provider will continue to perform such task until such task is completed or appropriate arrangements have been made to transfer performance or completion of such task to Purchaser.
(d) If, at any time during the term of this Agreement, Purchaser reasonably determines that in order to operate the Business it is necessary for a Service Provider to provide, or cause to be provided, any other services that were being provided by such Service Provider to the Business prior to Closing that are not yet reflected in Appendix A , Purchaser may request such Service Provider to make such services available, or to cause such services to be made available, to Purchaser, and if such service was performed by the Service Provider consistent with Sellers past practice in the ordinary course of their respective operation of the Business prior to Closing, such service will be made available to Purchaser as a Service upon Purchasers request, provided that, subject to Section 2.1(c) , such Service shall not exceed in duration the remaining term of the corresponding category of Services set forth in Appendix A (or, in any event, regardless of the start date for any such Service, a maximum term of six (6) months, as measured from the Closing Date). The Parties will negotiate in good faith mutually-acceptable terms and conditions (including any applicable fees) on which such Service Provider will make such services available to Purchaser, and Appendix A shall be amended to add such services and
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the mutually-agreed upon terms and conditions related thereto ( Additional Services ) and such Additional Services so provided by any of the Service Providers shall constitute Services under this Agreement and be subject in all respect to the provisions of this Agreement.
Section 2.2 Service Fees; Reimbursement of Expenses .
(a) To the extent that Appendix A provides that a particular Service is subject to the payment of fees and/or reimbursement of expenses by Purchaser ( Service Fees ), Purchaser will pay such Service Fees to the applicable Service Provider, as indicated on Appendix A . Unless otherwise set forth on Appendix A with respect to a particular Service, any Service Fees will be invoiced to Purchaser on a monthly basis. Each such invoice shall set forth detailed payment instructions, along with a reasonably detailed description of such Services and the Service Fees payable with respect to each of such Services. Purchaser will pay all such invoices within thirty (30) days of receipt.
(b) Each Service Provider shall bear all labor costs and overhead of such Service Provider associated with performing the Services for which it is responsible during normal business hours within the applicable time periods set forth on Appendix A . In the event that the Purchaser requests that a Service be provided following the termination of the applicable time periods set forth on Appendix A and the applicable Service Provider agrees to continue to provide such Service, then Purchaser and such Service Provider shall negotiate in good faith mutually-acceptable terms and conditions for the provision of such Service, including any applicable fees, which terms and conditions shall be set forth in an amendment to Appendix A to this Agreement as contemplated by Section 2.1(d) .
(c) Any Party (the Paying Party ) required to make a payment pursuant to this Agreement to the other Party (the Payee ) shall be entitled to deduct or withhold from the amount payable the Tax for which the Paying Party is liable to deduct or withhold under any provisions of Tax Law. Any invoices submitted by one Party to another Party hereunder shall include VAT or sales Tax as required by applicable Law.
Section 2.3 Exception to Obligation to Provide Services . Without limiting its obligations pursuant to Section 2.4 , Service Provider will in no case be obligated to (a) hire any additional employees, (b) maintain the employment of any specific employee, or (c) purchase, lease or license any additional equipment or software, unless any of the actions described in the subclauses (a) through (c) are necessary for Service Provider to satisfy its Service obligations under this Agreement.
Section 2.4 Standard for the Provision of Services . Each Service Provider shall, or shall cause the Third Party Providers to: (a) provide the Services, or cause the Services to be provided, (i) in accordance with all applicable Laws (including specifically all Health Care Laws), (ii) using substantially the same degree of skill, quality and care utilized by the applicable Service Provider in performing such activities for itself and (iii) by persons who are not debarred, restricted, suspended or deemed subject to debarment by the FDA, nor, to applicable Service Providers knowledge, subject of a conviction described in, Section 306 of the FDCA or 42 U.S.C. §1320a7 or any similar debarment or ineligibility provisions applicable to any health care program of a Governmental Authority; and (b) assign sufficient resources and qualified personnel (based on education, training and skill) to perform its obligations under this
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Agreement in accordance with the standards set forth in clause (a) (the standard set forth in this sentence, the Services Standard ).
Section 2.5 Purchaser Designees . Purchaser may designate any of its Affiliates and/or third party contractors to receive and/or otherwise interact with a Service Provider with respect to any one or more of the Services provided by such Service Provider (such designated Affiliates and third party contractors, the Purchaser Designees ); provided , however , that the Purchaser agrees that all of the Services shall be for the sole use and benefit of the Purchaser.
Section 2.6 Services Provided by Third Party Providers . A Service Provider may cause any Third Party Provider to provide any Services that such Service Provider is responsible for providing; provided , however , that (i) such Services are provided at no additional cost to Purchaser and (ii) such Third Party Provider shall be subject to service standards and confidentiality provisions at least equivalent to those set forth herein and that the applicable Service Provider shall remain primarily responsible and liable for the performance by its Third Party Provider of all of its obligations hereunder with respect to such Services so that such performance is in accordance with the terms and conditions hereof.
Section 2.7 Cooperation . Each Party (on behalf of itself and any Third Party Providers (in the case of Sellers and CPI) and any Purchaser Designees (in the case of Purchaser)) shall use its reasonable best efforts to (a) cooperate with each other Party with respect to the provision of any Service and (b) enable each other Party to provide the Services in accordance with this Agreement. Such cooperation will include: (i) exchanging information relevant to the performance of the Services to be provided hereunder, (ii) good faith efforts to mitigate problems with the work environment interfering with the performance of the Services required hereunder and (iii) requiring personnel, including employees of Third Party Providers (in the case of Sellers and CPI) or Purchaser Designees (in the case of Purchaser), to comply with any security regulations, confidentiality requirements and other published policies of the other Party while on the other Partys premises (on behalf of itself and any Third Party Providers (in the case of Sellers and CPI) and any Purchaser Designees (in the case of Purchaser)) or when given access to any equipment, computer, software, network or files owned or controlled by the other Party. None of the Parties shall take any action that would interfere with or materially increase the cost, inclusive of Taxes, of any Service Provider in providing any of the Services. Each Service Provider and Purchaser will comply with all applicable Laws, including for greater certainty Tax Laws, governing the Services to be provided hereunder. In the event of an assessment or enquiry by a Taxing authority the Parties shall take reasonable steps, as determined in the sole determination of each Party, to respond to such assessment or enquiry. Each Service Provider and Purchaser will comply with all applicable Laws governing the Services to be provided hereunder.
Section 2.8 Electronic and Other Access .
(a) To the extent that the performance or receipt of Services hereunder requires the Purchaser to have access to any Service Providers or any Third Party Providers intranet or other computer software, computer networks, hardware, technology or computer-based resources (including third-Person services, e-mail and access to computer networks, database and equipment) ( Required Technology ), the applicable Service Provider shall provide, or cause to be provided, limited access to such Required Technology, subject to the (x)
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satisfaction of any reasonable security requirements and (y) ongoing compliance with security, use, Virus protection, disaster recovery, confidentiality and other policies, procedures and limitations of such Service Provider and/or any applicable Third Party Provider, as they may be amended from time to time. The Purchaser shall, and shall cause all of its personnel having access to the Required Technology to, comply with all of the applicable Service Providers and any Third Party Providers reasonable security guidelines and procedures (including physical security, network access, internet security, confidentiality and personal data security guidelines and procedures) and use, Virus protection, disaster recovery and other policies, procedures and limitations of such Service Provider and any Third Party Providers, as they may be amended from time to time, that are applicable to the provision of any Service.
(b) Purchaser and each Service Provider each shall take, and each Service Provider shall cause any applicable Third Party Provider to take, commercially reasonable measures to ensure that, in connection with any Services provided pursuant to this Agreement, no Virus or similar items are coded or introduced into any other Partys intranet, computer software, hardware, technology, computer networks or databases. If, in connection with any Services, a Virus is found to have been introduced into such intranet, computer software, hardware, technology, computer networks or databases, Purchaser and the applicable Service Provider shall use, and the applicable Service Provider shall cause any applicable Third Party Provider to use, commercially reasonable efforts to cooperate and to diligently work together with each other to eliminate the effects of such Virus. The Parties shall exercise commercially reasonable care to prevent unauthorized Persons from accessing the Services, or the computer and technology systems or networks of any other Party, Third Party Providers or Purchaser Designees.
Section 2.9 Intellectual Property .
(a) Except as otherwise expressly provided in this Agreement, any Ancillary Agreement or the Purchase Agreement, Purchaser and each Service Provider each shall retain all right, title and interest in and to their respective Intellectual Property and any and all improvements, modifications and derivative works thereof. No license or right, express or implied, is granted under this Agreement by any Service Provider or by Purchaser in or to their respective Intellectual Property, except that, solely to the extent required for the provision or receipt of the Services in accordance with this Agreement, each Service Provider on the one hand, and the Purchaser on the other hand, hereby grants to the other (and (i) in the case of the license granted by Purchaser, to any Third Party Providers and (ii) in the case of the license granted by a Service Provider, to any applicable Purchaser Designees) (each Person granting a license, Licensor , and each Person receiving a license, Licensee ) a non-exclusive, royalty-free, revocable, non-transferable (except as provided in Section 6.4 ), non-sublicensable license, solely during the term of this Agreement, to internally use any Intellectual Property that is (x) either (1) owned by the Licensor or its Subsidiaries or (2) licensed to the Licensor or its Subsidiaries from third parties and sublicensable in accordance with this Section 2.9(a) without consent or requirement to make any payments, and (y) required for the provision or receipt of the Services in accordance with this Agreement, but only to the extent and for the duration necessary for the Licensee to provide or receive (in the case of the Purchaser only) the applicable Service in accordance with this Agreement. Upon the expiration of such time, or the earlier termination of such Service in accordance with Section 5.1(d) , the license to the relevant Intellectual Property will automatically and immediately terminate and be of no further force or effect;
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provided , however , that all licenses granted hereunder shall automatically and immediately terminate and be of no further force or effect upon the expiration or earlier termination of this Agreement unless otherwise amended, in accordance with the terms hereof. To the extent the license set forth in this Section 2.9(a) includes any Intellectual Property licensed to the Licensor or its Subsidiaries from third parties, such license is expressly conditioned upon, and subject to, any terms and conditions of any agreement pursuant to which such Intellectual Property is licensed to such Licensor or its Subsidiaries
(b) (i) Without limiting Section 2.9(a) , in the event that any Intellectual Property is created solely by a Service Provider in the performance of the Services, all right, title and interest throughout the world in and to all such Intellectual Property shall vest solely in such Service Provider unconditionally and immediately upon such Intellectual Property having been developed, written or produced, unless the Parties agree otherwise in writing; and (ii) each Service Provider shall grant and hereby grants to the Purchaser a non-exclusive, royalty-free, perpetual, irrevocable, transferable license to any records, reports and other work product created or delivered by such Service Provider for the Purchaser in the performance of the Services; provided, however, that any assets, rights, records or other work product conveyed in connection with, or pursuant to, the Services, which constitute Purchased Assets, shall be the sole and exclusive property of the Purchaser and not the Service Providers.
(c) Purchaser and its Affiliates may use, reproduce and display, and CPI, on behalf and itself and its Affiliates, hereby grants to Purchaser and its Affiliates a non-exclusive, paid-up and royalty-free right and license to use, reproduce and display, the NDC Numbers, Trademark Rights and trade dress of CPI and its Affiliates (in each case, excluding any rights that are licensed to Purchaser by Sellers pursuant to Section 6.8(a) of the Purchase Agreement), solely to the extent the foregoing are affixed to (i) the Inventory of finished, packaged Products that are included in the Purchased Assets and/or (ii) quantities of finished, packaged Products that are manufactured, within six (6) months after the Effective Date, for or on behalf of Purchaser or its Affiliates; provided that (A) except for any Products described in the foregoing clauses (i) and (ii), as of the date that is six (6) months after the Effective Date, Purchaser and its Affiliates shall cease and discontinue all use of such Trademark Rights, trade dress and NDC Numbers of CPI and its Affiliates, provided further that, with respect to any Products described in the foregoing clauses (i) and (ii), the license set forth in this Section 2.9(c) shall continue until Purchaser and its Affiliates have disposed of all such Products, and (B) Purchaser shall provide CPI, within a reasonable time, with written notice of the date and expiration date of the last lot of each Product sold that is described in the foregoing clause (ii).
(d) Except as otherwise expressly provided in this Agreement, the Purchase Agreement or in any other Ancillary Agreement, no Party shall have any rights or licenses with respect to any Intellectual Property (including software), hardware or facility of the other Party, expressly, by implication, estoppel, exhaustion or otherwise. All rights and licenses not expressly granted in this Agreement, the Purchase Agreement or in any other Ancillary Agreement are expressly reserved by the relevant Party. Each Party shall from time to time execute any documents and take any other actions reasonably requested by another Party to effectuate the intent of this Section 2.9 .
Section 2.10 Primary Points of Contact for this Agreement .
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(a) Each Party shall appoint individuals to act as the primary points of operational contact for the administration and operation of this Agreement, as follows:
(i) Each individual appointed by the Purchaser as the primary point of operational contact with respect to a given Service (a Purchaser Contract Manager ) shall have overall operational responsibility for coordinating, on behalf of the Purchaser, all activities undertaken by the Purchaser and any Purchaser Designees hereunder with respect to such Service, including the performance of the Purchasers obligations hereunder, acting as a day-to-day contact with the corresponding Service Provider Contract Manager and making available to the applicable Service Provider and any applicable Third Party Provider the data, facilities, resources and other support services from the Purchaser required for such Service Provider to be able to provide such Service in accordance with the requirements of this Agreement. The initial Purchaser Contract Manager for each Service is identified in Appendix A in the description of such Service. The Purchaser may change a Purchaser Contract Manager from time to time upon written notice to the Sellers pursuant to Section 6.2 . The Purchaser shall use commercially reasonable efforts to provide at least thirty (30) days prior written notice of any such change.
(ii) Each individual appointed by the applicable Service Provider as the primary point of operational contact with respect to a given Service (a Service Provider Contract Manager ) shall have overall operational responsibility for coordinating, on behalf of such Service Provider, all activities undertaken by such Service Provider and any Third Party Providers hereunder with respect to such Service, including the performance of such Service Providers obligations hereunder, the coordinating of the provision of such Service with the Purchaser and acting as a day-to-day contact with the corresponding Purchaser Contract Manager with respect to such Service. The initial Service Provider Contract Manager for each Service is identified in Appendix A in the description of such Service. The applicable Service Provider may change a Service Provider Contract Manager from time to time upon written notice to the Purchaser pursuant to Section 6.2 . Such Service Provider shall use commercially reasonable efforts to provide at least thirty (30) days prior written notice of any such change.
(b) Purchaser and the applicable Service Provider shall ensure that the applicable Service Provider Contract Managers and the Purchaser Contract Managers shall meet in person or telephonically as frequently as necessary or advisable for the performance of the Parties obligations hereunder.
ARTICLE III
WARRANTIES AND COMPLIANCE
Section 3.1 Representations . Each Party represents and warrants to the other Party that it has the power and authority to enter into and perform its obligations under this Agreement and has taken all actions necessary to execute and deliver this Agreement, to consummate the transactions contemplated hereby and to perform its obligations hereunder.
Section 3.2 Disclaimer of Warranties . EXCEPT AS EXPRESSLY SET FORTH HEREIN, EACH PARTY (ON BEHALF OF ITSELF AND ANY THIRD PARTY PROVIDERS (IN THE CASE OF SELLERS AND CPI) AND ANY PURCHASER DESIGNEES (IN THE CASE OF PURCHASER)) HEREBY ACKNOWLEDGES THAT THE SERVICES ARE FURNISHED WITHOUT WARRANTY OF ANY KIND, WHETHER
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EXPRESS OR IMPLIED, INCLUDING ANY WARRANTY IN REGARD TO MERCHANTABILITY OR FITNESS OF THE SERVICES FOR A PARTICULAR PURPOSE. In addition, Purchaser acknowledges and agrees that the Services do not include the exercise of business judgment or general management for Purchaser.
Section 3.3 Compliance with Laws and Regulations . Each Party shall be responsible for its own compliance with any and all Laws applicable to its performance under this Agreement.
ARTICLE IV
LIMITED LIABILITY AND INDEMNIFICATION
Section 4.1 Limited Liability of Service Providers . Notwithstanding anything to the contrary, no Service Provider (or any Third Party Provider that provides Services hereunder) shall have any liability to any Purchaser Indemnified Party or Purchaser Designee, in contract, tort or otherwise, for or in connection with (a) any Services provided or to be provided to Purchaser pursuant to this Agreement or (b) any Service Providers or Third Party Providers actions or inactions in connection with any such Services referred to in the immediately preceding clause (a); provided , however , that the foregoing limitation of liability will not apply to limit a Service Providers liability with respect to: (i) any Loss that a Purchaser Indemnified Party or Purchaser Designee suffers arising from the gross negligence, bad faith or willful misconduct of such Service Provider (or its Third Party Providers) in connection with any such Services, (ii) the indemnity obligations of Sellers under Section 4.2 or (iii) the indemnity obligations of CPI under Section 4.3 .
Section 4.2 Indemnification by Sellers . Subject to the limitations set forth in Section 4.5 , the Sellers shall indemnify each Purchaser Indemnified Party and Purchaser Designee against, and defend and hold each Purchaser Indemnified Party and Purchaser Designee harmless from, any and all Losses incurred by any Purchaser Indemnified Party or Purchaser Designee to the extent such Losses are caused by or result from (a) the gross negligence, bad faith or willful misconduct by or on behalf of the Sellers in providing any Services for which the Sellers are identified as the Service Provider on Appendix A or (b) the breach by the applicable Seller of any term of this Agreement, including the failure to perform any Services in accordance with the Services Standard (excluding any breach by the applicable Seller related to Services provided under Appendix A-4 , to the extent such breach is due to the acts or omissions of a Manufacturer (as defined on Appendix A-4 )). For the avoidance of doubt, Sellers indemnity obligations do not apply with respect to any matters to the extent covered by CPIs indemnity obligations under Section 4.3 or to the extent covered by Purchasers indemnity obligations under Section 4.4 . Sellers and Purchaser acknowledge and agree that Sellers obligations pursuant to this Section 4.2 are in no way intended to diminish or alter Purchasers obligations pursuant to the provisions of Article VIII of the Purchase Agreement, it being expressly acknowledged and agreed that Sellers have no obligation to indemnify any Purchaser Indemnified Party pursuant to this provision to the extent any such Loss incurred is indemnifiable pursuant to Section 8.2 of the Purchase Agreement, subject to and in accordance with the provisions of Article VIII of the Purchase Agreement.
Section 4.3 Indemnification by CPI . Subject to the limitations set forth in Section 4.5 , CPI shall indemnify each Purchaser Indemnified Party and Purchaser Designee
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against, and defend and hold each Purchaser Indemnified Party and Purchaser Designee harmless from, any and all Losses incurred by any Purchaser Indemnified Party or Purchaser Designee to the extent such Losses are caused by or result from (a) the gross negligence, bad faith or willful misconduct by or on behalf of CPI in providing any Services for which CPI is identified as the Service Provider on Appendix A or (b) the breach by CPI of any term of this Agreement, including the failure to perform any Services in accordance with the Services Standard. For the avoidance of doubt, CPIs indemnity obligations do not apply with respect to any matters to the extent covered by Sellers indemnity obligations under Section 4.2 or to the extent covered by Purchasers indemnity obligations under Section 4.4 .
Section 4.4 Indemnification by Purchaser . Subject to the limitations set forth in Section 4.5 , the Purchaser shall indemnify each Service Provider and Seller Indemnified Party against, and defend and hold each Service Provider and Seller Indemnified Party harmless from, any and all Losses incurred by any Service Provider, or Seller Indemnified Party to the extent such Losses are caused by or result from (a) any breach of this Agreement by Purchaser, (b) the gross negligence, bad faith or willful misconduct on the part of Purchaser in the performance of Purchasers obligations under this Agreement, (c) claims by Third Party Service Providers in the performance of their duties hereunder or (d) the performance of the Services set forth in Appendix A-4 ; provided , however , that the Purchaser shall not be responsible for any such Losses described in this Section 4.4 for which Sellers or CPI are required to indemnify the Purchaser Indemnified Parties and Purchaser Designees pursuant to Section 4.2 or Section 4.3 or to the extent that such Losses arise from the Sellers or CPIs breach of this Agreement (excluding any breach by the applicable Seller related to Services provided under Appendix A-4 , to the extent such breach is due to the acts or omissions of a Manufacturer (as defined on Appendix A-4 ) and/or any negligence, bad faith or willful misconduct or violation of applicable Law by any Service Provider or Third Party Provider in connection with the provision of the Services. Sellers and Purchaser acknowledge and agree that Purchasers obligations pursuant to this Section 4.4 are in no way intended to diminish or alter Sellers obligations pursuant to the provisions of Article VIII of the Purchaser Agreement, it being expressly acknowledged and agreed that Purchaser has no obligation to indemnify any Service Provider or Seller Indemnified Party pursuant to this provision to the extent any such Loss is indemnifiable pursuant to Section 8.1 of the Purchase Agreement, subject to and in accordance with the provisions of Article VIII of the Purchase Agreement.
Section 4.5 Additional Limitations on Liability .
(a) [REDACTED commercially sensitive information]
(b) Nothing contained in this Article IV is intended to, nor shall it be deemed to, limit or alter the indemnification obligations of Sellers or Purchaser pursuant to Article VIII of the Purchase Agreement.
Section 4.6 Procedures . The provisions of Section 8.3 of the Purchase Agreement shall govern indemnification under this ARTICLE IV with respect to Third-Party Claims (with CPI being treated as an Indemnified Party or Indemnifying Party (as applicable) for the purposes of applying such provisions to indemnification under this ARTICLE IV ).
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ARTICLE V
TERM AND TERMINATION
Section 5.1 Term and Termination .
(a) This Agreement shall commence on the Effective Date and end, with respect to each Service, at the time set forth with respect to such Service on Appendix A or such shorter term if earlier terminated pursuant to the terms of this Agreement (subject to a Service Providers obligations with respect to any particular task as described in Section 2.1(c) ).
(b) Notwithstanding the term for providing any Service as set forth on Appendix A , this Agreement may be terminated earlier by the Sellers or CPI if the Purchaser or any of its Purchaser Designees is in material breach of the terms of this Agreement and the Purchaser fails to cure such breach within [REDACTED commercially sensitive information] days of the Sellers or CPI (as applicable) delivering a written notice of such breach to the Purchaser.
(c) Notwithstanding the term for providing any Service as set forth on Appendix A , this Agreement may be terminated earlier by the Purchaser if the Sellers or CPI are in material breach of the terms of this Agreement and the Sellers or CPI fail to cure such breach within [REDACTED commercially sensitive information] days of the Purchaser delivering a written notice of such breach to the Sellers or CPI.
(d) With respect to any Service:
(i) Purchaser may terminate such Service, in whole but not in part with respect to such Service, for any reason or no reason upon providing at least [REDACTED commercially sensitive information]days prior, written notice to the applicable Service Provider, subject to the obligation to pay any applicable termination charges pursuant to Section 5.2 ; and
(ii) Purchaser and the applicable Service Provider may terminate such Service, in whole but not in part with respect to such Service: (A) at any time upon prior, written notice to the other Party if such Party has failed to perform any of its material obligations under this Agreement with respect to such Service, and such failure shall continue to exist [REDACTED commercially sensitive information] days after receipt by the other Party of a written notice of such failure from Purchaser or the applicable Service Provider or (B) immediately upon the other Partys receipt of written notice from Purchaser or the applicable Service Provider, if the continued performance of such Service would be a violation of any applicable Law.
(e) The Parties agree that the provisions of this Section 5.1 are subject to the provisions of Section 5.4 ( Force Majeure ) and that a good faith dispute between or among the Parties with respect to the provision of Services or payment therefor shall not be deemed a material breach or a failure to perform a material obligation as contemplated by Section 5.1(b) , Section 5.1(c) and Section 5.1(d) .
Section 5.2 Termination Charges . Upon early termination of any Service pursuant to Section 5.1(b) , Section 5.1(d)(i) or Section 5.1(d)(ii) (initiated by any Service Provider), Purchaser shall pay to the applicable Service Provider such early termination charges
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as may be payable by such Service Provider to any of its Third Party Providers or other Persons in order to discontinue earlier than originally anticipated the provision of such Service; provided , however , that, except in connection with the fees or obligations described in Appendix A with respect to [REDACTED commercially sensitive information] (as defined on Appendix A ), and the [REDACTED commercially sensitive information] (as defined on Appendix A ) and the Intermediary Services described in Appendix A , in no event will the Purchaser be responsible for any such early termination charges in excess of [REDACTED commercially sensitive information] in the aggregate, unless any of the Service Providers has previously notified Purchaser in writing of such early termination charges and Purchaser has approved them. Notwithstanding anything to the contrary, in no event will such early termination charge include any internal costs incurred by, or any amounts payable between or among any of the Service Providers. Each Service Provider shall use commercially reasonable efforts to minimize the existence and amount of such early termination charges related to the Services that it is responsible for providing; provided , however , that the foregoing obligations shall not alter or diminish Purchasers obligation to pay early termination charges as reasonably determined by Service Providers and such other Third Party Provider in accordance with the terms hereof. All termination charges shall be due and payable to the applicable Service Provider in immediately available funds within [REDACTED commercially sensitive information]days of the Purchasers receipt of any invoice therefor.
Section 5.3 Effect of Termination .
(a) Upon termination of any Service, in whole or in part, in accordance with this Agreement and subject to Section 5.2 , the applicable Service Provider will have no further obligation to provide such Service to the extent of its termination, except as provided in Section 2.1(c) . The Purchaser shall remain obligated to such Service Provider for any required amounts owed and payable in respect of such terminated Service that was provided prior to the effective date of termination. Except as expressly provided herein, any and all rights to Intellectual Property granted hereunder in connection with the provision of a terminated Service shall automatically and immediately terminate and be of no further force or effect upon such termination. In connection with the termination of any Service, the provisions of this Agreement not relating solely to such terminated Service shall survive any such termination in accordance with the terms hereof.
(b) In connection with any expiration or termination of this Agreement, the following provisions shall continue to survive indefinitely: ARTICLE I ( Definitions ), Section 2.9(b) , Section 3.1 ( Disclaimer of Warranties ), ARTICLE IV ( Limited Liability and Indemnification ), Section 5.2 ( Termination Charges ), Section 5.3 ( Effect of Termination ) and ARTICLE VI ( General Provisions ). Section 2.9(c) and Appendix A-4 shall survive any expiration or termination of this Agreement in accordance with their respective terms and conditions.
Section 5.4 Force Majeure .
(a) No Party (or any Person acting on its behalf) shall have any liability or responsibility for any interruption, delay or other failure to fulfill any obligation (other than a payment obligation) under this Agreement so long as and to the extent to which the fulfillment of such obligation is prevented, frustrated, hindered or delayed as a consequence of circumstances
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of a Force Majeure, provided that such Party (or such Person) shall have exercised commercially reasonable efforts to minimize the effect of a Force Majeure on its obligations. In the event of an occurrence of a Force Majeure, the Party whose performance is affected thereby shall give written notice of suspension as soon as reasonably practicable to the other Party (but in any event within forty-eight (48) hours of such Force Majeure) stating the date and extent of such suspension and the cause thereof, and such Party shall resume the performance of such obligations as soon as reasonably practicable upon the cessation of such Force Majeure and its effects. The suspension of performance due to a Force Majeure shall be of no greater scope and of no longer duration than is necessary. The Party suffering a Force Majeure shall use commercially reasonable efforts to mitigate the effects of the Force Majeure and remedy its inability to perform and the applicable termination date set forth in Appendix A for any affected Service shall extend automatically for a period of time equal to the duration of the suspension of performance of the Service.
(b) During the period of a Force Majeure, the Purchaser shall be entitled to seek an alternative service provider at its own cost with respect to the Services affected. If a Force Majeure shall continue to exist for more than [REDACTED commercially sensitive information] consecutive days, then the Parties shall meet to discuss and negotiate in good faith what modifications to this Agreement should result from the cause(s) of such Force Majeure. No Party shall be liable for the nonperformance or delay in performance of its respective obligations under this Agreement due to Force Majeure.
ARTICLE VI
GENERAL PROVISIONS
Section 6.1 Treatment of Confidential Information .
(a) From and after the Closing, each Party, shall, and shall cause their respective authorized representatives to, maintain in confidence. treat as confidential and safeguard any and all information, knowledge and data relating to or obtained from the other Party (including information regarding the other Partys and its Affiliates business, employees, development plans, programs, documentation, techniques, customer lists, supplier lists, trade secrets, designs, product formulations, product specifications, systems, know-how or any other proprietary or confidential information, however recorded or preserved, whether written or oral) in connection with or pursuant to this Agreement ( Confidential Information ), by using the same degree of care, but no less than a reasonable standard of care, to prevent the unauthorized use, dissemination or disclosure of such information, knowledge and data as any Party used with respect thereto prior to the execution of this Agreement; except that the foregoing requirements of this Section 6.1(a) shall not apply to the extent that (i) any such information is or becomes generally available to the public other than through an act of any other Party or any of its representatives; (ii) any such information (including any report, statement, testimony or other submission to a Governmental Authority) is required by applicable Law, Governmental Order or such Governmental Authority to be disclosed, after prior notice has been given to the other Party to the extent such notice is not prohibited by applicable Law; provided further , that such Party shall (A) use commercially reasonable efforts to obtain, at the request of the Party whose Confidential Information is affected, a protective order or other assurance that confidential treatment will be accorded to such portion of the Confidential Information required to be disclosed and (B) disclose only such portion of the Confidential Information as is strictly
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required by Law; or (iii) any such information was or becomes available to such Party on a non-confidential basis and from a source (other than a Party hereto or any authorized representative of such Party) that is not bound by a confidentiality agreement with respect to such information. Any Party receiving Confidential Information of another Party may use such Confidential Information only for the purposes of fulfilling its obligations under this Agreement. Each of the Parties hereto shall instruct its authorized representatives having access to such information of the obligations in this Section 6.1(a) .
(b) Each Party agrees, upon written request therefor to promptly return or destroy (at its option) all Confidential Information of the requesting Party. If such Confidential Information is destroyed, the destroying Party shall notify the other Party of such destruction in writing. Notwithstanding the foregoing, upon the termination of this Agreement, the Parties shall cooperate, and Service Providers shall use commercially reasonable efforts to cause any Third Party Providers and representatives to cooperate, to support any transfer (to the extent not previously transferred) to Purchaser of, at Purchasers cost, any Confidential Information relating to the Purchased Assets not previously transferred to Purchaser through the Services.
Section 6.2 Notices . All notices or other communications hereunder shall be deemed to have been duly given and made if in writing and if served by personal delivery upon the Party for whom it is intended, if delivered by registered or certified mail, return receipt requested, or by a national courier service, or if sent by facsimile, provided that the facsimile is promptly confirmed by telephone confirmation thereof, to the Person at the address set forth below, or such other address as may be designated in writing hereafter, in the same manner, by such Person:
To either Seller:
Covis Pharma S.à.r.l. and Covis Injectables S.à.r.l
[REDACTED personal information]
[REDACTED personal information]
Telephone: [REDACTED personal information]
Facsimile: [REDACTED personal information]
Attn: [REDACTED personal information]
with a copy (which shall not constitute notice) to:
Lowenstein Sandler LLP
[REDACTED personal information]
[REDACTED personal information]
[REDACTED personal information]
Telephone: [REDACTED personal information]
Facsimile: [REDACTED personal information]
Attn: [REDACTED personal information]
and a copy (which shall not constitute notice) to:
Cerberus Capital Management, L.P.
[REDACTED personal information]
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[REDACTED personal information]
[REDACTED personal information]
Telephone: [REDACTED personal information]
Facsimile: [REDACTED personal information]
Attn: [REDACTED personal information]
to CPI:
Covis Pharmaceuticals, Inc.
[REDACTED personal information]
[REDACTED personal information]
[REDACTED personal information]
Telephone: [REDACTED personal information]
Facsimile: [REDACTED personal information]
Attn: [REDACTED personal information]
with a copy (which shall not constitute notice) to:
Cerberus Capital Management, L.P.
[REDACTED personal information]
[REDACTED personal information]
[REDACTED personal information]
Telephone: [REDACTED personal information]
Facsimile: [REDACTED personal information]
Attn: [REDACTED personal information]
to Purchaser:
Concordia Pharmaceuticals Inc.
[REDACTED personal information]
[REDACTED personal information]
[REDACTED personal information]
Telephone: [REDACTED personal information]
Facsimile: [REDACTED personal information]
Attn: [REDACTED personal information]
with a copy (which shall not constitute notice) to:
Sullivan & Cromwell LLP
[REDACTED personal information]
[REDACTED personal information]
[REDACTED personal information]
Telephone: [REDACTED personal information]
Facsimile: [REDACTED personal information]
Attn: [REDACTED personal information]
Section 6.3 Amendment; Waiver . Any provision of this Agreement may be amended or waived if, and only if, such amendment or waiver is in writing and signed, in the
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case of an amendment, by Purchaser and Sellers (and, to the extent affecting CPI, also signed by CPI), or in the case of a waiver, by the Party against whom the waiver is to be effective. No failure or delay by any Party in exercising any right, power or privilege hereunder shall operate as a waiver thereof nor shall any single or partial exercise thereof preclude any other or further exercise thereof or the exercise of any other right, power or privilege.
Section 6.4 Assignment . No Party to this Agreement may assign any of its rights or obligations under this Agreement without the prior written consent of the other Parties; provided that nothing in the foregoing shall prohibit Purchaser from making any assignment (i) to any of its Affiliates so long as such Affiliate agrees in writing to be bound by all of the terms, conditions and provisions contained in this Agreement provided , further , no such assignment shall release Purchaser from its obligations under this Agreement; and (ii) to any successors to all or substantially all of the business and assets of Purchaser, whether in a merger, consolidation, sale of substantially all assets or other similar transaction. Any purported assignment, hypothecation or transfer in breach of this Section 6.4 shall be null and void. This Agreement shall be binding upon, and shall inure to the benefit of, and be enforceable by the Parties hereto and their successors and permitted assigns.
Section 6.5 Entire Agreement . This Agreement (including all Appendices hereto) and the Purchase Agreement contains the entire agreement among the Parties with respect to the subject matter hereof and supersedes all prior agreements and understandings, oral or written, with respect to such matters (except that this Agreement supersedes the summary of principal terms set forth on Exhibit C to the Purchase Agreement and the provisions set forth in Section 6.17(a) ( Product Returns ), Section 6.17(b) (Rebates) and Section 6.17(c) ( Chargeback Claims ) of the Purchase Agreement)).
Section 6.6 Parties in Interest . This Agreement shall inure to the benefit of and be binding upon the Parties and their respective successors and permitted assigns. Nothing in this Agreement, express or implied, is intended to confer upon any Person other than Purchaser, Sellers, CPI or their successors or permitted assigns, any rights or remedies under or by reason of this Agreement, provided , that the provisions of ARTICLE IV shall inure to the benefit of the Parties, the Purchaser Indemnified Parties, the Seller Indemnified Parties, the Third Party Providers and the Purchaser Designees, as applicable.
Section 6.7 Dispute Resolution . In the event of any dispute, controversy or claim arising out of or relating to the transactions contemplated by this Agreement, or the validity, interpretation, breach or termination of any provision of this Agreement, or calculation or allocation of the costs of any Service, including claims seeking redress or asserting rights under any Law (each, a Dispute ), the disputing Party shall deliver a notice setting forth the basis for the dispute in reasonable detail to the affected Party or Parties. The Parties agree that the applicable Service Provider Contract Manager and the applicable Purchaser Contract Manager shall negotiate in good faith in an attempt to resolve such Dispute amicably. If the Dispute has not been resolved to the mutual satisfaction of the Parties within [REDACTED commercially sensitive information] days after the initial notice of the Dispute has been given (or such longer period as the Parties may agree), then, [REDACTED personal information] on behalf of the Sellers and [REDACTED personal information] on behalf of the Purchaser (and, to the extent the Dispute relates to CPI, [REDACTED personal information] on behalf of CPI) shall negotiate in good faith in an attempt to resolve such Dispute amicably for an additional
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[REDACTED commercially sensitive information] days (or such longer period as such parties may agree). If at the end of such time such Persons are unable to resolve such Dispute amicably, the Parties may pursue any other rights, remedies or actions that may be available to them under this Agreement or at Law.
Section 6.8 Governing Law; Jurisdiction .
(a) This Agreement and its negotiation, execution, performance or non-performance, interpretation, termination, construction and all claims or causes of action (whether in contract, in tort, at law or otherwise) that may be based upon, arise out of, or relate to this Agreement, or the transactions contemplated hereby (including any claim or cause of action based upon, arising out of or related to any representation or warranty made in connection with this Agreement or as an inducement to enter this Agreement), shall be exclusively governed by, and construed in accordance with, the Laws of the State of Delaware regardless of Laws that might otherwise govern under any applicable conflict of Laws principles.
(b) Subject to Section 6.7 , any claim, demand, suit, action, cause of action, or proceeding (whether in contract, in tort, at law, or otherwise) (each, a Proceeding ) based upon, arising out of, or related to this Agreement and its negotiation, execution, performance, non-performance, interpretation, termination, construction or the transactions contemplated hereby shall be heard and determined in the Court of Chancery in the City of Wilmington, New Castle County, Delaware or, in the event such court lacks subject matter jurisdiction, the United States District Court sitting in Wilmington, Delaware or, in the event such federal district court lacks subject matter jurisdiction, then in the Superior Court in the City of Wilmington, New Castle County, Delaware. The Parties hereby irrevocably submit to the exclusive jurisdiction and venue of such courts in any such Proceeding and irrevocably and unconditionally waive the defense of an inconvenient forum, or lack of jurisdiction to the maintenance of any such Proceeding. The consents to jurisdiction and venue set forth herein shall not constitute general consents to service of process in the State of Delaware and shall have no effect for any purpose except as provided in this Section 6.8 and shall not be deemed to confer rights on any Person other than the Parties. Each Party agrees that the service of process upon such Party in any Proceeding arising out of or relating to this Agreement shall be effective if notice is given by overnight courier at the address set forth in Section 6.2 . Each of the Parties also agrees that any final, non-appealable judgment against a Party in connection with any Proceeding arising out of or relating to this Agreement shall be conclusive and binding on such Party and that such award or judgment may be enforced in any court of competent jurisdiction, either within or outside of the United States. A certified or exemplified copy of such award or judgment shall be conclusive evidence of the fact and amount of such award or judgment.
Section 6.9 WAIVER OF JURY TRIAL . TO THE FULLEST EXTENT PERMITTED BY LAW, THE PARTIES HEREBY WAIVE THEIR RESPECTIVE RIGHTS TO A JURY TRIAL OF ANY PROCEEDING (WHETHER IN CONTRACT, IN TORT, AT LAW OR OTHERWISE) BASED UPON, ARISING OUT OF, OR RELATED TO THIS AGREEMENT OR ANY OF THE TRANSACTIONS CONTEMPLATED BY THIS AGREEMENT. THE SCOPE OF THIS WAIVER IS INTENDED TO BE ALL-ENCOMPASSING OF ANY AND ALL DISPUTES THAT MAY BE FILED IN ANY COURT AND THAT RELATE TO THE SUBJECT MATTER OF THIS AGREEMENT, INCLUDING WITHOUT LIMITATION, CONTRACT CLAIMS, TORT CLAIMS, BREACH OF DUTY
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CLAIMS AND ALL OTHER COMMON LAW AND STATUTORY CLAIMS. THE PARTIES ACKNOWLEDGE THAT THIS WAIVER IS A MATERIAL INDUCEMENT TO ENTER INTO A BUSINESS RELATIONSHIP, THAT EACH HAS ALREADY RELIED ON THE WAIVER IN ENTERING INTO THIS AGREEMENT AND THAT EACH WILL CONTINUE TO RELY ON THE WAIVER IN THEIR RELATED FUTURE DEALINGS. THE PARTIES FURTHER WARRANT AND REPRESENT THAT EACH HAS REVIEWED THIS WAIVER WITH ITS LEGAL COUNSEL, AND THAT EACH KNOWINGLY AND VOLUNTARILY WAIVES ITS JURY TRIAL RIGHTS FOLLOWING CONSULTATION WITH LEGAL COUNSEL. THIS WAIVER IS IRREVOCABLE, MEANING THAT IT MAY NOT BE MODIFIED EITHER ORALLY OR IN WRITING, AND THIS WAIVER SHALL APPLY TO ANY SUBSEQUENT AMENDMENTS, RENEWALS, SUPPLEMENTS OR MODIFICATIONS TO THIS AGREEMENT OR TO ANY OTHER DOCUMENTS OR AGREEMENTS RELATING TO THE TRANSACTIONS CONTEMPLATED HEREBY. IN THE EVENT OF LITIGATION, THIS AGREEMENT MAY BE FILED AS A WRITTEN CONSENT TO A TRIAL BY THE COURT.
Section 6.10 Specific Performance . The Parties agree that irreparable damage may occur in the event that the provisions of this Agreement were not performed in accordance with their specific terms or were otherwise breached. Accordingly, each Party agrees that, in the event of any breach or threatened breach by any other Party of any covenant or obligation contained in this Agreement, the non-breaching Party shall be entitled (in addition to any other remedy that may be available to it, whether in law or equity) to a decree or order of specific performance to enforce the observance and performance of such covenant or obligation and an injunction restraining such breach or threatened breach.
Section 6.11 No Agency . Nothing in this Agreement shall be deemed in any way or for any purpose to constitute any Party acting as an agent of another unaffiliated Party in the conduct of such other Partys business. Sellers, CPI and any Third Party Providers of any Service hereunder shall act as an independent contractor and not as the agent of the Purchaser or any Purchaser Designee in performing such Service.
Section 6.12 Counterparts . This Agreement may be executed in one or more counterparts (including by facsimile or electronic .pdf submission), each of which shall be deemed an original, and all of which shall constitute one and the same agreement and shall become effective when one or more counterparts have been signed by each of the Parties and delivered (by telecopy or otherwise) to the other Party, it being understood that both Parties need not sign the same counterpart.
Section 6.13 Headings . The heading references herein are for convenience purposes only, do not constitute a part of this Agreement and shall not be deemed to limit or affect any of the provisions hereof.
Section 6.14 Severability . The provisions of this Agreement shall be deemed severable and the invalidity or unenforceability of any provision shall not affect the validity or enforceability of the other provisions hereof. If any term or other provision of this Agreement, or the application thereof to any Person or any circumstance, is invalid, illegal or unenforceable, (a) a suitable and equitable provision shall be substituted therefor in order to carry out, so far as may be valid and enforceable, the intent and purpose of such invalid or unenforceable provision
19
and (b) the remainder of this Agreement and the application of such provision to other Persons, entities or circumstances shall not be affected by such invalidity, illegality or unenforceability, nor shall such invalidity, illegality or unenforceability affect the validity or enforceability of such provision, or the application thereof, in any other jurisdiction.
Section 6.15 Mutual Drafting . The Parties are sophisticated and have been represented by lawyers throughout the transactions contemplated hereby who have carefully negotiated the provisions hereof. As a consequence, the Parties do not intend that the presumptions set forth in Laws or rules relating to the interpretation of contracts against the drafter of any particular clause should be applied to this Agreement or any Schedule or Appendix hereto, and therefore, waive their effects.
[ Remainder of The Page Intentionally Left Blank ]
20
IN WITNESS WHEREOF , the Parties have executed or caused this Agreement to be executed as of the date first written above.
SERVICE PROVIDERS: | ||
COVIS PHARMA S.À.R.L., | ||
Acting through its Zug Branch | ||
By: |
[REDACTED personal information] |
|
[REDACTED personal information] | ||
COVIS INJECTABLES S.À.R.L., | ||
Acting through its Zug Branch | ||
By: |
[REDACTED personal information] |
|
[REDACTED personal information] | ||
COVIS PHARMACEUTICALS, INC. | ||
By: |
[REDACTED personal information] |
|
[REDACTED personal information] | ||
PURCHASER: | ||
CONCORDIA PHARMACEUTICALS INC. | ||
By: |
[REDACTED personal information] |
|
[REDACTED personal information] |
[ Signature Page to Transition Services Agreement ]
APPENDIX A
SERVICES
[REDACTED personal information and commercially sensitive information]
A-1
Exhibit 99.25
Execution Version
CREDIT AND GUARANTY AGREEMENT
dated as of April 21, 2015
among
CONCORDIA HEALTHCARE CORP.,
as the Borrower,
and
CERTAIN SUBSIDIARIES OF THE BORROWER,
as Guarantors,
THE LENDERS PARTY HERETO,
RBC CAPITAL MARKETS*,
MORGAN STANLEY SENIOR FUNDING, INC.
GE CAPITAL MARKETS, INC.
and
TD SECURITIES (USA) LLC,
as Joint Lead Arrangers and Joint Bookrunners,
and
MORGAN STANLEY SENIOR FUNDING, INC.
GE CAPITAL MARKETS, INC.
TD SECURITIES (USA) LLC,
and
FIFTH THIRD BANK
as Co-Documentation Agents
and
ROYAL BANK OF CANADA,
as Administrative Agent and Collateral Agent
$575,000,000 Initial Term Loans
$125,000,000 Revolving Commitments
* | RBC Capital Markets is a brand name for the capital markets activities of Royal Bank of Canada and its affiliates. |
TABLE OF CONTENTS
Page | ||||||||
SECTION 1. DEFINITIONS AND INTERPRETATION | 1 | |||||||
1.1 |
Definitions |
2 | ||||||
1.2 |
Accounting Terms |
62 | ||||||
1.3 |
Interpretation, Etc. |
63 | ||||||
1.4 |
Letter of Credit Amounts |
64 | ||||||
1.5 |
Currency Translation |
64 | ||||||
1.6 |
Elections |
65 | ||||||
1.7 |
Québec Matters |
65 | ||||||
SECTION 2. LOANS AND LETTERS OF CREDIT | 66 | |||||||
2.1 |
Term Loans |
66 | ||||||
2.2 |
Revolving Loans |
66 | ||||||
2.3 |
Letters of Credit |
68 | ||||||
2.4 |
Pro Rata Shares; Availability of Funds |
78 | ||||||
2.5 |
Evidence of Debt; Register; Disqualified Persons; Lenders Books and Records; Notes |
79 | ||||||
2.6 |
Interest on Loans |
80 | ||||||
2.7 |
Conversion/Continuation |
82 | ||||||
2.8 |
Default Interest |
83 | ||||||
2.9 |
Commitment Fees |
83 | ||||||
2.10 |
Scheduled Payments |
84 | ||||||
2.11 |
Voluntary Prepayments/Commitment Reductions; Call Protection |
84 | ||||||
2.12 |
Mandatory Prepayments |
86 | ||||||
2.13 |
General Provisions Regarding Payments |
90 | ||||||
2.14 |
Ratable Sharing |
91 | ||||||
2.15 |
Making or Maintaining Eurocurrency Rate Loans |
92 | ||||||
2.16 |
Increased Costs; Capital Adequacy |
94 | ||||||
2.17 |
Taxes; Withholding, Etc. |
95 | ||||||
2.18 |
Mitigation Obligations; Replacement of a Lender |
97 | ||||||
2.19 |
Defaulting Lenders |
99 | ||||||
2.20 |
Incremental Facilities or Commitments |
101 | ||||||
2.21 |
Refinancing Amendments |
106 | ||||||
2.22 |
Extensions of Loans |
112 | ||||||
2.23 |
Swing Line Loans |
117 | ||||||
2.24 |
Bankers Acceptances and BA Equivalent Notes |
120 | ||||||
SECTION 3. CONDITIONS PRECEDENT | 123 | |||||||
3.1 |
Closing Date |
123 | ||||||
3.2 |
Conditions to Any Credit Extension After the Closing Date |
128 | ||||||
SECTION 4. REPRESENTATIONS AND WARRANTIES | 128 | |||||||
4.1 |
Organization; Powers |
129 | ||||||
4.2 |
Authorization |
129 |
4.3 |
Enforceability |
129 | ||||||
4.4 |
Governmental Approvals; Third-Party Consents |
129 | ||||||
4.5 |
Financial Statements |
130 | ||||||
4.6 |
No Material Adverse Effect |
130 | ||||||
4.7 |
Title to Properties |
130 | ||||||
4.8 |
Equity Interests and Ownership of Subsidiaries |
130 | ||||||
4.9 |
Litigation; Compliance with Laws |
130 | ||||||
4.10 |
Federal Reserve Regulations |
131 | ||||||
4.11 |
Investment Company Act |
131 | ||||||
4.12 |
Use of Proceeds |
131 | ||||||
4.13 |
Tax Returns |
131 | ||||||
4.14 |
No Material Misstatements |
132 | ||||||
4.15 |
Employee Benefit Plans |
132 | ||||||
4.16 |
Environmental Matters |
133 | ||||||
4.17 |
Collateral Documents |
133 | ||||||
4.18 |
Insurance |
134 | ||||||
4.19 |
Solvency |
135 | ||||||
4.20 |
Acquisition Agreement |
135 | ||||||
4.21 |
Intellectual Property |
135 | ||||||
4.22 |
Anti-Terrorism Laws |
135 | ||||||
4.23 |
Foreign Corrupt Practices Act |
136 | ||||||
4.24 |
Undisclosed Liabilities |
136 | ||||||
4.25 |
Labor Matters |
136 | ||||||
SECTION 5. AFFIRMATIVE COVENANTS | 137 | |||||||
5.1 |
Existence; Material Properties |
137 | ||||||
5.2 |
Insurance |
137 | ||||||
5.3 |
Payment of Obligations |
138 | ||||||
5.4 |
Financial Statements, Reports, Etc. |
138 | ||||||
5.5 |
Litigation and Other Notices |
139 | ||||||
5.6 |
Compliance with Laws |
140 | ||||||
5.7 |
Maintaining Records; Access to Properties and Inspections |
140 | ||||||
5.8 |
Lender Calls |
140 | ||||||
5.9 |
Use of Proceeds |
141 | ||||||
5.10 |
Compliance with Environmental Laws |
141 | ||||||
5.11 |
Further Assurances; Additional Security |
141 | ||||||
5.12 |
Maintenance of Ratings |
143 | ||||||
SECTION 6. NEGATIVE COVENANTS | 143 | |||||||
6.1 |
Indebtedness |
143 | ||||||
6.2 |
Liens |
147 | ||||||
6.3 |
Investments, Loans and Advances |
152 | ||||||
6.4 |
Mergers, Consolidations and Sales of Assets |
155 | ||||||
6.5 |
Restricted Payments |
158 | ||||||
6.6 |
Transactions with Affiliates |
160 | ||||||
6.7 |
Business of the Borrower and its Restricted Subsidiaries |
162 |
- ii -
6.8 |
Limitation on Modifications and Payments of Indebtedness; Modifications of Certificate of Incorporation, By-Laws and Certain Other Agreements; Etc. |
162 | ||||||
6.9 |
Changes in Fiscal Year |
165 | ||||||
6.10 |
Financial Performance Covenant |
165 | ||||||
6.11 |
Canadian Pension Plans |
165 | ||||||
6.12 |
Sale and Leaseback Transactions |
165 | ||||||
SECTION 7. GUARANTY | 166 | |||||||
7.1 |
Guaranty of the Obligations |
166 | ||||||
7.2 |
Contribution by Guarantors |
166 | ||||||
7.3 |
Payment by Guarantors |
167 | ||||||
7.4 |
Liability of Guarantors Absolute |
167 | ||||||
7.5 |
Waivers by Guarantors |
169 | ||||||
7.6 |
Guarantors Rights of Subrogation, Contribution, Etc. |
170 | ||||||
7.7 |
Subordination of Other Obligations |
170 | ||||||
7.8 |
Continuing Guaranty |
170 | ||||||
7.9 |
Authority of Guarantors or Borrower |
171 | ||||||
7.10 |
Financial Condition of Borrower |
171 | ||||||
7.11 |
Bankruptcy, Etc. |
171 | ||||||
7.12 |
Keepwell |
172 | ||||||
SECTION 8. EVENTS OF DEFAULT | 172 | |||||||
8.1 |
Events of Default |
172 | ||||||
8.2 |
Right to Cure |
176 | ||||||
SECTION 9. AGENTS | 177 | |||||||
9.1 |
Authorization and Action |
177 | ||||||
9.2 |
Agents Reliance, Etc. |
178 | ||||||
9.3 |
Royal Bank of Canada and its Affiliates |
179 | ||||||
9.4 |
Lender Credit Decision |
179 | ||||||
9.5 |
Indemnification of Agents |
180 | ||||||
9.6 |
Successor Agents |
180 | ||||||
9.7 |
Arrangers and Documentation Agents Have No Liability |
181 | ||||||
9.8 |
Administrative Agent May File Proofs of Claim |
181 | ||||||
9.9 |
Collateral and Guaranty Matters |
182 | ||||||
9.10 |
Withholding |
183 | ||||||
9.11 |
Intercreditor Agreements |
183 | ||||||
9.12 |
Québec Security |
184 | ||||||
9.13 |
Special Provisions relating to Currency other than Dollars |
184 | ||||||
SECTION 10. MISCELLANEOUS | 185 | |||||||
10.1 |
Notices; Communications |
185 | ||||||
10.2 |
Survival of Agreement |
186 | ||||||
10.3 |
Binding Effect |
187 | ||||||
10.4 |
Successors and Assigns |
187 | ||||||
10.5 |
Expenses; Indemnity |
193 | ||||||
10.6 |
Right of Set-off |
195 |
- iii -
10.7 |
Governing Law |
195 | ||||||
10.8 |
Waivers; Amendment |
196 | ||||||
10.9 |
Interest Rate Limitation |
198 | ||||||
10.10 |
Entire Agreement |
199 | ||||||
10.11 |
WAIVER OF JURY TRIAL |
199 | ||||||
10.12 |
Severability |
199 | ||||||
10.13 |
Counterparts |
199 | ||||||
10.14 |
Headings |
199 | ||||||
10.15 |
Jurisdiction; Consent to Service of Process |
199 | ||||||
10.16 |
Confidentiality |
201 | ||||||
10.17 |
Platform; Borrower Materials |
201 | ||||||
10.18 |
Release of Liens and Guarantees |
202 | ||||||
10.19 |
Judgment |
203 | ||||||
10.20 |
USA PATRIOT Act Notice |
204 | ||||||
10.21 |
Acknowledgements |
204 |
- iv -
APPENDICES: | A-1 | Initial Term Loan Commitments | ||
A-2 | Revolving Commitments | |||
SCHEDULES: | 1.1(a) | Guarantors | ||
1.1(b) | Immaterial Subsidiaries | |||
1.1(c) | Unrestricted Subsidiaries | |||
4.4 | Filings, Governmental Approvals and Third Party Consents | |||
4.8 | Equity Interests | |||
4.9 | Actions, Suits and Proceedings | |||
4.16 | Environmental Matters | |||
4.18 | Insurance | |||
4.21 | Intellectual Property | |||
5.11 | Post-Closing Deliverables | |||
6.1(a) | Certain Indebtedness | |||
6.2(a) | Certain Liens | |||
6.3(h) | Certain Investments | |||
6.5(c) | Certain Restricted Payments | |||
6.6(b) | Certain Affiliate Transactions | |||
6.8 | Non-Permitted Encumbrances | |||
10.1 | Notice Addresses | |||
EXHIBITS: | A-1 | Funding Notice | ||
A-2 | Conversion/Continuation Notice | |||
A-3 | Request for L/C Credit Extension | |||
B-1 | Initial Term Loan Note | |||
B-2 | Revolving Loan Note | |||
C | Compliance Certificate | |||
D | Joinder Agreement | |||
E | Assignment Agreement | |||
F | Certificate re Non-Bank Status | |||
G | Solvency Certificate | |||
H | Affiliated Lender Assignment Agreement | |||
I-1 | Pledge and Security Agreement | |||
I-2 | Canadian Pledge and Security Agreement | |||
J | Prepayment Notice | |||
K | Intra-Group Subordination Agreement |
- v -
CREDIT AND GUARANTY AGREEMENT
This CREDIT AND GUARANTY AGREEMENT , dated as of April 21, 2015, is entered into by and among CONCORDIA HEALTHCARE CORP. , a corporation incorporated under the laws of the Province of Ontario (the Borrower ), CERTAIN SUBSIDIARIES OF THE BORROWER , as Guarantors, the Lenders party hereto from time to time, ROYAL BANK OF CANADA ( Royal Bank ) as Administrative Agent (together with its permitted successors in such capacity, Administrative Agent ) and as Collateral Agent (together with its permitted successor in such capacity, Collateral Agent ).
RECITALS:
WHEREAS , Pursuant to the terms of that certain Asset Purchase Agreement, dated as of March 9, 2015, by and among the Borrower, the Sellers (as defined herein), Concordia Pharmaceuticals, Inc. and Covis Pharma Holdings S.à.r.l. (together with all exhibits, schedules and disclosure letters thereto, collectively, the Acquisition Agreement ), the Borrower will acquire the Target Assets (as defined herein) from the Sellers (the Acquisition );
WHEREAS , The Borrower will, at its option, issue and sell new cash common equity providing for gross proceeds in an aggregate principal amount of up to $450,000,000 on or prior to the Closing Date (the Equity Offering );
WHEREAS , The Borrower will issue and sell senior unsecured notes providing for gross proceeds of up to $735,000,000 (the Senior Notes ) pursuant to a Rule 144A and/or Regulation S offering, or other private placement;
WHEREAS , All the existing third party indebtedness for borrowed money of the Borrower and its subsidiaries, including the Existing Credit Agreement (as defined herein), except for Indebtedness permitted under Section 6.1, will be refinanced or repaid, and all security and guaranties in respect thereof discharged and released (the Refinancing );
WHEREAS , Lenders have agreed to extend certain credit facilities to the Borrower, consisting of (i) $575,000,000 aggregate principal amount of Initial Term Loans and (ii) $125,000,000 aggregate principal amount of Initial Revolving Commitments (together, the Facility ); and
WHEREAS , The proceeds of the Initial Term Loans, the Senior Notes and the proceeds from the Equity Offering will be applied, as applicable, (i) to pay the Acquisition consideration, (ii) to pay the fees and expenses incurred in connection with the Transactions (such fees and expenses, the Transaction Costs ) and (iii) to pay for the Refinancing.
NOW, THEREFORE, in consideration of the premises and the agreements, provisions and covenants herein contained, the parties hereto agree as follows:
SECTION 1. | DEFINITIONS AND INTERPRETATION |
1.1 Definitions . The following terms used herein, including in the preamble, recitals, exhibits and schedules hereto, shall have the following meanings:
Acquisition as defined in the recitals hereto.
Acquisition Agreement as defined in the recitals hereto.
Acquisition Agreement Representations means such of the representations and warranties made by or on behalf of the Sellers or any seller party in the Acquisition Agreement as are material to the interests of the Lenders, but only to the extent that a breach of such representations and warranties results in the Borrower (or its Affiliates) having the right to terminate the Borrowers (or its Affiliates) obligation to consummate the Acquisition under the Acquisition Agreement or to decline to consummate the Acquisition under the Acquisition Agreement (in each case, without giving effect to notice or lapse of time or both).
Additional Lender means any Person (other than a natural Person) that is not an existing Lender and that has agreed to provide Incremental Commitments pursuant to Section 2.20 or Refinancing Commitments pursuant to Section 2.21.
Adjusted LIBOR means, for any Interest Rate Determination Date with respect to an Interest Period in relation to a Eurocurrency Rate Loan, the rate per annum obtained by dividing (i)(a) the London interbank offered rate administered by the ICE Benchmark Association Limited (or any other Person which takes over the administration of that rate) for deposits (for delivery on the first day of such Interest Period) with a term equivalent to such Interest Period in Dollars, determined as of approximately 11:00 a.m. (London, England time) on such Interest Rate Determination Date, for the relevant Interest Period displayed on page LIBOR01 of the Reuters screen (or any replacement Reuters page which displays that rate); provided that if such Reuters page or service ceases to be available, the Agent may specify another page or service displaying the relevant rate after consultation with the Borrower or (b) if the rates referenced in the preceding clause (a) are not available, the rate per annum determined by the Administrative Agent as the rate of interest, expressed based upon a 360 day year, at which deposits in Dollars for delivery on the first day of such Interest Period in same day funds in the approximate amount of the Eurodollar Rate Loan being made, continued or converted by the Administrative Agent and with a term and amount comparable to such Interest Period and principal amount of such Eurodollar Rate Loan as would be offered by the Administrative Agents London Branch to major banks in the offshore Dollar market at their request at approximately 11:00 a.m. (London time) [REDACTED Time Period] prior to the first day of such Interest Period; provided that if (a) and (b) are not available, the terms of Section 2.15(a) shall apply; by (ii) an amount equal to (x) one minus (y) the Applicable Reserve Requirement; provided , however , that notwithstanding the foregoing, (x) the Adjusted LIBOR with respect to the Initial Term Loans shall at no time be less than [REDACTED Percentage] per annum and (y) the Adjusted LIBOR with respect to the Revolving Loans shall not be less than [REDACTED Percentage] and there shall otherwise be no Adjusted LIBOR floor for the Revolving Loans.
Administrative Agent as defined in the preamble hereto.
- 2 -
Administrative Questionnaire means an administrative questionnaire in a form supplied by the Administrative Agent.
Affiliate means, as applied to any Person, any other Person directly or indirectly controlling, controlled by, or under common control with, that Person.
Affiliated Lender Assignment Agreement as defined in Section 10.4(o).
Agent(s) means each of the Administrative Agent and the Collateral Agent.
Aggregate Amounts Due as defined in Section 2.14.
Aggregate Payments as defined in Section 7.2.
Agreement means this Credit and Guaranty Agreement, dated as of April 21, 2015 as it may be amended, restated, supplemented or otherwise modified from time to time.
All-In-Yield means, as to any Indebtedness, the yield thereof calculated in good faith consistent with generally accepted financial practices, whether in the form of interest rate, margin, original issue discount, upfront fees, Adjusted LIBOR floor (in the case of an Incremental Revolving Commitment, to the extent the operation of such Adjusted LIBOR floor would increase the yield on drawn amounts under any applicable existing Revolving Commitment on the proposed date of the initial availability thereof), or otherwise, in each case, incurred or payable by the Borrower generally to all the lenders or holders of such Indebtedness; provided that original issue discount and upfront fees shall be equated to interest rate assuming a [REDACTED Time Period] life to maturity (or, if less, the stated life to maturity at the time of its incurrence of the applicable Indebtedness); provided , further , that All-In-Yield shall not include ticking fees, unused line fees, amendment fees, arrangement fees, structuring fees, commitment fees, underwriting fees and similar fees (regardless of whether paid, in whole or in part, to any or all lenders or holders of such Indebtedness) or other fees not paid generally to all lenders or holders of such Indebtedness.
AML Legislation as defined in Section 3.1(k).
Amortizing Amount means the aggregate principal amount of all Initial Term Loans.
Anti-Terrorism Laws as defined in Section 4.22.
Applicable Margin means (a) with respect to Initial Term Loans that are Eurocurrency Rate Loans, [REDACTED Percentage] per annum and with respect to Initial Term Loans that are Base Rate Loans, [REDACTED Percentage] per annum and (b) with respect to Initial Revolving Loans, Unused Commitment Fees and Letter of Credit Fees for standby Letters of Credit, (i) until delivery of financial statements for the first full fiscal quarter commencing on or after the Closing Date pursuant to Section 5.4, (A) for Eurocurrency Rate Loans and Bankers Acceptance Loans, [REDACTED Percentage] , (B) for Base Rate Loans, Canadian Prime Rate Loans and any Designated Foreign Currency Alternate Rate Loans, [REDACTED Percentage] (C) for Letter of Credit Fees, [REDACTED Percentage] and
- 3 -
(D) for Unused Commitment Fees, [REDACTED Percentage] , and (ii) thereafter, with respect to the Revolving Loans, Letter of Credit Fees and Unused Commitment Fees the following percentages per annum, based upon the Senior Secured Net Leverage Ratio as specified in the most recent Compliance Certificate received by the Administrative Agent pursuant to Section 5.4(c):
Pricing Level |
Senior Secured Net Leverage
|
Unused Commitment Fees | ||
1 |
> 2.50:1.00 | [REDACTED Percentage] | ||
2 |
£ 2.50:1.00 | [REDACTED Percentage] |
Any increase or decrease in the Applicable Margin resulting from a change in the Senior Secured Net Leverage Ratio shall become effective as of the first Business Day immediately following the date a Compliance Certificate is delivered pursuant to Section 5.4(c); provided that Pricing Level 1 in the table immediately above shall apply (x) as of the first Business Day after the date on which a Compliance Certificate was required to have been delivered but was not delivered, and shall continue to so apply to and including the date on which such Compliance Certificate is so delivered (and thereafter the pricing level otherwise determined in accordance with this definition shall apply) or (y) at the option of the Administrative Agent and upon written notice to the Borrower ( provided , that in the case of an Event of Default pursuant to Sections 8.1(g) or (h), such notice shall automatically be deemed to have been provided), as of the first Business Day after an Event of Default shall have occurred and be continuing, and shall continue to so apply to but excluding the date on which such Event of Default is cured or waived (and thereafter the pricing level otherwise determined in accordance with this definition shall apply).
If it is subsequently determined before the date on which all Loans have been repaid and all Commitments have been terminated that the Senior Secured Net Leverage Ratio set forth in any Compliance Certificate delivered to the Administrative Agent is inaccurate for any reason and the result thereof is that the Lenders received interest or fees for any period based
- 4 -
on an Applicable Margin that is less than that which would have been applicable had the Senior Secured Net Leverage Ratio been accurately determined, then, for all purposes of this Agreement, the Applicable Margin for any day occurring within the period covered by such Compliance Certificate shall retroactively be deemed to be the relevant percentage as based upon the accurately determined Senior Secured Net Leverage Ratio for such period, and any shortfall in the interest or fees theretofore paid by the Borrower for the relevant period as a result of the miscalculation of the Senior Secured Net Leverage Ratio shall be deemed to be (and shall be) due and payable by the Borrower upon the date that is [REDACTED Time Period] Days after notice by the Administrative Agent to the Borrower of such miscalculation (even if, for the avoidance of doubt, such third Business Day occurs on or after the Maturity Date). During such three (3) Business Day period and thereafter, if the preceding sentence is complied with, the failure to previously pay such interest and fees at the correct Applicable Margin and the delivery of such inaccurate certificate shall not in and of themselves constitute a Default or Event of Default and no amounts shall be payable at the Default Rate in respect of any such interest or fees.
Applicable Reserve Requirement means, at any time, for any Eurocurrency Rate Loan, the maximum rate, expressed as a decimal, at which reserves (including any basic marginal, special, supplemental, emergency or other reserves) are required to be maintained with respect thereto against Eurocurrency liabilities (as such term is defined in Regulation D) under regulations issued from time to time by the Board of Governors or other applicable banking regulator. Without limiting the effect of the foregoing, the Applicable Reserve Requirement shall reflect any other reserves required to be maintained by such member banks with respect to (i) any category of liabilities which includes deposits by reference to which the applicable Adjusted LIBOR or any other interest rate of a Loan is to be determined, or (ii) any category of extensions of credit or other assets which include Eurocurrency Rate Loans. A Eurocurrency Rate Loan shall be deemed to constitute Eurocurrency liabilities and as such shall be deemed subject to reserve requirements without benefits of credit for proration, exceptions or offsets that may be available from time to time to the applicable Lender. The rate of interest on Eurocurrency Rate Loans shall be adjusted automatically on and as of the effective date of any change in the Applicable Reserve Requirement.
Appropriate Lender means, at any time, (a) with respect to Loans of any Class, the Lenders of such Class, (b) with respect to any Letters of Credit, (i) the relevant L/C Issuers and (ii) the Revolving Lenders and (c) with respect to the Swing Line Obligation, (i) the Swing Line Lender and (ii) if any Swing Line Loans are outstanding pursuant to Section 2.23, the Revolving Lenders.
Approved Fund as defined in Section 10.4(b).
Arrangers means RBC Capital Markets, Morgan Stanley Senior Funding, Inc., GE Capital Markets, Inc. and TD Securities (USA) LLC, as Joint Lead Arrangers and Joint Bookrunners.
Asset Sale means any sale, transfer or other disposition (other than by way of license or lease) of any assets by the Borrower or any Restricted Subsidiary. Notwithstanding the foregoing, none of the following shall constitute Asset Sales: (1) issuances of Equity
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Interests by the Borrower, (2) issuances of Equity Interests by any subsidiary of the Borrower to the Borrower or any other subsidiary of the Borrower to the extent such issuances do not result in a reduction of the percentage of such subsidiary directly or indirectly owned by the Borrower, or such subsidiary, or (3) any disposition of assets permitted by Section 6.4 (other than clause (i) thereof).
Assignment Agreement means, as applicable, an assignment and assumption agreement substantially in the form of Exhibit E , with such amendments or modifications as may be approved by the Administrative Agent and the Borrower.
Assignor as defined in Section 10.4(b)(i).
Attributable Indebtedness means, in respect of a Sale and Leaseback Transaction, at the time of determination, the present value (discounted at the rate of interest implicit in such transaction) of the total obligations of the lessee for rental payments during the remaining term of the lease included in such Sale and Leaseback Transaction (including any period for which such lease has been or may be extended).
Authorized Agent as defined in Section 10.15(c)(i).
Authorized Officer means, as applied to any Person, any individual holding the position of chairman of the board (if an officer), chief executive officer, president, vice president (or the equivalent thereof), chief financial officer, treasurer or controller of such Person or any other individual designated (i) by the Board of Directors or member of such Person or (ii) in writing to the Administrative Agent by an existing Authorized Officer of such Person as an authorized signatory of any document or certificate delivered hereunder.
Auto-Extension Letter of Credit as defined in Section 2.3(b)(iii).
Auto-Reinstatement Letter of Credit as defined in Section 2.3(b)(iv).
BA Discount Rate means: (i) with respect to Bankers Acceptances to be purchased by a Revolving Lender which is able to accept Drafts, the BA Rate; and (ii) with respect to Bankers Acceptances or completed Drafts to be purchased by a BA Equivalent Lender, the BA Rate plus [REDACTED Percentage] .
BA Equivalent Lender has the meaning specified in Section 2.24(a)(i).
BA Equivalent Note has the meaning specified in Section 2.24(c)(iii).
BA Instruments means, collectively, Bankers Acceptances, Drafts and BA Equivalent Notes, and, in the singular, any one of them.
BA Period means with respect to any Bankers Acceptance Loan, the period commencing on the date of such Borrowing and ending on the numerically corresponding day in the calendar month that is [REDACTED Time Period] thereafter, as a Borrower may elect; provided that (a) if any BA Period would end on a day other than a Business Day, such BA Period shall be extended to the next succeeding Business Day unless such next succeeding
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Business Day would fall in the next calendar month, in which case such BA Period shall end on the next preceding Business Day and (b) any BA Period that commences on the last Business Day of a calendar month (or on a day for which there is no numerically corresponding day in the last calendar month of such BA Period) shall end on the last Business Day of the last calendar month of such BA Period. For purposes hereof, the date of a Borrowing initially shall be the date on which such Borrowing is made and thereafter shall be the effective date of the most recent conversion or continuation of such Borrowing.
BA Rate means, for the interest period of each Bankers Acceptance Loan, the rate of interest per annum equal to the average annual rate applicable to Canadian dollar bankers acceptances having an identical or comparable term as the proposed Bankers Acceptance Loan displayed and identified as such on the display referred to as the CDOR Page (or any display substituted therefor) of Reuters Limited as at approximately 10:00 a.m. Toronto time on such day (or, if such day is not a business day, as of 10:00 a.m. Toronto time on the immediately preceding business day; provided that, if such rate does not appear on the CDOR Page at such time on such date, the rate for such date will be the rate of interest per annum equivalent to the annual discount rate as of 10:00 a.m. Toronto time on such day at which one of the five largest Canadian chartered banks (measured by assets) listed on Schedule 1 of the Bank Act (Canada) as selected by the Administrative Agent is then offering to purchase Canadian dollar bankers acceptances accepted by it having such specified term (or a term as closely as possible comparable to such specified term); provided that in no event shall the BA Rate be less than [REDACTED Percentage]
Bankers Acceptance has the meaning specified in Section 2.24(a).
Bankers Acceptance Loans means (i) the creation of Bankers Acceptances by a Revolving Lender that is not a BA Equivalent Lender and (ii) the creation and purchase of completed Drafts by a BA Equivalent Lender, in each case, as a component of the Canadian Dollar Revolving Loans and as contemplated by Section 2.24.
Bankruptcy Code means Title 11 of the United States Code entitled Bankruptcy, as now and hereafter in effect, or any successor statute.
Barbados Security Documents means (i) a Barbados law Charge over Shares in the Equity Interests in Concordia Pharmaceuticals Inc. by Concordia Healthcare Corp. and Concordia Healthcare Inc. in favor of the Administrative Agent and Collateral Agent, (ii) a Barbados law Charge over Shares in the Equity Interests in Concordia Laboratories Inc. by Concordia Healthcare Inc. in favor of the Administrative Agent and Collateral Agent, (iii) a Barbados law Debenture/Mortgage by Concordia Pharmaceuticals Inc. in favor of the Administrative Agent and Collateral Agent and (iv) a Barbados law Debenture/Mortgage by Concordia Pharmaceuticals Inc. in favor of the Administrative Agent and Collateral Agent.
Base Rate means, for any day a fluctuating rate per annum equal to the highest of (i) the Federal Funds Effective Rate plus [REDACTED Percentage] (ii) the Prime Rate in effect for such day as announced from time to time and (iii) the Adjusted LIBOR for a one-month Interest Period for a deposit in Dollars on such day (or if such day is not a Business Day, the immediately preceding Business Day) plus [REDACTED Percentage] ; provided that any
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change in such rate due to a change in the Prime Rate, the Federal Funds Effective Rate or the Adjusted LIBOR shall be effective as of the opening of business on the day of such change in the Prime Rate, the Federal Funds Effective Rate or the Adjusted LIBOR, as the case may be; provided , further , that for the purpose of clause (iii), the Adjusted LIBOR for any day shall be based on the rate determined on such day at approximately 11:00 a.m. (London time).
Base Rate Loan means a Loan bearing interest at a rate determined by reference to the Base Rate.
Below Threshold Asset Sale Proceeds as defined in the definition of Net Cash Proceeds.
Beneficiary means each Agent, L/C Issuer, Swing Line Lender, Lender and Lender Counterparty.
Board of Directors means (i) with respect to a corporation, the board of directors of such corporation or any duly authorized committee thereof; (ii) in the case of a limited liability company, the board of directors or managers, manager or managing member of such Person or duly authorized committee thereof; (iii) in the case of a partnership, the general partner of such Person or duly authorized committee thereof; and (iii) with respect to any other entity, the board of directors or similar body of the general partner or managers of such entity or any duly authorized committee thereof.
Board of Governors means the Board of Governors of the United States Federal Reserve System, or any successor thereto.
Borrower as defined in the preamble hereto.
Borrower Materials as defined in Section 10.17.
Borrowing means any Loans of the same Class and Type of Loan made, converted or continued on the same date and, in the case of Eurocurrency Rate Loans or Bankers Acceptance Loans, as to which a single Interest Period or BA Period, as the case may be, is in effect.
Borrowing Minimum means (a) with respect to a Borrowing of Revolving Loans denominated in Dollars, [REDACTED Dollar Amount] , (b) with respect to a Borrowing of Revolving Loans denominated in Canadian Dollars, Cdn. [REDACTED Dollar Amount] , and (c) with respect to a Borrowing of Revolving Loans denominated in any other Designated Foreign Currency, as the Administrative Agent and the Borrower shall agree.
Borrowing Multiple means (a) with respect to a Borrowing of Revolving Loans denominated in Dollars, [REDACTED Dollar Amount] , (b) with respect to a Borrowing of Revolving Loans denominated in Canadian Dollars, Cdn [REDACTED Dollar Amount] , and (c) with respect to a Borrowing of Revolving Loans denominated in any other Designated Foreign Currency, as the Administrative Agent and the Borrower shall agree.
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Business Day means (i) any day excluding Saturday, Sunday and any day on which banking institutions are authorized or required by law or other governmental action to close in the province of Ontario or New York, New York and (ii) with respect to all notices, determinations, fundings and payments in connection with any Eurocurrency Rate Loans, the term Business Day means any day which is a Business Day described in clause (i) and which is also a day for trading by and between banks in deposits in the applicable currency in the London interbank market.
Calculation Date shall mean (a) the date of delivery of each Funding Notice, (b) the date of issuance, extension or renewal of any Letter of Credit, (c) the date of conversion or continuation of any Borrowing of a Loan, (d) each date a calculation of fees due under this Agreement is required to be made and (e) the last Business Day of each calendar quarter.
Canadian Dollars and Cdn.$ means lawful money of Canada.
Canadian Domiciled Credit Party means the Borrower and any other Credit Party incorporated or otherwise organized under the laws of Canada or any province or territory thereof.
Canadian Pension Plan means a registered pension plan, as that term is defined in subsection 248(1) of the Income Tax Act (Canada), which is sponsored, administered or contributed to by the Borrower of any of its subsidiaries or under which the Borrower or any of its subsidiaries has any liability, contingent or otherwise.
Canadian Pledge and Security Agreement means the Canadian Pledge and Security Agreement to be executed by each Canadian Domiciled Credit Party substantially in the form of Exhibit I-2, as it may be amended, restated, supplemented or otherwise modified from time to time.
Canadian Prime Rate means, for any day, a fluctuating rate of interest per annum equal to the higher of (a) the rate of interest in effect for such day as determined from time to time by the Administrative Agent as its reference rate then in effect for determining interest rates on Canadian dollar denominated commercial loans made in Canada and (b) the interest rate per annum equal to the sum of (i) the BA Rate applicable to bankers acceptances with a term of [REDACTED Time Period] days on such day and (ii) [REDACTED Percentage] per annum. The Canadian Prime Rate is a rate set by the Administrative Agent based upon various factors and is used as a reference point for pricing some loans, which may be priced at, above, or below such announced rate. Any change in the Canadian Prime Rate so determined by the Administrative Agent shall be adjusted automatically with each quoted or published change in such rate, all without the necessity of any notice to the Borrower or any other Person.
Canadian Prime Rate Loans means any Revolving Loans that bear interest with reference to the Canadian Prime Rate.
Canadian Securities Laws means all applicable securities statutes of each of the provinces of Canada and the respective regulations and rules under such statutes, together
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with applicable multilateral or national instruments issued or adopted by the securities regulatory authorities in such provinces.
Capital Lease Obligations of any Person means the obligations of such Person to pay rent or other amounts under any lease of (or other arrangement conveying the right to use) real or personal property, or a combination thereof, which obligations are required to be classified and accounted for as capital leases on a balance sheet of such Person under IFRS and, for purposes hereof, the amount of such obligations at any time shall be the capitalized amount thereof at such time determined in accordance with IFRS; provided that any obligations that would not be accounted for as Capital Lease Obligations under IFRS as of the Closing Date shall not be included in Capital Lease Obligations after the Closing Date due to any changes in IFRS or interpretations thereunder or otherwise.
Cash Collateral Account means a blocked account at Royal Bank of Canada (or any successor Administrative Agent or another commercial bank selected by the Administrative Agent and reasonably acceptable to the Borrower) in the name of the Administrative Agent and under the sole dominion and control of the Administrative Agent, and otherwise established in a manner reasonably satisfactory to the Administrative Agent.
Cash Collateralize means to pledge and deposit with or deliver to the Administrative Agent, for the benefit of the Administrative Agent, the Swing Line Lender, the applicable L/C Issuer and the Lenders, as collateral for L/C Obligations, the Swing Line Loans or obligations of Lenders to fund participations in respect of either thereof (as the context may require), cash or deposit account balances or, if the applicable L/C Issuer or Swing Line Lender benefitting from such collateral shall agree in its sole discretion, other credit support, in each case pursuant to documentation in form and substance reasonably satisfactory to (a) the Administrative Agent, (b) the applicable L/C Issuer and (c) the Swing Line Lender.
Cash Collateral shall have a meaning correlative to the foregoing and shall include the proceeds of such cash collateral and other credit support.
Cash Equivalents means, as at any date of determination, any of the following: (i) marketable securities (a) issued or directly and unconditionally guaranteed as to interest and principal by the United States Government or the Government of Canada or (b) issued by any agency of the United States or Canada the obligations of which are backed by the full faith and credit of the United States or Canada, respectively, in each case, maturing within one year after such date; (ii) marketable direct obligations issued by any state of the United States of America, any province or territory of Canada or any political subdivision of any such state or province or territory or any public instrumentality thereof, in each case, maturing within one year after such date and having, at the time of the acquisition thereof, a rating of at least A-2 from S&P or at least P-2 from Moodys or at least R-1(low) from DBRS; (iii) commercial paper maturing no more than one year from the date of creation thereof and having, at the time of the acquisition thereof, a rating of at least A-2 from S&P or at least P-2 from Moodys or at least R-1(low) from DBRS; (iv) certificates of deposit, Dollar-denominated or Canadian Dollar-denominated time deposits, overnight bank deposits or bankers acceptances (or, in the case of Foreign Subsidiaries, the foreign equivalent) maturing within one year after such date and issued or accepted by any Lender or by any commercial bank organized under the laws of the United
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States of America or any state thereof or the District of Columbia or Canada or any province or territory thereof or any bank listed in Schedule III of the Bank Act (Canada) that (a) is at least adequately capitalized (as defined in the regulations of its primary Federal banking regulator) and (b) has Tier 1 capital (as defined in such regulations) of not less than [REDACTED Dollar Amount] or Dollar Equivalent (or, in the case of Foreign Subsidiaries, any local office of any commercial bank organized under the law of the relevant jurisdiction or any political subdivision thereof which has combined capital and surplus and undivided profits in excess of the Dollar Equivalent of [REDACTED Dollar Amount] ); (v) repurchase obligations for underlying securities of the types described in clauses (i) through (iv) above; and (vi) shares of any money market mutual fund that (a) has substantially all of its assets invested continuously in the types of investments referred to in clauses (i) and (ii) above, (b) has net assets of not less than [REDACTED Dollar Amount] or Dollar Equivalent, and (c) has one of the two highest ratings obtainable from either S&P or Moodys or at least R-1(low) from DBRS provided , that, in the case of any Investment by any Foreign Subsidiary of the Borrower, Cash Equivalents shall also include: (x) direct obligations of the sovereign nation (or any agency thereof) in which such Foreign Subsidiary is organized and is conducting business or in obligations fully and unconditionally guaranteed by such sovereign nation (or any agency thereof), in each case, maturing within a year after such date and having, at the time of the acquisition thereof, a rating equivalent to at least A-2 from S&P and at least P-2 from Moodys, (y) investments of the type and maturity described in clauses (i) through (vi) above of foreign obligors, which Investments or obligors (or the parents of such obligors) have ratings described in such clauses or equivalent ratings from comparable foreign rating agencies and (z) shares of any money market mutual or similar fund that has substantially all its assets invested continuously in the types of investments otherwise satisfying the requirements of this definition (including this proviso).
Cash Management Agreement means any agreement to provide to Borrower or any of its subsidiaries cash management services for collections, treasury management services (including controlled disbursement, overdraft, automated clearing house fund transfer services, return items and interstate depository network services), any demand deposit, payroll, trust or operating account relationships, commercial credit cards, merchant card, purchase or debit cards, non-card e-payables services, and other cash management services, including electronic funds transfer services, lockbox services, stop payment services and wire transfer services allocation.
Casualty Event means any settlement of, or payment in respect of, (i) any property or casualty insurance claim or (ii) any seizure, condemnation, confiscation or taking under the power of eminent domain or expropriation of, requisition of title to or use of, or any similar event in respect of, or proceeding relating to, any asset of the Borrower or any Restricted Subsidiary.
Certificate re Non-Bank Status means a certificate substantially in the form of Exhibit F , with such amendments or modifications that may be approved by the Administrative Agent and the Borrower.
CFC means a controlled foreign corporation within the meaning of Section 957 of the Internal Revenue Code.
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Change in Law means (a) the adoption of any law, rule or regulation after the Closing Date, (b) any change in law, rule or regulation or in the interpretation or application thereof by any Governmental Authority after the Closing Date or (c) compliance by any Lender (or, for purposes of Section 2.16, by any lending office of such Lender or by such Lenders holding company, if any) with any written request, guideline or directive (whether or not having the force of law) of any Governmental Authority, made or issued after the Closing Date; provided , however , that, notwithstanding anything herein to the contrary, (x) all requests, rules, guidelines or directives under or issued in connection with the Dodd-Frank Wall Street Reform and Consumer Protection Act or any equivalent European regulation, all interpretations and applications thereof and any compliance by a Lender with any request or directive relating thereto and (y) all requests, rules, guidelines or directives promulgated under or in connection with, all interpretations and applications of, and any compliance by a Lender with any request or directive relating to International Settlements, the Basel Committee on Banking Supervision (or any successor or similar authority) or the United States of America or foreign regulatory authorities, in each case pursuant to Basel III, shall in each case be deemed to be a Change in Law regardless of the date enacted, adopted, amended or issued, but only to the extent such rules, regulations, or published interpretation, written requests, guidelines or directives are applied to the Borrower and its subsidiaries by the Administrative Agent or any Lender in substantially the same manner as applied to other similarly situated borrowers under comparable syndicated credit facilities, including, without limitation, for purposes of Section 2.16.
Change of Control means: (a) the Borrower becomes aware (by way of a report or any other filing pursuant to Canadian Securities Laws or the Exchange Act, proxy, vote, written notice or otherwise) that any person or group of related persons (as such terms are used in Sections 13(d) and 14(d) of the Exchange Act as in effect on the Closing Date), is or becomes the beneficial owner (as defined in Rules 13d-3 and 13d-5 under the Exchange Act as in effect on the Closing Date), directly or indirectly, of more than [REDACTED Percentage] of the Equity Interests of the Borrower (or its successor by way or merger, amalgamation, arrangement, consolidation or purchase of all or substantially all of its assets);
(b) the merger, amalgamation, consolidation or arrangement of the Borrower, including by way of an exchange of securities or otherwise, with or into another Person or the merger, amalgamation, consolidation or arrangement of another Person with or into the Borrower, or the merger, amalgamation, consolidation or arrangement of any Person, including by way of an exchange of securities or otherwise, with or into a subsidiary of the Borrower, unless the holders of a majority of the aggregate voting power of the Voting Interests of the Borrower, immediately prior to such transaction, directly or indirectly, hold securities of the surviving or transferee Person that represent, immediately after such transaction, at least a majority of the aggregate voting power of the Equity Interests of the surviving or transferee Person;
(c) the Borrower sells, directly or indirectly, assigns, conveys, transfers, leases or otherwise disposes of (other than by way of merger, amalgamation, consolidation or arrangement), either in one transaction or a series of related transactions, all or substantially all of its assets to a Person other than a Restricted Subsidiary of the Borrower; or
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(d) any change of control or similar event under the Senior Notes, Permitted Pari Passu Secured Refinancing Debt, Permitted Junior Secured Refinancing Debt, Permitted Unsecured Refinancing Debt or any Junior Financing shall occur.
Charges as defined in Section 10.9.
Class (a) when used with respect to Lenders, refers to whether such Lenders have Loans or Commitments with respect to a particular Class of Loans or Commitments, (b) when used with respect to Commitments, refers to whether such Commitments are Initial Term Loan Commitments, Initial Revolving Commitments, Incremental Revolving Commitments, Refinancing Revolving Commitments, Extended Revolving Commitments of a given Extension Series, Incremental Term Commitments, Refinancing Term Commitments or Commitments in respect of Extended Term Loans of a given Extension Series, in each case, not designated part of another existing Class and (c) when used with respect to Loans, refers to whether such Loans, or the Loans, are Initial Term Loans, Initial Revolving Loans, Incremental Term Loans, Incremental Revolving Loans, Refinancing Revolving Loans, Extended Term Loans, Loans made pursuant to Extended Revolving Commitments or Refinancing Term Loans, in each case not designated part of another existing Class. Commitments (and, in each case, the Loans made pursuant to such Commitments) that have different terms and conditions shall be construed to be in different Classes. Commitments (and, in each case, the Loans made pursuant to such Commitments) that have the same terms and conditions shall be construed to be in the same Class.
Closing Date means the date that all of the conditions set forth in Section 3.1 are satisfied or waived and the Transactions have been consummated.
Collateral means, all the Collateral (or equivalent term) as defined in any Collateral Document.
Collateral Agent as defined in the preamble hereto.
Collateral and Guarantee Requirement means the requirement that:
(a) on the Closing Date, the Administrative Agent shall have received from each Credit Party, a counterpart of each Security Agreement to which such Credit Party is a party duly executed and delivered on behalf of such Credit Party;
(b) on the Closing Date, (i) the Administrative Agent shall have received subject to the exceptions (if any) set forth in the Security Agreements, a pledge of all the issued and outstanding Equity Interests of each wholly-owned direct subsidiary (other than any Immaterial Subsidiary) of the Borrower and each Guarantor and (ii) the Administrative Agent (or a designated bailee thereof) shall have received all certificates or other instruments (if any) representing such Equity Interests, together with stock powers or other instruments of transfer with respect thereto endorsed in blank;
(c) (i) on the Closing Date, all Indebtedness of the Borrower and each subsidiary of the Borrower having, in the case of each instance of Indebtedness, an aggregate principal amount in excess of [REDACTED Dollar Amount] (other than (A) intercompany
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current liabilities incurred in the ordinary course of business in connection with the cash management operations of the Borrower and its subsidiaries or (B) to the extent that a pledge of such promissory note or instrument would violate applicable law) that is owing to any Credit Party shall be evidenced by a promissory note or an instrument and shall have been pledged pursuant to the applicable Security Agreement (or other applicable Collateral Document as reasonably required by the Administrative Agent); and (ii) the Administrative Agent (or a designated bailee thereof) shall have received all such promissory notes or instruments, together with note powers or other instruments of transfer with respect thereto endorsed in blank;
(d) in the case of any Person that becomes or is required to become a Credit Party after the Closing Date, the Administrative Agent shall have received a Joinder Agreement and supplements to the applicable Security Agreement and the other applicable Credit Documents, in each case, substantially in the form specified therein, duly executed and delivered on behalf of such Credit Party and in accordance with Section 5.11;
(e) after the Closing Date, subject to the exceptions set forth in the Pledge and Security Agreements, (i) all the outstanding Equity Interests of (A) any Person that becomes a Credit Party after the Closing Date and (B) subject to Section 5.11(c), all the Equity Interests that are acquired by a Credit Party after the Closing Date, shall have been pledged pursuant to the Pledge and Security Agreement; provided that in no event shall any Credit Party be required to pledge more than [REDACTED Percentage] of the issued and outstanding voting Equity Interests of any Foreign Subsidiary that is a CFC or a Qualified CFC Holding Company; and (ii) the Administrative Agent (or a designated bailee thereof) shall have received all certificates or other instruments (if any) representing such Equity Interests, together with stock powers or other instruments of transfer with respect thereto endorsed in blank, to the extent required by the Security Agreements;
(f) except as otherwise contemplated by the Collateral Documents, all documents and instruments, including UCC financing statements, PPSA financing statements (and similar filings under any other applicable law, including the law of Barbados), filings with the United States Patent and Trademark Office, filings with the United States Copyright Office, filings with the Canadian Intellectual Property Office and all other instruments reasonably requested by the Administrative Agent to be filed, registered, recorded or delivered to create the Liens intended to be created by the Collateral Documents (in each case, including any supplements thereto) and perfect such Liens to the extent required by, and with the priority required by, the Collateral Documents, shall have been delivered to the Administrative Agent (or a designated bailee thereof) for filing, registration or the recording concurrently with, or promptly following, the execution and delivery of each such Collateral Document;
(g) except as otherwise contemplated by any Collateral Document, each Credit Party shall have obtained all consents and approvals required to be obtained by it in connection with (i) the execution and delivery of all Collateral Documents (or supplements thereto) to which it is a party and the granting by it of the Liens thereunder and (ii) the performance of its obligations thereunder; and
(h) after the Closing Date, the Administrative Agent shall have received (i) such other Collateral Documents as may be required to be delivered pursuant to Section 5.11
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and (ii) upon reasonable request by the Administrative Agent, evidence of compliance with any other requirements of Section 5.11.
Collateral Documents means the Security Agreements, the Herrera Subordination Agreement, any Intercreditor Agreement, if executed and delivered, and all other instruments, documents and agreements delivered by or on behalf of any Credit Party pursuant to this Agreement or any of the other Credit Documents in order to grant to, or perfect in favor of, Collateral Agent, for the benefit of Secured Parties, a Lien on any real, personal or mixed property of that Credit Party as security for the Obligations.
Commitment means any Revolving Commitment or Term Loan Commitment.
Commitment Letter means the Facilities Commitment Letter, dated March 9, 2015, among the Borrower, the Arrangers and the Administrative Agent, as amended and supplemented prior to the date hereof.
Commodity Exchange Act means the Commodity Exchange Act (7 U.S.C. § 1 et seq .), as amended from time to time, and any successor statute.
Compliance Certificate means a Compliance Certificate substantially in the form of Exhibit C or another form as may be agreed by the Borrower and Administrative Agent from time to time.
Consolidated Adjusted EBITDA means the Consolidated Net Income of the Borrower and its Restricted Subsidiaries determined on a consolidated basis for such period for which financial statements are available, which may include internal financial statements prepared in good faith by the Borrower:
(a) increased, in each case to the extent deducted (and not added back) in Consolidated Net Income, and in each case, without duplication with any other item described in this clause (a) or any item excluded pursuant to the definition of Consolidated Net Income, by:
(i) provision for Taxes based on income or profits or capital, including state, provincial, franchise, excise and similar Taxes and foreign withholding Taxes of such Person paid or accrued, including any penalties and interest relating to any Tax examinations; plus
(ii) Consolidated Interest Expense for such period; plus
(iii) depreciation and amortization expense of such Person for such period; plus (iv) extraordinary, non-recurring, unusual or exceptional losses, charges and expenses; plus
(v) losses, charges and expenses relating to the Transactions regardless of when paid (including, without limitation, the write-off of deferred financing fees capitalized on the balance sheet corresponding to the Existing Credit Agreement, any
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financial advisory fees, filing fees, accounting fees, legal fees and other similar advisory and consulting fees and related out-of-pocket expenses and other fees, discounts and commissions, including with regard to arranging or syndication); plus
(vi) (A) actual expenses, costs and charges related to business optimization, relocation or integration; (B) actual expenses, costs and charges related to Permitted Acquisitions after the Closing Date and (C) severance and other restructuring charges actually incurred; plus
(vii) losses, charges and expenses relating to asset dispositions or the sale or other disposition of any Equity Interests of any Person other than in the ordinary course of business, as determined in good faith by an Authorized Officer of the Borrower; plus
(viii) losses, charges and expenses attributable to disposed or discontinued operations and losses, charges and expenses related to the disposal of disposed, abandoned, closed or discontinued operations; plus
(ix) losses, charges and expenses attributable to the early extinguishment or conversion of Indebtedness, Hedge Agreements or other derivative instruments (including deferred financing expenses written off and premiums paid); plus
(x) charges, expenses and fees incurred, including financial advisory, accounting, auditor, legal and other consulting and advisory fees and any Canadian Securities Administration, SEDAR or other filing fees and expenses, or any amortization thereof, in connection with any equity offering, acquisition, merger, amalgamation, investment, recapitalization, asset disposition, incurrence or repayment of Indebtedness (including deferred financing expenses), refinancing transaction or amendment or modification of any debt instrument (in each case, including any such transaction consummated prior to the Closing Date and any transaction undertaken but not completed) and any non-recurring charges and expenses (including non-recurring merger or amalgamation expenses) incurred as a result of any such transaction; plus
(xi) the amount of cost savings and synergies projected by the Borrower in good faith to be realized as a result of specified actions taken or expected to be taken prior to or during such period (which cost savings or synergies shall be subject only to certification by an Authorized Officer of the Borrower and shall be calculated on a Pro Forma Basis as though such cost savings or synergies had been realized on the first day of the relevant period), net of the amount of actual benefits realized during such period from such actions; provided that (A) such cost savings or synergies are reasonably identifiable and factually supportable, (B) are expected to be realized (in the good faith determination of the Borrower) [REDACTED Time Period] after the date of such action and (C) the aggregate amount added back pursuant to this clause (xi) for any four Fiscal Quarter period shall not exceed, (x) solely with respect to the Transactions, amounts set forth for such four Fiscal Quarter Period in a schedule delivered to the Administrative Agent prior to the Closing Date and (y) otherwise, [REDACTED Percentage] of Consolidated Adjusted EBITDA; plus
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(xii) any other non-cash losses, charges and expenses, including any write offs or write downs, reducing Consolidated Net Income for such period;
(b) decreased (in each case to the extent added in Consolidated Net Income), by (without duplication):
(i) net unrealized gains on Hedge Agreements; plus
(ii) gains relating to asset dispositions or the sale or other disposition of any Equity Interests of any Person other than in the ordinary course of business; plus
(iii) cash payments during such period on account of accruals on or reserves added to Consolidated Adjusted EBITDA pursuant to clause (a) above; plus
(iv) non-cash gains, excluding any non-cash gains that represent the reversal of any accrual of, or cash reserve for, anticipated cash charges that were deducted (and not added back) in the calculation of Consolidated Adjusted EBITDA for any prior period.
Consolidated Current Assets means, as at any date of determination, the total assets of the Borrower and its Restricted Subsidiaries on a consolidated basis that may properly be classified as current assets in conformity with IFRS, excluding cash and Cash Equivalents, as of the most recent date for which for which financial statements are available, which may include internal financial statements prepared in good faith by the Borrower.
Consolidated Current Liabilities means, with respect to the Borrower and its Restricted Subsidiaries on a consolidated basis at any date of determination, all liabilities that would, in accordance with IFRS, be classified on a consolidated balance sheet of the Borrower and its Restricted Subsidiaries as current liabilities at such date of determination, other than (a) the current portion of any Indebtedness, (b) accruals of Consolidated Interest Expense (excluding Consolidated Interest Expense that is due and unpaid), (c) accruals for current or deferred Taxes based on income or profits, (d) accruals, if any, of transaction costs resulting from the Transactions, (e) accruals of any costs or expenses related to (i) severance or termination of employees prior to the Closing Date or (ii) bonuses, pension and other post-retirement benefit obligations, and (f) accruals for add-backs to Consolidated Adjusted EBITDA included in clauses (a)(v), (a)(vi), (a)(xi) and (a)(xii) of the definition thereof, as of the most recent date for which for which financial statements are available, which may include internal financial statements prepared in good faith by the Borrower.
Consolidated Interest Expense means, with respect to any Person for any period, without duplication, the sum of:
(1) the consolidated interest expense of such Person and its Restricted Subsidiaries for such period, to the extent such expense was deducted (and not added back) in computing Consolidated Net Income, as determined on a consolidated basis in accordance with IFRS, including, without limitation:
(a) any amortization of Indebtedness discount;
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(b) the net payments (less net payments received) under any Hedge Agreement in respect of interest rate protection (including any amortization of discounts, but excluding mark to market movements in the valuation of obligations pursuant to any Hedge Agreement);
(c) the interest portion of any deferred payment obligation;
(d) all commissions, discounts and other fees and charges owed with respect to letters of credit or bankers acceptances; and
(e) all accrued interest;
(2) the interest component of Capital Lease Obligations paid, accrued and/or scheduled to be paid or accrued by such Person and its Restricted Subsidiaries during such period determined on a consolidated basis in accordance with IFRS; and
(3) all capitalized interest of such Person and its Restricted Subsidiaries for such period;
less interest income of such Person and its Restricted Subsidiaries for such period; provided, however, that Consolidated Interest Expense will exclude (I) the amortization or write off of debt issuance costs and deferred financing fees, commissions, fees and expenses and (II) any expensing of interim loan commitment and other financing fees.
Consolidated Net Income means the net income (or loss) of the Borrower and its Restricted Subsidiaries determined on a consolidated basis for such period; provided that, without duplication:
(a) the cumulative effect of a change in accounting principles shall be excluded;
(b) the net after-Tax effect of extraordinary, non-recurring, unusual or exceptional gains, losses, charges and expenses, including any relating to or arising in connection with claims or litigation (including legal fees, settlements, judgments and awards), shall be excluded;
(c) the net after-Tax effect of gains, losses, charges and expenses attributable to asset dispositions or the sale or other disposition of any Equity Interests of any Person other than in the ordinary course of business, as determined in good faith by an Authorized Officer of the Borrower, shall be excluded;
(d) the net after-Tax effect of gains, losses, charges and expenses attributable to disposed, discontinued, closed or abandoned operations and any net after-Tax gains, losses, charges and expenses related to the disposal of disposed, abandoned, closed or discontinued operations shall be excluded;
(e) the net after-tax effect of gains, losses, charges and expenses attributable to the early extinguishment or conversion of Indebtedness, Hedge Agreements or other
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derivative instruments (including deferred financing expenses written off and premiums paid) shall be excluded;
(f) the net income for such period of any Person that is an Unrestricted Subsidiary, or that is accounted for by the equity method of accounting, shall be excluded; provided that Consolidated Net Income shall be increased by the amount of dividends or distributions or other payments that are actually paid to the Borrower or any Restricted Subsidiary thereof in such period in cash;
(g) the effects of adjustments (including the effects of such adjustments pushed down to the Borrower and its Restricted Subsidiaries) in any line item in such Persons consolidated financial statements pursuant to IFRS resulting from the application of recapitalization accounting or purchase accounting, as the case may be, in connection with the Transaction, any acquisition or any joint venture investments or the amortization or write off of any amounts thereof, net of taxes, shall be excluded;
(h) impairment and amortization charges, asset write offs and write downs, including impairment and amortization charges, asset write offs and write downs related to goodwill, intangible assets, long-lived assets, investments in debt and equity securities or as a result of a change in law or regulation, in each case, pursuant to IFRS shall be excluded;
(i) non-cash compensation charges and expenses, including any such charges and expenses arising from grants of stock appreciation or similar rights, phantom equity, stock options, restricted stock, deferred stock or other rights or equity incentive programs and non-cash deemed finance charges in respect of any pension liabilities or other provisions shall be excluded;
(j) (i) charges and expenses pursuant to any management equity plan, long-term incentive plan or stock option plan or any other management or employee benefit plan or agreement, any stock subscription or shareholder agreement and (ii) charges, expenses, accruals and reserves in connection with the rollover, acceleration or payout of Equity Interests held by management of the Borrower or any of the Restricted Subsidiaries, in the case of each of (i) and (ii) above, to the extent that (in the case of any cash charges and expenses) such charges, expenses, accruals and reserves are funded with cash proceeds contributed to the capital of the Borrower or net cash proceeds of an issuance of Equity Interests (other than Disqualified Stock) of the Borrower or any direct or indirect parent of the Borrower shall be excluded;
(k) any non-cash loss, charge or expense relating to the incurrence of obligations in respect of an earn out or other similar contingent obligations shall be excluded, but only for so long as such loss, charge or expense remains a non-cash contingent obligation;
(l) to the extent covered by insurance (including business interruption insurance) and actually reimbursed, or, so long as the Borrower has made a determination that there exists reasonable evidence that such amount will in fact be reimbursed by the insurer and only to the extent that (i) such coverage is not denied by the applicable carrier or indemnifying party in writing within [REDACTED Time Period] days and (ii) such amount is in fact reimbursed within [REDACTED Time Period] days of the date of such determination (with a
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deduction in the applicable future period for any amount so added back to the extent not so reimbursed within [REDACTED Time Period] days), losses, charges, expenses, accruals and reserves with respect to liability or casualty events or business interruption shall be excluded;
(m) (i) non-cash or unrealized gains or losses in respect of obligations under Hedge Agreements or any ineffectiveness recognized in earnings related to qualifying hedge transactions or the fair value of changes therein recognized in earnings for derivatives that do not qualify as hedge transactions, in each case, in respect of obligations under Hedge Agreements, and (ii) gains or losses resulting from currency translation gains or losses related to currency re-measurements of Indebtedness (including gains or losses resulting from (x) Hedge Agreements for currency exchange risk and (y) intercompany Indebtedness) and all other foreign currency translation gains or losses to the extent such gains or losses are non-cash items shall be excluded;
(n) non-cash interest charges on defined benefit, defined contribution or other pension plans shall be excluded;
(o) any expenses or charges to the extent paid by a third party that is not a Restricted Subsidiary on behalf of the Borrower or a Restricted Subsidiary (and not required to be reimbursed), and any gain resulting from such payment, shall be excluded; and
(p) solely for the purpose of determining the amount available under clause (a)(ii) of the definition of Cumulative Credit, the net income (or loss) for such period of any Restricted Subsidiary (other than any of the Guarantors) shall be excluded to the extent the declaration or payment of dividends or similar distributions by that Restricted Subsidiary of its net income is not at the date of determination permitted without any prior governmental approval (which has not been obtained) or, directly or indirectly, is otherwise restricted by the operation of the terms of its charter or any agreement, instrument, judgment, decree, order, statute, rule, or governmental regulation applicable to that Restricted Subsidiary or its equityholders; provided that Consolidated Net Income of the Borrower will be increased by the amount of dividends or other distributions or other payments actually paid in cash to the Borrower or a Restricted Subsidiary thereof in respect of such period, to the extent not already included therein.
Consolidated Total Assets means, as of any date of determination and on a Pro Forma Basis for any acquisition or disposition or other Specified Transaction that has been consummated on or prior to the date of determination, the total amount of all assets of the Borrower and its Restricted Subsidiaries, determined on a consolidated basis in accordance with IFRS, as of the most recent date for which for which financial statements are available, which may include internal financial statements prepared in good faith by the Borrower.
Consolidated Total Debt means, as of any date of determination, the aggregate principal amount of all Indebtedness of the Borrower and its Restricted Subsidiaries outstanding on such date and determined on a consolidated basis in accordance with IFRS consisting of the types of Indebtedness set forth in clauses (a), (b), (d), (f), (h) (to the extent of unreimbursed amounts under Letters of Credit) and (i) of the definition of Indebtedness and all guarantees by the Borrower or any of its Restricted Subsidiaries of Indebtedness described in the foregoing clauses of others; provided that, Consolidated Total Debt shall not include (i) Indebtedness in
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respect of letters of credit, except to the extent of drawn and unreimbursed amounts thereunder and (ii) obligations under Hedge Agreements.
Consolidated Working Capital means, as of any date of determination, with respect to the Borrower and its Restricted Subsidiaries on a consolidated basis, Consolidated Current Assets at such date of determination minus Consolidated Current Liabilities at such date of determination; provided that, increases or decreases in Consolidated Working Capital shall be calculated without regard to any changes in Consolidated Current Assets or Consolidated Current Liabilities as a result of (i) any reclassification in accordance with IFRS of assets or liabilities, as applicable, between current and non-current, (ii) the effects of purchase accounting or (iii) any changes in fair value of derivative instruments, to the extent those changes are excluded from Consolidated Net Income due to hedge accounting treatment of derivative instruments.
continuing means, with respect to any default or event of default, that such default or event of default has not been cured or waived.
Contributing Guarantors as defined in Section 7.2.
Conversion/Continuation Date means the effective date of a continuation or conversion, as the case may be, as set forth in the applicable Conversion/Continuation Notice.
Conversion/Continuation Notice means a Conversion/Continuation Notice substantially in the form of Exhibit A-2 .
Covenant Trigger Event means if as of the last day of the most recent Fiscal Quarter covered by the financial statements delivered pursuant to Section 5.4 the aggregate principal amount of outstanding Revolving Loans made pursuant to Section 2.2(a) and outstanding Letters of Credit (in the case of drawn Letters of Credit, excluding any drawn Letters of Credit that have been Cash Collateralized) is greater than [REDACTED Percentage] of the aggregate amount of Revolving Commitments (without giving effect to any adjustment or reduction due to the issuance or cancellation of a Letter of Credit or borrowing or repayment of a Revolving Loan subsequent to such day).
Credit Date means the date of a Credit Extension.
Credit Document means any of this Agreement, the Notes, if any, the Collateral Documents, the Intra-Group Subordination Agreement, any Issuer Documents, the Fee Letter and all other documents, certificates, instruments or agreements executed and delivered by or on behalf of a Credit Party for the benefit of any Agent, any L/C Issuer or any Lender in connection herewith on or after the date hereof.
Credit Extension means the making of a Loan or the issuing of a Letter of Credit.
Credit Party means the Borrower and each Guarantor.
Cumulative Credit means, at any time, an amount (which shall not be less than zero) equal to:
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(a) (i) the Retained Excess Cash Flow Amount at such time; plus
(ii) the aggregate amount of cash proceeds from the sale of Qualified Stock of the Borrower (including upon exercise of warrants or options or upon the conversion of Indebtedness of the Borrower or any Restricted Subsidiary owed to a Person other than a Restricted Subsidiary) received by the Borrower after the Closing Date and at or prior to such time; provided that this clause (ii) shall exclude sales of Disqualified Stock and Equity Interests issued in connection with the cure right pursuant to Section 8.2; plus
(iii) the cumulative amount of (x) capital contributions made to the Borrower in cash or Cash Equivalents (other than proceeds from (1) the issuance of Disqualified Stock, (2) Equity Interests issued in connection with the cure right pursuant to Section 8.2 and (3) capital contributions made on or prior to the Closing Date) and (y) the fair market value, as determined by the Borrower in good faith, of property or assets (other than cash) received by the Borrower as a capital contribution, in each case after the Closing Date; plus
(iv) an amount equal to the net reduction in Investments made pursuant to Section 6.3(dd) in respect of any returns in cash, Cash Equivalents and assets (valued at the fair market value thereof, as determined by the Borrower in good faith) (including dividends, interest, distributions, returns of principal, profits on sale, repayments, income and similar amounts) actually received by the Borrower or any Restricted Subsidiary from such Investments after the Closing Date and in each case to the extent not included in Consolidated Net Income used in calculating Excess Cash Flow and not required to be used for prepayments pursuant to Section 2.12 or are reinvested pursuant to Section 2.12; plus
(v) in the event any Unrestricted Subsidiary has been redesignated as a Restricted Subsidiary or has been merged, consolidated or amalgamated with or into, or transfers or conveys its assets to, or is liquidated into, the Borrower or any of its Restricted Subsidiaries after the Closing Date, the lesser of (x) the fair market value of the Investments of the Borrower or the applicable Restricted Subsidiary made with the Cumulative Credit in such Unrestricted Subsidiary at the time of such redesignation, merger or consolidation (or of the assets transferred or conveyed, as applicable) and (y) the fair market value of the original Investments by the Borrower or the applicable Restricted Subsidiary made with the Cumulative Credit in such Unrestricted Subsidiary, in each case, as determined by the Borrower in good faith; plus
(vi) the cumulative amount of mandatory prepayments declined by a Lender under Section 2.12(e) to the extent not used or required to make other permitted prepayments of permitted Indebtedness; minus
(b) the aggregate amount of any Investments made pursuant to Section 6.3(dd), any Restricted Payments made pursuant to Section 6.5(j) and any payments or distributions in respect of any Junior Financing made pursuant to Section 6.8(a)(1)(i)(d)(2) after the Closing Date and at or prior to such time.
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Cure Notice as defined in Section 8.2.
DB Plan as defined in Section 6.11(a).
DBRS means DBRS Limited, DBRS, Inc. or DBRS Ratings Limited, and any successors to their rating agency businesses.
Debtor Relief Laws means the Bankruptcy Code , the Bankruptcy and Insolvency Act (Canada), the Companies Creditors Arrangement Act (Canada), the Winding-up and Restructuring Act (Canada) and all other liquidation, conservatorship, bankruptcy, assignment for the benefit of creditors, moratorium, rearrangement, receivership, insolvency, winding-up, reorganization or similar debtor relief laws of the United States, Canada or other applicable jurisdictions from time to time in effect, including the arrangement provisions of any applicable Canadian corporate legislation as now or hereafter in effect.
Default means a condition or event that, after notice or lapse of time or both, would constitute an Event of Default.
Default Rate means an interest rate equal to (a) with respect to the amount of any principal or interest of any Loan not paid when due, the interest rate (including any Applicable Margin) otherwise applicable to such Loan plus [REDACTED Percentage] per annum or (b) with respect to all other overdue amounts, the Base Rate (or Canadian Prime Rate, to the extent applicable), plus the Applicable Margin applicable to Revolving Loans which are Base Rate Loans (or Canadian Prime Rate Loans, to the extent applicable), plus [REDACTED Percentage] per annum.
Defaulting Lender means any Lender whose acts or failure to act, whether directly or indirectly, cause it to meet any part of the definition of Lender Default.
Deposit Account means a demand, time, savings, passbook or like account with a bank, savings and loan association, credit union or like organization, other than an account evidenced by a negotiable certificate of deposit.
Designated Non-Cash Consideration means the fair market value (as determined in good faith by the Borrower) of non-cash consideration received by the Borrower or any Restricted Subsidiary in connection with an asset disposition that is so designated as Designated Non-Cash Consideration pursuant to a certificate of an Authorized Officer of the Borrower, setting forth the basis of such valuation, less the amount of cash or Cash Equivalents received in connection with a subsequent payment, redemption, retirement, sale or other disposition of such Designated Non-Cash Consideration.
Designated Foreign Currencies shall mean Canadian Dollars and any other currency acceptable to the Administrative Agent, each applicable Lender and, in the case of Letters of Credit, the L/C Issuer, that is freely convertible into Dollars and readily available in the London interbank market and designated in writing by the Administrative Agent, each applicable Lender, the Borrower and, in the case of Letters of Credit, the L/C Issuer, as a Designated Foreign Currency.
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Designated Foreign Currency Alternate Rate shall mean, for any day, the rate per annum which is quoted at approximately 10:00 a.m. (local time) to leading banks in the European, Canadian or other applicable interbank market by the Administrative Agent for the offering of overnight deposits in the relevant Designated Foreign Currency or, at the option of the Administrative Agent in respect of an outstanding reimbursement obligation in a Designated Foreign Currency, such other base rate as the Administrative Agent would customarily charge on similar obligations of companies of comparable credit standing.
Designated Foreign Currency Alternate Rate Loan means any Loan that bears interest with reference to the Designated Foreign Currency Alternate Rate.
Disqualified Persons means (a) persons identified by name in writing to the Administrative Agent by the Borrower on or prior to March 9, 2015, (b) any Person which is or becomes a competitor of the Borrower that is identified by name in writing to the Administrative Agent by the Borrower from time to time, and (c) any Affiliate of a Person identified pursuant to clause (a) or (b) that is either (x) identified in writing by the Borrower to the Administrative Agent or (y) readily identifiable by the Lenders or the Administrative Agent by name.
Disqualified Stock means any Equity Interests of such Person that, by their terms (or by the terms of any security into which such Equity Interests are convertible or for which such Equity Interests are redeemable or exchangeable), or upon the happening of any event or condition, (a) mature or are mandatorily redeemable, pursuant to a sinking fund obligation or otherwise (other than as a result of a change of control or asset sale so long as any rights of the holders thereof upon the occurrence of a change of control or asset sale event shall be subject to the prior repayment in full of the Loans and all other Obligations that are accrued and payable and the termination of the Commitments), (b) are convertible or exchangeable for Indebtedness or Disqualified Stock, or (c) are redeemable at the option of the holder thereof, in whole or in part, in each case prior to [REDACTED Time Period] following the latest Maturity Date at the time of issuance of such Equity Interests; provided , however , that only the portion of the Equity Interests that so mature or are mandatorily redeemable, are so convertible or exchangeable or are so redeemable at the option of the holder thereof prior to such date shall be deemed to be Disqualified Stock; provided further , however, that if such Equity Interests are issued to any employee or to any plan for the benefit of employees of the Borrower or its subsidiaries or by any such plan to such employees, such Equity Interests shall not constitute Disqualified Stock solely because they may be required to be repurchased by the Borrower in order to satisfy applicable statutory or regulatory obligations or as a result of such employees termination, death or disability; provided further , however, that any class of Equity Interests of such Person that by its terms authorizes such Person to satisfy its obligations thereunder by delivery of Equity Interests that are not Disqualified Stock shall not be deemed to be Disqualified Stock.
Distress Event means, with respect to any Person (a Distressed Person ), a voluntary or involuntary case filed with respect to such Distressed Person, under any debt relief law, or a custodian, conservator, receiver or similar official being appointed for such Distressed Person or any substantial part of such Distressed Persons assets, or such Distressed Person or any Person that directly or indirectly controls such Distressed Person being subject to a forced liquidation, or such Distressed Person making a general assignment for the benefit of creditors or
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being otherwise adjudicated as, or determined by any Governmental Authority having regulatory authority over such Distressed Person or its assets to be, insolvent or bankrupt; provided that a Distress Event shall not be deemed to have occurred solely by virtue of the ownership or acquisition of any Equity Interests in any Person or any Person that directly or indirectly controls such Person by a Governmental Authority or an instrumentality thereof.
Distressed Person as defined in the definition of Distress Event.
Documentation Agent means, collectively, Morgan Stanley Senior Funding, Inc., GE Capital Markets, Inc., TD Securities (USA) LLC and Fifth Third Bank, as co-Documentation Agents.
Dollar Equivalent as defined in Section 1.5.
Dollars and the sign $ mean the lawful money of the United States of America.
Domestic Subsidiary means each subsidiary of the Borrower organized under (i) the laws of the United States of America, any State thereof or the District of Columbia or (ii) the laws of Canada or any province or territory thereof.
Draft means, at any time, (i) a bill of exchange, within the meaning of the Bills of Exchange Act (Canada), drawn by a Borrower on a Revolving Lender and bearing such distinguishing letters and numbers as the Revolving Lender may determine; or (ii) a depository bill within the meaning of the Depository Bills and Notes Act (Canada).
Drawing means (i) the creation and purchase of Bankers Acceptances by a Revolving Lender pursuant to Section 2.24(c)(i); or (ii) the purchase of completed Drafts by a Revolving Lender pursuant to Section 2.24(c)(ii).
Drawing Date means any Business Day fixed for a Drawing pursuant to Section 2.24.
Drawing Fee means, with respect to each Draft drawn by a Borrower and purchased by any Revolving Lender on any Drawing Date, an amount equal to the Applicable Margin for Bankers Acceptance Loans, multiplied by the product of (i) a fraction, the numerator of which is the number of days, inclusive of the first day and exclusive of the last day, in the term to maturity of such Draft, and the denominator of which is 365; and (ii) the face amount of such Draft.
Drawing Notice has the meaning specified in Section 2.24(c)(i).
Drawing Price means, in respect of Drafts drawn by a Borrower to be purchased by one or more Revolving Lenders on any Drawing Date, the amount by which (i) the result (rounded to the nearest whole cent, with one-half of one cent being rounded up) obtained by dividing the aggregate face amount of the Drafts by the sum of one plus the product of (x) the BA Discount Rate multiplied by (y) a fraction, the numerator of which is the number of days,
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inclusive of the first day and exclusive of the last day, in the term to maturity of the Drafts and the denominator of which is 365; exceeds (ii) the applicable aggregate Drawing Fee.
Dutch Auction means an auction of Term Loans conducted pursuant to Section 10.4(o) to allow a Purchasing Borrower Party to prepay Term Loans at a discount to par value and on a non pro rata basis, in each case, in accordance with the applicable Dutch Auction Procedures.
Dutch Auction Procedures means, with respect to a purchase or prepayment of Term Loans by a Purchasing Borrower Party pursuant to Section 10.4(o), Dutch auction procedures as reasonably agreed upon by such Purchasing Borrower Party, as the case may be, and the Administrative Agent.
Eligible Assignee means any Person other than a natural Person that is (i) a Lender, an affiliate of any Lender or an Approved Fund (any two or more Approved Funds being treated as a single Eligible Assignee for all purposes hereof), or (ii) a commercial bank, insurance company, investment or mutual fund or other entity that is an accredited investor (as defined in Regulation D under the Securities Act or, if resident or domiciled in Canada, as defined in National Instrument 45-106 of the Canadian Securities Administrators) and which extends credit or buys loans in the ordinary course of business; provided , no (a) Defaulting Lender, Credit Party or Affiliate of a Credit Party shall be an Eligible Assignee (except assignments pursuant to Section 10.4(o)) and (b) Disqualified Person shall be an Eligible Assignee.
Employee Benefit Plan means any employee benefit plan as defined in Section 3(3) of ERISA (whether or not subject to ERISA) which is or was sponsored, maintained or contributed to by, or required to be contributed by, the Borrower, any of its subsidiaries or any of their respective ERISA Affiliates, including any Canadian Pension Plan and any employee health, welfare or other pension or retirement plans or arrangement maintained for employees employed in Canada.
Environmental Claim means any investigation, notice of violation, claim, action, suit, proceeding, demand, abatement order or other order (conditional or otherwise), by any Governmental Authority or any other Person, arising (i) pursuant to or in connection with any actual or alleged violation of any Environmental Law; (ii) in connection with any Hazardous Materials Activity; or (iii) in connection with any actual or alleged environmental damage, injury or harm.
Environmental Laws means any and all current or future foreign or domestic, federal, provincial or state (or any subdivision of any of them) laws, statutes, ordinances, orders, rules, or regulations relating to (i) environmental matters, including those relating to any Hazardous Materials Activity; (ii) the generation, use, storage, transportation or disposal of Hazardous Materials; or (iii) the protection of human, plant or animal health from exposure to any Hazardous Materials, in any manner applicable to the Borrower or any of its subsidiaries.
Equity Interests means any and all shares, interests, participations or other equivalents (however designated) of capital stock of a corporation, any and all equivalent
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ownership interests in a Person (other than a corporation), including partnership interests and membership interests, and any and all warrants, rights or options to purchase or other arrangements or rights to acquire any of the foregoing (in each case, other than debt securities convertible into the foregoing, and royalties).
Equity Offering as defined in the recitals hereto.
ERISA means the Employee Retirement Income Security Act of 1974, as amended from time to time, and any successor thereto.
ERISA Affiliate means, as applied to any Person, (i) any corporation which is a member of a controlled group of corporations within the meaning of Section 414(b) of the Internal Revenue Code of which that Person is a member; (ii) any trade or business (whether or not incorporated) which is a member of a group of trades or businesses under common control within the meaning of Section 414(c) of the Internal Revenue Code of which that Person is a member; and (iii) any member of an affiliated service group within the meaning of Section 414(m) or (o) of the Internal Revenue Code of which that Person, any corporation described in clause (i) above or any trade or business described in clause (ii) above is a member.
ERISA Event means (i) a reportable event within the meaning of Section 4043(c) of ERISA and the regulations issued thereunder with respect to any Pension Plan (excluding those for which the provision for 30-day notice to the PBGC has been waived by regulation); (ii) the failure to meet the minimum funding standard of Sections 412 and 430 of the Internal Revenue Code and Sections 302 and 303 of ERISA with respect to any Pension Plan (whether or not waived in accordance with Section 412(c) of the Internal Revenue Code and Section 302(c) of ERISA) or the failure to make by its due date a required installment under Section 430(j) of the Internal Revenue Code with respect to any Pension Plan or the failure to make any required contribution to a Multiemployer Plan; (iii) the provision by the administrator of any Pension Plan pursuant to Section 4041(a)(2) of ERISA of a notice of intent to terminate such plan in a distress termination described in Section 4041(c) of ERISA; (iv) the withdrawal by the Borrower, any of its subsidiaries or any of their respective ERISA Affiliates from any Pension Plan with two or more contributing sponsors or the termination of any such Pension Plan resulting in liability to the Borrower, any of its subsidiaries or any of their respective ERISA Affiliates pursuant to Section 4063 or 4064 of ERISA; (v) the institution by the PBGC of proceedings to terminate any Pension Plan, or the occurrence of any event or condition which constitutes grounds under Section 4042 of ERISA for the termination of, or the appointment of a trustee to administer, any Pension Plan; (vi) the imposition of liability on the Borrower, any of its subsidiaries or any of their respective ERISA Affiliates pursuant to Section 4062(e) or 4069 of ERISA or by reason of the application of Section 4212(c) of ERISA; (vii) the withdrawal of the Borrower, any of its subsidiaries or any of their respective ERISA Affiliates in a complete or partial withdrawal (within the meaning of Sections 4203 and 4205 of ERISA) from any Multiemployer Plan if there is any potential liability therefore, or the receipt by the Borrower, any of its subsidiaries or any of their respective ERISA Affiliates of notice from any Multiemployer Plan that it is in reorganization or insolvency pursuant to Section 4241 or 4245 of ERISA, or that it intends to terminate or has terminated under Section 4041A or 4042 of ERISA; (viii) receipt from the Internal Revenue Service of written notice of the failure of any Pension Plan (or any other Employee Benefit Plan intended to be qualified under Section 401(a) of the
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Internal Revenue Code) to qualify under Section 401(a) of the Internal Revenue Code, or the failure of any trust forming part of any Pension Plan to qualify for exemption from taxation under Section 501(a) of the Internal Revenue Code; (ix) the imposition of a lien pursuant to Section 430(k) of the Internal Revenue Code or Section 303(k) of ERISA or a violation of Section 436 of the Internal Revenue Code; (x) any event with respect to any Non-U.S. Plan which is similar to any event described in any of subsections (i) through (ix) hereof; (xi) the failure to make required contributions in a timely manner to any Canadian Pension Plan in accordance with its terms and applicable laws; (xii) the occurrence of any event which constitutes grounds under applicable pension standards legislation for the applicable pension regulator to remove the administrator of any Canadian Pension Plan; or (xiii) the revocation of the registration under the Income Tax Act (Canada) of any Canadian Pension Plan.
Euro or shall mean the single currency of the European Union as constituted by the Treaty on European Union and as referred to in the legislative measures of the European Union for the introduction of, changeover to or operation of the Euro in one or more member states.
Eurocurrency Rate Loan means a Loan bearing interest at a rate determined by reference to the Adjusted LIBOR.
Event of Default means each of the conditions or events set forth in Section 8.1; provided that a Financial Covenant Default shall not be an Event of Default with respect to the Term Loans in the circumstances described in the last sentence of Section 8.1.
Excess Cash Flow means, for any period, an amount (if positive) equal to:
(1) the Consolidated Net Income of the Borrower and its Restricted Subsidiaries for such period determined on a consolidated basis, increased, in each case, without duplication, by:
(a) an amount equal to the amount of all non-cash charges (including depreciation and amortization) to the extent deducted in arriving at such Consolidated Net Income, but excluding (i) any such non-cash charges representing an accrual or reserve for potential cash items in any future period and (ii) amortization of a prepaid cash item that was paid in a prior period;
(b) decreases in Consolidated Working Capital for such period;
(c) net cash receipts in respect of Hedge Agreements during such period to the extent not otherwise included in such Consolidated Net Income;
(d) the aggregate amount of any non-cash loss recognized as a result of any Asset Sale or Casualty Event (other than any Asset Sale in the ordinary course of business) that resulted in a decrease to Consolidated Net Income (up to the amount of such decrease);
reduced by (without duplication):
(2) the sum, in each case, without duplication, of:
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(a) an amount equal to the amount of all (i) non-cash credits included in arriving at such Consolidated Net Income (excluding any non-cash credit to the extent representing the reversal of an accrual or reserve described in clause (1)(a) above) and (ii) cash charges excluded by virtue of clauses (a) through (p) of the definition of Consolidated Net Income;
(b) the amount of any prepaid cash item deducted in part for such period, with the balance amortized over a subsequent period;
(c) the aggregate amount of all principal payments of Indebtedness of the Borrower and its Restricted Subsidiaries (including (i) the principal component of payments in respect of Capital Lease Obligations and (ii) the amount of any mandatory or voluntary prepayment of Indebtedness (excluding (A) all prepayments in respect of any revolving credit facility (including Revolving Commitments), except to the extent there is an equivalent permanent reduction in commitments thereunder, (B) prepayments of the Term Loans and (C) prepayments and payments of the Senior Notes)) made during such period, in each case financed with Internally Generated Cash of the Borrower and its Restricted Subsidiaries;
(d) increases in Consolidated Working Capital for such period;
(e) cash payments by the Borrower and its Restricted Subsidiaries during such period in respect of the permanent reduction of long-term liabilities of the Borrower and its Restricted Subsidiaries (other than Indebtedness) to the extent such payments are not expensed during such period or are not deducted in calculating Consolidated Net Income;
(f) [Reserved];
(g) without duplication of amounts deducted pursuant to clause (j) below in prior Fiscal Years, (i) the amount of capital expenditures, including but not limited to the purchase of fixed assets, and (ii) the aggregate amount of cash consideration paid by the Borrower and its Restricted Subsidiaries in connection with Investments constituting Permitted Acquisitions, Specified Investments and permitted acquisitions of Intellectual Property made during such period, in each case, to the extent financed with Internally Generated Cash of the Borrower and its Restricted Subsidiaries;
(h) the amount of Restricted Payments made in cash pursuant to clauses (b), (d) and (f) of Section 6.5 paid during such period in each case to the extent such Restricted Payments were financed with Internally Generated Cash of the Borrower and its Restricted Subsidiaries;
(i) the aggregate amount of any premium, make-whole or penalty payments actually paid in cash by the Borrower and its Restricted Subsidiaries during such period that are made in connection with any prepayment, early extinguishment or conversion of Indebtedness to the extent such payments are not expensed during such period or are not deducted in calculating Consolidated Net Income;
(j) without duplication of amounts deducted from Excess Cash Flow in prior periods, the aggregate consideration required to be paid in cash by the Borrower or any of its
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Restricted Subsidiaries pursuant to binding contracts entered into prior to or during such period relating to Permitted Acquisitions or other Investments, capital expenditures or permitted acquisitions of Intellectual Property to be consummated or made during the period of four consecutive Fiscal Quarters of the Borrower following the end of such period;
(k) the amount of cash taxes (including penalties and interest) paid or tax reserves set aside or payable (without duplication) in such period to the extent they exceed the amount of tax expense deducted in determining Consolidated Net Income for such period;
(l) cash expenditures in respect of Hedge Agreements during such period to the extent not deducted in arriving at such Consolidated Net Income;
(m) proceeds of any Asset Sale or Casualty Event to the extent otherwise included in the definition of Excess Cash Flow and to the extent the Borrower is in compliance with the applicable mandatory prepayment requirements set forth in Section 2.12;
(n) the aggregate amount of any non-cash gain recognized as a result of any Asset Sale or Casualty Event (other than any Asset Sale in the ordinary course of business) that resulted in an increase to Consolidated Net Income (up to the amount of such increase), and cash indemnity payments received pursuant to indemnification provisions in any acquisition or any other Investment permitted under this Agreement, in each case that resulted in an increase to Consolidated Net Income (up to the amount of such increase);
(o) the aggregate amount of fees, costs and expenses in connection with any Permitted Acquisition or Asset Sale, and any payments of Transaction Costs, to the extent not expensed and not deducted in calculating Consolidated Net Income; and
(p) to the extent not already deducted in calculating Consolidated Net Income, losses, charges and expenses related to internal software development that are expenses but could have been capitalized under alternative accounting policies in accordance with IFRS.
Excess Cash Flow Calculation Date as defined in Section 2.12(b).
Excess Cash Flow Period means each Fiscal Year of the Borrower, commencing with the Fiscal Year of the Borrower ending on December 31, 2015 (it being agreed that with respect to the Fiscal Year ending December 31, 2015, the period shall commence on the Closing Date).
Exchange Act means the Securities Exchange Act of 1934, as amended from time to time, and any successor statute.
Exchange Rate shall mean, on any day, with respect to any Designated Foreign Currency, the rate at which such currency may be exchanged into Dollars, as set forth at approximately 12:00 noon, Toronto time, on such day on the Bank of Canada noon mid-point spot rate for such currencies on such date of determination (as quoted or published from time to time by the Bank of Canada). In the event that such rate does not appear on the Bank of Canada noon spot page, the Exchange Rate shall be determined by reference to such other publicly available service for displaying exchange rates as may be agreed upon by the Administrative
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Agent and the Borrower, or, in the absence of such agreement, such Exchange Rate shall instead be the arithmetic average of the spot rates of exchange of the Administrative Agent in the market where its foreign currency exchange operations in respect of such currency are then being conducted, at or about 12:00 noon, Toronto time, on such date for the purchase of Dollars for delivery [REDACTED Time Period] later; provided , however, that if at the time of any such determination, for any reason, no such spot rate is being quoted, the Administrative Agent, after consultation with the Borrower, may use any reasonable method it deems appropriate to determine such rate, and such determination shall be presumed correct absent manifest error.
Excluded Amounts as defined in Section 2.12(g).
Excluded Indebtedness means all Indebtedness not incurred in violation of Section 6.1 (other than Refinancing Loans and Refinancing Equivalent Debt).
Excluded Property means (a) (1) all owned real property interests with a fair market value equal to or less than [REDACTED Dollar Amount] (as reasonably determined by the Borrower in good faith); and (2) all leasehold interests (it is understood that there shall be no requirement to obtain landlord waivers, estoppels or collateral access agreements or acknowledgements, bailee waivers and similar letters), (b) motor vehicles and other assets subject to certificates of title (unless otherwise capable of perfection by registration under the PPSA), letter of credit rights with an individual face amount not exceeding [REDACTED Dollar Amount] (except to the extent constituting a support obligation for other Collateral as to which perfection of the security interest in such other Collateral is accomplished solely by the filing of a UCC or PPSA financing statement (or similar filing in any applicable jurisdiction) and commercial tort claims below [REDACTED Dollar Amount] , (c) any lease, license or other agreement or any property subject to a purchase money security interest, Capital Lease Obligation or similar arrangements permitted hereunder, the property subject thereto, any insurance in respect thereof, any management or operating agreement with respect thereto and deposits made in respect thereof and all rights in relation to any of the foregoing, in each case, to the extent that a grant of a security interest therein would violate or invalidate such lease, license or agreement, purchase money, capital lease or a similar arrangement or create a right of termination in favor of any other party thereto (other than a Credit Party) (d) (1) Equity Interests which constitute Margin Stock (2) Equity Interests in Unrestricted Subsidiaries and (3) Equity Interests in any Person other than wholly-owned subsidiaries to the extent the granting of a security interest is not permitted by law or the terms of such subsidiarys organizational, shareholders, acquisition, joint venture or governance documents (including as a result of minority ownership) or would trigger termination pursuant to any change of control or similar provision, (e) pledges and security interests (including in respect of interests in partnerships, joint ventures and other non-wholly owned entities) to the extent prohibited by law or prohibited by agreements containing anti assignment clauses not overridden by the UCC, PPSA or other applicable law, (f) intellectual property specifically requiring a filing in a jurisdiction outside of the United States and Canada, (g) assets to the extent a security interest in such assets would result in material adverse tax consequences to any Credit Party (as reasonably determined by the Borrower), (h) deposit accounts, securities accounts, commodities accounts, futures accounts and other similar accounts of the Credit Parties (A) for the sole purpose of funding (1) payroll, healthcare and other employee wage and benefit accounts, (2) tax accounts (including without limitation, sales tax accounts), (3) escrow, defeasance, discharge and redemption accounts and
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(4) fiduciary and trust accounts, and, in the case of sub-clauses (1) through (4), the funds or other property held in or maintained in any such account, (B) that are zero-balance accounts, (C) that are accounts in jurisdictions other than in the jurisdiction of organization of the applicable granting Credit Party, the United States or any state thereof or Canada or any province or territory thereof, and (D) that are accounts other than those described in the preceding clauses (A) through (C) with respect to which the average daily balance of the funds maintained on deposit therein does not exceed [REDACTED Dollar Amount] , (i) intellectual property specifically requiring a filing in a jurisdiction outside of the United States and Canada and intent-to-use trademark applications to the extent and during the period in which the grant of a security interest therein would impair the validity or enforceability of such intent-to-use trademark applications under applicable federal law, including prior to the filing of a Statement of Use or Amendment to Allege Use with respect thereto, (j) assets in circumstances where the Administrative Agent and the Borrower reasonably determine in good faith that the cost, burden or consequences of obtaining or perfecting a security interest in such assets is excessive in relation to the practical benefit to the Lenders of the security to be afforded thereby and (i) the Companys or its subsidiaries rights in relation to corporate aircraft, including rights under any lease, sublease, charter, management, operating, crew, service, repair, maintenance, storage or other agreement relating to the aircraft, rights in the aircraft and any parts, accessions and accessories thereto, rights under insurance policies and security deposits and rights in income derived from and proceeds of any of the foregoing, in the ordinary course; provided that clauses (c), (d), (e) and (f) shall not include (x) items to the extent the prohibition or restriction on the assignment or pledge thereof under the Collateral Documents is ineffective under applicable anti-assignment provisions of the UCC or other applicable law or (y) proceeds and receivables of the assets referred to in such clause, the assignment of which is expressly deemed effective under applicable anti-assignment provisions of the UCC or other applicable law notwithstanding such prohibition.
Excluded Subsidiary means (a) Unrestricted Subsidiaries, (b) Immaterial Subsidiaries, (c) any subsidiary that is prohibited by applicable law, rule or regulation or by any contractual obligation existing on the Closing Date or on the date any such subsidiary is acquired (so long as, in respect of any such contractual prohibition, such prohibition is not incurred in contemplation of such acquisition), from guaranteeing the payment of the Obligations or which would require consent, approval, license or authorization from any Governmental Authority to provide a guarantee, (d) any Qualified CFC Holding Companies, (e) Foreign Subsidiaries that are CFCs, (f) direct or indirect subsidiaries of CFCs, (g) any not-for-profit subsidiaries, captive insurance subsidiaries or other special purpose entities, if any, and (h) notwithstanding the foregoing, additional subsidiaries may be excluded from the guarantee requirements in circumstances where the Administrative Agent and the Borrower determine in good faith that the cost or burden of providing such a guarantee is excessive in relation to the value afforded to the Lenders thereby.
Excluded Swap Obligation means, with respect to any Guarantor, as it relates to all or a portion of the Guaranteed Obligation of such Guarantor, any Swap Obligation if, and to the extent that, such Swap Obligation (or any guarantee thereof) is or becomes illegal under the Commodity Exchange Act or any rule, regulation or order of the Commodity Futures Trading Commission after giving effect to customary keepwell provisions (or the application or official interpretation of any thereof).
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Excluded Taxes means, with respect to the Administrative Agent, any Lender or any other recipient of any payment to be made by or on account of any obligation of a Credit Party hereunder, the following Taxes:
(a) any Taxes imposed on (or measured by) its net income, net profits, net gains or franchise Taxes, or, in the case of Canada, capital, that (x) are imposed by the country in which the applicable recipient is legally organized or any political subdivision thereof, or by the jurisdiction under the laws of which such recipient is organized or in which its principal office is located or, in the case of any Lender, in which its applicable lending office is located, in each case including any political subdivision thereof or (y) are Other Connection Taxes,
(b) any branch profits Taxes or any similar Tax (x) imposed by the United States of America or Canada, (y) imposed by any other jurisdiction described in clause (a) above or (z) that is an Other Connection Tax,
(c) any withholding Tax that is attributable to a Lenders failure to comply with Section 2.17(c),
(d) in the case of a Lender, any withholding Tax imposed by the United States or Canada on amounts payable by a Credit Party (or the Administrative Agent) to the applicable lending office of such Lender at the time such Lender becomes a party to this Agreement (other than pursuant to an assignment request by the Borrower under Section 2.18(b)) or designates a new lending office, except in each case to the extent that, pursuant to Section 2.17, amounts with respect to such Taxes were payable either to such Lenders assignor immediately before such Lender became a party hereto or to such Lender immediately before it changes its lending office,
(e) any withholding Tax payable under Part XIII of the Income Tax Act (Canada) that is imposed on amounts payable to or for the account of a Lender as a consequence of the Lender not dealing at arms length (within the meaning of the Income Tax Act (Canada)) with the Borrower at the time of such payment,
(f) any withholding Tax payable under Part XIII of the Income Tax Act (Canada) that is imposed on amounts payable to or for the account of a Lender as a consequence of the Lender being, at any time, a specified non-resident shareholder (within the meaning of subsection 18(5) of the Income Tax Act (Canada)) of the Borrower, or, at any time, not dealing at arms length (within the meaning of the Income Tax Act (Canada)) with a specified shareholder (within the meaning of subsection 18(5) of the Income Tax Act (Canada)) of the Borrower, and
(g) any U.S. withholding Taxes imposed under FATCA.
Executive Order as defined in Section 4.22(a).
Existing Credit Agreement means the Amended and Restated Credit Agreement, dated as of September 30, 2014, among the Borrower, the lenders party thereto and GE Capital Canada Finance, Inc., as administrative agent, as the same may be amended, modified or supplemented from time to time.
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Existing Revolver Tranche as defined in Section 2.22(b).
Existing Term Loan Tranche as defined in Section 2.22(a).
Extended Revolving Commitment as defined in Section 2.22(b).
Extended Term Loans as defined in Section 2.22(a).
Extending Lender means Extending Term Lender or Extending Revolving Lender, as the context may require.
Extending Revolving Lender as defined in Section 2.22(c).
Extending Term Lender as defined in Section 2.22(c).
Extension means the establishment of an Extension Series by amending a Loan and/or Commitment pursuant to Section 2.22 and the applicable Extension Amendment.
Extension Amendment as defined in Section 2.22(d).
Extension Election as defined in Section 2.22(c).
Extension Minimum Condition means a condition to consummating any Extension that a minimum amount (to be determined and specified in the relevant Extension Request, in the Borrowers sole discretion) of any or all applicable Class or Classes be submitted for Extension.
Extension Request means any Term Loan Extension Request or a Revolver Extension Request, as the case may be.
Extension Series means any Term Loan Extension Series or a Revolver Extension Series, as the case may be.
Fair Share as defined in Section 7.2.
Fair Share Contribution Amount as defined in Section 7.2.
FATCA means (a) Sections 1471 through 1474 of the Internal Revenue Code, as of the date of this Agreement (or any amended or successor version that is substantively comparable and not materially more onerous to comply with) and any current or future regulations or official interpretations thereof, (b) any agreements entered into pursuant to Section 1471(b)(1) of the Internal Revenue Code, and (c) any intergovernmental agreement between the U.S. and that other jurisdiction, which facilitates the implementation of any law or regulation referred to in paragraph (a) above.
FCPA as defined in Section 4.23.
Federal Funds Effective Rate means for any day, the rate per annum equal to the weighted average of the rates on overnight Federal funds transactions with members of the
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Federal Reserve System arranged by Federal funds brokers on such day, as published by the Federal Reserve Bank of New York on the Business Day next succeeding such day; provided , (i) if such day is not a Business Day, the Federal Funds Rate for such day shall be such rate on such transactions on the next preceding Business Day as so published on the next succeeding Business Day, and (ii) if no such rate is so published on such next succeeding Business Day, the Federal Funds Rate for such day shall be the average rate charged to Administrative Agent on such day on such transactions as determined by the Administrative Agent.
Fee Letter means the Fee Letter, dated as of March 9, 2015 between the Borrower and Royal Bank of Canada, as amended, restated, supplemented or otherwise modified from time to time.
Fees means the fees set forth in the Fee Letter and relating hereto.
Financial Covenant Default as defined in Section 8.1.
Financial Officer means, of any Person, the Chief Financial Officer, principal accounting officer, vice-president of finance, Treasurer, Assistant Treasurer or Controller of such Person (and, in the case of the Borrower, shall also mean each Person performing similar duties as the foregoing (including any director, manager or member of the Borrower)).
Financial Performance Covenant means the covenant set forth in Section 6.10.
Fiscal Quarter means any of the quarterly accounting periods of the Borrower ending on March 31, June 30, September 30 and December 31.
Fiscal Year means the twelve-month accounting period of the Borrower ending on December 31.
Flood Hazard Property means any real estate asset located in the United States of America subject to a mortgage and located in an area designated by the Federal Emergency Management Agency as having special flood or mud slide hazards.
Foreign Official shall mean a Person acting in an official capacity for or on behalf of any Governmental Authority.
Foreign Subsidiary means each subsidiary of the Borrower which is not a Domestic Subsidiary.
Fronting Exposure means, at any time there is a Defaulting Lender, with respect to any L/C Issuer, such Defaulting Lenders Pro Rata Share of the outstanding L/C Obligations other than L/C Obligations as to which such Defaulting Lenders participation obligation has been reallocated to other Lenders or Cash Collateralized in accordance with the terms hereof.
Funding Guarantors as defined in Section 7.2.
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Funding Notice means a notice substantially in the form of Exhibit A-1 .
GAAP means, subject to the provisions of Section 1.2, United States generally accepted accounting principles in effect as of the date of determination thereof.
Governmental Authority means any applicable foreign or domestic, federal, state, provincial, territorial, municipal, supranational, national or other government, governmental department, commission, board, bureau, court, agency or instrumentality or political subdivision thereof (which shall include, without limitation, the European Central Bank and the Council of Ministers of the European Union) or any entity, officer or examiner exercising executive, legislative, judicial, regulatory, taxing or administrative functions of or pertaining to any government or any court, in each case whether associated with a state of the United States, the United States, or a foreign entity or government.
Guaranteed Obligations as defined in Section 7.1.
Guarantor means each Restricted Subsidiary listed on Schedule 1.1(a) and each other Restricted Subsidiary of the Borrower thereafter that becomes, or is required to become, a Guarantor after the Closing Date in accordance with the Collateral and Guarantee Requirement.
Guaranty as defined in Section 7.2.
Hazardous Materials means any chemical, material or substance, exposure to which is prohibited, limited, governed or regulated by any Governmental Authority pursuant to any Environmental Law.
Hazardous Materials Activity means any use, manufacture, possession, storage, holding, Release, threatened Release, discharge, placement, generation, transportation, processing, construction, treatment, abatement, removal, remediation, disposal, disposition or handling of any Hazardous Materials, and any corrective action or response action with respect to any of the foregoing.
Hedge Agreement means any agreement with respect to any swap, spot, forward, future or derivative transaction or option or similar agreement involving, or settled by reference to, one or more rates, currencies, foreign exchange, commodities, equity or debt instruments or securities, or economic, financial or pricing indices or measures of economic, financial or pricing risk or value or any similar transaction or any combination of these transactions, in each case, not entered into for speculative purposes. For the avoidance of doubt, Hedge Agreements shall not be deemed speculative or entered into for speculative purposes if any Hedge Agreement is intended in good faith, at inception of execution, (A) to hedge or manage the interest rate exposure associated with any debt securities or debt facilities of the Borrower or its Restricted Subsidiaries, (B) for foreign exchange or currency exchange management or (C) to hedge any exposure that the Borrower or its Restricted Subsidiaries may have to counterparties under other Hedge Agreements such that the combination of such Hedge Agreements is not speculative taken as a whole.
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Herrera Subordination Agreement means that certain Subordination and Postponement Agreement dated as of the Closing Date among the Administrative Agent, the Borrower and Guillermo Herrera.
Honor Date as defined in Section 2.3(d)(i).
IFRS means International Financial Reporting Standards promulgated by the International Accounting Standards Board (or any successor board or agency), as adopted by the Chartered Professional Accountants of Canada and in effect from time to time.
Immaterial Subsidiary means any subsidiary of the Borrower (a) identified on Schedule 1.1(b) or (b) designated by the Borrower as an Immaterial Subsidiary hereunder after the Closing Date by prior written notice to the Administrative Agent, that (x) as of the last day of the Fiscal Quarter of the Borrower most recently ended, (i) such subsidiary did not have assets with a value in excess of [REDACTED Percentage] of Consolidated Total Assets or revenues representing in excess of [REDACTED Percentage] of Consolidated Adjusted EBITDA as of such date and (ii) when taken together with all other Immaterial Subsidiaries as of such date, such Immaterial Subsidiaries did not have assets with a value in excess of [REDACTED Percentage] of the Consolidated Total Assets or revenues representing in excess of [REDACTED Percentage] of Consolidated Adjusted EBITDA as of such date, and (y) the Borrower shall have delivered to the Administrative Agent an officers certificate executed by an Authorized Officer of the Borrower, certifying to such officers knowledge, compliance with the requirements of clause (x) above. Any Immaterial Subsidiary may be designated to be a Material Subsidiary for the purposes of this Agreement by written notice from the Borrower to the Administrative Agent. Any determination of whether a subsidiary shall cease to qualify as an Immaterial Subsidiary shall be made on the date that financial statements are delivered pursuant to Section 5.4(a). To the extent a subsidiary ceases to be an Immaterial Subsidiary in connection with such determination, the Borrower shall have [REDACTED Time Period] from the date of delivery of such financial statements to cause such subsidiary to comply with any applicable requirements of the Collateral and Guarantee Requirement with extensions of such 90-day period as may be reasonably requested by the Borrower and consented to by the Administrative Agent (such consent not to be unreasonably withheld, conditioned or delayed).
Increased Amoun t of any Indebtedness means any increase in the amount of such Indebtedness in connection with any accrual of interest, the accretion of accreted value, the amortization of original issue discount, the payment of interest in the form of additional Indebtedness with the same terms or in the form of common stock of the Borrower and the accretion of original issue discount or liquidation preference.
Incremental Amendment as defined in Section 2.20(f).
Incremental Commitments as defined in Section 2.20(a).
Incremental Equivalent Debt means Indebtedness issued in accordance with Section 2.20(h) consisting of one or more series of pari passu notes, junior lien notes, junior lien or subordinated loans, subordinated notes or unsecured notes or unsecured loans, in each case, issued in a public offering, Rule 144A or other private placement transaction, a bridge facility in
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lieu of the foregoing, or secured or unsecured mezzanine Indebtedness or debt securities, in each case, subject to the terms set forth in Section 2.20(i).
Incremental Lenders as defined in Section 2.20(c).
Incremental Loan as defined in Section 2.20(b).
Incremental Loan Request as defined in Section 2.20(a).
Incremental Revolving Commitments as defined in Section 2.20(a).
Incremental Revolving Lender as defined in Section 2.20(c).
Incremental Revolving Loan as defined in Section 2.20(b).
Incremental Term Commitments as defined in Section 2.20(a).
Incremental Term Lender as defined in Section 2.20(c).
Incremental Term Loan as defined in Section 2.20(b).
Incremental Tranche Closing Date as defined in Section 2.20(d).
Indebtedness means, with respect to any Person, without duplication (a) all obligations of such Person for borrowed money, (b) all obligations of such Person evidenced by bonds, debentures, notes or similar instruments, (c) all obligations of such Person under conditional sale or other title retention agreements relating to property or assets purchased by such Person, (d) all obligations of such Person issued or assumed as the deferred purchase price of property or services, (e) all guarantees by such Person of Indebtedness described in the other clauses of this definition of others, (f) all Capital Lease Obligations of such Person, (g) all net payments that such Person would have to make in the event of an early termination, on the date Indebtedness of such Person is being determined, in respect of outstanding Hedge Agreements, (h) the principal component of all obligations, contingent or otherwise, of such Person as an account party in respect of letters of credit (other than letters of credit issued in respect of trade payables), (i) the principal component of all obligations of such Person in respect of bankers acceptances (other than bankers acceptances issued in respect of trade payables) and (j) the amount of all obligations of such Person with respect to the redemption, repayment or other repurchase of any Disqualified Stock (excluding accrued dividends that have not increased the liquidation preference of such Disqualified Stock); provided that Indebtedness shall not include (i) current trade liabilities and current intercompany liabilities (other than any refinancings, extensions, renewals or replacements thereof) incurred in the ordinary course of business, (ii) prepaid or deferred revenue arising in the ordinary course of business and not overdue for more than [REDACTED Time Period] , (iii) purchase price holdbacks arising in the ordinary course of business in respect of a portion of the purchase price of an asset to satisfy unperformed obligations of the seller of such asset, (iv) earn-out obligations until such obligations become a liability on the balance sheet of such Person in accordance with IFRS, (v) obligations in respect of letters of credit or bankers acceptances issued in respect of trade payables or (vi) interest, fees, premium, and expenses and additional payments, if any. The Indebtedness of any Person
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shall include the Indebtedness of any partnership in which such Person is a general partner, other than to the extent that the instrument or agreement evidencing such Indebtedness expressly limits the liability of such Person in respect thereof.
Indemnified Costs as defined in Section 9.5.
Indemnified Taxes means all Taxes (other than Excluded Taxes and Other Taxes) imposed on or with respect to any payment made by or on account of any obligation of any Credit Party under any Credit Document.
Indemnitee as defined in Section 10.5(b).
Information as defined in Section 4.14(a).
Initial Revolving Commitment means the commitments as of the Closing Date of any Lender to make or otherwise fund any Revolving Loan and to acquire participations in Letters of Credit and Swing Line Loans hereunder and any Incremental Revolving Commitments deemed to be of the same Class as the Initial Revolving Commitments pursuant to Section 2.20. The aggregate amount of the Initial Revolving Commitments as of the Closing Date is [REDACTED Dollar Amount] .
Initial Revolving Loan means a Loan made by a Lender to a Borrower in respect of an Initial Revolving Commitment pursuant to Section 2.2 or Section 2.20.
Initial Term Loan means the term loans made by a Lender to the Borrower pursuant to Section 2.1(a) on the Closing Date.
Initial Term Loan Commitment means the commitment of a Lender to make or otherwise fund an Initial Term Loan and Initial Term Loan Commitments means such commitments of all Lenders in the aggregate. The amount of each Lenders Initial Term Loan Commitment, if any, is set forth on Appendix A-1 or in the applicable Assignment Agreement, subject to any adjustment or reduction pursuant to the terms and conditions hereof. The aggregate amount of the Initial Term Loan Commitments as of the Closing Date is [REDACTED Dollar Amount] .
Initial Term Loan Exposure means, with respect to any Lender, as of any date of determination, the outstanding principal amount of the Initial Term Loans of such Lender; provided , at any time prior to the making of the Initial Term Loans, the Initial Term Loan Exposure of any Lender shall be equal to such Lenders Initial Term Loan Commitment.
Initial Term Loan Note means a promissory note in the form of Exhibit B-1 , as it may be amended, restated, supplemented or otherwise modified from time to time.
Intellectual Property as defined in the Pledge and Security Agreement.
Intercreditor Agreement means collectively, any customary intercreditor agreement entered into by the Agents pursuant to Section 9.11 hereof, each as amended, restated,
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modified, supplemented or replaced from time to time in accordance with this Agreement or the terms of such intercreditor agreements.
Interest Payment Date means with respect to (i) any Loan that is a Base Rate Loan or Canadian Prime Rate Loan, the last Business Day of each March, June, September and December of each year, commencing on the first such date to occur after the Closing Date and the final maturity date of such Loan and (ii) any Loan that is a Eurocurrency Rate Loan, the last day of each Interest Period applicable to such Loan; provided , in the case of each Interest Period of longer than [REDACTED Time Period] Interest Payment Date shall also include each date that is [REDACTED Time Period] , or an integral multiple thereof, after the commencement of such Interest Period.
Interest Period means, in connection with a Eurocurrency Rate Loan, an interest period of [REDACTED Time Period] or, if agreed to by all relevant Lenders, [REDACTED Time Period] , as selected by the Borrower in the applicable Funding Notice or Conversion/Continuation Notice, (i) initially, commencing on the Credit Date or Conversion/Continuation Date thereof, as the case may be; and (ii) thereafter, commencing on the day on which the immediately preceding Interest Period expires; provided (a) if an Interest Period would otherwise expire on a day that is not a Business Day, such Interest Period shall expire on the next succeeding Business Day unless no further Business Day occurs in such month, in which case such Interest Period shall expire on the immediately preceding Business Day; (b) any Interest Period that begins on the last Business Day of a calendar month (or on a day for which there is no numerically corresponding day in the calendar month at the end of such Interest Period) shall, subject to clauses (c) and (d) of this definition, end on the last Business Day of a calendar month; (c) no Interest Period with respect to any portion of any Class of Term Loans shall extend beyond such Classs Maturity Date; and (d) no Interest Period with respect to any portion of the Revolving Loans shall extend beyond the Revolving Commitment Termination Date.
Interest Rate Determination Date means, with respect to any Interest Period, the date that is [REDACTED Time Period] prior to the first day of such Interest Period.
Internal Revenue Code means the Internal Revenue Code of 1986, as amended to the date hereof and from time to time hereafter, and any successor statute.
Internally Generated Cash means, with respect to any period, any cash of the Borrower or any subsidiary generated during such period, excluding Net Cash Proceeds and any cash that is generated from an incurrence of Indebtedness, an issuance of Equity Interests or a capital contribution.
Intra-Group Subordination Agreement shall mean the Intra-Group Subordination Agreement among Royal Bank, as Administrative Agent (as defined therein), each other agent party thereto, the Borrower and each subsidiary of the Borrower listed on the signature pages thereto or that becomes a party thereto pursuant to Section 3.12 thereof substantially in the form of Exhibit K, as the same may be amended, supplemented or modified from time to time in accordance with the terms thereof.
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Investment means (a) any purchase or other acquisition by the Borrower or any of its Restricted Subsidiaries of, or of a beneficial interest in, any of the Equity Interests of any other Person (other than the Borrower or any Restricted Subsidiary), (b) the acquisition by purchase or otherwise (other than purchases or other acquisitions of inventory, goods, materials, supplies and/or equipment in the ordinary course of business) of all or a substantial portion of the business, property or fixed assets of any Person or any division or line of business or other business unit of any Person (in each case, other than the Borrower or any Restricted Subsidiary to the extent the purchaser is a Loan Party following consummation thereof) and (c) any loan, advance (other than (i) advances to current or former employees, officers, directors and consultants of the Borrower or any Restricted Subsidiary for moving, entertainment and travel expenses, drawing accounts and similar expenditures in the ordinary course of business, (ii) advances made on an intercompany basis in the ordinary course of business for the purchase of inventory, (iii) accounts receivable and other extensions of trade credit in accordance with customary practices and (iv) prepaid expenses and workers compensation, utility, lease (including leases and other agreements related to aircraft) and similar deposits in the ordinary course of business) or capital contribution by the Borrower or any Restricted Subsidiary to any other Person (other than the Borrower or any Credit Party). Subject to Section 6.3, the amount of any Investment shall be the original cost of such Investment plus the cost of all additions thereto, without any adjustments for increases or decreases in value, or write-ups, write-downs or write-offs with respect to such Investment, but giving effect to any repayments of principal in the case of Investments in the form of loans and any return of capital or return on Investment in the case of equity Investments (whether as a distribution, dividend, redemption or sale but not in excess of the amount of the initial Investment).
ISP means, with respect to any Letter of Credit, the International Standby Practices 1998 published by the Institute of International Banking Law & Practice, Inc. (or such later version thereof as may be in effect at the time of issuance).
Issuer Documents means with respect to any Letter of Credit, the Letter of Credit Application, and any other document, agreement and instrument entered into by any L/C Issuer and the Borrower (or any subsidiary of the Borrower) or in favor of the L/C Issuer and relating to such Letter of Credit.
Issuing Country as defined in Section 9.3(a).
Joinder Agreement means an agreement substantially in the form of Exhibit D , with such changes as may be required by or reasonably acceptable to the Borrower and the Agent.
judgment currency as defined in Section 10.19.
Junior Financing as defined in Section 6.8(a).
L/C Advance means, with respect to each Lender, such Lenders funding of its participation in any L/C Borrowing in accordance with its Pro Rata Share.
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L/C Borrowing means an extension of credit resulting from a drawing under any Letter of Credit which has not been reimbursed on the date when made or refinanced as a Revolving Loan.
L/C Credit Extension means, with respect to any Letter of Credit, the issuance thereof or extension of the expiry date thereof, or the increase of the amount thereof.
L/C Exposure means at any time the sum of (a) the aggregate undrawn amount of all Letters of Credit outstanding at such time and (b) the aggregate principal amount of all L/C Advances that have not yet been reimbursed at such time. The L/C Exposure of any Lender at any time means its Pro Rata Share of the aggregate L/C Exposure at such time. For all purposes of this Agreement, if on any date of determination a Letter of Credit has expired by its terms but any amount may still be drawn thereunder by reason of the operation of Rule 3.14 of the International Standard Practices, International Chamber of Commerce No. 590, or by the reason of article 36 of UCP 600 being excluded as a governance, such Letter of Credit shall be deemed to be outstanding in the amount so remaining available to be drawn. Unless otherwise specified herein, the amount of a Letter of Credit at any time shall be deemed to be the stated amount of such Letter of Credit in effect at such time; provided that, with respect to any Letter of Credit that by its terms or the terms of any document related thereto provides for one or more automatic increases in the stated amount thereof, the amount of such Letter of Credit shall be deemed to be the maximum stated amount of such Letter of Credit after giving effect to all such increases, whether or not such maximum stated amount is in effect at such time.
L/C Issuer means with respect to any Letter of Credit, Royal Bank of Canada together with its successors and permitted assigns in such capacity and any Revolving Lender (including any Person who is a Revolving Lender as of the date such Person becomes an L/C Issuer but subsequently, after agreeing to become an L/C Issuer, ceases to be a Revolving Lender and is subject to Section 2.3(m)) which, at the request of the Borrower, and with the consent of the Administrative Agent (not to be unreasonably withheld), agrees in such Revolving Lenders sole discretion to become an L/C Issuer for the purposes of issuing such Letter of Credit, together with its permitted successors and assigns in such capacity. For the avoidance of doubt, Royal Bank of Canada will issue commercial letters of credit out of its Toronto branch.
L/C Obligations means, as at any date of determination, the aggregate amount available to be drawn under all outstanding Letters of Credit plus the aggregate of all Unreimbursed Amounts, including all L/C Borrowings. For purposes of computing the amount available to be drawn under any Letter of Credit, the amount of such Letter of Credit shall be determined in accordance with Section 1.4. For all purposes of this Agreement, if on any date of determination a Letter of Credit has expired by its terms but any amount may still be drawn thereunder by reason of the operation of Rule 3.14 of the ISP, such Letter of Credit shall be deemed to be outstanding in the amount so remaining available to be drawn.
L/C Overnight Rate means for any day, the greater of (i) the Federal Funds Effective Rate and (ii) an overnight rate determined by the applicable L/C Issuer in accordance with banking industry rules on interbank compensation.
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Latest Maturity Date means, at any date of determination, the latest maturity or expiration date applicable to any Loan or Commitment hereunder at such time, including the latest maturity or expiration date of any Incremental Revolving Commitments, Incremental Term Commitments, Incremental Revolving Loans, Incremental Term Loans, Refinancing Revolving Loans, Refinancing Term Loans, Extended Revolving Commitments or Extended Term Loans, in each case as extended in accordance with this Agreement from time to time.
Lender means each financial institution listed on the signature pages hereto as a Lender, the Swing Line Lender and any other Person that becomes a party hereto pursuant to an Assignment Agreement or a Joinder Agreement.
Lender Counterparty means each Lender, each Agent and each of their respective Affiliates counterparty to a Cash Management Agreement or a Hedge Agreement (including any Person who was an Agent or a Lender or an Affiliate thereof as of the date on which such Person became a counterparty to a Cash Management Agreement or a Hedge Agreement but subsequently ceases to be an Agent or a Lender or an Affiliate thereof, as the case may be); provided , at the time of entering into a Cash Management Agreement or a Hedge Agreement, no Lender Counterparty shall be a Defaulting Lender.
Lender Default means (a) the refusal (which may be given orally or in writing and has not been retracted) or failure of any Lender to make available its portion of any Loans, which refusal or failure is not cured within one (1) Business Day after the date of such refusal or failure, unless such Lender notifies the Administrative Agent and the Borrower in writing that such failure is the result of such Lenders good faith determination that one or more conditions precedent to funding (each of which conditions precedent, together with any applicable default, shall be specifically identified in such writing) has not been satisfied; (b) the failure of any Lender to pay over to the Administrative Agent or any other Lender any other amount required to be paid by it hereunder within one (1) Business Day of the date when due; (c) a Lender having notified the Borrower or the Administrative Agent that it does not intend to comply with its funding obligations or having made a public statement to that effect with respect to any of its funding obligations hereunder or under other agreements in which it commits to extend credit; (d) a Lender has failed, within [REDACTED Time Period] after request by the Administrative Agent, to confirm that it will comply with any of its funding obligations hereunder ( provided that such Lender shall cease to be a Defaulting Lender pursuant to this clause (d) upon receipt of such written confirmation by the Administrative Agent and the Borrower); or (e) a Lender becomes subject to a Distress Event or has admitted in writing that it is insolvent.
Lender Party means any of the Administrative Agent, the Collateral Agent, any Arranger or any Lender.
Letter of Credit means any letter of credit issued hereunder. A Letter of Credit shall be a standby letter of credit unless otherwise agreed to by the applicable L/C Issuer.
Letter of Credit Application means an application and agreement for the issuance or amendment of a Letter of Credit in the form from time to time in use by any L/C Issuer.
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Letter of Credit Expiration Date means the day that is [REDACTED Time Period] prior to the Revolving Commitment Termination Date then in effect (or, if such day is not a Business Day, the next preceding Business Day).
Letter of Credit Fee as defined in Section 2.3(i).
Letter of Credit Sublimit means an amount equal to the lesser of [REDACTED Dollar Amount] and the aggregate unused amount of the Revolving Commitments in effect. The Letter of Credit Sublimit is part of, and not in addition to, the Revolving Commitments.
Lien means with respect to any asset, (a) any mortgage, deed of trust, lien, hypothecation, pledge, encumbrance, charge, assignment by way of security or security interest in or on such asset, (b) the interest of a vendor or a lessor under any conditional sale agreement, capital lease or title retention agreement (or any financing lease having substantially the same economic effect as any of the foregoing) relating to such asset and (c) in the case of securities (other than securities representing an interest in a joint venture that is not a subsidiary), any purchase option, call or similar right of a third party with respect to such securities; provided that in no event shall an operating lease (including aircraft leases) or an agreement to sell be deemed to constitute a Lien.
Limited Conditionality Provisions as defined in Section 3.1.
Loan means an Initial Term Loan, a Revolving Loan, Swing Line Loan, an Incremental Loan, a Refinancing Loan or an Extended Term Loan as the context may require.
Margin Stock as defined in Regulation U.
Market Disruption Event as defined in Section 2.15(a).
Material Adverse Effect means:
(a) on the Closing Date, a Material Adverse Effect as defined in the Acquisition Agreement; and
(b) after the Closing Date, a material adverse effect on (i) the assets, business, financial condition or results of operations, of the Borrower and its Restricted Subsidiaries, taken as a whole, (ii) the ability of the Borrower and the other Credit Parties, taken as a whole, to perform their payment obligations under any Credit Document or (iii) the rights and remedies of the Administrative Agent, the Lenders or any Secured Party under any Credit Document.
Material Indebtedness means Indebtedness (other than the Term Loans) of the Borrower or any subsidiary in an aggregate principal amount exceeding [REDACTED Dollar Amount] .
Material Subsidiary means any subsidiary of the Borrower that is not an Immaterial Subsidiary.
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Maturity Date means (i) with respect to the Initial Term Loans, the earlier of (a) the seventh anniversary of the Closing Date, and (b) the date on which all Initial Term Loans shall become due and payable in full hereunder, whether by acceleration or otherwise, (ii) with respect to the Revolving Loans, the earlier of (a) the fifth anniversary of the Closing Date and (b) the date on which all Revolving Loans shall become due and payable in full hereunder, whether by acceleration or otherwise, (iii) with respect to any tranche of Extended Term Loans and Extended Revolving Commitments, the final maturity date as specified in the applicable Extension Request accepted by the respective Lender or Lenders, (iv) with respect to any Refinancing Term Loans or Refinancing Revolving Commitments, the final maturity date as specified in the applicable Refinancing Amendment and (v) with respect to any Incremental Loans or Incremental Revolving Commitments, the final maturity date as specified in the applicable Incremental Amendment; provided that, in each case, if such day is not a Business Day, the applicable Maturity Date shall be the Business Day immediately preceding such day.
Maximum Rate as defined in Section 10.9.
Moodys means Moodys Investors Service, Inc. and any successor to its rating agency business.
Mortgage Policies as defined in Section 5.11(b).
Multiemployer Plan means any Employee Benefit Plan which is a multiemployer plan as defined in Section 3(37) of ERISA.
Narrative Report means, with respect to the financial statements for which such narrative report is required, a customary managements discussion and analysis report describing the operations of the Borrower and its subsidiaries for the applicable Fiscal Quarter or Fiscal Year and for the period from the beginning of the then current Fiscal Year to the end of such period to which such financial statements relate. For the avoidance of doubt, such Narrative Report need not comply with the requirements of Regulation S-K of the Securities Act or of National Instrument 51-102 of the Canadian Securities Administrators applicable to a Managements Discussion and Analysis of Financial Conditions and Result of Operations.
Net Cash Proceeds means:
(a) [REDACTED Percentage] of the cash proceeds actually received by the Borrower or any of its Restricted Subsidiaries (including any cash payments received by way of deferred payment of principal pursuant to a note or installment receivable or purchase price adjustment receivable or otherwise, but only as and when actually received) in respect of any Asset Sale (except as provided below) or Casualty Event, net of (i) reasonable, documented and invoiced attorneys fees, auditors fees, securities laws filing fees, printers fees, accountants fees, consultant fees, investment banking, placement agent and advisory fees actually incurred by the Borrower or any of its Restricted Subsidiaries in connection with the applicable event, (ii) documented search and recording charges actually incurred by the Borrower or any of its Restricted Subsidiaries in connection with the applicable event, (iii) required debt payments and required payments of other obligations in respect of Indebtedness secured by a Permitted Lien on any asset that is the subject of such Asset Sale or Casualty Event (other than any Lien created
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pursuant to a Collateral Document or a Lien which is pari passu with the Liens created pursuant to any Collateral Document (in which case the pro rata portion (determined based on the then outstanding principal amount of all pari passu Indebtedness that would otherwise be required to be prepaid with such Net Cash Proceeds) of such Net Cash Proceeds applied in respect of any such payments secured by the Liens pursuant to any Collateral Document shall not constitute Net Cash Proceeds for purposes hereof) or junior to the Liens created pursuant to the Collateral Documents)), (iv) other customary expenses and brokerage, consultant and other customary fees actually incurred in connection therewith, (v) Taxes, including sales, goods and services, harmonized sales, transfer, deed or mortgage recording Taxes, paid or payable as a result thereof, and any other payment required by applicable law as a result of such Asset Sale, (vi) any reserve established in accordance with IFRS ( provided that such reserved amounts shall be Net Cash Proceeds to the extent and at the time of any reversal (without the satisfaction of any applicable liabilities in cash in a corresponding amount)), and (vii) any payment amount required to be paid by law, rule or regulation upon receipt to a third party related to the transaction (including to labor unions and environmental trusts) in each case, as determined in good faith by an Authorized Officer of the Borrower; provided that, with respect to any Asset Sale or Casualty Event, no proceeds realized in a single transaction or series of related transactions shall constitute Net Cash Proceeds unless such proceeds shall exceed [REDACTED Dollar Amount] in any Fiscal Year (the proceeds described in this proviso, the Below Threshold Asset Sale Proceeds ).
(b) [REDACTED Percentage] of the cash proceeds from the incurrence, issuance or sale by the Borrower or any of its Restricted Subsidiaries of (x) any Indebtedness not permitted to be incurred under this Agreement and (y) Refinancing Loans and Refinancing Equivalent Debt, net of all Taxes and fees (including investment banking fees), underwriting discounts, commissions, costs and other expenses, in each case, incurred in connection with such incurrence, issuance or sale.
New York Courts as defined in Section 10.15(a).
Non-Consenting Lender as defined in Section 2.18(c).
Non-Credit Party Limitation as defined in the definition of Permitted Acquisition.
Non-Defaulting Lender means, at any time, each Lender that is not a Defaulting Lender at such time.
Non-Extension Notice Date as defined in Section 2.3(b)(iii).
Non-Public Information means material non-public information (within the meaning of Canadian Securities Laws) with respect to the Borrower or its subsidiaries or securities.
Non-Reinstatement Deadline as defined in Section 2.3(b)(iv).
Non-U.S. Plan means any Employee Benefit Plan maintained by the Borrower or any of its subsidiaries for employees outside the United States.
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Note means an Initial Term Loan Note or a Revolving Loan Note.
Obligations means all obligations of every nature of each Credit Party, including obligations from time to time owed to Agents (including former Agents), Lenders or any of them and Lender Counterparties, under any Credit Document, Secured Cash Management Agreement or Secured Hedge Agreement, whether for principal, interest (including interest which, but for the filing of a petition in bankruptcy with respect to such Credit Party, would have accrued on any Obligation, whether or not a claim is allowed against such Credit Party for such interest in the related bankruptcy proceeding), reimbursement of amounts drawn under Letters of Credit, payments for early termination of Secured Hedge Agreements, fees, expenses, indemnification or otherwise, excluding, in each case (but only in respect of a Guarantor), Excluded Swap Obligations.
Obligations of the Borrower means all obligations of every nature of the Borrower, including obligations from time to time owed to Agents (including former Agents), Lenders or any of them and Lender Counterparties, under any Credit Document, Secured Cash Management Agreement or Secured Hedge Agreement, whether for principal, interest (including interest which, but for the filing of a petition in bankruptcy with respect to the Borrower, would have accrued on any Obligation, whether or not a claim is allowed against the Borrower for such interest in the related bankruptcy proceeding), reimbursement of amounts drawn under Letters of Credit, payments for early termination of Secured Hedge Agreements, fees, expenses, indemnification or otherwise.
Obligee Guarantor as defined in Section 7.7.
OFAC shall mean the Office of Foreign Assets Control of the United States Department of the Treasury.
OFAC Lists shall mean, collectively, the List of Specially Designated Nationals and Blocked persons maintained by OFAC, as amended from time to time, or any similar lists issued by OFAC.
Organizational Documents means (i) with respect to any corporation or company, its certificate, memorandum or articles of incorporation, amalgamation or continuance, organization or association, as amended, and its by-laws, as amended, (ii) with respect to any limited partnership, its certificate or declaration of limited partnership, as amended, and its partnership agreement, as amended, (iii) with respect to any general partnership, its partnership agreement, as amended, (iv) with respect to any limited liability company, its articles of organization, as amended, and its operating agreement, as amended, and (v) with respect to any Foreign Subsidiary, the equivalent thereof in its jurisdiction of incorporation or organization. In the event any term or condition of this Agreement or any other Credit Document requires any Organizational Document to be certified by a secretary of state or similar governmental official including an official of a non-United States government, the reference to any such Organizational Document shall only be to a document of a type customarily certified by such governmental official in such officials relevant jurisdiction.
Other Applicable Indebtedness as defined in Section 2.12(a)(ii).
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Other Connection Taxes means, with respect to the Administrative Agent and any Lender, Taxes imposed as a result of a present or former connection between such Administrative Agent or Lender and the jurisdiction imposing such Tax (other than connections arising solely from the Administrative Agent and such Lender having executed, delivered, become a party to, performed its obligations under, received payments under, received or perfected a security interest under, engaged in any other transaction pursuant to or enforced this Agreement, or sold or assigned an interest in this Agreement).
Other Taxes means any and all present or future stamp, court or documentary, intangible, recording, filing or similar Taxes or any other excise or property Taxes, charges or similar Taxes, charges or levies arising from any payment made hereunder or from the execution, delivery, performance, registration or enforcement of, from the receipt or perfection of a security interest under, or otherwise with respect to, this Agreement or any other Credit Document, and any interest, fines, penalties and additions related thereto, except any such Taxes that are Other Connection Taxes imposed with respect to an assignment (other than an assignment made pursuant to Section 2.18(b)).
Outstanding Amount means (i) with respect to Loans on any date, the amount of the aggregate outstanding principal amount thereof after giving effect to any borrowings and prepayments or repayments of Loans occurring on such date; and (ii) with respect to any L/C Obligations on any date, the amount of the aggregate outstanding amount of such L/C Obligations on such date after giving effect to any L/C Credit Extension occurring on such date and any other changes in the aggregate amount of the L/C Obligations as of such date, including as a result of any reimbursements by the Borrower of Unreimbursed Amounts.
Participant as defined in Section 10.4(d).
Participant Register as defined in Section 10.4(d).
PBGC means the Pension Benefit Guaranty Corporation or any successor thereto.
Pension Plan means any Employee Benefit Plan, other than a Multiemployer Plan, which is subject to Section 412 of the Internal Revenue Code or Section 302 of ERISA.
Permitted Acquisition means any acquisition, directly or indirectly (including in one transaction or a series of related transactions), of all or substantially all the assets of, or all the Equity Interests (other than directors qualifying shares or shares issued to foreign nationals) in, or merger or consolidation or amalgamation with, a Person or division or line of business of a Person or franchisee rights, assets or operations (or any subsequent investment made in a Person, division, line of business or franchisee rights, assets or operations previously acquired in a Permitted Acquisition), if immediately after giving effect thereto: (a) no Event of Default shall have occurred and be continuing or would result therefrom, (b) to the extent subject to testing, before and after giving effect to such acquisition on a Pro Forma Basis, the Borrower shall be in compliance with the Financial Performance Covenant, (c) all transactions related thereto shall be consummated in all material respects in accordance with applicable laws, (d) any Credit Party making such acquisition and any Person acquired in such acquisition comply with Section 5.11
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and (e) the aggregate consideration funded by a Credit Party for any and all such acquisitions of any Person that is not and will not become a Credit Party concurrently with or reasonably promptly following such acquisition shall not, when aggregated with Investments made pursuant to Section 6.3(l) and Indebtedness incurred by Restricted Subsidiaries that are not Credit Parties owing to a Credit Party pursuant to Section 6.1(g)(ii), exceed the greater of (i) [REDACTED Dollar Amount] and (ii) [REDACTED Percentage] of Consolidated Total Assets (the Non-Credit Party Limitation ); provided that if greater than [REDACTED Percentage] of the assets or Consolidated Adjusted EBITDA being acquired in any Permitted Acquisition is generated by entities that will become Credit Parties concurrently with or reasonably promptly following such Permitted Acquisition, assets being acquired by Credit Parties or any combination of the foregoing, such Investment shall not reduce the Non-Credit Party Limitation.
Permitted Junior Secured Refinancing Debt as defined in Section 2.21(h)(i).
Permitted Liens means each of the Liens permitted pursuant to Section 6.2.
Permitted Pari Passu Secured Refinancing Debt as defined in Section 2.21(h)(i).
Permitted Unsecured Refinancing Debt as defined in Section 2.21(h)(i).
Person means and includes natural persons, corporations, limited partnerships, general partnerships, limited liability companies, unlimited liability companies, limited liability partnerships, joint stock companies, joint ventures, associations, companies, trusts, banks, trust companies, land trusts, business trusts or other organizations, whether or not legal entities, and Governmental Authorities.
Platform as defined in Section 10.17.
Pledge and Security Agreement means the Pledge and Security Agreement to be executed by the Borrower and each Guarantor substantially in the form of Exhibit I-1 , as it may be amended, restated, supplemented or otherwise modified from time to time.
PPSA shall mean the Personal Property Security Act (Ontario); provided that, if perfection or the effect of perfection or non-perfection or the priority of any security interest in any Collateral is governed by a Personal Property Security Act as in effect in a Canadian jurisdiction other than Ontario or the Civil Code of Québec, PPSA means the Personal Property Security Act as in effect from time to time in such other jurisdiction or the Civil Code of Québec, as applicable, for purposes of the provisions hereof relating to such perfection, effect of perfection or non-perfection or priority in such Collateral.
Prepayment Minimum means, with respect to a payment of Loans or a reduction in Commitments, as the case may be, (a) with respect to Revolving Loans or Revolving Commitments denominated in Dollars, [REDACTED Dollar Amount] , (b) with respect to Revolving Loans or Revolving Commitment denominated in Canadian Dollars, Cdn. [REDACTED Dollar Amount] and (c) with respect to Revolving Loans or Revolving Commitments denominated in any other Designated Foreign Currency, as the Administrative Agent and the Borrower shall agree.
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Prepayment Multiple means, with respect to a payment of Loans or a reduction in Commitments, as the case may be, (a) with respect to Revolving Loans or Revolving Commitments denominated in Dollars [REDACTED Dollar Amount] , (b) with respect to Revolving Loans or Revolving Commitment denominated in Canadian Dollars, Cdn. [REDACTED Dollar Amount] and (c) with respect to Revolving Loans or Revolving Commitments denominated in any other Designated Foreign Currency, as the Administrative Agent and the Borrower shall agree.
Previously Absent Financial Maintenance Covenant means, at any time, any financial maintenance covenant that (a) is not included in the Credit Documents at such time or (b) is only applied to the Revolving Loans at such time.
Prime Rate means (a) for the purpose of Dollar denominated Loans made available to the Borrower in the United States, at any time, the rate of interest from time to time publicly announced by the principal office of the Administrative Agent as its prime commercial lending rate for Dollar loans in the United States for such day and (b) for the purpose of Dollar denominated Loans made available to the Borrower in Canada, at any time, the annual rate of interest from time to time publicly announced by the principal office of the Administrative Agent in Toronto, Ontario as its prime rate in effect for determining interest rates on Dollar denominated commercial loans made in Canada. The Prime Rate is based upon various factors including Royal Bank of Canadas costs and desired return, general economic conditions and other factors, and is used as a reference point for pricing some loans, which may be priced at, above, or below such announced rate. Any change in such rate announced by Royal Bank of Canada shall take effect at the opening of business on the day specified in the public announcement of such change.
Principal Office means, for each of the Administrative Agent and L/C Issuers, such Persons Principal Office as set forth on Schedule 10.1 , or such other office or office of a third party or sub-agent, as appropriate, as such Person may from time to time designate in writing to Borrower, the Administrative Agent and each Lender.
Pro Forma or Pro Forma Basis means, for purposes of determining compliance with any provision of this Agreement, including the determination of any financial ratio or test or the amount of revenue or Consolidated Total Assets or Consolidated Adjusted EBITDA, that any Specified Transaction occurring since the first day of the relevant period to and including the relevant date such determination is made (including after the relevant quarter or period end, if applicable) shall be deemed to have occurred as of the first day of the relevant period, including pro forma adjustments arising out of events attributable to such Specified Transaction (including giving effect to those specified in accordance with the definitions of Consolidated Adjusted EBITDA and Consolidated Net Income); provided that, any event, occurrence or transaction that would otherwise be deemed a Specified Transaction, but for failure to meet the monetary threshold in the definition thereof, shall also be given effect on a Pro Forma Basis. Upon giving effect to a transaction on a Pro Forma Basis, (i) any Indebtedness incurred by the Borrower or any Restricted Subsidiaries in connection with such Specified Transaction (or any other transaction which occurred during the relevant period) shall be deemed to have been incurred as of the first day of the relevant period, (ii) if such Indebtedness has a floating or formula rate, then the rate of interest for such Indebtedness for the
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applicable period for purposes of the calculations contemplated by this definition shall be determined by utilizing the rate which is or would be in effect with respect to such Indebtedness as at the relevant date of such calculations, (iii) income statement items (whether positive or negative) and Consolidated Adjusted EBITDA attributable to all property acquired in such Specified Transaction or to the Investment constituting such Specified Transaction, as applicable, shall be included as if such Specified Transaction has occurred as of the first day of the relevant period, (iv) income statement items (whether positive or negative) attributable to all property disposed of in any Specified Transaction (including any income statement items attributable to disposed, abandoned or discontinued operations), shall be excluded as if such Specified Transaction has occurred as of the first day of the relevant period, (v) such other pro forma adjustments which would be permitted or required by Canadian Securities Laws, as amended shall be taken into account (in addition to any adjustments permitted pursuant to any applicable financial definition or test) and (vi) such other adjustments made by the Borrower with the consent of the Administrative Agent (not to be unreasonably withheld, delayed or conditioned) shall be taken into account. Interest on a Capital Lease Obligation shall be deemed to accrue at an interest rate reasonably determined by an Authorized Officer of the Borrower to be the rate of interest implicit in such Capital Lease Obligation in accordance with IFRS. Interest on Indebtedness that may optionally be determined at an interest rate based upon a factor of a prime or similar rate, a eurocurrency interbank offered rate, bankers acceptances market rate, or other rate, shall be determined to have been based upon the rate actually chosen, or if none, then based upon such optional rate chosen as the Borrower or the applicable Restricted Subsidiary may designate. Any such adjustments included in calculations made on a Pro Forma Basis shall continue to apply to subsequent calculations of any applicable financial ratios or tests, including during any subsequent test period in which the effects thereof are expected to be realized.
Pro Rata Share means (i) with respect to all payments, computations and other matters relating to the Initial Term Loan of any Lender, the percentage obtained by dividing (a) the Initial Term Loan Exposure of that Lender by (b) the aggregate Initial Term Loan Exposure of all Lenders, (ii) with respect to all payments, computations and other matters relating to the Revolving Commitment or Revolving Loans of any Lender or any Letters of Credit issued or participations purchased therein by any Lender, the percentage obtained by dividing (a) the Revolving Exposure of that Lender by (b) the aggregate Revolving Exposure of all Lenders and (iii) with respect to all payments, computations and other matters relating to any other Class of Loan of any Lender, the percentage obtained by dividing (a) an amount equal to the sum of the outstanding principal amount of the Loans of such Class held by such Lender by (b) an amount equal to the sum of the outstanding principal amount of the Loans of such Class held by all Lenders. For all other purposes with respect to each Lender, Pro Rata Share means the percentage obtained by dividing (A) an amount equal to the sum of the Initial Term Loan Exposure and the Revolving Exposure of that Lender, by (B) an amount equal to the sum of the aggregate Initial Term Loan Exposure and the aggregate Revolving Exposure of all Lenders.
Prohibited Person shall mean any Person subject to international economic sanctions adopted, administered or enforced by the United Nations Security Council, the European Union, Canada (including any Persons subject to country-specific or activity-specific sanctions administered by the Department of Foreign Affairs, Trade and Development), the United Kingdom, OFAC (including any persons subject to country-specific or activity-specific
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sanctions administered by OFAC and any persons named on any OFAC List), the U.S. Department of Commerce Bureau of Industry and Security, the U.S. Department of State or pursuant to any other law, rules, regulations or other official acts of the United States (each of the foregoing, collectively, Sanctions ). As of the date hereof, certain information regarding Prohibited Persons issued by the United States can be found on the website of the United States Department of Treasury at www.treas.gov/ofac/.
Projections means the financial projections of the Borrower, dated as of March 3, 2015.
Public Lenders means Lenders that do not wish to receive material Non-Public Information with respect to the Borrower, its subsidiaries or their securities.
Purchasing Borrower Party means the Borrower or any Restricted Subsidiary that becomes an assignee hereof or Participant pursuant to Section 10.4.
Qualified CFC Holding Company means, in relation to any Credit Party, a Person (a) that is a wholly-owned subsidiary of such Credit Party and (b) who has no material assets other than Equity Interests in Foreign Subsidiaries that are CFCs in relation to such Credit Party or such Person.
Qualified ECP Guarantor means, in respect of any Swap Obligation, each Credit Party that constitutes an eligible contract participant under the Commodity Exchange Act or any regulations promulgated thereunder and can cause another Person to qualify as an eligible contract participant at such time by entering into a keepwell under Section 1a(18)(A)(v)(II) of the Commodity Exchange Act.
Qualified Stock of any Person means any Equity Interests of such Person that is not Disqualified Stock.
Refinance as defined in the definition of Refinancing Indebtedness.
Refinanced Debt as defined in Section 2.21(a).
Refinanced Loans as defined in Section 2.21(h)(i).
Refinancing as defined in the recitals hereto.
Refinancing Amendment as defined in Section 2.21(f).
Refinancing Closing Date as defined in Section 2.21(d).
Refinancing Commitments as defined in Section 2.21(a).
Refinancing Equivalent Debt as defined in Section 2.21(h)(i).
Refinancing Indebtedness means any Indebtedness issued in exchange for, or the net proceeds of which are used to extend, refinance, renew, replace, defease or refund
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(collectively, to Refinance ) the Indebtedness being Refinanced (or previous refinancings thereof constituting Refinancing Indebtedness); provided that (a) the principal amount (or accreted value, if applicable) of such Refinancing Indebtedness does not exceed the principal amount (or accreted value, if applicable) of the Indebtedness so Refinanced (plus the amount of unpaid accrued or capitalized interest and premiums thereon (including tender premiums), underwriting discounts, original issue discount, defeasance costs, fees (including upfront fees, underwriting fees, legal fees, accounting and audit fees and other similar or customary fees), commissions and expenses), (b) except with respect to Section 6.1(c), the Weighted Average Life to Maturity of such Refinancing Indebtedness is greater than or equal to the shorter of (i) the Weighted Average Life to Maturity of the Indebtedness being Refinanced and (ii) the Weighted Average Life to Maturity that would result if all payments of principal on the Indebtedness being Refinanced that were due on or after the date that is [REDACTED Time Period] following the Latest Maturity Date were instead due on the date that is [REDACTED Time Period] following the Latest Maturity Date; provided that no Refinancing Indebtedness incurred in reliance on this subclause (ii) shall have any scheduled principal payments due prior to the Latest Maturity Date in excess of, or prior to, the scheduled principal payments due prior to such Latest Maturity Date for the Indebtedness being Refinanced, (c) if the Indebtedness being Refinanced is subordinated in right of payment to the Obligations under this Agreement, such Refinancing Indebtedness shall be subordinated in right of payment to such Obligations on terms at least as favorable taken as a whole to the Lenders as those contained in the documentation governing the Indebtedness being Refinanced; provided , further , that with respect to a Refinancing of any Indebtedness permitted hereunder that is subordinated in right of payment, such Refinancing Indebtedness shall (A) be expressly subordinated in right of payment to the guarantee by the Borrower and the Guarantors of the Obligations and (B) be otherwise on terms not materially less favorable to the Lenders than those contained in the documentation governing the Indebtedness being Refinanced; provided , further , that Indebtedness constituting Refinancing Indebtedness shall not cease to constitute Refinancing Indebtedness as a result of the subsequent extension of the Latest Maturity Date, (d) no Refinancing Indebtedness shall have different obligors, or greater guarantees or security than, the Indebtedness being Refinanced ( provided that (i) Indebtedness (A) of any Credit Party may be Refinanced to add or substitute as an obligor another Credit Party and (B) of any subsidiary that is not a Credit Party may be Refinanced to add or substitute as an obligor another subsidiary that is not a Credit Party, in each case to the extent not prohibited by Section 6, and (ii) other guarantees and security may be added to the extent then permitted by Section 6) and (e) if the Indebtedness being Refinanced is secured by a Lien on any Collateral (whether equally and ratably with, or junior to, the Lien of the Secured Parties or otherwise), such Refinancing Indebtedness may be secured by a Lien on such Collateral (including any Collateral pursuant to after-acquired property clauses to the extent any such Collateral would have secured the Indebtedness being Refinanced) on terms relating to such Collateral not materially less favorable to the Secured Parties (as determined conclusively by the Borrower and evidenced by a certificate of an Authorized Officer of the Borrower) than those contained in the documentation (including any intercreditor agreement) governing the Indebtedness being Refinanced, or on terms otherwise then permitted by Section 6.2.
Refinancing Lenders as defined in Section 2.21(c).
Refinancing Loan as defined in Section 2.21(b).
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Refinancing Loan Request as defined in Section 2.21(a).
Refinancing Revolving Commitments as defined in Section 2.21(a).
Refinancing Revolving Lender as defined in Section 2.21(c).
Refinancing Revolving Loan as defined in Section 2.21(b).
Refinancing Term Commitments as defined in Section 2.21(a).
Refinancing Term Lender as defined in Section 2.21(c).
Refinancing Term Loan as defined in Section 2.21(b).
Refunded Swing Line Loans shall have the meaning assigned to such term in Section 2.23(b)(iv).
Register as defined in Section 2.5(b).
Regulation D means Regulation D of the Board of Governors, as in effect from time to time and all official rulings and interpretations thereunder or thereof.
Regulation T means Regulation T of the Board of Governors, as in effect from time to time and all official rulings and interpretations thereunder or thereof.
Regulation U means Regulation U of the Board of Governors, as in effect from time to time and all official rulings and interpretations thereunder or thereof.
Regulation X means Regulation X of the Board of Governors, as in effect from time to time and all official rulings and interpretations thereunder or thereof.
Reinvestment Deferred Amount means, with respect to any Reinvestment Event, the aggregate amount of Net Cash Proceeds received by the Borrower or any Restricted Subsidiary in connection therewith that are not applied to prepay the Term Loans as a result of the delivery of a Reinvestment Notice.
Reinvestment Event means any Asset Sale or Casualty Event in respect of which the Borrower has delivered a Reinvestment Notice.
Reinvestment Notice means a written notice executed by an Authorized Officer of the Borrower stating that the Borrower or any Restricted Subsidiary intends and expects to use all or a portion of the amount of Net Cash Proceeds of an Asset Sale or Casualty Event to restore, rebuild, repair, construct, improve, replace or otherwise acquire assets useful in the Borrowers or such Restricted Subsidiarys business.
Reinvestment Prepayment Amount means, with respect to any Reinvestment Event, the Reinvestment Deferred Amount relating thereto less any amount expended prior to the relevant Reinvestment Prepayment Date to restore, rebuild, repair, construct, improve, replace or otherwise acquire assets useful in the Borrowers or any Restricted Subsidiarys business.
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Reinvestment Prepayment Date means, with respect to any Reinvestment Event, the earlier of (a) the date (which shall be a Business Day) occurring [REDACTED Time Period] after such Reinvestment Event (or, if the Borrower or any Restricted Subsidiary shall have entered into a legally binding commitment [REDACTED Time Period] after such Reinvestment Event to restore, rebuild, repair, construct, improve, replace or otherwise acquire assets useful in the Borrowers or such Restricted Subsidiarys business with the applicable Reinvestment Deferred Amount, the date occurring [REDACTED Time Period] after such Reinvestment Event) and (b) the date on which the Borrower shall have determined not to, or shall have otherwise ceased to, restore, rebuild, repair, construct, improve, replace or otherwise acquire assets useful in the Borrowers or such Restricted Subsidiarys business with all or any portion of the relevant Reinvestment Deferred Amount.
Related Parties means, with respect to any Person, such Persons Affiliates and the partners, directors, officers, employees, agents, subagents, trustees, advisors and attorneys of such Person and of such Persons Affiliates.
Release means any release, spill, emission, leaking, pumping, pouring, injection, escaping, deposit, disposal, discharge, dispersal, dumping, leaching or migration of any Hazardous Material into the indoor or outdoor environment (including the abandonment or disposal of any barrels, containers or other closed receptacles containing any Hazardous Material), including the movement of any Hazardous Material through the air, soil, surface water or groundwater.
Relevant Four Fiscal Quarter Period as defined in Section 8.2.
Repatriation Limitation as defined in Section 2.12(g).
Repricing Transaction means, in connection with a transaction the primary purpose of which is to prepay, refinance, substitute or replace the Initial Term Loans or to amend this Agreement to reduce the All-In-Yield, (a) the prepayment, refinancing, substitution or replacement of all or a portion of the Initial Term Loans with the incurrence of any long-term debt financing or refinancing by the Borrower or any of its Restricted Subsidiaries having an All-In-Yield at the time of incurrence thereof that is less than the All-In-Yield of such Initial Term Loans at the time of such incurrence or (b) any amendment to this Agreement that, directly or indirectly, reduces the All-In-Yield of such Initial Term Loans (or any Lender must assign its Loans under the Term Loans as a result of its failure to consent to any such amendment). No Repricing Transaction shall be deemed to occur in connection with any Change of Control or transformative investment or acquisition.
Required Mortgages as defined in Section 5.11(f).
Required Percentage means, with respect to any Excess Cash Flow Period, [REDACTED Percentage] ; provided that (a) if the Total Net Leverage Ratio (calculated on a Pro Forma Basis) as of the end of the applicable Excess Cash Flow Period is less than or equal to 4.25:1.00 but greater than 3.75:1.00, such percentage shall be [REDACTED Percentage] , and (b) if the Total Net Leverage Ratio (calculated on a Pro Forma Basis) as of the end of the
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applicable Excess Cash Flow Period is less than or equal to 3.75:1.00, such percentage shall be [REDACTED Percentage] .
Requisite Class Lenders means, as of any date of determination, with respect to one or more Classes, Lenders having more than [REDACTED Percentage] of the sum of (a) the Outstanding Amount under such Class or Classes (with the aggregate amount of each Lenders risk participation and funded participation in L/C Obligations under such Class or Classes being deemed held by such Lender for purposes of this definition) and (b) the aggregate unused Commitments under such Class or Classes. The Outstanding Amount and Commitments of any Defaulting Lender shall be disregarded in determining Requisite Class Lenders at any time.
Requisite Lenders means one or more Lenders having or holding Initial Term Loan Exposure and/or Revolving Exposure and representing more than [REDACTED Percentage] of the sum of the aggregate Voting Power Determinants of all Lenders. The Initial Term Loan Exposure and/or Revolving Exposure, as applicable, of any Defaulting Lender shall be disregarded in determining Requisite Lenders at any time.
Reset Date as defined in Section 1.5.
Responsible Officer of any Person means the chief executive officer, the president, any vice president, the chief operating officer or any Financial Officer of such Person and any other officer or similar official thereof responsible for the administration of the obligations of such Person in respect of this Agreement, and, as to any document delivered on the Closing Date (but subject to the express requirements set forth in Section 3), shall include any secretary or assistant secretary of a Credit Party.
Restricted Payment means (a) any dividend or other distribution on account of any class of Equity Interests of the Borrower now or hereafter outstanding, except a dividend payable solely in shares of Equity Interests, (b) any redemption, retirement, sinking fund or similar payment, purchase or other acquisition for value of any shares of any class of the Equity Interests of the Borrower now or hereafter outstanding; and (c) any payment made to retire, or to obtain the surrender of, any outstanding warrants, options or other rights to acquire shares of any class of the Equity Interests of the Borrower now or hereafter outstanding.
Restricted Subsidiary means any subsidiary other than an Unrestricted Subsidiary.
Retained Excess Cash Flow Amount means, at any date of determination, an amount equal to (a) the sum of the amounts of Excess Cash Flow for all Excess Cash Flow Periods ending on or prior to the date of determination, minus (b) the sum at the time of determination of the aggregate amount of prepayments required to be made pursuant to Section 2.12(b) through the date of determination (if such prepayments are accepted by the Lenders) calculated without regard to any reduction in such sum that resulted from voluntary prepayments of the Term Loans or Revolving Loans referred to in Section 2.12(b) (provided that, in the case of any Excess Cash Flow Period in respect of which the amount of Excess Cash Flow shall have been calculated as contemplated by Section 2.12(b) but the prepayment required
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pursuant to Section 2.12(b) is not yet due and payable in accordance with the provisions of Section 2.12(b) as of the date of determination, the amount of prepayments that will be so required to be made in respect of such Excess Cash Flow shall be deemed to be made for purposes of this paragraph).
Revolver Extension Request as defined in Section 2.22(b).
Revolver Extension Series as defined in Section 2.22(b).
Revolving Commitment means the commitment of a Lender to make or otherwise fund any Revolving Loan and to acquire participations in Letters of Credit and Swing Line Loans hereunder and Revolving Commitments means such commitments of all Lenders in the aggregate. The amount of each Lenders Revolving Commitment, if any, is set forth on Appendix A-2 or in the applicable Assignment Agreement, Joinder Agreement, Incremental Amendment, Refinancing Amendment or Extension as applicable, subject to any adjustment or reduction pursuant to the terms and conditions hereof. The aggregate amount of the Revolving Commitments as of the Closing Date is [REDACTED Dollar Amount] .
Revolving Commitment Period means the period from the Closing Date to but excluding the Revolving Commitment Termination Date.
Revolving Commitment Termination Date means, with respect to any Class of Revolving Commitments, the earliest to occur of (a)(i) in the case of the Revolving Commitments in respect of the Initial Revolving Commitments, the fifth anniversary of the Closing Date, (ii) in the case of any Extended Revolving Commitments, the date specified in the applicable Extension Amendment and (iii) in the case of any Refinancing Revolving Commitments, the date specified in the relevant Refinancing Amendment, (b) the date the Revolving Commitments of such Class are permanently reduced to zero pursuant to Section 2.11(c), and (c) the date of the termination of the Revolving Commitments pursuant to Section 8.1.
Revolving Exposure means, with respect to any Lender as of any date of determination, (i) prior to the termination of the Revolving Commitments, that Lenders Revolving Commitment; and (ii) after the termination of the Revolving Commitments, the sum of (a) the aggregate outstanding principal amount of the Revolving Loans of that Lender, (b) in the case of any L/C Issuer, the aggregate L/C Obligations in respect of all Letters of Credit issued by that L/C Issuer (net of any participations by Lenders in such Letters of Credit), (c) the aggregate amount of all participations by that Lender in any outstanding Letters of Credit or any Unreimbursed Amount, (d) in the case of the Swing Line Lender, the aggregate outstanding principal amount of all Swing Line Loans (net of any participations therein by other Lenders), and (e) the aggregate amount of all participations therein by that Lender in any outstanding Swing Line Loans.
Revolving Lender means, at any time, a Lender that has a Revolving Commitment or a Revolving Loan at such time.
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Revolving Loan means a Loan made by a Lender to the Borrower pursuant to Section 2.2(a), Section 2.20, Section 2.21 or Section 2.22 (and pursuant to Sections 2.3 and 2.23 as provided therein).
Revolving Loan Note means a promissory note in the form of Exhibit B-2 , as it may be amended, restated, supplemented or otherwise modified from time to time.
Royal Bank means as defined in the preamble hereto.
S&P means Standard & Poors, a Division of The McGraw-Hill Companies, Inc. and any successor to its rating agency business.
Sale and Lease-Back Transaction means any arrangement, direct or indirect, with any Person whereby the Borrower sells or transfers any property, real or personal, used or useful in the Borrowers business, whether now owned or hereafter acquired, and thereafter rents or leases such property or other property that it intends to use for substantially the same purpose or purposes as the property being sold or transferred.
Same Day Funds means immediately available funds.
Sanctioned Jurisdiction means any of Iran, North Korea, Sudan, Syria or any other country or territory, in each case, to the extent that such country or territory itself is the subject (or becomes the subject) of Sanctions.
Sanctions as defined in the definition of Prohibited Person.
Secured Cash Management Agreement means a Cash Management Agreement entered into with a Lender Counterparty.
Secured Hedge Agreement means a Hedge Agreement entered into with a Lender Counterparty.
Secured Parties means (a) the Agents, the L/C Issuers, the Swing Line Lender, the Lenders and the Lender Counterparties and shall include, without limitation, all former Agents, L/C Issuers, Swing Line Lenders, Lenders and Lender Counterparties to the extent that any Obligations owing to such Persons were incurred while such Persons were Agents, L/C Issuers, Swing Line Lenders, Lenders or Lender Counterparties and such Obligations have not been paid or satisfied in full and (b) any Secured Parties under and as defined in any Permitted Pari Passu Secured Refinancing Debt.
Securities Act means the Securities Act of 1933, as amended from time to time, and any successor statute.
Security Agreements means, collectively, the Pledge and Security Agreement, the Barbados Security Documents and the Canadian Pledge and Security Agreement, and Security Agreement means each of them.
SEDAR as defined in Section 5.4(a).
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Sellers has the meaning specified in the Acquisition Agreement.
Senior Notes as defined in the recitals hereto.
Senior Notes Indenture means the Indenture dated as of April 21, 2015 among the Borrower, as the issuer, the guarantors thereunder and U.S. Bank National Association as trustee thereunder and pursuant to which the Senior Notes have been issued.
Senior Secured Net Leverage Ratio means the ratio of (i) Consolidated Total Debt secured by a Lien on the assets of any Credit Party (net of unrestricted cash and Cash Equivalents of the Borrower or any Restricted Subsidiary in an aggregate amount not to exceed [REDACTED Dollar Amount] , except the proceeds of Indebtedness that is incurred for which the Senior Secured Net Leverage Ratio is to be calculated and the proceeds of other Indebtedness incurred substantially contemporaneously therewith) to (ii) Consolidated Adjusted EBITDA for the trailing four Fiscal Quarter period ending on the most recent Fiscal Quarter for which financial statements are available, which may include internal financial statements prepared in good faith by the Borrower.
Solvency Certificate means a Solvency Certificate of any Financial Officer of the Borrower substantially in the form of Exhibit G .
Specified Equity Contribution as defined in Section 8.2.
Specified Event of Default means any Event of Default under Section 8.1(b), Section 8.1(c), Section 8.1(g) or Section 8.1(h).
Specified Investment means an Investment permitted by Section 6.3(a), (h), (o), (u), (cc) (provided that such investment is to finance the purchase of assets by the Borrower or its Restricted Subsidiaries) or (dd), in each case, in the nature of an acquisition or an investment in a joint venture; provided that for purposes of calculating Excess Cash Flow with respect to Section 6.3(u), to the extent such Restricted Payments would be subtracted pursuant to clause (2)(h) of the definition of Excess Cash Flow.
Specified Representations means the representations and warranties set forth in Sections 4.1(a), (b) and (d), 4.2(a), 4.2(b)(A)(i) and (ii), 4.3, 4.10, 4.11, 4.17, 4.19, 4.22 and 4.23.
Specified Transaction means with respect to any period, any (i) Investment involving the acquisition of an operating or geographical unit of a business or that constitutes an acquisition of all or substantially all of the common stock of a Person and involves the payment of consideration by the Borrower and its Restricted Subsidiaries in excess of [REDACTED Dollar Amount] , (ii) sale or transfer of assets or property or other asset disposition (including any disposal, abandonment or discontinuance of operations) that yields gross proceeds to the Borrower or any of its Restricted Subsidiaries in excess of [REDACTED Dollar Amount] or involves the abandonment or discontinuation of operations with a value in excess of [REDACTED Dollar Amount] , (iii) incurrence, amendment, modification, repayment or refinancing of Indebtedness, (iv) Restricted Payment, (v) designation or redesignation of an Unrestricted Subsidiary or Restricted Subsidiary, (vi) provision of Incremental Revolving
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Commitment increases or (vii) other event, in each case that by the terms of the Credit Documents requires pro forma compliance with a test or covenant hereunder or requires such test or covenant to be calculated on a Pro Forma Basis.
Spot Currency Exchange Rate as defined in Section 1.5.
subsidiary means, with respect to any Person, any corporation, partnership, limited liability company, association, joint venture or other business entity of which more than [REDACTED Percentage] of the total voting power of shares of stock or other ownership interests entitled (without regard to the occurrence of any contingency) to vote in the election of the Person or Persons (whether directors, managers, trustees or other Persons performing similar functions) having the power to direct or cause the direction of the management and policies thereof is at the time owned or controlled, directly or indirectly, by that Person or one or more of the other subsidiaries of that Person or a combination thereof; provided , in determining the percentage of ownership interests of any Person controlled by another Person, no ownership interest in the nature of a qualifying share of the former Person shall be deemed to be outstanding.
Subsidiary Redesignation as defined in the definition of Unrestricted Subsidiary.
Supplemental Agent as defined in Section 9.1(c).
Swap Obligation means, with respect to any Guarantor, any obligation to pay or perform under any agreement, contract or transaction that constitutes a swap within the meaning of Section 1a(47) of the Commodity Exchange Act.
Swing Line Lender means Royal Bank of Canada in its capacity as Swing Line Lender hereunder, together with its permitted successors and assigns in such capacity.
Swing Line Loan means a Loan made by Swing Line Lender to a Borrower pursuant to Section 2.23.
Swing Line Sublimit means the lesser of (a) [REDACTED Dollar Amount] and (b) the aggregate unused amount of Revolving Commitments then in effect.
Target Assets means, collectively, the Purchased Assets (as defined in the Acquisition Agreement) and the Assumed Liabilities (as defined in the Acquisition Agreement).
Tax means any present or future tax, levy, impost, duty, assessment, charge, fee, deduction or withholding (together with interest, penalties and other additions thereto) of any nature and whatever called imposed, levied, collected, withheld or assessed by any Governmental Authority.
Term Loan means an Initial Term Loan, an Incremental Term Loan, a Refinancing Term Loan or Extended Term Loan as the context may require.
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Term Loan Commitment means the Initial Term Loan Commitment, the Incremental Term Commitment or the Refinancing Term Commitment of a Lender, and Term Loan Commitments means such commitments of all Lenders.
Term Loan Extension Request as defined in Section 2.22(a).
Term Loan Extension Series as defined in Section 2.22(a).
Term Loan Increase as defined in Section 2.20(a).
Term Loan Lender means at any time, a Lender that has a Term Loan Commitment or holds a Term Loan, in each case, at such time.
Test Period means, at any date of determination, the most recently completed four consecutive fiscal quarters of the Borrower ending on or prior to such date for which financial statements have been or are required to be delivered pursuant to Section 5.4.
Total Net Leverage Ratio means the ratio of (i) Consolidated Total Debt (net of unrestricted cash and Cash Equivalents of the Borrower and its Restricted Subsidiaries in an aggregate amount not to exceed [REDACTED Dollar Amount] , except proceeds of Indebtedness that is incurred for which the Total Net Leverage Ratio is to be calculated and the proceeds of other Indebtedness incurred substantially contemporaneously therewith) to (ii) Consolidated Adjusted EBITDA for the trailing four Fiscal Quarter period ending on the most recent Fiscal Quarter for which financial statements are available, which may include internal financial statements prepared in good faith by the Borrower.
Total Utilization of Revolving Commitments means, as at any date of determination, the sum of (i) the aggregate principal amount of all outstanding Revolving Loans (other than Revolving Loans made for the purpose of repaying any Refunded Swing Line Loans or reimbursing any L/C Issuer for any amount drawn under any Letter of Credit, but not yet so applied), (ii) the aggregate principal amount of all outstanding Swing Line Loans and (iii) the aggregate L/C Obligations.
Transaction Costs as defined in the recitals hereto.
Transactions means, collectively, (a) the consummation of the transactions contemplated by the Acquisition Agreement, (b) the execution, delivery and performance by the Credit Parties of the Credit Documents and the borrowings contemplated hereby, (c) the Equity Offering, (d) the issuance and sale of the Senior Notes and the performance of obligations contemplated by the Senior Notes Indenture, (e) the Refinancing and (f) the payment of Transaction Costs.
TSD as defined in Section 4.16.
Type of Loan means with respect to either Term Loans or Revolving Loans, a Base Rate Loan, a Eurocurrency Rate Loan, a Canadian Prime Rate Loan, a Bankers Acceptance Loan or a IFRS Designated Foreign Currency Alternate Rate Loan.
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UCC means the Uniform Commercial Code (or any similar or equivalent legislation) as in effect from time to time in any applicable jurisdiction.
Unreimbursed Amount as defined in Section 2.3(d)(i).
Unrestricted Subsidiary means (a) any subsidiary of the Borrower identified on Schedule 1.1(c) , (b) any additional subsidiary of the Borrower that is designated by the Borrower as an Unrestricted Subsidiary hereunder by written notice to the Administrative Agent; provided that the Borrower shall only be permitted to so designate a new Unrestricted Subsidiary so long as (i) no Default or Event of Default has occurred and is continuing or would result therefrom, (ii) such subsidiary comprises no more than [REDACTED Percentage] of (x) Consolidated Total Assets and (y) Consolidated Adjusted EBITDA at the time of designation and (iii) after giving effect to such designation, all Unrestricted Subsidiaries comprise, in the aggregate, no more than [REDACTED Percentage] of (x) Consolidated Total Assets and (y) Consolidated Adjusted EBITDA at the time of designation; provided further that such designation shall constitute an Investment by the Borrower therein at the date of designation in an amount equal to the portion of the fair market value of the net assets of such subsidiary attributable to the Borrowers equity interest therein (and such designation shall only be permitted to the extent such Investment is permitted under Section 6.3), and (c) any subsidiary of an Unrestricted Subsidiary. The Borrower may designate any Unrestricted Subsidiary to be a Restricted Subsidiary for purposes of this Agreement (each, a Subsidiary Redesignation ); provided that (i) no Default or Event of Default has occurred and is continuing or would result therefrom, (ii) the Borrower shall have delivered to the Administrative Agent an officers certificate executed by an Authorized Officer of the Borrower, certifying to the best of such officers knowledge, compliance with the requirements of preceding clause (i) and (iii) if immediately after giving effect to such designation the Borrower would be in Pro Forma Basis compliance with the Financial Performance Covenant (whether or not then in effect); provided , further , that no Credit Party may be designated as an Unrestricted Subsidiary (unless such Credit Party ceases to be a Credit Party in accordance with the terms hereof in connection with such designation).
Unused Commitment Fee as defined in Section 2.9.
Voting Power Determinants means, collectively, Initial Term Loan Exposure and/or Revolving Exposure.
Weighted Average Life to Maturity means, when applied to any Indebtedness at any date, the number of years obtained by dividing (a) the sum of the products obtained by multiplying (i) the amount of each then remaining installment, sinking fund, serial maturity or other required payment of principal (excluding nominal amortization), including payment at final maturity, in respect thereof, by (ii) the number of years (calculated to the nearest 1/12) that will elapse between such date and the making of such payment by (b) the then outstanding principal amount of such Indebtedness.
1.2 Accounting Terms . (a) Except as otherwise expressly provided herein, all financial statements to be delivered pursuant to this Agreement shall be prepared in accordance with IFRS and all terms of an accounting or financial nature that are used in the computation of
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any covenant (including the computation of any financial covenant) set forth in any Credit Document shall be construed and interpreted in accordance with IFRS; provided that, in the event of any change in IFRS or the application thereof, or any conversion from IFRS to GAAP, in each case, from that applied in the preparation of the financial statements of the Sellers relating to the Target Assets most recently delivered on or prior to the Closing Date that would affect the computation of any financial covenant, ratio, accounting definition or requirement set forth in this Agreement or any other Credit Document, if the Borrower or the Requisite Lenders shall so request, the Administrative Agent, the Requisite Lenders and the Borrower shall negotiate in good faith, each acting reasonably (and without the requirement of any fee), to amend such financial covenant, ratio, accounting definition or requirement to preserve the original intent thereof in light of such change in IFRS or the application thereof or conversion to GAAP; provided , further, that, until so amended as provided in the preceding proviso, (a) such financial covenant, ratio, accounting definition or requirement shall continue to be computed in accordance with IFRS or the application thereof without regard to such change or conversion therein, and (b) the Borrower shall furnish to the Administrative Agent and the Lenders the financial statements required under this Agreement, and a reconciliation between such financial statements and the calculations of such financial covenant, ratio, accounting definition or requirement made before and after giving effect to such change in IFRS or conversion to GAAP; provided that (i) no amendment fee shall be payable in connection therewith, (ii) any such amendments that relate to Section 6.10 shall be subject to the prior written consent of the Requisite Class Lenders with respect to Revolving Loans (such consent not to be unreasonably withheld or delayed) and not the Requisite Lenders and (iii) all amendments relating to the Total Net Leverage Ratio and Senior Secured Net Leverage Ratio (other than in connection with Section 6.10) shall be subject to the prior written consent of the Requisite Lenders (such consent not to be unreasonably withheld or delayed) and not the Requisite Class Lenders with respect to Revolving Loans. Notwithstanding any other provision contained herein, (x) each financial covenant, ratio, accounting definition or requirement used herein shall be construed, and all computations of amounts and ratios referred to herein shall be made, without giving effect to any election under IFRS to value any Indebtedness or other liabilities of the Borrower or any Subsidiary at fair value, as defined therein and (y) Capital Lease Obligations shall be excluded for purposes of (1) calculating Consolidated Interest Expense, Consolidated Total Debt and Indebtedness and (2) any restriction, basket, covenant or carve-out, in each case, to the extent such Capital Lease Obligations would have been characterized as operating leases in accordance with IFRS as of the Closing Date, shall instead be treated as operating leases.
1.3 Interpretation, Etc. Any of the terms defined herein may, unless the context otherwise requires, be used in the singular or the plural, depending on the reference. References herein to any Section, Appendix, Schedule or Exhibit shall be to a Section, an Appendix, a Schedule or an Exhibit, as the case may be, hereof unless otherwise specifically provided. The use herein of the word include or including, when following any general statement, term or matter, shall not be construed to limit such statement, term or matter to the specific items or matters set forth immediately following such word or to similar items or matters, whether or not non-limiting language (such as without limitation or but not limited to or words of similar import) is used with reference thereto, but rather shall be deemed to refer to all other items or matters that fall within the broadest possible scope of such general statement, term or matter. The terms lease and license shall include sub-lease, charter (including related to corporate aircraft leases) and sub-license, as applicable. Unless otherwise specifically indicated, the term
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consolidated with respect to any Person refers to such Person consolidated with its Restricted Subsidiaries, and excludes from such consolidation any Unrestricted Subsidiary as if such Unrestricted Subsidiary were not an Affiliate of such Person.
1.4 Letter of Credit Amounts . Unless otherwise specified herein, the amount of a Letter of Credit at any time shall be the stated amount of such Letter of Credit in effect at such time; provided , however , that with respect to any Letter of Credit that, by its terms or the terms of any Issuer Document related thereto, provides for one or more automatic increases in the stated amount thereof, the amount of such Letter of Credit shall be deemed to be the maximum stated amount of such Letter of Credit after giving effect to all such increases, whether or not such maximum stated amount is in effect at such time.
1.5 Currency Translation .
For purposes of this Agreement and the other Credit Documents, where the permissibility of a transaction or determinations of required actions or circumstances depend upon compliance with, or are determined by reference to, amounts stated in Dollars, any requisite currency translation shall be based on the rate of exchange between the applicable currency and Dollars (as quoted by the Administrative Agent or if the Administrative Agent does not quote a rate of exchange on such currency, by a known dealer in such currency reasonably acceptable to the Borrower and the Administrative Agent (the Spot Currency Exchange Rate )) in effect on the Business Day immediately preceding the date of such transaction (except for such other time periods as provided for in Section 6.1) or determination and shall not be affected by subsequent fluctuations in exchange rates; provided that notwithstanding the foregoing, except as otherwise expressly set forth herein, all references herein and in the other Credit Documents to the amount of a Letter of Credit shall mean the Dollar Equivalent of such amount. Dollar Equivalent shall mean, at any time, with respect to any amount denominated in any currency other than Dollars, the equivalent amount thereof in Dollars, as determined by the Administrative Agent at the rate at which such currency may be exchanged into Dollars, as set forth at approximately 12:00 noon (New York time) on such day on the Reuters Fedspot page for such currency; provided that in the event that such rate does not appear on any Reuters page, the Dollar Equivalent shall be determined by the Administrative Agent to be the rate quoted by it at the spot rate purchased by it of Dollars through its principal foreign exchange trading office at approximately 12:00 noon on the date as of which the foreign exchange computation is made; provided, further, that if the Administrative Agent does not have, as of the relevant date of determination, a spot buying rate for any such currency, the Administrative Agent may obtain such spot rate from another major financial institution reasonably designated by the Administrative Agent.
On each Calculation Date, the Administrative Agent shall (a) determine the Exchange Rate as of such Calculation Date with respect to each Designated Foreign Currency and (b) give written notice thereof to the Borrower. The Exchange Rates so determined shall become effective on such Calculation Date (a Reset Date ), shall remain effective until the next succeeding Reset Date, and shall for all purposes of this Agreement (other than any provision expressly requiring the use of a current Exchange Rate and except for purposes of financial statements delivered by the Credit Parties hereunder or calculating financial ratios hereunder) be
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the Exchange Rates employed in converting any amounts between Dollars and Designated Foreign Currencies.
1.6 Elections . To the extent that any provision hereof requires (x) compliance with any financial ratio or test, including the Senior Secured Net Leverage Ratio and the Total Net Leverage Ratio, (y) the absence of any Default or Event of Default (or any type of Default or Event of Default) or (z) compliance with any cap expressed as a percentage of Consolidated Adjusted EBITDA or Consolidated Total Assets as a condition to (1) the consummation of any transaction in connection with any Permitted Acquisition or similar permitted Investment or (2) the incurrence of any Indebtedness (and any Liens related thereto) incurred to finance, or in connection with, such Permitted Acquisition or similar permitted Investment, the determination of whether the relevant condition is satisfied may be made, at the election of the Borrower: (A) in the case of any Permitted Acquisition or similar permitted Investment, either (I) at the time of the execution of the definitive agreement with respect to the relevant acquisition or investment or (II) at the time of the consummation of the relevant acquisition or investment, in either case after giving effect to the acquisition and any related Indebtedness and Liens on a Pro Forma Basis or (B) in the case of any Indebtedness (or any Liens related thereto) incurred to finance or in connection with such acquisition or similar investment, either (I) at the time of entry into the commitment for such Indebtedness ( provided that such election shall be required to have been made if the election under (A)(I) has been made) or (II) at the time of the incurrence of such Indebtedness or Liens ( provided that such election shall be required to have been made if the election under (A)(II) has been made), in either case after giving effect to the relevant Indebtedness, Liens and any related acquisition on a Pro Forma Basis.
1.7 Québec Matters . For purposes of any assets, liabilities or entities located in the Province of Québec and for all other purposes pursuant to which the interpretation or construction of this Agreement may be subject to the laws of the Province of Québec or a court or tribunal exercising jurisdiction in the Province of Québec, (a) personal property shall include movable property, (b) real property or real estate shall include immovable property, (c) tangible property shall include corporeal property, (d) intangible property shall include incorporeal property, (e) security interest, mortgage and lien shall include a hypothec, right of retention, prior claim and a resolutory clause, (f) all references to filing, perfection, priority, remedies, registering or recording under the Uniform Commercial Code or a Personal Property Security Act shall include publication under the Civil Code of Québec, (g) all references to perfection of or perfected liens or security interest shall include a reference to an opposable or set up lien or security interest as against third parties, (h) any right of offset, right of setoff or similar expression shall include a right of compensation, (i) goods shall include corporeal movable property other than chattel paper, documents of title, instruments, money and securities, (j) an agent shall include a mandatary, (k) construction liens shall include legal hypothecs, (l) joint and several shall include solidary, (m) gross negligence or willful misconduct shall be deemed to be intentional or gross fault, (n) beneficial ownership shall include ownership on behalf of another as mandatary, (o) easement shall include servitude, (p) priority shall include prior claim, (q) survey shall include certificate of location and plan, (r) state shall include province, (s) fee simple title shall include absolute ownership, (t) accounts shall include claims. The parties hereto confirm that it is their wish that this Agreement and any other document executed in connection with the transactions contemplated herein be drawn up in the English
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language only and that all other documents contemplated thereunder or relating thereto, including notices, may also be drawn up in the English language only. Les parties aux présentes confirment que cest leur volonté que cette convention et les autres documents de crédit soient rédigés en langue anglaise seulement et que tous les documents, y compris tous avis, envisagés par cette convention et les autres documents peuvent être rédigés en langue anglaise seulement .
SECTION 2. | LOANS AND LETTERS OF CREDIT |
2.1 Term Loans .
(a) Loan Commitments . Subject to the terms and conditions hereof, each Lender with an Initial Term Loan Commitment severally agrees to make, on the Closing Date, an Initial Term Loan to the Borrower in Dollars in an amount equal to such Lenders Initial Term Loan Commitment. The Borrower may make only one borrowing under the Initial Term Loan Commitment which shall be on the Closing Date. Any amount borrowed under this Section 2.1(a) and subsequently repaid or prepaid may not be reborrowed. Subject to Sections 2.11(a) and 2.12, all amounts owed hereunder with respect to the Initial Term Loans shall be paid in full no later than the Maturity Date applicable to such Initial Term Loans. Each Lenders Initial Term Loan Commitment shall terminate immediately and without further action on the Closing Date after giving effect to the funding of such Lenders Initial Term Loan Commitment on such date.
(b) Borrowing Mechanics for Term Loans .
(i) The Borrower shall deliver to the Administrative Agent a fully executed Funding Notice no later than (x) 12:00 noon (New York City time) [REDACTED Time Period] to the Closing Date with respect to Base Rate Loans and (y) [REDACTED Time Period] to the Closing Date with respect to Eurocurrency Rate Loans (or such shorter period as may be acceptable to Administrative Agent). Promptly upon receipt by the Administrative Agent of such Funding Notice, the Administrative Agent shall notify each Lender of the proposed borrowing.
(ii) Each Lender shall make its Initial Term Loan available to Administrative Agent not later than 9:00 a.m. (New York City time) on the Closing Date, by wire transfer of Same Day Funds in Dollars at the Principal Office designated by the Administrative Agent. Upon satisfaction or waiver of the conditions precedent specified herein, the Administrative Agent shall make the proceeds of the Initial Term Loans available to the Borrower on the Closing Date by causing an amount of Same Day Funds in Dollars equal to the proceeds of all such Loans received by the Administrative Agent from Lenders to be credited to the account of the Borrower at the Principal Office designated by the Administrative Agent or to such other account as may be designated in writing to Administrative Agent by the Borrower.
2.2 Revolving Loans .
(a) Revolving Commitments . During the Revolving Commitment Period, subject to the terms and conditions hereof, each Lender severally agrees to make Revolving
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Loans in Dollars and each Designated Foreign Currency to the Borrower in an aggregate amount up to but not exceeding such Lenders Revolving Commitment; provided , that after giving effect to the making of any Revolving Loans in no event shall the Total Utilization of Revolving Commitments exceed the Revolving Commitments then in effect. Amounts borrowed pursuant to this Section 2.2(a) may be repaid and reborrowed during the Revolving Commitment Period. Each Lenders Revolving Commitment shall expire on the Revolving Commitment Termination Date and all Revolving Loans and all other amounts owed hereunder with respect to the Revolving Loans and the Revolving Commitments shall be paid in full no later than such date.
(b) Borrowing Mechanics for Revolving Loans .
(i) Revolving Loans shall be made in an aggregate minimum amount of the Borrowing Minimum and integral multiples of the Borrowing Multiple in excess of that amount.
(ii) Whenever the Borrower desires that Lenders make Revolving Loans, the Borrower shall deliver to Administrative Agent a fully executed and delivered Funding Notice no later than 11:00 a.m. (New York City time) (x) in the case of a borrowing denominated in Dollars or Canadian Dollars (A) at least [REDACTED Time Period] in advance of the proposed Credit Date (which shall be [REDACTED Time Period] ) in the case of a Eurocurrency Rate Loan or Bankers Acceptance Loan, (B) [REDACTED Time Period] in advance of the proposed Credit Date (which shall be a Business Day) in the case of a Revolving Loan that is a Base Rate Loan or Canadian Prime Rate Loan and (y) in the case of a Loan denominated in a Designated Foreign Currency other than Canadian Dollars, [REDACTED Time Period] in advance of the proposed Credit Date (which shall be a Business Day), or, in each case, such later time as shall be acceptable to the Administrative Agent. Except as otherwise provided herein, a Funding Notice for a Revolving Loan that is a Eurocurrency Rate Loan shall be irrevocable on and after the related Interest Rate Determination Date, and the requesting Borrower shall be bound to make a borrowing in accordance therewith.
(iii) Notice of receipt of each Funding Notice in respect of Revolving Loans, together with the amount of each Lenders Pro Rata Share thereof, if any, together with the applicable interest rate, shall be provided by the Administrative Agent to each applicable Lender by telefacsimile with reasonable promptness, but ( provided Administrative Agent shall have received such notice by 10:00 a.m. (New York City time)) not later than 3:00 p.m. (New York City time) on the same day as Administrative Agents receipt of such Funding Notice from the Borrower unless the date on which the Funding Notice is received is the Credit Date, in which case by 12:00 p.m. (New York City time); provided , however , that if, on the date the Funding Notice with respect to such Revolving Loans is given by the Borrower, there are L/C Borrowings or Swing Line Loans outstanding, then the proceeds of such Revolving Loan, first , shall be applicable to the payment in full of any such L/C Borrowing and Swing Line Loans and second , shall be made available to the Borrower.
(iv) Each Lender shall make the amount of its Revolving Loan available to Administrative Agent not later than 2:00 p.m. (New York City time) on the
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applicable Credit Date by wire transfer of Same Day Funds in Dollars or the applicable Designated Foreign Currency at the Principal Office of the Administrative Agent. Except as provided herein, upon satisfaction or waiver of the conditions precedent specified herein, the Administrative Agent shall make the proceeds of such Revolving Loans available to the Borrower on the applicable Credit Date by causing an amount of Same Day Funds in Dollars or the applicable Designated Foreign Currency equal to the proceeds of all such Revolving Loans received by the Administrative Agent from Lenders to be credited to the account of the Borrower at the Principal Office designated by the Administrative Agent or such other account as may be designated in writing to Administrative Agent by the Borrower.
2.3 Letters of Credit .
(a) The Letter of Credit Commitment .
(i) Subject to the terms and conditions set forth herein, (A) each L/C Issuer agrees, in reliance upon the agreements of the Borrower and the Lenders set forth in this Section 2.3, (1) from time to time on any Business Day during the period from the Closing Date until the Letter of Credit Expiration Date, to issue Letters of Credit denominated in Dollars or Canadian Dollars for the account of the Borrower or its subsidiaries (subject to the approval of the applicable subsidiary by the applicable L/C Issuer), and to amend or extend Letters of Credit previously issued by it, in accordance with subsection (b) below, and (2) to honor drawings under the Letters of Credit; and (B) the Lenders severally agree to participate in Letters of Credit issued for the account of the Borrower or its subsidiaries and any drawings thereunder; provided that after giving effect to any L/C Credit Extension with respect to any Letter of Credit, (x) the Total Utilization of Revolving Commitments shall not exceed the Revolving Commitments then in effect, (y) the aggregate Outstanding Amount of the Revolving Loans of any Lender, plus such Lenders Pro Rata Share of the Outstanding Amount of L/C Obligations, shall not exceed such Lenders Revolving Commitment then in effect, and (z) the Outstanding Amount of L/C Obligations shall not exceed the Letter of Credit Sublimit. Each request by the Borrower for the issuance or amendment of a Letter of Credit shall be deemed to be a representation by the Borrower that the L/C Credit Extension so requested complies with the conditions set forth in the proviso to the preceding sentence. Within the foregoing limits, and subject to the terms and conditions hereof, the Borrowers ability to obtain Letters of Credit shall be fully revolving, and accordingly the Borrower may, during the foregoing period, obtain Letters of Credit to replace Letters of Credit that have expired or that have been drawn upon and reimbursed.
(ii) No L/C Issuer shall issue any Letter of Credit, if:
(A) subject to Section 2.3(b)(iii), the expiry date of the requested Letter of Credit would occur more than [REDACTED Time Period] after the date of issuance or last extension, unless the Requisite Lenders have approved such expiry date; or
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(B) the expiry date of the requested Letter of Credit would occur after the Letter of Credit Expiration Date, unless all the Lenders and the applicable L/C Issuer have approved such expiry date.
(iii) No L/C Issuer shall be under any obligation to issue any Letter of Credit if:
(A) any order, judgment or decree of any Governmental Authority or arbitrator shall by its terms purport to enjoin or restrain such L/C Issuer from issuing the Letter of Credit, or any law applicable to such L/C Issuer or any request or directive (whether or not having the force of law) from any Governmental Authority with jurisdiction over such L/C Issuer shall prohibit, or request that such L/C Issuer refrain from, the issuance of letters of credit generally or the Letter of Credit in particular or shall impose upon such L/C Issuer with respect to the Letter of Credit any restriction, reserve or capital requirement (for which such L/C Issuer is not otherwise compensated hereunder) not in effect on the Closing Date, or shall impose upon such L/C Issuer any unreimbursed loss, cost or expense which was not applicable on the Closing Date and which such L/C Issuer in good faith deems material to it;
(B) the issuance of the Letter of Credit would violate one or more policies of such L/C Issuer applicable to letters of credit generally;
(C) such Letter of Credit is a commercial Letter of Credit (unless the applicable L/C Issuer consents to the issuance of a commercial Letter of Credit);
(D) except as otherwise agreed by the Administrative Agent and the applicable L/C Issuer, the Letter of Credit is in an initial stated amount less than [REDACTED Dollar Amount] ;
(E) any Lender is at that time a Defaulting Lender, unless the applicable L/C Issuer has entered into arrangements, including the delivery of Cash Collateral, satisfactory to such L/C Issuer (in its sole discretion) with the Borrower or such Lender to eliminate such L/C Issuers actual or potential Fronting Exposure (after giving effect to Section 2.18(a)) with respect to the Defaulting Lender arising from either the Letter of Credit then proposed to be issued or that Letter of Credit and all other L/C Obligations as to which such L/C Issuer has actual or potential Fronting Exposure, as it may elect in its sole discretion; or
(F) the Letter of Credit contains any provisions for automatic reinstatement of the stated amount after any drawing thereunder.
(iv) No L/C Issuer shall amend any Letter of Credit if such L/C Issuer would not be permitted at such time to issue the Letter of Credit in its amended form under the terms hereof.
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(v) An L/C Issuer shall be under no obligation to amend any Letter of Credit if (A) such L/C Issuer would have no obligation at such time to issue the Letter of Credit in its amended form under the terms hereof, or (B) the beneficiary of the Letter of Credit does not accept the proposed amendment to the Letter of Credit.
(vi) Each L/C Issuer shall act on behalf of the Lenders with respect to any Letters of Credit issued by it and the documents associated therewith, and the L/C Issuers shall have all of the benefits and immunities (A) provided to the Administrative Agent in Section 9 with respect to any acts taken or omissions suffered by any L/C Issuer in connection with Letters of Credit issued by it or proposed to be issued by it and Issuer Documents pertaining to such Letters of Credit as fully as if the term Agent as used in Section 9 included such L/C Issuer with respect to such acts or omissions, and (B) as additionally provided herein with respect to each L/C Issuer.
(b) Procedures for Issuance and Amendment of Letters of Credit; Auto-Extension Letters of Credit .
(i) Each Letter of Credit shall be issued or amended, as the case may be, upon the request of the Borrower delivered to the applicable L/C Issuer (with a copy to the Administrative Agent) in the form of a Letter of Credit Application and Request for L/C Credit Extension substantially in the form of Exhibit A-3, appropriately completed and signed by an Authorized Officer of the Borrower. Such Letter of Credit Application and Request for L/C Credit Extension must be received by the applicable L/C Issuer and the Administrative Agent not later than 11:00 a.m. at least [REDACTED Time Period] (or such later date and time as the Administrative Agent and the applicable L/C Issuer may agree in a particular instance in their sole discretion) prior to the proposed issuance date or date of amendment, as the case may be. In the case of a request for an initial issuance of a Letter of Credit, such Letter of Credit Application shall specify in form and detail satisfactory to the applicable L/C Issuer: (A) the proposed issuance date of the requested Letter of Credit (which shall be a Business Day); (B) the amount and currency thereof; (C) the expiry date thereof (including a final expiration date in the case of an Auto-Extension Letter of Credit); (D) the name and address of the beneficiary thereof; (E) the documents to be presented by such beneficiary in case of any drawing thereunder; (F) the full text of any certificate to be presented by such beneficiary in case of any drawing thereunder; (G) the purpose and nature of the requested Letter of Credit; and (H) such other matters as the applicable L/C Issuer may require (which may include the form of the requested Letter of Credit). In the case of a request for an amendment of any outstanding Letter of Credit, such Letter of Credit Application shall specify in form and detail satisfactory to the applicable L/C Issuer (A) the Letter of Credit to be amended; (B) the proposed date of amendment thereof (which shall be a Business Day); (C) the nature of the proposed amendment; and (D) such other matters as the applicable L/C Issuer may require. Additionally, the Borrower shall furnish to the applicable L/C Issuer and the Administrative Agent such other documents and information pertaining to such requested Letter of Credit issuance or amendment, including any Issuer Documents, as the applicable L/C Issuer or the Administrative Agent may require.
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(ii) Promptly after receipt of any Letter of Credit Application, the applicable L/C Issuer will confirm with the Administrative Agent (by telephone or in writing) that the Administrative Agent has received a copy of such Letter of Credit Application from the Borrower and, if not, such L/C Issuer will provide the Administrative Agent with a copy thereof. Unless the applicable L/C Issuer has received written notice from the Administrative Agent (or any Lender or Credit Party through the Administrative Agent), at least [REDACTED Time Period] prior to the requested date of issuance or amendment of the applicable Letter of Credit, that one or more applicable conditions contained in Section 3 shall not then be satisfied, then, subject to the terms and conditions hereof, the applicable L/C Issuer shall, on the requested date, issue a Letter of Credit for the account of the Borrower (or the applicable subsidiary) or enter into the applicable amendment, as the case may be, in each case in accordance with such L/C Issuers usual and customary business practices. Immediately upon the issuance of each Letter of Credit, each Lender shall be deemed to, and hereby irrevocably and unconditionally agrees to, purchase from the applicable L/C Issuer a risk participation in such Letter of Credit in an amount equal to the product of such Lenders Pro Rata Share times the amount of such Letter of Credit.
(iii) If the Borrower so requests in any applicable Letter of Credit Application, the applicable L/C Issuer may, in its sole discretion, agree to issue a Letter of Credit that has automatic extension provisions (each, an Auto-Extension Letter of Credit ); provided that any such Auto-Extension Letter of Credit must permit such L/C Issuer to prevent any such extension at least once in each [REDACTED Time Period] period (commencing with the date of issuance of such Letter of Credit) by giving prior notice to the beneficiary thereof [REDACTED Time Period] (which shall be a Business Day) (the Non-Extension Notice Date ) in each such [REDACTED Time Period] period to be agreed upon at the time such Letter of Credit is issued. Once an Auto-Extension Letter of Credit has been issued, unless otherwise directed by the applicable L/C Issuer, the Borrower shall not be required to make a specific request to such L/C Issuer for any such extension. Once an Auto-Extension Letter of Credit has been issued, the Lenders shall be deemed to have authorized (but may not require) the applicable L/C Issuer to permit the extension of such Letter of Credit at any time to an expiry date not later than the Letter of Credit Expiration Date; provided , however , that the applicable L/C Issuer shall not permit any such extension if (A) such L/C Issuer has determined that it would not be permitted, or would have no obligation, at such time to issue such Letter of Credit in its revised form (as extended) under the terms hereof (by reason of the provisions of clause (ii) or (iii) of Section 2.3(a) or otherwise), or (B) it has received notice (which may be by telephone or in writing) on or before the [REDACTED Time Period] before the Non-Extension Notice Date (1) from the Administrative Agent that the Requisite Lenders have elected not to permit such extension or (2) from the Administrative Agent (or any Lender or Credit Party through the Administrative Agent) or the Borrower that one or more of the applicable conditions specified in Section 3.2 is not then satisfied (or a Default or Event of Default has occurred and is continuing), and in each such case directing such L/C Issuer not to permit such extension.
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(iv) If the Borrower so requests in any applicable Letter of Credit Application, the applicable L/C Issuer may, in its sole discretion, agree to issue a Letter of Credit that permits the automatic reinstatement of all or a portion of the stated amount thereof after any drawing thereunder (each, an Auto-Reinstatement Letter of Credit ). Once an Auto-Reinstatement Letter of Credit has been issued, unless otherwise directed by the applicable L/C Issuer, the Borrower shall not be required to make a specific request to such L/C Issuer to permit such reinstatement. Once an Auto-Reinstatement Letter of Credit has been issued, except as provided in the following sentence, the Lenders shall be deemed to have authorized (but may not require) the applicable L/C Issuer to reinstate all or a portion of the stated amount thereof in accordance with the provisions of such Letter of Credit. Notwithstanding the foregoing, if such Auto-Reinstatement Letter of Credit permits such L/C Issuer to decline to reinstate all or any portion of the stated amount thereof after a drawing thereunder by giving notice of such non-reinstatement within a specified number of days after such drawing (the Non-Reinstatement Deadline ), such L/C Issuer shall not permit such reinstatement if it has received a notice (which may be by telephone or in writing) on or before [REDACTED Time Period] before the Non-Reinstatement Deadline (A) from the Administrative Agent that the Requisite Lenders have elected not to permit such reinstatement or (B) from the Administrative Agent, any Lender or the Borrower that one or more of the applicable conditions specified in Section 3.2 is not then satisfied (or a Default or Event of Default has occurred and is continuing) (treating such reinstatement as an L/C Credit Extension for purposes of this clause) and, in each case, directing such L/C Issuer not to permit such reinstatement.
(v) Promptly after its delivery of any Letter of Credit or any amendment to a Letter of Credit to an advising bank with respect thereto or to the beneficiary thereof, the applicable L/C Issuer will also deliver to the Borrower and the Administrative Agent a true and complete copy of such Letter of Credit or amendment.
(vi) Anything herein to the contrary notwithstanding, in the event of any conflict between the terms of any Letter of Credit Application and those of this Agreement, the terms of this Agreement shall be controlling.
(c) Provisions Related to Extended Revolving Commitments . If the Letter of Credit Expiration Date in respect of any Class of Revolving Commitments occurs prior to the expiry date of any Letter of Credit, then (i) if consented to by such L/C Issuer which issued such Letter of Credit, if one or more other Classes of Revolving Commitments under which Letters of Credit are issued in respect of which the Letter of Credit Expiration Date shall not have occurred are then in effect, such Letters of Credit for which consent of the respective L/C Issuer has been obtained shall automatically be deemed to have been issued (including for purposes of the obligations of the Revolving Lenders to purchase participations therein and to make Revolving Loans and payments in respect thereof pursuant to Sections 2.3(d) and (e)) under (and ratably participated in by Revolving Lenders pursuant to) the Revolving Commitments in respect of such non-terminating Classes up to an aggregate amount not to exceed the aggregate principal amount of the unutilized Revolving Commitments thereunder at such time (it being understood that no partial face amount of any Letter of Credit may be so reallocated) and (ii) to the extent not reallocated pursuant to immediately preceding clause (i) and unless provisions reasonably
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satisfactory to the applicable L/C Issuer for the treatment of such Letter of Credit as a letter of credit under a successor credit facility have been agreed upon, the Borrower shall, on or prior to the applicable Maturity Date, cause all such Letters of Credit to be replaced and returned to the applicable L/C Issuer undrawn and marked cancelled or to the extent that the Borrower is unable to so replace and return any Letter(s) of Credit, such Letter(s) of Credit shall be secured by a back to back letter of credit reasonably satisfactory to the applicable L/C Issuer or the Borrower shall provide Cash Collateral for any such Letter of Credit. Commencing with the Maturity Date of any Class of Revolving Commitments, the sublimit for Letters of Credit shall be agreed solely with such L/C Issuer; provided that, at the request of the Borrower, the Letter of Credit Sublimit immediately following such Maturity Date shall be no less than the Letter of Credit Sublimit immediately prior to such Maturity Date multiplied by a fraction, the numerator of which is the aggregate amount of the Revolving Commitments immediately following such Maturity Date and the denominator of which is the aggregate amount of the Revolving Commitments immediately prior to such Maturity Date.
(d) Drawings and Reimbursements; Funding of Participations .
(i) Upon receipt from the beneficiary of any Letter of Credit of any notice of a drawing under such Letter of Credit, the applicable L/C Issuer shall notify the Borrower and the Administrative Agent thereof. Not later than 11:00 a.m. (New York City time) on the date of any payment by the applicable L/C Issuer, in accordance with normal banking procedures in the place of payment (each such date, an Honor Date ), the Borrower shall reimburse such L/C Issuer through the Administrative Agent in an amount equal to the amount of such drawing in Dollars or Canadian Dollars, as applicable. If the Borrower fails to so reimburse such L/C Issuer by such time, the Administrative Agent shall promptly notify each Lender of the Honor Date, the amount of the unreimbursed drawing (the Unreimbursed Amount ), and the amount of such Lenders Pro Rata Share thereof. In such event, the Borrower shall be deemed to have requested a Revolving Loan that is a Base Rate Loan (if denominated in Dollars) or Canadian Prime Rate Loan (if denominated in Canadian Dollars) to be disbursed on the Honor Date in an amount equal to the Unreimbursed Amount, without regard to the minimum and multiples specified in Section 2.2 for the principal amount of Base Rate Loans or Canadian Prime Rate Loans, but subject to the amount of the unutilized portion of the Revolving Commitments and the conditions set forth in Section 3.2 (other than the delivery of a Funding Notice). Any notice given by an L/C Issuer or the Administrative Agent pursuant to this Section 2.3(d)(i) may be given by telephone if immediately confirmed in writing; provided that the lack of such an immediate confirmation shall not affect the conclusiveness or binding effect of such notice.
(ii) Each Lender shall upon any notice pursuant to Section 2.3(d)(i) make funds available (and the Administrative Agent may apply Cash Collateral provided for this purpose) for the account of the applicable L/C Issuer, in Dollars or Canadian Dollars, as applicable, at the Principal Office designated by such L/C Issuer in an amount equal to its Pro Rata Share of the Unreimbursed Amount not later than 1:00 p.m. on the Business Day specified in such notice by the Administrative Agent, whereupon, subject to the provisions of Section 2.3(d)(iv), each Lender that so makes funds available shall be deemed to have made a Revolving Loan that is a Base Rate Loan or Canadian Prime Rate
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Loan, as the case may be, to the Borrower in such amount. The Administrative Agent shall reasonably promptly remit the funds so received to the applicable L/C Issuer in Dollars or Canadian Dollars, as applicable.
(iii) With respect to any Unreimbursed Amount that is not fully refinanced by a Revolving Loan that is a Base Rate Loan because the conditions set forth in Section 3.2 cannot be satisfied or for any other reason, the Borrower shall be deemed to have incurred from the applicable L/C Issuer an L/C Borrowing in the amount of the Unreimbursed Amount that is not so refinanced, which L/C Borrowing shall be due and payable on demand (together with interest) and shall bear interest at the Letter of Credit Fees Default Rate. In such event, each Lenders payment to the Administrative Agent for the account of such L/C Issuer pursuant to Section 2.3(d)(ii) shall be deemed payment in respect of its participation in such L/C Borrowing and shall constitute an L/C Advance from such Lender in satisfaction of its participation obligation under this Section 2.3.
(iv) Until each Lender funds its Revolving Loan or L/C Advance pursuant to this Section 2.3(d) to reimburse the applicable L/C Issuer for any amount drawn under any Letter of Credit, interest in respect of such Lenders Pro Rata Share of such amount shall be solely for the account of such L/C Issuer.
(v) Each Lenders obligation to make Revolving Loans or L/C Advances to reimburse the applicable L/C Issuer for amounts drawn under Letters of Credit, as contemplated by this Section 2.3(d), shall be absolute and unconditional and shall not be affected by any circumstance, including (A) any setoff, counterclaim, recoupment, defense or other right which such Lender may have against any L/C Issuer, the Borrower or any other Person for any reason whatsoever; (B) the occurrence or continuance of a Default or Event of Default, or (C) any other occurrence, event or condition, whether or not similar to any of the foregoing; provided , however , that each Lenders obligation to make Revolving Loans pursuant to this Section 2.3(d) is subject to the conditions set forth in Section 3.2 (other than delivery by the Borrower of a Funding Notice). No such making of an L/C Advance shall relieve or otherwise impair the obligation of the Borrower to reimburse the applicable L/C Issuer for the amount of any payment made by such L/C Issuer under any Letter of Credit, together with interest as provided herein.
(vi) If any Lender fails to make available to the Administrative Agent for the account of the applicable L/C Issuer any amount required to be paid by such Lender pursuant to the foregoing provisions of this Section 2.3(d) by the time specified in Section 2.3(d)(ii), then, without limiting the other provisions of this Agreement, such L/C Issuer shall be entitled to recover from such Lender (acting through the Administrative Agent), on demand, such amount with interest thereon for the period from the date such payment is required to the date on which such payment is immediately available to such L/C Issuer at a rate per annum equal to the L/C Overnight Rate from time to time in effect, plus any administrative, processing or similar fees customarily charged by such L/C Issuer in connection with the foregoing. If such Lender pays such amount (with interest and fees as aforesaid), the amount so paid shall constitute such Lenders Revolving Loan included in the relevant Revolving Commitment or L/C Advance in
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respect of the relevant L/C Borrowing, as the case may be. A certificate of the applicable L/C Issuer submitted to any Lender (through the Administrative Agent) with respect to any amounts owing under this clause (vi) shall be conclusive absent manifest error.
(e) Repayment of Participations .
(i) At any time after the applicable L/C Issuer has made a payment under any Letter of Credit and has received from any Lender such Lenders L/C Advance in respect of such payment in accordance with Section 2.3(d), if the Administrative Agent receives for the account of such L/C Issuer any payment in respect of the related Unreimbursed Amount or interest thereon (whether directly from the Borrower or otherwise, including proceeds of Cash Collateral applied thereto by the Administrative Agent), the Administrative Agent will distribute to such Lender its Pro Rata Share thereof in the same funds as those received by the Administrative Agent.
(ii) If any payment received by the Administrative Agent for the account of the applicable L/C Issuer pursuant to Section 2.3(a)(i) is required to be returned under any of the circumstances described in Section 10 (including pursuant to any settlement entered into by such L/C Issuer in its discretion), each Lender shall pay to the Administrative Agent for the account of such L/C Issuer its Pro Rata Share thereof on demand of the Administrative Agent, plus interest thereon from the date of such demand to the date such amount is returned by such Lender, at a rate per annum equal to the L/C Overnight Rate. The obligations of the Lenders under this clause shall survive the payment in full of the Obligations and the termination of this Agreement.
(f) Obligations Absolute . The obligation of the Borrower to reimburse the applicable L/C Issuer for each drawing under each Letter of Credit and to repay each L/C Borrowing (whether made to the Borrower or any of its subsidiaries) shall be absolute, unconditional and irrevocable, and shall be paid strictly in accordance with the terms of this Agreement under all circumstances, including the following:
(i) any lack of validity or enforceability of such Letter of Credit, this Agreement, or any other Credit Document;
(ii) the existence of any claim, counterclaim, setoff, defense or other right that the Borrower or any subsidiary may have at any time against any beneficiary or any transferee of such Letter of Credit (or any Person for whom any such beneficiary or any such transferee may be acting), any L/C Issuer or any other Person, whether in connection with this Agreement, the transactions contemplated hereby or by such Letter of Credit or any agreement or instrument relating thereto, or any unrelated transaction;
(iii) any draft, demand, certificate or other document presented under such Letter of Credit proving to be forged, fraudulent, invalid or insufficient in any respect or any statement therein being untrue or inaccurate in any respect; or any loss or delay in the transmission or otherwise of any document required in order to make a drawing under such Letter of Credit;
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(iv) any payment by the applicable L/C Issuer under such Letter of Credit against presentation of a draft or certificate that does not strictly comply with the terms of such Letter of Credit; or any payment made by the applicable L/C Issuer under such Letter of Credit to any Person purporting to be a trustee in bankruptcy, debtor-in-possession, assignee for the benefit of creditors, liquidator, receiver, curator or other representative of or successor to any beneficiary or any transferee of such Letter of Credit, including any arising in connection with any proceeding under any Debtor Relief Law; or
(v) any other circumstance or happening whatsoever, whether or not similar to any of the foregoing, including any other circumstance that might otherwise constitute a defense available to, or a discharge of, the Borrower or any subsidiary.
The Borrower shall promptly examine a copy of each Letter of Credit and each amendment thereto that is delivered to it and, in the event of any claim of noncompliance with the Borrowers instructions or other irregularity, the Borrower will immediately notify the applicable L/C Issuer. The Borrower shall be conclusively deemed to have waived any such claim against such L/C Issuer and its correspondents unless such notice is given as aforesaid.
(g) Role of an L/C Issuer . Each Lender and the Borrower agree that, in paying any drawing under a Letter of Credit, the applicable L/C Issuer shall not have any responsibility to obtain any document (other than any sight draft, certificates and documents expressly required by the Letter of Credit) or to ascertain or inquire as to the validity or accuracy of any such document or the authority of the Person executing or delivering any such document. None of the L/C Issuers, the Administrative Agent, any of their respective Related Parties nor any correspondent, participant or assignee of any L/C Issuer shall be liable to any Lender for (i) any action taken or omitted in connection herewith at the request or with the approval of the Lenders or the Requisite Lenders, as applicable; (ii) any action taken or omitted in the absence of gross negligence or willful misconduct (as determined by a court of competent jurisdiction in a final and non-appealable judgment); or (iii) the due execution, effectiveness, validity or enforceability of any document or instrument related to any Letter of Credit or Issuer Document. The Borrower hereby assumes all risks of the acts or omissions of any beneficiary or transferee with respect to its use of any Letter of Credit; provided , however , that this assumption is not intended to, and shall not, preclude the Borrowers pursuing such rights and remedies as it may have against the beneficiary or transferee at law or under any other agreement. None of the L/C Issuers, the Administrative Agent, any of their respective Related Parties nor any correspondent, participant or assignee of any L/C Issuer shall be liable or responsible for any of the matters described in clauses (i) through (v) of Section 2.3(d); provided , however , that anything in such clauses to the contrary notwithstanding, the Borrower may have a claim against any L/C Issuer, and such L/C Issuer may be liable to the Borrower, to the extent, but only to the extent, of any direct, as opposed to consequential or exemplary, damages suffered by the Borrower which the Borrower proves were caused by such L/C Issuers willful misconduct or gross negligence (as determined by a court of competent jurisdiction in a final and non-appealable judgment) or such L/C Issuers willful failure to pay under any Letter of Credit after the presentation to it by the beneficiary of all the documents specified in such Letter of Credit strictly complying with the terms and conditions of a Letter of Credit. In furtherance and not in limitation of the foregoing, any L/C Issuer may accept documents that appear on their face to be in order, without
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responsibility for further investigation, regardless of any notice or information to the contrary, and such L/C Issuer shall not be responsible for the validity or sufficiency of any instrument transferring or assigning or purporting to transfer or assign a Letter of Credit or the rights or benefits thereunder or proceeds thereof, in whole or in part, which may prove to be invalid or ineffective for any reason.
(h) Applicability of ISP and UCP . Unless otherwise expressly agreed by the applicable L/C Issuer and the Borrower when a Letter of Credit is issued or when it is amended with the consent of the beneficiary thereof, (i) the rules of the ISP shall apply to each standby Letter of Credit, and (ii) the rules of the Uniform Customs and Practice for Documentary Credits, as most recently published by the International Chamber of Commerce at the time of issuance shall apply to each commercial Letter of Credit.
(i) Letter of Credit Fees . The Borrower shall pay to the Administrative Agent for the account of each Lender in accordance with its Pro Rata Share, in Dollars, a Letter of Credit fee (the Letter of Credit Fee ) (i) for each commercial Letter of Credit equal to an amount per annum to be agreed at the time of issuance times the daily amount available to be drawn under such Letter of Credit, and (ii) for each standby Letter of Credit equal to the Applicable Margin times the daily amount available to be drawn under such Letter of Credit; provided , however , any Letter of Credit Fees otherwise payable for the account of a Defaulting Lender with respect to any Letter of Credit as to which such Defaulting Lender has not provided Cash Collateral satisfactory to the applicable L/C Issuer pursuant to Section 2.19 shall be payable, to the maximum extent permitted by applicable law, to the other Lenders in accordance with the upward adjustments in their respective Pro Rata Share allocable to such Letter of Credit pursuant to Section 2.19(a)(iv), with the balance of such fee, if any, payable to such L/C Issuer for its own account. For purposes of computing the daily amount available to be drawn under any Letter of Credit, the amount of such Letter of Credit shall be determined in accordance with Section 1.4. Letter of Credit Fees shall be (i) due and payable on [REDACTED Time Period] after the end of each March, June, September and December, commencing with the first such date to occur after the issuance of such Letter of Credit, on the Letter of Credit Expiration Date and thereafter on demand and (ii) computed on a quarterly basis in arrears. If there is any change in the Applicable Margin during any quarter, the daily amount available to be drawn under each standby Letter of Credit shall be computed and multiplied by the Applicable Margin separately for each period during such quarter that such Applicable Margin was in effect.
(j) Fronting Fee and Documentary and Processing Charges Payable to applicable L/C Issuer . The Borrower shall pay directly to the applicable L/C Issuer for its own account, in Dollars, a fronting fee (i) with respect to each commercial Letter of Credit, at the rate equal to an amount to be agreed at the time of issuance of each such commercial Letter of Credit, computed on the amount of such Letter of Credit, and payable upon the issuance thereof, (ii) with respect to any amendment of a commercial Letter of Credit increasing the amount of such Letter of Credit, at a rate separately agreed between the Borrower and the applicable L/C Issuer, computed on the amount of such increase, and payable upon the effectiveness of such amendment, and (iii) with respect to each standby Letter of Credit, at the rate per annum equal to [REDACTED Percentage] per annum, computed on the daily amount available to be drawn under such Letter of Credit on a quarterly basis in arrears. Such fronting fee shall be due and payable on [REDACTED Time Period] after the end of each March, June, September and
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December in respect of the most recently-ended quarterly period (or portion thereof, in the case of the first payment), commencing with the first such date to occur after the issuance of such Letter of Credit, on the Letter of Credit Expiration Date and thereafter on demand. For purposes of computing the daily amount available to be drawn under any Letter of Credit, the amount of such Letter of Credit shall be determined in accordance with Section 1.4. In addition, the Borrower shall pay directly to the applicable L/C Issuer for its own account, in Dollars, the customary issuance, presentation, amendment and other processing fees, and other standard costs and charges, of such L/C Issuer relating to letters of credit as from time to time in effect. Such customary fees and standard costs and charges are due and payable on demand and are nonrefundable.
(k) Conflict with Issuer Documents . In the event of any conflict between the terms hereof and the terms of any Issuer Document, the terms hereof shall control.
(l) Letters of Credit Issued for Subsidiaries . Notwithstanding that a Letter of Credit issued or outstanding hereunder is in support of any obligations of, or is for the account of, a subsidiary, the Borrower shall be obligated to reimburse the applicable L/C Issuer hereunder for any and all drawings under such Letter of Credit. The Borrower hereby acknowledges that the issuance of Letters of Credit for the account of subsidiaries inures to the benefit of the Borrower, and that the Borrowers business derives substantial benefits from the businesses of such subsidiaries.
(m) Resignation as L/C Issuer . Any L/C Issuer may, upon [REDACTED Time Period] notice to the Borrower and the Lenders resign as L/C Issuer. In the event of any such resignation as L/C Issuer the Borrower shall be entitled to appoint from among the Lenders a successor L/C Issuer hereunder; provided , however , that no failure by the Borrower to appoint any such successor shall affect the resignation of any L/C Issuer. If Royal Bank of Canada, or another Lender resigns as L/C Issuer, it shall retain all the rights, powers, privileges and duties of an L/C Issuer hereunder with respect to all Letters of Credit that it issued, including Letters of Credit outstanding as of the effective date of its resignation as L/C Issuer and all L/C Obligations with respect thereto (including the right to require the Lenders to make Revolving Loans that are Base Rate Loans or fund risk participations in Unreimbursed Amounts pursuant to Section 2.3(d)). Upon the appointment of a successor L/C Issuer, (a) such successor shall succeed to and become vested with all of the rights, powers, privileges and duties of the retiring L/C Issuer as the case may be, and (b) the successor L/C Issuer shall issue letters of credit in substitution for the Letters of Credit, if any, outstanding at the time of such succession or make other arrangements satisfactory to the applicable L/C Issuer to effectively assume the obligations of such L/C Issuer with respect to such Letters of Credit.
2.4 Pro Rata Shares; Availability of Funds .
(a) Pro Rata Shares . All Loans shall be made, and all participations purchased, by Lenders simultaneously and proportionately to their respective Pro Rata Shares, it being understood that no Lender shall be responsible for any default by any other Lender in such other Lenders obligation to make a Loan requested hereunder or purchase a participation required hereby nor shall any Term Loan Commitment or any Revolving Commitment of any Lender be increased or decreased as a result of a default by any other Lender in such other
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Lenders obligation to make a Loan requested hereunder or purchase a participation required hereby.
(b) Availability of Funds . Unless Administrative Agent shall have been notified by any Lender prior to the applicable Credit Date that such Lender does not intend to make available to Administrative Agent the amount of such Lenders Loan requested on such Credit Date, the Administrative Agent may assume that such Lender has made such amount available to Administrative Agent on such Credit Date and the Administrative Agent may, in its sole discretion, but shall not be obligated to, make available to Borrower a corresponding amount on such Credit Date. If such corresponding amount is not in fact made available to Administrative Agent by such Lender, the Administrative Agent shall be entitled to recover such corresponding amount on demand from such Lender together with interest thereon, for each day from such Credit Date until the date such amount is paid to Administrative Agent, at the customary rate set by the Administrative Agent for the correction of errors among banks for [REDACTED Time Period] and thereafter at the Base Rate. In the event that (i) Administrative Agent does not make available to Borrower a requested amount on the applicable Credit Date until such time as all applicable Lenders have made payment to Administrative Agent, (ii) any payment by or on behalf of a Lender hereunder is not made in Same Day Funds prior to the time period specified herein and (iii) such delay causes Administrative Agents failure to fund to Borrower in accordance with its Funding Notice, such payment shall be deemed a non-conforming payment and such Lender shall not receive interest hereunder with respect to the requested amount of such Lenders Loans for the period commencing with the time specified in this Agreement for receipt of payment by Borrower through and including the time of Borrowers receipt of the requested amount. If such Lender does not pay such corresponding amount forthwith upon Administrative Agents demand therefor, the Administrative Agent shall promptly notify Borrower and the Borrower shall immediately pay such corresponding amount to Administrative Agent together with interest thereon, for each day from such Credit Date until the date such amount is paid to Administrative Agent, at the rate payable hereunder for Base Rate Loans for such Class of Loans. Nothing in this Section 2.4(b) shall be deemed to relieve any Lender from its obligation to fulfill its Term Loan Commitments and Revolving Commitments hereunder or to prejudice any rights that Borrower may have against any Lender as a result of any default by such Lender hereunder.
2.5 Evidence of Debt; Register; Disqualified Persons; Lenders Books and Records; Notes .
(a) Lenders Evidence of Debt . Each Lender shall maintain on its internal records an account or accounts evidencing the Obligations of the Borrower to such Lender, including the amounts of the Loans made by it and each repayment and prepayment in respect thereof. In addition to the accounts and records referred to in subsection (b), each Lender and the Administrative Agent shall maintain in accordance with its usual practice accounts or records evidencing the purchases and sales by such Lender of participations in Letters of Credit. Any such recordation shall be conclusive and binding on the Borrower, absent manifest error; provided , that the failure to make any such recordation, or any error in such recordation, shall not affect any Lenders Revolving Commitments or the Borrowers Obligations in respect of any applicable Loans; and provided further , in the event of any inconsistency between the Register and any Lenders records, the recordations in the Register shall govern.
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(b) Register . The Administrative Agent (or its agent or sub-agent appointed by it) shall maintain at its Principal Office a register for the recordation of the names and addresses of Lenders and the Revolving Commitments and Loans of each Lender from time to time (the Register ). The Administrative Agent shall record, or shall cause to be recorded, in the Register the Revolving Commitments and the Loans in accordance with the provisions of Section 10.6, and each repayment or prepayment in respect of the principal amount of the Loans, and any such recordation shall be conclusive and binding on the Borrower and each Lender, absent manifest error; provided , that failure to make any such recordation, or any error in such recordation, shall not affect any Lenders Revolving Commitments or the Borrowers Obligations in respect of any Loan. The Borrower hereby designates Administrative Agent to serve as the Borrowers non-fiduciary agent solely for purposes of maintaining the Register as provided in this Section 2.5, and the Borrower hereby agrees that, to the extent Administrative Agent serves in such capacity, the Administrative Agent and its officers, directors, employees, agents, sub-agents and affiliates shall constitute Indemnitees.
(c) Disqualified Persons . The list of Disqualified Persons will be available to the Lenders and the Agents upon request to the Administrative Agent. The parties to this Agreement hereby acknowledge and agree that the Administrative Agent shall not be deemed to be in default under this Agreement or to have any duty or responsibility or to incur any liabilities as a result of a breach of this Section 2.5(c), nor shall the Administrative Agent have any duty, responsibility or liability to monitor or enforce assignments, participations or other actions in respect of Disqualified Persons, or otherwise take (or omit to take) any action with respect thereto (it being understood that any assignment or participation to any Disqualified Person shall be without effect and void and the Administrative Agent shall not consider any Disqualified Person to be a Lender or have any rights hereunder). The parties to this Agreement further acknowledge and agree that, notwithstanding the right of the Borrower to supplement the list of Disqualified Persons pursuant to clause (b) of the definition thereof, in no event shall any such supplement apply retroactively to disqualify any Person or Persons that have previously acquired an assignment or participation interest under this Agreement that is otherwise permitted hereunder; provided that upon the effectiveness of any such supplement, any such Person or Persons shall not be permitted to acquire additional Loans, Commitments or participations hereunder.
(d) Notes . If so requested by any Lender by written notice to Borrower (with a copy to Administrative Agent) [REDACTED Time Period] prior to the Closing Date, (or, if such notice is delivered after the Closing Date, promptly after receipt by Borrower of such notice) the Borrower shall execute and deliver to such Lender (or, if applicable and if so specified in such notice, to any Person who is an assignee of such Lender pursuant to Section 10.4) on the Closing Date (or, if such notice is delivered after the Closing Date, promptly after the Borrowers receipt of such notice) a Note or Notes to evidence such Lenders Initial Term Loan or Revolving Loan, as the case may be; provided that any excise, stamp or similar tax required to be paid by the Borrower or any other Credit Party pursuant to Rule 12B-4 of the Florida Administrative Code (or any successor or replacement provision thereto) as a result of the delivery of such Note shall be for the account of the Lender requesting such Note.
2.6 Interest on Loans .
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(a) Except as otherwise set forth herein, each Class of Loan shall bear interest on the unpaid principal amount thereof from the date made through repayment (whether by acceleration or otherwise) thereof as follows:
(i) if a Base Rate Loan, at the Base Rate plus the Applicable Margin;
(ii) if a Eurocurrency Rate Loan, at the Adjusted LIBOR plus the Applicable Margin;
(iii) if a Canadian Prime Rate Loan, at the Canadian Prime Rate plus the Applicable Margin;
(iv) if a Bankers Acceptance Loan, at the BA Rate plus the Applicable Margin; or
(v) if a Designated Foreign Currency Alternate Rate Loan, at the Designated Foreign Currency Alternate Rate plus the Applicable Margin.
(b) The basis for determining the rate of interest with respect to any Loan, and the Interest Period with respect to any Eurocurrency Rate Loan, and BA Period with respect to any Bankers Acceptance Loan shall be selected by the Borrower and notified to Administrative Agent and Lenders pursuant to the applicable Funding Notice or Conversion/Continuation Notice, as the case may be.
(c) In connection with Eurocurrency Rate Loans, there shall be initially no more than six (6) Interest Periods plus three (3) Interest Periods in respect of each additional Class of Commitments but in any event no more than an aggregate of twelve (12) Interest Periods outstanding at any time. With respect of the Initial Term Loans and Revolving Loans borrowed by the Borrower, in the event the Borrower fails to specify between a Base Rate Loan and a Eurocurrency Rate Loan in the applicable Funding Notice or Conversion/Continuation Notice, such Loan, (i) if outstanding as a Eurocurrency Rate Loan, will be automatically converted into a Base Rate Loan on the last day of the then-current Interest Period for such Loan, (ii) if outstanding as a Base Rate Loan, will remain as a Base Rate Loan, (iii) if denominated in Canadian Dollars, will be a Canadian Prime Rate Borrowing, (iv) if not then outstanding, will be made as a Base Rate Loan or (v) if denominated in a Designated Foreign Currency, a Eurocurrency Rate Loan with an Interest Period of one (1) month. In the event the Borrower fails to specify an Interest Period or BA Period for any Eurocurrency Rate Loan or Bankers Acceptance Loan in the applicable Funding Notice or Conversion/Continuation Notice, the Borrower shall be deemed to have selected an Interest Period or BA Period, as applicable, of one month. As soon as practicable after 10:00 a.m. (New York City time) on each Interest Rate Determination Date, the Administrative Agent shall determine (which determination shall, absent manifest error, be final, conclusive and binding upon all parties) the interest rate that shall apply to the Eurocurrency Rate Loans for which an interest rate is then being determined for the applicable Interest Period and shall promptly give notice thereof (in writing or by telephone confirmed in writing) to Borrower and each Lender.
(d) All interest hereunder shall be computed on the basis of a year of 360 days, except that (i) interest computed by reference to the Base Rate at times when the Base Rate
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is based on the Prime Rate shall be computed on the basis of a year of 365 days (or 366 days in a leap year), and in each case shall be payable for the actual number of days elapsed (including the first day but excluding the last day), (ii) interest computed by reference to the Canadian Prime Rate at times when the Canadian Prime Rate is based on the Prime Rate shall be computed on the basis of a year of 365 days (or 366 days in a leap year), and in each case shall be payable for the actual number of days elapsed (including the first day but excluding the last day) and (iii) interest computed by reference to the BA Rate shall be computed on the basis of a year of 365 days and shall be payable for the actual number of days elapsed (including the first day but excluding the last day). The applicable Base Rate, Designated Foreign Currency Alternate Rate, Canadian Prime Rate, Adjusted LIBOR or BA Rate shall be determined by the Administrative Agent, and such determination shall be conclusive absent manifest error. In computing interest on any Loan, the date of the making of such Loan or the first day of an Interest Period applicable to such Loan or, with respect to a Term Loan, the last Interest Payment Date with respect to such Term Loan or, with respect to a Base Rate Loan being converted from a Eurocurrency Rate Loan, the date of conversion of such Eurocurrency Rate Loan to such Base Rate Loan, as the case may be, shall be included, and the date of payment of such Loan or the expiration date of an Interest Period applicable to such Loan or, with respect to a Base Rate Loan being converted to a Eurocurrency Rate Loan, the date of conversion of such Base Rate Loan to such Eurocurrency Rate Loan, as the case may be, shall be excluded; provided , if a Loan is repaid on the same day on which it is made, one days interest shall be paid on that Loan.
(e) Except as otherwise set forth herein, interest on each Loan (i) shall accrue on a daily basis and shall be payable in arrears on each Interest Payment Date with respect to interest accrued on and to each such payment date; (ii) shall accrue on a daily basis and shall be payable in arrears upon any prepayment of that Loan, whether voluntary or mandatory, to the extent accrued on the amount being prepaid; and (iii) shall accrue on a daily basis and shall be payable in arrears at maturity of the Loans, including final maturity of the Loans; provided , however , with respect to any voluntary prepayment of a Base Rate Loan, accrued and unpaid interest shall instead be payable on the applicable Interest Payment Date.
(f) For the purposes of the Interest Act (Canada) and disclosure thereunder, whenever any interest or any fee to be paid hereunder or in connection herewith is to be calculated on the basis of a 360-day or 365-day year, the yearly rate of interest to which the rate used in such calculation is equivalent is the rate so used multiplied by the actual number of days in the calendar year in which the same is to be ascertained and divided by 360 or 365, as applicable. The rates of interest under this Agreement are nominal rates, and not effective rates or yields. The principle of deemed reinvestment of interest does not apply to any interest calculation under this Agreement.
2.7 Conversion/Continuation .
(a) Subject to Section 2.15 and so long as no Event of Default shall have occurred and then be continuing.
(i) The Borrower shall have the option to convert at any time all or any part of any Revolving Loans or any Initial Term Loan, in each case, equal to or greater than [REDACTED Dollar Amount] from one Type of Loan to another Type of
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Loan; provided , a Eurocurrency Rate Loan or Bankers Acceptance Loan, as applicable, may only be converted on the expiration of the Interest Period or BA Period applicable thereto unless the Borrower shall pay all amounts due under Section 2.15 in connection with any such conversion; or
(ii) Borrower shall have the option upon the expiration of any Interest Period or BA Period applicable to any Eurocurrency Rate Loan or Bankers Acceptance Loan, to continue all or any portion of such Loan equal to or greater than [REDACTED Dollar Amount] as a Eurocurrency Rate Loan or Bankers Acceptance Loan;
provided, that, in each case, no such continuation or conversion shall be made in a different currency than the subject Borrowing.
(b) Subject to Section 3.2(b), the Borrower shall deliver a Conversion/Continuation Notice to Administrative Agent no later than 10:00 a.m. (New York City time) [REDACTED Time Period] in advance of the proposed conversion date (in the case of a conversion to a Base Rate Loan or Canadian Prime Rate Loan), [REDACTED Time Period] of the proposed conversion/continuation date (in the case of a conversion to, or a continuation of, a Eurocurrency Rate Loan or Bankers Acceptance Loan) and in the case of an election to convert to or continue as a Eurocurrency Rate Loan in a Designated Foreign Currency, [REDACTED Time Period] of the proposed conversion or continuation. Except as otherwise provided herein, a Conversion/Continuation Notice for conversion to (solely with respect to Initial Term Loans), or continuation of, any Eurocurrency Rate Loans shall be irrevocable on and after 9:00 a.m. (New York City time) on the related Interest Rate Determination Date and the Borrower shall be bound to effect a conversion or continuation in accordance therewith. If on any day a Loan is outstanding with respect to which a Funding Notice or Conversion/Continuation Notice has not been delivered to Administrative Agent in accordance with the terms hereof specifying the applicable basis for determining the rate of interest, then for that day such Loan shall be a Base Rate Loan or Canadian Prime Rate Loan, as applicable (or in the case of a Designated Alternate Foreign Currency Loan, a Borrowing in the applicable currency bearing interest at the Designated Foreign Currency Alternate Rate).
2.8 Default Interest . During the continuance of any Specified Event of Default, the Borrower shall pay interest on past due amounts owing by it hereunder at a fluctuating interest rate per annum at all times equal to the Default Rate to the fullest extent permitted by applicable laws; provided that no interest at the Default Rate shall accrue or be payable to a Defaulting Lender so long as such Lender shall be a Defaulting Lender. Accrued and unpaid interest on such amounts (including interest on past due interest) shall be due and payable upon demand.
2.9 Commitment Fees . (a) The Borrower agrees to pay to the Administrative Agent for the account of each Revolving Lender in accordance with its Pro Rata Share or other applicable share provided for under this Agreement, an unused commitment fee (the Unused Commitment Fee ) equal to the Applicable Margin for Unused Commitment Fees times the actual daily amount by which the aggregate Revolving Commitments exceeds the sum of (A) the Outstanding Amount of Revolving Loans (for the avoidance of doubt, excluding Swing Line Loans) and (B) the Outstanding Amount of L/C Obligations; provided that any Unused Commitment Fee accrued with respect to any of the Revolving Commitments of a Defaulting
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Lender so long as such Lender shall be a Defaulting Lender during the period prior to the time such Lender became a Defaulting Lender and unpaid at such time shall not be payable by the Borrower so long as such Lender shall be a Defaulting Lender except to the extent that such commitment fee shall otherwise have been due and payable by the Borrower prior to such time; and provided , further , that no Unused Commitment Fee shall accrue on any of the Revolving Commitments of a Defaulting Lender. The Unused Commitment Fee on the Revolving Commitments shall accrue at all times from the Closing Date until the Maturity Date for the Revolving Loans, and shall be due and payable quarterly in arrears on the last Business Day of each of March, June, September and December, commencing with the last Business Day of the first full fiscal quarter after the Closing Date, and on the Maturity Date for the Revolving Loans. The Unused Commitment Fee shall be calculated quarterly in arrears, and if there is any change in the Applicable Margin during any quarter, the actual daily amount shall be computed and multiplied by the Applicable Margin separately for each period during such quarter that such Applicable Margin was in effect.
(b) Other Fees. The Borrower shall pay to the Agents such fees as shall have been separately agreed upon in writing in the amounts and at the times so specified. Such fees shall be fully earned when paid and shall not be refundable for any reason whatsoever (except as expressly agreed between the Borrower and the applicable Agent).
2.10 Scheduled Payments . (a) Term Loans . The Borrower shall repay to the Administrative Agent for the ratable account of the Lenders of the applicable Class (A) on the last Business Day of each March, June, September and December commencing with the last Business Day of the first full fiscal quarter after the Closing Date, an aggregate amount equal to [REDACTED Percentage] of the Amortizing Amount (which payments shall be reduced as a result of the application of prepayments in accordance with the order of priority set forth in Sections 2.11, 2.12 and 2.13, as applicable) and (B) on the Maturity Date for the Term Loans, the aggregate principal amount of all Term Loans outstanding on such date; provided that the amount of any such payment set forth above shall be adjusted to account for the addition of any Extended Term Loan or Incremental Term Loans to contemplate (A) the reduction in the aggregate principal amount of any Term Loans that were converted in connection with the incurrence of such Extended Term Loans, and (B) any increase to payments to the extent and as required pursuant to the terms of any applicable Incremental Amendment involving a Term Loan Increase to the Term Loans, a Refinancing Amendment to the amount of Term Loans or an Extension Amendment increasing the amount of Term Loans.
(b) Revolving Loans . The Borrower shall repay to the Administrative Agent for the ratable account of the Appropriate Lenders on the Maturity Date for the Revolving Loans the aggregate principal amount of all of its Revolving Loans outstanding on such date.
2.11 Voluntary Prepayments/Commitment Reductions; Call Protection .
(a) Voluntary Prepayments .
(i) Any time and from time to time, the Borrower may prepay any Loans on any Business Day in whole or in part upon notice substantially in the form of Exhibit J delivered no later than 1:00 p.m. (New York City time) one Business Day prior
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to such date, with any partial prepayment being (x) in the case of the Term Loans, in an aggregate minimum amount of [REDACTED Dollar Amount] and integral multiples of [REDACTED Dollar Amount] in excess of that amount and (y) in the case of the Revolving Loans, in an aggregate minimum amount of the Prepayment Minimum and integral multiples of the Prepayment Multiple in excess of that amount.
(ii) All such prepayments shall be made:
(1) [REDACTED Time Period] prior written or telephonic notice in the case of Base Rate Loans and Canadian Prime Rate Loans;
(2) [REDACTED Time Period] prior written or telephonic notice in the case of Eurocurrency Rate Loans; and
(3) [REDACTED Time Period] prior written or telephonic notice in the case of Designated Foreign Currency Alternate Rate Loans,
in each case given to Administrative Agent by 12:00 p.m. (New York City time) on the date required and, if given by telephone, promptly confirmed by delivery of written notice thereof to Administrative Agent, (and the Administrative Agent will promptly transmit such original notice for Term Loans or Revolving Loans, as the case may be, by telefacsimile or telephone to each Lender). Upon the giving of any such notice, the principal amount of the Loans specified in such notice shall become due and payable on the prepayment date specified therein; provided , that such prepayment obligation may be conditioned on the occurrence of any subsequent event (including a Change of Control, refinancing transaction or Permitted Acquisition or other Investment). Voluntary prepayments of any Class of Term Loan permitted hereunder shall be applied to the remaining scheduled installments of principal thereof pursuant to Section 2.10 in a manner determined at the sole discretion of the Borrower and specified in the notice of prepayment, and on a pro rata basis among Classes of Term Loans. In the event that the Borrower does not specify the order in which to apply prepayments to reduce scheduled installments of principal or as between Classes of Term Loans, the Borrower shall be deemed to have elected that such prepayment be applied to reduce the scheduled installments of principal in direct order of maturity on a pro rata basis among Classes of Term Loan.
(b) Term Loan Call Protection . Notwithstanding the foregoing, in the event that, on or prior to the date which is [REDACTED Time Period] after the Closing Date, the Borrower (x) prepays, refinances, substitutes or replaces any Initial Term Loans pursuant to a Repricing Transaction, or (y) effects any amendment of this Agreement resulting in a Repricing Transaction, the Borrower shall pay to the Administrative Agent, for the ratable account of each of the applicable Term Loan Lenders, (I) in the case of clause (x), a prepayment premium of [REDACTED Percentage] of the aggregate principal amount of the Initial Term Loans so prepaid, refinanced, substituted or replaced and (II) in the case of clause (y), a fee equal to [REDACTED Percentage] of the aggregate principal amount of the applicable Initial Term Loans outstanding immediately prior to such amendment. Such amounts shall be due and payable on the date of effectiveness of such Repricing Transaction; provided that, for the
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avoidance of doubt, the Borrower shall not be subject to the requirements of this Section 2.11 with respect to any Repricing Transaction occurring after [REDACTED Time Period] of the Closing Date.
(c) Voluntary Commitment Reductions .
(i) The Borrower may, upon not less than [REDACTED Time Period] prior written or telephonic notice promptly confirmed by delivery of written notice thereof to Administrative Agent (which original written notice Administrative Agent will promptly transmit by telefacsimile or telephone to each applicable Lender), at any time and from time to time terminate in whole or permanently reduce in part, without premium or penalty, the Revolving Commitments in an amount up to the amount by which the Revolving Commitments exceed the Total Utilization of Revolving Commitments at the time of such proposed termination or reduction; provided , any such partial reduction of the Revolving Commitments shall be in an aggregate minimum amount of [REDACTED Dollar Amount] and integral multiples of [REDACTED Dollar Amount] in excess of that amount.
(ii) The Borrowers notice to Administrative Agent shall designate the date (which shall be a Business Day) of such termination or reduction and the amount of any partial reduction, and such termination or reduction of the Revolving Commitments shall be effective on the date specified in the Borrowers notice and shall reduce the Revolving Commitment of each Lender proportionately to its Pro Rata Share thereof; provided , that any such termination or reduction may be conditioned on the occurrence of any subsequent event (including a Change of Control, refinancing transaction, Permitted Acquisition or other Investment).
(iii) If, after giving effect to any reduction of the Revolving Commitments, the Letter of Credit Sublimit or the Swing Line Sublimit exceeds the amount of the Revolving Commitments, such sublimit shall be automatically reduced by the amount of such excess.
2.12 Mandatory Prepayments .
(a) Asset Sales; Casualty Events; Debt . The Borrower shall apply all Net Cash Proceeds to prepay Term Loans:
(i) [REDACTED Time Period] following actual receipt of the Net Cash Proceeds from an Asset Sale or the Net Cash Proceeds from a Casualty Event (unless the Borrower shall have delivered a Reinvestment Notice on or prior to [REDACTED Time Period] ); provided that notwithstanding the foregoing, (A) on each Reinvestment Prepayment Date, an amount equal to the Reinvestment Prepayment Amount with respect to the relevant Reinvestment Event shall be applied to such prepayment (together with accrued interest thereon); (B) the Borrower shall only be required to make a mandatory prepayment with the Net Cash Proceeds of any Asset Sale or Casualty Event pursuant to this Section 2.12(a)(i) if the aggregate Net Cash Proceeds in any Fiscal Year in respect of all Asset Sales or all Casualty Events, respectively,
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exceeds the greater of [REDACTED Dollar Amount] and [REDACTED Percentage] of Consolidated Total Assets; and (C) to the extent such aggregate Net Cash Proceeds do not exceed the greater of [REDACTED Dollar Amount] and [REDACTED Percentage] of Consolidated Total Assets in any Fiscal Year, then the Borrower and its Restricted Subsidiaries shall be entitled to retain any such Net Cash Proceeds, with no prepayment obligation, and use such Net Cash Proceeds for any purposes not prohibited under this Agreement; and
(ii) [REDACTED Time Period] following receipt of Net Cash Proceeds from the incurrence, issuance or sale by the Borrower or any Restricted Subsidiary of any Indebtedness (other than Excluded Indebtedness);
provided , in the case of each of (i) and (ii) above, if at the time that any such prepayment would be required, the Borrower shall be required to, or to offer to, repurchase or redeem or repay or prepay any Refinancing Loans or any Indebtedness secured on a pari passu basis with or senior to the Obligations pursuant to the terms of the documentation governing such Indebtedness with the Net Cash Proceeds of such Asset Sale, Casualty Event or incurrence, issuance or sale of Indebtedness (such Indebtedness required to be offered to be so repurchased, Other Applicable Indebtedness ), then the Borrower (or any Restricted Subsidiary) may apply such Net Cash Proceeds on a pro rata basis (determined on the basis of the aggregate outstanding principal amount of the Term Loans (but not the Revolving Loans) and Other Applicable Indebtedness at such time); provided , that if no Term Loans subject to such mandatory prepayment requirement are outstanding or will be outstanding after the application of such prepayment, then the Borrower may apply all such Net Cash Proceeds after the repayment of such Term Loans to repay the Other Applicable Indebtedness; provided , further , that the portion of such Net Cash Proceeds allocated to the Other Applicable Indebtedness shall not exceed the amount of such Net Cash Proceeds required to be allocated to the Other Applicable Indebtedness pursuant to the terms thereof, and the remaining amount, if any, of such Net Cash Proceeds shall be allocated to the Term Loans (in accordance with the terms hereof); provided , further , that to the extent the holders of Other Applicable Indebtedness decline to have such Indebtedness repurchased or repaid with such Net Cash Proceeds, the declined amount of such Net Cash Proceeds shall promptly (and in any event within [REDACTED Time Period] after the date of such rejection) be applied to prepay the Term Loans in accordance with the terms hereof (to the extent such Net Cash Proceeds would otherwise have been required to be so applied if such Other Applicable Indebtedness was not then outstanding).
(b) Excess Cash Flow . Commencing with respect to the Fiscal Year ending December 31, 2015, [REDACTED Time Period] after the earlier of the date on which the Borrower is required to deliver financial statements with respect to the end of such Excess Cash Flow Period under Section 5.4(a) and the date on which the Borrower actually delivers the financial statements required under Section 5.4(a) for such Excess Cash Flow Period, the Borrower shall calculate Excess Cash Flow for the relevant Excess Cash Flow Period (the Excess Cash Flow Calculation Date ) and the Borrower shall prepay the Term Loans in an amount equal to (i) the Required Percentage times the amount of such Excess Cash Flow, minus (ii) the amount of any voluntary prepayments of principal during such Excess Cash Flow Period
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or on or prior to the Excess Cash Flow Calculation Date (to the extent not financed with (A) the proceeds of the incurrence of Indebtedness having a maturity of [REDACTED Time Period] from the date of incurrence thereof or (B) the proceeds of Refinancing Loans or the proceeds of Refinancing Equivalent Debt), in each case, not previously deducted pursuant to this clause (ii) in any prior period, of (w) Term Loans ( provided , that with respect to any prepayment of Term Loans below the par value thereof, the aggregate amount of such prepayment for purposes of this clause shall be the amount of the Borrowers cash payment in respect of such prepayment), (x) Revolving Loans or Incremental Revolving Loans (in each case, to the extent commitments in respect thereof are permanently reduced by the amount of such prepayments), (y) Refinancing Loans, Incremental Loans, Incremental Equivalent Debt and any other Indebtedness permitted under Section 6.1 that in each case is secured by the Collateral on a pari passu basis with the Obligations and (z) any Refinancing Indebtedness in respect of any of the foregoing that is secured by the same collateral, and with the same priority, as the Indebtedness being refinanced, in each case, permitted hereunder.
(c) [Reserved].
(d) Exceeding Revolving Commitments . (i) If for any reason (other than with respect to any Currency Excess Amount) the aggregate Outstanding Amount of Revolving Loans, Swing Line Loans and L/C Obligations at any time exceeds the aggregate Revolving Commitments then in effect, the Borrower shall promptly (but in any event, [REDACTED Time Period] prepay Revolving Loans, Swing Line Loans and/or Cash Collateralize the L/C Obligations in an aggregate amount equal to such excess; provided that the Borrower shall not be required to Cash Collateralize any other L/C Obligations pursuant to this Section 2.12(d). If any such excess amount resulting from fluctuations in Exchange Rates on a Calculation Date (any such excess being referred to in this Section 2.12(d) as a Currency Excess Amount ) with respect to any Revolving Lender is equal to or greater than [REDACTED Percentage] of the Revolving Commitment of such Revolving Lender, then the repayment of the Currency Excess Amount to such Revolving Lender shall be made by the Borrower [REDACTED Time Period] after the Administrative Agent requests such repayment. To the extent the Currency Excess Amount of any Revolving Lender is less than [REDACTED Percentage] , any such Revolving Lender may request that its then existing Currency Excess Amount (the Specified Excess ) be paid on the next Interest Payment Date to the extent of the lesser of such Specified Excess and the Currency Excess Amount as determined on [REDACTED Time Period] prior to such Interest Payment Date; provided that the Borrower shall only be obligated to pay such amounts to a Revolving Lender that has made such request by delivery of written notice to the Borrower and the Administrative Agent on or prior to [REDACTED Time Period] prior to such Interest Payment Date. The Administrative Agent shall request repayment of any Currency Excess Amount forthwith upon request therefor by any Revolving Lender, but the Administrative Agent is not otherwise required to monitor Currency Excess Amount levels or to request repayment thereof.
(e) Declining Lender . Notwithstanding anything in this Section 2.12 to the contrary, any Lender may elect, by notice to the Administrative Agent by telephone (confirmed by hand delivery, facsimile transmission or PDF attachment to an e-mail) [REDACTED Time Period] prior to the required prepayment date, to decline all or any portion of any mandatory prepayment of its Loans pursuant to this Section 2.12, in which case the aggregate amount of the
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mandatory prepayment that would have been applied to prepay Loans but was so declined shall be applied as required under the terms of any permitted Indebtedness of the Borrower or its Restricted Subsidiaries and may otherwise be retained by the Borrower and shall increase the Cumulative Credit.
(f) [Reserved].
(g) Other Foreign Entities . Notwithstanding the foregoing, to the extent that any Net Cash Proceeds in respect of any Asset Sale or Casualty Event or any Excess Cash Flow attributable to a Foreign Subsidiary that is required to be applied to prepay the Term Loans pursuant to Sections 2.12(a)(i) or (b), (i) would be prohibited or restricted under applicable local law (including, without limitation, as a result of laws or regulations relating to financial assistance, corporate benefit, restrictions on upstreaming of cash intragroup and fiduciary and statutory duties of directors of relevant subsidiaries) ( provided that the Borrower and its Restricted Subsidiaries shall take all commercially reasonable actions available under local law to permit such repatriation) or (ii) would result in material adverse tax consequences as determined in good faith by the Borrower (which shall be conclusively evidenced by a certificate of the Borrower) in consultation with the Administrative Agent (including, without limitation, as a result of any withholding tax), then in each case, the Borrower shall not be required to prepay such amounts (the Excluded Amounts ) as required under Sections 2.12(a)(i) or (b) (any such limitation, a Repatriation Limitation ). The non-application of the Excluded Amounts as a consequence of any Repatriation Limitation will not constitute an Event of Default hereunder. For purposes of the foregoing, Excess Cash Flow shall be allocated among Restricted Subsidiaries in various jurisdictions determined by the Borrower and the Excluded Amounts shall be available for working capital or other purposes of the Borrower, the Foreign Subsidiary or any Restricted Subsidiary. Excluded Amounts shall not be deemed to be Net Cash Proceeds or Excess Cash Flow, regardless of whether the Repatriation Limitation ceases to apply after such initial determination.
(h) Order of Payments . Except as may be otherwise set forth with respect to Loans incurred in connection with any Refinancing Amendment, Term Loan Extension Request, or any Incremental Amendment, (i) each prepayment of Term Loans pursuant to this Section 2.12 shall be applied ratably to each Class of Term Loans then outstanding, except that the Borrower may direct that any proceeds of Refinancing Term Loans, Refinancing Revolving Loans or Refinancing Equivalent Debt shall be applied to the Class or Classes of Term Loans being refinanced as selected by the Borrower ( provided that any Class of Incremental Term Loans, Refinancing Term Loans or Extended Term Loans may specify that one or more other Classes of Term Loans may be prepaid prior to such Class of Incremental Term Loans, Refinancing Term Loans or Extended Term Loans); (ii) with respect to each Class of Term Loans, each prepayment pursuant to clauses (a) and (b) of this Section 2.12 shall be applied in direct order of maturity for the [REDACTED Time Period] following the prepayment event and thereafter, ratably to remaining installments of Term Loans and (iii) each such prepayment shall be paid to the Appropriate Lenders in accordance with their respective Pro Rata Shares of such prepayment.
(i) Break-Funding Savings Clause . Notwithstanding any of the other provisions of this Section 2.12, so long as no Event of Default shall have occurred and be
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continuing, if any prepayment of Eurocurrency Rate Loans is required to be made under this Section 2.12, prior to the last day of the Interest Period therefor, in lieu of making any payment pursuant to this Section 2.12 in respect of any such Eurocurrency Rate Loan prior to the last day of the Interest Period therefor, the Borrower may, in its sole discretion, deposit an amount sufficient to make any such prepayment otherwise required to be made thereunder together with accrued interest to the last day of such Interest Period into a Cash Collateral Account until the last day of such Interest Period, at which time the Administrative Agent shall be authorized (without any further action by or notice to or from the Borrower or any other Credit Party) to apply such amount to the prepayment of such Loans in accordance with this Section 2.12. Upon the occurrence and during the continuance of any Event of Default, the Administrative Agent shall also be authorized (without any further action by or notice to or from the Borrower or any other Credit Party) to apply such amount to the prepayment of the outstanding Loans in accordance with the relevant provisions of Section 8.1. Such deposit shall be deemed to be a prepayment of such Loans by the Borrower for all purposes under this Agreement.
(j) Prepayment Certificate . Concurrently with any prepayment of the Loans pursuant to Sections 2.12(a) and (b), the Borrower shall deliver to Administrative Agent a certificate of an Authorized Officer demonstrating the calculation of the amount of the applicable Net Cash Proceeds or Excess Cash Flow, as the case may be. In the event that Borrower shall subsequently determine that the actual amount of Net Cash Proceeds received exceeded the amount set forth in such certificate, the Borrower shall promptly make an additional prepayment of the Loans in an amount equal to such excess in accordance with Section 2.12(a), and the Borrower shall concurrently therewith deliver to Administrative Agent a certificate of an Authorized Officer demonstrating the derivation of such excess.
2.13 General Provisions Regarding Payments .
(a) All payments by the Borrower of principal, interest, fees and other Obligations shall be made in the currency specified therefor, and if not so specified, in Dollars in Same Day Funds, without defense, recoupment, setoff or counterclaim, free of any restriction or condition, and delivered to Administrative Agent not later than, 12:00 p.m. (New York City time) on the date due at the Principal Office of the Administrative Agent for the account of Lenders; for purposes of computing interest and fees, funds received by the Administrative Agent after that time on such due date shall be deemed to have been paid by Borrower on [REDACTED Time Period] .
(b) All payments in respect of the principal amount of any Loan (other than voluntary prepayments of Revolving Loans) shall be accompanied by payment of accrued interest on the principal amount being repaid or prepaid, and all such payments (and, in any event, any payments in respect of any Loan on a date when interest is due and payable with respect to such Loan) shall be applied to the payment of interest then due and payable before application to principal.
(c) Administrative Agent (or its agent or sub-agent appointed by it) shall promptly distribute to each Lender at such address as such Lender shall indicate in writing, such Lenders applicable share of all payments and prepayments of principal and interest due
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hereunder, together with all other amounts due thereto, including all fees payable with respect thereto, to the extent received by the Administrative Agent.
(d) Notwithstanding the foregoing provisions hereof, if any Conversion/Continuation Notice is withdrawn as to any Lender requesting compensation pursuant to Section 2.16(b), the Administrative Agent shall give effect thereto in apportioning payments received thereafter.
(e) Subject to the provisos set forth in the definition of Interest Period as they may apply to Revolving Loans, whenever any payment to be made hereunder with respect to any Loan shall be stated to be due on a day that is not a Business Day, such payment shall be made on the next succeeding Business Day and, with respect to Revolving Loans only, such extension of time shall be included in the computation of the payment of interest hereunder or of the Revolving Commitment fees hereunder.
(f) Administrative Agent shall deem any payment by or on behalf of Borrower hereunder that is not made in Same Day Funds prior to 12:00 p.m. (New York City time) for any payments in Dollars to be a non-conforming payment. Any such payment shall not be deemed to have been received by the Administrative Agent until the later of (i) the time such funds become available funds, and (ii) the applicable next Business Day. The Administrative Agent shall give prompt telephonic notice to the Borrower and each applicable Lender (confirmed in writing) if any payment is non-conforming. Any non-conforming payment may constitute or become a Default or Event of Default in accordance with the terms of Section 8.1(a). Interest shall continue to accrue on any principal as to which a non-conforming payment is made until such funds become available funds (but in no event less than the period from the date of such payment to the next succeeding applicable Business Day) at the rate determined pursuant to Section 2.6 from the date such amount was due and payable until the date such amount is paid in full.
(g) If an Event of Default shall have occurred and not otherwise been waived, and the maturity of the Obligations shall have been accelerated pursuant to Section 8.1 or pursuant to any sale of, any collection from, or other realization upon all or any part of the Collateral, all payments or proceeds received by the Administrative Agent or Collateral Agent in respect of any of the Obligations, shall be applied in accordance with the application arrangements described in Section 4.02 of the Pledge and Security Agreement.
2.14 Ratable Sharing . Lenders hereby agree among themselves that, except as otherwise expressly provided in this Agreement or the Collateral Documents with respect to amounts realized from the exercise of rights with respect to Liens on the Collateral, if any of them shall, whether by voluntary or mandatory payment (other than a voluntary or mandatory prepayment of Loans made and applied in accordance with the terms hereof), through the exercise of any right of set-off or bankers lien, by counterclaim or cross action or by the enforcement of any right under the Credit Documents or otherwise, or as adequate protection of a deposit treated as cash collateral under the Bankruptcy Code, receive payment or reduction of a proportion of the aggregate amount of principal, interest, amounts payable in respect of Letters of Credit, fees and other amounts then due and owing to such Lender hereunder or under the other Credit Documents (collectively, the Aggregate Amounts Due to such Lender) which is
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greater than the proportion received by any other Lender in respect of the Aggregate Amounts Due to such other Lender, then the Lender receiving such proportionately greater payment shall (a) notify Administrative Agent and each other Lender of the receipt of such payment and (b) apply a portion of such payment to purchase participations (which it shall be deemed to have purchased from each seller of a participation simultaneously upon the receipt by such seller of its portion of such payment) in the Aggregate Amounts Due to the other Lenders so that all such recoveries of Aggregate Amounts Due shall be shared by all Lenders in proportion to the Aggregate Amounts Due to them; provided , if all or part of such proportionately greater payment received by such purchasing Lender is thereafter recovered from such Lender upon the bankruptcy or reorganization of the Borrower or otherwise, those purchases shall be rescinded and the purchase prices paid for such participations shall be returned to such purchasing Lender ratably to the extent of such recovery, but without interest. The Borrower expressly consents to the foregoing arrangement and agrees that any holder of a participation so purchased may exercise any and all rights of bankers lien, consolidation, set-off or counterclaim with respect to any and all monies owing by the Borrower to that holder with respect thereto as fully as if that holder were owed the amount of the participation held by that holder. The provisions of this Section 2.14 shall not be construed to apply to (a) any payment made by the Borrower pursuant to and in accordance with the express terms of this Agreement (including the application of funds arising from the existence of a Defaulting Lender) or (b) any payment obtained by any Lender as consideration for the assignment or sale of a participation in any of its Loans or other Obligations owed to it.
2.15 Making or Maintaining Eurocurrency Rate Loans .
(a) Inability to Determine Applicable Interest Rate . If prior to the commencement of any Interest Period for a Eurocurrency Rate Loan or Bankers Acceptance Loan:
(i) the Administrative Agent determines (which determination shall be conclusive absent manifest error) that adequate and reasonable means do not exist for ascertaining the Adjusted LIBOR or BA Rate for such Interest Period or BA Period; or
(ii) the Administrative Agent is advised by the Requisite Lenders that the Adjusted LIBOR or the BA Rate, as applicable, for such Interest Period or BA Period will not adequately and fairly reflect the cost to such Lenders of making or maintaining such Loans included for such Interest Period or BA Period (each of clause (a) and (b), a Market Disruption Event );
then the Administrative Agent shall give notice thereof to the Borrower and the applicable Lenders by telephone, facsimile transmission or PDF attachment to an e-mail as promptly as practicable thereafter and, until the Administrative Agent notifies the Borrower and the Lenders that the circumstances giving rise to such notice no longer exist, (i) any Funding Notice that requests the conversion of any applicable Loan to, or continuation of any such Loan as, a Eurocurrency Rate Loan or Bankers Acceptance Loan may be revoked by the Borrower or, failing revocation, shall be ineffective and such Eurocurrency Rate Loan or Bankers Acceptance Loan shall be converted to (x) in the case of any Dollar- denominated Borrowing, a Base Rate Borrowing in Dollars, (y) in the case of Canadian Dollar-denominated Borrowing, a Canadian
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Prime Rate Borrowing in Canadian Dollars or (z) in the case of a Borrowing denominated in a Designated Foreign Currency other than Canadian Dollars, a Borrowing in the applicable currency bearing interest at the Designated Foreign Currency Alternate Rate, in each case on the last day of the Interest Period or BA Period applicable thereto. During any period in which a Market Disruption Event is in effect, the Borrower may request that the Administrative Agent or the Requisite Lenders, as applicable, to confirm that the circumstances giving rise to the Market Disruption Event continue to be in effect; provided that (A) the Borrower shall not be permitted to submit any such request more than once in any [REDACTED Time Period] period and (B) nothing contained in this Section 2.15 or the failure to provide confirmation of the continued effectiveness of such Market Disruption Event shall in any way affect the Administrative Agents or Requisite Lenders right to provide any additional notices of a Market Disruption Event as provided in this Section 2.15. If the Administrative Agent or Requisite Lenders, as applicable, have not confirmed within 10 Business Days after request of such report from the Borrower that a Market Disruption Event has occurred, then such Market Disruption Event shall be deemed to be no longer existing.
(b) Illegality . If any Lender reasonably determines that any Change in Law has made it unlawful, or if any Governmental Authority has asserted after the Closing Date that it is unlawful, for any Lender or its applicable lending office to make or maintain any Eurocurrency Rate Loans or Bankers Acceptance Loans, then, upon notice thereof by such Lender to the Borrower through the Administrative Agent, any obligations of such Lender to make or continue Eurocurrency Rate Loans or Bankers Acceptance Loans or to convert Base Rate Loans to Eurocurrency Rate Loans or to convert Canadian Prime Rate Loans to Bankers Acceptance Loans shall be suspended until such Lender notifies the Administrative Agent and the Borrower that the circumstances giving rise to such determination no longer exist. Upon receipt of such notice, the Borrower shall upon demand from such Lender (with a copy to the Administrative Agent), either convert all Borrowings of such Lender to (x) in the case of Dollar-denominated Borrowings, Base Rate Borrowings in Dollars, (y) in the case of Canadian Dollar-denominated Borrowings, Canadian Prime Rate Borrowings in Canadian Dollars or (z) in the case of Borrowings denominated in a Designated Foreign Currency other than Canadian Dollars, Borrowings in the applicable currency bearing interest at the Designated Foreign Currency Alternate Rate, in each case, either on the last day of the Interest Period or BA Period therefor, if such Lender may lawfully continue to maintain such Loans to such day, or immediately, if such Lender may not lawfully continue to maintain such Term Loans. Upon any such conversion, the Borrower shall also pay accrued interest on the amount so converted.
(c) Compensation for Breakage or Non-Commencement of Interest Periods . In the event of (a) the payment of any principal of any Eurocurrency Rate Loan other than on the last day of an Interest Period applicable thereto (including as a result of an Event of Default), (b) the conversion of any Eurocurrency Rate Loan other than on the last day of the Interest Period applicable thereto, (c) the failure to borrow, convert, continue or prepay any Eurocurrency Rate Loan on the date specified in any notice delivered pursuant hereto or (d) the assignment of any Eurocurrency Rate Loan other than on the last day of the Interest Period applicable thereto as a result of a request by the Borrower pursuant to Section 2.18, then, in any such event, the Borrower shall compensate each Lender for the loss, cost and expense attributable to such event. Such loss, cost or expense to any Lender shall be deemed to be the amount determined by such Lender to be the excess, if any, of (i) the amount of interest which would have accrued on the
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principal amount of such Loan had such event not occurred, at the Adjusted LIBOR that would have been applicable to such Loan, for the period from the date of such event to the last day of the then current Interest Period therefor (or, in the case of a failure to borrow, convert or continue a Eurocurrency Rate Loan for the period that would have been the Interest Period for such Loan) over (ii) the amount of interest that would accrue on such principal amount for such period at the interest rate that such Lender would bid were it to bid, at the commencement of such period, for deposits in the applicable currency of a comparable amount and period from other banks in the eurocurrency market. A certificate of any Lender setting forth any amount or amounts that such Lender is entitled to receive pursuant to this Section 2.15 shall be delivered to the Borrower and shall be conclusive absent manifest error. The Borrower shall pay such Lender the amount shown as due on any such certificate within [REDACTED Time Period] after receipt thereof.
2.16 Increased Costs; Capital Adequacy .
(a) If any Change in Law shall:
(i) impose, modify or deem applicable any reserve, special deposit, compulsory loan, insurance charge or similar requirement against assets of, deposits with or for the account of, or credit extended by, any Lender (except any such reserve requirement reflected in Adjusted LIBOR);
(ii) subject the Administrative Agent or any Lender to any Taxes (other than Indemnified Taxes, Excluded Taxes or Other Taxes) on its loans, loan principal, letters of credit, commitments, or other obligations, or its deposits, reserves, other liabilities or capital attributable thereto; or
(iii) impose on any Lender or the London interbank market any other condition, cost or expense (other than Taxes) affecting this Agreement or Loans made by such Lender;
and the result of any of the foregoing shall be to increase the cost to such Lender of making or maintaining any Loan (or of maintaining its obligation to make any such Loan) or to reduce the amount of any sum received or receivable by such Lender (whether of principal, interest or otherwise), then the Borrower will pay to such Lender such additional amount or amounts as will compensate such Lender for such additional costs incurred or reduction suffered.
(b) If any Lender determines that any Change in Law regarding capital or liquidity requirements has or would have the effect of reducing the rate of return on such Lenders capital or on the capital of such Lenders holding company, if any, as a consequence of this Agreement or the Loans made by such Lender, to a level below that which such Lender or such Lenders holding company could have achieved but for such Change in Law (taking into consideration such Lenders policies and the policies of such Lenders holding company with respect to capital adequacy or liquidity), then from time to time the Borrower shall pay to such Lender such additional amount or amounts as will compensate such Lender or such Lenders holding company for any such reduction suffered. Notwithstanding any other provision herein, no Lender shall demand compensation pursuant to this Section 2.16(b) as a result of a Change in
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Law resulting from Basel III or the Dodd-Frank Wall Street Reform and Consumer Protection Act if it shall not at the time be the general policy or practice of such Lender to demand such compensation from similarly situated borrowers (to the extent that, with respect to such Change in Law, such Lender has the right to do so under its credit facilities with similarly situated borrowers).
(c) A certificate of a Lender setting forth the amount or amounts necessary to compensate such Lender or its holding company, as applicable, as specified in paragraph (a) or (b) of this Section 2.16 shall be delivered to the Borrower and shall be conclusive absent manifest error. The Borrower shall pay such Lender the amount shown as due on any such certificate within [REDACTED Time Period] after receipt thereof.
(d) Promptly after any Lender has determined that it will make a request for increased compensation pursuant to this Section 2.16, such Lender shall notify the Borrower. Failure or delay on the part of any Lender to demand compensation pursuant to this Section 2.16 shall not constitute a waiver of such Lenders right to demand such compensation; provided that the Borrower shall not be required to compensate a Lender pursuant to this Section 2.16 for any increased costs or reductions incurred more than [REDACTED Time Period] prior to the date that such Lender notifies the Borrower of the Change in Law giving rise to such increased costs or reductions and of such Lenders intention to claim compensation therefor; provided , further , that if the Change in Law giving rise to such increased costs or reductions is retroactive, then the [REDACTED Time Period] period referred to above shall be extended to include the period of retroactive effect thereof.
2.17 Taxes; Withholding, Etc.
(a) Payments to Be Free and Clear . All sums payable by or on behalf of any Credit Party hereunder and under the other Credit Documents to or for the benefit of the Administrative Agent or any Lender shall (except to the extent required by applicable law) be paid free and clear of, and without any deduction or withholding on account of, any Tax.
(b) Withholding of Taxes . If any Credit Party, other applicable withholding agent or Administrative Agent is required by applicable law or the administrative practice of any Governmental Authority to make any deduction or withholding on account of any Tax from any sum paid or payable by any Credit Party under any of the Credit Documents to or for the benefit of the Administrative Agent or any Lender: (i) the Borrower shall notify Administrative Agent of any such requirement or any change in any such requirement as soon as it becomes aware of it; (ii) the applicable Credit Party shall pay, or cause to be paid, any such Tax before the date on which penalties attach thereto, if the liability to pay is imposed on any Credit Party; (iii) if the Tax is an Indemnified Tax or Other Tax, the sum payable by such Credit Party in respect of which the relevant deduction, withholding or payment is required shall be increased to the extent necessary to ensure that, after the making of the deduction, withholding or payment for Indemnified Taxes or Other Taxes (including any deduction, withholding or payment applicable to additional sums payable under this Section 2.17), the Administrative Agent or the applicable Lender, as the case may be, receives on the due date a net sum equal to what it would have received had no such deduction, withholding or payment for Indemnified Taxes or Other Taxes been required or made; and (iv) as soon as practicable after the due date of payment of any Tax
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which it is required by clause (ii) above to pay, the applicable Credit Party shall deliver to Administrative Agent the original or a certified copy of a receipt issued by such Governmental Authority evidencing such payment, a copy of the return reporting such payment or other evidence satisfactory to the Administrative Agent of such deduction, withholding or payment and of the remittance thereof to the relevant Governmental Authority.
(c) Any Lender that is entitled to an exemption from or reduction of withholding Tax with respect to payments made under any Credit Document shall deliver, to the extent it is legally entitled to do so, to the Borrower and the Administrative Agent, at the time or times reasonably requested in writing by the Borrower or the Administrative Agent, such properly completed and executed documentation that is required by applicable law or the administrative practice of any Governmental Authority and that is reasonably requested in writing by the Borrower or the Administrative Agent as will permit such payments to be made without withholding or at a reduced rate of withholding. In addition, any Lender, if reasonably requested in writing by the Borrower or the Administrative Agent, shall, to the extent it is legally entitled to do so, deliver such other documentation prescribed by applicable law and reasonably requested in writing by the Borrower or the Administrative Agent as will enable the Borrower or the Administrative Agent to determine whether or not such Lender is subject to backup withholding or information reporting requirements.
(d) The Borrower shall timely pay all Other Taxes to the relevant Governmental Authorities in accordance with applicable law, or at the option of the Administrative Agent, timely reimburse it for such Other Taxes. The Borrower shall deliver to Administrative Agent the original or a certified copy of a receipt issued by such Governmental Authority evidencing such payment, a copy of the return reporting such payment or other evidence of such payment reasonably satisfactory to Administrative Agent in respect of any Other Taxes payable hereunder as soon as practicable after payment of such Other Taxes.
(e) Each Credit Party shall indemnify the Administrative Agent and any Lender [REDACTED Time Period] after written demand therefor, for the full amount of Indemnified Taxes imposed on or with respect to any payment made by or on account of an obligation of such Credit Party under any Credit Document and Other Taxes that arise from payments made hereunder by such Credit Party or from the execution, delivery, performance, registration or enforcement of, from the receipt or perfection of a security interest under, or otherwise with respect to, this Agreement or any Credit Document relating to such Credit Party (including any such Indemnified Taxes or Other Taxes imposed or asserted on or attributable to amounts payable under this Section 2.17) paid by the Administrative Agent or Lender or any of their respective Affiliates or required to be withheld or deducted from a payment to such Person, and for any reasonable expenses arising therefrom or with respect thereto, whether or not such Indemnified Taxes or Other Taxes were correctly or legally imposed or asserted by the relevant Governmental Authority. A certificate as to the amount of such payment or liability delivered to such Credit Party shall be conclusive absent manifest error.
(f) If any party determines, in its sole discretion exercised in good faith, that it has received a refund, from the authority imposing the Tax, of any Taxes as to which it has been indemnified pursuant to this Section 2.17 (including by the payment of additional amounts pursuant to this Section 2.17), it shall pay to the indemnifying party an amount equal to such
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refund (but only to the extent of indemnity payments made under this Section 2.17 with respect to the Taxes giving rise to such refund), net of all reasonable and documented out-of-pocket expenses (including Taxes) of such indemnified party and without interest (other than any interest paid by the relevant Governmental Authority with respect to such refund). Such indemnifying party, upon the request of such indemnified party, shall repay to such indemnified party as soon as reasonably practicable the amount paid over pursuant to this paragraph (f) (plus any penalties, interest or other charges imposed by the relevant Governmental Authority) in the event that such indemnified party is required to repay such refund to such Governmental Authority. Notwithstanding anything to the contrary in this paragraph (f), in no event will the indemnified party be required to pay any amount to an indemnifying party pursuant to this paragraph (f) the payment of which would place the indemnified party in a less favorable net after-Tax position than the indemnified party would have been in if the Tax subject to indemnification and giving rise to such refund had not been deducted, withheld or otherwise imposed and the indemnification payments or additional amounts giving rise to such refund had never been paid. This paragraph shall not be construed to require any indemnified party to make available its Tax returns (or any other information relating to its Taxes that it deems confidential) to the indemnifying party or any other Person, or to arrange its affairs in any particular manner.
(g) If a payment made to a Lender under any Credit Document would be subject to Tax imposed by FATCA if such Lender were to fail to comply with the applicable reporting requirements of FATCA (including those contained in Section 1471(b) or 1472(b) of the Internal Revenue Code, as applicable), such Lender shall deliver to the Borrower and the Administrative Agent at the time or times prescribed by law and at such time or times reasonably requested by the Borrower or the Administrative Agent such documentation prescribed by applicable law (including as prescribed by Section 1471(b)(3)(C)(i) of the Internal Revenue Code) and such additional documentation reasonably requested by the Borrower or the Administrative Agent as may be necessary for the Borrower and the Administrative Agent to comply with their obligations under FATCA and to determine that such Lender has complied with such Lenders obligations under FATCA or to determine the amount to deduct and withhold from such payment. Solely for purposes of this clause (g), FATCA shall include any amendments made to FATCA after the date of this Agreement. Each Lender agrees that if any form or certification it previously delivered expires or becomes obsolete or inaccurate in any respect, it shall update such form or certification or promptly notify the Borrower and the Administrative Agent in writing of its legal inability to do so.
(h) Each partys obligations under this Section 2.17 shall survive the resignation or replacement of the Administrative Agent or any assignment of rights by, or the replacement of, a Lender, the termination of the Commitments and the repayment, satisfaction or discharge of all obligations under any Credit Document.
2.18 Mitigation Obligations; Replacement of a Lender .
(a) If any Lender requests compensation under Section 2.16, or if the Borrower is required to pay any additional amount to any Lender or any Governmental Authority for the account of any Lender pursuant to Section 2.17, then such Lender shall use reasonable efforts to designate a different lending office for funding or booking its Term Loans, Revolving Loans or participations in L/C Advances and Swing Line Loans made hereunder or assign its
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rights and obligations hereunder to another of its offices, branches or Affiliates if, in the reasonable judgment of such Lender, such designation or assignment (i) would eliminate or reduce amounts payable pursuant to Section 2.16 or 2.17, as applicable, in the future and (ii) would not subject such Lender to any unreimbursed cost or expense and would not otherwise be disadvantageous to such Lender in any respect. The Borrower hereby agrees to pay all reasonable and documented out-of-pocket costs and expenses incurred by any Lender in connection with any such designation or assignment.
(b) If any Lender requests compensation under Section 2.16, or if the Borrower is required to pay any additional amount to any Lender or any Governmental Authority for the account of any Lender pursuant to Section 2.17, or the Borrower is borrowing any Extended Term Loans or Extended Revolving Commitments and such Lender is not an Extending Lender or any Lender is a Defaulting Lender, then the Borrower may, at its sole expense and effort, upon notice to such Lender and the Administrative Agent, either (i) so long as no Default or Event of Default has occurred and is continuing, prepay such Lenders outstanding Loans and participations in L/C Advances and Swing Line Loans hereunder in full on a non- pro rata basis without premium or penalty or (ii) require such Lender to assign and delegate, without recourse (in accordance with and subject to the restrictions contained in Section 10.4), all its interests, rights and obligations under this Agreement to an assignee that shall assume such obligations (which assignee may be another Lender, if a Lender accepts such assignment); provided that (A) in the case of clause (ii) above, the Borrower shall have received the prior written consent of the Administrative Agent, which consent shall not unreasonably be withheld, (B) such Lender shall have received payment of an amount equal to the outstanding principal of its Term Loans, Revolving Loans and participations in L/C Advances and Swing Line Loans, accrued interest thereon, accrued fees and all other amounts payable to it hereunder, from the assignee (to the extent of such outstanding principal and accrued interest and fees) or the Borrower (in the case of all other amounts) and (iii) in the case of any such assignment resulting from a claim for compensation under Section 2.16 or payments required to be made pursuant to Section 2.17, such assignment will result in a reduction in such compensation or payments. No action by or consent of the replaced Lender shall be necessary in connection with such removal or assignment, in the case of clause (ii) above, which shall be immediately and automatically effective upon payment of such purchase price. In connection with any such assignment, the Borrower, the Administrative Agent, such replaced Lender and the replacement Lender shall otherwise comply with Section 10.4; provided that if such replaced Lender does not comply with Section 10.4 [REDACTED Time Period] after the Borrowers request, compliance with Section 10.4 shall not be required to effect such assignment.
(c) If any Lender (such Lender, a Non-Consenting Lender ) has failed to consent to a proposed amendment, waiver, discharge or termination which, pursuant to the terms of Section 10.8, requires the consent of all of the Lenders affected or all Lenders and with respect to which the Requisite Lenders or Requisite Class Lenders, as applicable, shall have granted their consent, then the Borrower shall have the right (unless such Non-Consenting Lender grants such consent) at its sole expense, to either (i) so long as no Default or Event of Default has occurred and is continuing, prepay such Lenders outstanding Term Loans, Revolving Loans and participations in L/C Advances and Swing Line Loans hereunder in full on a non- pro rata basis without premium or penalty (including with respect to the processing and recordation fee referred to in Section 10.4(b)(ii)(C)) or (ii) replace such Non-Consenting Lender
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by deeming such Non-Consenting Lender to have assigned its Loans and its Commitments hereunder to one or more assignees reasonably acceptable to the Administrative Agent; provided that (A) all Obligations of the Borrower owing to such Non-Consenting Lender (including accrued fees and any amounts due under Section 2.11(a), Section 2.15, Section 2.16 or Section 2.17) being removed or replaced shall be paid in full to such Non-Consenting Lender concurrently with such removal or assignment and (B) in the case of clause (ii) above, the replacement Lender shall purchase the foregoing by paying to such Non-Consenting Lender a price equal to the principal amount thereof plus accrued and unpaid interest thereon. No action by or consent of the Non-Consenting Lender shall be necessary in connection with such removal or assignment, in the case of clause (ii) above, which shall be immediately and automatically effective upon payment of such purchase price. In connection with any such assignment, the Borrower, the Administrative Agent, such Non-Consenting Lender and the replacement Lender shall otherwise comply with Section 10.4; provided that if such Non-Consenting Lender does not comply with Section 10.4 [REDACTED Time Period] after the Borrowers request, compliance with Section 10.4 shall not be required to effect such assignment.
2.19 Defaulting Lenders .
(a) Adjustments . Notwithstanding anything to the contrary contained in this Agreement, if any Lender becomes a Defaulting Lender, then, until such time as that Lender is no longer a Defaulting Lender, to the extent permitted by applicable law:
(i) Waivers and Amendments . Such Defaulting Lenders right to approve or disapprove any amendment, waiver or consent with respect to this Agreement shall be restricted as set forth in Section 10.8.
(ii) Reallocation of Payments . Any payment of principal, interest, fees or other amounts received by the Administrative Agent for the account of that Defaulting Lender (whether voluntary or mandatory, at maturity, pursuant to Section 8.1 or otherwise) shall be applied at such time or times as may be determined by the Administrative Agent as follows: first , to the payment of any amounts owing by that Defaulting Lender to the Administrative Agent hereunder; second , to the payment on a pro rata basis of any amounts owing by that Defaulting Lender to an L/C Issuer or Swing Line Lender hereunder; third , if so determined by the Administrative Agent or requested by an L/C Issuer, to be held as Cash Collateral for future funding obligations of that Defaulting Lender of any participation or Letter of Credit; fourth , as the Borrower may request (so long as no Default has occurred and is continuing), to the funding of any Loan in respect of which that Defaulting Lender has failed to fund its portion thereof as required by this Agreement, as determined by the Administrative Agent; fifth , if so determined by the Administrative Agent and the Borrower, to be held in a non-interest bearing deposit account and released in order to satisfy obligations of that Defaulting Lender to fund Loans under this Agreement; sixth , to the payment of any amounts owing to the Lenders, the L/C Issuers or the Swing Line Lenders as a result of any judgment of a court of competent jurisdiction obtained by any Lender, L/C Issuer or Swing Line Lender against that Defaulting Lender as a result of that Defaulting Lenders breach of its obligations under this Agreement; seventh , so long as no Default has occurred and is continuing, to the payment of any amounts owing to the Borrower as a result of any
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judgment of a court of competent jurisdiction obtained by the Borrower against that Defaulting Lender as a result of that Defaulting Lenders breach of its obligations under this Agreement; and eighth , to that Defaulting Lender or as otherwise directed by a court of competent jurisdiction; provided that if (x) such payment is a payment of the principal amount of any Loans or L/C Borrowings in respect of which that Defaulting Lender has not fully funded its appropriate share and (y) such Loans, L/C Borrowings or Swing Line Loans were made at a time when the conditions set forth in Section 3.2 were satisfied or waived, such payment shall be applied solely to pay the Loans of, and L/C Borrowings or Swing Line Loans owed to, all Non-Defaulting Lenders on a pro rata basis prior to being applied to the payment of any Loans of, or L/C Borrowings owed to, that Defaulting Lender. Any payments, prepayments or other amounts paid or payable to a Defaulting Lender that are applied (or held) to pay amounts owed by a Defaulting Lender or to post Cash Collateral pursuant to this Section 2.19(a)(ii) shall be deemed paid to and redirected by that Defaulting Lender, and each Lender irrevocably consents hereto.
(iii) Certain Fees . That Defaulting Lender (x) shall not be entitled to receive any commitment fee pursuant to Section 2.9(a) for any period during which that Lender is a Defaulting Lender (and the Borrower shall not be required to pay any such fee that otherwise would have been required to have been paid to that Defaulting Lender) and (y) shall be limited in its right to receive Letter of Credit Fees as provided in Section 2.3(i).
(iv) Reallocation of Pro Rata Share to Reduce Fronting Exposure . During any period in which there is a Defaulting Lender, for purposes of computing the amount of the obligation of each Non-Defaulting Lender to acquire, refinance or fund participations in Letters of Credit pursuant to Section 2.3 or Swing Line Loans, the Pro Rata Share of each Non-Defaulting Lenders Revolving Loans, L/C Obligations and Swing Line Loans shall be computed without giving effect to the Commitment of that Defaulting Lender; provided that (i) each such reallocation shall be given effect only if, at the date the applicable Lender becomes a Defaulting Lender, no Default has occurred and is continuing; and (ii) such reallocation does not cause the Revolving Exposure of any Non-Defaulting Lender to exceed such Non-Defaulting Lenders Revolving Commitments.
(b) Defaulting Lender Cure . If Borrower, the Administrative Agent and each L/C Issuer agree in writing that a Lender is no longer a Defaulting Lender, the Administrative Agent will so notify the parties hereto, whereupon as of the effective date specified in such notice and subject to any conditions set forth therein (which may include arrangements with respect to any Cash Collateral), that Lender will, to the extent applicable, purchase at par that portion of outstanding Loans of the other Lenders or take such other actions as Administrative Agent may determine to be necessary to cause the Loans and funded and unfunded participations in Letters of Credit and Swing Line Loans to be held pro rata by the Lenders in accordance with the applicable Commitments (without giving effect to Section 2.19(a)(iv)), whereupon such Lender will cease to be a Defaulting Lender; provided that no adjustments will be made retroactively with respect to fees accrued or payments made by or on behalf of the Borrower while that Lender was a Defaulting Lender; and provided further that except to the extent otherwise expressly agreed by the affected parties, no change hereunder from Defaulting Lender
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to Lender will constitute a waiver or release of any claim of any party hereunder arising from that Lender having been a Defaulting Lender.
2.20 Incremental Facilities or Commitments .
(a) Incremental Commitments . The Borrower may at any time or from time to time after the Closing Date, by notice to the Administrative Agent (an Incremental Loan Request ), indicate that it has obtained or is requesting (A) one or more new commitments which may be of the same Class as any outstanding Term Loan (a Term Loan Increase ) or a new Class of Term Loans (collectively with any Term Loan Increase, the Incremental Term Commitments ), and/or (B) one or more increases in the amount of the Revolving Commitments (including Extended Revolving Commitments of a given Extension Series and Refinancing Revolving Commitments) (the Incremental Revolving Commitments and the Incremental Revolving Commitments, collectively with any Incremental Term Commitments, the Incremental Commitments ), whereupon the Administrative Agent shall promptly deliver a copy of such Incremental Loan Request to each of the Lenders.
(b) Incremental Loans . On any Incremental Tranche Closing Date on which any Incremental Term Commitments of any Class are effected (including through any Term Loan Increase), subject to the satisfaction of the terms and conditions in this Section 2.20, (i) each Incremental Term Lender of such Class shall make a Loan to the requesting Borrower (an Incremental Term Loan ) in an amount equal to its Incremental Term Commitment of such Class and (ii) each Incremental Term Lender of such Class shall become a Lender hereunder with respect to the Incremental Term Commitment of such Class and the Incremental Term Loans of such Class made pursuant thereto. On any Incremental Tranche Closing Date on which any Incremental Revolving Commitments of any Class are effected, subject to the satisfaction of the terms and conditions in this Section 2.20, (i) each Incremental Revolving Lender of such Class shall make its Incremental Revolving Commitment available to the requesting Borrower (when borrowed, an Incremental Revolving Loan and collectively with any Incremental Term Loan, an Incremental Loan ) in an amount equal to its Incremental Revolving Commitment of such Class and (ii) each Incremental Revolving Lender of such Class shall become a Lender hereunder with respect to the Incremental Revolving Commitment of such Class and the Incremental Revolving Loans of such Class made pursuant thereto. Notwithstanding the foregoing, Incremental Term Loans may have identical terms (other than with respect to closing conditions, issuance date and other terms necessary to effectuate the implementation of such Incremental Term Loans) to any of the Term Loans and be treated as the same Class as any of such Term Loans.
(c) Incremental Loan Request . Each Incremental Loan Request from the Borrower pursuant to this Section 2.20 shall set forth the requested amount and proposed terms of the relevant Incremental Term Loans or Incremental Revolving Commitments. Incremental Term Loans may be made, and Incremental Revolving Commitments may be provided, by any existing Lender (but no existing Lender will have an obligation to make any Incremental Commitment, nor will the Borrower have any obligation to approach any existing Lenders to provide any Incremental Commitment) or by any Additional Lender (each such existing Lender or Additional Lender providing such Commitment or Loan, an Incremental Revolving Lender or Incremental Term Lender , as applicable, and, collectively, the Incremental
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Lenders ); provided that the Administrative Agent, each L/C Issuer and the Swing Line Lender shall have consented (not to be unreasonably conditioned, withheld or delayed) to such Additional Lenders making such Incremental Term Loans or providing such Incremental Revolving Commitments to the extent such consent, if any, would be required under Section 10.4(b) for an assignment of Loans or Revolving Commitments, as applicable, to such Additional Lender.
(d) Effectiveness of Incremental Amendment . The effectiveness of any Incremental Amendment, and the Incremental Commitments thereunder, shall be subject to the satisfaction on the date thereof (the Incremental Tranche Closing Date ) of each of the following conditions:
(i) (A) no Default or Event of Default exists or shall exist after giving effect to such Incremental Amendment; provided that if the primary purpose of proceeds of such Incremental Loans is to finance a Permitted Acquisition or Specified Investment then the foregoing shall be limited to the Specified Events of Default and (B) to the extent subject to testing, the Borrower shall be in compliance on a Pro Forma Basis with the Financial Performance Covenant after giving effect to such Incremental Amendment;
(ii) either (x) the representations and warranties of each Credit Party set forth in Section 4 and in each other Credit Document shall be true and correct in all material respects on and as of the Incremental Tranche Closing Date with the same effect as though made on and as of such date, except to the extent such representations and warranties expressly relate to an earlier date, in which case they shall be true and correct in all material respects as of such earlier date; provided that any representation and warranty that is qualified as to materiality, Material Adverse Effect or similar language shall be true and correct (after giving effect to any qualification therein) in all respects on such respective dates or (y) with respect to any Incremental Amendment the primary purpose of which is to finance a Permitted Acquisition or Specified Investment, and if agreed to by the Incremental Lenders providing such Incremental Commitments and/or Incremental Loans, the Specified Representations and the Acquisition Agreement Representations (conformed as necessary for such acquisition or the incurrence of the relevant Incremental Commitments and/or Incremental Loans) shall, in each case, be true and correct in all material respects on and as of the Incremental Tranche Closing Date with the same effect as though made on and as of such date, except to the extent such representations and warranties expressly relate to an earlier date, in which case they shall be true and correct in all material respects as of such earlier date; provided that any representation and warranty that is qualified as to materiality, Material Adverse Effect or similar language shall be true and correct (after giving effect to any qualification therein) in all respects on such respective dates;
(iii) each Incremental Term Commitment shall be in an aggregate principal amount that is not less than [REDACTED Dollar Amount] and shall be in an increment of [REDACTED Dollar Amount] ( provided that such amount may be less than [REDACTED Dollar Amount] and not in an increment of [REDACTED Dollar Amount] if such amount represents all remaining availability under the limit set forth in clause (iv) below), and each Incremental Revolving Commitment shall be in an
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aggregate principal amount that is not less than [REDACTED Dollar Amount] and shall be in an increment of [REDACTED Dollar Amount] ( provided that such amount may be less than [REDACTED Dollar Amount] and not in an increment of [REDACTED Dollar Amount] if such amount represents all remaining availability under the limit set forth in clause (iv) below); and
(iv) the aggregate amount of the Incremental Loans shall not exceed (A) [REDACTED Dollar Amount] , plus (B) at the Borrowers option, up to an unlimited additional amount of Incremental Term Loans or Incremental Revolving Commitments so long as, after giving effect to any such incurrence on a Pro Forma Basis (and after giving effect to any Permitted Acquisition or other Investment consummated in connection therewith on a Pro Forma Basis), and with respect to any Incremental Revolving Commitment, assuming a borrowing of the maximum amount of Loans available thereunder, the Senior Secured Net Leverage Ratio on a Pro Forma Basis is no greater than 3.00:1.00, (1) calculated without netting the cash proceeds of any Incremental Loan or Incremental Revolving Commitment and (2) assuming, in the case of any Incremental Revolving Commitment that such Incremental Revolving Commitment was fully drawn on the date of effectiveness thereof (it being understood that Incremental Term Loans and Incremental Revolving Commitments may not be incurred under clause (B) unless there is no capacity under clause (A)).
(e) Required Terms . The terms, provisions and documentation of any Incremental Term Loan or any Incremental Term Commitment shall be as agreed between the Borrower and the applicable Incremental Lenders providing such Incremental Term Loans or Incremental Term Commitments, and except as otherwise set forth herein, to the extent not substantially consistent with the Term Loans existing on the Incremental Tranche Closing Date (as determined by the Borrower and conclusively evidenced by a certificate of the Borrower), shall be consistent with clauses (i) and (ii) below, as applicable, and otherwise shall be reasonably satisfactory to the Administrative Agent (in its capacity as such) (other than in respect of pricing, fees, rate floors, optional prepayment, redemption terms, amortization or maturity), it being understood that to the extent any Previously Absent Financial Maintenance Covenant is added for the benefit of any Incremental Loan or Incremental Commitment, no consent shall be required from the Administrative Agent or any existing Lender to the extent such Previously Absent Financial Maintenance Covenant is (A) also added for the benefit of the Term Loans or Revolving Commitments, as applicable, existing on the Incremental Tranche Closing Date (it being understood that a Previously Absent Financial Maintenance Covenant that is added solely for the benefit of any Incremental Revolving Commitments shall not be required to be added for the benefit of any Term Loans) or (B) only applicable after the Maturity Date of any Term Loan or Revolving Commitment, as applicable, existing on the Incremental Tranche Closing Date. Notwithstanding the foregoing, in the case of a Term Loan Increase or Incremental Revolving Commitment, the terms, provisions and documentation of such Term Loan Increase or Incremental Revolving Commitment shall be identical (other than with respect to underwriting, commitment or upfront fees, original issue discount or similar fees) to the applicable Term Loans or Revolving Commitments being increased. In any event,
(i) each Incremental Term Loan or Incremental Term Commitment:
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(A) will rank pari passu in right of payment and in right of security with the other Loans or Commitments, as applicable, of such Class;
(B) shall not mature earlier than the Maturity Date with respect to the Initial Term Loans (prior to giving effect to any extensions thereof);
(C) shall have a Weighted Average Life to Maturity not shorter than the remaining Weighted Average Life to Maturity of the Initial Term Loans on the date of incurrence of such Incremental Term Loans (except by virtue of amortization or prepayment of the Initial Term Loans prior to the time of such incurrence);
(D) shall have fees and, subject to clauses (e)(i)(B) and (e)(i)(C) above and clause (e)(ii) below, amortization determined by the Borrower and the applicable Incremental Term Lenders; and
(E) may provide for the ability to participate on a pro rata basis, or on a less than pro rata basis (but not on a greater than pro rata basis), in any voluntary or mandatory prepayments of Term Loans hereunder, as specified in the applicable Incremental Amendment.
(ii) the All-In-Yield applicable to the Incremental Term Loans of each Class shall be determined by the Borrower and the applicable new Lenders and shall be set forth in each applicable Incremental Amendment; provided , however , that the All-In-Yield applicable to such Incremental Term Loans shall not be greater than the applicable All-In-Yield payable pursuant to the terms of this Agreement with respect to the Initial Term Loans plus 50 basis points per annum, unless the interest rate (together with, as provided in the proviso below, Adjusted LIBOR or Base Rate floor) with respect to such Initial Term Loans is increased so as to cause the then applicable All-In-Yield under this Agreement on such Initial Term Loans to equal the All-In-Yield then applicable to the Incremental Term Loans minus 50 basis points (with the All-In-Yield then applicable to the Revolving Facility also increased by like amount); provided that any increase in All-In-Yield to the Initial Term Loans due to the application of an Adjusted LIBOR floor or Base Rate floor on any Incremental Term Loan shall be effected solely through an increase in (or implementation of, as applicable) any Adjusted LIBOR floor or Base Rate floor applicable to the Initial Term Loans; and
(iii) there shall be no borrowers or guarantors in respect of such Incremental Term Loan or any Incremental Revolving Commitment that are not the Borrower or a Guarantor, and Incremental Term Loans and Incremental Revolving Commitments shall not be secured by assets other than Collateral (except pursuant to an escrow or similar arrangement with respect to the proceeds of such Incremental Term Loans or Incremental Revolving Commitments).
(f) Incremental Amendment . Commitments in respect of Incremental Term Loans and Incremental Revolving Commitments shall become Commitments (or in the case of an Incremental Revolving Commitment to be provided by a Lender with an existing Revolving
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Commitment, an increase in such Lenders applicable Revolving Commitment), under this Agreement pursuant to an amendment (an Incremental Amendment ) to this Agreement and, as appropriate, the other Credit Documents, executed by the Borrower, each Incremental Lender providing such Commitments and the Administrative Agent. The Incremental Amendment may, without the consent of any other Credit Party, Agent or Lender, effect such amendments to this Agreement and the other Credit Documents (i) as may be necessary or appropriate, in the reasonable opinion of the Administrative Agent and the Borrower, to effect the provisions of this Section 2.20, including amendments as deemed necessary by the Administrative Agent in its reasonable judgment to effect any lien subordination and associated rights of the applicable Lenders to the extent any Incremental Loans are to rank junior in right of security and/or (ii) so long as such amendments are not materially adverse to the Lenders, such other changes as may be necessary or appropriate, in the reasonable opinion of the Administrative Agent and the Borrower, to maintain the fungibility of any such Incremental Term Loans with any tranche of then-outstanding Term Loans. The Borrower may use the proceeds, if any, of the Incremental Term Loans and Incremental Revolving Commitments for any purpose not prohibited by this Agreement. No Lender shall be obligated to provide any Incremental Term Loans or Incremental Revolving Commitments unless it so agrees.
(g) Reallocation of Revolving Exposure . Upon any Incremental Tranche Closing Date on which Incremental Revolving Commitments are effected, if, on the date of such increase, there are any Revolving Loans outstanding, each of the Lenders that has an existing Revolving Commitment or Revolving Exposure, as applicable, under such Class shall assign to each of the Incremental Revolving Lenders, and each of the Incremental Revolving Lenders shall purchase from each such Lender under such Class, at par, such interests in the Revolving Loans outstanding on such Incremental Tranche Closing Date as shall be necessary in order that, after giving effect to all such assignments and purchases, such Revolving Loans under such Class will be held by Lenders with existing Revolving Commitments or Revolving Exposure, as applicable, under such Class and Incremental Revolving Lenders ratably in accordance with their Revolving Commitments under such Class after giving effect to the addition of such Incremental Revolving Commitments to the Revolving Commitments under such Class. The Administrative Agent and the Lenders hereby agree that the minimum borrowing and prepayment requirements in Sections 2.2 and 2.11 of this Agreement shall not apply to the transactions effected pursuant to the immediately preceding sentence.
(h) At any time and from time to time, subject to the terms and conditions set forth herein, the Borrower may issue one or more series of Incremental Equivalent Debt in an aggregate principal amount not to exceed, as of the date of and after giving effect to the issuance of any such Incremental Equivalent Debt, the aggregate amount of Incremental Loans permitted to be incurred under Section 2.20(d)(iv); provided that the incurrence of any Incremental Equivalent Debt shall reduce, on a dollar-for-dollar basis, the aggregate amount of Incremental Loans permitted to be incurred under Section 2.20(d)(iv).
(i) The issuance of any Incremental Equivalent Debt pursuant to this Section 2.20, shall (i) in all cases, be subject to the terms and conditions applicable to Incremental Commitments set forth under Sections 2.20(d)(i), (d)(ii), (d)(iii), (e)(i) and (e)(iii), as if set forth in this Section 2.20(i), mutatis mutandis (and, for the avoidance of doubt, the interest rate, upfront fees and original issue discount for any Incremental Equivalent Debt shall
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be as determined by the Borrower) and (ii) the covenants, events of default, guarantees and other terms of such Incremental Equivalent Debt shall be customary for similar debt instruments in light of then-prevailing market conditions at the time of issuance and in any event not materially more restrictive, taken as a whole, to the Borrower and the other Restricted Subsidiaries than those set forth in this Agreement (other than with respect to interest rate and redemption provisions), except for covenants or other provisions applicable only to periods after the Latest Maturity Date at the time of issuance, it being understood that a certificate of an Authorized Officer of the Borrower delivered to the Administrative Agent prior to or at the incurrence of such Incremental Equivalent Debt, together with a reasonably detailed description of the material terms and conditions of such Incremental Equivalent Debt or drafts of the documentation relating thereto, stating that the Borrower has determined in good faith that such terms and conditions of the Incremental Equivalent Debt satisfy the requirement set forth in this clause (ii), shall be conclusive evidence that such terms and conditions have been satisfied.
(j) This Section 2.20 shall supersede any provisions in Section 2.14 or Section 10.8 to the contrary.
2.21 Refinancing Amendments .
(a) Refinancing Commitments . The Borrower may, at any time or from time to time after the Closing Date, by notice to the Administrative Agent (a Refinancing Loan Request ), request (i) the establishment of one or more new Classes of term loans under this Agreement (any such new Class, Refinancing Term Commitments ) or (ii) the establishment of one or more new Classes of revolving commitments under this Agreement (any such new Class, Refinancing Revolving Commitments and collectively with any Refinancing Term Commitments, Refinancing Commitments ), in each case, established in exchange for, or to replace, repurchase, retire or refinance, in whole or in part, as selected by the Borrower, any one or more then-existing Class or Classes of Loans or Commitments (with respect to a particular Refinancing Commitment or Refinancing Loan, such existing Loans or Commitments, Refinanced Debt ), whereupon the Administrative Agent shall promptly deliver a copy of each such notice to each of the Lenders.
(b) Refinancing Loans . Any Refinancing Term Loans made pursuant to Refinancing Term Commitments or any Refinancing Revolving Commitments made on a Refinancing Closing Date shall be designated a separate Class of Refinancing Term Loans or Refinancing Revolving Commitments, as applicable, for all purposes of this Agreement. On any Refinancing Closing Date on which any Refinancing Term Commitments of any Class are effected, subject to the satisfaction of the terms and conditions in this Section 2.21, (i) each Refinancing Term Lender of such Class shall make a Term Loan to the Borrower (a Refinancing Term Loan ) in an amount equal to its Refinancing Term Commitment of such Class and (ii) each Refinancing Term Lender of such Class shall become a Lender hereunder with respect to the Refinancing Term Commitment of such Class and the Refinancing Term Loans of such Class made pursuant thereto. On any Refinancing Closing Date on which any Refinancing Revolving Commitments of any Class are effected, subject to the satisfaction of the terms and conditions in this Section 2.21, (i) each Refinancing Revolving Lender of such Class shall make its Refinancing Revolving Commitment available to the Borrower (when borrowed, a Refinancing Revolving Loan and collectively with any Refinancing Term Loan, a
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Refinancing Loan ) and (ii) each Refinancing Revolving Lender of such Class shall become a Lender hereunder with respect to the Refinancing Revolving Commitment of such Class and the Refinancing Revolving Loans of such Class made pursuant thereto.
(c) Refinancing Loan Request . Each Refinancing Loan Request from the Borrower pursuant to this Section 2.21 shall set forth the requested amount and proposed terms of the relevant Refinancing Term Loans or Refinancing Revolving Commitments and identify the Refinanced Debt with respect thereto. Refinancing Term Loans may be made, and Refinancing Revolving Commitments may be provided, by any existing Lender (but no existing Lender will have an obligation to make any Refinancing Commitment, nor will the Borrower have any obligation to approach any existing Lender to provide any Refinancing Commitment) or by any Additional Lender (each such existing Lender or Additional Lender providing such Commitment or Loan, a Refinancing Revolving Lender or Refinancing Term Lender, as applicable, and, collectively, Refinancing Lenders ); provided that the Administrative Agent, the L/C Issuer and Swing Line Lender shall have consented (not to be unreasonably conditioned, withheld or delayed) to such Lenders or Additional Lenders making such Refinancing Term Loans or providing such Refinancing Revolving Commitments to the extent such consent, if any, would be required under Section 10.4(b) for an assignment of Loans or Revolving Commitments, as applicable, to such Additional Lender.
(d) Effectiveness of Refinancing Amendment . The effectiveness of any Refinancing Amendment, and the Refinancing Commitments thereunder, shall be subject to the satisfaction on the date thereof (a Refinancing Closing Date ) of each of the following conditions, together with any other conditions set forth in the Refinancing Amendment:
(i) after giving effect to such Refinancing Commitments, the conditions of Sections 3.2(b) and 3.2(d) shall be satisfied (it being understood that all references to the date of such Credit Extension or similar language in such Section 3.2 shall be deemed to refer to the applicable Refinancing Closing Date);
(ii) each Refinancing Commitment shall be in an aggregate principal amount that is not less than [REDACTED Dollar Amount] and shall be in an increment of [REDACTED Dollar Amount] ( provided that such amount may be less than [REDACTED Dollar Amount] and not in an increment of [REDACTED Dollar Amount] if such amount is equal to (x) the entire outstanding principal amount of Refinanced Debt that is in the form of Term Loans or (y) the entire outstanding principal amount of Refinanced Debt (or commitments) that is in the form of Revolving Commitments); and
(iii) the principal amount (or accreted value, if applicable) of such Refinancing Indebtedness does not exceed the principal amount (or accreted value, if applicable) of the Refinanced Debt (plus the amount of unpaid accrued or capitalized interest and premiums thereon (including make-whole premiums, prepayment premiums, tender premiums and amounts required to be paid in connection with defeasance and satisfaction and discharge), underwriting discounts, original issue discount, defeasance costs, fees (including upfront fees), commissions and expenses).
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(e) Required Terms . The terms, provisions and documentation of the Refinancing Term Loans and Refinancing Term Commitments or the Refinancing Revolving Loans and Refinancing Revolving Commitments, as the case may be, of any Class shall be as agreed between the Borrower and the applicable Refinancing Lenders providing such Refinancing Commitments, and except as otherwise set forth herein, to the extent not substantially identical to any Class of Term Loans or Revolving Commitments, as applicable, each existing on the Refinancing Closing Date, shall be consistent with clauses (i) or (ii) below, as applicable, and otherwise shall be (taken as a whole) not materially more favorable (as reasonably determined by the Borrower and conclusively evidenced by a certificate of the Borrower) to the Refinancing Lenders than those applicable to such Class (taken as a whole) being refinanced (except for (1) covenants or other provisions applicable only to periods after the Maturity Date (as of the applicable Refinancing Closing Date) of such Class being refinanced, (2) pricing, fees, rate floors, optional prepayment, redemption terms and (3) subject to the immediately succeeding proviso, a Previously Absent Financial Maintenance Covenant); provided that, notwithstanding anything to the contrary herein, if any such terms, provisions and documentation of the Refinancing Term Loans and Refinancing Term Commitments or the Refinancing Revolving Loans and Refinancing Revolving Commitments, as the case may be, contains a Previously Absent Financial Maintenance Covenant, such Previously Absent Financial Maintenance Covenant shall be included for the benefit of each other Loan or Commitment of such Class ( provided , however , that if (I) the applicable Refinanced Debt includes a revolving tranche and a Refinancing Revolving Commitment is to be provided (whether or not the documentation therefor includes any other facilities) and (II) the applicable Previously Absent Financial Maintenance Covenant is a financial maintenance covenant solely for the benefit of Revolving Loans thereunder, the Previously Absent Financial Maintenance Covenant shall not be required to be included in this Agreement for the benefit of any Term Loans hereunder). In any event:
(i) the Refinancing Term Loans:
(A) as of the Refinancing Closing Date, shall not have a final scheduled maturity date earlier than the Maturity Date of the Refinanced Debt,
(B) shall have a Weighted Average Life to Maturity not shorter than the remaining Weighted Average Life to Maturity of the Refinanced Debt on the date of incurrence of such Refinancing Loans (except by virtue of amortization or prepayment of the Refinanced Debt prior to the time of such incurrence),
(C) shall have an Applicable Margin and, subject to clauses (e)(i)(A) and (e)(i)(B) above, amortization determined by the Borrower and the applicable Refinancing Term Lenders,
(D) shall not be subject to any guarantee by any Person other than a Credit Party and shall not include any borrower other than the Borrower hereunder,
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(E) in the case of any Refinancing Term Loans secured on a pari passu basis with the Initial Term Loans, may provide for the ability to participate on a pro rata basis, or on a less than pro rata basis (but not on a greater than pro rata basis), in any voluntary or mandatory prepayments of Term Loans hereunder, as specified in the applicable Refinancing Amendment, and
(F) (I) shall rank pari passu in right of payment with the Obligations under the then existing Term Loans and Revolving Loans and (II) shall either be (x) secured by the Collateral (and shall not be secured by any assets of the Borrower or any Restricted Subsidiary not constituting Collateral) and shall rank pari passu or junior in right of security with the Obligations or (y) unsecured; and
(ii) the Refinancing Revolving Commitments and Refinancing Revolving Loans:
(A) (I) shall rank pari passu in right of payment with the Obligations and (II) shall either be (x) secured by the Collateral (and shall not be secured by any assets of the Borrower or any Restricted Subsidiary not constituting Collateral) and shall rank pari passu or junior in right of security with the Obligations or (y) unsecured,
(B) shall not have a final scheduled maturity date earlier than, or mandatory scheduled commitment reductions prior to, the Maturity Date with respect to the Refinanced Debt,
(C) shall provide that the borrowing and repayment (except for (1) payments of interest and fees at different rates on Refinancing Revolving Commitments (and related outstandings), (2) repayments required upon the Maturity Date of the Refinancing Revolving Commitments and (3) repayments made in connection with a permanent repayment and termination of commitments (in accordance with clause (E) below)) of Loans with respect to Refinancing Revolving Commitments after the associated Refinancing Closing Date shall be made on a pro rata basis with all other Revolving Commitments,
(D) subject to the provisions of Section 2.3(c) to the extent dealing with Letters of Credit which mature or expire after a Maturity Date when there exists Refinancing Revolving Commitments with a longer Maturity Date, all Letters of Credit shall be participated on a pro rata basis by all Lenders with Commitments in accordance with their percentage of the Revolving Commitments existing on the Refinancing Closing Date (and except as provided in Section 2.3(c), without giving effect to changes thereto on an earlier Maturity Date with respect to Letters of Credit theretofore incurred or issued),
(E) in the case of any Refinancing Revolving Commitments secured on a pari passu basis with the Revolving Commitments, shall provide that the permanent repayment of Revolving Loans with respect to, and termination or
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reduction of, Refinancing Revolving Commitments after the associated Refinancing Closing Date shall be made on a pro rata basis, or on a less than (but not greater than, except that Refinancing Revolving Commitments may participate on a greater than pro rata basis in any permanent prepayments and termination with other Revolving Commitments, other than the Revolving Commitments in effect on the Closing Date) pro rata basis, with all other Revolving Commitments, except that the Borrower shall be permitted to permanently repay and terminate Commitments in respect of any such Class of Revolving Loans on a greater than pro rata basis as compared to any other Class of Revolving Loans with a later Maturity Date than such Class or in connection with any refinancing thereof permitted by this Agreement,
(F) shall provide that assignments and participations of Refinancing Revolving Commitments and Refinancing Revolving Loans shall be governed by the same assignment and participation provisions applicable to Revolving Commitments and Revolving Loans existing on the Refinancing Closing Date,
(G) shall provide that any Refinancing Revolving Commitments may constitute a separate Class or Classes, as the case may be, of Commitments from the Classes constituting the applicable Revolving Commitments prior to the Refinancing Closing Date; provided at no time shall there be Revolving Commitments hereunder (including Refinancing Revolving Commitments and any original Revolving Commitments) which have more than two (2) different Maturity Dates unless otherwise agreed to by the Administrative Agent,
(H) shall have an Applicable Margin determined by the Borrower and the applicable Refinancing Revolving Lenders, and
(I) shall not be subject to any guarantee by any Person other than a Credit Party and shall not include any borrower other than the Borrower hereunder.
(f) Refinancing Amendment . Commitments in respect of Refinancing Term Loans and Refinancing Revolving Commitments shall become additional Commitments under this Agreement pursuant to an amendment (a Refinancing Amendment ) to this Agreement and, as appropriate, the other Credit Documents, executed by the Borrower, each Refinancing Lender providing such Commitments and the Administrative Agent. The Refinancing Amendment may, without the consent of any other Credit Party, Agent or Lender, effect such amendments to this Agreement and the other Credit Documents as may be necessary or appropriate, in the reasonable opinion of the Administrative Agent and the Borrower, to effect the provisions of this Section 2.21, including, if applicable, amendments as deemed necessary by the Administrative Agent in its reasonable judgment to effect (i) any lien subordination and associated rights of the applicable Lenders to the extent any Refinancing Loans are to rank junior in right of security and (ii) that any Previously Absent Financial Maintenance Covenant does not benefit any Term Loan hereunder. The Borrower will use the proceeds, if any, of the
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Refinancing Term Loans and Refinancing Revolving Commitments in exchange for, or to extend, renew, replace, repurchase, retire or refinance, and shall permanently terminate applicable commitments under, substantially concurrently, the applicable Refinanced Debt.
(g) Reallocation of Revolving Exposure . Upon any Refinancing Closing Date on which Refinancing Revolving Commitments are effected through the establishment of a new Class of revolving commitments pursuant to this Section 2.21, (i) if, on such date, there are any Revolving Loans outstanding, such Revolving Loans shall be prepaid from the proceeds of new Refinancing Revolving Loans under such new Class of Refinancing Revolving Commitments in such amounts as shall be necessary in order that, after giving effect to such Loans and all such related prepayments, all Revolving Loans will be held by all Lenders under the Revolving Commitments (including Lenders providing such Refinancing Revolving Commitments) ratably in accordance with their revolving commitments under all Revolving Commitments (after giving effect to the establishment of such Refinancing Revolving Commitments), (b) in the case of a Revolving Commitment, there shall be an automatic adjustment to the participations hereunder in Letters of Credit held by each Lender under the Revolving Commitments so that each such Lender shares ratably in such participations in accordance with their revolving commitments under all Revolving Commitments (after giving effect to the establishment of such Refinancing Revolving Commitments), (c) each Refinancing Revolving Commitment shall be deemed for all purposes a Revolving Commitment and each Loan made thereunder shall be deemed, for all purposes, a Revolving Loan and (d) each Refinancing Revolving Lender shall become a Lender with respect to the Refinancing Revolving Commitments and all matters relating thereto.
(h) Refinancing Equivalent Debt .
(i) In lieu of incurring any Refinancing Term Loans, the Borrower may, upon notice to the Administrative Agent, at any time or from time to time after the Closing Date issue, incur or otherwise obtain (A) secured Indebtedness in the form of one or more series of senior secured notes that are secured on a pari passu basis with the Obligations (but without regard to the control of remedies) (such notes, Permitted Pari Passu Secured Refinancing Debt ), (B) secured Indebtedness in the form of one or more series of second lien (or other junior lien) secured notes or second lien (or other junior lien) secured term loans (such notes or loans, Permitted Junior Secured Refinancing Debt ) and (C) unsecured or subordinated Indebtedness in the form of one or more series of unsecured or subordinated notes or term loans (such notes or loans, Permitted Unsecured Refinancing Debt and together with Permitted Pari Passu Secured Refinancing Debt and Permitted Junior Secured Refinancing Debt, Refinancing Equivalent Debt ), in each case, in exchange for, or to extend, renew, replace, repurchase, retire or refinance, in whole or in part, any existing Class or Classes of Loans (such Loans, Refinanced Loans ).
(ii) Any Refinancing Equivalent Debt:
(A) (1) shall not have a final scheduled maturity date earlier than the Maturity Date of the Refinanced Loans, (2) shall not have a Weighted Average Life to Maturity shorter than the remaining Weighted Average Life to Maturity of the Refinanced Loans (except by virtue of amortization or
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prepayment of the Refinanced Loans prior to the time of such incurrence), (3) shall not have scheduled amortization or payments of principal and not be subject to mandatory redemption, repurchase or prepayment (except with respect to change of control, asset sale, insurance and casualty and condemnation event mandatory offers to purchase or prepayment events and events of default), in each case prior to the Maturity Date of the Refinanced Loans except, in the case of Refinancing Equivalent Debt that is secured on a pari passu basis with the Obligations, to the extent any such payment, redemption, repurchase or prepayment obligation is required to be applied on a pro rata or greater than pro rata basis to the Refinanced Term Loans and except with respect to customary AHYDO catch-up payments, (4) shall not be guaranteed by persons other than Guarantors and shall not include any borrower or issuer other than the Borrower hereunder, (5) if in the form of subordinated Permitted Unsecured Refinancing Debt, shall be subject to a subordination agreement or provisions as reasonably agreed by the Administrative Agent and (6) except as otherwise set forth in this clause (h)(ii), shall have terms and conditions (other than with respect to pricing, fees, rate floors and optional prepayment or redemption terms) which are (taken as a whole) no more favorable (as reasonably determined by the Borrower and conclusively evidenced by a certificate of the Borrower) to the lenders or holders providing such Refinancing Equivalent Debt, than those applicable to the Refinanced Loans (except for covenants or other provisions applicable only to periods after the Maturity Date of the applicable Refinanced Loans at the time of the issuance or incurrence of such Refinancing Equivalent Debt),
(B) (1) if either Permitted Pari Passu Secured Refinancing Debt or Permitted Junior Secured Refinancing Debt, shall be subject to security agreements relating to such Refinancing Equivalent Debt that are substantially the same as or more favorable to the Credit Parties than the Collateral Documents (with such differences as are reasonably satisfactory to the Administrative Agent), (2) if Permitted Pari Passu Secured Refinancing Debt, (x) shall be secured by the Collateral on a pari passu basis with the Obligations and shall not be secured by any property or assets of the Borrower or any Restricted Subsidiary other than the Collateral, and (y) shall be subject to an Intercreditor Agreement, and (3) if Permitted Junior Secured Refinancing Debt, (x) shall be secured by the Collateral on a second priority (or other junior priority) basis to the Liens securing the Obligations and shall not be secured by any property or assets of the Borrower or any Restricted Subsidiary other than the Collateral, and (y) shall be subject to an Intercreditor Agreement, and
(C) shall be incurred, and the proceeds thereof used, solely to repay, repurchase, retire or refinance substantially concurrently the Refinanced Loans and terminate all commitments thereunder.
(iii) This Section 2.21 shall supersede any provisions in Section 2.14 or 10.1 to the contrary.
2.22 Extensions of Loans .
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(a) Extension of Term Loans . The Borrower may, at any time and from time to time, request that all or a portion of the Term Loans of a given Class (each, an Existing Term Loan Tranche ) be amended to extend the scheduled Maturity Date(s) with respect to all or a portion of any principal amount of such Term Loans (any such Term Loans which have been so amended, Extended Term Loans ) and to provide for other terms consistent with this Section 2.22. In order to establish any Extended Term Loans, the Borrower shall provide a notice to the Administrative Agent (who shall provide a copy of such notice to each of the Lenders under the applicable Existing Term Loan Tranche) (each, a Term Loan Extension Request ) setting forth the proposed terms of the Extended Term Loans to be established, which shall (x) be identical as offered to each Lender under such Existing Term Loan Tranche (including as to the proposed interest rates and fees payable, but excluding any arrangement, structuring or other fees payable in connection therewith that are not generally shared with all Extending Term Lenders) and offered pro rata to each Lender under such Existing Term Loan Tranche and (y) be identical to the Term Loans under the Existing Term Loan Tranche from which such Extended Term Loans are to be amended, except that: (i) all or any of the scheduled amortization payments of principal of the Extended Term Loans may be delayed to later dates than the scheduled amortization payments of principal of the Term Loans of such Existing Term Loan Tranche, to the extent provided in the applicable Extension Amendment; provided , however , that at no time shall there be Classes of Term Loans hereunder (including Refinancing Term Loans and Extended Term Loans) which have more than three (3) different Maturity Dates (unless otherwise consented to by the Administrative Agent); (ii) the All-In-Yield with respect to the Extended Term Loans (whether in the form of interest rate margin, upfront fees, original issue discount or otherwise) may be different than the All-In-Yield for the Term Loans of such Existing Term Loan Tranche, in each case, to the extent provided in the applicable Extension Amendment; (iii) the Extension Amendment may provide for other covenants and terms that apply solely to any period after the Latest Maturity Date that is in effect on the effective date of the Extension Amendment (immediately prior to the establishment of such Extended Term Loans); and (iv) Extended Term Loans may have call protection as may be agreed by the Borrower and the Lenders thereof; provided that (A) in no event shall the final Maturity Date of any Extended Term Loans of a given Term Loan Extension Series at the time of establishment thereof be earlier than the then Latest Maturity Date of any other Term Loans hereunder, (B) the Weighted Average Life to Maturity of any Extended Term Loans of a given Term Loan Extension Series at the time of establishment thereof shall be no shorter than the remaining Weighted Average Life to Maturity of any Existing Term Loan Tranche, (C) any such Extended Term Loans (and the Liens securing the same) shall be permitted by the terms of the Intercreditor Agreements (to the extent any Intercreditor Agreement is then in effect), (D) all documentation in respect of such Extension Amendment shall be consistent with the foregoing and (E) any Extended Term Loans may participate on a pro rata basis or less than a pro rata basis (but not on a greater than pro rata basis) in any voluntary or mandatory repayments or prepayments hereunder, in each case as specified in the respective Term Loan Extension Request. Any Extended Term Loans amended pursuant to any Term Loan Extension Request shall be designated a Class (each, a Term Loan Extension Series ) of Extended Term Loans for all purposes of this Agreement; provided that any Extended Term Loans amended from an Existing Term Loan Tranche may, to the extent provided in the applicable Extension Amendment, be designated as an increase in any previously established Term Loan Extension Series with respect to such Existing Term Loan Tranche (in which case scheduled amortization with respect thereto
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shall be proportionately increased). Each request for a Term Loan Extension Series of Extended Term Loans proposed to be incurred under this Section 2.22 shall be in an aggregate principal amount that is not less than [REDACTED Dollar Amount] (it being understood that the actual principal amount thereof provided by the applicable Lenders may be lower than such minimum amount) and the Borrower may impose an Extension Minimum Condition with respect to any Term Loan Extension Request, which may be waived by the Borrower in its sole discretion.
(b) Extension of Revolving Commitments . The Borrower may, at any time and from time to time, request that all or a portion of the Revolving Commitments of a given Class (each, an Existing Revolver Tranche ) be amended to extend the Maturity Date with respect to all or a portion of any principal amount of such Revolving Commitments (any such Revolving Commitments which have been so amended, Extended Revolving Commitments ) and to provide for other terms consistent with this Section 2.22. In order to establish any Extended Revolving Commitments, the Borrower shall provide a notice to the Administrative Agent (who shall provide a copy of such notice to each of the Lenders under the applicable Existing Revolver Tranche) (each, a Revolver Extension Request ) setting forth the proposed terms of the Extended Revolving Commitments to be established, which shall (x) be identical as offered to each Lender under such Existing Revolver Tranche (including as to the proposed interest rates and fees payable, but excluding any arrangement, structuring or other fees payable in connection therewith that are not generally shared with all Extending Revolving Lenders) and offered pro rata to each Lender under such Existing Revolver Tranche and (y) be identical to the Revolving Commitments under the Existing Revolver Tranche from which such Extended Revolving Commitments are to be amended, except that: (i) the Maturity Date of the Extended Revolving Commitments may be delayed to a later date than the Maturity Date of the Revolving Commitments of such Existing Revolver Tranche, to the extent provided in the applicable Extension Amendment; provided , however , that at no time shall there be Classes of Revolving Commitments hereunder (including Refinancing Revolving Commitments and Extended Revolving Commitments) which have more than two (2) different Maturity Dates (unless otherwise consented to by the Administrative Agent in its reasonable discretion); (ii) the All-In-Yield with respect to extensions of credit under the Extended Revolving Commitments (whether in the form of interest rate margin, upfront fees, original issue discount or otherwise) may be different than the All-In-Yield for extensions of credit under the Revolving Commitments of such Existing Revolver Tranche, in each case, to the extent provided in the applicable Extension Amendment; (iii) the Extension Amendment may provide for other covenants and terms that apply solely to any period after the Latest Maturity Date that is in effect on the effective date of the Extension Amendment (immediately prior to the establishment of such Extended Revolving Commitments); and (iv) all borrowings under the applicable Revolving Commitments (i.e., the Existing Revolver Tranche and the Extended Revolving Commitments of the applicable Revolver Extension Series) and repayments thereunder shall be made on a pro rata basis (except (I) for payments of interest and fees at different rates on Extended Revolving Commitments (and related outstandings), (II) for repayments required upon the Maturity Date of the non-extending Revolving Commitments and (III) Extended Revolving Commitments may participate on a less than (but not greater than, except that Extended Revolving Commitments may participate on a greater than pro rata basis in any permanent prepayments and termination with other Revolving Commitments, other than the Revolving Commitments in effect on the Closing Date) pro rata basis, with all other Revolving Commitments existing on the date of effectiveness of any
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Extension Amendment), except that the Borrower shall be permitted to permanently repay and terminate Commitments in respect of any such Class of Revolving Loans on a greater than pro rata basis as compared to any other Class of Revolving Loans with a later Maturity Date than such Class or in connection with any refinancing thereof permitted by this Agreement; provided , further , that (A) in no event shall the final Maturity Date of any Extended Revolving Commitments of a given Revolver Extension Series at the time of establishment thereof be earlier than the then Latest Maturity Date of any other Revolving Commitments hereunder, (B) any such Extended Revolving Commitments (and the Liens securing the same) shall be permitted by the terms of the Intercreditor Agreements (to the extent any Intercreditor Agreement is then in effect) and (C) all documentation in respect of such Extension Amendment shall be consistent with the foregoing. Any Extended Revolving Commitments amended pursuant to any Revolver Extension Request shall be designated a Class (each, a Revolver Extension Series ) of Extended Revolving Commitments for all purposes of this Agreement; provided that any Extended Revolving Commitments amended from an Existing Revolver Tranche may, to the extent provided in the applicable Extension Amendment, be designated as an increase in any previously established Revolver Extension Series with respect to such Existing Revolver Tranche. Each request for a Revolver Extension Series of Extended Revolving Commitments proposed to be incurred under this Section 2.22 shall be in an aggregate principal amount that is not less than [REDACTED Dollar Amount] (it being understood that the actual principal amount thereof provided by the applicable Lenders may be lower than such minimum amount) and the Borrower may impose an Extension Minimum Condition with respect to any Revolver Extension Request, which may be waived by the Borrower in its sole discretion.
(c) Extension Request . The Borrower shall provide the applicable Extension Request at least [REDACTED Time Period] (or such shorter period as may be agreed by the Administrative Agent) prior to the date on which Lenders under the Existing Term Loan Tranche or Existing Revolver Tranche, as applicable, are requested to respond, and shall agree to such procedures, if any, as may be established by, or acceptable to, the Administrative Agent, in each case acting reasonably to accomplish the purposes of this Section 2.22. No Lender shall have any obligation to agree to have any of its Term Loans of any Existing Term Loan Tranche amended into Extended Term Loans or any of its Revolving Commitments amended into Extended Revolving Commitments, as applicable, pursuant to any Extension Request. Any Lender holding a Loan under an Existing Term Loan Tranche (each, an Extending Term Lender ) wishing to have all or a portion of its Term Loans under the Existing Term Loan Tranche subject to such Extension Request amended into Extended Term Loans and any Revolving Lender (each, an Extending Revolving Lender ) wishing to have all or a portion of its Revolving Commitments under the Existing Revolver Tranche subject to such Extension Request amended into Extended Revolving Commitments, as applicable, shall notify the Administrative Agent (each, an Extension Election ) on or prior to the date specified in such Extension Request of the amount of its Term Loans under the Existing Term Loan Tranche or Revolving Commitments under the Existing Revolver Tranche, as applicable, which it has elected to request be amended into Extended Term Loans or Extended Revolving Commitments, as applicable (subject to any minimum denomination requirements imposed by the Administrative Agent). In the event that the aggregate principal amount of Term Loans under the Existing Term Loan Tranche or Revolving Commitments under the Existing Revolver Tranche, as applicable, in respect of which applicable Term Loan Lenders or Revolving Lenders, as the case may be, shall have accepted the relevant Extension Request exceeds the amount of
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Extended Term Loans or Extended Revolving Commitments, as applicable, requested to be extended pursuant to the Extension Request, Term Loans or Revolving Commitments, as applicable, subject to Extension Elections shall be amended to Extended Term Loans or Extended Revolving Commitments, as applicable, on a pro rata basis (subject to rounding by the Administrative Agent, which shall be conclusive) based on the aggregate principal amount of Term Loans or Revolving Commitments, as applicable, included in each such Extension Election.
(d) Extension Amendment . Extended Term Loans and Extended Revolving Commitments shall be established pursuant to an amendment (each, a Extension Amendment ) to this Agreement among the Borrower, the Administrative Agent and each Extending Term Lender or Extending Revolving Lender, as applicable, providing an Extended Term Loan or Extended Revolving Commitment, as applicable, thereunder, which shall be consistent with the provisions set forth in Section 2.22(a) or (b) above, respectively (but which shall not require the consent of any other Lender). The effectiveness of any Extension Amendment shall be subject to the satisfaction on the date thereof of each of the conditions set forth in Section 3.2 and, to the extent reasonably requested by the Administrative Agent, receipt by the Administrative Agent of (i) legal opinions, board resolutions and officers certificates consistent with those delivered on the Closing Date (conformed as appropriate) other than changes to such legal opinions resulting from a Change in Law, change in fact or change to counsels form of opinion reasonably satisfactory to the Administrative Agent and (ii) reaffirmation agreements and/or such amendments to the Collateral Documents as may be reasonably requested by the Administrative Agent in order to ensure that the Extended Term Loans or Extended Revolving Commitments, as applicable, are provided with the benefit of the applicable Credit Documents. The Administrative Agent shall promptly notify each Lender as to the effectiveness of each Extension Amendment. Each of the parties hereto hereby agrees that this Agreement and the other Credit Documents may be amended pursuant to an Extension Amendment, without the consent of any other Lenders, to the extent (but only to the extent) necessary to (i) reflect the existence and terms of the Extended Term Loans or Extended Revolving Commitments, as applicable, incurred pursuant thereto, (ii) modify the scheduled repayments set forth in Section 2.10 with respect to any Existing Term Loan Tranche subject to an Extension Election to reflect a reduction in the principal amount of the Term Loans required to be paid thereunder in an amount equal to the aggregate principal amount of the Extended Term Loans amended pursuant to the applicable Extension (with such amount to be applied ratably to reduce scheduled repayments of such Term Loans required pursuant to Section 2.10), (iii) modify the prepayments set forth in Section 2.11 and Section 2.12 to reflect the existence of the Extended Term Loans and the application of prepayments with respect thereto and (iv) effect such other amendments to this Agreement and the other Credit Documents as may be necessary or appropriate, in the reasonable opinion of the Administrative Agent and the Borrower, to effect the provisions of this Section 2.22, and the Requisite Lenders hereby expressly authorize the Administrative Agent to enter into any such Extension Amendment.
(e) No conversion or extension of Loans or Commitments pursuant to any Extension in accordance with this Section 2.22 shall constitute a voluntary or mandatory prepayment or repayment for purposes of this Agreement.
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(f) This Section 2.22 shall supersede any provisions in Section 2.14 or 10.1 to the contrary.
2.23 Swing Line Loans .
(a) Swing Line Loans Commitments . During the Revolving Commitment Period, subject to the terms and conditions hereof, the Swing Line Lender agrees to make Swing Line Loans to the Borrower, in Dollars and Canadian Dollars, in the aggregate amount up to but not exceeding the Swing Line Sublimit; provided that after giving effect to the making of any Swing Line Loan, in no event shall the Total Utilization of Revolving Commitments exceed the Revolving Commitments then in effect. Amounts borrowed pursuant to this Section 2.23 may be repaid and reborrowed during the Revolving Commitment Period. The Swing Line Lenders Commitment to make Swing Line Loans shall expire on the latest Revolving Commitment Termination Date and all Swing Line Loans and all other amounts owed hereunder with respect to the Swing Line Loans shall be paid in full no later than such date. Within the foregoing limits, and subject to the other terms and conditions hereof, the Borrower may borrow under this Section 2.23, prepay under Section 2.12, and reborrow under this Section 2.23.
(b) Borrowing Mechanics for Swing Line Loans .
(i) Swing Line Loans shall be made in an aggregate minimum amount of [REDACTED Dollar Amount] (or Cdn. [REDACTED Dollar Amount] ) and integral multiples of [REDACTED Dollar Amount] (or Cdn. [REDACTED Dollar Amount] ) in excess of that amount.
(ii) To request the making of a Swing Line Loan hereunder, the Borrower shall notify the Swing Line Lender of such request in writing by delivery (which may be by facsimile) of a Funding Notice signed by such Borrower not later than 1:00 p.m. (New York City time) on the date of the proposed Borrowing.
(iii) The Swing Line Lender shall make the amount of its Swing Line Loan available to the Borrower not later than 2:00 p.m. (New York City time) on the date specified in the relevant Funding Notice by wire transfer of same day funds in Dollars or Canadian Dollars to be credited to the account of the Borrower at the principal office designated by the Administrative Agent or such other account as may be designated in writing to the Swing Line Lender by such Borrower.
(iv) With respect to any Swing Line Loans which have not been voluntarily prepaid by the Borrower pursuant to Section 2.12, the Swing Line Lender may at any time in its sole and absolute discretion, deliver to the Administrative Agent (with a copy to the Borrower) at least [REDACTED Time Period] in advance of the proposed Borrowing, a notice (which shall be deemed to be a Funding Notice given by the Borrower) requesting that each Lender holding a Revolving Commitment make Revolving Loans that are Base Rate Loans or Canadian Prime Rate Loans to the Borrower on the date of such Borrowing in an amount equal to the amount of such Swing Line Loans (the Refunded Swing Line Loans ) outstanding on the date such notice is given which the Swing Line Lender requests Lenders to prepay. Anything contained in this Agreement to the contrary notwithstanding, (A) the proceeds of such Revolving
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Loans made by the Lenders other than the Swing Line Lender shall be immediately delivered to the Swing Line Lender (and not to any Borrower) and applied to repay a corresponding portion of the Refunded Swing Line Loans and (B) if the Swing Line Lender is a Revolving Lender, on the day such Revolving Loans are made, the Swing Line Lenders Pro Rata Share of the Refunded Swing Line Loans shall be deemed to be paid with the proceeds of a Revolving Loan made by the Swing Line Lender to the Borrower, and such portion of the Swing Line Loans deemed to be so paid shall no longer be outstanding as Swing Line Loans but shall instead constitute part of the Swing Line Lenders outstanding Revolving Loans to the Borrower. The Borrower hereby authorizes the Swing Line Lender to charge such Borrowers accounts with the Swing Line Lender (up to the amount available in each such account) in order to immediately pay the Swing Line Lender the amount of the Refunded Swing Line Loans to the extent the proceeds of such Revolving Loans made by the Lenders, including the Revolving Loans deemed to be made by the Swing Line Lender, are not sufficient to repay in full the Refunded Swing Line Loans. If any portion of any such amount paid (or deemed to be paid) to the Swing Line Lender should be recovered by or on behalf of any Borrower from the Swing Line Lender in bankruptcy or insolvency, by assignment for the benefit of creditors or otherwise, the loss of the amount so recovered shall be ratably shared among all Lenders.
(v) If for any reason Revolving Loans are not made pursuant to Section 2.23(b)(iv) in an amount sufficient to repay any amounts owed to the Swing Line Lender in respect of any outstanding Swing Line Loans on or before [REDACTED Time Period] after demand for payment thereof by the Swing Line Lender, each Lender holding a Revolving Commitment shall be deemed to, and hereby agrees to, have purchased a participation in such outstanding Swing Line Loans, and in an amount equal to its Pro Rata Share of the applicable unpaid amount together with accrued interest thereon. Upon [REDACTED Time Period] notice from the Swing Line Lender, each Lender holding a Revolving Commitment shall deliver to the Swing Line Lender an amount equal to its respective participation in the applicable unpaid amount in Same Day Funds at the principal office of the Swing Line Lender. In order to evidence such participation each Lender holding a Revolving Commitment agrees to enter into a participation agreement at the request of the Swing Line Lender in form and substance reasonably satisfactory to the Swing Line Lender. In the event any Lender holding a Revolving Commitment fails to make available to the Swing Line Lender the amount of such Lenders participation as provided in this paragraph, the Swing Line Lender shall be entitled to recover such amount on demand from such Lender together with interest thereon at the rate customarily used by the Swing Line Lender for the correction of errors among banks and thereafter at the Base Rate or Canadian Prime Rate, as applicable. A certificate of the Swing Line Lender submitted to any Lender with respect to amounts owing under this Section 2.23(b)(v) shall be conclusive absent manifest error. No funding of risk participations hereunder shall relieve or otherwise impair the obligation of the Borrower to repay Swing Line Loans, together with interest, as provided for in this Agreement.
(vi) Notwithstanding anything contained herein to the contrary, (A) each Lenders obligation to make Revolving Loans for the purpose of repaying any Refunded Swing Line Loans pursuant to Section 2.23(b)(iv) and each Lenders obligation to purchase a participation in any unpaid Swing Line Loans pursuant to Section 2.23(b)(v) shall be absolute and unconditional and shall not be affected by any circumstance, including (1) any set-off, counterclaim, recoupment, defense or other right which such Lender may have against the Swing
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Line Lender, any Credit Party or any other Person for any reason whatsoever; (2) the occurrence or continuation of a Default or Event of Default; (3) any adverse change in the business, operations, properties, assets, condition (financial or otherwise) or prospects of any Credit Party; (4) any breach of this Agreement or any other Credit Document by any party thereto; or (5) any other circumstance, happening or event whatsoever, whether or not similar to any of the foregoing; provided that such obligations of each Lender to make Revolving Loans hereunder (but not to purchase and fund risk participations in Swing Line Loans pursuant Section 2.23(b)(iii) above) are subject to the condition that the Swing Line Lender had not received prior notice from a Borrower or the Required Lenders that any of the conditions under Section 3.2 to the making of the applicable Refunded Swing Line Loans or other unpaid Swing Line Loans, were not satisfied at the time such Refunded Swing Line Loans or unpaid Swing Line Loans were made; and (B) the Swing Line Lender shall not be obligated to make any Swing Line Loans (1) if it has elected not to do so after the occurrence and during the continuation of a Default or Event of Default or (2) at a time when any Lender is a Defaulting Lender unless the participations therein have been reallocated in the manner specified in Section 2.19(a)(iv) above or, if not so reallocated, the Swing Line Lender has entered into arrangements reasonably satisfactory to it and the Borrower to eliminate the Swing Line Lenders risk with respect to the Defaulting Lenders participation in such Swing Line Loan, including by Cash Collateralizing such Defaulting Lenders Pro Rata Share of the outstanding Swing Line Loans.
(c) Resignation and Removal of Swing Line Lender . So long as a replacement Swing Line Lender reasonably acceptable to the Borrower has been identified and has agreed to assume the responsibilities of the Swing Line Lender, the Swing Line Lender may resign as the Swing Line Lender upon [REDACTED Time Period] prior written notice to the Administrative Agent, the Lenders and the Borrower. The Swing Line Lender may be replaced at any time by written agreement among the Borrower, the Administrative Agent, the replaced Swing Line Lender (provided that no consent of the replaced Swing Line Lender will be required if the replaced Swing Line Lender is a Defaulting Lender or has no Swing Line Loans outstanding or such Swing Line Loans will be prepaid on the effective date of such removal) and the successor Swing Line Lender. The Administrative Agent shall notify the Lenders of any such replacement of the Swing Line Lender. At the time any such replacement or resignation shall become effective, the Borrower shall prepay any outstanding Swing Line Loans made by the resigning or removed Swing Line Lender. From and after the effective date of any such replacement or resignation, (x) any successor Swing Line Lender shall have all the rights and obligations of a Swing Line Lender under this Agreement with respect to Swing Line Loans made thereafter and (y) references herein to the term Swing Line Lender shall be deemed to refer to such successor or to any previous Swing Line Lender, or to such successor and all previous Swing Line Lenders, as the context shall require.
(d) If the Maturity Date shall have occurred in respect of any Class of Revolving Commitments at a time when another Class or Classes of Revolving Commitments is or are in effect with a longer Maturity Date, then on the earliest occurring Maturity Date all then outstanding Swing Line Loans shall be repaid in full on such date (and there shall be no adjustment to the participations in such Swing Line Loans as a result of the occurrence of such Maturity Date); provided, however, that if on the occurrence of such earliest Maturity Date (after giving effect to any repayments of Revolving Loans and any reallocation of Letter of Credit participations as contemplated in Section 2.3(c)), there shall exist one or more Classes of
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sufficient unutilized Revolving Commitments so that the respective outstanding Swing Line Loans could be incurred pursuant to such Revolving Commitments which will remain in effect after the occurrence of such Maturity Date, then there shall be an automatic adjustment on such date of the participations in such Swing Line Loans and same shall be deemed to have been incurred solely pursuant to the relevant Revolving Commitments, and such Swing Line Loans shall not be so required to be repaid in full on such earliest Maturity Date.
2.24 Bankers Acceptances and BA Equivalent Notes .
(a) Acceptances and Drafts .
(i) Each Revolving Lender severally agrees, on the terms and conditions of this Agreement and from time to time on any Business Day prior to the applicable Maturity Date (A) in the case of a Revolving Lender which is able to accept Drafts, to create acceptances ( Bankers Acceptances ) by accepting Drafts and to purchase such Bankers Acceptances in accordance with Section 2.24(c)(ii)(A) hereof, and (B) in the case of a Revolving Lender that is unable to accept Drafts (each, a BA Equivalent Lender ), to purchase completed Drafts (which have not and will not be accepted by such Revolving Lender or any other Revolving Lender) in accordance with Section 2.24(c)(ii)(B) hereof.
(ii) If the Administrative Agent determines that the Bankers Acceptances to be created and purchased or Drafts to be purchased on any Drawing (upon a conversion or otherwise) will not be created and purchased ratably by the applicable Revolving Lenders in accordance with clause (a)(i) above, then the requested face amount of Bankers Acceptances and Drafts shall be reduced to such lesser amount as the Administrative Agent determines will permit ratable sharing and the amount by which the requested face amount shall have been so reduced shall be converted or continued, as the case may be, as a Canadian Prime Rate Loan to be made contemporaneously with the Drawing by the applicable Revolving Lenders.
(b) Form of Drafts . Each Draft presented by a Borrower shall (i) be in a minimum amount of Cdn. [REDACTED Dollar Amount] or in an integral multiple of Cdn. [REDACTED Dollar Amount] , (ii) be dated the date of the Drawing, which shall be a Business Day, and (iii) mature and be payable by such Borrower (in common with all other Drafts presented in connection with such Drawing) upon expiration of the applicable BA Period for such Draft, or such other period as agreed upon by such Borrower and the Revolving Lenders, after the Drawing Date and on or prior to the applicable Maturity Date.
(c) Procedures for Drawing .
(i) Each Drawing shall be made on notice (a Drawing Notice ) given by the Borrower to the Administrative Agent not later than 12:00 p.m. (New York City time) at least [REDACTED Time Period] in advance of such proposed Drawing. Each Drawing Notice shall be substantially in the form of
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Exhibit A-1, shall be irrevocable and binding on such Borrower and shall specify (A) the Drawing Date, (B) the aggregate face amount of Drafts to be accepted and purchased (or purchased, as the case may be), and (C) the BA Period for such Drafts. The Administrative Agent shall provide the applicable Revolving Lenders with notice of the calculations for the Drafts for each applicable Revolving Lender on or before 11:00 a.m. (Toronto time) on the Drawing Date.
(ii) Not later than 2:00 p.m. (Toronto time) on an applicable Drawing Date, each applicable Revolving Lender shall complete one or more Drafts in accordance with the Drawing Notice and either (A) accept the Drafts and purchase the Bankers Acceptances so created for the Drawing Price, or (B) in the case of a BA Equivalent Lender, purchase the Drafts for the Drawing Price. In each case, upon receipt of the Drawing Price, the Administrative Agent shall make funds available to the Borrower in accordance with Section 2.2(b)(iv) of this Agreement.
(iii) The Borrower shall, at the request of a Revolving Lender, issue one or more non-interest bearing promissory notes (each, a BA Equivalent Note ) payable on the date of maturity of the unaccepted Draft referred to below, in such form as the applicable Revolving Lender may specify and in a principal amount equal to the face amount of, and in exchange for, any unaccepted Drafts which such Revolving Lender has purchased or has arranged to have purchased in accordance with clause (c)(ii) above.
(iv) Bankers Acceptances purchased by a Revolving Lender may be held by it for its own account until the end of the relevant BA Period or sold by it at any time prior to that date in any relevant Canadian market in such Persons sole discretion.
(d) Presigned Draft Forms/Power of Attorney . To facilitate acceptance of the Borrowings by way of Bankers Acceptances, the Borrower hereby appoints each Revolving Lender as its attorney to sign and endorse on its behalf, in handwriting or by facsimile or mechanical or electronic signature as and when deemed necessary by such Revolving Lender, blank forms of Drafts. In this respect, it is each Revolving Lenders responsibility to maintain an adequate supply of blank forms of Drafts for acceptance under this Agreement. The Borrower recognizes and agrees that all Drafts signed and/or endorsed on its behalf by a Revolving Lender in accordance with each Drawing Notice shall bind the Borrower fully and effectively as if signed in the handwriting of and duly issued by the proper signing officers of the Borrower. Each Revolving Lender is hereby authorized to issue such Drafts endorsed in blank in such face amounts as may be determined by such Revolving Lender; provided, that the aggregate amount thereof is equal to the aggregate amount of Bankers Acceptances required to be accepted and purchased by such Revolving Lender. No Revolving Lender shall be liable for any damage, loss or other claim arising by reason of any loss or improper use of any such instrument, except the bad faith, gross negligence or willful misconduct of such Revolving Lender. Each Revolving Lender shall maintain a record with respect to Bankers Acceptances held by it in blank hereunder, voided by it for any reason, accepted and purchased by it hereunder, and cancelled at
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the respective maturities. Each Revolving Lender agrees to provide such records to the Borrower at such Borrowers expense upon written request.
Drafts drawn by a Borrower to be accepted as Bankers Acceptances shall be signed by a duly authorized officer or officers of such Borrower or by its attorneys. Notwithstanding that any Person whose signature appears on any Bankers Acceptance may no longer be an authorized signatory for the Borrower at the time of issuance of a Bankers Acceptance; that signature shall nevertheless be valid and sufficient for all purposes as if the authority had remained in force at the time of issuance and any Bankers Acceptance so signed shall be binding on the Borrower.
Each Revolving Lender will exercise such care in the custody and safekeeping of Drafts as it would exercise in the custody and safekeeping of similar property owned by it and will, upon request by the Borrower, promptly advise such Borrower of the number and designations, if any, of uncompleted Drafts held by it for such Borrower. The signature of any officer of a Borrower on a Draft may be mechanically or electronically reproduced and BA Instruments bearing a facsimile or electronic signature shall be binding upon such Borrower as if they had been manually signed.
(e) Payment, Conversion or Renewal of BA Instruments.
(i) Upon the maturity of a BA Instrument at the end of its BA Period, the Borrower may (A) elect to issue a replacement BA Instrument by giving a Drawing Notice in accordance with Section 2.24(c)(i) hereof, (B) elect to have all or a portion of the face amount of the BA Instrument converted to a Canadian Prime Rate Loan by providing to the Administrative Agent a Drawing Notice in accordance with Section 2.2, or (C) pay, on or before 10:00 a.m. (Toronto time), an amount in Canadian Dollars equal to the face amount of the BA Instrument (notwithstanding that the Revolving Lender may not be the holder of it at maturity). Any such payment shall satisfy the Borrowers obligations under the BA Instrument to which it relates and the relevant Revolving Lender shall then be solely responsible for the payment of the BA Instrument.
(ii) If the Borrower fails to pay any BA Instrument when due or issue a replacement in the face amount of such BA Instrument pursuant to clause (e)(i) above, the unpaid amount due and payable shall be converted to a Canadian Prime Rate Loan made by the applicable Revolving Lenders ratably and shall bear interest calculated and payable as provided in Section 2.6. This conversion shall occur as of the due date and without any necessity for the Borrower to give a Drawing Notice.
(iii) Upon the maturity of a BA Instrument, if a Default or an Event of Default has occurred and is continuing, the unpaid amount due and payable shall be converted to a Canadian Prime Rate Loan made by the applicable Revolving Lenders ratably and shall bear interest calculated and payable as provided in Section 2.6. Such conversion shall occur as of the due date and without any necessity for the Borrower to give a Drawing Notice.
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(f) Circumstances Making Bankers Acceptances Unavailable .
(i) If, at any time, the Administrative Agent determines (acting reasonably) that there is no market for Bankers Acceptances for the term requested by a Borrower or at all or that the applicable Revolving Lenders cannot for other reasons, after reasonable efforts, readily sell Bankers Acceptances or perform their other obligations under this Agreement with respect to Bankers Acceptances, (A) the right of the Borrower to request a Drawing shall be suspended until the circumstances causing a suspension no longer exist, and (B) any Drawing Notice which is outstanding shall be cancelled and the requested Drawing shall not be made.
(ii) The Administrative Agent shall promptly notify the Borrower in writing of the suspension of the Borrower right to request a Drawing and of the termination of any suspension.
(g) Prepayment/Repayment of Bankers Acceptance Loans.
(i) Notwithstanding anything to the contrary in this Agreement, the Borrower may not prepay a Bankers Acceptance Loan prior to expiration of the BA Period thereof, provided that Bankers Acceptance Loans may be Cash Collateralized on terms and conditions acceptable to the Administrative Agent. Any amount otherwise required by the terms of this Agreement to be applied to the repayment of outstanding Bankers Acceptance Loans shall be paid by the Borrower to the Administrative Agent and held by the Administrative Agent for the account of the applicable Revolving Lenders and applied to the repayment of the applicable Bankers Acceptance Loans at the end of the BA Period applicable thereto.
(ii) Notwithstanding anything to the contrary set forth herein, the Borrower shall not be permitted to request a Bankers Acceptance Loan at any time a Default or Event of Default has occurred and is continuing (and upon such event, any outstanding Bankers Acceptance Loans shall be converted into Canadian Prime Rate Loans at the end of the BA Period applicable thereto).
SECTION 3. | CONDITIONS PRECEDENT |
3.1 Closing Date . The obligation of each Lender or L/C Issuer, as applicable, to make Credit Extensions on the Closing Date shall not become effective until the date on which each of the following conditions is satisfied (or waived), in each case, as determined by each Arranger:
(a) Credit Documents . Subject to the Limited Conditionality Provisions, the Administrative Agent shall have received (i) this Agreement, the Intra-Group Subordination Agreement, the Security Agreements, and each other Collateral Document required to be delivered on or prior to the Closing Date, in each case, duly executed and delivered by an Authorized Officer of each Credit Party that is a party thereto and (ii) for the account of each
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Lender that has requested the same at least [REDACTED Time Period] prior to the Closing Date, a Note executed and delivered by an Authorized Officer of the Borrower.
(b) Funding Notice . Prior to the Closing Date, the Administrative Agent shall have received a Funding Notice meeting the requirements of Section 2.1.
(c) The Acquisition . The following transactions shall be consummated substantially concurrently with the initial Credit Extensions on the Closing Date:
(i) the Acquisition, in all material respects in accordance with the terms of the Acquisition Agreement, but without giving effect to any amendment, waiver or consent by the Borrower that is materially adverse to the interests of the Arrangers and their respective affiliates that are party hereto as Lenders on the Closing Date in their respective capacities as such without the consent of the Arrangers, such consent not to be unreasonably withheld, delayed or conditioned; provided , that (x) any increase in the purchase price shall not be deemed to be materially adverse to the Lenders or the Arrangers if it is solely funded by equity or internally-generated cash of the Borrower, and (y) any decrease in the purchase price of less than [REDACTED Percentage] shall be deemed not materially adverse to the Lenders or the Arrangers provided that such reduction of the purchase price is allocated first, to a reduction in the amounts to be funded under the Senior Notes until the aggregate principal amount thereof is [REDACTED Dollar Amount] and second, to a reduction in the amounts to be funded under the Initial Term Loan Commitment; and provided further that any modification, amendment, consent or waiver in respect of the definition of Material Adverse Effect shall be deemed to be material and adverse to the interests of the Lenders; and
(ii) the issuance and sale of the Senior Notes.
(d) Financial Statements . (i) The Arrangers shall have received (1) IFRS audited consolidated balance sheets and related statements of income and comprehensive income, changes in equity and cash flows of the Borrower for the most recent Fiscal Year ended at least [REDACTED Time Period] prior to the Closing Date, (2) consolidated quarterly balance sheets and related statements of income and comprehensive income, changes in equity and cash flows of the Borrower for each subsequent fiscal quarter (other than the fourth fiscal quarter) ended [REDACTED Time Period] before the Closing Date and (3) a pro forma consolidated balance sheet of the Borrower as of the end of the most recent fiscal quarter ended [REDACTED Time Period] prior to the Closing Date and a pro forma statement of operations of the Borrower (in each case, after giving effect to the Transactions, the other transactions related thereto and such other adjustments as are reflected in the agreed financial model and prepared in accordance with applicable disclosure requirements) for (i) if such balance sheet is as at December 31, 2014 the Fiscal Year to which such pro forma consolidated balance sheet relates, and (ii) if such balance sheet is as at any fiscal quarter ended after December 31, 2014 the pro forma statement of operations of the Borrower referred to in (i) above together with a pro forma statement of operations for the period commencing January 1, 2015 and ending on the date of such balance sheet.
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(ii) In addition, the Arrangers shall have received: (1) audited carve-out financial statements of Sellers related to the Target Assets, prepared in accordance with GAAP, which shall be comprised of (A) a consolidated statement of comprehensive income, a consolidated statement of changes in equity and a consolidated statement of cash flows in respect of the Sellers fiscal years ended December 31, 2014 and December 31, 2013 and (B) a consolidated statement of financial position or balance sheet as at December 31, 2014 and December 31, 2013; and (2) if the Closing Date does not occur before May 15, 2015, unaudited interim carve-out financial statements of Sellers related to the Target Assets, prepared in accordance with GAAP, which shall be comprised of a (A) consolidated statement of comprehensive income, a consolidated statement of changes in equity and a consolidated statement of cash flows for each fiscal quarter following December 31, 2014 ended [REDACTED Time Period] prior to the Closing Date and the comparable fiscal quarter(s) in the preceding fiscal year and (B) consolidated statement of financial position or balance sheet as of the end of the most recent fiscal quarter following December 31, 2014 ended [REDACTED Time Period] prior to the Closing Date and the comparable fiscal quarter in the preceding fiscal year (which shall have been reviewed by the independent auditors for the Sellers as provided in the procedures specified by the American Institute of Certified Public Accountants in AU-C Section 930).
(e) Fees . All accrued and reasonable fees, costs and expenses (including legal fees and expenses and the fees and expenses of any other advisors) and other compensation due and payable to the Administrative Agent, the Arrangers and the Lenders shall have been paid to the extent due and payable and to the extent invoiced at least [REDACTED Time Period] prior to the Closing Date.
(f) Solvency Certificate . The Administrative Agent shall have received the Solvency Certificate duly executed by a Financial Officer of the Borrower.
(g) Closing Deliverables . Subject to the Limited Conditionality Provisions, the Administrative Agent shall have received a certificate of an Authorized Officer of each Credit Party listed on the signature pages hereto dated the Closing Date and certifying:
(i) that attached thereto is a true and complete copy of the Organizational Documents of such Credit Party, (1) in the case of a corporation or limited liability company, certified as of a recent date by the Secretary of State (or other similar official of the applicable Governmental Authority where such certification is available) of the jurisdiction of its organization or (2) otherwise certified by the Secretary or Assistant Secretary or a director of such Credit Party or another Person duly authorized by the constituent documents of such Credit Party, in each case with a certification that such governing document has not been amended since the date of the last amendment disclosed pursuant to this subclause (g)(i);
(ii) that attached thereto is a certificate as to the good standing (or equivalent document to the extent such concept or a similar concept exists under the laws of such jurisdiction) of such Credit Party as of a recent date from the Secretary of State (or other similar official of the jurisdiction of its organization, to the extent readily available in the relevant jurisdiction);
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(iii) that attached thereto is a true and complete copy of resolutions duly adopted by the Board of Directors or (in the case of a unanimous shareholder declaration) the shareholder, of such Credit Party authorizing (A) the Transactions and the execution, delivery and performance of the Credit Documents to which it is a party or any other document delivered in connection herewith and that such resolutions have not been modified, rescinded or amended and are in full force and effect and (B) a named Person or persons to sign such Credit Documents and any documents to be delivered by such Credit Party pursuant thereto; and
(iv) as to the incumbency and specimen signature of each Authorized Officer executing the Credit Documents or any other document delivered in connection herewith on behalf of such Credit Party.
(h) Legal Opinions . The Arrangers shall have received:
(i) a customary legal opinion of Sullivan & Cromwell LLP, New York counsel to the Borrower;
(ii) a customary legal opinion of Fasken Martineau LLP, Canadian counsel to the Borrower;
(iii) a customary legal opinion of Chancery Chambers, Barbados counsel to the Borrower; and
(iv) a customary legal opinion of Lewis, Rice & Fingersh, L.C., Missouri counsel to the Borrower.
(i) Pledged Equity Interests; Pledged Notes . Subject to the Limited Conditionality Provisions and except as otherwise agreed by the Administrative Agent, the Administrative Agent shall have received (i) the certificates representing the Equity Interests pledged pursuant to the Security Agreements (if such Equity Interests are certificated), together with an undated stock power for each such certificate executed in blank by a duly authorized officer of the pledgor thereof and (ii) each promissory note required to be delivered by the Credit Parties pursuant to the Security Agreements endorsed in blank (or accompanied by an executed transfer form in blank) by the pledgor thereof.
(j) Security Interests . The Administrative Agent shall have received the results of a search of the UCC, PPSA (or equivalent, if any) filings made with respect to the Credit Parties in the applicable jurisdictions for each Credit Party (subject to the Limited Conditionality Provisions) and copies of the financing statements (or similar documents, if any) disclosed by such search and evidence reasonably satisfactory to the Administrative Agent that the Liens indicated by such financing statements (or similar documents) are permitted by Section 6.2 or have been or will contemporaneously with the initial funding of the Loans on the Closing Date be released or terminated. Subject to the Limited Conditionality Provisions, each document (including any UCC or PPSA financing statement (or similar documents)) required by the Collateral Documents or reasonably requested by the Administrative Agent (subject to the terms of each Security Agreement) to be filed, registered or recorded in order to create in favor of the Administrative Agent, for the benefit of the Secured Parties, a perfected Lien on the
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Collateral described therein, prior and superior in right to any other Person (other than with respect to Permitted Liens), shall have been filed, registered or recorded or shall have been delivered to the Administrative Agent in proper form for filing, registration or recordation.
(k) Know Your Customer and Other Required Information . The Administrative Agent shall have received, no later than [REDACTED Time Period] prior to the Closing Date, all documentation and other information about the Credit Parties that is required by bank regulatory authorities under applicable know your customer, anti-terrorist financing, government sanction and anti-money laundering rules, guidelines, orders and regulations including the U.S.A. PATRIOT Act and the Proceeds of Crime (Money Laundering) and Terrorist Financing Act (Canada) (collectively, AML Legislation ) to the extent reasonable and customary and requested in writing by the Administrative Agent and the Arrangers [REDACTED Time Period] to the Closing Date.
(l) No Material Adverse Effect . Since March 9, 2015, there shall not have occurred any Material Adverse Effect.
(m) Indebtedness . After giving effect to the Transactions and the other transactions contemplated hereby, the Borrower and the Restricted Subsidiaries shall not have any outstanding Indebtedness for borrowed money other than (i) the Obligations, (ii) the Senior Notes and (iii) other Indebtedness permitted under Section 6.1. Prior to or substantially concurrently with the initial funding of the Loans, the Refinancing shall have occurred and all related guaranties and security interests will be terminated and released.
(n) Officers Certificate as to Certain Representations and Warranties . The Acquisition Agreement Representations and the Specified Representations shall be true and correct in all material respects as of the Closing Date, except in the case of any Acquisition Agreement Representation or Specified Representation which expressly relates to a given date or period, in which case such representation and warranty shall be true and correct in all material respects as of the respective date or respective period, as the case may be ( provided that, to the extent any Specified Representation is qualified by, or subject to, materiality, material adverse effect or similar language, (i) such qualification shall refer to the definition of Material Adverse Effect and (ii) the same shall be true and correct in all respects). The Administrative Agent shall have received a closing certificate, signed by a Responsible Officer of the Borrower, dated the Closing Date, in form and substance reasonably satisfactory to the Administrative Agent.
For purposes of determining whether the conditions specified in this Section 3.1 have been satisfied, by releasing its signature page hereto, the Administrative Agent and each Lender shall be deemed to have consented to, approved or accepted or waived, or to be satisfied with, each document or other matter required hereunder to be consented to or approved by or acceptable or satisfactory to the Administrative Agent or such Lender, as the case may be.
Notwithstanding the foregoing, including the requirements set forth in the definition of Collateral and Guarantee Requirement, to the extent any security interest in the Collateral (other than the creation and perfection of security interests (x) in any Collateral the security interest in which may be perfected by the filing of a UCC, PPSA (or any equivalent in
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thereof in the Province of Quebec and Barbados) financing statement and (y) in capital stock with respect to which a lien may be perfected by the delivery of certificates evidencing Equity Interests (together with undated powers executed in blank) for the Borrower and wholly-owned subsidiaries of the Borrower that are not Immaterial Subsidiaries and that are not direct or indirect subsidiaries of CFCs in relation to the Borrower) is not or cannot be provided or perfected on the Closing Date after Borrowers use of commercially reasonable efforts to do so without undue burden or expense, then the provision of any such lien search and/or the perfection of security interests in such Collateral shall not constitute a condition precedent to the making of any Credit Extension on the Closing Date, but shall be required to be delivered and/or perfected within [REDACTED Time Period] the Closing Date (in each case, subject to extensions to be agreed upon by the Administrative Agent in its reasonable discretion). The provisions in this paragraph are referred to as the Limited Conditionality Provisions .
3.2 Conditions to Any Credit Extension After the Closing Date . Subject to Section 2.20 (with respect to Incremental Loans), the obligation of each Lender to make any Loan or each L/C Issuer to issue any Letter of Credit, on any Credit Date (other than the Closing Date), are subject to the satisfaction (or waiver), of the following conditions precedent:
(a) Administrative Agent shall have received a fully executed and delivered Funding Notice or Letter of Credit Application, as the case may be;
(b) after making the Credit Extensions requested on such Credit Date, the Total Utilization of Revolving Commitments shall not exceed the Revolving Commitments then in effect;
(c) as of such Credit Date, the representations and warranties contained herein and in the other Credit Documents shall be true and correct in all material respects on and as of that Credit Date to the same extent as though made on and as of that date, except to the extent such representations and warranties specifically relate to an earlier date, in which case such representations and warranties shall have been true and correct in all material respects on and as of such earlier date; provided that, in each case, such materiality qualifier shall not be applicable to any representations and warranties that already are qualified or modified by materiality in the text thereof; and
(d) as of such Credit Date, no event shall have occurred and be continuing or would result from the consummation of the applicable Credit Extension that would constitute a Default or an Event of Default.
SECTION 4. | REPRESENTATIONS AND WARRANTIES |
In order to induce Agents, Lenders and L/C Issuers to enter into this Agreement and to make each Credit Extension to be made thereby, the Borrower, with respect to itself and each of its Restricted Subsidiaries, represents and warrants (other than on the Closing Date, with respect to Section 4.6) to each Agent, Lender and L/C Issuer that the following statements are true and correct:
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4.1 Organization; Powers . Each of the Borrower and its Restricted Subsidiaries (a) is a limited liability company, corporation or partnership duly organized and validly existing under the laws of the jurisdiction of its organization, (b) is in good standing (or, if applicable in a foreign jurisdiction, enjoys the equivalent status to the extent such equivalent status exists under the laws of any foreign jurisdiction of organization) under the laws of its jurisdiction of organization and has all requisite power and authority to own its property and assets and to carry on its business as now conducted, (c) is qualified to do business in each jurisdiction where such qualification is required and (d) has the power and authority to execute, deliver and perform its obligations under each of the Credit Documents to which it is a party and, in the case of the Borrower, to borrow and otherwise obtain credit hereunder; except in each case referred to in clauses (b) (other than with respect to the Borrower to the extent existing under the laws of Canada or a province thereof) and (c) where the failure to do so, individually or in the aggregate, would not reasonably be expected to have a Material Adverse Effect.
4.2 Authorization . The execution, delivery and performance by each of the Credit Parties of each of the Credit Documents to which it is a party and the borrowings hereunder (a) have been duly authorized by all corporate, stockholder or limited liability company or partnership or organizational action required to be obtained by such Credit Party and (b) will not (A) violate (i) any provision of applicable law, statute, rule or regulation, (ii) any provision of the certificate or articles of incorporation or other constitutive documents or by-laws of such Credit Party, (iii) any applicable order of any court or any rule, regulation or order of any Governmental Authority that has jurisdiction over such Credit Party or (iv) any provision of any indenture, certificate of designation for preferred stock, agreement or other instrument to which such Credit Party is a party or by which any of them or any of their property is or may be bound or (B) be in conflict with, result in a breach of or constitute a default under, give rise to a right of or result in any cancellation or acceleration of any right or obligation (including any payment) under any such indenture, certificate of designation for preferred stock, agreement or other instrument, where any such conflict, violation, breach or default referred to in clause (b)(A)(i) or (iv) or (b)(B), would reasonably be expected to have, individually or in the aggregate, a Material Adverse Effect.
4.3 Enforceability . The Credit Documents have been duly executed and delivered by each Credit Party that is a party thereto and constitute the legal, valid and binding obligations of such Credit Party and are enforceable against each such Credit Party in accordance with their respective terms, subject to (a) the effects of bankruptcy, insolvency, moratorium, reorganization, fraudulent conveyance or other similar laws affecting creditors rights generally, (b) general principles of equity (regardless of whether such enforceability is considered in a proceeding in equity or at law) and (c) implied covenants of good faith and fair dealing.
4.4 Governmental Approvals; Third-Party Consents . No action, consent or approval of, registration or filing with or any other action by any Governmental Authority or third party is or will be required in connection with the Transactions, the perfection or maintenance of the Liens created under the Collateral Documents (other than Liens with respect to Intellectual Property, the perfection of which is addressed in Section 4.17(c)) or the exercise by any Agent or any Lender of its rights under the Credit Documents or the remedies in respect of the Collateral, except for (a) the filing of UCC and PPSA financing statements (or similar documents), (b) filings with the United States Patent and Trademark Office and the United States
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Copyright Office and Canadian Intellectual Property Office, (c) recordation of any mortgages, (d) such as have been made or obtained and are in full force and effect, (e) such other actions, consents and approvals with respect to which the failure to be obtained or made would not reasonably be expected to have a Material Adverse Effect and (f) filings or other actions listed on Schedule 4.4 .
4.5 Financial Statements . The financial statements referenced in Section 3.1(d)(i), together with the unqualified auditors reports thereon in the case of annual audited financial statements referred to therein, fairly present in all material respects the consolidated financial condition of Borrower as of the date thereof and its financial performance and cash flows for the periods covered thereby in accordance with IFRS, except as otherwise expressly noted therein. The pro forma financial statements referenced in Section 3.1(d)(ii) have been properly computed and presented based on reasonable assumptions and appropriate adjustments to give effect to the Transactions.
4.6 No Material Adverse Effect . Since March 9, 2015, there has been no event, development or circumstance that has had a Material Adverse Effect.
4.7 Title to Properties . Each of the Borrower and the Restricted Subsidiaries has valid fee simple title to, or valid leasehold interests in, or easements or other limited property interests in, all its owned or leased material real properties and has valid title to its personal property and assets, except where the failure to have such title, interests or easements would not reasonably be expected to have, individually or in the aggregate, a Material Adverse Effect. All such properties and assets fee-owned (or in jurisdictions where no fee-owned concept is applicable, owned) by any Credit Party, are free and clear of Liens, other than (i) Liens and encumbrances permitted by Section 6.2, and (ii) licenses, sublicenses, covenants not to sue, releases or other rights under Intellectual Property granted to others in the ordinary course of business or in the reasonable business judgment of the Borrower or any of the Restricted Subsidiaries.
4.8 Equity Interests and Ownership of Subsidiaries .
(a) Schedule 4.8 sets forth as of the Closing Date the name and jurisdiction of incorporation, formation or organization of each subsidiary of the Borrower and, as to each such subsidiary, the percentage of each class of Equity Interests owned by the Borrower or any such subsidiary.
(b) As of the Closing Date, there are no outstanding subscriptions, options, warrants, calls, rights or other agreements or commitments (other than stock options granted to employees or directors and directors qualifying shares) of any nature relating to any Equity Interests of any of its Restricted Subsidiaries.
4.9 Litigation; Compliance with Laws .
(a) As of the Closing Date, except as set forth on Schedule 4.9 , there are no actions, suits or proceedings at law or in equity or, to the knowledge of the Borrower, investigations by or on behalf of any Governmental Authority or in arbitration now pending, or, to the knowledge of the Borrower, threatened in writing against the Borrower or its Restricted
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Subsidiaries: (i) that involve any Credit Document or (ii) as to which an adverse determination is reasonably probable and which, if adversely determined, would reasonably be expected to have, individually or in the aggregate, a Material Adverse Effect.
(b) None of the Borrower or its Restricted Subsidiaries or their respective properties or assets is in violation of (nor will the continued operation of their material properties and assets as currently conducted violate) any law, rule or regulation, or is in default with respect to any judgment, writ, injunction or decree of any Governmental Authority, where such violation or default would reasonably be expected to have, individually or in the aggregate, a Material Adverse Effect.
4.10 Federal Reserve Regulations .
(a) None of the Borrower or any of its Restricted Subsidiaries is engaged principally, or as one of its important activities, in the business of extending credit for the purpose of purchasing or carrying Margin Stock.
(b) No part of the proceeds of any Loan will be used by the Credit Parties, whether directly or indirectly, and whether immediately, incidentally or ultimately, (i) to purchase or carry Margin Stock or to extend credit to others for the purpose of purchasing or carrying Margin Stock or to refund indebtedness originally incurred for such purpose or (ii) for any purpose that entails a violation of, or that is inconsistent with, the provisions of the regulations of the Board of Governors, including Regulation U or Regulation X.
4.11 Investment Company Act . Neither the Borrower nor any of its Restricted Subsidiaries is an investment company as defined in, or subject to regulation under, the Investment Company Act of 1940, as amended.
4.12 Use of Proceeds .
(a) The proceeds of the Revolving Loans will be used (1) on the Closing Date (x) to fund Transactions Costs in an amount not to exceed [REDACTED Dollar Amount] and (y) to fund any original issue discount or upfront fees in connection with the flex provisions in the Fee Letter and (2) after the Closing Date, for working capital and general corporate purposes (including Permitted Acquisitions).
(b) The Borrower shall use the proceeds of the Term Loans made on the Closing Date (x) to pay, directly or indirectly, the consideration for the Acquisition, (y) to finance the Refinancing and (z) to fund the Transaction Costs.
4.13 Tax Returns . Except as would not reasonably be expected to have a Material Adverse Effect, each of the Borrower and its Restricted Subsidiaries (i) has timely filed or caused to be timely filed (after giving effect to all extensions) all Tax returns required to have been filed by it and each such Tax return is true and correct in all material respects and (ii) has timely paid or caused to be timely paid all Taxes shown thereon to be due and payable by it and all other Taxes or assessments, except Taxes or assessments that are being contested in good faith by appropriate proceedings in accordance with Section 5.3 and for which the Borrower or
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its Restricted Subsidiaries (as the case may be) has set aside on its books adequate reserves in accordance with IFRS.
4.14 No Material Misstatements .
(a) All written information (other than the Projections, estimates, forecasts, forward looking information and information of a general economic nature or general industry nature) (the Information ) concerning the Borrower or any of its Restricted Subsidiaries (but as of the Closing Date, only to the knowledge of the Borrower with respect to any Restricted Subsidiary that was not a subsidiary of the Borrower prior to the Closing Date) or the Transactions (but only to the knowledge of the Borrower for all Information as it relates to the Sellers or the Target Assets) and otherwise furnished by or on behalf of the foregoing or their representatives and made available to any Lender or the Administrative Agent in connection with the Transactions for use in evaluating the Transactions or the other transactions contemplated hereby, when taken as a whole, was true and correct in all material respects as of the date such Information was furnished to the Lenders and as of the Closing Date and did not, taken as a whole, contain any untrue statement of a material fact as of any such date or omit to state a material fact necessary in order to make the statements contained therein, taken as a whole, not materially misleading in any material respect in light of the circumstances under which such statements were made (after giving effect to all supplements and updates thereto delivered to the Arrangers prior to such time).
(b) The Projections, estimates, forecasts and forward-looking information (other than information of a general economic nature or general industry nature) furnished by or on behalf of the Borrower or its Restricted Subsidiaries and furnished to the Administrative Agent or Lenders have been prepared in good faith based upon assumptions believed by the Borrower to be reasonable at the time made and at the time such Projections were furnished (it being understood that actual results may vary materially from the Projections) and as of the Closing Date.
4.15 Employee Benefit Plans . (a) (i) The Borrower and each of its subsidiaries are in compliance with all applicable provisions and requirements of all applicable laws, rules and regulations with respect to each Employee Benefit Plan, and have performed all their obligations under each Employee Benefit Plan, (ii) each Employee Benefit Plan which is intended to qualify under Section 401(a) of the Internal Revenue Code has received a favorable determination letter from the Internal Revenue Service indicating that such Employee Benefit Plan is so qualified and, to the knowledge of the Borrower, nothing has occurred subsequent to the issuance of such determination letter which could cause such Employee Benefit Plan to lose its qualified status, (iii) no liability to the PBGC (other than required premium payments), the Internal Revenue Service, any Employee Benefit Plan or any trust established under Title IV of ERISA has been or is expected to be incurred by the Borrower, any of its subsidiaries or any of their ERISA Affiliates, (iv) no ERISA Event has occurred or, to the knowledge of the Borrower, is reasonably expected to occur, (v) the Borrower, each of its subsidiaries and each of their ERISA Affiliates have complied with the requirements of Section 515 of ERISA with respect to each Multiemployer Plan and are not in material default (as defined in Section 4219(c)(5) of ERISA) with respect to payments to a Multiemployer Plan and (vi) all contributions required to
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be made under any Canadian Pension Plan have been timely made; in each case, except as would not reasonably be expected to result, in the aggregate, in a Material Adverse Effect.
(b) As at the Closing Date, none of the Borrower nor any of its subsidiaries sponsors, administers, contributes to, participates in or has any liability in respect of any Canadian Pension Plan.
4.16 Environmental Matters . Except as set forth on Schedule 4.16 , neither the Borrower nor any of its Restricted Subsidiaries is subject to any outstanding written order, consent decree or settlement agreement with any Person relating to any Environmental Law, any Environmental Claim, or any Hazardous Materials Activity that, individually or in the aggregate, would reasonably be expected to have a Material Adverse Effect. To the knowledge of the Borrower and its subsidiaries, neither the Borrower nor any of its subsidiaries has received any letter or request for information under Section 104 of the Comprehensive Environmental Response, Compensation, and Liability Act (42 U.S.C. § 9604) or any comparable state law that, individually or in the aggregate, would reasonably be expected to have a Material Adverse Effect. There are and, to each of the Borrowers and its subsidiaries knowledge, have been, no conditions, occurrences, or Hazardous Materials Activities which could reasonably be expected to form the basis of an Environmental Claim against Borrower or any of its subsidiaries that, individually or in the aggregate, would reasonably be expected to have a Material Adverse Effect. Except as, individually or in the aggregate, would not reasonably be expected to have a Material Adverse Effect, neither the Borrower nor any of its subsidiaries has filed any notice under any Environmental Law indicating past or present treatment of Hazardous Materials at any facility, and none of the Borrowers or any of its Restricted Subsidiaries operations involves the treatment, storage or disposal ( TSD ) of hazardous waste, such as could subject it to regulation as a TSD facility as defined under 40 C.F.R. Parts 260-270 or any state equivalent. Both the Borrower and the Restricted Subsidiaries are, and for the past [REDACTED Time Period] have been, in compliance in all material respects with all Environmental Laws, and future compliance with all requirements pursuant to or under Environmental Laws would not be reasonably expected to have, individually or in the aggregate, a Material Adverse Effect. To the knowledge of the Borrower and each of its subsidiaries, no event or condition has occurred or is occurring with respect to the Borrower or any of its subsidiaries relating to any Environmental Law, any Release of Hazardous Materials, or any Hazardous Materials Activity which individually or in the aggregate has had, or would reasonably be expected to have, a Material Adverse Effect.
4.17 Collateral Documents .
(a) Subject to laws affecting creditors rights generally, each Lien under each Collateral Document (other than the Pledge and Security Agreement and the Canadian Pledge and Security Agreement) creates the Lien which it is expressed to create with the ranking and priority it is expressed to have over the property which it is expressed to apply, subject to the Permitted Liens.
(b) Each of the Pledge and Security Agreement and the Canadian Pledge and Security Agreement is effective to create in favor of the Collateral Agent (for the benefit of the Secured Parties) a legal, valid and enforceable security interest in the Collateral described therein
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and proceeds thereof. In the case of the pledged collateral described in each of the Pledge and Security Agreement and the Canadian Pledge and Security Agreement, when certificates or promissory notes, as applicable, representing such pledged collateral are delivered to the Collateral Agent, and in the case of the other Collateral described in such Security Agreement (other than Intellectual Property), when financing statements and other filings specified in such Security Agreement are filed in the offices specified in the schedules to such Security Agreement, the Collateral Agent (for the benefit of the Secured Parties) shall have a perfected Lien on, and security interest in, all right, title and interest of the Credit Parties in such Collateral (other than Intellectual Property, which is addressed in Section 4.17(c)) and, subject to Section 9-315 of the New York UCC in the case of the Pledge and Security Agreement (or any similar or equivalent legislation as in effect from time to time in the applicable jurisdiction), the proceeds thereof, as security for the Obligations to the extent perfection can be obtained by filing UCC financing statements (or similar documents, if any), in each case prior and superior in right to the Lien of any other Person, except for Permitted Liens, to the extent any such Permitted Lien would have priority over the Liens in favor of the Collateral Agent pursuant to applicable law or any contract).
(c) In the case of Collateral (described in each of the Pledge and Security Agreement and the Canadian Pledge and Security Agreement) that consists of Intellectual Property, when the Pledge and Security Agreement or a short-form version thereof is properly filed in the United States Patent and Trademark Office and the United States Copyright Office, and, with respect to Collateral in which a security interest cannot be perfected by such filings, upon the proper filing of the financing statements referred to in paragraph (b) of this Section 4.17, the Collateral Agent (for the benefit of the Secured Parties) shall have, solely if and to the extent that a Lien on and security interest in such Intellectual Property can be perfected by such filings in such offices, a fully perfected Lien on, and security interest in, all right, title and interest of the Credit Parties thereunder in all such Intellectual Property in the United States, in each case prior and superior in right to the Lien of any other Person (except for Permitted Liens, to the extent any such Permitted Lien would have priority over the Liens in favor of the Collateral Agent pursuant to applicable law or any contract) (it being understood that subsequent recordings in the United States Patent and Trademark Office and the United States Copyright Office may be necessary to perfect a Lien on registered trademarks and patents, trademark and patent applications and registered copyrights and copyright applications applied for, acquired by, or issued to the Grantors (as defined in the Pledge and Security Agreement) after the Closing Date).
Notwithstanding anything in this Agreement (including this Section 4.17) or in any other Credit Document to the contrary, other than to the extent set forth in this Agreement, no Credit Party makes any representation or warranty as to the effects of perfection or non-perfection or as to the rights and remedies of the Agents or any Lender with respect thereto, under foreign law.
4.18 Insurance . Schedule 4.18 sets forth a true, complete and correct description of all material casualty and liability insurance maintained by the Borrower and its subsidiaries as of the Closing Date. The Borrower and its Restricted Subsidiaries (after giving effect to all self-insurance) have insurance in such amounts, with such deductibles and covering such risks as are customarily carried by companies engaged in similar businesses of the same size and character as
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the business of the Borrower or the Restricted Subsidiary, as applicable, and, to the extent relevant, owning similar properties in localities where such Person operates.
4.19 Solvency . On the Closing Date, after giving effect to the consummation of the Transactions, including the making of the Loans hereunder and the issuance and sale of the Senior Notes, and after giving effect to the application of the proceeds of such Indebtedness under such Transactions:
(a) the amount of the fair saleable value of the assets of the Borrower on a going concern basis exceeds the value of all liabilities of the Borrower, including contingent and other liabilities, as generally determined in accordance with applicable United States federal laws governing determinations of the insolvency of debtors;
(b) the amount of the fair saleable value of the assets of the Borrower on a going concern basis exceeds the amount that will be required to pay the probable liabilities of the Borrower on its existing debts (including contingent liabilities) as such debts become absolute and matured;
(c) the Borrower does not have an unreasonably small amount of capital for the operation of the businesses in which it is engaged or proposed to be engaged; and
(d) the Borrower will be able to pay its liabilities, including contingent and other liabilities, as they mature.
For the purposes hereof, the amount of any contingent liability at any time shall be computed as the amount that could reasonably be expected to become an actual and matured liability.
4.20 Acquisition Agreement . As of the Closing Date, the Acquisition Agreement is in full force and effect in accordance with the terms thereof.
4.21 Intellectual Property . Except as set forth on Schedule 4.21 or as would not reasonably be expected to have, individually or in the aggregate, a Material Adverse Effect, (a) to the knowledge of the Borrower, none of the Borrower or its Restricted Subsidiaries, nor the operation of their respective businesses, is infringing, misappropriating or otherwise violating any Intellectual Property of any Person, (b) neither the Borrower nor any of its Restricted Subsidiaries has received any written notice that any claim or litigation regarding any of the foregoing is pending or, to the knowledge of the Borrower, threatened and (c) to the knowledge of the Borrower, no Person has infringed, misappropriated or violated any Intellectual Property owned by the Borrower or any of its Restricted Subsidiaries.
4.22 Anti-Terrorism Laws .
(a) No Credit Party is in material violation of any applicable law relating to Sanctions, terrorism or money laundering ( Anti-Terrorism Laws ), including, without limitation, Executive Order No. 13224 on Terrorist Financing, effective September 24, 2001 (the Executive Order ) , the U.S.A. Patriot Act, the laws and regulations administered by OFAC, the Trading with the Enemy Act (12 U.S.C. §95), the Proceeds of Crime (Money Laundering)
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and Terrorist Financing Act (Canada) and the International Emergency Economic Powers Act (50 U.S.C. §§1701-1707).
(b) Neither any Credit Party, nor any Restricted Subsidiary, nor any of their respective officers or directors nor, to their knowledge, any of their respective employees or agents, is any of the following:
(i) a Prohibited Person or a Person controlled by, or acting for or on behalf of, any Person that is a Prohibited Person;
(ii) a Person who commits, threatens or conspires to commit or supports terrorism as defined in the Executive Order; or
(iii) a Person who is located, incorporated, organized or ordinarily resident in a Sanctioned Jurisdiction.
(c) The use of proceeds of the Loans and the Letters of Credit by the Borrower or any Restricted Subsidiary will not violate any Anti-Terrorism Laws or the FCPA.
4.23 Foreign Corrupt Practices Act . Neither any Credit Party nor any Restricted Subsidiary has paid, offered, promised to pay, or authorized the payment of, directly or indirectly, any money or anything of value to any Foreign Official for the purpose of influencing any act or decision of such Foreign Official or of such Foreign Officials Governmental Authority or to secure any improper advantage, for the purpose of obtaining or retaining business for or with, or directing business to, any Person, in each case in material violation of any applicable law in the jurisdictions in which it operates including but not limited to the Foreign Corrupt Practices Act 1977, as amended (the FCPA ) and the Corruption of Foreign Public Officials Act (Canada).
4.24 Undisclosed Liabilities . The Borrower and the Restricted Subsidiaries have no material obligations or liabilities, matured or unmatured, fixed or contingent, other than (i) those set forth or adequately provided for in the financial statements delivered to the Administrative Agent pursuant to this Agreement, (ii) those incurred in the ordinary course of business and not required to be set forth in the financial statements under IFRS or GAAP, as applicable, (iii) those incurred in the ordinary course of business since the date of the most recently delivered balance sheet, (iv) those incurred in connection with the execution of this Agreement and (v) those that would not reasonably be expected to have, individually or in the aggregate, a Material Adverse Effect.
4.25 Labor Matters . As of the Closing Date, except as would not reasonably be expected to have, individually or in the aggregate, a Material Adverse Effect (a) there are no strikes, lockouts, slowdowns or other labor disputes against any Credit Party, to the knowledge of any Responsible Officer of the Borrower, threatened, (b) the hours worked by and payments made to employees of the Credit Parties and the subsidiaries are not, to the knowledge of any Responsible Officer of the Borrower, in violation of the Fair Labor Standards Act or any other applicable Federal, state, provincial, territorial, local or foreign law dealing with such matters, (c) there is, to the knowledge of any Responsible Officer of the Borrower, no union organization activity and (d) all payments due from any Credit Party or any Subsidiary, on account of wages
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and employee health and welfare insurance and other benefits, have been paid or accrued as a liability on the books of the Credit Party or such Subsidiary to the extent required by IFRS or GAAP, as applicable, and each Credit Party has withheld and remitted all employee withholdings to be withheld or remitted by it and has made all employer contributions to be made by it, in each case pursuant to applicable law on account of employment insurance and employee income taxes and any other required payroll deduction. Except as would not reasonably be expected to have, individually or in the aggregate, a Material Adverse Effect, the consummation of the Transactions will not give rise to a right of termination or right of renegotiation on the part of any union under any collective bargaining agreement to which the Borrower or any of the subsidiaries is a party or by the Borrower or any of the subsidiaries is bound.
SECTION 5. | AFFIRMATIVE COVENANTS |
The Borrower covenants and agrees that, so long as the Revolving Commitments have not been terminated and until the payment in full of the principal of and interest on each Loan, cancellation or expiration (without any pending drawing) of all Letters of Credit, and the payment in full of all fees and all other expenses or amounts payable under any Credit Document (other than amounts in respect of indemnification, expense reimbursement, yield protection or tax gross-up and other contingent obligations with respect to which no claim has been made), the Borrower shall perform, and shall cause its Restricted Subsidiaries to perform all covenants in this Section 5.
5.1 Existence; Material Properties .
(a) Do or cause to be done all things necessary to preserve, renew and keep in full force and effect its legal existence, except as otherwise expressly permitted under this Agreement, and maintain all rights and franchises, licenses and permits material to the conduct of its business, in each case, except where the failure to so maintain would not reasonably be expected to result in a Material Adverse Effect.
(b) Do or cause to be done all things necessary to at all times maintain and preserve all material property necessary to the normal conduct of its business and keep such property in good repair, working order and condition (with ordinary wear and tear and any casualty or condemnation excepted), except where the failure to do so would not reasonably be expected, individually or in the aggregate, to have a Material Adverse Effect.
5.2 Insurance . Maintain casualty and liability insurance in such amounts and against such risks as are customarily maintained by similarly situated companies engaged in the same or similar businesses operating in the same or similar locations (after giving effect to any self-insurance) and, with respect to the Collateral, use commercially reasonable efforts to cause any material (i) property and property casualty insurance policies to be endorsed or otherwise amended to include a standard or New York lenders loss payable endorsement (or comparable provisions applicable in the relevant foreign jurisdiction) and (ii) liability policy to identify the Administrative Agent (on behalf of itself and the Secured Parties) as additional insured thereunder as its interest may appear, in each case in form and substance reasonably
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satisfactory to the Administrative Agent. Without limiting the generality of the foregoing, the Borrower will maintain or cause to be maintained flood insurance with respect to each Flood Hazard Property that is subject to a mortgage that is located in a community that participates in the National Flood Insurance Program, in each case in compliance with any applicable regulations of the Board of Directors.
5.3 Payment of Obligations . Pay and discharge promptly when due all obligations and liabilities (including, without limitation, Taxes imposed upon it or upon its income or profits or in respect of its property), before the same shall become delinquent or in default, as well as all lawful claims that, if unpaid, might give rise to a Lien upon such properties or any part thereof; provided , however , that such payment and discharge shall not be required (a) with respect to any such Tax so long as the validity or amount thereof shall be contested in good faith by appropriate proceedings and Borrower or the affected Restricted Subsidiary, as applicable, shall have set aside on its books adequate reserves to the extent required in accordance with IFRS with respect thereto, or (b) except to the extent failure to do so would reasonably be expected to, individually or in the aggregate, have a Material Adverse Effect. Timely file or cause to be timely filed (after giving effect to all extensions) all Tax returns required to be filed by it, except to the extent failure to do so would not reasonably be expected to, individually or in the aggregate, have a Material Adverse Effect.
5.4 Financial Statements, Reports, Etc. Furnish to the Administrative Agent, who shall furnish to each Lender (including each Public Lender):
(a) (i) [REDACTED Time Period] the end of each Fiscal Year, (i) a consolidated balance sheet and related statements of income and comprehensive income, changes in equity and cash flows showing the financial position of the Borrower and its subsidiaries as of the close of such Fiscal Year and their consolidated financial performance and cash flows for such year and setting forth in comparative form the corresponding figures for the prior Fiscal Year and (ii) a Narrative Report for such Fiscal Year, which consolidated balance sheet and related statements of income and comprehensive income, changes in equity and cash flows shall be audited by chartered professional accountants of recognized national standing in Canada (or equivalent) and accompanied by an opinion of such accountants (which opinion shall not be qualified as to scope of audit or as to the status of the Borrower or any Material Subsidiary as a going concern (other than, in the case of going concern, an explanatory note with respect to an upcoming maturity of any series of indebtedness, Loans or Commitments) to the effect that such consolidated financial statements present fairly, in all material respects, the financial position and financial performance and cash flows of the Borrower and its subsidiaries on a consolidated basis in accordance with IFRS (it being understood that the delivery by the Borrower of an Annual Report on Form 10-K, or the equivalent filed with the Canadian Securities Administrators and the Canadian Securities Administrators System for Electronic Document Analysis and Retrieval ( SEDAR ) website shall satisfy the requirements of this Section 5.4(a) to the extent such Annual Report includes the information specified herein);
(b) [REDACTED Time Period] the end of each of the first three Fiscal Quarters of each Fiscal Year, commencing with the Fiscal Quarter ending June 30, 2015, (i) a consolidated balance sheet and related statements of income and comprehensive income, changes in equity and cash flows showing the financial position of the Borrower and its subsidiaries as of
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the close of such Fiscal Quarter and the consolidated financial performance and cash flows for such Fiscal Quarter and the then-elapsed portion of the Fiscal Year and setting forth in comparative form the corresponding figures for the corresponding periods of the prior Fiscal Year and (ii) a Narrative Report for such Fiscal Quarter, all of which shall be in reasonable detail and which consolidated balance sheet and related statements of income and comprehensive income, changes in equity and cash flows shall be certified by a Financial Officer of the Borrower on behalf of the Borrower as fairly presenting, in all material respects, the financial performance and cash flows of the Borrower and its subsidiaries on a consolidated basis in accordance with IFRS (subject to normal year-end audit adjustments and the absence of footnotes) (it being understood that the delivery by the Borrower of a Quarterly Report on Form 10-Q or the equivalent filed with the SEDAR website shall satisfy the requirements of this Section 5.4(b) to the extent such quarterly reports include the information specified herein);
(c) [REDACTED Time Period] of any delivery of financial statements under paragraph (a) or (b) of this Section 5.4, a Compliance Certificate of a Financial Officer of the Borrower (i) certifying that no Event of Default or Default has occurred that is then continuing, except as set forth therein, (ii) setting forth the calculation of the Senior Secured Net Leverage Ratio (calculated on a Pro Forma Basis) for the [REDACTED Time Period] period ending at the end of such fiscal period and (iii) in connection with the financial statements delivered under Section 5.4(a), a certificate setting forth the calculation of Excess Cash Flow for the applicable Excess Cash Flow Period;
(d) [REDACTED Time Period] the beginning of each Fiscal Year, a consolidated annual budget for such Fiscal Year, including a description of underlying assumptions with respect thereto, which budget shall in each case be accompanied by the statement of a Financial Officer of the Borrower to the effect that such budget is based on assumptions believed by such Financial Officer to be reasonable as of the date of delivery thereof;
(e) promptly, from time to time, such other customary information (which is readily available) regarding the operations, business affairs and financial condition of the Credit Parties and their Restricted Subsidiaries and their compliance with the terms of any Credit Document, in each case, as the Administrative Agent may reasonably request (for itself or on behalf of any Lender); and
(f) promptly upon becoming aware of the occurrence of any ERISA Event, a written notice specifying the nature thereof, what action Borrower, any of its subsidiaries or any of their respective ERISA Affiliates has taken, is taking or proposes to take with respect thereto and, when known, any action taken or threatened in writing by the Internal Revenue Service, the Department of Labor, the PBGC or the applicable pension regulator in Canada with respect thereto.
5.5 Litigation and Other Notices . Furnish to the Administrative Agent written notice (promptly after any Authorized Officer of the Borrower obtains actual knowledge thereof) of the following and which notice the Administrative Agent shall furnish to the Lenders:
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(a) any Default, specifying the nature and extent thereof and the corrective action (if any) proposed to be taken with respect thereto; and
(b) the filing or commencement of, or any written threat or written notice of intention of any Person to file or commence, any action, suit or proceeding, whether at law or in equity or by or before any Governmental Authority or in arbitration, against Borrower or any other Credit Party as to which an adverse determination is reasonably probable and that, if adversely determined, would reasonably be expected to have a Material Adverse Effect.
5.6 Compliance with Laws . Comply with all laws, rules, regulations and orders of any Governmental Authority applicable to it or its property (including, without limitation, ERISA, the FCPA and Anti-Terrorism Laws), except (other than in the case of Sanctions and Anti-Terrorism Laws) where the failure to do so would not reasonably be expected to result in a Material Adverse Effect; provided that this Section 5.6 shall not apply to Environmental Laws, which are the subject of Section 5.10, or to laws related to Taxes, which are the subject of Section 5.3.
5.7 Maintaining Records; Access to Properties and Inspections . Maintain adequate books of record and account in which full, true and correct entries in conformity in all material respects, with IFRS or GAAP, as applicable, shall be made of all dealings and transactions in relation to its business and activities and, upon at least [REDACTED Time Period] notice (or, if an Event of Default has occurred and is continuing, [REDACTED Time Period] notice), permit the Administrative Agent to visit and inspect the financial records and the properties of the Borrower and its Restricted Subsidiaries at reasonable times to be agreed during normal business hours, up to [REDACTED Time Period] (or, if an Event of Default shall have occurred and be continuing, such visit and inspection may occur from time to time), subject to (i) reasonable requirements of confidentiality, including requirements imposed by law or by contract and (ii) the rights of tenants (to the extent the tenants are not the Borrower or any of its subsidiaries), if applicable. The Borrower shall reimburse the Administrative Agent for its actual out-of-pocket costs incurred in connection with such visits or inspections following the occurrence and during the continuance of an Event of Default.
5.8 Lender Calls . Following receipt by the Borrower of a written request by the Administrative Agent (which request may only be given by the Administrative Agent to the Borrower [REDACTED Time Period] following delivery of the annual financial statements pursuant to Section 5.4(a) or any quarterly financial statement pursuant to Section 5.4(b)), the Borrower shall hold an update call (which call shall take place [REDACTED Time Period] following the receipt of such notice, as selected by the Borrower or on such other date as may be agreed with the Administrative Agent) with a Financial Officer of the Borrower and the Lenders to discuss the financial position, financial performance and cash flows of the Borrower and its Restricted Subsidiaries for the period covered by the applicable financial statements; provided , however, if the Borrower is holding a conference call open to the public to discuss such results, the Borrower will not be required to hold a separate call for the Lenders; provided , further , however , that the Borrower shall provide a supplemental call to the Lenders for the purpose of discussing any material non-public information not otherwise addressed during any such public call.
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5.9 Use of Proceeds . (a) Use the proceeds of the Loans in the manner set forth in Section 4.12;
(b) Ensure that no Credit Party will use the proceeds of the Loans or the Letters of Credit in violation of any Anti-Terrorism Law or the FCPA; and
(c) No part of the proceeds of any Loan will be used, whether directly or indirectly, for any purpose that would entail a violation of Regulation T, Regulation U or Regulation X.
5.10 Compliance with Environmental Laws . Comply with all Environmental Laws applicable to its operations and properties; and comply with and obtain and renew all material permits, licenses and other approvals required pursuant to Environmental Law for its operations and properties, except, in each case with respect to this Section 5.10, to the extent the failure to do so would not reasonably be expected to have, individually or in the aggregate, a Material Adverse Effect.
5.11 Further Assurances; Additional Security .
(a) (i) As promptly as practicable, and in any event within the time periods after the Closing Date specified in Schedule 5.11 (or such later date as the Administrative Agent reasonably agrees to in writing), the Borrower shall deliver, or cause to be delivered, the documents or take the actions specified on Schedule 5.11 and (ii) after the Closing Date, the Borrower or any other Credit Party shall execute any and all further documents, financing statements, agreements and instruments, and take all such further actions (including the filing and recording of financing statements and other documents and recordings of Liens in stock registries), that may be required under any applicable law, or that the Administrative Agent may reasonably request, to satisfy the Collateral and Guarantee Requirement and to cause the Collateral and Guarantee Requirement to be and remain satisfied, all at the expense of the Borrower, and provide to the Administrative Agent, from time to time upon reasonable request, evidence reasonably satisfactory to the Administrative Agent as to the perfection and priority of the Liens created or intended to be created by the Collateral Documents.
(b) If the Borrower or any Credit Party directly or indirectly acquires fee-owned real property after the Closing Date (with any fee-owned real property of (x) any Restricted Subsidiary that is acquired after the Closing Date and becomes a Credit Party, (y) any subsidiary that is designated a Restricted Subsidiary pursuant to a Subsidiary Redesignation and becomes a Credit Party and (z) any Immaterial Subsidiary that is designated a Material Subsidiary and becomes a Credit Party being deemed to have been acquired after the Closing Date) that has a fair market value of [REDACTED Dollar Amount] or more on an individual basis at the time of acquisition of fee ownership of such real property (i) notify the Administrative Agent and provide the Administrative Agent with a complete description of such property (including its legal description) reasonably promptly following the acquisition thereof, (ii) cause each such fee-owned real property to be subject to a registered mortgage or deed of trust securing the Obligations, in form and substance reasonably acceptable to the Administrative Agent [REDACTED Time Period] of the date of such acquisition (or such longer period as may be agreed by the Administrative Agent), (iii) obtain fully paid American Land
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Title Association Lenders Extended Coverage title insurance policies (or local equivalent lenders title insurance policies for real property outside of the United States) in form and substance, with endorsements (including zoning endorsements where available) and in amounts reasonably acceptable to the Administrative Agent (the Mortgage Policies ), (iv) to the extent reasonably requested by the Administrative Agent, obtain American Land Title Association/American Congress on Surveying and Mapping form surveys (or local equivalent), dated no more than [REDACTED Time Period] the date of their delivery to the Administrative Agent, certified to the Administrative Agent and the issuer of the Mortgage Policies in a manner reasonably satisfactory to the Administrative Agent, (v) obtain (A) customary, favorable opinions of local counsel or title insurance to the applicable Credit Parties (x) with respect to the enforceability and perfection of any such mortgage or deed of trust in the states or provinces in which such fee-owned real properties are located and (y) with respect to the valid existence, corporate power and authority of the applicable Credit Parties in the granting of such mortgage or deed of trust in the states, provinces or federal jurisdictions in which the Credit Parties party to such mortgages or deeds of trust are organized or formed or (B) title insurance, as applicable, (vi) if any such fee-owned real property is located within a special flood hazard area as determined by the Federal Emergency Management Agency, provide to the Administrative Agent (A) written acknowledgment by the applicable Credit Party of receipt of written notification from the Administrative Agent that such property is in a special flood hazard area and whether such property is participating in the National Flood Insurance Program and (B) evidence of such flood insurance as may be required under applicable law and otherwise consistent with the requirements of Section 5.2 and naming the Administrative Agent as sole loss payee on behalf of the Secured Parties or evidence of such other insurance required by the Administrative Agent, acting reasonably, in any other jurisdiction where a Credit Party acquires fee-owned real property subject to this provision and (vii) take, and cause the applicable Credit Party to take, such actions as shall be necessary or reasonably requested by the Administrative Agent to perfect such Liens, including actions described in paragraph (a) of this Section 5.11, in each case, at the expense of the Credit Parties, subject to paragraph (e) of this Section 5.11.
(c) If any additional subsidiary of the Borrower (other than an Excluded Subsidiary) is formed or acquired after the Closing Date, within [REDACTED Time Period] after the date such subsidiary is formed or acquired (or such longer period as may be agreed by the Administrative Agent), notify the Administrative Agent and the Lenders thereof and, [REDACTED Time Period] after the date such subsidiary is formed or acquired (or such longer period as the Administrative Agent shall agree), cause the Collateral and Guarantee Requirement to be satisfied with respect to such subsidiary and with respect to any Equity Interest in or Indebtedness of such subsidiary owned by or on behalf of the Borrower or any other Credit Party, subject to paragraph (e) of this Section 5.11.
(d) (i) In each case other than in connection with the Acquisition, furnish to the Administrative Agent within [REDACTED Time Period] thereafter written notice of any change in (A) corporate or organization name, (B) organizational structure or (C) organizational identification number (or equivalent) with respect to the Borrower and the other Credit Parties; provided that the Borrower shall not effect or permit any such change unless all filings have been made, or will have been made within any statutory period, under the UCC or otherwise that are required in order for the Administrative Agent to continue at all times following such change to have a valid, legal and perfected security interest in all Collateral (to the extent otherwise
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required hereunder) for the benefit of the applicable Secured Parties and (ii) promptly notify the Administrative Agent if any material portion of the Collateral is damaged or destroyed.
(e) The Collateral and Guarantee Requirement and the other provisions of this Section 5.11 need not be satisfied with respect to any Excluded Property or any exclusions and carve-outs from the perfection requirements set forth in the applicable Security Agreement.
(f) With respect to real property, no perfection steps shall be required by any means other than (1) solely with respect to any properties subject to any mortgages on fee-owned real property not excluded from the Collateral pursuant to this Agreement ( Required Mortgages ), fixture filings pursuant to the UCC in the applicable UCC filing office of the relevant jurisdiction in which such fee-owned real property is located and (2) the recording of Required Mortgages in the applicable county offices referred to in the foregoing clause (1).
Notwithstanding anything to the contrary in this Agreement, the Pledge and Security Agreement or any other Credit Document, (x) the Administrative Agent may grant extensions of time for, or waive the requirements to obtain, the creation or perfection of security interests in, or the obtaining of title insurance and surveys with respect to, particular assets (including extensions beyond the Closing Date for the perfection of security interests in the assets of the Credit Parties on such date) where it determines, in consultation with the Borrower, that the cost, burden or consequences (including adverse Tax consequences) of obtaining or perfecting a security interest in such assets is excessive in relation to the practical benefit afforded thereby; and (y) Liens required to be granted from time to time pursuant to the Collateral Documents shall be subject to exceptions and limitations set forth in the Collateral Documents and, to the extent appropriate in the applicable jurisdictions, as otherwise agreed between the Administrative Agent and the Borrower.
5.12 Maintenance of Ratings . Use commercially reasonable efforts to maintain at all times a credit rating by each of S&P and Moodys in respect of the Initial Term Loans and a corporate rating by S&P and a corporate family rating by Moodys for the Borrower, in each case, with no requirement to maintain any specific minimum rating.
SECTION 6. | NEGATIVE COVENANTS |
The Borrower covenants and agrees that, as long as the Revolving Commitments have not been terminated and until the payment in full of the principal of and interest on each Loan, the cancellation or expiration (without any pending drawing) of all Letters of Credit, and the payment in full of all fees and all other expenses or amounts payable under any Credit Document (other than amounts in respect of indemnification, expense reimbursement, yield protection or tax gross-up and other contingent obligations with respect to which no claim has been made), the Borrower shall perform, and shall cause each of its Restricted Subsidiaries to perform, all covenants in this Section 6.
None of the Borrower or any Restricted Subsidiary shall:
6.1 Indebtedness . Incur, create, assume, guarantee or permit to exist any Indebtedness, except:
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(a) Indebtedness existing on the Closing Date either (i) set forth on Schedule 6.1(a) or (ii) individually with a principal amount of less than [REDACTED Dollar Amount] , and, in each case, any Refinancing Indebtedness incurred to Refinance any such Indebtedness;
(b) Indebtedness created hereunder or under the other Credit Documents, Refinancing Loans, Refinancing Equivalent Debt, Incremental Loans, Incremental Equivalent Debt and any Refinancing Indebtedness incurred to Refinance any of the foregoing Indebtedness;
(c) (i) other Indebtedness of the Borrower or any Restricted Subsidiary secured on a pari passu or junior Lien basis with respect to the Liens securing the Obligations or on an unsecured basis; provided , that (A) in the case of Indebtedness secured on a pari passu or junior Lien basis, the Senior Secured Net Leverage Ratio (calculated on a Pro Forma Basis) as of the end of the most recent Test Period is not greater than 3.00:1.00 and (B) in the case of unsecured Indebtedness, the Total Net Leverage Ratio (calculated on a Pro Forma Basis) as of the end of the most recent Test Period is not greater than 5.50:1.00; provided further that, in the case of any Indebtedness incurred under this clause (c), (1) such Indebtedness shall not mature prior to the date that is [REDACTED Time Period] after the Maturity Date of the Term Loans or have a Weighted Average Life to Maturity less than the Weighted Average Life to Maturity of the Term Loans plus [REDACTED Time Period] , (2) such Indebtedness shall not have mandatory prepayment, redemption or offer to purchase events more onerous than those set forth in this Agreement except to the extent applying to periods solely after the Latest Maturity Date of Loans outstanding hereunder, (3) the other terms and conditions of such Indebtedness (excluding pricing and optional prepayment or redemption terms) reflect market terms and conditions at the time of incurrence or issuance of such Indebtedness, (4) if any such Indebtedness contains any financial maintenance covenants, such financial maintenance covenants shall not be tighter than (or in addition to) those contained in this Agreement unless such financial maintenance covenants are added to this Agreement for the benefit of the Lenders hereunder and (5) if any such Indebtedness is secured on a pari passu basis with respect to the Liens securing the Obligations, then such Indebtedness shall be in the form of notes or other debt securities in each case and (ii) any Refinancing Indebtedness incurred in respect thereof;
(d) the Senior Notes and any Refinancing Indebtedness incurred in respect thereof;
(e) Indebtedness pursuant to Hedge Agreements not entered into for speculative purposes;
(f) Indebtedness owed to (including obligations in respect of letters of credit or bank guarantees or similar instruments for the benefit of) any Person providing workers compensation, health, disability or other employee benefits or property, casualty or liability insurance pursuant to reimbursement or indemnification obligations to such Person, in each case, in the ordinary course of business; provided that, upon the incurrence of Indebtedness with respect to reimbursement obligations regarding workers compensation claims, such obligations are reimbursed not later than [REDACTED Time Period] following such incurrence;
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(g) Indebtedness of the Borrower to any Restricted Subsidiary and of any Restricted Subsidiary to the Borrower or any other Restricted Subsidiary; provided that (i) any Indebtedness (including intercompany loans and other Investments constituting Indebtedness) owing by a Credit Party to a Restricted Subsidiary that is not a Credit Party and will not become a Credit Party in connection with the incurrence of such Indebtedness (or related Investment) shall be subordinated to the Obligations on terms reasonably satisfactory to the Administrative Agent and (ii) the aggregate principal amount of such Indebtedness incurred pursuant to this subclause (g) by a Restricted Subsidiary that is not a Credit Party owing to a Credit Party and Investments by Credit Parties in Restricted Subsidiaries that are not Credit Parties and will not become a Credit Party in connection with the incurrence of such Investment pursuant to Section 6.3(l), shall not exceed in the aggregate the greater of (x) [REDACTED Dollar Amount] and (y) [REDACTED Percentage] of Consolidated Total Assets;
(h) Indebtedness in respect of performance bonds, bid bonds, appeal bonds, surety bonds and completion guarantees and similar obligations, including (i) those incurred to secure health, safety and environmental obligations and (ii) performance guarantees of suppliers, customers, franchisees and licensees of the Borrower and its Restricted Subsidiaries;
(i) Indebtedness arising from the honoring by a bank or other financial institution of a check, draft or similar instrument drawn against insufficient funds in the ordinary course of business or other cash management treasury services in the ordinary course of business;
(j) Indebtedness of the Borrower and the Restricted Subsidiaries assumed in connection with Permitted Acquisitions at any time outstanding so long as (i) such Indebtedness is not incurred to finance or in contemplation of any such acquisition, (ii) after giving effect to the assumption of such Indebtedness and such Permitted Acquisition on a Pro Forma Basis as of the last day of the most recent Fiscal Quarter of the Borrower for which financial statements have been made available (or were required to be made available) pursuant to Section 5.4(a) or (b), the Total Net Leverage Ratio (calculated on a Pro Forma Basis) (x) does not exceed 5.50:1.00 or (y) would be equal to or less than immediately prior to such assumption of Indebtedness and such Permitted Acquisition, and (iii) before and after giving effect thereto, no Default or Event of Default shall have occurred and be continuing;
(k) Capital Lease Obligations and other Indebtedness incurred to finance the acquisition, installations, repairs, improvement and removal of fixed or capital assets in an aggregate outstanding principal amount not to exceed, at the time of incurrence of such Indebtedness (and after giving effect thereto), the greater of (i) [REDACTED Dollar Amount] and (ii) [REDACTED Percentage] of Consolidated Total Assets;
(l) guarantees (i) by the Borrower or any Credit Party of any Indebtedness of the Borrower or any Credit Party permitted to be incurred under this Agreement, (ii) by the Borrower or any Credit Party of Indebtedness otherwise permitted hereunder of any Restricted Subsidiary that is not a Credit Party to the extent such guarantees are permitted by Section 6.3 and (iii) by any Restricted Subsidiary of the Borrower that is not a Credit Party of Indebtedness of another Restricted Subsidiary of the Borrower that is not a Credit Party permitted to be incurred under this Agreement; provided that guarantees by the Borrower or any Credit Party
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under this Section 6.1(l) of any other Indebtedness of a Person that is subordinated to other Indebtedness of such Person shall be expressly subordinated to the Obligations on terms not less favorable to the Lenders than the subordination terms applicable to such other Indebtedness;
(m) Indebtedness arising from agreements of the Borrower or any Restricted Subsidiary providing for indemnification, adjustment of purchase price or similar obligations (including contingent earn-out obligations), in each case, incurred or assumed in connection, and substantially simultaneously with, or prior to and for the purpose of consummating, any Permitted Acquisition or other Investment or the disposition of any business, assets or a subsidiary not prohibited by this Agreement, other than guarantees of Indebtedness for borrowed money incurred for the purpose of financing such Permitted Acquisition or other Investment or the acquisition of such business, assets or subsidiary;
(n) Indebtedness arising pursuant to appeal bonds or similar instruments required in connection with judgments that do not result in a Default or Event of Default;
(o) Indebtedness consisting of (x) the financing of insurance premiums or (y) take-or-pay obligations contained in supply arrangements, in each case, in the ordinary course of business;
(p) all premium (if any), interest (including post-petition interest), fees, expenses, charges and additional or contingent interest on obligations described in subclauses (a) through (o) above and subclauses (q) through (z) below;
(q) Indebtedness of the Borrower and the Restricted Subsidiaries incurred under overdraft facilities (including, but not limited to, intraday, automated clearing house and purchasing card services) extended by one or more financial institutions and established for the Borrowers and the Restricted Subsidiaries ordinary course of operations;
(r) Indebtedness in respect of letters of credit, bank guarantees, warehouse receipts or similar instruments issued to support performance obligations and trade letters of credit (other than obligations in respect of other Indebtedness) in each case, incurred in the ordinary course of business;
(s) unsecured Indebtedness in respect of obligations to pay the deferred purchase price of goods or services or progress payments in connection with such goods and services incurred in the ordinary course of business and not in connection with the borrowing of money or any Hedge Agreements;
(t) Indebtedness representing deferred compensation to employees, directors or consultants incurred in the ordinary course of business;
(u) Indebtedness consisting of promissory notes issued to current or former officers, directors and employees, or their respective estates or family members, in each case, to finance the purchase or redemption of Equity Interests of the Borrower permitted by Section 6.3;
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(v) Indebtedness consisting of obligations under deferred compensation or other similar arrangements incurred by such Person in connection with Permitted Acquisitions or any other Investment permitted hereunder;
(w) guarantees of any lease permitted hereunder of real property entered into by the Borrower or any Restricted Subsidiary;
(x) Indebtedness in an aggregate amount equal to [REDACTED Percentage] of the net cash proceeds received by the Borrower from the issuance or sale of its Equity Interests (other than Disqualified Stock) after the Closing Date excluding (x) any Equity Interests issued or capital contribution made on or prior to the Closing Date and (y) the proceeds of a Specified Equity Contribution; provided that, the amount of such proceeds or capital contribution shall not count toward Cumulative Credit;
(y) [Reserved]; and
(z) other Indebtedness in an aggregate principal amount outstanding not to exceed the greater of (x) [REDACTED Dollar Amount] and (y) [REDACTED Percentage] of Consolidated Total Assets.
For purposes of determining compliance with this Section 6.1, (A) Indebtedness need not be permitted solely by reference to one category of permitted Indebtedness described in Section 6.1(a) and (d) through (z) but may be permitted in part under any combination thereof and (B) in the event that an item of Indebtedness (or any portion thereof) meets the criteria of one or more of the categories of permitted Indebtedness described in Sections 6.1(a) and (d) through (z), the Borrower shall, in its sole discretion, classify or reclassify, or later divide, classify or reclassify, such item of Indebtedness (or any portion thereof) in any manner that complies with this Section 6.1 and will only be required to include the amount and type of such item of Indebtedness (or any portion thereof) in one of the above clauses and such item of Indebtedness shall be treated as having been incurred or existing pursuant to only one of such clauses; provided , however , that no such reclassification or division shall be permitted with respect to any Indebtedness incurred pursuant to Section 6.1(b) or (c). In addition, with respect to any Indebtedness that was permitted to be incurred hereunder on the date of such incurrence, any Increased Amount of such Indebtedness shall also be permitted hereunder after the date of such incurrence.
6.2 Liens . Create, incur, assume or permit to exist any Lien on any property or assets (including stock or other securities of any Person, including any subsidiary) at the time owned by it or on any income or revenues or rights in respect of any thereof, except:
(a) (i) Liens described in Schedule 6.2(a) and any modifications, replacements, renewals or extensions thereof and (ii) Liens existing on the Closing Date securing property or assets having a fair market value not to exceed [REDACTED Dollar Amount] individually, and [REDACTED Dollar Amount] in the aggregate and, in each case, any modifications, replacements, renewals or extensions thereof;
(b) any Lien created under the Credit Documents (including, without limitation, Liens created under the Collateral Documents securing obligations in respect of
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Hedge Agreements to the extent such obligations constitute Obligations secured pursuant to the Collateral Documents), any Lien created under the definitive documentation evidencing any other Indebtedness permitted under Section 6.1(b), and any Lien securing Refinancing Loans, Refinancing Equivalent Debt, Incremental Loans, Incremental Equivalent Debt and any Refinancing Indebtedness incurred to Refinance any of the foregoing Indebtedness;
(c) any Lien securing Indebtedness permitted by Section 6.1(q) or Refinancing Indebtedness in respect thereof;
(d) Liens securing pari passu or junior Lien Indebtedness permitted pursuant to Section 6.1(c); provided that (i) in the case of junior Lien Indebtedness, such Liens rank junior to the Liens on the Collateral securing the Obligations (but may not be secured by any assets that are not Collateral) and (ii) in each case, the beneficiaries thereof (or an agent on their behalf), shall have entered into an Intercreditor Agreement or other intercreditor arrangements reasonably acceptable to the Administrative Agent;
(e) Indebtedness permitted by Section 6.1(j) may be secured by Liens on the newly acquired assets or assets of the newly acquired Subsidiary; provided that such Indebtedness was not created in contemplation of the acquisition of such assets or subsidiary by the Borrower or any Restricted Subsidiary;
(f) Liens for Taxes, assessments or other governmental charges or levies not yet delinquent or that are being contested in compliance with Section 5.3;
(g) Liens imposed by law (including landlords, carriers, warehousemens, mechanics, materialmens, repairmens, construction or other like Liens) arising in the ordinary course of business and securing obligations that are not overdue by more than [REDACTED Time Period] or that are being contested in good faith by appropriate proceedings and in respect of which, if applicable, the Borrower or any Restricted Subsidiary shall have set aside on its books reserves in accordance with IFRS;
(h) (i) pledges and deposits and other Liens made in the ordinary course of business in compliance with the Federal Employers Liability Act or any other workers compensation, unemployment insurance and other social security laws or regulations and deposits securing liability to insurance carriers under insurance or self-insurance arrangements in respect of such obligations and (ii) pledges and deposits and other Liens securing liability for reimbursement or indemnification obligations of (including obligations in respect of letters of credit or bank guarantees for the benefit of) insurance carriers providing property, casualty or liability insurance;
(i) deposits and other Liens to secure the performance of bids, trade contracts (other than for Indebtedness), leases (other than Capital Lease Obligations), statutory obligations, surety and appeal bonds, performance and return of money bonds, bids, leases, government contracts, trade contracts, agreements with public utilities, customs duties, and other obligations of a like nature (including letters of credit in lieu of any such bonds or to support the issuance thereof) incurred by the Borrower or any Restricted Subsidiary in the ordinary course of business that do not materially and adversely affect the conduct of the business of the Borrower and its
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Restricted Subsidiaries taken as a whole, including those incurred to secure health, safety and environmental obligations in the ordinary course of business;
(j) zoning restrictions, survey exceptions and such matters as an accurate survey would disclose, easements, trackage rights, leases (other than Capital Lease Obligations), licenses, special assessments, rights-of-way covenants, conditions, restrictions and declarations on or agreements with respect to the use of real property, servicing agreements, development agreements, site plan agreements and other similar encumbrances incurred in the ordinary course of business and title defects or irregularities that, in the aggregate, do not interfere in any material respect with the business of the Borrower and the Restricted Subsidiaries, taken as a whole;
(k) Liens securing Indebtedness permitted to be incurred pursuant to any Sale and Lease-Back Transactions so long as such liens attach only to the property to which such Indebtedness relates (or accessions to such property and proceeds thereof);
(l) Liens securing judgments that do not constitute an Event of Default under Section 8.1(i);
(m) Liens in favor of the Borrower or any Restricted Subsidiary;
(n) Liens on property existing at the time of a Permitted Acquisition thereof by the Borrower or any Restricted Subsidiary of the Borrower; provided that such Liens were not incurred in contemplation of or in connection with such Permitted Acquisition and do not extend to any property other than the property so acquired by the Borrower or the Restricted Subsidiary;
(o) [Reserved];
(p) any interest or title of a lessor or sublessor under any leases or subleases entered into by the Borrower or any Restricted Subsidiary in the ordinary course of business;
(q) Liens that are contractual rights of set-off, off-set or recourse to account balances (i) relating to the establishment of depository relations with banks not given in connection with the issuance of Indebtedness, (ii) relating to pooled deposit or sweep accounts or cash pooling arrangements (including with respect to any joint and several liability provisions in relation thereto) of the Borrower or any Restricted Subsidiary to permit satisfaction of overdraft or similar obligations incurred in the ordinary course of business of the Borrower and the Restricted Subsidiaries, (iii) relating to debit card or other payment services or (iv) relating to purchase orders and other agreements (other than Indebtedness for borrowed money) entered into with customers in the ordinary course of business;
(r) Liens arising by virtue of any statutory or common law provisions or similar provisions applicable in foreign jurisdictions relating to bankers liens, rights of set-off or similar rights;
(s) Liens securing obligations in respect of trade-related letters of credit, trade-related bank guarantees or similar trade-related obligations permitted under Section 6.1(r)
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and covering the goods (or the documents of title in respect of such goods) financed by such letters of credit, bank guarantees or similar obligations and the proceeds and products thereof;
(t) leases or subleases, licenses or sublicenses granted to or from others in the ordinary course of business and not interfering in any material and adverse respect with the business of the Borrower and the Restricted Subsidiaries, taken as a whole;
(u) Liens in favor of customs and revenue authorities arising as a matter of law to secure payment of customs duties in connection with the importation of goods;
(v) Liens on the assets of a subsidiary of the Borrower that is not a Credit Party that secure obligations of a subsidiary of the Borrower that is not a Credit Party permitted to be incurred under Section 6.1;
(w) set-off and early termination rights under Hedge Agreements;
(x) (i) Liens solely on any cash earnest money deposits made by the Borrower or any of the Restricted Subsidiaries in connection with any letter of intent or purchase agreement permitted hereunder and (ii) Liens on the proceeds of Indebtedness in favor of the lenders or holders of such Indebtedness and their agents or representatives pending the application of such proceeds to a Permitted Acquisition or other Investment permitted hereunder or any refinancing;
(y) Liens arising out of consignment or similar arrangements for the sale of goods entered into in the ordinary course of business;
(z) Liens securing insurance premium financing arrangements, provided that such Liens are limited to the applicable unearned insurance premiums;
(aa) Liens securing Hedge Agreements and submitted for clearing in accordance with applicable law;
(bb) Liens arising from precautionary UCC financing statements or similar or analogous financing statements in any jurisdiction;
(cc) Liens arising from the right of distress enjoyed by landlords or lessors or Liens otherwise granted to landlords or lessors, in either case, to secure the payment of arrears of rent in respect of leased properties;
(dd) other Liens so long as, (i) after giving effect to any such Lien and the incurrence of any Indebtedness incurred at the time such Lien is created, or incurred, on a Pro Forma Basis, the Senior Secured Net Leverage Ratio (when tested for purposes of the incurrence of such Lien) does not exceed 3.00:1.00; provided that, if such Liens are on the Collateral, such Liens shall, if secured on a pari passu basis, be subject to an Intercreditor Agreement or, if secured on a junior basis with respect to the Obligations, be subject to an Intercreditor Agreement or customary intercreditor arrangements reasonably satisfactory to the Administrative Agent (it being understood that any such intercreditor agreement that is substantially similar to the Intercreditor Agreements shall be reasonably satisfactory;
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(ee) deemed trusts or other Liens that are unregistered and that secure amounts that are not yet due and payable and delinquent in respect of unpaid wages, vacation pay, employee or non-resident withholding tax source deductions, goods and services taxes, sales taxes, harmonized sales taxes, municipal taxes, workers compensation, unemployment insurance, pension fund obligations and realty taxes;
(ff) Liens on Equity Interests of any joint venture or Unrestricted Subsidiary (i) securing obligations of such joint venture or Unrestricted Subsidiary, as the case may be, or (ii) pursuant to the relevant joint venture agreement or arrangement;
(gg) Liens on securities that are the subject of repurchase agreements constituting Cash Equivalents under clause (iii) of the definition thereof;
(hh) Liens securing the Borrowers or its subsidiaries obligations in relation to corporate aircraft, including rights under any lease, sublease, charter, management, operating, crew, service, repair, maintenance, storage or other agreement relating to the aircraft, rights in the aircraft and any parts, accessions and accessories thereto, rights under insurance policies and security deposits and rights in income derived from and proceeds of any of the foregoing, in the ordinary course;
(ii) Liens securing obligations under any Secured Hedge Agreements or Secured Cash Management Agreements;
(jj) [Reserved];
(kk) licenses, sublicenses, covenants not to sue, releases or other rights under Intellectual Property granted to others (including in connection with distribution, license and supply agreements) in the ordinary course of business or in the reasonable business judgment of the Borrower or any of the Restricted Subsidiaries;
(ll) Liens securing Indebtedness permitted to be incurred pursuant to Section 6.1(k); provided that (i) such Liens attach concurrently with or within [REDACTED Time Period] after the acquisition, installation, repair or improvement (as applicable) of the property subject to such Liens, (ii) such Liens do not at any time encumber any property other than the property financed by such Indebtedness, replacements thereof and additions and accessions to such property, the proceeds and the products thereof, customary security deposits and insurance and (iii) with respect to Capital Lease Obligations, such Liens do not at any time extend to or cover any assets (except for additions and accessions to such assets, replacements and products thereof, customary security deposits and insurance) other than the assets subject to such Capital Lease Obligations; provided , further , that individual financings of equipment provided by one creditor may be cross-collateralized to other financings of equipment provided by such creditor; and
(mm) Liens securing Indebtedness or other obligations in an aggregate principal or other amount outstanding at any time not exceeding the greater of (x) [REDACTED Dollar Amount] and (y) [REDACTED Percentage] of Consolidated Total Assets.
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For purposes of determining compliance with this Section 6.2 and subject to the immediately following proviso, (A) a Lien securing an item of Indebtedness need not be permitted solely by reference to one category of permitted Liens described in Sections 6.2(a) through 6.2(mm) but may be permitted in part under any combination thereof and (B) in the event that a Lien securing an item of Indebtedness (or any portion thereof) meets the criteria of one or more of the categories of permitted Liens described in Sections 6.2(a) through 6.2(mm), the Borrower shall, in its sole discretion, classify or reclassify, or later divide, classify or reclassify, such Lien securing such item of Indebtedness (or any portion thereof) in any manner that complies with this covenant and will only be required to include the amount and type of such Lien or such item of Indebtedness secured by such Lien in one of the above clauses and such Lien securing such item of Indebtedness will be treated as being incurred or existing pursuant to only one of such clauses; provided , however , that no such reclassification or division shall be permitted with respect to any Liens incurred pursuant to Section 6.2(b). In addition, with respect to any Lien securing Indebtedness that was permitted to secure such Indebtedness at the time of the incurrence of such Indebtedness, such Lien shall also be permitted to secure any Increased Amount of such Indebtedness.
Any reference in any of the Credit Documents to a permitted Lien described in this Section 6.2 is not intended to subordinate or postpone, and shall not be interpreted as subordinating or postponing, or as any agreement to subordinate or postpone, any Lien created by any of the Credit Documents to any such permitted Lien.
6.3 Investments, Loans and Advances . Make or acquire an Investment except:
(a) Investments in a joint venture, when taken together with all other Investments made pursuant to this Section 6.3 that are at the time outstanding (and not otherwise converted or applied to another clause of this Section 6.3), not to exceed [REDACTED Dollar Amount] at any one time outstanding;
(b) [Reserved];
(c) Cash Equivalents and Investments that were Cash Equivalents when made;
(d) Investments arising out of the receipt by the Borrower or any Restricted Subsidiary of non-cash consideration for the sale or other disposition of assets permitted under Section 6.4;
(e) loans and advances to officers, directors, employees or consultants of the Borrower or any Restricted Subsidiary (i) not to exceed in the aggregate [REDACTED Dollar Amount] at any time outstanding, (ii) for reasonable and customary business and related travel, entertainment, relocation and analogous ordinary business purposes, or (iii) in respect of payroll payments and expenses in the ordinary course of business;
(f) accounts receivable, security deposits and prepayments arising and trade credit granted in the ordinary course of business and any assets or securities received in satisfaction or partial satisfaction thereof from financially troubled account debtors and any prepayments and other credits to suppliers made in the ordinary course of business;
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(g) Hedge Agreements not entered into for speculative purposes;
(h) Investments existing on, or contractually committed as of, the Closing Date and set forth on Schedule 6.3(h) ;
(i) Investments resulting from pledges and deposits referred to in Sections 6.2, (h), (i), (x), (z), (cc) and (gg);
(j) repurchases of the Senior Notes permitted pursuant to Section 6.8(a)(1);
(k) Investments constituting Permitted Acquisitions;
(l) Investments of the Borrower in any Restricted Subsidiary or any entity that becomes a Restricted Subsidiary in connection and substantially concurrently with such Investment and of any Restricted Subsidiary in the Borrower or in any other Restricted Subsidiary or any entity that becomes a Restricted Subsidiary in connection and substantially concurrently with such Investment; provided that the aggregate principal amount of such Investments (including intercompany loans and other Investments) made pursuant to this Section 6.3(l) by Credit Parties in Restricted Subsidiaries that are not Credit Parties and will not become a Credit Party in connection with the incurrence of such Investment, when aggregated with Indebtedness incurred by Restricted Subsidiaries that are not Credit Parties owing to a Credit Party pursuant to Section 6.1(g)(ii) and acquisitions of Persons that do not become Credit Parties pursuant to Section 6.3(k), shall not exceed the greater of (x) [REDACTED Dollar Amount] and (y) [REDACTED Percentage] of Consolidated Total Assets;
(m) the Transactions;
(n) Investments received in connection with the bankruptcy or reorganization of, or settlement of delinquent accounts and disputes with or judgments against, customers, distributors and suppliers, or Investments acquired by the Borrower or any Restricted Subsidiary as a result of a foreclosure by the Borrower or any of the Restricted Subsidiaries with respect to any secured Investments or other transfer of title with respect to any secured Investment in default;
(o) Investments of a Restricted Subsidiary acquired after the Closing Date or of an entity merged into, or amalgamated or consolidated with, the Borrower or merged into or amalgamated or consolidated with a Restricted Subsidiary in accordance with Section 6.4 after the Closing Date to the extent that such Investments were not made in contemplation of or in connection with such acquisition, merger or consolidation and were in existence or had been committed to be made on the date of such acquisition, merger or consolidation;
(p) Investments in exchange for Equity Interests of the Borrower;
(q) guarantees by the Borrower or any Restricted Subsidiary of obligations that do not constitute Indebtedness and are not otherwise prohibited hereunder, in each case, entered into by the Borrower or any Restricted Subsidiary in the ordinary course of business;
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(r) Investments consisting of the redemption, purchase, repurchase or retirement of any Equity Interests permitted under Section 6.5; provided that any such Investments shall constitute a utilization of the applicable provision or provisions (without double counting) under Section 6.5;
(s) Investments in the ordinary course of business consisting of UCC Article 3 endorsements for collection or deposit and UCC Article 4 customary trade arrangements with customers and foreign law equivalent interests;
(t) advances in the form of a prepayment of expenses, so long as such expenses are being paid in accordance with customary trade terms of the Borrower or any Restricted Subsidiary;
(u) Investments by the Borrower or any Restricted Subsidiaries, if the Borrower or any Restricted Subsidiary would otherwise be permitted to make a Restricted Payment in such amount ( provided that the amount of any such Investment shall also be deemed to be a Restricted Payment under the appropriate clause of Section 6.5 for all purposes of this Agreement);
(v) acquisitions by any Credit Party of Investments evidencing obligations owed by one or more officers or other employees of the Borrower, such Credit Party or its subsidiaries in connection with such officers or employees acquisition of Equity Interests of the Borrower, so long as no cash is actually advanced in connection with the acquisition of any such obligations;
(w) guarantees permitted under Section 6.1 (except to the extent such guarantee is expressly subject to this Section 6.3);
(x) Investments consisting of the licensing, sublicensing, covenants not to sue, releases or other rights under Intellectual Property (including in connection with distribution, license and supply agreements) in the ordinary course of business or in the reasonable business judgment of the Borrower or the Restricted Subsidiaries;
(y) Investments consisting of purchases and acquisitions of inventory, supplies, goods, materials and equipment or purchases of contract rights or leases, in each case, in the ordinary course of business;
(z) Investments consisting of purchases and acquisitions of Intellectual Property in the ordinary course of business or in the reasonable business judgment of the Borrower or the Restricted Subsidiaries;
(aa) Investments in assets useful in the business of the Borrower and any of its Restricted Subsidiaries made with the proceeds of any Reinvestment Deferred Amount or Below Threshold Asset Sale Proceeds; provided that if the underlying Asset Sale or Casualty Event was with respect to the Borrower or a Guarantor, then such Investment shall be consummated by the Borrower or a Guarantor;
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(bb) Investments in the Term Loans and other permitted Indebtedness of the Borrower and its Restricted Subsidiaries, in each case, solely (i) to the extent permitted hereunder and under the definitive documentation governing any such other permitted Indebtedness and (ii) consummated in accordance with the terms and conditions set forth in Section 10.4(o) hereof or pursuant to the corresponding provisions of the definitive documentation governing any such other permitted Indebtedness, as applicable;
(cc) other Investments by the Borrower or any Restricted Subsidiary; provided that, after giving effect to such Investment, the aggregate amount of all Investments made pursuant to this paragraph (cc) (valued at the time of the making thereof, and without giving effect to any write-downs or write-offs thereof) shall not exceed the greater of (x) [REDACTED Dollar Amount] and (y) [REDACTED Percentage] of Consolidated Total Assets; and
(dd) so long as no Event of Default has occurred and is continuing, Investments made with any portion of the Cumulative Credit.
For purposes of determining compliance with this Section 6.3 and subject to the immediately following proviso, (A) Investments need not be permitted solely by reference to one category of permitted Indebtedness described in Sections 6.3(a) through (dd) but may be permitted in part under any combination thereof and (B) in the event that an Investment (or any portion thereof) meets the criteria of one or more of the categories of permitted Investments described in Sections 6.3(a) through (dd), the Borrower shall, in its sole discretion, classify or reclassify, or later divide, classify or reclassify, such Investment (or any portion thereof) in any manner that complies with this Section 6.3 and will only be required to include the amount and type of such Investment (or any portion thereof) in one of the above clauses and such Investment shall be treated as having been made or existing pursuant to only one of such clauses; provided , however , that no such reclassification shall be permitted with respect to any Investment made pursuant to Section 6.3(dd).
6.4 Mergers, Consolidations and Sales of Assets . Merge into or consolidate, amalgamate or liquidate, wind up or dissolve themselves (or suffer any liquidation or dissolution), or convey, sell, lease or sublease (as lessor or sub-lessor), transfer or otherwise dispose of, in a single transaction or in a related series of transactions, all or any part of its business, assets or property of any kind whatsoever, whether real, personal or mixed and whether tangible or intangible, whether now owned or hereafter acquired, except:
(a) the sale, transfer or other disposition of the assets relating to the injectables business purchased in the Transactions; provided that (i) such sale, transfer or disposition is made pursuant to a binding agreement executed [REDACTED Time Period] of the Closing Date and (ii) such sale, transfer or disposition is completed [REDACTED Time Period] after the date of such binding agreement;
(b) any Restricted Subsidiary may be merged or consolidated or amalgamated with or into the Borrower or any Restricted Subsidiary; provided that (i) in the case of a merger, amalgamation or consolidation involving the Borrower, the Borrower shall be the continuing or surviving Person and (ii) in the case of a merger, amalgamation or consolidation involving any other Credit Party, either (x) such Credit Party shall be the continuing or surviving Person or the
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continuing or surviving Person shall be or become a Credit Party or (y) such transaction shall be treated as an Investment and shall comply with Section 6.3;
(c) sales or other dispositions among the Borrower and its Restricted Subsidiaries or by and among Restricted Subsidiaries (upon voluntary liquidation or otherwise); provided that any such sale or disposition by a Credit Party to a Person that is not a Credit Party shall be (i) for fair market value or (ii) treated as an Investment and otherwise made in compliance with Section 6.3 (other than Sections 6.3(d) and (o));
(d) the liquidation or dissolution of any Restricted Subsidiary or change in form of entity of any Restricted Subsidiary if (A) the Borrower determines in good faith that such liquidation, dissolution or change in form is (1) in the best interests of the Borrower and its Restricted Subsidiaries, taken as a whole, and (2) either the Borrower or a Restricted Subsidiary receives any assets of such dissolved or liquidated Restricted Subsidiary; provided that in the case of a dissolution or liquidation of a Credit Party that results in a distribution of assets to a subsidiary that is not a Credit Party, such distribution shall be treated as an Investment and shall be permitted under Section 6.3 and (3) any merger, amalgamation, dissolution, liquidation or consolidation, the purpose of which is to effect (A) a sale or disposition otherwise permitted under this Section 6.4 (other than Sections 6.4(c) or Section 6.4(d)); provided , further , in the case of a change in the form of entity of any Restricted Subsidiary that is a Credit Party, after such change, the security interests of the Collateral Agent and the Secured Parties in the Collateral of such Credit Party shall remain in full force and effect and be perfected to the same extent as prior to such change or (B) an Investment permitted under Section 6.3;
(e) (x) sales or leases of inventory in the ordinary course of business, (y) the leasing or subleasing of real property in the ordinary course of business and (z) leases, subleases, assignments, licenses, cross-licenses and sublicenses of assets in the ordinary course of business to third persons not interfering in any material respect with the business of the Borrower or any of its Restricted Subsidiaries and otherwise in accordance with the provisions of this Agreement, including charters related to corporate aircraft leases;
(f) disposals of surplus, obsolete, damaged, used or worn out property or other property that is no longer useful;
(g) dispositions of Cash Equivalents;
(h) dispositions, mergers, amalgamations, consolidations or conveyances that constitute Liens permitted by Section 6.2, Investments permitted pursuant to Section 6.3 or Restricted Payments permitted by Section 6.5;
(i) sales or other dispositions of any assets of the Borrower or any Restricted Subsidiary for fair market value; provided that at least [REDACTED Percentage] of the consideration for such sale or disposition shall consist of cash and Cash Equivalents ( provided that for purposes of the [REDACTED Percentage] consideration requirement (x) any liabilities, as shown on the most recent consolidated balance sheet of the Borrower or any Restricted Subsidiary (other than Indebtedness or other liabilities that are by their terms subordinated to the Obligations) that are assumed by the transferee of any such assets pursuant to
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a customary assignment and assumption agreement that releases the Borrower or such Restricted Subsidiary from further liability, (y) any securities, notes, Equity Interests or other obligations received by the Borrower or any such Restricted Subsidiary from such transferee that are converted by the Borrower or such Restricted Subsidiary into cash [REDACTED Time Period] of their receipt to the extent of the cash received in that conversion, and (z) any Designated Non-Cash Consideration received by the Borrower or any such Restricted Subsidiary in such sale or other disposition having an aggregate fair market value, taken together with all other Designated Non-Cash Consideration received pursuant to this clause (z) that is at that time outstanding, not to exceed [REDACTED Percentage] of Consolidated Total Assets at the time of the receipt of such Designated Non-Cash Consideration, with the fair market value of each item of Designated Non-Cash Consideration being measured at the time received and without giving effect to subsequent changes in value, in each case, shall be deemed to be Cash Equivalents);
(j) to the extent that (i) the relevant property or assets are exchanged for credit against the purchase price of similar replacement property or (ii) the proceeds of the relevant sale or disposition are promptly applied to the purchase price of such replacement property, so long as the exchange, sale or disposition is made for fair value and on an arms length basis for like property or assets; provided that upon the consummation thereof, in the case of any Credit Party, the Administrative Agent has a perfected Lien on the replacement property having the same priority as any Lien held on the property or assets so exchanged, sold or disposed;
(k) dispositions of Investments in joint ventures to the extent required by, or made pursuant to, contractual buy/sell arrangements between the joint venture parties set forth in joint venture arrangements and similar binding arrangements;
(l) sales, discounting or forgiveness of accounts receivable in the ordinary course of business or in connection with the collection or compromise thereof;
(m) dispositions and/or terminations of leases, subleases, licenses or sublicenses (including the provision of software under an open source license), which (i) are in the ordinary course of business, (ii) do not materially interfere with the business of the Borrower and its Restricted Subsidiaries taken as a whole or (iii) relate to closed facilities or closed storage or distribution centers or the discontinuation of any product line;
(n) (i) the expiration of any option agreement in respect of real or personal property and (ii) any surrender or waiver of contractual rights or the settlement, release or surrender of contractual rights or other litigation claims in the ordinary course of business;
(o) transfers of property subject to a Casualty Event upon receipt of Net Cash Proceeds of such Casualty Event;
(p) [Reserved];
(q) sales of non-core assets acquired in connection with an acquisition permitted hereunder and sales of real estate assets acquired in an acquisition permitted hereunder which, [REDACTED Time Period] of the date of the acquisition, are designated in writing to
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the Administrative Agent as being held for sale and not for the continued operation of the Borrower or any of the Restricted Subsidiaries or any of their respective businesses;
(r) substantially contemporaneous exchanges or swaps, including transactions covered by Section 1031 of the Internal Revenue Code, of property or assets so long as the exchange or swap is made for fair value and on an arms length basis for like property or assets and not to exceed [REDACTED Dollar Amount] in the aggregate; provided that upon the consummation of such exchange or swap, in the case of any Credit Party, the Administrative Agent has a perfected Lien having the same priority as any Lien held on the property or assets so exchanged or swapped;
(s) (i) licenses, sublicenses, covenants not to sue, releases or other rights under Intellectual Property (including in connection with distribution, license and supply agreements) granted to or from others (or expiration or termination of any of the foregoing) in the ordinary course of business or in the reasonable business judgment of the Borrower or the Restricted Subsidiaries, (ii) the sale or disposal of Intellectual Property, or any issuances or registrations, or applications for issuances or registrations, of any Intellectual Property, which are in the ordinary course of business or, in the reasonable good faith determination of the Borrower, are uneconomical, negligible, or not material to the conduct of the business of the Borrower and the Restricted Subsidiaries taken as a whole, and (iii) the abandonment, cancellation or lapse of Intellectual Property, or any issuances or registrations, or applications for issuances or registrations, of any Intellectual Property, in each case, in the ordinary course of business or in the reasonable business judgment of the Borrower or the Restricted Subsidiaries;
(t) terminations of Hedge Agreements; and
(u) sales or dispositions of Equity Interests or debt or other securities of or in Unrestricted Subsidiaries.
To the extent any Collateral is disposed of as expressly permitted by this Section 6.4 to any Person other than a Credit Party, such Collateral shall automatically be sold free and clear of the Liens created by the Credit Documents, and the Administrative Agent shall be authorized to take, and shall take, any actions deemed appropriate in order to effect the foregoing.
For purposes of determining compliance with this Section 6.4, (A) actions need not be permitted solely by reference to one category of permitted actions described in Sections 6.4(a) through 6.4(u) but may be permitted in part under any combination thereof and (B) in the event that an action meets the criteria of one or more of the categories of permitted actions described in Sections 6.4(a) through 6.4(u), the Borrower shall, in its sole discretion, classify or reclassify, or later classify or reclassify, such action in any manner that complies with this Section 6.4 and will only be required to include such action in one of the above clauses and such action shall be treated as having been made or existing pursuant to only one of such clauses.
6.5 Restricted Payments . Pay or make, directly or indirectly, any Restricted Payment, except:
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(a) the Borrower may make Restricted Payments payable solely in Qualified Stock of the Borrower;
(b) any Restricted Subsidiary of the Borrower may declare and pay cash dividends to the Borrower or to any Credit Party of which it is a subsidiary;
(c) as required by the terms of contracts of the Borrower or any Restricted Subsidiary that are in effect on the Closing Date and set forth in Schedule 6.5(c) ;
(d) the Borrower may repurchase Equity Interests of the Borrower upon exercise of options or warrants if such Equity Interests represents all or a portion of the exercise price of such options or warrants and/or amounts on account of required withholding taxes and brokerage fees with respect to such options as part of a cashless exercise;
(e) dividend adjustments and repurchases of Equity Interests deemed to occur upon the exercise of stock options, warrants or other convertible or exchangeable securities or the vesting of restricted stock units or deferred stock units (including any management equity plan or stock option plan or any other management or employee benefit plan or agreement, or any stock subscription or shareholder agreement);
(f) payments for the repurchase of Equity Interests of the Borrower held by any present or former employee, director, member of management, officer, manager or consultant (or any Affiliate or family member thereof) as a result of the exercise by such Person of employee stock options or the vesting of restricted stock units or deferred stock units, in an amount not to exceed [REDACTED Dollar Amount] in a Fiscal Year;
(g) the Borrower may make Restricted Payments the proceeds of which are applied on the Closing Date, solely to effect the consummation of the Transactions;
(h) to make regularly scheduled quarterly dividends in respect of common Equity Interests of the Borrower in an amount not to exceed [REDACTED Dollar Amount] in any Fiscal Year;
(i) the Borrower and the Restricted Subsidiaries may make Restricted Payments not otherwise specified in this Section 6.5 in an aggregate amount that does not exceed the greater of (i [REDACTED Dollar Amount] and (ii) [REDACTED Percentage] Consolidated Total Assets; and
(j) the Borrower may make Restricted Payments with the Cumulative Credit amount if at the time such Restricted Payment is made, no Event of Default shall have occurred and be continuing or would result therefrom and after giving effect to such Restricted Payments on a Pro Forma Basis, the Total Net Leverage Ratio shall not exceed 5.25:1.00.
For purposes of determining compliance with this Section 6.5 and subject to the immediately following proviso, (A) Restricted Payments need not be permitted solely by reference to one category of permitted Restricted Payments described in Section 6.5(a) through (j) but may be permitted in part under any combination thereof and (B) in the event that a Restricted Payment (or any portion thereof) meets the criteria of one or more of the categories of
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permitted Restricted Payments described in Sections 6.5(a) through (j), the Borrower shall, in its sole discretion, classify or reclassify, or later divide, classify or reclassify, such Restricted Payment (or any portion thereof) in any manner that complies with this Section 6.5 and will only be required to include the amount and type of such Restricted Payment (or any portion thereof) in one of the above clauses and such Restricted Payment shall be treated as having been made or existing pursuant to only one of such clauses; provided , however , that no such reclassification shall be permitted with respect to any Restricted Payment made pursuant to Section 6.5(j).
6.6 Transactions with Affiliates .
(a) Sell or transfer any property or assets to, or purchase or acquire any property or assets from, or otherwise engage in any other transaction with, any of its Affiliates in a transaction involving consideration in excess of [REDACTED Dollar Amount] for such transaction or series of transactions, unless such transaction or series of transactions are (i) otherwise expressly permitted (or required) with such Affiliates or holders under this Agreement or (ii) upon terms that are not materially less favorable to the Borrower or such Restricted Subsidiary, as applicable, than would be obtained in a comparable arms length transaction with a Person that is not an Affiliate.
(b) The foregoing paragraph (a) shall not prohibit, to the extent otherwise permitted under this Agreement:
(1) any issuance of securities, or other payments, awards or grants in cash, securities or otherwise pursuant to, or the funding of, employment arrangements, equity purchase agreements, stock options, restricted stock units or deferred stock units and stock ownership and long-term incentive plans approved by the Board of Directors of the Borrower;
(2) (i) payments by the Borrower and any of its Restricted Subsidiaries pursuant to any tax sharing agreements among the Borrower and any of its Restricted Subsidiaries on customary terms that require each party to make payments when taxes are due or refunds received of amounts equal to the income tax liabilities and refunds generated by each such party and (ii) payments by the Borrower or any of its Restricted Subsidiaries pursuant to any tax sharing agreements among the Borrower and any of its Restricted Subsidiaries on customary terms that require each party to make payments when taxes are due or refunds received of amounts equal to the income tax liabilities and refunds generated by each such party calculated on a separate return basis, and payments to the party generating tax benefits and credits of amounts equal to the value of such tax benefits and credits made available to the party making the payments;
(3) transactions among the Borrower and any Restricted Subsidiary or any entity that becomes a Restricted Subsidiary as a result of such transaction (including via merger, amalgamation or consolidation in which the Borrower or a Restricted Subsidiary is the surviving entity) not prohibited by this Agreement;
(4) [Reserved];
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(5) the Transactions and other transactions pursuant to the agreements and arrangements in existence on the Closing Date and set forth on Schedule 6.6(b) or any amendment thereto to the extent such amendment is not adverse to the Lenders in any material respect;
(6) (A) any employment, severance or consulting agreements entered into by the Borrower or any of the Restricted Subsidiaries in the ordinary course of business, (B) any subscription agreement or similar agreement pertaining to the repurchase of Equity Interests pursuant to put/call rights or similar rights with employees, consultants, officers or directors, and (C) any employee, severance or consultant compensation, indemnification arrangement, benefit plan or arrangement, any health, disability or similar insurance plan which covers employees or consultants, and any reasonable employment or consulting contract and transactions pursuant thereto;
(7) Restricted Payments permitted under Section 6.5;
(8) any purchase of Equity Interests (other than Disqualified Stock) of the Borrower or any contribution to the equity capital of the Borrower;
(9) transactions between or among the Borrower and/or its Restricted Subsidiaries;
(10) transactions with customers, distributors, clients, suppliers or purchasers or sellers of goods or services, in each case, in the ordinary course of business and on terms that are not materially less favorable to the Borrower or such Restricted Subsidiary, as the case may be, as determined in good faith by the Borrower, than those that could be obtained in a comparable arms length transaction with a Person that is not an Affiliate of the Borrower;
(11) any transaction in respect of which the Borrower delivers to the Administrative Agent a letter addressed to the Board of Directors of the Borrower from an accounting, appraisal or investment banking firm, in each case of nationally recognized standing in the United States or Canada, which letter states that (A) such transaction is on terms that are no less favorable to the Borrower or such Restricted Subsidiary, as applicable, than would be obtained in a comparable arms-length transaction with a Person that is not an Affiliate or (B) is fair, from a financial point of view, to the Borrower or such Restricted Subsidiary;
(12) transactions with a joint venture for the purchase or sale of goods, equipment and services entered into in the ordinary course of business and in a manner consistent with prudent business practice followed by companies in the industry of the Borrower and its subsidiaries; and
(13) transactions permitted by, and complying with, the provisions of Section 6.4.
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6.7 Business of the Borrower and its Restricted Subsidiaries . Notwithstanding any other provisions hereof, engage at any time in any business or business activity other than in the case of the Borrower or any Restricted Subsidiary, (x) any business or business activity conducted by any of them on the Closing Date and any business or business activities incidental or related thereto, or any business or business activity that is reasonably similar or complementary thereto or a reasonable extension, development or expansion thereof or ancillary thereto, including the consummation of the Transactions and (y) such other business or business activity as may be consented to by the Requisite Lenders from time to time, such consent not to be unreasonably withheld, delayed or conditioned.
6.8 Limitation on Modifications and Payments of Indebtedness; Modifications of Certificate of Incorporation, By-Laws and Certain Other Agreements; Etc.
(a)
(1) (i) Make, directly or indirectly, any payment or other distribution (whether in cash, securities or other property) of or in respect of any Indebtedness of the Borrower or any Restricted Subsidiary that is (x) expressly subordinate to the Obligations, (y) unsecured or secured by a Lien that is junior to the Lien securing the Collateral or (z) any Refinancing Indebtedness in respect of (x) and (y) (clauses (x), (y) and (z), each, a Junior Financing ), or any payment or other distribution (whether in cash, securities or other property), including any sinking fund or similar deposit, on account of the purchase, redemption, retirement, acquisition, cancellation or termination in respect of any Junior Financing except for (a) Refinancing Indebtedness, (b) payments of regularly scheduled interest, and, to the extent this Agreement is then in effect, principal on the scheduled maturity date of any Junior Financing, (c) the conversion of any Junior Financing to Equity Interests (other than Disqualified Stock) of the Borrower, (d) so long as no Event of Default has occurred and is continuing or would result therefrom, payments or distributions in respect of Junior Financings prior to their scheduled maturity (1) in an aggregate amount not to exceed the greater of (x) [REDACTED Dollar Amount] and (y) [REDACTED Percentage] of Consolidated Total Assets or (2) made with any portion of the Cumulative Credit, subject to compliance with a Total Net Leverage Ratio of 5.50:1.00 after giving effect to such payment or distribution on a Pro Forma Basis and (e) payments or distributions in amounts that would otherwise have been permitted to be made as Restricted Payments; provided that any such prepayment shall constitute a utilization of the applicable Restricted Payment capacity; or
(2) Amend or modify, or permit the amendment or modification of, any provision of (i) any of its Organizational Documents in a manner materially adverse to the Administrative Agent and the Lenders or (ii) any Junior Financing (or any Refinancing Indebtedness in respect thereof) or any agreement, document or instrument evidencing or relating thereto, other than amendments or modifications that (a) do not affect the subordination or payment provisions thereof (if any) in a manner adverse to the Lenders (as determined in good faith
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by the Borrower and the Administrative Agent) or (b) otherwise comply with the definition of Refinancing Indebtedness .
(b) Enter into, or permit any Restricted Subsidiary to enter into, any agreement or instrument that by its terms restricts (i) the payment of dividends or distributions or the making of cash advances by such Restricted Subsidiary to the Borrower or any other Restricted Subsidiary that is a direct or indirect parent of such Restricted Subsidiary or (ii) the granting, perfection or enforcement of Liens by such Restricted Subsidiary or the Borrower pursuant to the Collateral Documents in respect of the Loans, in each case other than those arising under any Credit Document, except, in each case, restrictions existing by reason of:
(A) restrictions imposed by applicable law;
(B) contractual encumbrances or restrictions (i) in effect on the Closing Date and (to the extent not otherwise permitted by this Section 6.8 are listed on Schedule 6.8), (ii) on the granting of Liens pursuant to documentation governing Indebtedness incurred in compliance with Section 6.1 that is secured by Liens pursuant to Section 6.2 on terms that are consistent with, or not materially more restrictive, taken as a whole, than, the restrictions set forth herein (as determined conclusively by the Borrower and evidenced by a certificate of an Authorized Officer of the Borrower), or (iii) pursuant to documentation related to any permitted renewal, extension or refinancing of any Indebtedness existing on the Closing Date that does not expand the scope of any such encumbrance or restriction in any material respect (as determined conclusively by the Borrower and evidenced by a certificate of an Authorized Officer of the Borrower);
(C) any restriction on a Restricted Subsidiary imposed pursuant to an agreement entered into for the sale or disposition of all or substantially all the Equity Interests or assets of such Restricted Subsidiary pending the closing of such sale or disposition;
(D) customary provisions in joint venture agreements and other similar agreements applicable to joint ventures entered into in the ordinary course of business and applicable solely to that joint venture;
(E) any restrictions imposed by any agreement relating to secured Indebtedness permitted by this Agreement (other than Indebtedness secured by second-priority Liens on the Collateral) to the extent that such restrictions apply only to the property or assets securing such Indebtedness;
(F) customary provisions contained in licenses, sublicenses, covenants not to sue, releases and other agreements in connection with Intellectual Property (including in connection with distribution, license and supply agreements) and other similar agreements entered into in the ordinary course of business;
(G) customary provisions restricting subletting or assignment of any lease governing a leasehold interest;
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(H) customary provisions restricting assignment of any agreement entered into in the ordinary course of business;
(I) customary restrictions and conditions contained in any agreement relating to the sale, transfer, lease or other disposition of any asset permitted under Section 6.4 pending the consummation of such sale, transfer, lease or other disposition;
(J) any agreement in effect at the time such subsidiary becomes a Restricted Subsidiary, so long as any such contractual restrictions were not entered into in contemplation of such Person becoming a Restricted Subsidiary;
(K) customary net worth provisions contained in real property leases and customer contracts entered into by the Borrower or its Restricted Subsidiaries, so long as the Borrower has determined in good faith that such net worth provisions would not reasonably be expected to impair the ability of the Borrower and its Restricted Subsidiaries to meet their ongoing obligations;
(L) restrictions in agreements representing Indebtedness permitted under Section 6.1 of a subsidiary of the Borrower that is not a Credit Party;
(M) restrictions on cash or other deposits imposed by customers under contracts entered into in the ordinary course of business;
(N) any restriction with respect to the Borrower or a Restricted Subsidiary (or any of its property or assets) imposed by customary provisions in a Hedge Agreement not entered into for speculative purposes;
(O) any restrictions imposed by any agreement relating to Indebtedness incurred pursuant to Section 6.1 or Refinancing Indebtedness in respect thereof, on prevailing market terms and conditions available to borrowers at the time such transactions are entered into and will not materially impair the Borrowers ability to pay interest, premium, if any, or principal pursuant to the Credit Documents, when due;
(P) any encumbrances or restrictions of the type referred to in Sections 6.8(b)(i) and 6.8(b)(ii) imposed by any amendments, modifications, restatements, renewals, increases, supplements, refundings, replacements or refinancings of the contracts, instruments or obligations referred to in clauses (A) through (O) above; provided that such amendments, modifications, restatements, renewals, increases, supplements, refundings, replacements or refinancings are, in the good faith judgment of the Borrower, on prevailing market terms and conditions available to borrowers at the time such transactions are entered into and will not materially impair the Borrowers ability to pay interest, premium, if any, or principal pursuant to the Credit Documents, when due; or
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(Q) any restrictions with respect to the corporate aircraft, including under any lease, sublease, charter, management, operating, crew, service, repair, maintenance, storage or other agreement relating to the aircraft.
6.9 Changes in Fiscal Year . Borrower shall not permit its fiscal year to end on any date other than December 31 or permit its fiscal quarters to end on a date other than on or about March 31, June 30 or September 30 without the prior consent of the Requisite Lenders (such consent not to be unreasonably conditioned, withheld or delayed).
6.10 Financial Performance Covenant . Upon the occurrence and during the continuance of a Covenant Trigger Event, the Borrower shall not permit the Senior Secured Net Leverage Ratio (calculated on a Pro Forma Basis) as of the last day of any Test Period during any period set forth below to be greater than the ratio set forth opposite such Test Period below. Such covenant shall be tested following a Covenant Trigger Event, and for so long as such Covenant Trigger Event is continuing as of the last day of the most recent Fiscal Quarter covered by such financial statements, upon the delivery of each set of financial statements pursuant to Section 5.4 after (and for so long as) such Covenant Trigger Event has been triggered.
Senior Secured Net | ||||
Test Period Ended |
Leverage Ratio | |||
[REDACTED Time Period] |
4.00:1.00 | |||
[REDACTED Time Period] |
3.75:1.00 | |||
[REDACTED Time Period] |
3.50:1.00 |
6.11 Canadian Pension Plans . The Borrower shall not:
(a) Establish, contribute to, commence participation in or assume any liability in respect of any Canadian Pension Plan that contains a defined benefit provision, as that terms is defined in subsection 147.1(1) of the Income Tax Act (Canada) (a DB Plan ), where doing so would reasonably be expected to have a Material Adverse Effect.
(b) Permit a DB Plan referred to in Section 6.11(a) to have an unfunded liability that would reasonably be expected to have a Material Adverse Effect.
(c) Terminate or wind-up a DB Plan referred to in Section 6.11(a) if doing so would reasonably be expected to have a Material Adverse Effect.
(d) Fail to withhold, make, remit or pay when due any employee or employer payments, contributions or premiums to or in respect of any Canadian Pension Plan if doing so would reasonably be expected to have a Material Adverse Effect.
6.12 Sale and Leaseback Transactions . The Borrower shall not enter into any Sale and Lease-Back Transaction unless, after giving effect thereto, the aggregate outstanding amount of Attributable Indebtedness in respect of all Sale and Lease-Back Transactions does not at any time exceed [REDACTED Dollar Amount] and the Liens in respect thereof are permitted under Section 6.2.
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SECTION 7. | GUARANTY |
7.1 Guaranty of the Obligations . Subject to the provisions of Section 7.2, the Guarantors jointly and severally hereby irrevocably and unconditionally guaranty (the Guaranty ) to Administrative Agent for the ratable benefit of the Beneficiaries the due and punctual payment in full of all Obligations of the Borrower when the same shall become due, whether at stated maturity, by required prepayment, declaration, acceleration, demand or otherwise (including amounts that would become due but for the operation of the automatic stay under Section 362(a) of the Bankruptcy Code, 11 U.S.C. § 362(a) or any equivalent provision in any applicable jurisdiction) (each, a Guaranteed Obligation and, collectively, the Guaranteed Obligations ).
7.2 Contribution by Guarantors . All Guarantors desire to allocate among themselves (collectively, the Contributing Guarantors ), in a fair and equitable manner, their obligations arising under this Guaranty. Accordingly, in the event any payment or distribution is made on any date by a Guarantor (a Funding Guarantor ) under this Guaranty such that its Aggregate Payments exceeds its Fair Share as of such date, such Funding Guarantor shall be entitled to a contribution from each of the other Contributing Guarantors in an amount sufficient to cause each Contributing Guarantors Aggregate Payments to equal its Fair Share as of such date. Fair Share means, with respect to a Contributing Guarantor as of any date of determination, an amount equal to (a) the ratio of (i) the Fair Share Contribution Amount with respect to such Contributing Guarantor to (ii) the aggregate of the Fair Share Contribution Amounts with respect to all Contributing Guarantors multiplied by (b) the aggregate amount paid or distributed on or before such date by all Funding Guarantors under this Guaranty in respect of the obligations Guaranteed. Fair Share Contribution Amount means, with respect to a Contributing Guarantor as of any date of determination, the maximum aggregate amount of the obligations of such Contributing Guarantor under this Guaranty that would not render its obligations hereunder or thereunder subject to avoidance as a fraudulent transfer or conveyance under Section 548 of Title 11 of the United States Code or any applicable law; provided , solely for purposes of calculating the Fair Share Contribution Amount with respect to any Contributing Guarantor for purposes of this Section 7.2, any assets or liabilities of such Contributing Guarantor arising by virtue of any rights to subrogation, reimbursement or indemnification or any rights to or obligations of contribution hereunder shall not be considered as assets or liabilities of such Contributing Guarantor. Aggregate Payments means, with respect to a Contributing Guarantor as of any date of determination, an amount equal to (1) the aggregate amount of all payments and distributions made on or before such date by such Contributing Guarantor in respect of this Guaranty (including in respect of this Section 7.2), minus (2) the aggregate amount of all payments received on or before such date by such Contributing Guarantor from the other Contributing Guarantors as contributions under this Section 7.2. The amounts payable as contributions hereunder shall be determined as of the date on which the related payment or distribution is made by the applicable Funding Guarantor. The allocation among Contributing Guarantors of their obligations as set forth in this Section 7.2 shall not be construed in any way to limit the liability of any Contributing Guarantor hereunder. Each Guarantor is a third party beneficiary to the contribution agreement set forth in this Section 7.2.
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7.3 Payment by Guarantors . Subject to Section 7.2, the Guarantors hereby jointly and severally agree, in furtherance of the foregoing and not in limitation of any other right which any Beneficiary may have at law or in equity against any Guarantor by virtue hereof, that upon the failure of the Borrower to pay any of the applicable Guaranteed Obligations when and as the same shall become due, whether at stated maturity, by required prepayment, declaration, acceleration, demand or otherwise (including amounts that would become due but for the operation of the automatic stay under Section 362(a) of the Bankruptcy Code, 11 U.S.C. § 362(a) or any equivalent provision in any applicable jurisdiction), the Guarantors will upon demand pay, or cause to be paid, in cash, to Administrative Agent for the ratable benefit of Beneficiaries, an amount equal to the sum of the unpaid principal amount of all applicable Guaranteed Obligations then due as aforesaid, accrued and unpaid interest on such Guaranteed Obligations (including interest which, but for Borrowers becoming the subject of a case under the Bankruptcy Code, whether or not a claim is allowed against Borrower for such interest in the related bankruptcy case) and all other applicable Guaranteed Obligations then owed to Beneficiaries as aforesaid.
7.4 Liability of Guarantors Absolute . Each Guarantor agrees that its obligations hereunder are irrevocable, absolute, independent and unconditional and shall not be affected by any circumstance which constitutes a legal or equitable discharge of a guarantor or surety other than payment in full of the applicable Guaranteed Obligations. In furtherance of the foregoing and without limiting the generality thereof, each Guarantor agrees as follows:
(a) this Guaranty is a guaranty of payment when due and not of collectability;
(b) this Guaranty is a primary obligation of each Guarantor and not merely a contract of surety;
(c) Administrative Agent may enforce this Guaranty upon the occurrence of an Event of Default notwithstanding the existence of any dispute between Borrower and any Beneficiary with respect to the existence of such Event of Default;
(d) the obligations of each Guarantor hereunder are independent of the obligations of Borrower and the obligations of any other guarantor (including any other Guarantor) of the obligations of Borrower, and a separate action or actions may be brought and prosecuted against such Guarantor, whether or not any action is brought against Borrower or any of such other guarantors and whether or not Borrower is joined in any such action or actions;
(e) payment by any Guarantor of a portion, but not all, of the applicable Guaranteed Obligations shall in no way limit, affect, modify or abridge any Guarantors liability for any portion of the applicable Guaranteed Obligations which has not been paid (without limiting the generality of the foregoing, if Administrative Agent is awarded a judgment in any suit brought to enforce any Guarantors covenant to pay a portion of the applicable Guaranteed Obligations, such judgment shall not be deemed to release such Guarantor from its covenant to pay the portion of the applicable Guaranteed Obligations that is not the subject of such suit, and such judgment shall not, except to the extent satisfied by such Guarantor, limit, affect, modify or abridge any other Guarantors liability hereunder in respect of the applicable Guaranteed Obligations);
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(f) any Beneficiary, upon such terms as it deems appropriate, without notice or demand and without affecting the validity or enforceability hereof or giving rise to any reduction, limitation, impairment, discharge or termination of any Guarantors liability hereunder, from time to time may (i) renew, extend, accelerate, increase the rate of interest on, or otherwise change the time, place, manner or terms of payment of the applicable Guaranteed Obligations; (ii) settle, compromise, release or discharge, or accept or refuse any offer of performance with respect to, or substitutions for, the applicable Guaranteed Obligations or any agreement relating thereto and/or subordinate the payment of the same to the payment of any other obligations; (iii) request and accept other guaranties of the applicable Guaranteed Obligations and take and hold security for the payment hereof or the applicable Guaranteed Obligations; (iv) release, surrender, exchange, substitute, compromise, settle, rescind, waive, alter, subordinate or modify, with or without consideration, any security for payment of the applicable Guaranteed Obligations, any other guaranties of the applicable Guaranteed Obligations, or any other obligation of any Person (including any other Guarantor) with respect to the applicable Guaranteed Obligations; (v) enforce and apply any security now or hereafter held by or for the benefit of such Beneficiary in respect hereof or the applicable Guaranteed Obligations and direct the order or manner of sale thereof, or exercise any other right or remedy that such Beneficiary may have against any such security, in each case as such Beneficiary in its discretion may determine consistent herewith or the applicable Hedge Agreement and any applicable security agreement, including foreclosure on any such security pursuant to one or more judicial or nonjudicial sales, whether or not every aspect of any such sale is commercially reasonable, and even though such action operates to impair or extinguish any right of reimbursement or subrogation or other right or remedy of any Guarantor against any other Credit Party or any security for the applicable Guaranteed Obligations; and (vi) exercise any other rights available to it under the Credit Documents or any Hedge Agreements; and
(g) this Guaranty and the obligations of Guarantors hereunder shall be valid and enforceable and shall not be subject to any reduction, limitation, impairment, discharge or termination for any reason (other than payment in full of the applicable Guaranteed Obligations), including the occurrence of any of the following, whether or not any Guarantor shall have had notice or knowledge of any of them: (i) any failure or omission to assert or enforce or agreement or election not to assert or enforce, or the stay or enjoining, by order of court, by operation of law or otherwise, of the exercise or enforcement of, any claim or demand or any right, power or remedy (whether arising under the Credit Documents or any Hedge Agreements, at law, in equity or otherwise) with respect to the applicable Guaranteed Obligations or any agreement relating thereto, or with respect to any other guaranty of or security for the payment of the applicable Guaranteed Obligations; (ii) any rescission, waiver, amendment or modification of, or any consent to departure from, any of the terms or provisions (including provisions relating to events of default) hereof, any of the other Credit Documents, any of the Hedge Agreements or any agreement or instrument executed pursuant thereto, or of any other guaranty or security for the applicable Guaranteed Obligations, in each case whether or not in accordance with the terms hereof or such Credit Document, such Hedge Agreement or any agreement relating to such other guaranty or security; (iii) the applicable Guaranteed Obligations, or any agreement relating thereto, at any time being found to be illegal, invalid or unenforceable in any respect; (iv) the application of payments received from any source (other than payments received pursuant to the other Credit Documents or any of the Hedge Agreements or from the proceeds of any security for the applicable Guaranteed Obligations, except to the extent such security also serves as
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collateral for indebtedness other than the applicable Guaranteed Obligations) to the payment of indebtedness other than the applicable Guaranteed Obligations, even though any Beneficiary might have elected to apply such payment to any part or all of the applicable Guaranteed Obligations; (v) any Beneficiarys consent to the change, reorganization or termination of the corporate structure or existence of the Borrower or any of its subsidiaries and to any corresponding restructuring of the applicable Guaranteed Obligations; (vi) any failure to perfect or continue perfection of a security interest in any collateral which secures any of the applicable Guaranteed Obligations; (vii) any defenses, set-offs or counterclaims which Borrower may allege or assert against any Beneficiary in respect of the applicable Guaranteed Obligations, including failure of consideration, breach of warranty, payment, statute of frauds, statute of limitations, accord and satisfaction and usury; and (viii) any other act or thing or omission, or delay to do any other act or thing, which may or might in any manner or to any extent vary the risk of any Guarantor as an obligor in respect of the applicable Guaranteed Obligations.
7.5 Waivers by Guarantors . Each Guarantor hereby waives, for the benefit of Beneficiaries: (a) any right to require any Beneficiary, as a condition of payment or performance by such Guarantor, to (i) proceed against the Borrower, any other guarantor (including any other Guarantor) of the applicable Guaranteed Obligations or any other Person, (ii) proceed against or exhaust any security held from the Borrower, any such other guarantor or any other Person, (iii) proceed against or have resort to any balance of any Deposit Account or credit on the books of any Beneficiary in favor of any Credit Party or any other Person, or (iv) pursue any other remedy in the power of any Beneficiary whatsoever; (b) any defense arising by reason of the incapacity, lack of authority or any disability or other defense of the Borrower or any other Guarantor including any defense based on or arising out of the lack of validity or the unenforceability of the applicable Guaranteed Obligations or any agreement or instrument relating thereto or by reason of the cessation of the liability of the Borrower or any other applicable Guarantor from any cause other than payment in full of the Guaranteed Obligations; (c) any defense based upon any statute or rule of law which provides that the obligation of a surety must be neither larger in amount nor in other respects more burdensome than that of the principal; (d) any defense based upon any Beneficiarys errors or omissions in the administration of the applicable Guaranteed Obligations, except behavior which amounts to bad faith; (e)(i) any principles or provisions of law, statutory or otherwise, which are or might be in conflict with the terms hereof and any legal or equitable discharge of such Guarantors obligations hereunder, (ii) the benefit of any statute of limitations affecting such Guarantors liability hereunder or the enforcement hereof, (iii) any rights to set-offs, recoupments and counterclaims, and (iv) promptness, diligence and any requirement that any Beneficiary protect, secure, perfect or insure any security interest or lien or any property subject thereto; (f) notices, demands, presentments, protests, notices of protest, notices of dishonor and notices of any action or inaction, including acceptance hereof, notices of default hereunder, the Hedge Agreements or any agreement or instrument related thereto, notices of any renewal, extension or modification of the applicable Guaranteed Obligations or any agreement related thereto, notices of any extension of credit to the Borrower and notices of any of the matters referred to in Section 7.4 and any right to consent to any thereof; and (g) any defenses or benefits that may be derived from or afforded by law which limit the liability of or exonerate guarantors or sureties, or which may conflict with the terms hereof.
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7.6 Guarantors Rights of Subrogation, Contribution, Etc. Until the applicable Guaranteed Obligations shall have been indefeasibly paid in full and the Revolving Commitments shall have terminated and all Letters of Credit shall have expired or been cancelled, each Guarantor hereby waives, any claim, right or remedy, direct or indirect, that such Guarantor now has or may hereafter have against the Borrower or any other Guarantor or any of its assets in connection with this Guaranty or the performance by such Guarantor of its obligations hereunder, in each case whether such claim, right or remedy arises in equity, under contract, by statute, under common law or otherwise and including (a) any right of subrogation, reimbursement or indemnification that such Guarantor now has or may hereafter have against the Borrower with respect to the applicable Guaranteed Obligations, (b) any right to enforce, or to participate in, any claim, right or remedy that any Beneficiary now has or may hereafter have against the Borrower, and (c) any benefit of, and any right to participate in, any collateral or security now or hereafter held by any Beneficiary. In addition, until the applicable Guaranteed Obligations shall have been indefeasibly paid in full and the Revolving Commitments shall have terminated and all Letters of Credit shall have expired (without any pending drawing) or been cancelled, each Guarantor shall withhold exercise of any right of contribution such Guarantor may have against any other guarantor (including any other Guarantor) of the applicable Guaranteed Obligations, including any such right of contribution as contemplated by Section 7.2. Each Guarantor further agrees that, to the extent the waiver or agreement to withhold the exercise of its rights of subrogation, reimbursement, indemnification and contribution as set forth herein is found by a court of competent jurisdiction to be void or voidable for any reason, any rights of subrogation, reimbursement or indemnification such Guarantor may have against the Borrower or against any collateral or security, and any rights of contribution such Guarantor may have against any such other guarantor, shall be junior and subordinate to any rights any Beneficiary may have against the Borrower, to all right, title and interest any Beneficiary may have in any such collateral or security, and to any right any Beneficiary may have against such other guarantor. If any amount shall be paid to any Guarantor on account of any such subrogation, reimbursement, indemnification or contribution rights at any time when all applicable Guaranteed Obligations shall not have been finally and indefeasibly paid in full, such amount shall be held in trust for the Administrative Agent on behalf of Beneficiaries and shall forthwith be paid over to Administrative Agent for the benefit of Beneficiaries to be credited and applied against the applicable Guaranteed Obligations, whether matured or unmatured, in accordance with the terms hereof.
7.7 Subordination of Other Obligations . Any Indebtedness of the Borrower or any Guarantor now or hereafter held by any Guarantor (the Obligee Guarantor ) is hereby subordinated in right of payment to the applicable Guaranteed Obligations, and any such Indebtedness collected or received by the Obligee Guarantor after an Event of Default has occurred and is continuing shall be held in trust for the Administrative Agent on behalf of Beneficiaries and shall forthwith be paid over to Administrative Agent for the benefit of Beneficiaries to be credited and applied against the applicable Guaranteed Obligations but without affecting, impairing or limiting in any manner the liability of the Obligee Guarantor under any other provision hereof.
7.8 Continuing Guaranty . This Guaranty is a continuing guaranty and shall remain in effect until all of the applicable Guaranteed Obligations shall have been paid in full and the Revolving Commitments shall have terminated and all Letters of Credit shall have expired
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(without any pending drawing) or been cancelled. Each Guarantor hereby irrevocably waives any right to revoke this Guaranty as to future transactions giving rise to any applicable Guaranteed Obligations.
7.9 Authority of Guarantors or Borrower . It is not necessary for any Beneficiary to inquire into the capacity or powers of any Guarantor or the Borrower or the officers, directors or any agents acting or purporting to act on behalf of any of them.
7.10 Financial Condition of Borrower . Any Credit Extension may be made to the Borrower or continued from time to time, and any Hedge Agreements may be entered into from time to time, in each case without notice to or authorization from any Guarantor regardless of the financial or other condition of the Borrower at the time of any such grant or continuation or at the time such Hedge Agreement is entered into, as the case may be. No Beneficiary shall have any obligation to disclose or discuss with any Guarantor its assessment, or any Guarantors assessment, of the financial condition of the Borrower. Each Guarantor has adequate means to obtain information from the Borrower on a continuing basis concerning the financial condition of the Borrower and its ability to perform its obligations under the Credit Documents and the Hedge Agreements, and each Guarantor assumes the responsibility for being and keeping informed of the financial condition of the Borrower and of all circumstances bearing upon the risk of nonpayment of the applicable Guaranteed Obligations. Each Guarantor hereby waives and relinquishes any duty on the part of any Beneficiary to disclose any matter, fact or thing relating to the business, operations or conditions of the Borrower now known or hereafter known by any Beneficiary.
7.11 Bankruptcy, Etc.
(a) So long as any applicable Guaranteed Obligations remain outstanding, no Guarantor shall, without the prior written consent of the Administrative Agent acting pursuant to the instructions of Requisite Lenders, commence or join with any other Person in commencing any bankruptcy, reorganization or insolvency case or proceeding of or against the Borrower or any other Guarantor. The obligations of Guarantors hereunder shall not be reduced, limited, impaired, discharged, deferred, suspended or terminated by any case or proceeding, voluntary or involuntary, involving the bankruptcy, insolvency, receivership, reorganization, winding-up, liquidation or arrangement of the Borrower or any other Guarantor or by any defense which the Borrower or any other Guarantor may have by reason of the order, decree or decision of any court or administrative body resulting from any such proceeding.
(b) Each Guarantor acknowledges and agrees that any interest on any portion of the applicable Guaranteed Obligations which accrues after the commencement of any case or proceeding referred to in clause (a) above (or, if interest on any portion of the applicable Guaranteed Obligations ceases to accrue by operation of law by reason of the commencement of such case or proceeding, such interest as would have accrued on such portion of the applicable Guaranteed Obligations if such case or proceeding had not been commenced) shall be included in the applicable Guaranteed Obligations because it is the intention of Guarantors and Beneficiaries that the applicable Guaranteed Obligations which are guaranteed by Guarantors pursuant hereto should be determined without regard to any rule of law or order which may relieve the Borrower of any portion of such applicable Guaranteed Obligations. Guarantors will
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permit any trustee in bankruptcy, receiver, receiver and manager, interim receiver, debtor in possession, assignee for the benefit of creditors, curator or similar Person to pay Administrative Agent, or allow the claim of the Administrative Agent in respect of, any such interest accruing after the date on which such case or proceeding is commenced.
(c) In the event that all or any portion of the applicable Guaranteed Obligations are paid by the Borrower, the obligations of Guarantors hereunder shall continue and remain in full force and effect or be reinstated, as the case may be, in the event that all or any part of such payment(s) are rescinded or recovered directly or indirectly from any Beneficiary as a preference, fraudulent transfer or otherwise, and any such payments which are so rescinded or recovered shall constitute applicable Guaranteed Obligations for all purposes hereunder.
7.12 Keepwell . Each Qualified ECP Guarantor hereby jointly and severally absolutely, unconditionally and irrevocably undertakes to provide such funds or other support as may be needed from time to time by each other Credit Party to honor all of its obligations under this Guaranty in respect of Swap Obligations ( provided , however , that each Qualified ECP Guarantor shall only be liable under this Section 7.12 for the maximum amount of such liability that can be hereby incurred without rendering its obligations under this Section 7.12, or otherwise under this Guaranty, voidable under applicable law relating to fraudulent conveyance or fraudulent transfer, and not for any greater amount); provided , that for the avoidance of doubt, any Foreign Subsidiary that is a CFC and any Qualified CFC Holding Company shall not make any contribution in support of any Obligations of the Borrower. The obligations of each Qualified ECP Guarantor under this Section shall remain in full force and effect until the Guaranteed Obligations have been paid in full and the Revolving Commitments shall have terminated and all Letters of Credit shall have expired (without any pending drawing) or have been cancelled or Cash Collateralized with at least [REDACTED Percentage] coverage. Each Qualified ECP Guarantor intends that this Section 7.12 constitute, and this Section 7.12 shall be deemed to constitute, a keepwell, support, or other agreement for the benefit of each other Credit Party for all purposes of Section 1a(18)(A)(v)(II) of the Commodity Exchange Act.
SECTION 8. | EVENTS OF DEFAULT |
8.1 Events of Default . If any one or more of the following conditions or events shall occur:
(a) any representation or warranty made or deemed made by any Credit Party in any Credit Document, or any representation, warranty, or certification contained in any certificate furnished by the Borrower or any other Credit Party in connection with or pursuant to any Credit Document, shall prove to have been false in any material respect when so made, deemed made or furnished;
(b) default shall be made in the payment of any principal of any Loan when and as the same shall become due and payable, whether at the due date thereof, at a date fixed for prepayment thereof, by acceleration thereof or otherwise;
(c) default shall be made in the payment of any interest on any Loan or in the payment of any Fee or any other amount (other than an amount referred to in paragraph (b)
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above) due under any Credit Document, when and as the same shall become due and payable, and such default shall continue unremedied for a period of [REDACTED Time Period];
(d) (i) any default shall be made in the due observance or performance by the Borrower or any of its Restricted Subsidiaries of any covenant contained in Section 5.1(a), Section 5.5(a), Section 5.9 or Section 6 (other than Section 6.10), (ii) any default shall be made in the due observance or performance by the Borrower or any of its Restricted Subsidiaries of any covenant contained in Section 6.10; provided , that an Event of Default under this clause (ii) shall not constitute an Event of Default for purposes of any Term Loans unless and until the Revolving Lenders have declared all obligations to be immediately due and payable in accordance with this Section 8.1 and such declaration has not been rescinded on or before such date or (iii) any default shall be made in the due observance or performance by any Credit Party of any covenant, condition or agreement contained in any Credit Document (other than any default specified in paragraph (b) or (c) above or clause (d)(i) above) and such default shall continue unremedied for a period of [REDACTED Time Period] after written notice thereof from the Administrative Agent or the Requisite Lenders to the Borrower;
(e) (i) the Borrower or any Restricted Subsidiary fails to pay when due any principal of, interest on or premiums in respect of any Material Indebtedness, in each case giving effect to any grace or cure period, or (ii) any event or condition shall occur that (A) results in any Material Indebtedness becoming due prior to its scheduled maturity or (B) enables or permits (with all applicable grace periods having expired) the holder or holders of any Material Indebtedness or any trustee or agent on its or their behalf to cause, with the giving of notice if required, any Material Indebtedness to become due, or to require the prepayment, repurchase, redemption or defeasance thereof, prior to its scheduled maturity; provided that this clause (e)(ii) shall not apply to (x) any secured Indebtedness that becomes due as a result of the voluntary sale or transfer of the property or assets securing such Indebtedness if such sale or transfer is permitted hereunder and under the documents providing for such Indebtedness, (y) any Indebtedness that becomes due pursuant to customary prepayment or redemption provisions solely as a result of a voluntary sale or transfer of property or assets or a change of control or (z) any Indebtedness that becomes due solely as a result of a refinancing thereof permitted by this Agreement; provided , further , that notwithstanding the foregoing, any breach of, or default under, any other Material Indebtedness solely as a result of a Financial Covenant Default shall not constitute an Event of Default under this paragraph (e) unless and until the date on which such breach or default constitutes an Event of Default under paragraph (d);
(f) there shall have occurred a Change of Control;
(g) (i) an involuntary case or proceeding shall be commenced or an involuntary petition, application or other originating process shall be filed relating to (A) the liquidation, reorganization, winding up, dissolution or suspension of general operations or other relief in respect of the Borrower or any Material Subsidiary, or of a substantial part of the property or assets of the Borrower or any Material Subsidiary under any Debtor Relief Law, (B) the appointment of a liquidator, receiver, administrator, administrative receiver, compulsory manager, interim receiver, receiver and manager, trustee, custodian, sequestrator, conservator or similar official for the Borrower or any Material Subsidiary, or for a substantial part of the property or assets of the Borrower or any Material Subsidiary; or (C) the winding-up or
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liquidation of the Borrower or any Material Subsidiary (except, in the case of any Material Subsidiary, in a transaction permitted by Section 6.4); and such proceeding or petition, application or other originating process shall continue undismissed for [REDACTED Time Period] or an order or decree approving or ordering any of the foregoing shall be entered;
(h) the Borrower or any Material Subsidiary shall (i) voluntarily commence any proceeding or file any petition or application or its shareholders shall pass a resolution seeking liquidation, winding up, reorganization or other relief under any Debtor Relief Law (including the making of a proposal or the filing of a notice of intention to make a proposal), (ii) consent to the institution of, or fail to contest in a timely and appropriate manner, any proceeding or the filing of any petition described in paragraph (g) above, (iii) apply for or consent to the appointment of a liquidator, receiver, administrative receiver, administrator, compulsory manager, interim receiver, receiver and manager, receiver, trustee, custodian, sequestrator, conservator or similar official for the Borrower or any of the Material Subsidiaries or for a substantial part of the property or assets of the Borrower or any of the Material Subsidiaries, (iv) file an answer admitting the material allegations of a petition, application or other originating process filed against it in any such proceeding, (v) make a general assignment for the benefit of creditors or (vi) become unable, admit in writing its inability or fail generally to pay its debts as they become due;
(i) the failure by the Borrower or any Restricted Subsidiary to pay one or more final and non-appealable judgments aggregating in excess of [REDACTED Dollar Amount] (to the extent not covered by third-party insurance for which the insurer has not disputed coverage), which judgments are not discharged or effectively waived or stayed for a period of [REDACTED Time Period] , or any action shall be legally taken by a judgment creditor to levy upon assets or properties of the Borrower or any Restricted Subsidiary to enforce any such judgment;
(j) (i) a trustee shall be appointed by a U.S. district court to administer any Pension Plan, (ii) an ERISA Event or ERISA Events shall have occurred, (iii) the Borrower or any of its subsidiaries shall engage in any non-exempt prohibited transaction (as defined in Section 406 of ERISA or Section 4975 of the Internal Revenue Code) involving any Pension Plan, or (iv) the applicable pension regulator appoints a replacement administrator for any Canadian Pension Plan; and in each case in clauses (i) through (iii) above, such event or condition, together with all other such events or conditions, if any, would reasonably be expected to have a Material Adverse Effect; or
(k) (i) any Credit Document shall for any reason be asserted in writing by any Credit Party not to be a legal, valid and binding obligation of such party thereto, (ii) any security interest purported to be created by any Collateral Document relating to a material portion of the Collateral of the Credit Parties on a consolidated basis shall cease to be, or shall be asserted in writing by the Borrower or any other Credit Party not to be, a valid and perfected security interest (perfected as or having the priority required by this Agreement or the relevant Collateral Document and subject to such limitations and restrictions as are set forth herein and therein) in the Collateral covered thereby, except to the extent that any such loss of perfection or priority results from the limitations of foreign laws, rules and regulations as they apply to pledges of Equity Interests in Foreign Subsidiaries or the application thereof, or from the failure of the
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applicable Agent to maintain possession of certificates actually delivered to it representing securities pledged under the Pledge and Security Agreement, or to file UCC continuation statements or similar filings in other jurisdictions and except, as to Collateral consisting of real property, to the extent that such loss is covered by a lenders title insurance policy and the Administrative Agent shall be reasonably satisfied with the credit of such insurer and such insurer has not denied coverage, (iii) the guarantees pursuant to the Collateral Documents by any Credit Party of any of the Obligations shall cease to be in full force and effect (other than in accordance with the terms thereof), or shall be asserted in writing by any Credit Party not to be in effect or not to be legal, valid and binding obligations (other than in accordance with the terms thereof) or (iv) any Intercreditor Agreement or subordination agreement in respect of Material Indebtedness of the Borrower which is subordinated to the Obligations shall for any reason be asserted in writing by any party thereto not to be a legal, valid and binding obligation of such party (other than an Agent or Lender);
then, except as provided below with respect to a Financial Covenant Default, (i) in every such event (other than an event with respect to the Borrower described in clause (g) or (h) of this Section 8.1), and at any time thereafter during the continuance of such event, the Administrative Agent may and, at the request of the Requisite Lenders, shall, by notice to the Borrower, take any or all of the following actions, at the same or different times: (A) declare the Loans then outstanding to be forthwith due and payable in whole or in part, whereupon the principal of the Loans so declared to be due and payable, together with accrued interest thereon and any unpaid accrued fees and all other liabilities of the Borrower accrued hereunder and under any other Credit Document, shall become forthwith due and payable, without presentment, demand, protest or any other notice of any kind, all of which are hereby expressly waived by the Borrower, anything contained herein or in any other Credit Document to the contrary notwithstanding; (B) declare Commitments of each Lender and any obligation of the L/C Issuers to make L/C Credit Extensions to be terminated, whereupon such Commitments and obligation shall be terminated; (C) require that the Borrower Cash Collateralize the L/C Obligations (in an amount equal to the then Outstanding Amount thereof); and (D) exercise all rights and remedies granted to it under any Credit Document and all of its rights under any other applicable law or in equity, and (ii) in any event with respect to the Borrower described in clause (g) or (h) of this Section 8.1, the principal of the Loans then outstanding, together with accrued interest thereon and any unpaid accrued fees and all other liabilities of the Borrower accrued hereunder and under any other Credit Document, shall automatically become due and payable, without presentment, demand, protest or any other notice of any kind, all of which are hereby expressly waived by the Borrower, anything contained herein or in any other Credit Document to the contrary notwithstanding. Upon the occurrence of a failure by the Borrower to comply with the requirements of the Financial Performance Covenant (a Financial Covenant Default ), the Requisite Class Lenders with respect to the Revolving Loans may (x) to the extent the Borrower is permitted to make a Specified Equity Contribution pursuant to the terms of Section 8.2, on the date that is [REDACTED Time Period] after the date on which financial statements are required to be delivered pursuant to Section 5.4(a) or (b), as applicable, and only if such Financial Covenant Default has not been cured pursuant to Section 8.2 or (y) to the extent the Borrower is not permitted to make a Specified Equity Contribution pursuant to the terms of Section 8.2, on the date on which financial statements are required to be delivered pursuant to Section 5.4(a) or (b), as applicable, either (1) terminate the Revolving Commitments and/or (2) take the actions specified above in this Section 8.1 in respect of the Revolving Commitments
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and the Revolving Loans; provided that, solely to the extent the Borrower is permitted to make a Specified Equity Contribution pursuant to the terms of Section 8.2, neither the Administrative Agent, the Collateral Agent nor any Lender shall exercise the right (or have the right) to accelerate the Loans, terminate the Commitments, foreclose on or take possession of the Collateral or take or have the right to take any other remedy under the Credit Documents on the basis of such Financial Covenant Default until the [REDACTED Time Period] Business Day following the date the applicable financial statements are to be delivered; provided , further , however , that no Lender shall have any obligation to make any Loans hereunder and no L/C Issuer shall have any obligation to issue or extend any Letter of Credit hereunder during such [REDACTED Time Period] Business Day period during which any Financial Covenant Default exists until the date upon which the Borrower has cured the Financial Covenant Default in accordance with Section 8.2. In respect of a Financial Covenant Default that is continuing, the Requisite Lenders may take the actions specified in this Section 8.1 on the date the Requisite Class Lenders with respect to the Revolving Loans have terminated the Revolving Commitments and accelerated all Obligations in respect of the Revolving Loans; provided , however , that the Requisite Lenders may not take such actions if either (A) prior to the date of any such termination of Revolving Commitments and acceleration of Obligations in respect of Revolving Loans by the Requisite Class Lenders with respect to the Revolving Loans, the Revolving Loans have been repaid in full (other than contingent indemnification and reimbursement obligations for which no claim has been made), no Letters of Credit are outstanding (unless Cash Collateralized) or unreimbursed and the Revolving Commitments have been terminated by the Borrower or (B) the Financial Covenant Default has been waived by the Requisite Class Lenders with respect to the Revolving Loans.
8.2 Right to Cure . Notwithstanding anything to the contrary contained in Section 8.1, for purposes of determining whether a Financial Covenant Default has occurred, any equity contribution (in the form of cash common equity or other equity reasonably acceptable to the Administrative Agent) made to the Borrower after the last day of any Fiscal Quarter and on or prior to the day that is [REDACTED Time Period] after the day on which financial statements are required to be delivered for that Fiscal Quarter will, upon the delivery of a written request by the Borrower to the Administrative Agent (such request, the Cure Notice ), be included as an addition in the calculation of Consolidated Adjusted EBITDA solely for the purposes of calculating the Financial Performance Covenant on a Pro Forma Basis at the end of such Fiscal Quarter and any subsequent period that includes such Fiscal Quarter (any such equity contribution, a Specified Equity Contribution ); provided that (a) the Borrower shall not be permitted to so request that a Specified Equity Contribution be included as an addition in the calculation of Consolidated Adjusted EBITDA with respect to any Fiscal Quarter unless, after giving effect to such requested Specified Equity Contribution, (x) there will be a period of at least two (2) Fiscal Quarters in the Relevant Four Fiscal Quarter Period in which no Specified Equity Contribution has been made, and (y) there have been no more than five (5) Fiscal Quarters in which a Specified Equity Contribution has been made, (b) the amount of any Specified Equity Contribution and the use of proceeds therefrom will be no greater than the amount required to cause the Senior Secured Net Leverage Ratio on a Pro Forma Basis to be in compliance with Section 6.10 and (c) all Specified Equity Contributions and the use of proceeds therefrom will be disregarded for all other purposes under the Credit Documents (including calculating Cumulative Credit, Consolidated Adjusted EBITDA for purposes of determining basket levels, Applicable Margin and other items governed by reference to Consolidated
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Adjusted EBITDA). To the extent that the proceeds of the Specified Equity Contribution are used to repay Indebtedness, such Indebtedness shall not be deemed to have been repaid for purposes of calculating the Senior Secured Net Leverage Ratio on a Pro Forma Basis set forth in Section 6.10 for the Relevant Four Fiscal Quarter Period. For purposes of this paragraph, the term Relevant Four Fiscal Quarter Period means, with respect to any requested Specified Equity Contribution, the four Fiscal Quarter period ending on (and including) the Fiscal Quarter in which Consolidated Adjusted EBITDA will be increased as a result of such Specified Equity Contribution.
SECTION 9. | AGENTS |
9.1 Authorization and Action . (a) Each Lender and each L/C Issuer (in its capacity as such and on behalf of itself and its Affiliates as potential Lender Counterparties (if applicable)) hereby irrevocably appoints Royal Bank of Canada to act on its behalf as the Administrative Agent hereunder and under the other Credit Documents, as applicable, for the benefit of the Secured Parties, and hereby irrevocably appoints Royal Bank of Canada to act on its behalf as the Collateral Agent hereunder and under the other Credit Documents, as applicable, for the benefit of the Secured Parties, and each such Lender and each such L/C Issuer irrevocably authorizes each Agent to take such action as agent on its behalf and to exercise such powers and discretion under this Agreement and the other Credit Documents as are delegated to such Agent by the terms hereof and thereof, together with such powers and discretion as are reasonably incidental thereto. As to any matters not expressly provided for by the Credit Documents (including, without limitation, enforcement or collection of the Notes or Loans), no Agent shall be required to exercise any discretion or take any action, but shall be required to act or to refrain from acting (and shall be fully protected in so acting or refraining from acting) upon the instructions of the Requisite Lenders (or, if required hereby, all Lenders), and such instructions shall be binding upon all Lenders, all L/C Issuers, all Lender Counterparties and all holders of Notes; provided , however , that no Agent shall be required to take any action that exposes such Agent to personal liability or that is contrary to this Agreement or applicable law. Without any further consent of the Lenders, the L/C Issuers or any Lender Counterparty, the Administrative Agent and the Collateral Agent shall be authorized to negotiate, execute and deliver on behalf of the Secured Parties any Intercreditor Agreement or any amendment (or amendment and restatement) to the Collateral Documents that are, in each case, consistent with the terms of this Agreement.
(b) In further of the foregoing, each Lender and each L/C Issuer (in its capacity as such and on behalf of itself and its Affiliates as potential Lender Counterparties (if applicable)), hereby appoints the Collateral Agent to act as the agent of such Lender and/or L/C Issuer for purposes of acquiring, holding and enforcing any and all Liens on Collateral granted by any of the Credit Parties to secure any of the Obligations, together with such powers and discretion as are reasonably incidental or related thereto. In this connection, the Collateral Agent (and any Supplemental Agents appointed by the Collateral Agent pursuant to Section 9.1(c) below for purposes of holding or enforcing any Lien on the Collateral (or any portion thereof) granted under the Collateral Documents, or for exercising any rights or remedies thereunder at the direction of the Collateral Agent), shall be entitled to the benefits of this Section 9 (including, without limitation, Section 9.5, as though any such Supplemental Agent were an Agent under the Credit Documents) as if set forth in full herein with respect thereto.
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(c) Any Agent may execute any of its duties under this Agreement or any other Credit Document (including for purposes of holding or enforcing any Lien on the Collateral (or any portion thereof) granted under the Collateral Documents or of exercising any rights and remedies thereunder at the direction of the Collateral Agent) by or through agents, employees or attorneys-in-fact and shall be entitled to advice of counsel and other consultants or experts concerning all matters pertaining to such duties. Each Agent may also from time to time, when such Agent deems it to be necessary or desirable, perform any and all of its duties and exercise its rights and powers hereunder or under any other Credit Document by or through any one or more sub-agents appointed by the Agent (each, a Supplemental Agent ). Each Agent and any such sub-agent may perform any and all of its duties and exercise its rights and powers by or through their respective Related Parties; provided , however , that no such Supplemental Agent shall be authorized to take any action with respect to any Collateral unless and except to the extent expressly authorized in writing by the Collateral Agent. Should any instrument in writing from the Borrower or any other Credit Party be required by any Supplemental Agent so appointed by an Agent to more fully or certainly vest in and confirm to such Supplemental Agent such rights, powers, privileges and duties, the Borrower shall, or shall cause such Credit Party to, execute, acknowledge and deliver any and all such instruments promptly upon request by the Agent. If any Supplemental Agent, or successor thereto, shall die, become incapable of acting, resign or be removed, all rights, powers, privileges and duties of such Supplemental Agent, to the extent permitted by applicable law, shall automatically vest in and be exercised by the Agent until the appointment of a new Supplemental Agent. The exculpatory provisions of this Section 9 shall apply to any such sub-agent and to the Related Parties of each Agent and any such sub-agent, and shall apply to their respective activities in connection with the syndication of the credit facilities provided for herein as well as activities as Agent. No Agent shall be responsible for the negligence or misconduct of any sub-agents except to the extent that a court of competent jurisdiction determines in a final and non-appealable judgment that the Agent acted with gross negligence or willful misconduct in the selection of such sub-agents.
9.2 Agents Reliance, Etc. Neither any Agent nor any of their respective directors, officers, agents or employees shall be liable for any action taken or omitted to be taken by it or them under or in connection with the Credit Documents, (i) with the consent or at the request of the Requisite Lenders (or such other number or percentage of the Lenders as shall be necessary, or as such Agent shall believe in good faith shall be necessary) or (ii) in the absence of such Agents own gross negligence or willful misconduct as determined by a court of competent jurisdiction in a final and non-appealable judgment. Without limitation to the generality of the foregoing, each Agent: (a) may treat the payee of any Note as the holder thereof until, in the case of the Administrative Agent, the Administrative Agent receives and accepts an Assignment Agreement entered into by the Lender that is the payee of such Note, as assignor, and an Eligible Assignee, as assignee, or, in the case of the Collateral Agent, such Agent has received notice from the Administrative Agent that it has received and accepted such Assignment Agreement, in each case as provided in Section 10.4; (b) may consult with legal counsel (including counsel for any Credit Party), independent public accountants and other experts selected by it and shall not be liable for any action taken or omitted to be taken in good faith by it in accordance with the advice of such counsel, accountants or experts; (c) makes no warranty or representation to any Secured Party and shall not be responsible to any Secured Party for any statements, warranties or representations (whether written or oral) made in or in connection with the Credit Documents; (d) shall not have any duty to ascertain or to inquire as to the performance, observance or
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satisfaction of any of the terms, covenants or conditions of any Credit Document on the part of any Credit Party or the existence at any time of any Default under the Credit Documents or to inspect the property (including the books and records) of any Credit Party, and shall be deemed to have no knowledge of any Default or Event of Default unless such Agent shall have received notice thereof in writing from a Lender or a Credit Party stating that a Default or Event of Default has occurred and specifying the nature thereof; (e) shall not be responsible to any Secured Party for the due execution, legality, validity, enforceability, genuineness, sufficiency or value of, or the perfection or priority of any lien or security interest created or purported to be created under or in connection with, any Credit Document or any other instrument or document furnished pursuant thereto; (f) shall not be subject to any fiduciary or other implied duties, regardless of whether a Default or Event of Default has occurred and is continuing; (g) shall not have any duty to take any discretionary action or exercise any discretionary powers, except discretionary rights and powers expressly contemplated hereby or by the other Credit Documents that the Administrative Agent is required to exercise as directed in writing by the Requisite Lenders (or such other number or percentage of Lenders as shall be expressly provided for herein or in the other Credit Documents) ( provided that no Agent shall be required to take any action that, in its opinion or the opinion of its counsel, may expose such Agent to liability or that is contrary to any Credit Document or applicable law, including for the avoidance of doubt, any action that may be in violation of the automatic stay or similar provision under any Debtor Relief Law or that may affect a forfeiture, modification or termination of property of a Defaulting Lender in violation of any Debtor Relief Law and (h) shall incur no liability under or in respect of any Credit Document by acting upon any notice, consent, certificate or other instrument or writing (which may be by facsimile, electronic mail or Internet or intranet posting or other distribution) believed by it to be genuine and signed or sent by the proper party or parties.
9.3 Royal Bank of Canada and its Affiliates . With respect to its Commitments, the Loans made by it and the Notes issued to it, if any, Royal Bank of Canada shall have the same rights and powers under the Credit Documents as any other Lender or other Secured Party and may exercise the same as though it were not an Agent; and each of the terms Lender and Secured Party shall, unless otherwise expressly indicated, include Royal Bank of Canada in its individual capacity. Royal Bank of Canada and its Affiliates may accept deposits from, lend money to, act as trustee under indentures of, accept investment banking engagements from and generally engage in any kind of business with, any Credit Party, any subsidiaries of any Credit Party and any Person that may do business with or own securities of any Credit Party or any such subsidiary, all as if Royal Bank of Canada was not an Agent and without any duty to account therefor to the Lenders or any other Secured Party. No Agent shall have any duty to disclose any information obtained or received by it or any of its Affiliates relating to any Credit Party or any subsidiaries of any Credit Party to the extent such information was obtained or received in any capacity other than as such Agent.
9.4 Lender Credit Decision . Each Lender acknowledges that it has, independently and without reliance upon any Agent or any other Lender and based on the financial statements referred to in Section 5.4 and such other documents and information as it has deemed appropriate, made its own credit analysis and decision to enter into this Agreement. Each Lender also acknowledges that it will, independently and without reliance upon any Agent or any other Lender and based on such documents and information as it shall deem appropriate at the time, continue to make its own credit decisions in taking or not taking action under this Agreement.
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9.5 Indemnification of Agents .
(a) Each Lender severally agrees to indemnify each Agent or any Related Party (in each case, to the extent not reimbursed by the Borrower) from and against such Lenders Pro Rata Share (to be determined on the basis of the sum of (i) the Outstanding Amount of all Loans outstanding at such time and (ii) the Outstanding Amount of all L/C Obligations outstanding at such time) of any and all liabilities, obligations, losses, damages, penalties, actions, judgments, suits or other proceedings, reasonable and documented out-of-pocket costs, expenses or disbursements of any kind or nature whatsoever that may be imposed on, incurred by, or asserted against such Agent, any L/C Issuer or any Related Party in any way relating to or arising out of the Credit Documents or any action taken or omitted by such Agent, any L/C Issuer or any Related Party under the Credit Documents (collectively, the Indemnified Costs ); provided , however , that no Lender shall be liable for any portion of such liabilities, obligations, losses, damages, penalties, actions, judgments, suits or other proceedings, costs, expenses or disbursements resulting from such Agents, any L/C Issuers or any Related Partys gross negligence, bad faith or willful misconduct or a material breach of the obligations of such Agent, L/C Issuer or any Related Party as found in a final non-appealable judgment by a court of competent jurisdiction. Without limitation of the foregoing, each Lender agrees to reimburse each Agent, each L/C Issuer or any Related Party promptly upon demand for its Pro Rata Share of any costs and expenses (determined as of the time that the applicable unreimbursed expense or indemnity payment is sought) (including, without limitation, reasonable fees and expenses of counsel) payable by the Borrower under Section 10.5, to the extent that such Agent, each L/C Issuer or any Related Party is not promptly reimbursed for such costs and expenses by the Borrower. In the case of any investigation, litigation or proceeding giving rise to any Indemnified Costs, this Section 9.5 applies whether any such investigation, litigation or proceeding is brought by any Lender or any other Person. The obligations of the Lenders under this subsection (a) are subject to the provisions of Section 2.1(a).
(b) The failure of any Lender to reimburse any Agent, each L/C Issuer or any Related Party, as the case may be, promptly upon demand for its Pro Rata Share of any amount required to be paid by the Lenders to such Agent, any L/C Issuer or any Related Party, as the case may be, as provided herein shall not relieve any other Lender of its obligation hereunder to reimburse such Agent, any L/C Issuer or Related Party, as the case may be, for its Pro Rata Share of such amount, but no Lender shall be responsible for the failure of any other Lender to reimburse such Agent, any L/C Issuer or Related Party, as the case may be, for such other Lenders Pro Rata Share of such amount. Without prejudice to the survival of any other agreement of any Lender hereunder, the agreement and obligations of each Lender contained in this Section 9.5 shall survive the payment in full of principal, interest and all other amounts payable hereunder and under the other Credit Documents.
9.6 Successor Agents . (a) Any Agent may resign or, if it or its controlling Affiliate thereof is subject to a Distress Event, be removed by the Borrower or the Requisite Lenders, in each case, at any time by giving ten [REDACTED Time Period] written notice thereof to the Lenders and the Borrower. Upon any such resignation or removal as Administrative Agent, the Requisite Lenders shall have the right to appoint a successor Agent that is not a Disqualified Person which successor Agent (unless an Event of Default has occurred and is continuing at the time of such appointment), shall be subject to approval by the Borrower (which approval shall
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not be unreasonably withheld if such successor Agent is a commercial bank with a combined capital and surplus of at least [REDACTED Dollar Amount] and otherwise may be withheld in the Borrowers sole discretion). If no successor Agent shall have been so appointed by the Requisite Lenders, and shall have accepted such appointment, [REDACTED Time Period] after the retiring Agents giving of notice of resignation, then the retiring Agent may, on behalf of the Lenders, appoint a successor Agent that is not a Disqualified Person, subject to approval by the Borrower in accordance with the preceding sentence. Upon the acceptance of any appointment as Agent hereunder by a successor Agent and, in the case of a successor Collateral Agent, upon the execution and filing or recording of such financing statements, or amendments thereto, and such other instruments or notices, as may be necessary or desirable, or as the Requisite Lenders may request, in order to continue the perfection of the Liens granted or purported to be granted by the Collateral Documents, such successor Agent shall succeed to and become vested with all the rights, powers, discretion, privileges and duties of the retiring Agent, and the retiring Agent shall be discharged from its duties and obligations under the Credit Documents; provided that the Borrower shall have no obligation to pay any fee to any successor Agent that is greater than or in addition to the fees payable to the Administrative Agent on the Closing Date. If within [REDACTED Time Period] after written notice is given of the retiring Agents resignation under this Section 9.6 no successor Agent shall have been appointed and shall have accepted such appointment, then on such [REDACTED Time Period] (a) the retiring Agents resignation shall become effective, (b) the retiring Agent shall thereupon be discharged from its duties and obligations under the Credit Documents and (c) the Requisite Lenders shall thereafter perform all duties of the retiring Agent under the Credit Documents (and, except for any indemnity payments or other amount then owed to the retiring or removed Agent, all payments, communications and determinations provided to be made by, to or through such Agent shall instead be made by or to each Lender directly) until such time, if any, as the Requisite Lenders appoint a successor Agent that is not a Disqualified Person as provided above. After any retiring Agents resignation hereunder as Agent shall have become effective, the provisions of this Section 9 shall inure to its benefit as to any actions taken or omitted to be taken by it while it was Agent under this Agreement.
9.7 Arrangers and Documentation Agents Have No Liability . It is understood and agreed that none of the Arrangers nor any Documentation Agent shall have any duties, responsibilities or liabilities under or in respect of this Agreement whatsoever.
9.8 Administrative Agent May File Proofs of Claim .
(a) In case of the pendency of any receivership, insolvency, liquidation, bankruptcy, reorganization, arrangement, adjustment, composition or other judicial proceeding relative to any Credit Party, the Administrative Agent (irrespective of whether the principal of any Loan or L/C Obligation shall then be due and payable as herein expressed or by declaration or otherwise and irrespective of whether the Administrative Agent shall have made any demand on the Borrower) shall be entitled and empowered, by intervention in such proceeding or otherwise:
(i) to file and prove a claim for the whole amount of the principal and interest owing and unpaid in respect of the Loans, L/C Obligations and all other Obligations that are owing and unpaid and to file such other documents as may be
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necessary or advisable in order to have the claims of the Lenders, the Agents and the other Secured Parties (including any claim for the reasonable compensation, expenses, disbursements and advances of the Lenders, the Agents and the other Secured Parties and their respective agents and counsel and all other amounts due the Lenders and the Agents under Sections 2.3(j), 2.9 and 10.5) allowed in such judicial proceeding; and
(ii) to collect and receive any monies or other property payable or deliverable on any such claims and to distribute the same;
and any custodian, receiver, assignee, trustee, liquidator, sequestrator or other similar official in any such judicial proceeding is hereby authorized by each Lender to make such payments to the Administrative Agent and, in the event that the Administrative Agent shall consent to the making of such payments directly to the Lenders, to pay to the Administrative Agent any amount due for the reasonable compensation, expenses, disbursements and advances of the Agents and their respective agents and counsel, and any other amounts due the Agents under Section 2.9 and Section 10.5.
(b) Nothing contained herein shall be deemed to authorize the Administrative Agent to authorize or consent to or accept or adopt on behalf of any Lender or any other Secured Party any plan of reorganization, arrangement, adjustment or composition affecting the Obligations or the rights of any Lender or any other Secured Party or to authorize the Administrative Agent to vote in respect of the claim of any Lender or any other Secured Party in any such proceeding.
9.9 Collateral and Guaranty Matters .
(a) Each Lender and each L/C Issuer hereby authorizes and directs the Administrative Agent and the Collateral Agent to enter into the Collateral Documents and any Intercreditor Agreements as required herein for the benefit of the Lenders and the other Secured Parties. Without limiting the provisions of Section 9.8, the Lenders and the L/C Issuers, on behalf of themselves and their respective Affiliates as potential Lender Counterparties (if applicable), irrevocably authorize the Collateral Agent and the Administrative Agent, at such Agents option and in such Agents discretion:
(i) to release any Lien on any property granted to or held by the Collateral Agent under any Credit Document (A) upon termination of the aggregate Commitments and payment in full of all Obligations, including all obligations under all Hedge Agreements, and the expiration or termination of all Letters of Credit, (B) that is sold or to be sold as part of or in connection with any sale permitted hereunder or under any other Credit Document, or (C) subject to Section 10.8, if approved, authorized or ratified in writing by the Requisite Lenders;
(ii) to release any Guarantor from its obligations under the applicable Guaranty if such Person ceases to be a Restricted Subsidiary as a result of a transaction permitted hereunder; and
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(iii) to subordinate any Lien on any property granted to or held by the Collateral Agent under any Credit Document to the holder of any Lien on such property that is permitted by Section 6.12.
(b) Upon request by the Administrative Agent or the Collateral Agent at any time, the Requisite Lenders (or, if necessary, all Lenders) will confirm in writing the authority of the Agents to release its interest in particular types or items of property, or to release any Guarantor from its obligations under the applicable Guaranty pursuant to this Section 9.9. In each case as specified in this Section 9.9, the Administrative Agent and the Collateral Agent will, at the Borrowers expense, execute and deliver to the applicable Credit Party such documents as such Credit Party may reasonably request to evidence the release of such item of Collateral from the assignment and security interest granted under the Collateral Documents, or to release such Guarantor from its obligations under the applicable Guaranty, in each case in accordance with the terms of the Credit Documents and this Section 9.9.
9.10 Withholding . To the extent required by any applicable law, any Administrative Agent may withhold from any payment to any Lender an amount equivalent to any withholding Tax applicable to such payment. If any Governmental Authority asserts a claim that an Administrative Agent did not properly withhold Tax from amounts paid to or for the account of any Lender for any reason, or an Administrative Agent has paid over to any Governmental Authoritys applicable withholding Tax relating to a payment to a Lender but no deduction has been made from such payment, such Lender shall indemnify such Administrative Agent fully for all amounts paid, directly or indirectly, by such Administrative Agent as Tax or otherwise, including any penalties or interest and together with any and all expenses incurred, unless such amounts have been indemnified by any Credit Party or the relevant Lender. Each Lender hereby authorizes the Administrative Agent to set off and apply any and all amounts at any time owing to such Lender under any Credit Document or otherwise payable by the Administrative Agent to the Lender from any other source against any amount due to the Administrative Agent under this Section 9.10. Each partys obligations under this Section 9.10 shall survive the resignation or replacement of the Administrative Agent or any assignment of rights by, or the replacement of, a Lender, the termination of the Commitments and the repayment, satisfaction or discharge of all obligations under any Credit Document.
9.11 Intercreditor Agreements . Each Lender (in its capacity as such and on behalf of itself and its Affiliates as Lender Counterparties) hereunder (x) agrees that it will be bound by and will take no actions contrary to the provisions of the Intercreditor Agreements and (y) authorizes and instructs Royal Bank of Canada to enter into the Intercreditor Agreements as Collateral Agent on behalf of such Lender, and Royal Bank of Canada to enter into the Intercreditor Agreements as First Lien Administrative Agent (as defined therein) on behalf of such Lender. Each Lender (in its capacity as such and on behalf of itself and its Affiliates as Lender Counterparties) hereby further agrees that (a) the Agents may, from time to time on and after the Closing Date, without any further consent of any Lender, enter into amendments to, amendments and restatements of, supplements to and/or replacements of, any Intercreditor Agreement, and to enter into any other intercreditor agreement with the collateral agent or other representatives of the holders of Indebtedness that is permitted to be secured by a Lien on the Collateral that is permitted under this Agreement, in each case, in order to effect the relative priority of Liens on the Collateral and to provide for certain additional rights, obligations and
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limitations in respect of, any Liens permitted by the terms of this Agreement to be pari passu with or junior or senior to the Liens securing the Obligations with respect to part or all of the Collateral, which are, in each case, incurred in accordance with Section 6 of this Agreement, and to establish certain relative rights as between the holders of the Obligations and the holders of the Indebtedness secured by such Liens, (b) the Agents may rely exclusively on a certificate of an Authorized Officer of Borrower as to whether any such Liens are permitted, and (c) such Intercreditor Agreements and any other intercreditor agreement referred to in the foregoing clause (a) entered into by the Agents shall be binding on the Secured Parties. Furthermore, each Lender (in its capacity as such and on behalf of itself and its Affiliates as Lender Counterparties) hereby authorizes the Agents to release or subordinate any Lien on any property granted to or held by the Agents under any Credit Document as provided in Section 10.18.
9.12 Québec Security . For the purposes of any hypothec or other security document granted under the laws of the Province of Quebec as security for any debenture, bond or other title of indebtedness which may now or in the future be required to be provided by any Credit Party, the Collateral Agent is hereby irrevocably authorized and appointed by each of the Secured Parties and, if applicable, on behalf of any of its Affiliates which is a Secured Party, to act as the holder of an irrevocable power of attorney ( fondé de pouvoir ) (within the meaning of Article 2692 of the Civil Code of Quebec) to act on behalf of the present and future holders of any debenture, bond or other title of indebtedness and to exercise such rights and duties as are conferred upon a fondé de pouvoir under the relevant deed of hypothec and applicable laws (with the power to delegate any such rights or duties). Moreover, in respect of any pledge by any such Credit Party of any such debenture, bond or other title of indebtedness as security for any obligations arising under the Credit Documents, the Collateral Agent shall also be authorized to hold such debenture, bond or other title of indebtedness as agent and pledgee for its own account and for the benefit of all Secured Parties, the whole notwithstanding the provisions of Section 32 of the An Act respecting the Special Powers of Legal Persons (Quebec). The execution prior to the date hereof by the Collateral Agent in its capacity as fondé de pouvoir of any deed of hypothec or other security documents made pursuant to the laws of the Province of Quebec, is hereby ratified and confirmed. Any Person who becomes a Secured Party or successor Collateral Agent shall be deemed to have consented to and ratified the foregoing appointment of the Collateral Agent as fondé de pouvoir , agent and mandatary on behalf of all Secured Parties, including such Person and any Affiliate of such Person designated above as a Secured Party. For greater certainty, the Collateral Agent, acting as the holder of an irrevocable power of attorney ( fondé de pouvoir ), shall have the same rights, powers, immunities, indemnities and exclusions from liability as are prescribed in favor of the Collateral Agent in this Agreement, which shall apply mutatis mutandis. In the event of the resignation of the Collateral Agent and appointment of a successor Collateral Agent, such successor Collateral Agent shall also act as the holder of an irrevocable power of attorney ( fondé de pouvoir ).
9.13 Special Provisions relating to Currency other than Dollars . (a) If at any time that a Loan (or Letter of Credit) denominated in an Designated Foreign Currency is outstanding and the relevant Designated Foreign Currency is fully replaced by the Euro as the lawful currency of the country that issued such Designated Foreign Currency (the Issuing Country ) so that all payments are to be made in the Issuing Country in Euro and not in the Designated Foreign Currency previously the lawful currency of such country, then such Loan (or Letter of Credit) denominated in such Designated Foreign Currency shall be automatically converted into
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a Loan (or Letter of Credit) denominated in Euro in a principal amount equal to the amount of Euro into which the principal amount of such Designated Foreign Currency denominated Loan (or Letter of Credit) would be converted pursuant to law and thereafter no further Loans or Letters of Credit will be available in such Designated Foreign Currency.
(b) All funds to be made available to Administrative Agent or the L/C Issuer, as applicable, pursuant to this Agreement in any currency other than Dollars shall be made available to the Administrative Agent or the L/C Issuer, as applicable, in immediately available, freely transferable, cleared funds to such account with such bank in such principal financial center as the Administrative Agent or the L/C Issuer, as applicable, shall from time to time nominate for this purpose. In relation to the payment of any amount denominated in any currency other than Dollars, neither the Administrative Agent nor the L/C Issuer shall be liable to any Borrower or any of the Lenders for any delay, or the consequences of any delay, in the crediting to any account of any amount required by this Agreement to be paid by the Administrative Agent or the L/C Issuer if the Administrative Agent or L/C Issuer shall have taken all relevant and necessary steps to achieve, on the date required by this Agreement, the payment of such amount in immediately available, freely transferable, cleared funds (in the relevant currency) to the account with the bank in the principal financial center in the participating member state which the applicable Borrower or, as the case may be, any Lender shall have specified for such purpose. As used in this Section 9.13, all relevant and necessary steps means all such steps as may be prescribed from time to time by the regulations or operating procedures of such clearing or settlement system as the Administrative Agent or L/C Issuer may from time to time determine for the purpose of clearing or settling payments of such currency. Furthermore, and without limiting the foregoing, neither the Administrative Agent nor the L/C Issuer shall be liable to any Borrower or any of the Lenders with respect to the foregoing matters in the absence of its bad faith, gross negligence or willful misconduct (as determined in the final non-appealable judgment of a court of competent jurisdiction).
SECTION 10. | MISCELLANEOUS |
10.1 Notices; Communications .
(a) Except in the case of notices and other communications expressly permitted to be given by telephone (and except as provided in Section 10.1(b)), all notices and other communications provided for herein shall be in writing and shall be delivered by hand or overnight courier service, mailed by certified or registered mail or sent by facsimile or e-mail, and all notices and other communications expressly permitted hereunder to be given by telephone shall be made to the applicable telephone number, in each case, as follows:
(i) if to any Credit Party or the Administrative Agent, to the address, facsimile number, e-mail address or telephone number specified for such Person on Schedule 10.1 ; and
(ii) if to any other Lender, to the address, facsimile number, e-mail address or telephone number specified in its Administrative Questionnaire.
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(b) Notices and other communications to the Lenders may be delivered or furnished by electronic communication (including e-mail and internet or intranet websites) pursuant to procedures approved by the Administrative Agent. The Administrative Agent or the Borrower may, in its discretion, agree to accept notices and other communications hereunder by electronic communications pursuant to procedures approved by them; provided that approval of such procedures may be limited to particular notices or communications.
(c) Notices sent by hand or overnight courier service, or mailed by certified or registered mail, shall be deemed to have been given when received. Notices sent by facsimile shall be deemed to have been given when sent (except that, if not given during normal business hours for the recipient, shall be deemed to have been given at the opening of business on the next Business Day for the recipient). Notices delivered through electronic communications to the extent provided in Section 10.1(b) shall be effective as provided in such Section 10.1(b).
(d) Any party hereto may change its address, facsimile number or e-mail address for notices and other communications hereunder by notice to the other parties hereto.
(e) Documents required to be delivered pursuant to Section 5.4 (to the extent any such documents are included in materials otherwise filed with the SEC or SEDAR) may be delivered electronically (including as set forth in Section 10.17) and if so delivered, shall be deemed to have been delivered on the date (i) on which the Borrower files such documents or provides a link thereto on its website on the internet at the website address listed on Schedule 10.1 or (ii) on which such documents are posted on the Borrowers behalf on an internet or intranet website, if any, to which each Lender and the Administrative Agent have access (whether a commercial, governmental, regulatory agency, third-party website or whether sponsored by the Administrative Agent); provided that, upon reasonable request by the Administrative Agent, the Borrower shall also provide a hard copy to the Administrative Agent of any such document; provided , further , that any documents posted for which a link is provided after normal business hours for the recipient shall be deemed to have been given at the opening of business on the next Business Day for such recipient. The Administrative Agent shall have no obligation to request the delivery or to maintain copies of the documents referred to above, and in any event shall have no responsibility to monitor compliance by the Credit Parties with any such request for delivery, and each Lender shall be solely responsible for requesting delivery to it or maintaining its copies of such documents.
10.2 Survival of Agreement . All covenants, agreements, representations and warranties made by the Credit Parties herein, in the other Credit Documents and in the certificates or other instruments prepared or delivered in connection with or pursuant to this Agreement or any other Credit Document shall be considered to have been relied upon by the Lenders and the L/C Issuers and shall survive the making by the Lenders of the Loans, the execution and delivery of the Credit Documents and the issuance of the Letters of Credit, regardless of any investigation made by such persons or on their behalf, and shall continue in full force and effect as long as the principal of or any accrued interest on any Loan or L/C Obligation or any other amount payable under this Agreement or any other Credit Document is outstanding and unpaid and so long as the Commitments have not been terminated. Without prejudice to the survival of any other agreements contained herein, indemnification and reimbursement obligations contained herein (including pursuant to Section 2.15, Section 2.16, Section 2.17,
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Section 2.19 and Section 10.5) shall survive the payment in full of the principal and interest hereunder and the termination of the Commitments or this Agreement.
10.3 Binding Effect . This Agreement shall become effective when it has been executed by the Borrower, the Guarantors and the Administrative Agent and when the Administrative Agent has received copies hereof which, when taken together, bear the signatures of each of the other parties hereto, and thereafter shall be binding upon and inure to the benefit of the Borrower, the Guarantors, each Agent, each Lender and their respective permitted successors and assigns.
10.4 Successors and Assigns .
(a) The provisions of this Agreement shall be binding upon and inure to the benefit of the parties hereto and their respective successors and assigns permitted hereby, except that (i) except as otherwise expressly permitted under Sections 5.1 and 6.4, the Borrower may not assign or otherwise transfer any of their rights or obligations hereunder without the prior written consent of each Lender (and any attempted assignment or transfer by the Borrower without such consent shall be null and void), and (ii) no Lender may assign or otherwise transfer its rights or obligations hereunder except in accordance with this Section 10.4. Nothing in this Agreement, expressed or implied, shall be construed to confer upon any Person (other than the parties hereto, their respective successors and assigns permitted hereby, Participants (to the extent provided in paragraph (d) of this Section 10.4) and, to the extent expressly contemplated hereby, the Related Parties of each of the Agents and the Lenders) any legal or equitable right, remedy or claim under or by reason of this Agreement or the other Credit Documents.
(b) (i) Subject to the conditions set forth in paragraph (b)(ii) of this Section 10.4, any Lender (in such capacity, an Assignor ) may assign to one or more Eligible Assignees all or a portion of its rights and obligations under this Agreement including all or a portion of its Commitments and the Loans at the time owing to it with the prior written consent of:
(A) the Borrower (not to be unreasonably withheld, conditioned or delayed) (it being understood that the withholding of consent with respect to any assignment of Revolving Loans or Revolving Commitments to any Person that is not a bank or an Approved Fund that is managed by a bank shall not be deemed to be unreasonable); provided that no consent of the Borrower shall be required (1) for an assignment of Term Loans to a Lender, an Affiliate of a Lender or an Approved Fund, (2) for an assignment of Revolving Loans or Revolving Commitments to a Lender, an Affiliate of a Lender or an Approved Fund, (3) for an assignment of the Loans in connection with initial syndication, or (4) if an Event of Default has occurred and is continuing, for an assignment to any other Person; provided , further , that with respect to any assignment of Loans, such consent shall be deemed to have been given if the Borrower has not responded within [REDACTED Time Period] after written notice by the Administrative Agent or the respective Assignor;
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(B) the Administrative Agent (not to be unreasonably withheld, conditioned or delayed); provided that no consent of the Administrative Agent shall be required for an assignment of all or any portion of a Term Loan to a Lender, an Affiliate of a Lender or an Approved Fund;
(C) the L/C Issuers (not to be unreasonably withheld, conditioned or delayed); provided that no consent of any L/C Issuer shall be required for an assignment of all or any portion of a Term Loan; and
(D) the Swing Line Lender (not to be unreasonably withheld, conditioned or delayed); provided that no consent of any Swing Line Lender shall be required for an assignment of all or any portion of a Term Loan.
(ii) Assignments shall be subject to the following additional conditions:
(A) except in the case of an assignment to a Lender, an Affiliate of a Lender or an Approved Fund or an assignment of the entire remaining amount of the Assignors Commitments or Loans, the amount of the Commitments or Loans of the Assignor subject to each such assignment (determined as of the date the Assignment Agreement with respect to such assignment is delivered to the Administrative Agent) shall not be less than (x) in the case of an assignment of Term Loans, [REDACTED Dollar Amount] and (y) in the case of an assignment of Revolving Loans or Revolving Commitments, [REDACTED Dollar Amount] , in each case, unless the Borrower and the Administrative Agent otherwise consent; provided that (1) no such consent of the Borrower shall be required if an Event of Default has occurred and is continuing and (2) such amounts shall be aggregated in respect of each Lender and its Affiliates or Approved Funds (with simultaneous assignments to or by two or more Approved Funds shall be treated as one assignment for purposes of meeting the minimum assignment amount requirement), if any;
(B) [reserved];
(C) the parties to each assignment shall execute and deliver to the Administrative Agent an Assignment Agreement via an electronic settlement system acceptable to the Administrative Agent (or, if previously agreed with the Administrative Agent, manually), and, except in the case of an assignment by a Lender to one of its Approved Funds, shall pay to the Administrative Agent a processing and recordation fee of [REDACTED Dollar Amount] (which fee may be waived or reduced in the sole discretion of the Administrative Agent);
(D) the Eligible Assignee, if it shall not be a Lender, shall deliver to the Administrative Agent an Administrative Questionnaire and any tax forms required to be delivered pursuant to Section 2.17;
(E) the Assignor shall deliver to the Administrative Agent any Note issued to it with respect to the assigned Loan;
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(F) the Assignor may only assign or otherwise transfer such rights or obligations so long as there will be at least two Lenders after doing so; and
(G) the Administrative Agent and the Collateral Agent shall have carried out all know your customer or other similar checks which it is required to comply with in relation to the assignment to the Eligible Assignee.
For the purposes of this Section 10.4, Approved Fund means any Person (other than a natural Person) that is engaged in making, purchasing, holding or investing in bank loans and similar extensions of credit in the ordinary course and that is administered or managed by (a) a Lender, (b) an Affiliate of a Lender or (c) an entity or an Affiliate of an entity that administers or manages a Lender.
(iii) Subject to acceptance and recording thereof pursuant to paragraph (b)(v) of this Section 10.4, from and after the effective date specified in each Assignment Agreement, the Eligible Assignee thereunder shall be a party hereto and, to the extent of the interest assigned by such Assignment Agreement, have the rights and obligations of a Lender under this Agreement, and the Assignor thereunder shall, to the extent of the interest assigned by such Assignment Agreement, be released from its obligations under this Agreement (and, in the case of an Assignment Agreement covering all of the Assignors rights and obligations under this Agreement, such Assignor shall cease to be a party hereto but shall continue to be entitled to the benefits of Section 2.15, Section 2.16, Section 2.17 and Section 10.5). Any assignment or transfer by a Lender of rights or obligations under this Agreement that does not comply with this Section 10.4 shall be treated for purposes of this Agreement as a sale by such Lender of a participation in such rights and obligations in accordance with paragraph (d) of this Section 10.4.
(iv) The Administrative Agent, acting for this purpose as a non-fiduciary agent of the Borrower, shall maintain at one of its offices a copy of each Assignment Agreement delivered to it and the Register. The entries in the Register shall be conclusive, and the Borrower, the Administrative Agent and the Lenders may treat each Person whose name is recorded in the Register pursuant to the terms hereof as a Lender hereunder for all purposes of this Agreement, notwithstanding notice to the contrary. The Register shall be available for inspection by the Borrower and any Lender (solely with respect to such Lenders Loans) at any reasonable time and from time to time upon reasonable prior notice.
(v) Upon its receipt of a duly completed Assignment Agreement executed by an Assignor and an Eligible Assignee, the Eligible Assignees completed Administrative Questionnaire (unless the Eligible Assignee shall already be a Lender hereunder), all applicable tax forms, any Note outstanding with respect to an assigned Loan, the processing and recordation fee referred to in paragraph (C) of Section 10.4(b)(ii), the satisfaction of all know your customer checks referred to in paragraph (G) of Section 10.4(b)(ii) and any written consent to such assignment required by paragraph (b) of this Section 10.4, the Administrative Agent promptly shall accept such Assignment Agreement and record the information contained therein in the Register.
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No assignment, whether or not evidenced by a promissory note, shall be effective for purposes of this Agreement unless it has been recorded in the Register as provided in this paragraph (b)(v).
(c) By executing and delivering an Assignment Agreement, the Assignor thereunder and the Eligible Assignee thereunder shall be deemed to confirm to and agree with each other and the other parties hereto as follows: (i) such Assignor warrants that it is the legal and beneficial owner of the interest being assigned thereby free and clear of any Lien or other adverse claim and that the outstanding balances of its Loans and the L/C Exposure owing to it, in each case, without giving effect to assignments thereof which have not become effective, are as set forth in such Assignment Agreement; (ii) except as set forth in clause (i) above, such Assignor makes no representation or warranty and assumes no responsibility with respect to any statements, warranties or representations made in or in connection with this Agreement, or the execution, legality, validity, enforceability, genuineness, sufficiency or value of this Agreement, any other Credit Document or any other instrument or document furnished pursuant hereto, or the financial condition of the Borrower or any subsidiary or the performance or observance by the Borrower or any subsidiary of any of their respective obligations under this Agreement, any other Credit Document or any other instrument or document furnished pursuant hereto; (iii) the Eligible Assignee represents and warrants that it is legally authorized to enter into such Assignment Agreement; (iv) the Eligible Assignee confirms that it has received a copy of this Agreement, together with copies of the most recent financial statements delivered pursuant to Section 5.4, and such other documents and information as it has deemed appropriate to make its own credit analysis and decision to enter into such Assignment Agreement; (v) the Eligible Assignee will independently and without reliance upon the Administrative Agent or the Collateral Agent, such Assignor or any other Lender and based on such documents and information as it shall deem appropriate at the time, continue to make its own credit decisions in taking or not taking action under this Agreement; (vi) the Eligible Assignee appoints and authorizes the Administrative Agent to take such action as agent on its behalf and to exercise such powers under this Agreement as are delegated to the Administrative Agent by the terms of this Agreement, together with such powers as are reasonably incidental thereto; and (vii) the Eligible Assignee agrees that it will perform in accordance with their terms all the obligations which by the terms of this Agreement are required to be performed by it as a Lender.
(d) (i) Any Lender may, without the consent of the Borrower or the Administrative Agent, sell participations to one or more banks or other entities (a Participant ) in all or a portion of such Lenders rights and obligations under this Agreement (including all or a portion of its Commitments and the Loans owing to it); provided that (A) such Lenders obligations under this Agreement shall remain unchanged, (B) such Lender shall remain solely responsible to the other parties hereto for the performance of such obligations and (C) the Borrower, the Administrative Agent and the other Lenders shall continue to deal solely and directly with such Lender in connection with such Lenders rights and obligations under this Agreement. Any agreement pursuant to which a Lender sells such a participation shall provide that such Lender shall retain the sole right to enforce this Agreement and the other Credit Documents and to approve any amendment, modification or waiver of any provision of this Agreement and the other Credit Documents; provided that (x) such agreement may provide that such Lender will not, without the consent of the Participant, agree to any amendment, modification or waiver that (1) requires the consent of each Lender directly affected thereby
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pursuant to Section 10.4(b) or clauses (i), (ii), (iii) or (v) of the second proviso to Section 10.8(b) and (2) directly affects such Participant and (y) no other agreement with respect to amendment, modification or waiver may exist between such Lender and such Participant. Subject to clause (d)(ii) of this Section 10.4, the Borrower agrees that each Participant shall be entitled to the benefits of Section 2.15, Section 2.16 and Section 2.17 to the same extent as if it were a Lender and had acquired its interest by assignment pursuant to paragraph (b) of this Section 10.4. To the extent permitted by law, each Participant also shall be entitled to the benefits of Section 10.6 as though it were a Lender; provided that such Participant shall be subject to Section 2.4 as though it were a Lender. Each Lender that sells a participation shall, acting solely for this purpose as a non-fiduciary agent of the Borrower, maintain a register on which it enters the name and address of each Participant and the principal amounts (and stated interest) of each Participants interest in the Loans or other obligations under the Credit Documents (the Participant Register ); provided that no Lender shall have any obligation to disclose all or any portion of the Participant Register (including the identity of any Participant or any information relating to a Participants interest in any commitments, loans, letters of credit or its other obligations under any Credit Document) to any Person except to the extent that such disclosure is necessary to establish that such commitment, loan, letter of credit or other obligation is in registered form under Section 5f.103-1(c) of the United States Treasury Regulations. The entries in the Participant Register shall be conclusive absent manifest error, and such Lender shall treat each Person whose name is recorded in the Participant Register as the owner of such participation for all purposes of this Agreement notwithstanding any notice to the contrary. For the avoidance of doubt, the Administrative Agent (in its capacity as Administrative Agent) shall have no responsibility for maintaining a Participant Register.
(ii) A Participant shall not be entitled to receive any greater payment under Section 2.15, Section 2.16 or Section 2.17 than the applicable Lender would have been entitled to receive with respect to the participation sold to such Participant, except to the extent such entitlement to receive a greater payment results from a Change in Law that occurs after the Participant acquired the applicable participation.
(e) Any Lender may at any time pledge or assign a security interest in all or any portion of its rights under this Agreement to secure obligations of such Lender, including any pledge or assignment to secure obligations to a Federal Reserve Bank or other central banking authority and in the case of any Lender that is an Approved Fund, any pledge or assignment to any holders of obligations owed, or securities issued, by such Lender, including to any trustee for, or any other representative of, such holders, and this Section 10.4 shall not apply to any such pledge or assignment of a security interest; provided that no such pledge or assignment of a security interest shall release a Lender from any of its obligations hereunder or substitute any such pledgee or Eligible Assignee for such Lender as a party hereto.
(f) The Borrower, upon receipt of written notice from the relevant Lender, agrees to issue Notes to any Lender requiring Notes to facilitate transactions of the type described in paragraph (e) of this Section 10.4.
(g) [Reserved].
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(h) If the Borrower wishes to replace the Loans with ones having different terms, it shall have the option, with the consent of the Administrative Agent and subject to [REDACTED Time Period] advance notice to the Lenders, instead of prepaying the Loans to be replaced, to (i) require the Lenders to assign such Loans to the Administrative Agent or its designees and (ii) amend the terms thereof in accordance with Section 10.8 (with such replacement, if applicable, being deemed to have been made pursuant to Section 10.8(d)). Pursuant to any such assignment, all Loans to be replaced shall be purchased at par (allocated among the Lenders in the same manner as would be required if such Loans were being optionally prepaid), accompanied by payment of any accrued interest and fees thereon and any amounts owing pursuant to Section 10.5(b). By receiving such purchase price, the Lenders shall automatically be deemed to have assigned the Loans pursuant to the terms of the form of Assignment Agreement attached hereto as Exhibit E , and accordingly no other action by such Lenders shall be required in connection therewith. The provisions of this paragraph (h) are intended to facilitate the maintenance of the perfection and priority of existing security interests in the Collateral during any such replacement.
(i) Notwithstanding the foregoing, no assignment may be made or participation sold to a Disqualified Person without the prior written consent of the Borrower, and any assignment made or participation sold to a Disqualified Person shall be without effect and void. Notwithstanding anything herein to the contrary, the Administrative Agent shall have no responsibility for, or liability in connection with, monitoring or enforcing the prohibition on assignments or participations to Disqualified Assignees.
(j) [Reserved].
(k) [Reserved].
(l) [Reserved].
(m) [Reserved].
(n) [Reserved].
(o) Notwithstanding anything to the contrary contained in this Agreement, any Lender may assign all or a portion of its Term Loans to the Borrower or any Restricted Subsidiary; provided that:
(i) the Assignor and the Purchasing Borrower Party purchasing such Lenders Term Loans, as applicable, shall execute and deliver to the Administrative Agent an assignment agreement substantially in the form of Exhibit H (an Affiliated Lender Assignment Agreement ) in lieu of an Assignment Agreement;
(ii) such assignment shall be made pursuant to a Dutch Auction open to all Lenders of the applicable Class on a pro rata basis;
(iii) any Term Loans assigned to any Purchasing Borrower Party shall be automatically and permanently cancelled upon the effectiveness of such assignment and will thereafter no longer be outstanding for any purpose hereunder;
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(iv) immediately after giving effect to any such purchase, no Default or Event of Default shall exist;
(v) the applicable Purchasing Borrower Party shall in the relevant offer document delivered by it with respect to such Dutch Auction and at the time of consummation of any purchase of Term Loans pursuant thereto affirm the representation that it is not in possession of any material non-public information;
(vi) the aggregate outstanding principal amount of the Term Loans of the applicable Class shall be deemed reduced by the full par value of the aggregate principal amount of the Term Loans purchased pursuant to this Section 10.4(o) and each principal repayment installment with respect to the Term Loans of such Class shall be reduced pro rata by the aggregate principal amount of Term Loans purchased; and
(vii) no proceeds from Revolving Loans shall be used to consummate any such purchase.
10.5 Expenses; Indemnity .
(a) The Borrower agrees to pay all reasonable, documented or invoiced out-of-pocket expenses (including Other Taxes) incurred by the Administrative Agent, the Collateral Agent, each L/C Issuer and each Arranger in connection with the preparation of this Agreement and the other Credit Documents and in connection with the syndication and distribution of the credit facilities provided for therein, or by the Administrative Agent (and in the case of enforcement of this Agreement, the Administrative Agent, the Collateral Agent, the Lenders, the Swing Line Lender and L/C Issuers) in connection with the preparation, execution and delivery, amendment, modification, waiver or enforcement of this Agreement or in connection with the administration of this Agreement and any amendments, modifications or waivers of the provisions hereof or thereof (whether or not the Transactions hereby contemplated shall be consummated), including the reasonable, documented and invoiced fees, charges and disbursements of one primary outside counsel for the Administrative Agent, the Collateral Agent and the Arrangers (and in the case of enforcement of this Agreement, the Administrative Agent, the Collateral Agent, the Lenders, the Swing Line Lender and L/C Issuers), one firm of local counsel in each appropriate jurisdiction and, in the case of any actual or perceived conflict of interest, one additional firm of counsel for the Administrative Agent and the Arrangers (and in the case of enforcement of this Agreement, the Lenders, the Swing Line Lender and L/C Issuers).
(b) The Borrower agrees to indemnify and hold harmless each Agent, each Arranger, each Lender, the Swing Line Lender, each L/C Issuer, each of their respective Affiliates (including, without limitation, controlling persons) and each of their respective directors, officers, employees, agents, advisors, controlling persons, equityholders, partners, members and other representatives and each of their respective successors and permitted assigns (each such Person being called an Indemnitee ) against, and to hold each Indemnitee harmless from, any and all joint and several actions, suits, judgments and other proceedings, investigations, inquiry, losses, claims, damages, liabilities, obligations, penalties and reasonable and documented out-of-pocket expenses, costs or disbursements (including reasonable, documented and invoiced fees, charges and disbursements of one primary outside counsel for all
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Indemnitees, taken as a whole, and, if reasonably necessary, a single outside local counsel in each appropriate jurisdiction (which may include a single special counsel in multiple jurisdictions) for all Indemnitees taken as a whole (and, in the case of an actual or perceived conflict of interest, an additional counsel for all Indemnitees subject to such conflict taken as a whole)), incurred by or asserted against any Indemnitee arising out of, in any way connected with, or as a result of (i) the execution or delivery of this Agreement or any other Credit Document, the performance by the parties hereto and thereto of their respective obligations thereunder or the consummation of the Transactions and the other transactions contemplated hereby, (ii) the use or proposed use of the proceeds of the Loans or any Letter of Credit or (iii) any claim, litigation, investigation or proceeding relating to any of the foregoing, whether or not any Indemnitee is a party thereto and regardless of whether such matter is initiated by a third party or by the Borrower or any of its subsidiaries or Affiliates or Related Parties; provided that such indemnity shall not, as to any Indemnitee, be available to the extent that such losses, claims, damages, liabilities or related expenses (A) are determined by a final, non-appealable judgment of a court of competent jurisdiction to have resulted from (1) the gross negligence, bad faith or willful misconduct of such Indemnitee or any of its Related Parties or (2) a material breach of the obligations of such Indemnitee hereunder or (B) result from any proceeding solely between or among Indemnitees that does not involve an act or omission by the Borrower or the Restricted Subsidiaries (other than claims against any Agent or any Arranger in its capacity or in fulfilling its role as an Agent or an Arranger or any similar role hereunder (excluding its role as a Lender)).
(c) Subject to and without limiting the generality of the foregoing sentence, the Borrower agrees to indemnify each Indemnitee against, and hold each Indemnitee harmless from, any and all losses, claims, damages, liabilities and related expenses, including reasonable, documented and invoiced fees, charges and disbursements of one firm of counsel for all Indemnitees, taken as a whole, and, if necessary, one firm of local counsel in each appropriate jurisdiction (which may include a single special counsel in multiple jurisdictions) for all Indemnitees subject to such conflict taken as a whole (and, in the case of an actual or perceived conflict of interest, an additional counsel for all Indemnitees taken as a whole) and reasonable, documented and invoiced consultant fees, in each case, incurred by or asserted against any Indemnitee arising out of, relating to, or as a result of any claim related to Environmental Laws and the Borrower or any of the Restricted Subsidiaries, or any actual or alleged presence, Release or threatened Release of Hazardous Materials at, under, on or from any property for which the Borrower or any of its Restricted Subsidiaries is, or is alleged to be, liable under Environmental Laws; provided that such indemnity shall not, as to any Indemnitee, be available to the extent that such losses, claims, damages, liabilities or related expenses are determined by a final, non-appealable judgment of a court of competent jurisdiction to have resulted from the gross negligence, bad faith or willful misconduct of such Indemnitee or any of its Related Parties.
(d) Except as expressly provided in Section 10.5(a) with respect to Other Taxes, which shall not be duplicative with any amounts paid pursuant to Section 2.17, this Section 10.5 shall not apply to Taxes other than any Taxes that represent losses or damages from any non-Tax claim.
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(e) To the fullest extent permitted by applicable law, the Borrower shall not assert, and hereby waives, any claim against any Indemnitee, on any theory of liability, for special, indirect, consequential or punitive damages (as opposed to direct or actual damages) arising out of, in connection with, or as a result of, this Agreement, any other Credit Document or any agreement or instrument contemplated hereby, the transactions contemplated hereby or thereby, any Loan or the use of the proceeds thereof; provided that nothing in this Section 10.5(e) shall limit the Borrowers indemnity and reimbursement obligations to the extent that such special, indirect, consequential or punitive damages are included in any claim by a third party unaffiliated with the applicable Indemnitee with respect to which the applicable Indemnitee is entitled to indemnification as set forth in this Section 10.5. Notwithstanding anything herein to the contrary, no Indemnitee shall be liable for any damages arising from the use by others of any information or other materials obtained through telecommunications, electronic or other information transmission systems, except to the extent such damages are found in a final non-appealable judgment of a court of competent jurisdiction to have resulted from the willful misconduct, bad faith or gross negligence of such Indemnitee, in connection with this Agreement or the other Credit Documents or the transactions contemplated hereby or thereby.
(f) The agreements in this Section 10.5 shall survive the resignation of the Administrative Agent, the replacement of any Lender, the termination of the Commitments and the repayment, satisfaction or discharge of all the other Obligations and the termination of this Agreement. All amounts due under this Section 10.5 shall be payable on written demand therefor accompanied by reasonable documentation with respect to any reimbursement, indemnification or other amount requested.
10.6 Right of Set-off . If an Event of Default shall have occurred and be continuing, each Lender is hereby authorized at any time and from time to time, to the fullest extent permitted by law, to set off and apply any and all deposits (general or special, time or demand, provisional or final) at any time held and other indebtedness at any time owing by such Lender to or for the credit or the account of the Borrower or any Guarantor against any of and all the obligations of the Borrower or any Guarantor now or hereafter existing under this Agreement or any other Credit Document held by such Lender, irrespective of whether or not such Lender shall have made any demand under this Agreement or such other Credit Document and although the obligations may be unmatured. The rights of each Lender under this Section 10.6 are in addition to other rights and remedies (including other rights of set-off) of such Lender that may be exercised only at the direction of the Administrative Agent or the Requisite Lenders.
10.7 Governing Law . THIS AGREEMENT AND THE OTHER CREDIT DOCUMENTS (OTHER THAN AS EXPRESSLY SET FORTH IN OTHER CREDIT DOCUMENTS) AND ANY CLAIM, CONTROVERSY OR DISPUTE ARISING UNDER OR RELATED TO THIS AGREEMENT OR THE CREDIT DOCUMENTS OR THE TRANSACTIONS CONTEMPLATED HEREBY OR THEREBY SHALL BE CONSTRUED IN ACCORDANCE WITH AND GOVERNED BY THE LAWS OF THE STATE OF NEW YORK; PROVIDED, HOWEVER, THAT THE INTERPRETATION OF THE DEFINITION OF CLAUSE (A) OF THE MATERIAL ADVERSE EFFECT AND THE DETERMINATION OF THE ACCURACY OF THE ACQUISITION AGREEMENT REPRESENTATIONS AND WHETHER AS A RESULT OF ANY INACCURACY THEREOF THE BORROWER (OR ANY OF ITS AFFILIATES) HAS THE RIGHT TO TERMINATE ITS (OR THEIR)
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OBLIGATIONS UNDER THE ACQUISITION AGREEMENT OR DECLINE TO CONSUMMATE THE ACQUISITION, SHALL BE GOVERNED BY AND CONSTRUED IN ACCORDANCE WITH, THE LAWS OF DELAWARE APPLICABLE THEREIN, REGARDLESS OF THE LAWS THAT MIGHT OTHERWISE GOVERN UNDER APPLICABLE PRINCIPLES OF CONFLICTS OF LAWS.
10.8 Waivers; Amendment .
(a) No failure or delay of the Administrative Agent or any Lender in exercising any right or power hereunder or under any Credit Document shall operate as a waiver thereof, nor shall any single or partial exercise of any such right or power, or any abandonment or discontinuance of steps to enforce such a right or power, preclude any other or further exercise thereof or the exercise of any other right or power. The rights and remedies of each Agent and the Lenders hereunder and under the other Credit Documents are cumulative and are not exclusive of any rights or remedies that they would otherwise have. No waiver of any provision of this Agreement or any other Credit Document or consent to any departure by the Borrower or any other Credit Party therefrom shall in any event be effective unless the same shall be permitted by paragraph (b) of this Section 10.8, and then such waiver or consent shall be effective only in the specific instance and for the purpose for which given. No notice or demand on the Borrower or any other Credit Party in any case shall entitle such Person to any other or further notice or demand in similar or other circumstances.
(b) Neither this Agreement nor any other Credit Document nor any provision hereof or thereof may be waived, amended or modified except (x) as provided in Section 2.20, Section 2.21 and Section 2.22, (y) in the case of this Agreement, pursuant to an agreement or agreements in writing entered into by the Borrower and the Requisite Lenders; provided that any waiver, amendment or modification that relates to a particular Class and does not amend, waive or modify such provisions with respect to another Class shall only require a writing entered into by the Borrower and the Requisite Lenders of such Class directly affected, and (z) in the case of any other Credit Document, pursuant to an agreement or agreements in writing entered into by each party thereto and the Administrative Agent and consented to by the Requisite Lenders; provided , however , that except as provided in Section 2.15(b), Section 2.20 and Section 2.21, no such agreement shall:
(i) decrease, forgive, waive or excuse the principal amount of, or any interest (other than Default Rate interest) on, or any premiums or fees in respect of, or extend the final maturity of, or decrease the rate of interest on, any Loan or any L/C Advance (other than by waiver or modification of a condition precedent, mandatory prepayment, Default, Event of Default, financial ratio or covenant), without the prior written consent of each Lender directly affected thereby;
(ii) increase or extend the Commitment of any Lender or decrease, forgive, waive or excuse the fees of any Lender or fees of any Agent without the prior written consent of such Lender or Agent, as applicable (it being understood that waivers or modifications of conditions precedent, covenants, Defaults or Events of Default shall not constitute an increase or extension of the Commitments of any Lender);
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(iii) postpone any date fixed by this Agreement or any other Credit Document for any payment (excluding mandatory prepayments) of principal, interest, fees or other amounts due to the Lenders (or any of them) hereunder or under such other Credit Document without written consent of each Lender adversely affected thereby;
(iv) amend or modify the provisions of this Section 10.8 or the definition of the term Requisite Lenders or any other provision hereof specifying the number or percentage of Lenders required to waive, amend or modify any rights hereunder or make any determination or grant any consent hereunder, without the prior written consent of each Lender (it being understood that, with the consent of the Requisite Lenders, additional extensions of credit pursuant to this Agreement may be included in the determination of the Requisite Lenders on substantially the same basis as the Loans, Commitments, and L/C Obligations are included on the Closing Date);
(v) release all or substantially all of the Collateral (or subordinate the Liens in favor of the Administrative Agent or Collateral Agent, as applicable, on all or substantially all of the Collateral) or release all or substantially all of the value of the guarantees under the Pledge and Security Agreement, without the prior written consent of each Lender;
(vi) amend the provisions of Section 2.14 of this Agreement or any analogous provision of any other Credit Document, in a manner that would by its terms alter the pro rata sharing of payments required thereby, without the consent of each Lender adversely affected thereby;
(vii) amend, modify or otherwise affect the rights or duties of the Administrative Agent, the Swing Line Lender or L/C Issuer hereunder without the prior written consent of the Administrative Agent, Swing Line Lender or L/C Issuer, as applicable, acting as such at the effective date of such agreement, as applicable; or
(viii) change the coin or currency in which the principal of any Loan or the interest thereon is payable pursuant to Section 2.1, 2.2 or 2.6, without the prior written consent of each Lender directly affected thereby (it being understood that designations of additional Designated Foreign Currencies in accordance with the definition thereof shall not constitute a change of currency for purposes of this clause (viii)).
Each Lender shall be bound by any waiver, amendment or modification authorized by this Section 10.8 and any consent by any Lender pursuant to this Section 10.8 shall bind any assignee of such Lender.
Notwithstanding anything herein, the Financial Performance Covenant and any financial definition for purposes of calculating the Financial Performance Covenant and the cure right in Section 8.2 or other related Events of Default may only be amended, waived or modified by the Requisite Class Lenders for the Revolving Commitments.
(c) Without the consent of the Administrative Agent, any L/C Issuer or any Lender, the Credit Parties and the Administrative Agent or Collateral Agent, as applicable, may
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(in their respective sole discretion, or shall, to the extent required by any Credit Document) enter into any amendment, modification or waiver of any Credit Document, or enter into any new agreement or instrument, to effect the granting, perfection, protection, expansion or enhancement of any security interest in any Collateral or additional property to become Collateral for the benefit of the Secured Parties, or as required by local law to give effect to, or protect any security interest for the benefit of the Secured Parties, in any property or so that the security interests therein comply with applicable law.
(d) This Agreement and the other Credit Documents may be amended (or amended and restated) with the written consent of the Requisite Lenders, the Administrative Agent and the Borrower (i) to add one or more additional credit facilities to this Agreement and to permit the extensions of credit from time to time outstanding thereunder and the accrued interest and fees in respect thereof to share ratably in the benefits of this Agreement and the other Credit Documents with the Term Loans and the accrued interest and fees in respect thereof and (ii) to include appropriately the Lenders holding such credit facilities in any determination of the Requisite Lenders.
(e) Notwithstanding anything in this Agreement or any other Credit Document to the contrary, the Borrower may enter into Incremental Amendments in accordance with Section 2.20, Refinancing Amendments in accordance with Section 2.21 and Extension Amendments in accordance with Section 2.22, and implement additional Designated Foreign Currencies, and such Incremental Amendments, Refinancing Amendments and Extension Amendments shall be effective to amend the terms of this Agreement and the other applicable Credit Documents, in each case, without any further action or consent of any other party to any Credit Document.
(f) Notwithstanding the foregoing, the Administrative Agent, with the consent of the Borrower, may amend, modify or supplement any Credit Document without the consent of any Lender or the Requisite Lenders in order to correct, amend or cure any ambiguity, inconsistency or defect or correct any typographical error or other manifest error in any Credit Document; provided that the Administrative Agent shall promptly give the Lenders notice of any such amendment, modification or supplement.
(g) Notwithstanding the foregoing, Repricing Transactions shall be permitted without the approval or consent of the Lenders other than any Lender holding Term Loans subject to such Repricing Transactions that will continue as a Lender hereunder in respect of the repriced tranche of Loans or modified Loans.
10.9 Interest Rate Limitation . Notwithstanding anything herein to the contrary, if at any time the applicable interest rate, together with all fees and charges that are treated as interest under applicable law (collectively, the Charges ), as provided for herein or in any other document executed in connection herewith, or otherwise contracted for, charged, received, taken or reserved by any Lender, shall exceed the maximum lawful rate (the Maximum Rate ) that may be contracted for, charged, taken, received or reserved by such Lender in accordance with applicable law, the rate of interest payable hereunder, together with all Charges payable to such Lender, shall be limited to the Maximum Rate; provided that such excess amount shall be paid to such Lender on subsequent payment dates to the extent not exceeding the legal limitation.
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10.10 Entire Agreement . This Agreement, the other Credit Documents and the agreements regarding certain fees referred to herein constitute the entire contract between the parties relative to the subject matter hereof. Any previous agreement among or representations from the parties or their Affiliates with respect to the subject matter hereof is superseded by this Agreement and the other Credit Documents. Notwithstanding the foregoing, the Fee Letter shall survive the execution and delivery of this Agreement and remain in full force and effect. Nothing in this Agreement or in the other Credit Documents, expressed or implied, is intended to confer upon any party other than the parties hereto and thereto any rights, remedies, obligations or liabilities under or by reason of this Agreement or the other Credit Documents.
10.11 WAIVER OF JURY TRIAL . EACH PARTY HERETO HEREBY WAIVES, TO THE FULLEST EXTENT PERMITTED BY APPLICABLE LAW, ANY RIGHT IT MAY HAVE TO A TRIAL BY JURY IN RESPECT OF ANY LITIGATION DIRECTLY OR INDIRECTLY ARISING OUT OF, UNDER OR IN CONNECTION WITH THIS AGREEMENT OR ANY OF THE OTHER CREDIT DOCUMENTS. EACH PARTY HERETO (A) CERTIFIES THAT NO REPRESENTATIVE, AGENT OR ATTORNEY OF ANY OTHER PARTY HAS REPRESENTED, EXPRESSLY OR OTHERWISE, THAT SUCH OTHER PARTY WOULD NOT, IN THE EVENT OF LITIGATION, SEEK TO ENFORCE THE FOREGOING WAIVER AND (B) ACKNOWLEDGES THAT IT AND THE OTHER PARTIES HERETO HAVE BEEN INDUCED TO ENTER INTO THIS AGREEMENT AND THE OTHER CREDIT DOCUMENTS, AS APPLICABLE, BY, AMONG OTHER THINGS, THE MUTUAL WAIVERS AND CERTIFICATIONS IN THIS SECTION 10.11.
10.12 Severability . In the event any one or more of the provisions contained in this Agreement or in any other Credit Document should be held invalid, illegal or unenforceable in any respect, the validity, legality and enforceability of the remaining provisions contained herein and therein shall not in any way be affected or impaired thereby. The parties shall endeavor in good faith negotiations to replace the invalid, illegal or unenforceable provisions with valid provisions the economic effect of which comes as close as possible to that of the invalid, illegal or unenforceable provisions.
10.13 Counterparts . This Agreement may be executed in two or more counterparts, each of which shall constitute an original but all of which, when taken together, shall constitute but one contract, and shall become effective as provided in Section 10.3. Delivery of an executed counterpart to this Agreement by facsimile or other electronic transmission (e.g., PDF or TIFF) shall be as effective as delivery of a manually signed original.
10.14 Headings . Section headings and the Table of Contents used herein are for convenience of reference only, are not part of this Agreement and are not to affect the construction of, or to be taken into consideration in interpreting, this Agreement.
10.15 Jurisdiction; Consent to Service of Process .
(a) Each of the parties hereto hereby irrevocably and unconditionally submits, for itself and its property, to the exclusive jurisdiction of any New York State court or federal court of the United States of America sitting in New York County, and any appellate court from
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any thereof (collectively, New York Courts ) and any court of competent jurisdiction in the Province of Ontario (collectively, the Ontario Courts ) in any action or proceeding arising out of or relating to this Agreement or the other Credit Documents (other than as expressly set forth in other Credit Documents), or for recognition or enforcement of any judgment, and each of the parties hereto hereby irrevocably and unconditionally agrees that all claims in respect of any such action or proceeding shall be heard and determined in such Ontario Court, New York Court or, to the extent permitted by law, in such federal court. Each of the parties hereto agrees that a final judgment in any such action or proceeding shall be conclusive and may be enforced in other jurisdictions by suit on the judgment or in any other manner provided by law. Nothing in this Agreement shall affect any right that any party may otherwise have to bring any action or proceeding relating to this Agreement or any of the other Credit Documents in the courts of any jurisdiction, except that each of the Credit Parties agrees that (a) it will not bring any such action or proceeding in any court other than New York Courts or Ontario Court (it being acknowledged and agreed by the parties hereto that any other forum would be inconvenient and inappropriate in view of the fact that more of the Lenders who would be affected by any such action or proceeding have contacts with the State of New York or the Province of Ontario than any other jurisdiction), and (b) in any such action or proceeding brought against any Credit Party in any other court, it will not assert any cross-claim, counterclaim or setoff, or seek any other affirmative relief, except to the extent that the failure to assert the same will preclude such Credit Party from asserting or seeking the same in the New York Courts or Ontario Courts.
(b) Each of the parties hereto hereby irrevocably and unconditionally waives, to the fullest extent it may legally and effectively do so, any objection which it may now or hereafter have to the laying of venue of any suit, action or proceeding arising out of or relating to this Agreement or the other Credit Documents in any New York State or federal court. Each of the parties hereto hereby irrevocably waives, to the fullest extent permitted by law, the defense of an inconvenient forum to the maintenance of such action or proceeding in any such court.
(c) Each Credit Party hereby irrevocably and unconditionally:
(i) appoints the Borrower, with an office specified in Schedule 10.1 , as the authorized agent (in such capacity, the Authorized Agent ) upon whom process may be served in any suit, action or proceeding arising out of or based upon this Agreement or the transactions contemplated herein.
(ii) agrees that service of process in any such action or proceeding may be effected by delivering a copy of such process to the Credit Parties in the care of the Authorized Agent at such Authorized Agents above address, and by mailing a copy thereof by registered or certified mail (or substantially similar form of mail), postage prepaid, to the Credit Parties at the address set forth in Schedule 10.1 .
(d) Each Credit Party hereby represents and warrants that the Authorized Agent has accepted such appointment and has agreed to act as agent for service of process, and each Credit Party agrees to take any and all actions that may be necessary to continue such appointment in full force and effect as aforesaid. Service of process upon the Authorized Agent shall be deemed, in every respect, effective service of process upon such Credit Party.
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10.16 Confidentiality . Each of the Lenders and each of the Agents agrees that it shall maintain in confidence any information relating to the Borrower and any of the subsidiaries furnished to it by or on behalf of the Borrower or any of the subsidiaries (other than information that (a) has become generally available to the public other than as a result of a disclosure by such party, (b) has been independently developed by such Lender or such Agent without violating this Section 10.16, as evidenced by its written records, or (c) was available to such Lender or such Agent from a third party having, to such Persons knowledge, no obligations of confidentiality to the Borrower or any other Credit Party) and shall not reveal the same other than to its respective officers, directors, employees, stockholders, partners, members, accountants, attorneys, agents, representatives and advisors with a need to know or to any Person that approves or administers the Loans on behalf of such Lender or such Agent (so long as each such Person shall have been instructed to keep the same confidential in accordance with this Section 10.16), except: (A) to the extent necessary to comply with law or any legal, judicial or administrative process, as otherwise required by law or the requests of any Governmental Authority, the National Association of Insurance Commissioners or of any securities exchange on which securities of the disclosing party or any Affiliate of the disclosing party are listed or traded, (B) as part of normal reporting or review procedures to, or examinations by, Governmental Authorities or self-regulatory authorities including the National Association of Insurance Commissioners or the National Association of Securities Dealers, Inc., (C) to its parent companies, Affiliates or auditors (so long as each such Person shall have been instructed to keep the same confidential in accordance with this Section 10.16), (D) in order to enforce its rights under any Credit Document in a legal proceeding, (E) to any pledge under Section 10.4(e) or any other prospective assignee of, or prospective Participant in, any of its rights under this Agreement (so long as such Person shall have been instructed to keep the same confidential in accordance with this Section 10.16), (F) to any direct or indirect contractual counterparty in Hedge Agreements or such contractual counterpartys professional advisor (so long as such contractual counterparty or professional advisor to such contractual counterparty agrees to be bound by the provisions of this Section 10.16) and (G) on a confidential basis to (x) any rating agency in connection with rating the Borrower or any of its subsidiaries or the Loans hereunder, the CUSIP Service Bureau or any similar agency in connection with the issuance and monitoring of CUSIP numbers with respect to the facilities or (y) market data collectors, similar service providers to the lending industry and service providers to the Administrative Agent in connection with the administration and management of this Agreement and the other Credit Documents. Notwithstanding the foregoing, no such information shall be disclosed to a Disqualified Person that constitutes a Disqualified Person at the time of such disclosure without the Borrowers prior written consent.
10.17 Platform; Borrower Materials . The Borrower hereby acknowledges that (a) the Administrative Agent or the Arrangers will make available to the Lenders materials or information provided by or on behalf of the Borrower hereunder (collectively, Borrower Materials ) by posting the Borrower Materials on IntraLinks or another similar electronic system (the Platform ), and (b) certain of the Lenders may be Public Lenders that do not wish to receive material non-public information with respect to the Borrower or its securities. The Borrower hereby agrees that it will use commercially reasonable efforts to identify that portion of the Borrower Materials that may be distributed to the Public Lenders and that (a) all the Borrower Materials shall be clearly and conspicuously marked PUBLIC which, at a minimum, means that the word PUBLIC shall appear prominently on the first page thereof, (b) by marking Borrower Materials PUBLIC, the Borrower shall be deemed to have authorized the
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Administrative Agent, each Arranger and the Lenders to treat the Borrower Materials as either publicly available information or not material information (although it may be sensitive and proprietary) with respect to the Borrower or its securities for purposes of Canadian securities laws, (c) all Borrower Materials marked PUBLIC are permitted to be made available through a portion of the Platform designated Public Investor; and (d) the Administrative Agent and the Arrangers shall be entitled to treat the Borrower Materials that are not marked PUBLIC as being suitable only for posting on a portion of the Platform not designated Public Investor.
10.18 Release of Liens and Guarantees .
(a) The Administrative Agent, Collateral Agent, Lenders and the L/C Issuers hereby irrevocably agree that the Liens granted to the Collateral Agent by the Credit Parties on any Collateral shall be released and to the extent permitted under applicable law, automatically released: (i) as set forth in Section 10.18(c), Section 10.18(d) or Section 10.18(e) below; (ii) upon the sale or other disposition of such Collateral by any Credit Party to a Person that is not (and is not required to become) a Credit Party in a transaction not prohibited by this Agreement (and the Collateral Agent may rely conclusively on a certificate to that effect provided to it by an Authorized Officer of the Borrower upon its reasonable request without further inquiry), (iii) if the release of such Lien is approved, authorized or ratified in writing by the Requisite Lenders (or such other Lenders whose consent may be required in accordance with Section 10.8(b)), (iv) to the extent that the property constituting such Collateral is owned by any Guarantor, upon the release of such Guarantor from its obligations under the Guaranteed Obligation in accordance with clause (b) below, (v) to the extent any asset or property constitutes Excluded Property, (vi) as required by the Collateral Agent to effect any sale or disposition of Collateral in connection with any exercise of remedies of the Collateral Agent pursuant to the Collateral Documents. Any such release shall not in any manner discharge, affect, or impair the Obligations or any Liens (other than those being released) upon (or Obligations (other than those being released) of the Credit Parties in respect of) all interests retained by the Credit Parties, including the proceeds of any sale or disposition, all of which shall continue to constitute part of the Collateral except to the extent otherwise released in accordance with the provisions of the Credit Documents.
(b) In addition, the Administrative Agent, Collateral Agent, Lenders and the L/C Issuers hereby irrevocably agree that a Guarantor shall be released from the guarantees and the Collateral Documents upon consummation of any transaction not prohibited hereunder resulting in such Guarantor ceasing to constitute a Guarantor or otherwise a subsidiary (and the Collateral Agent may rely conclusively on a certificate to that effect provided to it by an Authorized Officer of the Borrower upon its reasonable request without further inquiry).
(c) Notwithstanding anything to the contrary contained herein or any other Credit Document, upon request of the Borrower, the Administrative Agent, or the Collateral Agent, as applicable, shall (without notice to, or vote or consent of, any other Secured Party) take such actions as shall be required to release or subordinate any Lien on any property granted to or held by the Collateral Agent under any Credit Document to the holder of any Lien on such property that is permitted by Section 6.2 to be senior to the Liens of the Collateral Agent on such property; provided that, prior to any such request, the Borrower shall have in each case delivered to the Administrative Agent a certificate of an Authorized Officer of the Borrower certifying that
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such Lien is permitted to be senior to the Liens under this Agreement or that such property is Excluded Property, as applicable.
(d) Notwithstanding anything to the contrary contained herein or in any other Credit Document, the Lenders and the L/C Issuers hereby irrevocably authorize the Administrative Agent and the Collateral Agent, as applicable, to execute and deliver any instruments, documents, and agreements and take any action necessary or desirable to evidence and confirm the release of any Guarantor or Collateral pursuant to the foregoing provisions of this Section 10.18, all without the requirement of notice to or the further consent or joinder of any Lender or L/C Issuer. Any representation, warranty or covenant contained in any Credit Document relating to any such Collateral or Guarantor shall no longer be deemed to be made. In connection with any release hereunder, the Administrative Agent and the Collateral Agent shall promptly (and the Lenders and the L/C Issuers hereby authorize the Administrative Agent and the Collateral Agent to) take such action and execute any such documents as may be reasonably requested by the Borrower, at the Borrowers expense, in connection with the release of any Liens created by any Credit Document in respect of such Restricted Subsidiary, property or asset.
(e) Notwithstanding anything to the contrary contained herein or any other Credit Document, when all Obligations (other than any (i) Obligations in respect of any Secured Hedge Agreements that have been novated or collateralized, to the extent required by the terms thereof, (ii) Obligations in respect of any Secured Cash Management Agreements and (iii) contingent or indemnification obligations not yet due and payable and for which no claim has been asserted) have been paid in full in cash or equivalents thereof, all Commitments have terminated or expired and no Letter of Credit shall be outstanding that is not Cash Collateralized or back-stopped, upon request of the Borrower, the Administrative Agent and/or Collateral Agent, as applicable, shall (without notice to, or vote or consent of, any Lender) take such actions (and each Lender hereby authorizes the Administrative Agent and Collateral Agent to take such actions) as shall be required to release its Liens on and any other security interest in all Collateral, and to release all obligations under any Credit Document, whether or not on the date of such release there may be any (i) Obligations in respect of any Secured Hedge Agreements that have been novated or collateralized, to the extent required by the terms thereof, (ii) Obligations in respect of any Secured Cash Management Agreements and (iii) contingent or indemnification obligations not yet due and payable and for which no claim has been asserted. Any such release of Obligations shall be deemed subject to the provision that such Obligations shall be reinstated if after such release any portion of any payment in respect of the Obligations guaranteed thereby shall be rescinded or must otherwise be restored or returned upon the insolvency, bankruptcy, dissolution, liquidation or reorganization of the Borrower or any Guarantor, or upon or as a result of the appointment of a receiver, intervenor or conservator of, or trustee or similar officer for, the Borrower or any Guarantor or any substantial part of its property, or otherwise, all as though such payment had not been made.
10.19 Judgment . The Obligations of the Borrower due to any party hereto shall, notwithstanding any judgment in a currency (the judgment currency ) other than Dollars, be discharged only to the extent that on the Business Day following receipt by such party of any sum adjudged to be so due in the judgment currency such party may, in accordance with normal banking procedures, purchase Dollars with the judgment currency; if the amount of Dollars so purchased is less than the sum originally due to such party in Dollars, the Borrower agrees, as a
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separate obligation and notwithstanding any such judgment, to indemnify such party against such loss, if the amount of Dollars so purchased exceeds the sum originally due to any party to this Agreement, such party agrees to remit to the Borrower, such excess.
10.20 USA PATRIOT Act Notice . Each Lender that is subject to the USA PATRIOT Act and the Administrative Agent (for itself and not on behalf of any Lender) hereby notifies the Borrower that pursuant to the requirements of the USA PATRIOT Act, it is required to obtain, verify and record information that identifies each Credit Party, which information includes the name, address and tax identification of each Credit Party and other information that will allow such Lender or the Administrative Agent, as applicable, to identify each Credit Party in accordance with the USA PATRIOT Act. Each Lender and the Administrative Agent (for itself and not on behalf of any Lender) may also pursuant to the applicable AML Legislation be required to obtain, verify and record information regarding the Credit Parties, their directors, authorized signing officers, direct or indirect shareholders and the Transactions contemplated hereby. Each Credit Party shall, promptly following a request by the Administrative Agent or any Lender, provide all documentation and other information that the Administrative Agent or such Lender reasonably requests in order to comply with its ongoing obligations under applicable AML Legislation, including the USA PATRIOT Act.
10.21 Acknowledgements . The Borrower hereby acknowledges and agrees that (a) no fiduciary, advisory or agency relationship between the Lender Parties and the Credit Parties is intended to be or has been created in respect of any of the transactions contemplated by this Agreement or the other Credit Documents, irrespective of whether the Lender Parties have advised or are advising the Credit Parties on other matters, and the relationship between the Lender Parties, on the one hand, and the Credit Parties, on the other hand, in connection herewith and therewith is solely that of creditor and debtor, (b) the Lender Parties, on the one hand, and the Credit Parties, on the other hand, have an arms length business relationship that does not directly or indirectly give rise to, nor do the Credit Parties rely on, any fiduciary duty to the Credit Parties or their Affiliates on the part of the Lender Parties, (c) the Credit Parties are capable of evaluating and understanding, and the Credit Parties understand and accept, the terms, risks and conditions of the transactions contemplated by this Agreement and the other Credit Documents, (d) the Credit Parties have been advised that the Lender Parties are engaged in a broad range of transactions that may involve interests that differ from the Credit Parties interests and that the Lender Parties have no obligation to disclose such interests and transactions to the Credit Parties, (e) the Credit Parties have consulted their own legal, accounting, regulatory and tax advisors to the extent the Credit Parties have deemed appropriate in the negotiation, execution and delivery of this Agreement and the other Credit Documents, (f) each Lender Party has been, is, and will be acting solely as a principal and, except as otherwise expressly agreed in writing by it and the relevant parties, has not been, is not, and will not be acting as an advisor, agent or fiduciary for the Credit Parties, any of their Affiliates or any other Person, (g) none of the Lender Parties has any obligation to the Credit Parties or their Affiliates with respect to the transactions contemplated by this Agreement or the other Credit Documents except those obligations expressly set forth herein or therein or in any other express writing executed and delivered by such Lender Party and the Credit Parties or any such Affiliate and (h) no joint venture is created hereby or by the other Credit Documents or otherwise exists by virtue of the transactions contemplated hereby among the Lender Parties or among the Lender Parties and the Credit Parties.
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[Remainder of page intentionally left blank]
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IN WITNESS WHEREOF, the parties hereto have caused this Agreement to be duly executed and delivered by their respective officers thereunto duly authorized as of the date first written above.
CONCORDIA LABORATORIES INC. , as Guarantor |
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By: |
[REDACTED Personal Information] |
|
COMPLETE MEDICAL HOMECARE, INC. , as Guarantor |
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By: |
[REDACTED Personal Information] |
|
PINNACLE BIOLOGICS, INC. , as Guarantor |
||
By: |
[REDACTED Personal Information] |
ROYAL BANK OF CANADA , as Administrative Agent and Collateral Agent |
||
By: | [REDACTED Signature] |
ROYAL BANK OF CANADA , as Lender, Swing Line Lender and L/C Issuer |
||
By: | [REDACTED Signature] |
MORGAN STANLEY SENIOR FUNDING, INC. , as Lender | ||
By: | [REDACTED Signature] |
GENERAL ELECTRIC CAPITAL CORPORATION , as Lender | ||
By: | [REDACTED Signature] |
EXPORT DEVELOPMENT CANADA , as Lender | ||
By: | [REDACTED Signature] | |
By: | [REDACTED Signature] |
THE TORONTO-DOMINION BANK , as Lender | ||
By: | [REDACTED Signature] | |
By: | [REDACTED Signature] |
FIFTH THIRD BANK , an Ohio banking corporation, as Lender | ||
By: | [REDACTED Signature] |
Appendix A-1
Initial Term Loan Commitments
[REDACTED Initial Term Loan Commitments]
Appendix A-2
Revolving Commitments
[REDACTED Revolving Commitments]
Schedule 1.1(a)
Guarantors
[REDACTED Guarantors]
Schedule 1.1(a)-1
Schedule 1.1(b)
Immaterial Subsidiaries
[REDACTED Immaterial Subsidiaries]
Schedule 1.1(b)-1
Schedule 1.1(c)
Unrestricted Subsidiaries
[REDACTED Unrestricted Subsidiaries]
Schedule 1.1(c)-1
Schedule 4.4
Filings, Governmental Approvals and Third Party Consents
[REDACTED Filings, Governmental Approvals and Third Party Consents]
Schedule 4.4-1
Schedule 4.8
Equity Interests and Ownership of Subsidiaries
[REDACTED Equity Interests and Ownership of Subsidiaries]
Schedule 4.8-1
Schedule 4.9
Actions, Suits and Proceedings
[REDACTED Actions, Suits and Proceedings]
Schedule 4.9-1
Schedule 4.16
Environmental Matters
[REDACTED Environmental Matters]
Schedule 4.9-1
Schedule 4.18
Insurance
[REDACTED Insurance Schedule]
Schedule 4.18-1
Schedule 4.21
Intellectual Property
[REDACTED Intellectual Property]
Schedule 4.21-1
Schedule 5.11
Post-Closing Deliverables
[REDACTED Post-Closing Deliverables]
Schedule 5.11-1
Schedule 6.1(a)
Certain Indebtedness
[REDACTED Certain Indebtedness]
Schedule 6.1(a)-1
Schedule 6.2(a)
Certain Liens
[REDACTED Certain Liens]
Schedule 6.2(a)-1
Schedule 6.3(h)
[REDACTED Certain Investments]
Schedule 6.2(a)-2
Schedule 6.5(c)
Certain Restricted Payments
[REDACTED Certain Restricted Payments]
Schedule 6.5(c)-1
Schedule 6.6(b)
Certain Affiliate Transactions
[REDACTED Certain Affiliate Transactions]
Schedule 6.6(b)-1
Schedule 6.8(b)
Non-Permitted Encumbrances
[REDACTED Non-Permitted Encumberances]
Schedule 6.8(b)-1
Schedule 10.1
Notice Addresses
[REDACTED Notice Addresses]
Schedule 10.1-1
Exhibit 99.26
BUSINESS ACQUISITION REPORT
Form 51-102F4
Item 1 - Identity of the Company
1.1 | Name and Address of the Company |
Concordia Healthcare Corp. (formerly Mercari Acquisition Corp.) (the Company )
277 Lakeshore Road East
Suite 302
Oakville, Ontario
L6J 1H9
1.2 | Executive Officer |
For further information in respect of this report and the significant acquisition described herein, please contact:
Leith J. Tessy
Chief Financial Officer and Secretary of the Company
(905) 842-5150
Item 2 - Details of Acquisition
2.1 | Nature of Business Acquired |
On December 20, 2013, Concordia Healthcare Inc. ( Concordia Subco ), a wholly-owned subsidiary of the Company, completed the purchase of Pinnacle Biologics, Inc. ( Pinnacle ), pursuant to the terms and conditions of an Agreement of Plan and Merger dated November 8, 2013.
Pinnacle is a biopharmaceutical research and development company specializing in orphan diseases. One of Pinnacles on-market products is PHOTOFRIN®, a photosensitizer used in photodynamic therapy ( PDT ) of tumors.
Pinnacles PDT with PHOTOFRIN® is approved by the United States Federal Drug Administration ( FDA ) for multiple indications including the treatment of non-small cell lung cancer and esophageal cancer. PHOTOFRIN® also is approved for high-grade dysplasia in Barretts esophagus in North America. It has Orphan Drug Designation for cholangiocarcinoma (cancer of the bile duct) and as adjuvant therapy to surgery for the treatment of malignant pleural mesothelioma.
2.2 | Date of the Acquisition |
The effective date of the acquisition of Pinnacle was December 20, 2013 (the Closing Date ). The date of acquisition for accounting purposes is the [Closing Date] .
2.3 | Consideration |
Concordia Subco, through its subsidiaries, acquired 100% of the shares of Pinnacle for total consideration of USD$58,012,285 comprised of $32,667,992 of cash consideration, $5,000,000
of Concordia Subcos common shares issued at a price of CAD $5.63 per common share (being a 10% discount to the price of the Subscription Receipts (as defined below) issued under the Private Placement (as defined below)), 10 annual cash payments with an estimated present value of USD$5,018,769 and milestone and other contingency payments with an estimated present value of USD$15,325,524.
The acquisition of Pinnacle was financed through a combination of available cash, which included net proceeds of CAD$34,500,000 received by Concordia Subco through a private placement offering (the Private Placement ) of subscription receipts (the Subscription Receipts ) of Concordia Subco, which closed on December 19, 2013. The Subscription Receipts issued under the Private Placement were issued at a price of CAD$6.25 per Subscription Receipt.
2.4 | Effect on Financial Position |
The acquisition of Pinnacle complements the Companys Orphan Drugs Division. Except as described below, the Company has no current plans or proposals for material changes in its business affairs or the affairs of Pinnacle which may have a significant effect on the results of operations and financial position of the Company.
PHOTOFRIN®, Pinnacles legacy pharmaceutical product, has been approved by the FDA to treat three rare forms of cancer. The product is also prescribed on a compassionate use basis for other indications where doctors believe that patients will benefit from the treatment and there is some clinical support for the efficacy of the product. The Company intends to complete the clinical work necessary to achieve FDA approval for other follow-on indications for PHOTOFRIN®. The Company intends to fund the clinical work through the Companys operating cash flows.
2.5 | Prior Valuations |
Not applicable.
2.6 | Parties to the Acquisition |
The acquisition did not involve an informed person, associate or affiliate of the Company.
2.7 | Date of Report |
This report is dated February 10, 2014.
Item 3 - Financial Statements
The following financial statements have been included with this report:
(a) | Schedule A: Pinnacle Biologics, Inc. and Subsidiaries Consolidated Financial Statements and Independent Accountants Report for the Nine Months Ended September 30, 2013 and 2012 and for the Years Ended December 31, 2012 and 2011; |
(b) | Schedule B: Unaudited Pro Forma Consolidated Financial Statements of Concordia Healthcare Corp. as at September 30, 2013. |
- 2 -
SCHEDULE A
Pinnacle Biologics, Inc.
and Subsidiaries
Consolidated Financial Statements
and Independent Auditors Review Report
Nine Months Ended September 30, 2013 and 2012
and Years Ended December 31, 2012 and 2011
A-2
PINNACLE BIOLOGICS, INC. AND SUBSIDIARIES
TABLE OF CONTENTS
Page | ||||
INDEPENDENT AUDITORS REVIEW REPORT |
1 | |||
CONSOLIDATED FINANCIAL STATEMENTS |
||||
Consolidated Balance Sheets |
2 | |||
Consolidated Statements of Income |
3 | |||
Consolidated Statements of Comprehensive Income |
4 | |||
Consolidated Statements of Changes in Stockholders Equity (Deficit) |
5 | |||
Consolidated Statements of Cash Flows |
6 | |||
Notes to the Consolidated Financial Statements |
7 15 |
A-3
|
Page 1 |
INDEPENDENT AUDITORS REVIEW REPORT
Board of Directors and Stockholders
Pinnacle Biologics, Inc. and Subsidiaries
We have reviewed the condensed consolidated financial statements of Pinnacle Biologics, Inc. and Subsidiaries, which comprise the consolidated balance sheet as of September 30, 2013, and the related consolidated statements of income, comprehensive income, changes in stockholders equity (deficit) and cash flows for the nine months ended September 30, 2013 and 2012.
Managements Responsibility for the Financial Information
Management is responsible for the preparation and fair presentation of the condensed financial information in accordance with accounting principles generally accepted in the United States of America; this responsibility includes the design, implementation, and maintenance of internal control sufficient to provide a reasonable basis for the preparation and fair presentation of interim financial information in accordance with accounting principles generally accepted in the United Suites of America.
Auditors Responsibility
Our responsibility is to conduct our reviews in accordance with auditing standards generally accepted in the United States of America applicable to reviews of interim financial information. A review of interim financial information consists principally of applying analytical procedures and making inquiries of persons responsible for financial and accounting matters. It is substantially less in scope than an audit conducted in accordance with auditing standards generally accepted in the United States of America, the objective of which is the expression of an opinion regarding the financial information. Accordingly, we do not express such an opinion.
Conclusion
Based on our reviews, we are not aware of any material modifications that should be made to the accompanying condensed financial information referred to above for it to be in accordance with accounting principles generally accepted in the United States of America.
Independent Auditors Report on 2012 and 2011 Annual Financial Statements
We have previously audited, in accordance with auditing standards generally accepted in the United States of America, the consolidated balance sheets of Pinnacle Biologics, Inc. and Subsidiaries as of December 31, 2012 and 2011, and the related consolidated statements of income, comprehensive income, changes in stockholders equity (deficit) and cash flows for the years then ended and we expressed an unmodified audit opinion on those consolidated financial statements in our report dated March 28, 2013.
December 12, 2013
2801 Lakeside Drive
3rd Floor
Bannockburn, IL 60015
847 374 0400 v
847 374 0420 f
www.fgmk.net
A-4
|
Page 1 |
INDEPENDENT AUDITORS REPORT
Board of Directors and Stockholders
Pinnacle Biologics, Inc. and Subsidiaries
We have audited the accompanying financial statements of Pinnacle Biologics, Inc. and Subsidiaries, which comprise the balance sheets as of December 31, 2012 and 2011, and the related statements of income, comprehensive income, changes in stockholders equity, and cash flows for the years then ended, and the related notes to the financial statements.
Managements Responsibility for the Financial Statements
Management is responsible for the preparation and fair presentation of these financial statements in accordance with accounting principles generally accepted in the United States of America; this includes the design, implementation, and maintenance of internal control relevant to the preparation and fair presentation of financial statements that are free from material misstatement, whether due to fraud or error.
Auditors Responsibility
Our responsibility is to express an opinion on these financial statements based on our audits. We conducted our audits in accordance with auditing standards generally accepted in the United States of America. Those standards require that we plan and perform the audit to obtain reasonable assurance about whether the financial statements are free from material misstatement.
An audit involves performing procedures to obtain audit evidence about the amounts and disclosures in the financial statements. The procedures selected depend on the auditors judgment, including the assessment of the risks of material misstatement of the financial statements, whether due to fraud or error. In making those risk assessments, the auditor considers internal control relevant to the entitys preparation and fair presentation of the financial statements in order to design audit procedures that are appropriate in the circumstances, but not for the purpose of expressing an opinion on the effectiveness of the entitys internal control. Accordingly, we express no such opinion. An audit also includes evaluating the appropriateness of accounting policies used and the reasonableness of significant accounting estimates made by management, as well as evaluating the overall presentation of the financial statements.
We believe that the audit evidence we have obtained is sufficient and appropriate to provide a basis for our audit opinion.
Opinion
In our opinion, the financial statements referred to above present fairly, in all material respects, the financial position of Pinnacle Biologics, Inc. and Subsidiaries as of December 31, 2012 and 2011, and the results of their operations and their cash flows for the years then ended in accordance with accounting principles generally accepted in the United States of America.
Bannockburn, Illinois
March 28, 2013
2801 Lakeside Drive
3rd Floor
Bannockburn, IL 60015
847 374 0400 v
847 374 0420 f
www.fgmk.net
A-5
PINNACLE BIOLOGICS, INC. AND SUBSIDIARIES
CONSOLIDATED STATEMENTS OF CASH FLOWS
NINE MONTHS ENDED SEPTEMBER 30, 2013 AND 2012 AND
YEARS ENDED DECEMBER 31, 2012 AND 2011
See Independent Auditors Review Report.
The accompanying notes are an integral part of these statements.
A-6
PINNACLE BIOLOGICS, INC. AND SUBSIDIARIES
CONSOLIDATED BALANCE SHEETS
SEPTEMBER 30, 2013, DECEMBER 31, 2012 AND DECEMBER 31, 2011
ASSETS
See Independent Auditors Review Report.
The accompanying notes are an integral part of these statements.
A-7
Page 2
LIABILITIES AND STOCKHOLDERS EQUITY
A-8
Page 3
PINNACLE BIOLOGICS, INC. AND SUBSIDIARIES
CONSOLIDATED STATEMENTS OF INCOME
NINE MONTHS ENDED SEPTEMBER 30, 2013 AND 2012 AND
YEARS ENDED DECEMBER 31, 2012 AND 2011
See Independent Auditors Review Report.
The accompanying notes are an integral part of these statements.
A-9
Page 4
PINNACLE BIOLOGICS, INC. AND SUBSIDIARIES
CONSOLIDATED STATEMENTS OF COMPREHENSIVE INCOME
NINE MONTHS ENDED SEPTEMBER 30, 2013 AND 2012 AND
YEARS ENDED DECEMBER 31, 2012 AND 2011
Nine Months Ended
September 30, (Unaudited) |
Year Ended
December 31, (Audited) |
|||||||||||||||
2013 | 2012 | 2012 | 2011 | |||||||||||||
NET INCOME |
$ | 1,164,129 | $ | 1,326,986 | $ | 1,442,210 | $ | 1,385,720 | ||||||||
OTHER COMPREHENSIVE INCOME (LOSS) |
||||||||||||||||
Foreign currency translation gain (loss) |
44,717 | (11,319 | ) | 21,335 | (85,223 | ) | ||||||||||
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COMPREHENSIVE INCOME |
$ | 1,208,846 | $ | 1,315,667 | $ | 1,463,545 | $ | 1,300,497 | ||||||||
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|
|
|
|
See Independent Auditors Review Report.
The accompanying notes are an integral part of these statements.
A-10
Page 5
PINNACLE BIOLOGICS, INC. AND SUBSIDIARIES
CONSOLIDATED STATEMENTS OF CHANGES IN STOCKHOLDERS EQUITY (DEFICIT)
NINE MONTH PERIOD ENDED SEPTEMBER 30, 2013 AND
YEARS ENDED DECEMBER 31, 2012 AND 2011
Controlling Interest | ||||||||||||||||||||||||||||||||||||
Series A Preferred Stock | Common Stock |
Additional Paid-In |
Retained Earnings (Accumulated |
Accumulated Other Comprehensive |
Noncontrolling |
Total Stockholders |
||||||||||||||||||||||||||||||
Shares | Amount | Shares | Amount | Capital | Deficit) | Income (Loss) | Interest | Equity (Deficit) | ||||||||||||||||||||||||||||
Balance - January 1, 2011 (Audited) |
21,429 | $ | 214 | 100,000 | $ | 1,000 | $ | 911,459 | $ | (185,131 | ) | $ | 17,477 | $ | | $ | 745,019 | |||||||||||||||||||
Dividends |
| | | | | (667 | ) | | | (667 | ) | |||||||||||||||||||||||||
Repurchase of stock |
(21,429 | ) | (214 | ) | | | (132,139 | ) | (2,656,956 | ) | | | (2,789,309 | ) | ||||||||||||||||||||||
Issuance of stock, net |
7,609 | 76 | | | 865,961 | | | | 866,037 | |||||||||||||||||||||||||||
Foreign currency translation loss |
| | | | | | (85,223 | ) | | (85,223 | ) | |||||||||||||||||||||||||
Net income |
| | | | | 1,385,720 | | (20,953 | ) | 1,364,767 | ||||||||||||||||||||||||||
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Balance - December 31, 2011 (Audited) |
7,609 | 76 | 100,000 | 1,000 | 1,645,281 | (1,457,034 | ) | (67,746 | ) | (20,953 | ) | 100,624 | ||||||||||||||||||||||||
Dividends |
| | | | | (261,523 | ) | | | (261,523 | ) | |||||||||||||||||||||||||
Issuance of stock, net |
18,823 | 188 | | | 2,337,978 | | | | 2,338,166 | |||||||||||||||||||||||||||
Compensation expense for stock options |
| | | | 129,939 | | | | 129,939 | |||||||||||||||||||||||||||
Issuance of warrants |
| | | | 134,620 | | | | 134,620 | |||||||||||||||||||||||||||
Foreign currency translation gain |
| | | | | | 21,335 | | 21,335 | |||||||||||||||||||||||||||
Net income |
| | | | | 1,442,210 | | (8,861 | ) | 1,433,349 | ||||||||||||||||||||||||||
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Balance - December 31, 2012 (Audited) |
26,432 | $ | 264 | 100,000 | $ | 1,000 | $ | 4,247,818 | $ | (276,347 | ) | $ | (46,411 | ) | $ | (29,814 | ) | $ | 3,896,510 | |||||||||||||||||
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Balance - September 30, 2013 (Unaudited) |
26,432 | $ | 264 | 100,000 | $ | 1,000 | $ | 4,428,338 | $ | 674,216 | $ | (1,694 | ) | $ | (29,207 | ) | $ | 5,072,917 | ||||||||||||||||||
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See Independent Auditors Review Report.
The accompanying notes are an integral part of these statements.
A-11
Page 6
A-12
Page 7
PINNACLE BIOLOGICS, INC. AND SUBSIDIARIES
NOTES TO THE CONSOLIDATED FINANCIAL STATEMENTS
NOTE 1 DESCRIPTION OF BUSINESS AND SUMMARY OF SIGNIFICANT ACCOUNTING POLICIES
Description of Business . Pinnacle Biologics, Inc. (PBI), a Delaware corporation, specializes in revitalizing healthcare therapies by promoting, developing, and managing innovative approaches to the commercialization of products with a focus on oncology and orphan diseases.
Pinnacle Biologics, BV (PB BV), a Netherlands private limited liability company, and Compagnie Biologiques Pinnacle (Compagnie), a Quebec, Canada company, are wholly-owned subsidiaries of PBI. Pinnacle Oncology, LLC (Oncology), a limited liability company, is a majority-owned subsidiary of PBI. PB BV, Compagnie and Oncology are referred to collectively as the Subsidiaries.
Principles of Consolidation . The accompanying consolidated financial statements include the accounts of PBI, PB BV, Compagnie and Oncology (collectively the Company). All significant intercompany accounts and transactions have been eliminated in consolidation. The noncontrolling interest in Oncology is presented as a separate component of stockholders equity on the consolidated balance sheets and consolidated statements of changes in stockholders equity, and as a separate component of net income on the consolidated statements of income. These separate components are titled noncontrolling interest.
Management Estimates and Assumptions . The preparation of financial statements in conformity with accounting principles generally accepted in the United States of America (GAAP) requires management to make estimates and assumptions that affect the amounts reported in the consolidated financial statements and accompanying notes. Actual results could differ from those estimates. The Companys significant estimates include (1) reserves for inventory obsolescence (2) valuation of goodwill and (3) purchase price consideration. Future events and their effects cannot be predicted with certainty; accordingly, accounting estimates require the exercise of judgment. Accounting estimates used in the preparation of these consolidated financial statements change as new events occur, as more experience is acquired, as additional information is obtained and as the operating environment changes.
Condensed Financial Information . The condensed interim financial information presented as of September 30, 2013 and for the nine months ended September 30, 2013 and 2012, has been prepared in accordance with GAAP and does not represent complete financial statements. Accordingly, certain related information and disclosures have not been included with the condensed interim financial information. The condensed interim financial information has been presented in a comparative format; along with the Companys audited financial statements as of and for the years ended December 31, 2012 and 2011 and should be read in conjunction with the audited financial statements.
Cash and Cash Equivalents . All highly liquid investments purchased with an original maturity of three months or less are considered to be cash equivalents. The Company regularly maintains cash balances that may exceed Federal Depository Insurance Corporation limits.
Accounts Receivable and Allowance for Doubtful Accounts . Accounts receivable are generally uncollateralized customer obligations due under normal trade terms granted by the Company on the basis of each customers own creditworthiness. The carrying amount of accounts receivable is reduced by a valuation allowance that reflects managements best estimate of amounts that will not be collected. Management individually reviews past due accounts receivable balances and based on an assessment of each customers current creditworthiness, estimates the portion, if any that will not be collected. Additionally, management assesses the remaining balance of accounts receivable based on past experience and an assessment of future economic conditions to determine its best estimate of the portion that will not be collected. The Company determined no allowance was necessary as of September 30, 2013 and December 31, 2012 and 2011.
Inventory . Inventory is valued at the lower of cost, determined by using either the first-in, first-out method or standard cost method, or market and consist only of finished goods and work-in-process. Management reviews inventory for obsolescence based on the specific inventory categories, aging of inventory categories, and projected future consumption of its customers. The Companys reserve for inventory obsolescence was approximately $199,000, $134,000 and $529,000 as of September 30, 2013, December 31, 2012 and 2011, respectively.
(Continued)
See Independent Auditors Review Report.
A-13
Page 8
PINNACLE BIOLOGICS, INC. AND SUBSIDIARIES
NOTES TO THE CONSOLIDATED FINANCIAL STATEMENTS
NOTE 1 DESCRIPTION OF BUSINESS AND SUMMARY OF SIGNIFICANT ACCOUNTING POLICIES (Continued)
Property and Equipment . Property and equipment are stated at cost. Depreciation is computed primarily using the straight- line method over estimated useful lives ranging from three to six years. Property and equipment are reviewed for impairment when events or changes in circumstances indicate that the carrying amount of the assets may not be recoverable. There were no such impairment charges for the nine months ended September 30, 2013 and 2012 and the years ended December 31, 2012 and 2011.
Goodwill . Goodwill represents the excess of fair value of consideration transferred over the fair value of the underlying net assets acquired. The Company annually reviews goodwill to evaluate whether changes have occurred that would suggest such assets might be impaired. If circumstances suggest that the associated costs are not recoverable, the carrying value is reduced to fair value. There were no impairment charges for the nine months ended September 30, 2013 and 2012 and the
Deferred Financing Fees . During 2012, the Company capitalized costs totaling $248,851 related to costs in securing financing with NXT Capital SBIC, LP (see Note 4). These costs are amortized over the life of the respective loan. Accumulated amortization was $121,454 as of September 30, 2013 and $57,756 as of December 31, 2012. Capitalized costs include a deferred closing fee liability of $48,150 in connection with the same financing which is payable upon the earlier of maturity date, date of prepayment of loan or the occurrence of a default on loan.
Revenue Recognition . The Company recognizes revenue when persuasive evidence of an arrangement exists, delivery of products has occurred, the sales price charged is fixed and determinable, and collectability is reasonably assured. This generally means that the Company recognizes revenue when title is transferred to customers, which typically occurs upon shipments to or receipt at customer locations, as determined by specific sales terms of the transactions, Sales terms generally do not: allow for a right of return except for matters related to manufacturing defects. In the United States, expired product may be returned only for replacement by product with current dating.
Research and Development Costs . Internal research and development costs are expensed as incurred. Clinical trial costs performed by third parties under contract are expensed as the work is performed. Such expenses were $2,250 for the nine months ended September 30, 2013 and $236,162 and $227,196 for the years ended December 31, 2012 and 2011. respectively.
Foreign Operations . The functional currency for the consolidated foreign subsidiaries, Pinnacle Biologics, BV (Netherlands) and Compagnie Biologiques Pinnacle (Canada), are the applicable local currencies, Euros and Canadian Dollars, respectively. The translation of the applicable foreign currency into U.S. dollars is performed for balance sheet accounts using current exchange rates in effect at the balance sheet date and for revenue and expense accounts using a weighted average rate during the period. The gains or losses resulting from such translation are included as a component of accumulated other comprehensive income in stockholders equity. Assets located outside the United States totaled $2,976,531 as of September 31, 2013. Revenues outside the United States totaled $1,956,442 and $2,391,156 for the nine months ended September 30, 2013 and 2012, respectively. Assets located outside the United States totaled $3,067,942 and $1,866,821 as of December 31, 2012 and 2011, respectively. Revenues outside the United States totaled $2,625,865 and $4,542,635 for the years ended December 31, 2012 and 2011, respectively.
Income Taxes . Income taxes are accounted for in accordance with the provisions of Financial Accounting Standards Board (FASB) Accounting Standards Codification (ASC) 740, Income Taxes, which requires the recognition of deferred income taxes for differences between the basis of assets and liabilities for financial statement and income tax purposes. These differences for the Company relate primarily to differences in deductibility of certain accrued expenses, inventory reserve, calculating depreciation on property and equipment, calculating amortization on intangible assets and the change from the cash method of accounting to the accrual method of accounting for income tax purposes (effective January 1, 2011). Deferred tax asset and liabilities represent future tax consequences for those differences, which will either be deductible or taxable when the assets and liabilities are recovered or settled. Valuation allowances are established when necessary to reduce net deferred tax assets to amounts expected to be realized. There is no valuation allowance recognized as of September 30, 2013 and December 31, 2012 and 2011.
(Continued)
See Independent Auditors Review Report.
A-14
Page 9
PINNACLE BIOLOGICS, INC. AND SUBSIDIARIES
NOTES TO THE CONSOLIDATED FINANCIAL STATEMENTS
NOTE 1 DESCRIPTION OF BUSINESS AND SUMMARY OF SIGNIFICANT ACCOUNTING POLICIES (Concluded)
GAAP requires management to evaluate tax positions taken by the Company and recognize it liability (or asset) if the Company has taken an uncertain tax position that more likely than not would be sustained upon examination by the Internal Revenue Service and either the Netherlands or Canadian taxing authorities. Management has analyzed the tax positions taken by the Company, and has concluded that as of September 30, 2013, December 31, 2012 and 2011 there are no uncertain tax positions taken or expected to be taken that would require recognition of a liability (or asset) or disclosure in the financial statements, The Company files tax returns in ail appropriate jurisdictions, which include a United States federal tax return and state tax returns. The Company is subject to routine audits by taxing jurisdictions; however, there are currently no audits for any tax periods in progress. Management believes it is no longer subject to United States or state income tax examinations for years prior to 2009. The Company has not incurred any significant penalties or interest on its income tax returns for the nine months ended September 30, 2013 and the years ended December 31, 2012 and 2011.
Reclassifications . Certain reclassifications were made to 2011 consolidated financial statements to conform to the 2012 presentation.
NOTE 2 BUSINESS COMBINATION
On March 28, 2011, PBI and PB BV acquired certain assets, including inventory and related product rights, and assumed certain liabilities of Aptalis Pharma Inc. (formerly Axcan Pharma, Inc.), as defined in the underlying Product Acquisition Agreement. The assets were acquired for $1,250,437 of existing inventory, an initial purchase price of $3,000,000, and additional purchase price consideration up to $4,844,550, which consists of milestones payments, $3,000,000, and earn-out payments, $1,844,550, The milestone payments are defined as upon the dose of a calendar year if the Companys cumulative sales of the product acquired exceed (1) $10,000,000 worldwide then $1,000,000 payment due, (2) $20,000,000 worldwide then $1,000,000 payment due, and (3) $25,000,000 worldwide then $1,000,000 payment due, The milestone payments are due to seller, Aptalis Pharma Inc., within 30 days of notification that the milestone was achieved. A milestone payment of $1,000,000 was made when due in 2013, and milestone payments of $2,000,000 are presented as a current liability in the September 30, 2013 consolidated balance sheets.
The earn-out payments are defined as five percent of worldwide annual net sales of the product acquired not to exceed $2,200,000. The full amount of $2,200,000 was discounted to the present value of future cash flow using a 9% discount rate. The earn-out payments are due to seller, Aptalis Pharma Inc., within 45 days following each calendar quarter. The estimated discount earn-out payments remaining of $547,966 and $274,408 are presented as a current and long-term liability, respectively, on the accompanying consolidated balance sheets as of September 30, 2013.
The business combination was accounted for under the acquisition method of accounting. The assets acquired and liabilities assumed were recorded at book value, which management determined approximated fair value. The fair value measurement for these assets and liabilities are all level 3 inputs which are unobservable and significant to the fair value measurement. As of September 30, 2013, December 31, 2012 and 2011, the excess of the purchase price paid over the fair value of the assets acquired and liabilities assumed has been recorded as goodwill.
A summary of the assets acquired and liabilities assumed by PBI and PB BV are as follows;
Amount | ||||
Inventory |
$ | 1,250,437 | ||
Goodwill |
7,844,550 | |||
|
|
|||
Total assets acquired |
9,094,987 | |||
Less: Accounts payable in connection with inventory |
1,250,437 | |||
|
|
|||
$ | 7,844,550 | |||
|
|
(Continued)
See Independent Auditors Review Report.
A-15
Page 10
PINNACLE BIOLOGICS, INC. AND SUBSIDIARIES
NOTES TO THE CONSOLIDATED FINANCIAL STATEMENTS
NOTE 2 BUSINESS COMBINATION (Concluded)
On November 30, 2012, PBI acquired certain assets, including inventory and related product rights, and assumed certain liabilities of AngioDynamics, Inc., as defined in the underlying Asset Purchase Agreement. The assets were acquired for purchase price of $1,163,795. The Company is also required to make royalty payments to AngioDynamics, Inc. of 10% of worldwide annual net sales of one of the products over a four year period.
The business combination was accounted for under the acquisition method of accounting. The assets acquired and liabilities assumed were recorded at book value, which management determined approximated fair value. The fair value measurement for these assets and liabilities are all level 3 inputs which are unobservable and significant to the fair value measurement. As of September 30, 2013 and December 31, 2012, the excess of the purchase price paid over the fair value of the assets acquired and liabilities assumed has been recorded as goodwill.
A summary of the assets acquired and liabilities assumed are as follows:
Amount | ||||
Inventory |
$ | 363,440 | ||
Goodwill |
800,355 | |||
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|
|||
Total assets acquired |
$ | 1,163,795 | ||
|
|
As of September 30, 2013, December 31, 2012 and 2011, the balance of goodwill on the accompanying consolidated balance sheets is impacted by foreign currency effects.
NOTE 3 PROPERTY AND EQUIPMENT
Major classes of property and equipment consist of the following:
September 30, | December 31, | Estimated | ||||||||||||
2013 | 2012 | 2011 | Useful Life | |||||||||||
Office furniture and fixtures |
$ | 5,430 | $ | 5,430 | $ | 5,430 | 3 - 5 years | |||||||
Leasehold improvements |
47,153 | 47,153 | 23,031 | Lease term | ||||||||||
Service equipment |
136,364 | 124,020 | | 3 years | ||||||||||
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|||||||||
$ | 188,947 | $ | 176,603 | $ | 28,461 | |||||||||
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|
NOTE 4 LONG-TERM DEBT
Series A Preferred Stock Repurchase Promissory Notes . As further described in Note 5, the Company repurchased Series A Preferred Stock as defined in the Series A Preferred Stock Repurchase Agreement. The Company has executed three promissory notes on November 4, 2011 as form of remaining payments. Each promissory note is for $772,138 and all carry an interest rate of 9%. The maturity date of each remaining promissory note is October 31, 2013 and October 31, 2014. As of September 30, 2013 and December 31, 2012, the current and long-term portions of these notes are $772,138 and $772,138, respectively. As of December 31, 2011, the current and long-term portions of these notes are $772,138 and $1,544,276, respectively.
(Continued)
See Independent Auditors Review Report.
A-16
Page 11
PINNACLE BIOLOGICS, INC. AND SUBSIDIARIES
NOTES TO THE CONSOLIDATED FINANCIAL STATEMENTS
NOTE 4 LONG-TERM DEBT (Concluded)
Promissory Note Payables . The Company executed seven secured promissory notes payable, all dated June 27, 2011, in connection with a Secured Note Purchase Agreement. The maturity dates for all of the notes was March 31, 2015. Furthermore, the Company executed subscription agreements dated December 13, 2011 with certain note holders for purchase or conversion of principal amounts into Series A Preferred Stock of the Company. As of September 30, 2013 and December 31, 2012, long-term portion of these notes is $175,000. As of December 31, 2011, the current and long-term portions of these notes are $1,325,000 and $175,000, respectively.
Senior Loan and Security Agreement . On March 28. 2012, the Company entered into a $1,500,000 senior secured credit facility with NXT Capital SBIC, LP (NXT). On November 30, 2012, the Company executed a Second Loan Modification Agreement with NXT for an additional loan of $640,000. The credit facility accrues interest at a rate of 11.50% per annum on the outstanding unpaid principal balance. Interest shall be paid on first day of calendar month starting May 1, 2012 through April 1, 2013 and beginning on May 1, 2013 the Company shall make twenty-four equal payments of principal and interest on the first day of each calendar month. The credit facility has a maturity date of April 1, 2015. The Company has granted to NXT a valid, perfected and continuing first priority security interest of substantially all of the business assets of the Company, as defined in the Senior Loan and Security Agreement. The credit facility contains certain affirmative and negative covenants. According to management, the Company was in compliance with all such covenants as of September 30, 2013 and December 31, 2012.
In connection with the NXT credit facility, the Company entered into two warrant agreements dated March 28, 2012 and November 30, 2012. The warrant agreements grant the right to NXT to purchase a total of 1,372 shares of 2011 Series A Preferred Stock as additional consideration for extending the credit facilities. The exercise price per share is $131.43 for the 1,085 warrants granted in March 2012, and $212.08 for the 287 warrants granted in November 2012; the warrant agreements also provide for a reduction in the exercise price to par value of $0.01 per share upon the first to occur of a liquidation event or the date of the registration statement covering the securities is offered in the Companys initial public offering is declared effective by the Securities Exchange Commission (IPO date). The fair value of these warrants was determined to be $134,620 and was recorded as a discount to the debt using the effective interest method, to be expensed over the life of the debt. The warrants terminate at the earlier of either a ten year exercise period or live years from the IPO date. The warrants granted in November 2012 contain an additional provision that if a liquidation event occurs prior to June 1, 2013 this warrant agreement will be surrendered and those warrants terminated.
Maturities on long-term debt as of December 31, 2012 are as follows:
Year Ending December 31 |
Principal
Payments |
Debt
Discount |
Net
Amount |
|||||||||
2013 |
$ | 1,430,766 | $ | (63,070 | ) | $ | 1,367,696 | |||||
2014 |
1,861,429 | (29,946 | ) | 1,831,483 | ||||||||
2015 |
567,082 | (1,619 | ) | 565,463 | ||||||||
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$ | 3,859,277 | $ | (94,635 | ) | $ | 3,764,642 | ||||||
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NOTE 5 STOCKHOLDERS EQUITY
2008 Series A Preferred Stock Repurchase . The Company executed a Series A Preferred Stock Repurchase Agreement with MedImmune, LLC as of November 4, 2011. Per the Agreement, MedImmune, LLC surrendered for repurchase by the Company their 21,429 shares of Series A Preferred Stock. The Company has repurchased these shares for consideration in form of payment of $2,816,413 as the accepted purchase price. Furthermore, Medlmmune has forfeited their dividends owed by the Company of $27,104. Payment of the purchase price will occur in four installments. As of September 30, 2013 and December 31, 2012, the Company has paid $1,272,138 and the two remaining installments of $772,138 each are recognized as debt. See terms of this debt in Note 4.
(Continued)
See Independent Auditors Review Report.
A-17
Page 12
PINNACLE BIOLOGICS, INC. AND SUBSIDIARIES
NOTES TO THE CONSOLIDATED FINANCIAL STATEMENTS
NOTE 5 STOCKHOLDERS EQUITY (Concluded)
2011 Series A Preferred Stock . The Company amended its Certificate of Incorporation on December 9, 2011 to, amongst other things, create a new class of Series A Preferred Stock replacing the previous class of Series A Preferred Stock. Shares of the new class of Series A Preferred Stock have a dividend preference to the common stock at the rate of 8% per annum, non-compounding. The dividends accrue daily from the date of issuance whether or not declared and are payable each January 1 with respect to all accrued but unpaid dividends through December 31 of the prior calendar year, to the extent of the Companys assets legally available for payment. If the dividends are not declared they continue to cumulate until paid. No such dividends have been declared as of September 30, 2013, December 31, 2012 and 2011. Cumulative unpaid Series A Preferred Stock dividends total $475,759, $262,190 and $667 as of September 30, 2013, December 31, 2012 and 2011, respectively.
The Series A Preferred Stock has a liquidation preference to the common stock upon a liquidation event, as defined in the Certificate of Incorporation of an amount equal to the Series A Original Issue Price, as defined in the Certificate of Incorporation and has the right to participate with the common stock in the remaining proceeds.
The Series A Preferred Stock has conversion rights which allows the holders of Series A Preferred Stock at their option any time after issuance to convert their shares into common stock at the Series A Conversion Price, as defined in the Certificate of Incorporation. Each share of Series A Preferred Stock automatically converts into a share of common stock at the Series A Conversion Price upon a public offering which meets certain criteria as defined in the Certificate of Incorporation.
Each holder of shares of Series A Preferred Stock has the right to redeem his shares at any time after the fifth anniversary of the November 2011 closing of the issuance of Series A Preferred Stock. The redemption price would be the amount which is the greater of the Series A Original issue Price, or the fair market value per share.
The Series A Preferred Stock holders have general voting rights which equal one vote for each share of common stock into which their shares of Series A Preferred Stock convert.
On December 1, 2011, the Company entered into a subscription agreement with Numoda Capital Innovations, LLC (NCI) whereby NCI agreed to purchase shares of the 2011 Series A Preferred Stock for up to $1,500,000 with purchases pegged to certain percentages of invoices from its affiliate, Numoda Corporation, for services performed under a Master Service Agreement (MSA). NCI pays the Company in tranches which continues until either NCI has invested the full purchase price of $1,500,000 or the MSA has been terminated. Based on the payments received from NCI, the Company issues shares of Series A Preferred Stock to NCI on a calendar quarterly basis with the share price determined by a trailing revenue calculation, as defined in the subscription agreement.
Common Stock . The Common Stock has dividend and liquidation rights that are subject to the prior rights of Series A Preferred Stock. The Common Stock has no redemption rights. The Common Stock holders have general voting rights which equal one vote for each share of Common Stock.
NOTE 6 OPERATING LEASE
The Company teases its main corporate office location in Bannockburn, Illinois. Total rent expense under this non- cancelable lease was approximately $73,000 for the nine months ended September 30, 2013 and $86,000 and $76,000 for the years ended December 31, 2012 and 2011.
(Continued)
See Independent Auditors Review Report.
A-18
Page 13
PINNACLE BIOLOGICS, INC. AND SUBSIDIARIES
NOTES TO THE CONSOLIDATED FINANCIAL STATEMENTS
NOTE 6 OPERATING LEASE (Concluded)
Approximate future minimum lease commitments under this lease as of December 31, 2012 are as follows;
Year Ending December 31 |
Amount | |||
2013 |
$ | 96,000 | ||
2014 |
98,000 | |||
2015 |
100,000 | |||
2016 |
72,000 | |||
|
|
|||
$ | 366,000 | |||
|
|
NOTE 7 - INCOME TAXES
The components of the net deferred income tax (asset) liability are as follows as of:
September 30, | December 31, | |||||||||||
2013 | 2012 | 2011 | ||||||||||
Tax effects of: |
||||||||||||
Depreciation |
$ | 38,080 | $ | 48,972 | $ | 9,327 | ||||||
Amortization |
320,580 | 139,166 | 23,104 | |||||||||
Accrued wages |
| | (11,812 | ) | ||||||||
Inventory reserve |
(68,909 | ) | (46,930 | ) | (43,435 | ) | ||||||
Organization costs |
(1,759 | ) | (1,909 | ) | | |||||||
Stock option expense |
(118,114 | ) | (56,074 | ) | | |||||||
Cash to accrual adjustment |
59,671 | 96,383 | 154,946 | |||||||||
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|||||||
$ | 229,549 | $ | 179,608 | $ | 132,130 | |||||||
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The net deferred income tax liability has been classified in the accompanying consolidated balance sheets as follows as of:
September 30, | December 31, | |||||||||||
2013 | 2012 | 2011 | ||||||||||
Current liability |
$ | | $ | | $ | 99,699 | ||||||
Current asset |
(139,280 | ) | (54,813 | ) | | |||||||
Non-current liability |
368,835 | 234,421 | 32,431 | |||||||||
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|||||||
$ | 229,549 | $ | 179,608 | $ | 132,130 | |||||||
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(Continued)
See Independent Auditors Review Report.
A-19
Page 14
PINNACLE BIOLOGICS, INC. AND SUBSIDIARIES
NOTES TO THE CONSOLIDATED FINANCIAL STATEMENTS
NOTE 7 INCOME TAXES (Concluded)
The components of the provision for income taxes are as follows for the period and years ended:
September 30,
2013 |
December 31, | |||||||||||
2012 | 2011 | |||||||||||
Current |
||||||||||||
Federal |
$ | 408,532 | $ | 597,640 | $ | 149,287 | ||||||
State |
10,437 | 27,199 | 22,222 | |||||||||
Foreign |
44,774 | 37,524 | 258,500 | |||||||||
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|||||||
463,743 | 662,363 | 430,009 | ||||||||||
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Deferred |
||||||||||||
Federal |
(69,063 | ) | 3,739 | 182,775 | ||||||||
Stale |
(2,540 | ) | (8,735 | ) | 18,815 | |||||||
Foreign |
117,354 | 51,136 | | |||||||||
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45,751 | 46,140 | 201,590 | ||||||||||
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$ | 509,494 | $ | 708,503 | $ | 631,599 | |||||||
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NOTE 8 CONCENTRATIONS
For the nine months ended September 30, 2013, one customer accounted for approximately 79% of revenue. As of September 30, 2013, the same customer accounted for approximately 94% of accounts receivable.
For the year ended December 31, 2012, one customer accounted for approximately 79% of revenue. As of December 31, 2012, the same customer accounted for approximately 75% of accounts receivable.
For the year ended December 31, 2011, two customers accounted for approximately 59% and 21% of revenue, respectively. As of December 31, 2011, the same two customers accounted for approximately 53% and 19% of accounts receivable, respectively.
Two products, Photofrin and Ethyol, account for substantially all of the Companys revenue for the nine months ended September 30, 2013 and 2012 and the years ended December 31, 2012 and 2011.
NOTE 9 STOCK OPTION PLAN
During 2008, PBI granted non-qualified stock options in connection with their 2008 Non-Qualified Stock Option Plan, As of the date of grant, June 16, 2008, FBI granted 21,232 stock options under this plan, subsequent to this grant 500 stock options have been forfeited. All stock options vested immediately and the maximum term of a stock option is 10 years. Each stock option, at the Option Holders decision, is exercisable at the defined stock option price to purchase shares of the Companys common stock. The exercise price of all options granted with this plan is $6.17635 per share. The 2008 Non-Qualified Stock Option Plan authorized the issuance of 21,924 stock options and in December 2011, the Company authorized and approved an additional 27,841 stock options available for issuance. As of December 31, 2011, 20,732 stock options with this plan are outstanding and exercisable. As of December 31, 2011, there were 29,033 stock options available for future grant in connection with this plan.
(Continued)
See Independent Auditors Review Report.
A-20
Page 15
PINNACLE BIOLOGICS, INC. AND SUBSIDIARIES
NOTES TO THE CONSOLIDATED FINANCIAL STATEMENTS
NOTE 9 STOCK OPTION PLAN (Concluded)
During 2012, PBI granted additional non-qualified stock options in connection with their 2008 Non-Qualified Stock Option Plan. PBI granted 14,400 and 3,250 stock options on March 9, 2012 and June 4, 2012, respectively under this plan. All of these stock options cliff vest over three years and the maximum term of each stock option is 10 years. Each stock option, at the Option Holders decision, is exercisable at the defined stock option price to purchase shares of the Companys common stock. The exercise price of the March 9, 2012 and June 4, 2012 options granted is $131.43 and $215.95 per share, respectively. As of December 31, 2012, 38,382 stock options with this plan are outstanding and exercisable. As of December 31, 2012, there were 11,383 stock options available for future grant in connection with this plan. Subsequently, 3,000 of these stock options granted have been forfeited.
On February 11, 2013, PBI granted 11,383 additional non-qualified stock options in connection with their 2008 Non-Qualified Stock Option Plan. All of these stock options cliff vest over three years and the maximum term of each stock option is 10 years. Each stock option, at the Option Holders decision, is exercisable at the defined stock option price to purchase shares of the Companys common stock. The exercise price of these options granted is $131.43 per share. As of September 30, 2013, 46,765 stock options with this plan are outstanding and exercisable. As of September 10, 2013, there were 3,000 stock options available for future grant in connection with this plan.
The Company used the Black-Scholes option pricing model to calculate the grant-date fair value of the stock option. During the nine months ended September 30, 2013, and the years December 31, 2012 and 2011, the Company recognized compensation expense for these stock options of $180,520, $129,939 and $-0-, respectively.
NOTE 10 COMMITMENTS AND CONTINGENCIES
Litigation . From time to time, the Company is subject to litigation arising in the ordinary course of business It is the opinion of the Companys management that any claims pending are either covered by insurance or that there is no material exposure to the Company in connection with any proceedings.
Employee Profit Sharing Plan . The Company, effective July 1, 2011, has a 401(k) Profit Sharing Plan. All Company matching and profit sharing contributions are at the discretion of the Company. No such matching or profit sharing contributions were elected for the nine months ended September 30, 2013 or the years ended December 31, 2012 and 2011.
Photofrin Research. The Company has an executed grant agreement with a university to perform certain research related to Photofrin. The Company expects to fund a total of approximately $1,034,600 in payments upon achievement of certain milestones for this grant through August 2015.
Purchase Commitment. The Company has an executed agreement for the manufacture of product each calendar year or alternatively owe a fee based on the manufacturers production cost. The initial term of this contract would terminate April 15, 2017. The Company has determined that no product will be manufactured in 2013. As a result, the Company expects to incur a fee in the aggregate of approximately $721,000 of which approximately $541,000 has been accrued as of September 30, 2013.
NOTE 11 SUBSEQUENT EVENTS
Management has evaluated all known subsequent events from September 30, 2013 through December 12, 2013, the date the accompanying consolidated financial statements were available to be issued. During this period, the following subsequent events occurred:
On November 8, 2013 the Company entered into an Agreement and Plan of Merger with Concordia Healthcare Inc., Concordia Labs Inc., and Concordia Healthcare USA (Midwest Medical) Inc.
(Continued)
See Independent Auditors Review Report.
A-21
SCHEDULE B
Concordia Healthcare Corp.
PRO-FORMA CONSOLIDATED FINANCIAL STATEMENTS
September 30, 2013
B-2
Concordia Healthcare Corp.
PRO-FORMA CONSOLIDATED BALANCE SHEET
(Unaudited prepared by management)
September 30, 2013
Mercari
Acquisition Corp. Jul-30-13 CDN $ |
Exchange
Rate |
Mercari
Acquisition Corp. Jul-30-13 USD $ |
Concordia
Healthcare Inc. Sep-30-13 |
Global
Medical Direct Sep-30-13 |
Pinnacle
Biologics Sep-30-13 |
Total | Adjustments | Ref |
Pro Forma
Consolidated Concordia Healthcare Inc. Sep-30-13 |
|||||||||||||||||||||||||||||||||
Debit | Credit | |||||||||||||||||||||||||||||||||||||||||
Assets |
||||||||||||||||||||||||||||||||||||||||||
Current |
||||||||||||||||||||||||||||||||||||||||||
Cash |
272,533 | 0.97 | 264,984 | 23,426,220 | 6,639,731 | 1,712,430 | 32,043,365 | | 6,139,731 | 2(a) | 18,297,980 | |||||||||||||||||||||||||||||||
| 5,000,000 | 2(a) | ||||||||||||||||||||||||||||||||||||||||
32,409,582 | | 2(e) | ||||||||||||||||||||||||||||||||||||||||
| 3,240,958 | 2(e) | ||||||||||||||||||||||||||||||||||||||||
| 31,774,278 | 2(f) | ||||||||||||||||||||||||||||||||||||||||
Accounts receivable |
100,000 | 0.97 | 97,230 | 26,549,897 | 3,319,029 | 1,788,142 | 31,754,298 | | 3,319,029 | 2(a) | 28,435,269 | |||||||||||||||||||||||||||||||
Inventory |
| | | 2,063,452 | 372,237 | 1,695,116 | 4,130,805 | | | 4,130,805 | ||||||||||||||||||||||||||||||||
Prepaid expenses and other current assets |
941 | 0.97 | 915 | 885,118 | 117,327 | 467,919 | 1,471,279 | | | 1,471,279 | ||||||||||||||||||||||||||||||||
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373,474 | 363,129 | 52,924,687 | 10,448,324 | 5,663,607 | 69,399,747 | 32,409,582 | 49,473,996 | 52,335,333 | ||||||||||||||||||||||||||||||||||
Intangibles |
| | | 26,392,000 | 124,642 | 8,647,367 | 35,164,009 | 13,747,857 | | 2(a) | 95,015,379 | |||||||||||||||||||||||||||||||
46,103,513 | | 2(f) | ||||||||||||||||||||||||||||||||||||||||
Capital assets |
| | | 53,811 | 189,815 | 120,468 | 364,094 | | | 364,094 | ||||||||||||||||||||||||||||||||
Other assets |
| | | | 237,791 | 135,485 | 373,276 | | | 373,276 | ||||||||||||||||||||||||||||||||
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373,474 | 363,129 | 79,370,498 | 11,000,572 | 14,566,927 | 105,301,126 | 92,260,952 | 49,473,996 | 148,088,082 | ||||||||||||||||||||||||||||||||||
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Liabilities |
||||||||||||||||||||||||||||||||||||||||||
Current |
||||||||||||||||||||||||||||||||||||||||||
Accounts payable and accrued liabilities |
15,955 | 0.97 | 15,513 | 5,658,990 | 11,245,510 | 2,845,410 | 19,765,423 | 11,245,510 | | 2(a) | 7,987,013 | |||||||||||||||||||||||||||||||
532,900 | | 2(f) | ||||||||||||||||||||||||||||||||||||||||
Provisions |
| | | 30,239,744 | | | 30,239,744 | | | 30,239,744 | ||||||||||||||||||||||||||||||||
Current portion of long term debt |
| | | 15,075,795 | 1,140,313 | 1,791,367 | 18,007,475 | 1,140,313 | | 2(a) | 15,075,795 | |||||||||||||||||||||||||||||||
1,791,367 | | 2(f) | ||||||||||||||||||||||||||||||||||||||||
Purchase price consideration payable |
| | | 792,000 | | 2,547,966 | 3,339,966 | 2,000,000 | | 2(f) | 1,339,966 | |||||||||||||||||||||||||||||||
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15,955 | 15,513 | 51,766,529 | 12,385,823 | 7,184,743 | 71,352,608 | 16,710,090 | | 54,642,518 | ||||||||||||||||||||||||||||||||||
Promissory note |
| | | 8,883,238 | | 8,883,238 | 8,883,238 | 7,000,000 | 2(a) | 7,000,000 | ||||||||||||||||||||||||||||||||
Note payable |
| | | 1,457 | | 1,457 | | | 1,457 | |||||||||||||||||||||||||||||||||
Lease payable |
| | | 19,245 | | 19,245 | | | 19,245 | |||||||||||||||||||||||||||||||||
Long-term debt |
| | 3,429,133 | | 1,617,874 | 5,047,007 | 1,617,874 | | 2(f) | 3,429,133 | ||||||||||||||||||||||||||||||||
Warrants |
| | 4,531,401 | | 4,531,401 | | | 4,531,401 | ||||||||||||||||||||||||||||||||||
Purchase price consideration payable |
| | | | 274,408 | 274,408 | | 3,268,967 | 2(a) | 23,887,668 | ||||||||||||||||||||||||||||||||
20,344,293 | 2(f) | |||||||||||||||||||||||||||||||||||||||||
Other Long-Term Liabilities |
| | | | 416,985 | 416,985 | | | 416,985 | |||||||||||||||||||||||||||||||||
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15,955 | 15,513 | 59,727,063 | 21,289,763 | 9,494,010 | 90,526,349 | 27,211,202 | 30,613,260 | 93,928,407 | ||||||||||||||||||||||||||||||||||
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Shareholders Equity |
||||||||||||||||||||||||||||||||||||||||||
Share capital |
922,050 | 0.97 | 896,509 | 9,500,148 | 126 | 4,400,395 | 14,797,178 | 126 | 2,870,000 | 2(a) | 48,162,870 | |||||||||||||||||||||||||||||||
896,509 | | 2(d) | ||||||||||||||||||||||||||||||||||||||||
| 1,624,098 | 2(d) | ||||||||||||||||||||||||||||||||||||||||
| 32,409,582 | 2(e) | ||||||||||||||||||||||||||||||||||||||||
3,240,958 | | 2(e) | ||||||||||||||||||||||||||||||||||||||||
4,400,395 | 5,000,000 | 2(f) | ||||||||||||||||||||||||||||||||||||||||
Equity |
(564,531 | ) | 0.97 | (548,893 | ) | 10,143,287 | (10,289,317 | ) | 672,522 | (22,401 | ) | | 10,289,317 | 2(a) | 5,996,805 | |||||||||||||||||||||||||||
2,870,000 | | 2(a) | ||||||||||||||||||||||||||||||||||||||||
| 548,893 | 2(d) | ||||||||||||||||||||||||||||||||||||||||
1,340,287 | | 2(d) | ||||||||||||||||||||||||||||||||||||||||
| 63,805 | 2(d) | ||||||||||||||||||||||||||||||||||||||||
672,522 | | 2(f) | ||||||||||||||||||||||||||||||||||||||||
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357,519 | 347,616 | 19,643,435 | (10,289,191 | ) | 5,072,917 | 14,774,777 | 13,420,797 | 52,805,695 | 54,159,675 | |||||||||||||||||||||||||||||||||
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373,474 | 363,129 | 79,370,498 | 11,000,572 | 14,566,927 | 105,301,126 | 40,631,999 | 83,418,955 | 148,088,082 | ||||||||||||||||||||||||||||||||||
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See accompanying notes to the unaudited Pro-Forma Consolidated Financial Statements.
B-3
Concordia Healthcare Corp.
PRO-FORMA CONSOLIDATED INCOME STATEMENT
(Unaudited prepared by management)
For the nine months ended September 30, 2013
Mercari
Acquisition Corp. Jul-30-13 CDN $ |
Exchange
Rate |
Mercari
Acquisition Corp. Jul-30-13 USD $ |
Concordia
Healthcare Inc. Sep-30-13 |
Global
Medical Direct Sep-30-13 |
Pinnacle
Biologics Sep-30-13 |
Total | Adjustments | Ref |
Pro Forma
Consolidated Concordia Healthcare Inc. Sep-30-13 |
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Debit | Credit | |||||||||||||||||||||||||||||||||||||||||
Revenue |
| | 23,763,479 | 24,941,190 | 11,023,198 | 59,727,867 | | 22,761,499 | 2(b) | 82,489,366 | ||||||||||||||||||||||||||||||||
Cost of sales |
| | 4,282,395 | 7,885,303 | 1,996,792 | 14,164,490 | 4,282,519 | | 2(b) | 18,447,009 | ||||||||||||||||||||||||||||||||
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Gross profit (loss) |
| | 19,481,084 | 17,055,887 | 9,026,406 | 45,563,377 | 4,282,519 | 22,761,499 | 64,042,357 | |||||||||||||||||||||||||||||||||
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Expenses |
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Selling, general and administrative |
9,061 | 0.98 | 8,890 | 3,961,978 | 6,943,107 | 4,945,325 | 15,859,300 | 15,326,629 | | 2(b) | 31,185,929 | |||||||||||||||||||||||||||||||
Scientific Affairs |
| | | | 2,010,582 | 2,010,582 | | | 2,010,582 | |||||||||||||||||||||||||||||||||
Consulting and professional fees |
2,532 | 0.98 | 2,484 | | | | 2,484 | | | 2,484 | ||||||||||||||||||||||||||||||||
Transition services |
| | 544,225 | | | 544,225 | | | 544,225 | |||||||||||||||||||||||||||||||||
Interest expense |
| | 3,867,770 | 439,655 | 413,179 | 4,720,604 | | | 4,720,604 | |||||||||||||||||||||||||||||||||
Salaries and management fees |
| | 637,658 | 3,933,160 | | 4,570,818 | 8,415,595 | | 2(b) | 12,986,413 | ||||||||||||||||||||||||||||||||
Provision |
| | | 1,692,006 | | 1,692,006 | | | 1,692,006 | |||||||||||||||||||||||||||||||||
Share-based compensation |
| | 644,000 | | | 644,000 | | | 644,000 | |||||||||||||||||||||||||||||||||
Amortization of intangibles |
| | | | | | 741,729 | | 2(b) | 741,729 | ||||||||||||||||||||||||||||||||
Royalties Income |
| | (2,234 | ) | | | (2,234 | ) | | | (2,234 | ) | ||||||||||||||||||||||||||||||
Transaction costs relating to identification of qualifying transactions |
41,163 | 0.98 | 40,385 | | | | 40,385 | | 40,385 | 2(d) | | |||||||||||||||||||||||||||||||
Other Income / Expenses |
| | | | | (16,303 | ) | (16,303 | ) | | | (16,303 | ) | |||||||||||||||||||||||||||||
Reimbursed expenses |
(12,000 | ) | 0.98 | (11,773 | ) | | | | (11,773 | ) | 11,773 | | 2(d) | | ||||||||||||||||||||||||||||
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40,756 | 39,986 | 9,653,397 | 13,007,928 | 7,352,783 | 30,054,094 | 24,495,726 | 40,385 | 54,509,435 | ||||||||||||||||||||||||||||||||||
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Income (loss) before income taxes |
(40,756 | ) | (39,986 | ) | 9,827,687 | 4,047,959 | 1,673,623 | 15,509,283 | 28,778,245 | 22,801,884 | 9,532,922 | |||||||||||||||||||||||||||||||
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Income taxes |
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Current |
| | 328,400 | | 509,494 | 837,894 | | | 837,894 | |||||||||||||||||||||||||||||||||
Deferred |
| | | | | | | | | |||||||||||||||||||||||||||||||||
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| | 328,400 | | 509,494 | 837,894 | | | 837,894 | ||||||||||||||||||||||||||||||||||
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Net earnings (loss) and other comprehensive income (loss) |
(40,756 | ) | (39,986 | ) | 9,499,287 | 4,047,959 | 1,164,129 | 14,671,389 | 28,778,245 | 22,801,884 | 8,695,028 | |||||||||||||||||||||||||||||||
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See accompanying notes to the unaudited Pro-Forma Consolidated Financial Statements.
B-4
Concordia Healthcare Corp.
PRO-FORMA CONSOLIDATED INCOME STATEMENT
(Unaudited prepared by management)
For the year ended December 31, 2012
Mercari
Acquisition Corp. Jan-31-12 CDN $ |
Exchange
Rate |
Mercari
Acquisition Corp. Jan-31-12 USD $ |
Concordia
Healthcare Inc. Dec-31-12 |
Global
Medical Direct Dec-31-12 |
Pinnacle
Biologics Dec-31-12 |
Total | Adjustments | Ref |
Pro Forma
Consolidated Concordia Healthcare Inc. Dec-31-12 |
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Debit | Credit | |||||||||||||||||||||||||||||||||||||||||
Revenue |
| | 59,073,492 | 50,310,280 | 12,875,026 | 122,258,798 | | | 122,258,798 | |||||||||||||||||||||||||||||||||
Cost of sales |
| | 10,925,963 | 17,235,315 | 1,690,198 | 29,851,476 | | | 29,851,476 | |||||||||||||||||||||||||||||||||
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Gross profit (loss) |
| | 48,147,529 | 33,074,965 | 11,184,828 | 92,407,322 | | | 92,407,322 | |||||||||||||||||||||||||||||||||
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Expenses |
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Selling, general and administrative |
36,182 | 1.01 | 36,500 | 39,777,587 | 14,854,427 | 5,619,418 | 60,287,932 | | | 60,287,932 | ||||||||||||||||||||||||||||||||
Scientific Affairs |
| | | | 2,803,416 | 2,803,416 | | | 2,803,416 | |||||||||||||||||||||||||||||||||
Consulting and professional fees |
16,484 | 1.01 | 16,629 | | | | 16,629 | | 16,629 | |||||||||||||||||||||||||||||||||
Interest expense |
(177 | ) | 1.01 | (179 | ) | | 997,788 | 601,592 | 1,599,201 | | 521,424 | 2(a) | 1,077,777 | |||||||||||||||||||||||||||||
Impairment of intangibles |
| 26,170,101 | | | 26,170,101 | | | 26,170,101 | ||||||||||||||||||||||||||||||||||
Salaries and management fees |
| 21,841,205 | 6,056,056 | | 27,897,261 | | | 27,897,261 | ||||||||||||||||||||||||||||||||||
Provision |
| | | 2,698,594 | | 2,698,594 | | | 2,698,594 | |||||||||||||||||||||||||||||||||
Amortization |
| | 3,723,912 | | | 3,723,912 | | | 3,723,912 | |||||||||||||||||||||||||||||||||
Transaction costs |
| | | | | | 2,870,000 | | 2(a) | 2,870,000 | ||||||||||||||||||||||||||||||||
Listing expense |
| | | | | | 1,536,189 | | 2(d) | 1,536,189 | ||||||||||||||||||||||||||||||||
Transaction costs relating to identification of qualifying transactions |
151,523 | 1.01 | 152,856 | | | | 152,856 | | 152,856 | 2(d) | | |||||||||||||||||||||||||||||||
Other Income / Expenses |
| | | 9,689 | 9,689 | | | 9,689 | ||||||||||||||||||||||||||||||||||
Reimbursed expenses |
(200,000 | ) | 1.01 | (201,760 | ) | | | | (201,760 | ) | 201,760 | | 2(d) | | ||||||||||||||||||||||||||||
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4,012 | 4,047 | 91,512,805 | 24,606,865 | 9,034,115 | 125,157,832 | 4,607,949 | 674,280 | 129,091,501 | ||||||||||||||||||||||||||||||||||
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Income (loss) before income taxes |
(4,012 | ) | (4,047 | ) | (43,365,276 | ) | 8,468,100 | 2,150,713 | (32,750,510 | ) | 4,607,949 | 674,280 | (36,684,179 | ) | ||||||||||||||||||||||||||||
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Income taxes |
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Current |
| | | | 708,503 | 708,503 | | | 708,503 | |||||||||||||||||||||||||||||||||
Deferred |
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| | | | 708,503 | 708,503 | | | 708,503 | ||||||||||||||||||||||||||||||||||
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Net earnings (loss) and other comprehensive income (loss) |
(4,012 | ) | (4,047 | ) | (43,365,276 | ) | 8,468,100 | 1,442,210 | (33,459,013 | ) | 4,607,949 | 674,280 | (37,392,682 | ) | ||||||||||||||||||||||||||||
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See accompanying notes to the unaudited Pro-Forma Consolidated Financial Statements.
B-5
Concordia Healthcare Corp.
NOTES TO PRO-FORMA CONSOLIDATED FINANCIAL STATEMENTS
(Unaudited prepared by management)
September 30, 2013
1. BASIS OF PRESENTATION
The unaudited pro-forma consolidated financial statements of Concordia Healthcare Corp. (Concordia or the Company) have been prepared by management in accordance with International Financial Reporting Standards for inclusion in the Business Acquisition Report dated February 10, 2014. In the opinion of management, the pro-forma consolidated financial statements include all adjustments necessary for fair presentation of the transactions as described below.
The unaudited pro-forma consolidated financial statements of the Company have been compiled from the following financial information:
| Audited financial statements of Mercari for the year ended January 31, 2013; |
| Unaudited interim financial statements of Mercari for the six months ended July 31, 2013; |
| Audited financial statements of Concordia for the period from the date of incorporation (December 5, 2012) to September 30, 2013; |
| Audited combined financial statements of Global Medical Direct Group (Global) for the year ended December 31, 2012; |
| Unaudited interim financial statements of Global for the nine months ended September 30, 2013; |
| Audited carve out financial statements of Pediatric Product Lines of Shionogi Inc. (Pediatric) for the year ended March 31, 2013. |
| Audited consolidated financial statements of Pinnacle Biologics, Inc. and Subsidiaries (Pinnacle) for the year ended December 31, 2012. |
| Unaudited consolidated financial statements of Pinnacle for the nine months ended September 30, 2013. |
The unaudited pro-forma consolidated balance sheet has been prepared as if the transactions described in Note 2 had occurred on September 30, 2013. The unaudited pro-forma consolidated income statements have been prepared as if the transactions described in Note 2 had occurred on January 1, 2012.
The unaudited pro-forma consolidated financial statements are not intended to reflect the financial position or performance of the Company which would have actually resulted had the proposed transactions described in Note 2 and other pro-forma adjustments occurred as assumed. Further, these unaudited pro-forma consolidated financial statements are not necessarily indicative of the financial position or performance that may be attained in the future. The unaudited pro-forma consolidated financial statements should be read in conjunction with the financial information referred to above.
B-6
Concordia Healthcare Corp.
NOTES TO PRO-FORMA CONSOLIDATED FINANCIAL STATEMENTS
(Unaudited prepared by management)
September 30, 2013
2. PRO-FORMA ASSUMPTIONS
The unaudited pro-forma consolidated financial statements incorporate the following pro-forma assumptions:
(a) | Completion of the purchase of assets of Global will be as follows: |
Net assets acquired
Cash |
$ | 500,000 | ||
Inventory |
372,237 | |||
Prepaid expenses |
117,327 | |||
Goodwill and intangibles |
13,872,499 | |||
Capital assets |
189,815 | |||
Deposits |
237,791 | |||
Long-term liabilities |
(20,702 | ) | ||
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$ | 15,268,967 | |||
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Consideration comprised of:
Cash |
$ | 5,000,000 | ||
Contingent consideration payable |
3,268,967 | |||
Promissory notes |
7,000,000 | |||
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$ | 15,268,967 | |||
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Concordia issued 1,000,000 common shares at CAD $3.00 (USD $2.87) per share to satisfy finder fees in connection with this transaction. Accordingly, USD $2,870,000 has been expensed as transaction costs.
An amount of $521,424 was reversed for interests that will not be incurred on debt not assumed.
(b) | The following amounts were added to the historical expenses of the Company representing sales, cost of sales and expenses from January 1, 2013 to March 31, 2013: |
Sales |
$ | (22,761,499 | ) | |
Cost of sales |
4,282,519 | |||
Selling, general and administrative |
15,326,629 | |||
Salaries and management fees |
8,415,595 | |||
Amortization of intangibles |
741,729 | |||
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$ | 6,004,973 | |||
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B-7
Concordia Healthcare Corp.
NOTES TO PRO-FORMA CONSOLIDATED FINANCIAL STATEMENTS
(Unaudited prepared by management)
September 30, 2013
(c) | Following the completion of the Reverse Takeover (2(d)), Mercari intends to change its name and operate under the name Concordia Healthcare Corp. |
2. PRO-FORMA ASSUMPTIONS (continued)
(d) | Completion of an amalgamation agreement (the Amalgamation Agreement) which will result in the reverse takeover of Mercari by Concordia (the Reverse Takeover). After the Reverse Takeover transaction, the shareholders of Concordia will control the Company and for accounting purposes Concordia will be deemed the acquirer. The transaction constitutes a reverse takeover of Mercari but does not meet the definition of a business combination under IFRS 3; accordingly, Concordia will account for the transaction in accordance with IFRS 2. The assets and liabilities of Mercari will be included in the consolidated balance sheet at fair value, which approximate their pre-combination carrying values. Share capital, contributed surplus, accumulated other comprehensive loss and the deficit of Mercari will be eliminated. |
Net assets of Mercari:
Cash |
$ | 264,984 | ||
Amounts receivable |
97,230 | |||
Prepaid expenses |
915 | |||
Accounts payable and accrued liabilities |
(15,513 | ) | ||
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347,616 | ||||
Listing expense |
1,340,287 | |||
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$ | 1,687,903 | |||
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Consideration comprised of:
Fair value of common shares [assumed price] |
$ | 1,624,098 | ||
Fair value of stock options [assumed price] |
63,805 | 1 | ||
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|
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1,687,903 | ||||
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1 | Options and warrants issued to Mercari option holders were valued using the Black-Scholes option pricing model with the following weighted average parameters: Share price $4.81; Exercise price $4.81; Dividend yield Nil; expected volatility 100%; risk-free interest rate 1.20%; and expected life (years) 2. |
The following amounts were adjusted from the historical expenses of Mercari to adjust for certain costs which will not recur in the new structure of the Company:
Sept 30, 2013 | Dec 31, 2012 | |||||||
Expenses relating to qualifying transactions |
$ | (40,385 | ) | $ | (152,856 | ) | ||
Reimbursed expenses |
11,773 | 201,760 | ||||||
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B-8
Concordia Healthcare Corp.
NOTES TO PRO-FORMA CONSOLIDATED FINANCIAL STATEMENTS
(Unaudited prepared by management)
September 30, 2013
$ | (29,163 | ) | $ | 48,904 | ||||
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(e) | In connection with the completion of the Reverse Takeover, Concordia will complete an offering of 5,520,000 subscription receipts for gross proceeds of CAD $34,500,000 (USD $32,409,582 assuming an exchange rate of USD:CAD of 1.0645) at an issuance price of CAD $6.25 (USD $5.87) per subscription receipt. Each subscription receipt is exchangeable for one common share of Concordia. Transaction costs are estimated at $3,240,958. |
(f) | Completion of the purchase of assets of Pinnacle will be as follows: |
Net assets acquired
Cash |
$ | 1,712,430 | ||
Accounts Receivable |
1,788,142 | |||
Inventory |
1,695,116 | |||
Prepaid expenses and Other Current Assets |
467,919 | |||
Goodwill and intangibles |
54,750,880 | |||
Capital assets |
120,468 | |||
Other Assets |
135,485 | |||
Current Liabilities |
(2,860,476 | ) | ||
Long-Term Liabilities |
(691,393 | ) | ||
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$ | 57,118,571 | |||
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Consideration comprised of:
Cash |
$ | 31,774,278 | ||
Common Shares of Concordia Corp. |
5,000,000 | |||
Contingent consideration payable |
20,344,293 | |||
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$ | 57,118,571 | |||
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|
As part of the consideration for this transaction, Concordia will issue 946,222 shares at a price of CAD $5.63 (being a 10% discount to the subscription receipts discussed in Note 2(e) above). Assuming an exchange rate of USD:CAD of 1.0645, the value of the shares issued will be USD $5,000,000.
The cash consideration of $31,774,278 includes an estimated working capital adjustment of $1,774,278 as at September 30, 2013 which is subject to change based on Pinnacles final working capital balance as on the closing date of the transaction.
B-9
Concordia Healthcare Corp.
NOTES TO PRO-FORMA CONSOLIDATED FINANCIAL STATEMENTS
(Unaudited prepared by management)
September 30, 2013
3. CAPITAL STOCK
Capital Stock as at September 30, 2013 in the unaudited pro-forma consolidated statement of financial position is comprised of the following:
Number of Shares |
Stated Capital |
|||||||
Opening balance Concordia Corporation |
8,666,666 | $ | 9,500,148 | |||||
Shares issued to effect the Reverse Takeover (Note 2(d)) |
276,616 | 1,624,098 | ||||||
Shares issued relating to the financing (Note 2(e)) |
5,520,000 | 29,168,624 | ||||||
Shares issued relating to the acquisition of Global (Note 2(a)) |
1,000,000 | 2,870,000 | ||||||
Shares issued relating to the acquisition of Pinnacle (Note 2(f)) |
946,222 | 5,000,000 | ||||||
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16,409,504 | $ | 48,162,870 | ||||||
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4. OUTSTANDING STOCK OPTIONS
The weighted average terms of the options outstanding as at September 30, 2013 are as follows:
Number | Exercise Price | Time to expiry | ||||||||||
Concordia Options |
1,025,000 | US$ | 3.00 | 10 years | ||||||||
Mercari Acquisition Corp. Options |
25,998 | US$ | 4.81 | 6.7 years |
5. OUTSTANDING WARRANTS
Number | Exercise Price | Time to expiry | ||||||||||
Concordia Warrants |
1,875,000 | US$ | 1.00 | 5 years |
B-10
Exhibit 99.27
BUSINESS ACQUISITION REPORT
Form 51-102F4
Item 1 - Identity of the Company
1.1 | Name and Address of the Company |
Concordia Healthcare Corp. (the Company )
277 Lakeshore Road East
Suite 302
Oakville, Ontario
L6J 1H9
1.2 | Executive Officer |
For further information in respect of this report and the significant acquisition described herein, please contact:
Leith J. Tessy
Chief Financial Officer and Secretary of the Company
(905) 842-5150
Item 2 - Details of Acquisition
2.1 | Nature of Business Acquired |
On May 15, 2014, Concordia Pharmaceuticals Inc. ( CPI ), a wholly-owned subsidiary of the Company, completed the purchase of Donnatal®, pursuant to the terms and conditions of a previously announced asset purchase and sale agreement entered into on March 19, 2014 (the Asset Purchase Agreement ), from a privately held specialty pharmaceutical company carrying on business as Revive Pharmaceuticals ( Revive Pharmaceuticals ).
Donnatal® is an adjunctive therapy in the treatment of irritable bowel syndrome ( IBS ) and acute enterocolitis and is available in two formulations: immediate release Donnatal® Tablets, and immediate release Donnatal® Elixir, a fast acting liquid. In addition to the drug, the Company acquired the sales and marketing infrastructure related to the product.
2.2 | Date of the Acquisition |
The effective date of the acquisition of Donnatal® was May 15, 2014 (the Closing Date ). The date of acquisition for accounting purposes is the Closing Date.
2.3 | Consideration |
The Company acquired Donnatal® for total consideration of USD$329,151,334, comprised of USD$200,000,000 in cash and an aggregate of 4,605,833 common shares of the Company valued at USD$129,151,334 based on the closing price of the Companys stock on May 15, 2014 of CAD$30.50 per share converted to USD using the May 15, 2014 Bank of Canada closing USD:CAD exchange rate of 1:1.0877.
On the date of the Asset Purchase Agreement, the 4,605,833 common shares of the Company were valued at USD$65,342,697 based on the closing trading price of the Companys common shares on the Toronto Stock Exchange on March 18, 2014 of CAD$15.80 per share converted to USD using the March 18, 2014 Bank of Canada closing USD:CAD exchange rate of 1:1.1137.
The Company paid for the cash component of the acquisition through a combination of available cash and debt financing. In this respect, the Company entered into a secured credit facility having a principal amount of up to USD$195,000,000, consisting of a USD$170,000,000 term loan and a USD$25,000,000 operating line (the Credit Facility ) with GE Capital, Healthcare Financial Services and a syndicate of lenders. The Credit Facility is secured by the assets of the Company and the assets of its material subsidiaries.
2.4 | Effect on Financial Position |
The acquisition of Donnatal® complements the Companys Legacy Drugs Division. The Company has no current plans or proposals for material changes in its business affairs or the affairs of Donnatal®, which may have a significant effect on the results of operations and financial position of the Company.
2.5 | Prior Valuations |
Not applicable.
2.6 | Parties to the Acquisition |
The acquisition did not involve an informed person, associate or affiliate of the Company.
2.7 | Date of Report |
This report is dated June 9, 2014.
Item 3 - Financial Statements
The following financial statements have been included with this report:
(a) | Schedule A: Audited carve out financial statements for Donnatal® for the years ended December 31, 2013 and December 31, 2012 and unaudited carve out financial statements for Donnatal® for the three months ended March 31, 2014 and the three months ended March 31, 2013. |
(b) | Schedule B: Unaudited Pro Forma Consolidated Balance Sheet of the Company as at March 31, 2014, Unaudited Pro Forma Consolidated Income Statement of the Company for the Three Months Ended March 31, 2014 and Unaudited Pro Forma Consolidated Income Statement of the Company for the Year Ended December 31, 2013. |
- 2 -
SCHEDULE A
DONNATAL PRODUCT LINE
OF PBM PHARMACEUTICALS, INC.
Carve-Out Financial Statements
(in US Dollars)
For the Three Months Ended March 31, 2014 and 2013
and the Years Ended December 31, 2013 and 2012
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> Certified Public |
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Accountants & Consultants |
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4401 Dominion Boulevard, 2 nd Floor |
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Glen Allen, VA 23060 |
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210 Ridge-Mclntire Road, Suite 500 |
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Charlottesville, VA 22903 |
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www.keitercpa.com |
DONNATAL PRODUCT LINE OF PBM PHARMACEUTICALS, INC.
Table of Contents
Page | ||||
Reports of Independent Accountants |
1 | |||
Financial Statements: |
||||
Carve-Out Balance Sheets |
3 | |||
Carve-Out Statements of Income |
4 | |||
Carve-Out Statements of Changes in Net Equity |
5 | |||
Carve-Out Statements of Cash Flows |
6 | |||
Notes to Carve-Out Financial Statements |
7 |
REPORT OF INDEPENDENT ACCOUNTANTS
To the Directors of Concordia Healthcare Corp.:
Report on the Financial Statements
We have audited the accompanying carve-out balance sheets of the Donnatal Product Line of PBM Pharmaceuticals, Inc. (the Company), as defined in Note 1 to the carve-out financial statements as of December 31, 2013 and 2012, and the related carve-out statements of income, changes in net equity, and cash flows for the years then ended, and the related notes to the carve-out financial statements.
Managements Responsibility for the Carve-Out Financial Statements
Management is responsible for the preparation and fair presentation of these carve-out financial statements in accordance with accounting principles generally accepted in the United States; this includes the design, implementation, and maintenance of internal control relevant to the preparation and fair presentation of carve-out financial statements that are free from material misstatement, whether due to fraud or error.
Auditors Responsibility
Our responsibility is to express an opinion on these carve-out financial statements based on our audits. We conducted our audits in accordance with auditing standards generally accepted in the United States. Those standards require that we plan and perform the audits to obtain reasonable assurance about whether the carve-out financial statements are free from material misstatement.
An audit involves performing procedures to obtain audit evidence about the amounts and disclosures in the carve-out financial statements. The procedures selected depend on the auditors judgment, including the assessment of the risks of material misstatement of the carve-out financial statements, whether due to fraud or error. In making those risk assessments, the auditor considers internal control relevant to the entitys preparation and fair presentation of the carve-out financial statements in order to design audit procedures that are appropriate in the circumstances, but not for the purpose of expressing an opinion on the effectiveness of the entitys internal control. Accordingly, we express no such opinion. An audit also includes evaluating the appropriateness of accounting policies used and the reasonableness of significant accounting estimates made by management, as well as evaluating the overall presentation of the carve-out financial statements.
We believe that the audit evidence we have obtained is sufficient and appropriate to provide a basis for our audit opinion.
Opinion
In our opinion, the carve-out financial statements referred to above present fairly, in all material respects, the carve-out financial position of the Donnatal Product Line of PBM Pharmaceuticals, Inc. as of December 31, 2013 and 2012, and the results of its operations and its cash flows for the years then ended in accordance with accounting principles generally accepted in the United States.
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> Certified Public |
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Accountants & Consultants |
||
June 6, 2014 |
4401 Dominion Boulevard, 2 nd Floor |
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Glen Allen, Virginia |
Glen Allen, VA 23060 |
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T:804.747.0000 F:804.747.3632 |
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www.keitercpa.com |
REPORT OF INDEPENDENT ACCOUNTANTS
To the Directors of Concordia Healthcare Corp.:
We have reviewed the accompanying carve-out balance sheet of the Donnatal Product Line of PBM Pharmaceuticals Inc. (the Company), as defined in Note 1 to the carve-out financial statements as of March 31, 2014, and the related carve-out statements of income, changes in net equity, and cash flows for the three months ended March 31, 2014, and the related carve-out statements of income and cash flows for the three months ended March 31, 2013, and the related notes to the carve-out financial statements. A review includes primarily applying analytical procedures to managements financial data and making inquiries of Company management. A review is substantially less in scope than an audit, the objective of which is the expression of an opinion regarding the carve-out financial statements as a whole. Accordingly, we do not express such an opinion.
Management is responsible for the preparation and fair presentation of the carve-out financial statements in accordance with accounting principles generally accepted in the United States and for designing, implementing, and maintaining internal control relevant to the preparation and fair presentation of the carve-out financial statements.
Our responsibility is to conduct the reviews in accordance with Statements on Standards for Accounting and Review Services issued by the American Institute of Certified Public Accountants. Those standards require us to perform procedures to obtain limited assurance that there are no material modifications that should be made to the carve-out financial statements. We believe that the results of our procedures provide a reasonable basis for our report.
Based on our reviews, we are not aware of any material modifications that should be made to the accompanying carve-out financial statements in order for them to be in conformity with accounting principles generally accepted in the United States.
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June 6, 2014 |
Glen Allen, Virginia |
> Certified Public |
||
Accountants & Consultants |
||
4401 Dominion Boulevard, 2 nd Floor |
||
Glen Allen, VA 23060 |
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T:804.747.0000 F:804.747.3632 |
||
www.keitercpa.com |
DONNATAL PRODUCT LINE OF PBM PHARMACEUTICALS, INC.
(in US Dollars)
Carve-Out Balance Sheets
Reviewed | Audited | |||||||||||
March 31,
2014 |
December 31,
2013 |
December 31,
2012 |
||||||||||
Assets | ||||||||||||
Current assets: |
||||||||||||
Accounts receivable, net |
$ | 7,575,146 | $ | 6,508,054 | $ | 4,408,132 | ||||||
Inventories, net |
1,805,987 | 1,975,989 | 1,101,378 | |||||||||
Prepaid expenses and other current assets |
630,291 | 787,734 | 250,793 | |||||||||
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Total current assets |
10,011,424 | 9,271,777 | 5,760,303 | |||||||||
Property and equipment, net |
828,824 | 848,915 | 89,316 | |||||||||
Intangible assets, net |
377,240 | 418,906 | 585,573 | |||||||||
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Total assets |
$ | 11,217,488 | $ | 10,539,598 | $ | 6,435,192 | ||||||
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Liabilities and Net Equity | ||||||||||||
Current liabilities: |
||||||||||||
Accounts payable |
$ | 389,728 | $ | 547,336 | $ | 305,009 | ||||||
Accrued expenses |
1,425,515 | 1,885,571 | 922,340 | |||||||||
Allowance for sales returns |
6,071,339 | 5,444,891 | 2,622,042 | |||||||||
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Total current liabilities |
7,886,582 | 7,877,798 | 3,849,391 | |||||||||
Net equity |
3,330,906 | 2,661,800 | 2,585,801 | |||||||||
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Total liabilities and net equity |
$ | 11,217,488 | $ | 10,539,598 | $ | 6,435,192 | ||||||
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See accompanying notes to carve-out financial statements.
3
DONNATAL PRODUCT LINE OF PBM PHARMACEUTICALS, INC.
(in US Dollars)
Carve-Out Statements of Income
Reviewed | Audited | |||||||||||||||
Three Months Ended March 31, | Years Ended December 31, | |||||||||||||||
2014 | 2013 | 2013 | 2012 | |||||||||||||
Net sales |
$ | 12,027,884 | $ | 10,083,650 | $ | 49,792,483 | $ | 16,406,341 | ||||||||
Cost of sales |
590,743 | 447,582 | 2,253,950 | 1,662,636 | ||||||||||||
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Gross profit |
11,437,141 | 9,636,068 | 47,538,533 | 14,743,705 | ||||||||||||
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Operating expenses: |
||||||||||||||||
Selling, general, and administrative expenses |
2,963,667 | 1,439,670 | 8,118,941 | 4,190,375 | ||||||||||||
Depreciation and amortization |
75,812 | 51,879 | 258,868 | 199,259 | ||||||||||||
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Total operating expenses |
3,039,479 | 1,491,549 | 8,377,809 | 4,389,634 | ||||||||||||
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Net income |
$ | 8,397,662 | $ | 8,144,519 | $ | 39,160,724 | $ | 10,354,071 | ||||||||
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|
|
|
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|
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See accompanying notes to carve-out financial statements.
4
DONNATAL PRODUCT LINE OF PBM PHARMACEUTICALS, INC.
(in US Dollars)
Carve-Out Statements of Changes in Net Equity
Reviewed | Audited | |||||||||||
Three Months Ended | Years Ended December 31, | |||||||||||
March 31, 2014 | 2013 | 2012 | ||||||||||
Net equity, beginning of period |
$ | 2,661,800 | $ | 2,585,801 | $ | 596,514 | ||||||
Net income |
8,397,662 | 39,160,724 | 10,354,071 | |||||||||
Distributions to owner |
(7,728,556 | ) | (39,084,725 | ) | (8,364,784 | ) | ||||||
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Net equity, end of period |
$ | 3,330,906 | $ | 2,661,800 | $ | 2,585,801 | ||||||
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See accompanying notes to carve-out financial statements.
5
DONNATAL PRODUCT LINE OF PBM PHARMACEUTICALS, INC.
(in US Dollars)
Carve-Out Statements of Cash Flows
Reviewed | Audited | |||||||||||||||
Three Months Ended March 31, | Years Ended December 31, | |||||||||||||||
2014 | 2013 | 2013 | 2012 | |||||||||||||
Cash flows from operating activities: |
||||||||||||||||
Net income |
$ | 8,397,662 | $ | 8,144,519 | $ | 39,160,724 | $ | 10,354,071 | ||||||||
net income to net cash from operating activities: |
||||||||||||||||
Depreciation and amortization |
75,812 | 51,879 | 258,868 | 199,259 | ||||||||||||
Changes in operating assets and liabilities: |
||||||||||||||||
Accounts receivable, net |
(1,067,092 | ) | (2,169,452 | ) | (2,099,922 | ) | (3,754,942 | ) | ||||||||
Inventories, net |
170,002 | 53,133 | (874,611 | ) | 244,021 | |||||||||||
Prepaid expenses and other current assets |
157,443 | (153,486 | ) | (536,941 | ) | (69,768 | ) | |||||||||
Accounts payable |
(157,608 | ) | 324,857 | 242,327 | 108,051 | |||||||||||
Accrued expenses |
(460,056 | ) | 179,001 | 963,231 | 581,697 | |||||||||||
Allowance for sales returns |
626,448 | 175,051 | 2,822,849 | 704,219 | ||||||||||||
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Net cash provided by operating activities |
7,742,611 | 6,605,502 | 39,936,525 | 8,366,608 | ||||||||||||
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Cash flows used in investing activities: |
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Purchase of property and equipment |
(14,055 | ) | (46,466 | ) | (851,800 | ) | (1,824 | ) | ||||||||
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Cash flows used in financing activities: |
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Distributions to owner |
(7,728,556 | ) | (6,559,036 | ) | (39,084,725 | ) | (8,364,784 | ) | ||||||||
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Net change in cash |
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Cash, beginning of period |
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Cash, end of period |
$ | | $ | | $ | | $ | | ||||||||
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See accompanying notes to carve-out financial statements.
6
DONNATAL PRODUCT LINE OF PBM PHARMACEUTICALS, INC.
(in US Dollars)
Notes to Carve-Out Financial Statements
1. | Summary of Significant Accounting Policies: |
Nature of Operations: PBM Pharmaceuticals, Inc. (the Company) is incorporated in Delaware and was formed on February 7, 2001. The Company distributes several branded prescription products including Donnatal® (the Drug), a mild antispasmodic medication used for relief of cramps and pain associated with various stomach, intestinal, and bowel disorders, including irritable bowel syndrome.
On May 15, 2014, a subsidiary of Concordia Healthcare Corp. (the Acquiring Company) purchased all rights and patents to the Drug from the Company for consideration of approximately $329 million.
Basis of Presentation: These carve-out financial statements have been prepared on a carve-out basis from the Companys accounting records to represent the assets, liabilities, and operating activities of the Drug, purchased by the Acquiring Company, on a stand-alone basis as of March 31, 2014, December 31, 2013, and December 31, 2012, and three months ended March 31, 2014 and 2013, and for the years ended December 31, 2013, and 2012 in accordance with accounting principles generally accepted in the United States.
The carve-out financial statements are not necessarily indicative of the results that would have been attained if the Drug were owned by a separate legal entity during the periods presented and therefore are not necessarily indicative of future operating results. No adjustments have been made to reflect possible incremental changes to the cost structure as a result of the acquisition by the Acquiring Company. The basis for the allocation of assets, liabilities, and results of operations to the accounts of the carve-out financial statements are as follows:
Accounts receivable - net were allocated to the carve-out financial statements based on the net sales ratio of the Drug relative to the total net sales of the Company.
Inventories - net, intangible assets - net, sales - net, allowance for sales returns, and cost of sales were allocated to the carve-out financial statements based on the Companys existing accounting records specific to the carved-out assets, liabilities, and operations.
Prepaid expenses, accounts payable, accrued expenses, net property and equipment, and selling, general, and administrative expenses were allocated to the carve-out financial statements based on a blended methodology, based first on the Companys accounting records specific to the carved-out assets, liabilities, and operations, and if not specifically identifiable, they were allocated based on the net sales ratio of the Drug relative to the total net sales of the Company, as applicable.
7
DONNATAL PRODUCT LINE OF PBM PHARMACEUTICALS, INC.
(in US Dollars)
Notes to Carve-Out Financial Statements, Continued
1. | Summary of Significant Accounting Policies, Continued: |
Basis of Presentation, Continued: These carve-out financial statements are prepared on the historical cost basis. The accounting policies have been consistently applied to all the periods presented unless otherwise stated. The carve-out financial statements are presented in U.S. dollars. The functional currency is also the U.S. dollar as this is the principal currency of the economic environment in which the Company operates.
Use of Estimates: The preparation of carve-out financial statements in conformity with generally accepted accounting principles requires management of the Company to make a number of estimates and assumptions relating to the reported amounts of assets and liabilities and disclosure of contingent assets and liabilities at the date of the carve-out financial statements and the reported amounts of revenues and expenses during the periods reported. Significant items subject to such estimates and assumptions include the carrying amount of trademarks and valuation of allowances for receivables, customer returns, and inventories. Actual results could differ from those estimates.
Revenue Recognition: Sales and related cost of sales (including shipping costs) are recognized when title and risk of loss pass to the customer, which is generally upon delivery, provided collectability is probable. Sales are shown net of the estimated sales returns and sales discounts. Discounts are reductions to invoiced amounts offered to customers for payment within a specified period and/or standard fees associated with the Companys distribution agreements. Provisions for discounts and sales returns are estimates based on the Companys experience and expectations.
Accounts Receivable, Net: Accounts receivables are reported net of an allowance for doubtful accounts. The allowance is based on managements estimate of the amount of receivables that will actually be collected. The allowance was $26,656 at March 31, 2014. The allowance was $26,656 and $0 at December 31, 2013 and 2012, respectively.
Concentrations of Credit Risk and Significant Customers: Financial instruments which potentially expose the Company to concentrations of credit risk consist primarily of accounts receivable. The Company performs ongoing credit evaluations of its trade customers prior to delivery and generally does not require collateral. At March 31, 2014, three customers accounted for 88% of the Drugs gross accounts receivable. For the three months ended March 31, 2014 and 2013, three customers accounted for 90% and 94%, respectively of the Drugs gross sales. At December 31, 2013, three customers accounted for 98% of the Drugs gross accounts receivable, and at December 31, 2012 three customers accounted for 93% of the Drugs gross accounts receivable. For the years ended 2013 and 2012, three customers accounted for 94% and 93%, respectively, of the Drugs gross sales.
8
DONNATAL PRODUCT LINE OF PBM PHARMACEUTICALS, INC.
(in US Dollars)
Notes to Carve-Out Financial Statements, Continued
1. | Summary of Significant Accounting Policies, Continued: |
Inventories, Net: Inventories consist of merchandise held for resale and are stated at the lower of cost determined on first-in, first-out (FIFO) method, or market. There is an inventory reserve for all damaged and expired merchandise, including merchandise with less than six months of shelf life remaining.
Property and Equipment: Property and equipment are stated at cost less accumulated depreciation and amortization. Depreciation and amortization is calculated on the straight-line method over the estimated useful lives ranging from three to ten years. Costs of repairs and maintenance are expensed as incurred.
Intangible Assets: Intangible assets are amortized over their respective estimated useful lives to their estimated residual values in accordance with the provisions of Financial Accounting Standards Board (FASB) guidance on goodwill and other intangible assets, and are reviewed for impairment in accordance with FASB guidance on accounting for impairment or disposal of long-lived assets. No impairment losses were recognized in 2014, 2013 or 2012.
Income Taxes: The Company, with the consent of its stockholders, has elected for federal income tax purposes to be an S Corporation. In lieu of corporate income taxes, the stockholders of an S Corporation are taxed on their proportionate share of the Companys taxable income or loss. Accordingly, no provision or liability for income taxes has been included in the accompanying carve-out financial statements.
Income Tax Uncertainties: The Company follows FASB guidance related to accounting for uncertainty in income taxes, which clarifies the accounting for income taxes by prescribing the minimum recognition threshold that a tax position is required to meet before being recognized in the Companys carve-out financial statements. Management has evaluated the effect of guidance surrounding uncertain income tax positions and concluded that the Company has no significant carve-out financial statement exposure to uncertain income tax positions at March 31, 2014, and December 31, 2013, and December 31, 2012. The Companys income tax returns for years from 2010 remain open for examination by tax authorities. The Company is not under audit by any tax jurisdiction.
Risks and Uncertainties: The pharmaceutical industry is highly regulated by federal laws and regulations. In addition, the introduction of generic drug competition could impair the value of the Companys intangible assets or significantly affect sales volume.
Marketing and Advertising Expenses: The Company expenses marketing and advertising costs as they are incurred. Advertising and marketing expense related to the Drug were $328,302 for the three months ended March 31, 2014, and $534,765 for the three months ended March 31, 2013. Advertising and marketing expenses related to the Drug were $1,735,047 for 2013 and $407,918 for 2012.
9
DONNATAL PRODUCT LINE OF PBM PHARMACEUTICALS, INC.
(in US Dollars)
Notes to Carve-Out Financial Statements, Continued
1. | Summary of Significant Accounting Policies, Continued: |
Research and Development: Research and development costs are charged to operations as incurred. The costs related to the Drug were $79,452 for the three months ended March 31, 2014 and $51,023 for the three months ended March 31, 2013. The costs related to the Drug were $897,016 for 2013 and $127,588 for 2012.
2. | Inventories: |
Inventories consisted of the following components at:
Reviewed | Audited | |||||||||||
March 31,
2014 |
December 31,
2013 |
December 31,
2012 |
||||||||||
Purchased for resale |
$ | 1,753,013 | $ | 1,955,999 | $ | 1,236,063 | ||||||
Promotional stock/samples |
356,210 | 221,836 | 80,015 | |||||||||
Packaging |
171,587 | 238,668 | 68,358 | |||||||||
Inventory reserve |
(474,823 | ) | (440,514 | ) | (283,058 | ) | ||||||
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$ | 1,805,987 | $ | 1,975,989 | $ | 1,101,378 | |||||||
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3. | Property and Equipment: |
Property and equipment consisted of the following at December 31:
Reviewed | Audited | |||||||||||
March 31,
2014 |
December 31,
2013 |
December 31,
2012 |
||||||||||
Computer equipment |
$ | 231,454 | $ | 224,081 | $ | 139,611 | ||||||
Furniture and fixtures |
221,403 | 221,609 | 29,959 | |||||||||
Leasehold improvements |
593,961 | 586,656 | 8,023 | |||||||||
|
|
|
|
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|
|||||||
1,046,818 | 1,032,346 | 177,593 | ||||||||||
Less accumulated depreciation |
217,994 | 183,431 | 88,277 | |||||||||
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|
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|||||||
$ | 828,824 | $ | 848,915 | $ | 89,316 | |||||||
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10
DONNATAL PRODUCT LINE OF PBM PHARMACEUTICALS, INC.
(in US Dollars)
Notes to Carve-Out Financial Statements, Continued
3. | Property and Equipment, Continued: |
Depreciation expense was $34,145 for the three months ended March 31, 2014 and $10,212 for the three months ended March 31, 2013. Depreciation expense was $92,201 and $32,592 for the years ended December 31, 2013 and 2012, respectively.
4. | Intangible Assets: |
Intangible assets consist of the Drugs brand trademarks and are amortized using the straight-line method over 15 years. Accumulated amortization at March 31, 2014 was $2,122,760. Accumulated amortization at December 31, 2013 and 2012 was $2,081,094 and $1,914,427, respectively. Amortization expense was $41,667 for the three months ended March 31, 2014 and 2013, respectively. Amortization expense was $167,667 for the years ended December 31, 2013 and 2012, respectively. Future amortization expense from March 31, 2014 is as follows:
Year |
Amortization | |||
2014 |
$ | 125,000 | ||
2015 |
166,667 | |||
2016 |
85,573 | |||
|
|
|||
$ | 377,240 | |||
|
|
5. | Commitments and Contingencies: |
In September 2012, due to a manufacturing problem at its supplier, the Company initiated a product recall for the Drug that had been manufactured by its supplier which were then in the supply chain. All recalled quantities of the Drug were subsequently returned to the Company and the Company returned the recalled Drug quantities to the supplier. Since September 2012, the Company has not been able to purchase this Drug from its supplier. The Company believes it has adequately addressed the manufacturing issue and has limited its exposure through the voluntary recall.
The Company is a party to a Master Logistics Agreement (the Logistics Agreement) with UPS Supply Chain Solutions, Inc. (UPS) through February 14, 2015. Under the Logistics Agreement, UPS provides warehouse services for the Drug, including receiving and unloading the Drug at the distribution facility, placing the Drug in storage, picking the Drug for shipment, and loading outbound trailers. UPS also provides customer service functions, including coordination of order acceptance, inquiry response, product returns management, and accounts receivable processing and oversight. Payments under this agreement were approximately $144,561 and $86,755 for the three months ended March 31, 2014 and 2013, respectively, and $347,021 and $284,050 for the years ended December 31, 2013 and 2012, respectively.
11
DONNATAL PRODUCT LINE OF PBM PHARMACEUTICALS, INC.
(in US Dollars)
Notes to Carve-Out Financial Statements, Continued
5. | Commitments and Contingencies, Continued: |
The Company has agreed to indemnify its distributors (and, in turn, is indemnified by its suppliers) of the Companys products for events that may arise regarding product quality, defects, and conformity with federal laws and regulations. From time to time, the Company is involved in litigation related to the Drug that the Company considers to be in the normal course of business. The Company is not presently involved in any legal proceedings related to the Drug which management expects individually or in the aggregate to have a material adverse effect on its financial condition or results of operations.
The Company leases office space in Charlottesville, Virginia from a related party for its administrative headquarters and call center. Minimum future payments under its operating leases at March 31, 2014 are $211,006 for 2014 and $67,929 for 2015. Rent expense was $52,752 and $47,164 for the three months ended March 31, 2014 and 2013, respectively, and $188,654 and $68,348 for the years ended December 31, 2013 and 2012, respectively.
6. | Employee Retirement Plan: |
Employees are eligible to participate in an employee savings/retirement plan under Section 401(k) of the Internal Revenue Code. The plan provides for salary reduction contributions by eligible participants, subject to certain limitations, and matching contributions of 50% of the participants first 6% of elective deferrals. The Company contributed $343 and $434 to the plan for the three months ended March 31, 2014 and 2013, respectively, and $1,736 and $1,370 to the plan for the years ended December 31, 2013 and 2012, respectively.
7. | Subsequent Events: |
The Company has evaluated subsequent events as they relate to the Drug for potential recognition or disclosure through June 6, 2014, the date the carve-out financial statements were available to be issued, and has determined there are no subsequent events to be reporting in the accompanying carve-out financial statements.
12
SCHEDULE B
Concordia Healthcare Corp.
UNAUDITED PRO FORMA CONSOLIDATED FINANCIAL STATEMENTS
March 31, 2014
Concordia Healthcare Corp.
PRO FORMA CONSOLIDATED BALANCE SHEET
(Unaudited prepared by management)
As at March 31, 2014
(Stated in thousands of U.S. Dollars)
Concordia
Healthcare Corp |
Donnatal |
Pro Forma
Adjustments |
Reference |
Pro Forma
Consolidated |
||||||||||||||
Assets |
||||||||||||||||||
Current |
||||||||||||||||||
Cash |
$ | 77,973 | $ | | $ | (35,500 | ) | 3(a) | $ | 42,473 | ||||||||
Accounts receivable |
10,063 | 7,575 | (7,575 | ) | 3(b) | 10,063 | ||||||||||||
Inventory |
3,719 | 1,806 | | 5,525 | ||||||||||||||
Prepaid expenses and other current assets |
4,317 | 630 | | 4,947 | ||||||||||||||
Deferred income taxes |
127 | | | 127 | ||||||||||||||
|
|
|
|
|
|
|
|
|||||||||||
96,199 | 10,011 | (43,075 | ) | 63,135 | ||||||||||||||
Fixed assets |
578 | 829 | (829 | ) | 3(b) | 578 | ||||||||||||
Intangible assets |
61,120 | | | 61,120 | ||||||||||||||
Unallocated goodwill and intangibles |
36,249 | 377 | 326,338 | 3(a) | 362,964 | |||||||||||||
|
|
|
|
|
|
|
|
|||||||||||
Total Assets |
$ | 194,146 | $ | 11,217 | $ | 282,434 | $ | 487,797 | ||||||||||
|
|
|
|
|
|
|
|
|||||||||||
Liabilities |
||||||||||||||||||
Current |
||||||||||||||||||
Accounts payable |
$ | 3,422 | $ | 390 | $ | (390 | ) | 3(b) | $ | 3,422 | ||||||||
Accrued liabilities |
3,358 | 1,425 | (1,425 | ) | 3(b) | 3,358 | ||||||||||||
Provisions |
26,918 | 6,071 | (6,071 | ) | 3(b) | 26,918 | ||||||||||||
Royalties payable |
3,755 | | | 3,755 | ||||||||||||||
Taxes payable |
1,182 | | | 1,182 | ||||||||||||||
Current portion of notes payable |
662 | | | 662 | ||||||||||||||
Current portion of Long-Term Debt: Term Loan A |
| | 8,500 | 3(a) | 8,500 | |||||||||||||
Current portion of purchase consideration payable |
2,751 | | | 2,751 | ||||||||||||||
|
|
|
|
|
|
|
|
|||||||||||
42,048 | 7,886 | 614 | 50,548 | |||||||||||||||
Notes payable |
5,297 | | | 5,297 | ||||||||||||||
Purchase consideration payable |
22,277 | | | 22,277 | ||||||||||||||
Long-term Debt: Term Loan A |
| | 156,000 | 3(a) | 156,000 | |||||||||||||
Deferred taxes |
6,408 | | | 6,408 | ||||||||||||||
Other liabilities |
15 | | | 15 | ||||||||||||||
|
|
|
|
|
|
|
|
|||||||||||
Total Liabilities |
$ | 76,045 | $ | 7,886 | $ | 156,614 | $ | 240,545 | ||||||||||
|
|
|
|
|
|
|
|
|||||||||||
Shareholders Equity |
||||||||||||||||||
Share capital |
$ | 115,511 | $ | | $ | 129,151 | 3(a) | $ | 244,662 | |||||||||
Net equity |
| 3,331 | (3,331 | ) | 3(a) | | ||||||||||||
Reserve for share based compensation |
1,993 | | | 1,993 | ||||||||||||||
Accumulated other comprehensive income |
2 | | | 2 | ||||||||||||||
Retained earnings |
595 | | | 595 | ||||||||||||||
|
|
|
|
|
|
|
|
|||||||||||
Total Shareholders Equity |
$ | 118,101 | $ | 3,331 | $ | 125,820 | $ | 247,252 | ||||||||||
|
|
|
|
|
|
|
|
|||||||||||
Total Liabilities and Shareholders Equity |
$ | 194,146 | $ | 11,217 | $ | 282,434 | $ | 487,797 | ||||||||||
|
|
|
|
|
|
|
|
Concordia Healthcare Corp.
PRO FORMA CONSOLIDATED INCOME STATEMENT
(Unaudited prepared by management)
For the three months ended March 31, 2014
(Stated in thousands of U.S. Dollars)
Concordia
Healthcare Corp |
Donnatal |
Pro Forma
Adjustments |
Reference |
Pro Forma
Consolidated |
||||||||||||||
Revenue |
$ | 16,810 | $ | 12,028 | $ | | $ | 28,838 | ||||||||||
Cost of sales |
3,854 | 591 | | 4,445 | ||||||||||||||
|
|
|
|
|
|
|
|
|||||||||||
Gross profit |
12,956 | 11,437 | | 24,393 | ||||||||||||||
|
|
|
|
|
|
|
|
|||||||||||
Operating expenses |
||||||||||||||||||
General and administrative |
4,691 | 2,142 | | 6,833 | ||||||||||||||
Selling and marketing |
944 | 742 | | 1,686 | ||||||||||||||
Research and development |
1,418 | 79 | | 1,497 | ||||||||||||||
Share-based compensation |
756 | | | 756 | ||||||||||||||
Business acquisition related costs |
174 | | | 174 | ||||||||||||||
Depreciation expense |
34 | 76 | | 110 | ||||||||||||||
|
|
|
|
|
|
|
|
|||||||||||
Total operating expenses |
8,017 | 3,039 | | 11,056 | ||||||||||||||
|
|
|
|
|
|
|
|
|||||||||||
|
||||||||||||||||||
|
|
|
|
|
|
|
|
|||||||||||
Operating income |
4,939 | 8,398 | | 13,337 | ||||||||||||||
|
|
|
|
|
|
|
|
|||||||||||
Other income and expense |
||||||||||||||||||
Interest and accretion expense (income) |
4,705 | | 1,479 | 3(c) | 6,184 | |||||||||||||
Change in fair value of contingent consideration |
567 | | | 567 | ||||||||||||||
Amortization of intangible assets |
580 | | | 580 | ||||||||||||||
Foreign exchange (gain) loss |
865 | | | 865 | ||||||||||||||
Other (income) expense |
(5 | ) | | | (5 | ) | ||||||||||||
|
|
|
|
|
|
|
|
|||||||||||
Net Income (Loss) before tax |
(1,773 | ) | 8,398 | (1,479 | ) | 5,146 | ||||||||||||
|
|
|
|
|
|
|
|
|||||||||||
Income taxes |
63 | | | 63 | ||||||||||||||
|
|
|
|
|
|
|
|
|||||||||||
Net Income (Loss) |
$ | (1,836 | ) | $ | 8,398 | $ | (1,479 | ) | $ | 5,083 | ||||||||
|
|
|
|
|
|
|
|
|||||||||||
Weighted Average number of shares outstanding (000s) |
||||||||||||||||||
Basic |
23,933 | |||||||||||||||||
Fully Diluted |
26,194 | |||||||||||||||||
Earnings Per Share |
||||||||||||||||||
Basic |
$ | 0.21 | ||||||||||||||||
Fully Diluted |
$ | 0.19 |
Concordia Healthcare Corp.
PRO FORMA CONSOLIDATED INCOME STATEMENT
(Unaudited prepared by management)
For the year ended December 31, 2013
(Stated in thousands of U.S. Dollars)
Concordia
Healthcare Corp |
Donnatal |
Pro Forma
Adjustments |
Reference |
Pro Forma
Consolidated |
||||||||||||||
Revenue |
$ | 40,447 | $ | 49,792 | $ | | $ | 90,239 | ||||||||||
Cost of sales |
8,338 | 2,254 | | 10,592 | ||||||||||||||
|
|
|
|
|
|
|
|
|||||||||||
Gross profit |
32,109 | 47,538 | | 79,647 | ||||||||||||||
|
|
|
|
|
|
|
|
|||||||||||
Operating expenses |
||||||||||||||||||
General and administrative |
8,476 | 3,795 | | 12,271 | ||||||||||||||
Selling and marketing |
2,464 | 3,427 | | 5,891 | ||||||||||||||
Research and development |
| 897 | | 897 | ||||||||||||||
Share-based compensation |
1,070 | | | 1,070 | ||||||||||||||
Exchange listing expenses |
2,404 | | | 2,404 | ||||||||||||||
Business acquisition related costs |
3,692 | | 7,883 | 3(d) | 11,575 | |||||||||||||
Depreciation expense |
18 | 259 | | 277 | ||||||||||||||
|
|
|
|
|
|
|
|
|||||||||||
Total operating expenses |
18,124 | 8,378 | 7,883 | 34,385 | ||||||||||||||
|
|
|
|
|
|
|
|
|||||||||||
|
||||||||||||||||||
|
|
|
|
|
|
|
|
|||||||||||
Operating income |
13,985 | 39,160 | (7,883 | ) | 45,262 | |||||||||||||
|
|
|
|
|
|
|
|
|||||||||||
Other income and expense |
||||||||||||||||||
Interest and accretion expense (income) |
6,382 | | 5,972 | 3(e) | 12,354 | |||||||||||||
Change in fair value of derivative warrants |
4,648 | | | 4,648 | ||||||||||||||
Amortization of intangible assets |
120 | | | 120 | ||||||||||||||
Foreign exchange (gain) loss |
129 | | | 129 | ||||||||||||||
Other (income) expense |
(150 | ) | | | (150 | ) | ||||||||||||
|
|
|
|
|
|
|
|
|||||||||||
Net Income (Loss) before tax |
2,856 | 39,160 | (13,855 | ) | 28,161 | |||||||||||||
|
|
|
|
|
|
|
|
|||||||||||
Income taxes |
425 | | | 425 | ||||||||||||||
|
|
|
|
|
|
|
|
|||||||||||
Net Income (Loss) |
$ | 2,431 | $ | 39,160 | $ | (13,855 | ) | $ | 27,736 | |||||||||
|
|
|
|
|
|
|
|
|||||||||||
Weighted Average number of shares outstanding (000s) |
||||||||||||||||||
Basic |
10,938 | |||||||||||||||||
Fully Diluted |
11,038 | |||||||||||||||||
Earnings Per Share |
||||||||||||||||||
Basic |
$ | 2.54 | ||||||||||||||||
Fully Diluted |
$ | 2.51 |
Concordia Healthcare Corp.
NOTES TO PRO FORMA CONSOLIDATED FINANCIAL STATEMENTS
(Unaudited prepared by management)
1. ACQUISITION OF DONNATAL®
Concordia Healthcare Corp. ( Concordia or the Company ) is a diverse healthcare company focused on legacy pharmaceutical products, orphan drugs, and medical devices for the diabetic population. The Companys Legacy Drugs division consists of an ADHD-treatment drug, Kapvay® (clonidine extended release tablets), Ulesfia® (benzyl alcohol) Lotion, a Head Lice Treatment, and an Asthma-related medication, Orapred ODT® (prednisolone sodium phosphate orally disintegrating tablets). Concordias Specialty Healthcare Distribution (SHD) division distributes medical supplies targeting diabetes and related conditions. Concordias orphan drugs division, Pinnacle, markets Photofrin® in the United States.
On May 15, 2014, Concordia Pharmaceuticals Inc. ( CPI ), a wholly-owned subsidiary of the Company, completed the purchase of Donnatal®, pursuant to the terms and conditions of a definitive agreement announced previously and entered into on March 19, 2014, from a privately held specialty pharmaceutical company carrying on business as Revive Pharmaceuticals ( Revive Pharmaceuticals ). Donnatal® will be added to the Companys Legacy Drugs division.
Donnatal®, an adjunctive therapy in the treatment of irritable bowel syndrome ( IBS ) and acute enterocolitis, is available in two formulations: immediate release Donnatal® Tablets, and immediate release Donnatal® Elixir, a fast acting liquid. For decades, Donnatal® has delivered gentle relief from the symptoms of IBS. In addition to the drug, the Company acquired the sales and marketing infrastructure related to the product.
The Company acquired Donnatal® for total consideration of US$329,151,334 comprised of US$200,000,000 in cash and an aggregate of 4,605,833 common shares of the Company valued at US$129,151,334 based on the closing price of the Companys stock on May 15, 2014 of CAD$30.50 per share converted to USD using the May 15, 2014 Bank of Canada closing USD:CAD exchange rate of 1:1.0877.
The Company paid for the cash component of the acquisition through a combination of available cash and debt financing. In this respect, the Company entered into a secured credit facility having a principal amount of up to US$195 million, consisting of a US$170 million term loan and a US$25 million operating line (the Credit Facility ) with GE Capital, Healthcare Financial Services and a syndicate of lenders. The Credit Facility is secured by the assets of the Company and the assets of its material subsidiaries.
2. BASIS OF PRESENTATION
The unaudited pro forma consolidated financial statements of Concordia have been prepared by management in accordance with International Financial Reporting Standards for inclusion in the Business Acquisition Report dated June 9, 2014. In the opinion of management, the pro forma consolidated financial statements include all adjustments necessary for fair presentation of the transactions as described above.
The unaudited pro forma consolidated financial statements of the Company have been compiled from the following financial information:
| Unaudited interim financial statements of Concordia for the three months ended March 31, 2014; |
| Audited financial statements of Concordia for the year ended December 31, 2013; |
| Audited carve out financial statements of Donnatal® for the year ended December 31, 2013 and unaudited carve out financial statements of Donnatal® for the three months ended March 31, 2014. |
The conversion of Donnatals financial statement from US GAAP to IFRS has no material impact.
The unaudited pro forma consolidated balance sheet has been prepared as if the transactions described in Note 1 had occurred on March 31, 2014. The unaudited pro forma consolidated income statements have been prepared as if the transactions described in Note 1 had occurred on January 1, 2013.
The unaudited pro forma consolidated financial statements are not intended to reflect the financial position or performance of the Company which would have actually resulted had the proposed transactions described in Note 1 and other pro forma adjustments occurred as assumed. Further, these unaudited pro forma consolidated financial statements are not necessarily indicative of the financial position or performance that may be attained in the future. The unaudited pro forma consolidated financial statements should be read in conjunction with the financial information referred to above.
3. PRO FORMA CONSOLIDATED ADJUSTMENTS
The unaudited pro forma consolidated financial statements incorporate the following assumptions:
(a) | Completion of the purchase of Donnatal® will be as follows: |
Net Assets Acquired |
||||
Inventory |
$ | 1,806 | ||
Prepaid expenses and deposits |
630 | |||
Unallocated Goodwill and Intangibles |
326,715 | |||
|
|
|||
Total |
$ | 329,151 | ||
|
|
|||
Consideration Comprised of: |
||||
Cash |
$ | 35,500 | ||
Debt: |
||||
Term Loan A - short term |
8,500 | |||
Term Loan A - long term |
161,500 | |||
Less: Debt Issuance Costs |
(5,500 | ) | ||
|
|
|||
Total Debt net of issuance costs |
164,500 | |||
Equity Issued |
129,151 | |||
|
|
|||
Total Consideration |
$ | 329,151 | ||
|
|
The above allocation of the purchase price is preliminary. The Company continues to assess and review the fair values of the net assets acquired. Since the Company continues to finalize the valuation of assets acquired and liabilities assumed at the date of the acquisition, the allocation of the purchase price could vary significantly from the amounts used in these unaudited pro forma consolidated financial statements.
As part of the above allocation of the purchase price, the net equity balance in the equity section of the Donnatal pro forma balance sheet as at March 31, 2014 of $3,331 has been eliminated.
(b) | The unaudited pro forma consolidated financial statements have been adjusted to eliminate the following assets and liabilities not acquired as part of the acquisition: |
Net Assets not acquired |
||||
Accounts receivable |
$ | 7,575 | ||
Fixed assets |
829 | |||
Accounts payable |
(390 | ) | ||
Accrued liabilities |
(1,425 | ) | ||
Provisions |
(6,071 | ) | ||
|
|
|||
Total net assets not acquired |
$ | 518 | ||
|
|
(c) | The unaudited pro forma consolidated income statement for the three months ended March 31, 2014 includes an adjustment to increase interest and accretion expense by $1,479 to reflect the impact of the additional debt in the form of the Term Loan A, as described in Note 3(a), incurred by the Company to finance the acquisition of Donnatal®. |
(d) | The unaudited pro forma consolidated income statement for the year ended December 31, 2013 includes an adjustment to increase business acquisition related costs by $7,883 representing the estimated advisory, consulting and legal costs incurred by the Company related to the acquisition of Donnatal®. |
(e) | The unaudited pro forma consolidated income statement for the year ended December 31, 2013 includes an adjustment to increase interest and accretion expense by $5,972 to reflect the impact of the additional debt in the form of the Term Loan A, as described in Note 3(a), incurred by the Company to finance the acquisition of Donnatal®. |
Exhibit 99.28
BUSINESS ACQUISITION REPORT
Form 51-102F4
Item 1 - Identity of the Company
1.1 | Name and Address of the Company |
Concordia Healthcare Corp. (the Company )
277 Lakeshore Road East
Suite 302
Oakville, Ontario
L6J 1H9
1.2 | Executive Officer |
For further information in respect of this report and the significant acquisition described herein, please contact:
Leith J. Tessy
Chief Financial Officer and Secretary of the Company
(905) 842-5150
Item 2 - Details of Acquisition
2.1 | Nature of Business Acquired |
On September 30, 2014, the Company, through its wholly owned subsidiary Concordia Pharmaceuticals Inc. (CPI), completed the acquisition of Zonegran ® from Eisai Inc. (Eisai), for commercialization and sale in the United States, including Puerto Rico, pursuant to the terms and conditions of an asset purchase agreement between Eisai and CPI dated September 3, 2014. Zonegran ® is an adjunctive therapy in the treatment of partial seizures in adults with epilepsy.
2.2 | Date of the Acquisition |
The effective date of the acquisition of Zonegran ® was September 30, 2014 (the Closing Date ). The date of acquisition for accounting purposes is the Closing Date.
2.3 | Consideration |
The Company, through CPI, acquired Zonegran ® for total cash consideration of USD$91,402,258 which included $1,402,258 in purchased inventory.
Management paid for the acquisition through debt financing. In this respect, the Company entered into an incremental senior credit facility of USD$95,000,000 by way of an amendment and restatement of its existing credit agreement with GE Capital, Healthcare Financial Services, as agent, the Company, as borrower, certain credit parties thereto and certain lenders thereto (the Amended and Restated Credit Agreement). All of the Companys obligations under the Amended and Restated Credit Agreement are secured by the assets of the Company and the assets of its material subsidiaries.
2.4 | Effect on Financial Position |
The acquisition of Zonegran ® complements the Companys Legacy Pharmaceutical Division. The Company has no current plans or proposals for material changes in its business affairs or the affairs of Zonegran ® , which may have a significant effect on the results of operations and financial position of the Company.
2.5 | Prior Valuations |
Not applicable.
2.6 | Parties to the Acquisition |
The acquisition did not involve an informed person, associate or affiliate of the Company.
2.7 | Date of Report |
This report is dated December 12, 2014.
Item 3 - Financial Statements
The following financial statements have been included with this report:
(a) | Schedule A: Audited carve out financial statements for Zonegran ® for the year ended March 31, 2014 and unaudited carve out financial statements for Zonegran ® for the year ended March 31, 2013 and the six months ended September 30, 2014 and 2013. |
(b) | Schedule B: Unaudited pro forma consolidated income statement of the Company for the nine months ended September 30, 2014 and unaudited pro forma consolidated income statement of the Company for the year ended December 31, 2013. |
- 2 -
SCHEDULE A
ZONEGRAN PRODUCT LINE
OF EISAI INC.
Carve Out Financial Statements
(in U.S. Dollars)
For the Six Months Ended September 30, 2014 and 2013
And For the Years Ended March 31, 2014 and 2013
Page | 1
ZONEGRAN PRODUCT LINE OF EISAI INC.
Table of Contents
Page | ||||
INDEPENDENT AUDITORS REPORT |
3 - 4 | |||
Financial Statements: |
||||
Carve out Balance Sheets |
5 | |||
Carve out Statements of Operations |
6 | |||
Carve out Statements of Changes in Net Investment |
7 | |||
Carve out Statements of Cash Flows |
8 | |||
Notes to Carve out Financial Statements |
9 -17 |
Page | 2
Collins Barrow Toronto LLP | ||||
Collins Barrow Place | ||||
11 King Street West | ||||
Suite 700, PO Box 27 | ||||
Toronto, Ontario | ||||
M5H 4C7 Canada | ||||
INDEPENDENT AUDITORS REPORT | ||||
T. 416.480.0160 | ||||
F. 416.480.2646 | ||||
To the Directors of Concordia Healthcare Corp. | ||||
www.collinsbarrow.com |
We have audited the accompanying carve out financial statements of the Zonegran Product Line of Eisai Inc. as described in note 1 to the carve out financial statements, which comprise the carve out balance sheet as at March 31, 2014, and the related carve out statements of operations, changes in net investment, and cash flows for the year ended March 31, 2014, and a summary of significant accounting policies and other explanatory information.
Managements Responsibility for the Carve out Financial Statements
Management is responsible for the preparation and fair presentation of these carve out financial statements in accordance with accounting principles generally accepted in the United States of America, and for such internal control as management determines necessary to enable the preparation of carve out financial statements that are free from material misstatement, whether due to fraud or error.
Auditors Responsibility
Our responsibility is to express an opinion on these carve out financial statements based on our audit. We conducted our audit in accordance with Canadian generally accepted auditing standards. Those standards require that we comply with ethical requirements and plan and perform the audit to obtain reasonable assurance about whether the combined carve out financial statements are free from material misstatement.
An audit involves performing procedures to obtain audit evidence about the amounts and disclosures in the carve out financial statements. The procedures selected depend on the auditors judgment, including the assessment of the risks of material misstatement of the carve out financial statements, whether due to fraud or error. In making those risk assessments, the auditor considers internal control relevant to the entitys preparation and fair presentation of the carve out financial statements in order to design audit procedures that are appropriate in the circumstances, but not for the purpose of expressing an opinion on the effectiveness of the entitys internal control. An audit also includes evaluating the appropriateness of accounting policies used and the reasonableness of significant accounting estimates made by management, as well as evaluating the overall presentation of the carve out financial statements.
We believe that the audit evidence we have obtained is sufficient and appropriate to provide a basis for our audit opinion.
Opinion
In our opinion, the carve out financial statements referred to above present fairly, in all material respects, the carve out financial position of the Zonegran Product Line of Eisai Inc. as of March 31, 2014 and the results of its operations and its cash flows for the year then ended in accordance with accounting principles generally accepted in the United States of America.
This office is independently owned and operated by Collins Barrow Toronto LLP. The Collins Barrow trademarks are used under license. |
|
Page | 3
Other Matters
The carve out financial statements for the Zonegran Product Line of Eisai Inc. at March 31, 2013 were not audited or reviewed by us. Consequently, we take no responsibility for these carve out financial statements.
Collins Barrow Toronto LLP
Licensed Public Accountants
Chartered Accountants
December 12, 2014
Page | 4
ZONEGRAN PRODUCT LINE OF EISAI INC.
Carve out Balance Sheets
As of September 30, 2014 and 2013 and March 31, 2014 and 2013
(U.S. dollars in thousands)
See accompanying notes to carve out financial statements
Page | 5
ZONEGRAN PRODUCT LINE OF EISAI INC.
Carve out Statements of Operations
For the Six Months Ended September 30, 2014 and 2013 and for the
Years Ended March 31, 2014 and 2013
(U.S. dollars in thousands)
Unaudited | Audited | Unaudited | ||||||||||||||
Six Months Ended September 30, | Years Ended March 31, | |||||||||||||||
2014 | 2013 | 2014 | 2013 | |||||||||||||
Net sales |
$ | 12,378 | $ | 10,565 | $ | 22,123 | $ | 21,974 | ||||||||
Cost of goods sold |
1,774 | 5,610 | 11,075 | 11,112 | ||||||||||||
|
|
|
|
|
|
|
|
|||||||||
Gross profit |
10,604 | 4,955 | 11,048 | 10,862 | ||||||||||||
|
|
|
|
|
|
|
|
|||||||||
Operating expenses: |
||||||||||||||||
Selling expenses |
334 | 407 | 838 | 894 | ||||||||||||
General and administrative expenses |
1,393 | 868 | 2,284 | 1,686 | ||||||||||||
|
|
|
|
|
|
|
|
|||||||||
Total operating expenses |
1,727 | 1,275 | 3,122 | 2,580 | ||||||||||||
|
|
|
|
|
|
|
|
|||||||||
Operating Income |
8,877 | 3,680 | 7,926 | 8,282 | ||||||||||||
Other income (expense) |
(90 | ) | 202 | 306 | (199 | ) | ||||||||||
|
|
|
|
|
|
|
|
|||||||||
Income before income taxes |
8,787 | 3,882 | 8,232 | 8,083 | ||||||||||||
Income taxes [note 9] |
3,376 | 1,510 | 3,206 | 3,147 | ||||||||||||
|
|
|
|
|
|
|
|
|||||||||
Net income |
$ | 5,411 | $ | 2,372 | $ | 5,026 | $ | 4,936 | ||||||||
|
|
|
|
|
|
|
|
See accompanying notes to carve out financial statements
Page | 6
ZONEGRAN PRODUCT LINE OF EISAI INC.
Carve out Statements of Changes in Net Investment
For the Six Months Ended September 30, 2014 and 2013 and for the
Years Ended March 31, 2014 and 2013
(U.S. dollars in thousands)
Unaudited | Audited | Unaudited | ||||||||||||||
September 30, | September 30, | March 31, | March 31, | |||||||||||||
2014 | 2013 | 2014 | 2013 | |||||||||||||
Net investment - beginning of period |
$ | 19,502 | $ | 27,036 | $ | 27,036 | $ | 36,920 | ||||||||
Net income |
5,411 | 2,372 | 5,026 | 4,936 | ||||||||||||
Net Distributions to Eisai Inc. |
(5,195 | ) | (3,411 | ) | (12,560 | ) | (14,820 | ) | ||||||||
|
|
|
|
|
|
|
|
|||||||||
Net investment - end of period |
$ | 19,718 | $ | 25,997 | $ | 19,502 | $ | 27,036 | ||||||||
|
|
|
|
|
|
|
|
See accompanying notes to carve out financial statements
Page | 7
ZONEGRAN PRODUCT LINE OF EISAI INC.
Carve out Statements of Cash Flows
For the Six Months Ended September 30, 2014 and 2013 and for the
Years Ended March 31, 2014 and 2013
(U.S. dollars in thousands)
See accompanying notes to carve out financial statements
Page | 8
Zonegran Product Line of Eisai Inc.
Notes to Carve Out Financials Statements
(U.S. dollars in thousands)
1. | Basis of Presentation |
The accompanying carve out financial statements have been prepared under Generally Accepted Accounting Principles in the United States of America (GAAP) on the historical cost basis and are presented in U.S. dollars. Eisai Inc. (the Company) is a wholly-owned subsidiary of Eisai Corporation of North America (ECA) which is, in turn, a wholly-owned subsidiary of Eisai Co., Ltd. (ECL or Parent), a Japanese corporation. The Company is an integrated pharmaceutical business with discovery, clinical, manufacturing and marketing capabilities whose key areas of focus include oncology and specialty care products (neurology and metabolic disorders). The Company is also engaged in pharmaceutical research and development on behalf of ECL and other affiliated companies.
In September 2014, the Company entered into an Asset Purchase Agreement and agreed to sell its Zonegran Product Line in the U.S. and Puerto Rico to Concordia Pharmaceuticals Inc. (Concordia). Zonegran is an adjunctive therapy pharmaceutical drug that is used in the treatment of partial seizures in adults with epilepsy. Concurrent with entering into the Asset Purchase Agreement, the Company entered into a long-term Supply Agreement to supply Concordia with Zonegran finished goods for an initial term of 10 years and shall automatically renew for successive two-year periods unless cancelled earlier by Concordia.
These carve out financial statements are not necessarily indicative of the financial position, results of operations or cash flows that would have been attained if the Zonegran Product Line were owned by a separate legal entity as of and during the periods presented and are therefore not necessarily indicative of future financial position, results of operations and cash flows. The accompanying carve out financial statements reflect assets, liabilities, revenues and expenses directly attributable to the Zonegran Product Line as well as allocations deemed reasonable by management to present the carve out financial statements on a carve out basis. The carve out financial statements have been derived from the financial statements of ECA. The Company has applied the following methodologies for allocation and presentation of assets, liabilities, revenues and expenses:
Carve out Balance Sheets:
| Inventories, intangible asset - net, other assets, accounts payable and accrued rebates have been included in the carve out financial statements based on the Companys existing accounting records specific to these assets and liabilities. |
| Accounts receivable trade - on average, the Companys days-sales-outstanding of accounts receivable is 35 days. The balances shown in the carve out balance sheets represent the ratio of 35 days over the number of days in the quarters ending September 30, 2014 and 2013 and March 31, 2014 and 2013 multiplied by the Zonegran sales for the respective quarter. Allowances for doubtful accounts associated with these receivables are allocated based on the ratio of Zonegran sales to all Company sales. |
Page | 9
Zonegran Product Line of Eisai Inc.
Notes to Carve Out Financials Statements
(U.S. dollars in thousands)
Carve out Balance Sheets (continued):
| Prepaid expenses and other current assets, property and equipment net, accrued expenses and taxes payable include allocation methodologies based on proportionate sales; direct labor ratios or overhead ratios depending on the type of asset or liability. |
| Deferred income taxes are determined by actual computations in accordance with applicable accounting standards on accounting for income taxes as applied to the carve out assets and liabilities. |
Carve out Statements of Operations:
| Net sales, cost of goods sold and selling expenses are based on the Companys existing accounting records specific to the sales and expenses. |
| General and administrative expenses and other income (expense) are allocated based on proportionate sales. |
| The provisions for income taxes are determined by actual computations in accordance with applicable accounting standards on accounting for income taxes as applied to the carve out financial statements. |
The accompanying carve out balance sheets present no cash position since the cash management of the Zonegran Product Line was centralized within Eisai Inc. The net result of all cash transactions is assumed to be distributed to Eisai Inc. or contributed by Eisai Inc. and is presented under the caption net distributions as part of its net investment.
2. | Summary of Significant Accounting Policies |
Inventories Inventories are stated at the lower of cost (first-in, first-out method) or market.
Property and Equipment Property and equipment are stated at cost, less accumulated depreciation and amortization. Depreciation is computed by the straight-line method over the estimated useful lives of the related assets. Amortization of leasehold improvements is computed by the straight-line method over the estimated useful lives of the related assets or the lease term, if shorter.
Impairment of Long-Lived Assets Current facts or circumstances are periodically evaluated to determine if the carrying value of long-lived assets may not be recoverable. If such circumstances exist, an estimate of undiscounted future cash flows generated by the long-lived asset, or the appropriate grouping of assets, is compared to the carrying value to determine whether impairment exists at its lowest level of identifiable cash flows. If an asset is determined to be impaired, the loss is measured based on the difference between the assets fair value and its carrying value. An estimate of the assets fair value is based on quoted market prices in active markets, if available. If quoted market prices are not available, the estimate of fair value is based on various valuation techniques, including a discounted value of estimated future cash flows.
Page | 10
Zonegran Product Line of Eisai Inc.
Notes to Carve Out Financials Statements
(U.S. dollars in thousands)
Intangible Asset Intangible asset includes a license to the Zonegran product rights and is recorded at cost, net of accumulated amortization. Amortization of the intangible asset is computed on a straight-line basis over its estimated useful life. The estimated useful life is determined based on the period in which the asset is expected to contribute to future cash flows. The intangible asset is tested for impairment when facts and circumstances suggest that the carrying value of the asset may not be recoverable. If the carrying value exceeds the projected undiscounted pre-tax cash flows of the intangible asset, an impairment loss equal to the excess of the carrying value over the estimated fair value of the asset is recognized. Amortization of the intangible asset is included in cost of goods sold.
Fair Value Measurements The Company utilizes the fair value hierarchy to apply fair value measurements. The fair value hierarchy is based on inputs to valuation techniques that are used to measure fair values that are either observable or unobservable. Observable inputs reflect assumptions market participants would use in pricing an asset or liability based on market data obtained from independent sources, while unobservable inputs reflect a reporting entitys pricing based upon its own market assumptions. The basis for fair value measurements for each level within the hierarchy is described below:
Level 1 Quoted prices for identical assets or liabilities in active markets.
Level 2 Quoted prices for similar assets or liabilities in active markets; quoted prices for identical or similar assets or liabilities in markets that are not active; or model-derived valuations whose inputs are observable or whose significant value drivers are observable.
Level 3 Valuations derived from valuation techniques in which one or more significant inputs to the valuation model are unobservable.
Revenue Recognition Net product sales are recognized when title and risk of loss passes to the customer and collectability is reasonably assured and when reliable estimates of discounts, rebates, chargebacks, and returns can be made. Product sales are reported net of sales incentives, discounts, and rebates. Sales incentives are recorded as a reduction of revenue at the time the related revenue is recorded or when the incentive is offered, whichever is later. Provisions for returns, discounts, and rebates to customers are recorded in the same period the related sales are recorded. The Company determines the provision for Medicaid, Medicare, and other governmental discounts, managed care rebates, Tricare rebates, coupons, and chargebacks based on an estimate of reimbursable prescriptions filled for individuals covered by such programs. These provisions are subject to adjustment based on changes in historical experience and management assumptions as to amounts that will ultimately be paid.
Advertising Costs for print and digital media advertising are expensed in the period incurred and are included in selling expenses.
Page | 11
Zonegran Product Line of Eisai Inc.
Notes to Carve Out Financials Statements
(U.S. dollars in thousands)
Income Taxes The provision for income taxes represents income taxes paid or payable for the current year plus the change in deferred taxes during the year. Income taxes are accounted for using an asset and liability approach that requires the recognition of deferred tax assets and liabilities for the expected future tax consequences of temporary differences between the carve out financial statement and tax bases of assets and liabilities at the applicable tax rates. A valuation allowance is provided when it is more likely than not that some portion or all of the deferred tax assets will not be realized.
Tax benefits are recognized from an uncertain tax position only if it is more likely than not that the tax position will be sustained upon examination by a taxing authority and based upon the technical merits of the tax position. The tax benefit recognized in the carve out financial statements for a particular tax position is based on the largest benefit that is more likely than not to be realized upon settlement. Interest costs and penalties related to uncertain tax positions are classified as income tax expense in the carve out statements of operations.
Use of Estimates The preparation of carve out financial statements in conformity with GAAP requires management to make estimates and assumptions that affect the reported amounts of assets and liabilities and disclosure of contingent assets and liabilities at the date of the carve out financial statements. In addition, estimates and assumptions affect the reported amounts of revenues and expenses during the reporting period. Actual results could differ from those estimates. Significant items subject to such estimates include Medicaid, Medicare, and other governmental discounts, managed care rebates, chargebacks, returns, and valuation allowances for accounts receivable, inventories, and deferred tax assets.
3. | Inventories |
Inventories consist of the following:
Unaudited | Audited | Unaudited | ||||||||||||||
September 30,
2014 |
September 30,
2013 |
March 31,
2014 |
March 31,
2013 |
|||||||||||||
Raw materials |
$ | 7,462 | $ | 5,009 | $ | 6,420 | $ | 5,847 | ||||||||
Semi-finished goods |
1,680 | 2,281 | 897 | 1,588 | ||||||||||||
Finished goods |
| 1,437 | 1,207 | 1,407 | ||||||||||||
|
|
|
|
|
|
|
|
|||||||||
9,142 | 8,727 | 8,524 | 8,842 | |||||||||||||
Less: raw materials classified as non-current other assets |
3,909 | 3,270 | 3,134 | 2,796 | ||||||||||||
|
|
|
|
|
|
|
|
|||||||||
Inventories |
$ | 5,233 | $ | 5,457 | $ | 5,390 | $ | 6,046 | ||||||||
|
|
|
|
|
|
|
|
Page | 12
Zonegran Product Line of Eisai Inc.
Notes to Carve Out Financials Statements
(U.S. dollars in thousands)
4. | Property and Equipment |
Eisai Inc.s manufacturing of Zonegran consists of packaging semi-finished products, received from an affiliated company, on a production line that is shared with several other Eisai Inc. products. Property and equipment consist of the following:
Unaudited | Audited | Unaudited | ||||||||||||||||||
September 30, | September 30, | March 31, | March 31, | |||||||||||||||||
Useful Lives | 2014 | 2013 | 2014 | 2013 | ||||||||||||||||
Building improvements, machinery and equipment |
5 - 30 years | $ | 650 | $ | 654 | $ | 618 | $ | 452 | |||||||||||
Less accumulated depreciation |
317 | 281 | 283 | 180 | ||||||||||||||||
|
|
|
|
|
|
|
|
|||||||||||||
Property and equipment - net |
$ | 333 | $ | 373 | $ | 335 | $ | 272 | ||||||||||||
|
|
|
|
|
|
|
|
Depreciation and amortization expense was $19 for each of the six months ended September 30, 2014 and 2013. Depreciation and amortization expense was $36 and $27 for the years ended March 31, 2014 and 2013, respectively.
5. | Intangible Asset Net |
The intangible asset is comprised of the sales rights to the Zonegran product. The intangible asset was acquired in May 2004 for $117 million and has been amortized on a straight-line basis over an estimated useful life of 10 years. In October 2009, the Company recognized an impairment charge on the intangible asset and established a new basis in the intangible asset. The values of the intangible asset are as follows:
Unaudited | Audited | Unaudited | ||||||||||||||
September 30, | September 30, | March 31, | March 31, | |||||||||||||
2014 | 2013 | 2014 | 2013 | |||||||||||||
Cost |
$ | 117,000 | $ | 117,000 | $ | 117,000 | $ | 117,000 | ||||||||
Accumulated amortization |
(117,000 | ) | (113,751 | ) | (116,536 | ) | (110,967 | ) | ||||||||
|
|
|
|
|
|
|
|
|||||||||
Intangible asset - net |
$ | | $ | 3,249 | $ | 464 | $ | 6,033 | ||||||||
|
|
|
|
|
|
|
|
Amortization expense for the six months ended September 30, 2014 and 2013 was $464 and $2,784, respectively. Amortization expense was $5,569 for each of the years ended March 31, 2014 and 2013.
Page | 13
Zonegran Product Line of Eisai Inc.
Notes to Carve Out Financials Statements
(U.S. dollars in thousands)
6. | Accounts Payable Trade |
Accounts payable trade consists of amounts due to Dainippon Sumitomo Pharma, Co. Ltd. for the purchases of raw materials inventory.
7. | Accrued Rebates |
Accrued rebates includes accrued liabilities for Medicare, Medicaid and Managed Care rebates, chargebacks, returns, Tri-Care rebates, fee for service and other sales adjustments.
8. | Branded Prescription Drug Fee |
In March 2010, legislation under the Patient Protection and Affordable Care Act imposed an annual fee on companies in the pharmaceutical manufacturing industry. The fee ranges from $2.5 billion to $4.1 billion and is allocated across all pharmaceutical companies based on a companys relative market share of sales of branded prescription drugs to specified U.S. government programs such as Medicare, Medicaid, TRICARE, Department of Veterans Affairs and Department of Defense.
At the time the legislation was enacted, the accounting guidance for pharmaceutical companies was to recognize their respective share of the annual fee in the calendar year only if they had qualifying sales in the following year. The full estimated amount of the obligation was recognized as a liability upon the first qualifying sale in the following year with a corresponding deferred cost that was amortized to operating expense on a straight-line method. In July 2014, the IRS issued final regulations that provide guidance on the annual fee that suggest a company becomes liable for the fee based on sales in the current year rather than the liability only being due upon the first qualifying sale of the following year. As a result of this change, the Zonegran Product Line carve out financial statements reflect a catch-up adjustment in September 2014 to record an additional liability for the current years qualifying sales and an expense to write off the unamortized balance of the deferred charge.
Page | 14
Zonegran Product Line of Eisai Inc.
Notes to Carve Out Financials Statements
(U.S. dollars in thousands)
9. | Income Taxes |
A summary of the provision for income taxes for the six months ended September 30, 2014 and 2013 and for the years ended March 31, 2014 and 2013 is as follows:
Unaudited | Audited | Unaudited | ||||||||||||||
September 30,
2014 |
September 30,
2013 |
March 31,
2014 |
March 31,
2013 |
|||||||||||||
Current: |
||||||||||||||||
Federal |
$ | 1,069 | $ | 792 | $ | 1,831 | $ | 1,839 | ||||||||
State |
111 | 82 | 190 | 191 | ||||||||||||
|
|
|
|
|
|
|
|
|||||||||
Total current |
1,180 | 874 | 2,021 | 2,030 | ||||||||||||
|
|
|
|
|
|
|
|
|||||||||
Deferred: |
||||||||||||||||
Federal |
1,997 | 578 | 1,077 | 1,016 | ||||||||||||
State |
199 | 58 | 108 | 101 | ||||||||||||
|
|
|
|
|
|
|
|
|||||||||
Total deferred |
2,196 | 636 | 1,185 | 1,117 | ||||||||||||
|
|
|
|
|
|
|
|
|||||||||
Income tax expense |
$ | 3,376 | $ | 1,510 | $ | 3,206 | $ | 3,147 | ||||||||
|
|
|
|
|
|
|
|
The effective income tax rate of the accompanying carve out statements of operations differs from the federal statutory tax rate due primarily to non-deductible expenses for the excise tax on the sale of branded pharmaceutical products and state income taxes.
Page | 15
Zonegran Product Line of Eisai Inc.
Notes to Carve Out Financials Statements
(U.S. dollars in thousands)
A summary of the significant components of net deferred tax assets is as follows:
Unaudited | Audited | Unaudited | ||||||||||||||
September 30,
2014 |
September 30,
2013 |
March 31,
2014 |
March 31,
2013 |
|||||||||||||
Deferred income taxes - current: |
||||||||||||||||
Accounts receivable |
$ | 4 | $ | 4 | $ | 2 | $ | 2 | ||||||||
Inventories |
| 17 | 1 | 4 | ||||||||||||
Accrued rebates, expenses and Other current liabilities |
506 | 740 | 1,010 | 604 | ||||||||||||
|
|
|
|
|
|
|
|
|||||||||
Net current deferred tax assets |
$ | 510 | $ | 761 | $ | 1,013 | $ | 610 | ||||||||
|
|
|
|
|
|
|
|
|||||||||
Deferred income taxes - non-current: |
||||||||||||||||
Zonegran intangible asset |
$ | 17,129 | $ | 19,615 | $ | 18,818 | $ | 20,412 | ||||||||
Depreciation |
14 | 19 | 18 | 12 | ||||||||||||
|
|
|
|
|
|
|
|
|||||||||
Net non-current deferred tax assets |
$ | 17,143 | $ | 19,634 | $ | 18,836 | $ | 20,424 | ||||||||
|
|
|
|
|
|
|
|
The deferred income tax assets are derived primarily from the differences between the book basis and the tax basis of the Zonegran sales rights intangible asset. There were no liabilities for uncertain tax positions as of September 30, 2014 and 2013 and March 31, 2014 and 2013.
10. | Related Party Transactions |
ECL performs a toll manufacturing process on Zonegrans Active Pharmaceutical Ingredient (API), an essential raw material component of the Zonegran finished product, at its Kawashima, Japan manufacturing plant. The Companys affiliate, Eisai Manufacturing, Limited U.K. (EML), performs further manufacturing of the semi-finished Zonegran product to convert it into a capsule form on behalf of ECL. The Companys manufacturing facility in Research Triangle Park, North Carolina packages the Zonegran product into a finished good for commercial sale.
Total purchases from ECL for toll manufacturing services of the Zonegran API for the six months ended September 30, 2014 and 2013 were $329 and $325 respectively. The total amount due to ECL at September 30, 2014 and 2013 was $141 and $0, respectively. The total purchases from ECL for toll manufacturing services of the Zonegran API for the years ended March 31, 2014 and 2013 were $456 and $639, respectively. The total amount due to ECL at March 31, 2014 and 2013 was $47 and $118, respectively.
Page | 16
Zonegran Product Line of Eisai Inc.
Notes to Carve Out Financials Statements
(U.S. dollars in thousands)
11. | Concentration of Risk |
The Companys sales are concentrated with three large wholesale distributors and make up approximately 95% of the Companys net product sales and accounts receivable for the six months ended September 30, 2014 and 2013 and for the years ended March 31, 2014 and 2013.
12. | Subsequent Events |
The Company has evaluated subsequent events as they relate to the Zonegran Product Line for potential recognition or disclosure through December 12, 2014, the date the carve out financial statements were available to be issued, and has determined that there are no subsequent events that should be reported or disclosed in the accompanying carve out financial statements.
Page | 17
SCHEDULE B
Concordia Healthcare Corp.
UNAUDITED PRO FORMA CONSOLIDATED FINANCIAL STATEMENTS
September 30, 2014
Concordia Healthcare Corp.
PRO FORMA CONSOLIDATED INCOME STATEMENT
(Unaudited prepared by management)
For the nine months ended September 30, 2014
(Stated in thousands of U.S. Dollars)
Concordia
Healthcare Corp |
Donnatal
®
Jan 1 - May 15, 2014 |
Zonegran ® |
Pro Forma
Adjustments |
Reference |
Pro Forma
Consolidated |
|||||||||||||||||
Revenue |
$ | 79,295 | $ | 17,607 | $ | 17,281 | $ | | $ | 114,183 | ||||||||||||
Cost of sales |
12,904 | 900 | 4,311 | | 18,115 | |||||||||||||||||
|
|
|
|
|
|
|
|
|
|
|||||||||||||
Gross profit |
66,391 | 16,707 | 12,970 | | 96,068 | |||||||||||||||||
|
|
|
|
|
|
|
|
|
|
|||||||||||||
Operating expenses |
||||||||||||||||||||||
General and administrative |
14,623 | 3,280 | 1,994 | | 19,897 | |||||||||||||||||
Selling and marketing |
6,895 | 1,159 | 566 | | 8,620 | |||||||||||||||||
Research and development |
6,270 | 94 | | | 6,364 | |||||||||||||||||
Share-based compensation |
3,394 | | | | 3,394 | |||||||||||||||||
Business acquisition related costs |
12,581 | | | (11,732 | ) | 3(e) | 849 | |||||||||||||||
Depreciation expense |
90 | 114 | | | 204 | |||||||||||||||||
|
|
|
|
|
|
|
|
|
|
|||||||||||||
Total operating expenses |
43,853 | 4,647 | 2,560 | (11,732 | ) | 39,328 | ||||||||||||||||
|
|
|
|
|
|
|
|
|
|
|||||||||||||
|
|
|
|
|
|
|
|
|
|
|||||||||||||
Operating income |
22,538 | 12,060 | 10,410 | 11,732 | 56,740 | |||||||||||||||||
|
|
|
|
|
|
|
|
|
|
|||||||||||||
Other income and expense |
||||||||||||||||||||||
Interest and accretion expense (income) |
8,597 | | | 2,219 | 3(a) | 13,695 | ||||||||||||||||
2,879 | 3(b) | |||||||||||||||||||||
Change in fair value of contingent consideration |
2,129 | | | | 2,129 | |||||||||||||||||
Amortization of intangible assets |
1,740 | | | | 1,740 | |||||||||||||||||
Foreign exchange (gain) loss |
938 | | | | 938 | |||||||||||||||||
Other (income) expense |
92 | | 38 | | 130 | |||||||||||||||||
|
|
|
|
|
|
|
|
|
|
|||||||||||||
Net Income (Loss) before tax |
9,042 | 12,060 | 10,372 | 6,634 | 38,108 | |||||||||||||||||
|
|
|
|
|
|
|
|
|
|
|||||||||||||
Income taxes |
1,170 | | 3,994 | | 5,164 | |||||||||||||||||
|
|
|
|
|
|
|
|
|
|
|||||||||||||
Net Income (Loss) |
$ | 7,872 | $ | 12,060 | $ | 6,378 | $ | 6,634 | $ | 32,944 | ||||||||||||
|
|
|
|
|
|
|
|
|
|
|||||||||||||
Weighted Average number of shares outstanding (000s) |
||||||||||||||||||||||
Basic |
24,759 | |||||||||||||||||||||
Fully Diluted |
26,100 | |||||||||||||||||||||
Earnings Per Share |
||||||||||||||||||||||
Basic |
$ | 1.33 | ||||||||||||||||||||
Fully Diluted |
$ | 1.26 |
Concordia Healthcare Corp.
PRO FORMA CONSOLIDATED INCOME STATEMENT
(Unaudited prepared by management)
For the year ended December 31, 2013
(Stated in thousands of U.S. Dollars)
Concordia | ||||||||||||||||||||||
Healthcare
Corp |
Donnatal ® | Zonegran ® (1) |
Pro Forma
Adjustments |
Reference |
Pro Forma
Consolidated |
|||||||||||||||||
Revenue |
$ | 40,447 | $ | 49,792 | $ | 22,123 | $ | | $ | 112,362 | ||||||||||||
Cost of sales |
8,338 | 2,254 | 11,075 | | 21,667 | |||||||||||||||||
|
|
|
|
|
|
|
|
|
|
|||||||||||||
Gross profit |
32,109 | 47,538 | 11,048 | | 90,695 | |||||||||||||||||
|
|
|
|
|
|
|
|
|
|
|||||||||||||
Operating expenses |
||||||||||||||||||||||
General and administrative |
8,476 | 3,795 | 2,284 | | 14,555 | |||||||||||||||||
Selling and marketing |
2,464 | 3,427 | 838 | | 6,729 | |||||||||||||||||
Research and development |
| 897 | | | 897 | |||||||||||||||||
Share-based compensation |
1,070 | | | | 1,070 | |||||||||||||||||
Exchange listing expenses |
2,404 | | | | 2,404 | |||||||||||||||||
Business acquisition related costs |
3,692 | | | 11,732 | 3(e) | 15,424 | ||||||||||||||||
Depreciation expense |
18 | 259 | | | 277 | |||||||||||||||||
|
|
|
|
|
|
|
|
|
|
|||||||||||||
Total operating expenses |
18,124 | 8,378 | 3,122 | 11,732 | 41,356 | |||||||||||||||||
|
|
|
|
|
|
|
|
|
|
|||||||||||||
|
|
|
|
|
|
|
|
|
|
|||||||||||||
Operating income |
13,985 | 39,160 | 7,926 | (11,732 | ) | 49,339 | ||||||||||||||||
|
|
|
|
|
|
|
|
|
|
|||||||||||||
Other income and expense |
||||||||||||||||||||||
Interest and accretion expense (income) |
6,382 | | | 5,972 | 3(c) | 16,212 | ||||||||||||||||
3,858 | 3(d) | |||||||||||||||||||||
Change in fair value of derivative warrants |
4,648 | | | | 4,648 | |||||||||||||||||
Amortization of intangible assets |
120 | | | | 120 | |||||||||||||||||
Foreign exchange (gain) loss |
129 | | | | 129 | |||||||||||||||||
Other (income) expense |
(150 | ) | | (306 | ) | | (456 | ) | ||||||||||||||
|
|
|
|
|
|
|
|
|
|
|||||||||||||
Net Income (Loss) before tax |
2,856 | 39,160 | 8,232 | (21,562 | ) | 28,686 | ||||||||||||||||
|
|
|
|
|
|
|
|
|
|
|||||||||||||
Income taxes |
425 | | 3,206 | | 3,631 | |||||||||||||||||
|
|
|
|
|
|
|
|
|
|
|||||||||||||
Net Income (Loss) |
$ | 2,431 | $ | 39,160 | $ | 5,026 | $ | (21,562 | ) | $ | 25,055 | |||||||||||
|
|
|
|
|
|
|
|
|
|
|||||||||||||
Weighted Average number of shares outstanding (000s) |
||||||||||||||||||||||
Basic |
10,938 | |||||||||||||||||||||
Fully Diluted |
11,038 | |||||||||||||||||||||
Earnings Per Share |
||||||||||||||||||||||
Basic |
$ | 2.29 | ||||||||||||||||||||
Fully Diluted |
$ | 2.27 |
(1) | The Zonegran ® income statement is for the year ended March 31, 2014. |
Concordia Healthcare Corp.
NOTES TO PRO FORMA CONSOLIDATED FINANCIAL STATEMENTS
(Unaudited prepared by management)
(Stated in thousands of U.S dollars)
1. ACQUISITION OF DONNATAL ® AND ZONEGRAN ®
Concordia Healthcare Corp. (the Company or Concordia ) is an integrated healthcare company that targets three areas: (a) legacy pharmaceutical products; (b) specialized healthcare distribution that services the growing diabetic market; and (c) the acquisition and/or development of orphan drugs.
These three business units are run as separate divisions but are inter-related. The cash-flow from legacy pharmaceutical products is used to fund operations and is also intended to fund the expansion of indications for potential orphan drugs. The specialized healthcare distribution division provides additional growth and cash-flow generation. Additionally, through its registered pharmacy operation, this business is intended to provide a specialty distribution capability for orphan drugs once acquired and/or developed. The three business units were acquired during 2013 and are expected to provide the Company with an increased market share of the related products, as well as savings in costs through economies of scale.
On May 15, 2014, Concordia Pharmaceuticals Inc. ( CPI ), a wholly-owned subsidiary of the Company, completed the purchase of Donnatal ® , pursuant to the terms and conditions of an agreement announced previously and entered into on March 19, 2014, from a privately held specialty pharmaceutical company carrying on business as Revive Pharmaceuticals ( Revive Pharmaceuticals ).
Donnatal ® , an adjunctive therapy in the treatment of irritable bowel syndrome ( IBS ) and acute enterocolitis, is available in two formulations: immediate release Donnatal ® Tablets, and immediate release Donnatal ® Elixir, a fast acting liquid. In addition to the drug, the Company acquired the sales and marketing infrastructure related to the product.
The Company, through CPI, acquired Donnatal ® for total consideration of US$329,151 comprised of US$200,000 in cash and an aggregate of 4,605,833 common shares of the Company valued at US$129,151 based on the closing price of the Companys stock on May 15, 2014 of CAD$30.50 per share converted to USD using the May 15, 2014 Bank of Canada closing USD: CAD exchange rate of 1:1.0877.
Management paid for the cash component of the acquisition through a combination of available cash and debt financing. In this respect, the Company entered into a secured credit facility having a principal amount of up to US$195,000, consisting of a US$170,000 term loan and a US$25,000 operating line (the Credit Facility ) with GE Capital, Healthcare Financial Services and a syndicate of lenders.
On September 30, 2014, Concordia, through its wholly owned subsidiary CPI, completed the purchase of Zonegran ® for commercialization and sale in the United States, including Puerto Rico, from Eisai Inc. ( Eisai ), pursuant to the terms and conditions of a definitive asset purchase agreement. Zonegran ® is an adjunctive therapy in the treatment of partial seizures in adults with epilepsy.
The purchase price paid to Eisai was $91,402 in cash, which included $1,402 for purchased inventory.
Management paid for the acquisition of Zonegran ® through debt financing. In this respect, the Company entered into an incremental senior credit facility of USD$95,000 by way of an amendment and restatement of the Credit Facility. All of the Companys obligations under the amended and restated credit facility are secured by the assets of the Company and the assets of its material subsidiaries.
2. BASIS OF PRESENTATION
The unaudited pro forma consolidated financial statements of Concordia have been prepared by management in accordance with International Financial Reporting Standards for inclusion in the business acquisition report dated
December 12, 2014. In the opinion of management, the pro forma consolidated financial statements include all adjustments necessary for fair presentation of the transactions as described above.
The unaudited pro forma consolidated financial statements of the Company have been compiled from the following financial information:
| Unaudited interim financial statements of Concordia for the nine months ended September 30, 2014; |
| Audited financial statements of Concordia for the year ended December 31, 2013; |
| Audited carve out financial statements of Donnatal ® for the year ended December 31, 2013 and unaudited carve out financial information of Donnatal ® for the period January 1, 2014 to May 15, 2014; |
| Audited carve out financial statements of Zonegran ® for the year ended March 31, 2014 and unaudited carve our financial statements of Zonegran ® for the year ended March 31, 2013 and the six months ended September 30, 2014 and 2013. |
The conversion of the Donnatal ® and Zonegran ® financial statements from US GAAP to IFRS have no material impact.
The Companys interim balance sheet filed on SEDAR as part of the unaudited interim financial statements of Concordia for the nine months ended September 30, 2014 included the impact of both the Donnatal ® and Zonegran ® acquisitions. As a result, a pro forma balance sheet as at September 30, 2014 is not required for the purposes of the business acquisition report dated December 12, 2014. The unaudited pro forma consolidated income statements have been prepared as if the transactions described in Note 1 had occurred on January 1, 2013.
The unaudited pro forma consolidated financial statements are not intended to reflect the financial position or performance of the Company which would have actually resulted had the proposed transactions described in Note 1 and other pro forma adjustments occurred as assumed. Further, these unaudited pro forma consolidated financial statements are not necessarily indicative of the financial position or performance that may be attained in the future. The unaudited pro forma consolidated financial statements should be read in conjunction with the financial information referred to above.
3. PRO FORMA CONSOLIDATED ADJUSTMENTS
The unaudited pro forma consolidated financial statements incorporate the following assumptions:
(a) | The unaudited pro forma consolidated income statement for the nine months ended September 30, 2014 includes an adjustment to increase interest and accretion expense by $2,219 to reflect the impact of the additional debt of $170,000, as described in Note 1, incurred by the Company to finance the acquisition of Donnatal ® . |
(b) | The unaudited pro forma consolidated income statement for the nine months ended September 30, 2014 includes an adjustment to increase interest and accretion expense by $2,879 to reflect the impact of the additional debt of $95,000, as described in Note 1, incurred by the Company to finance the acquisition of Zonegran ® . |
(c) | The unaudited pro forma consolidated income statement for the year ended December 31, 2013 includes an adjustment to increase interest and accretion expense by $5,972 to reflect the impact of the additional debt of $170,000, as described in Note 1, incurred by the Company to finance the acquisition of Donnatal ® . |
(d) | The unaudited pro forma consolidated income statement for the year ended December 31, 2013 includes an adjustment to increase interest and accretion expense by $3,858 to reflect the impact of the additional debt of $95,000, as described in Note 1, incurred by the Company to finance the acquisition of Zonegran ® . |
(e) | The unaudited pro forma consolidated income statement for the year ended December 31, 2013 includes an adjustment to increase acquisition related costs by $11,732 to reflect legal and advisory fees related to the acquisitions of Donnatal ® of $7,883 and Zonegran ® of $3,849. The unaudited pro forma consolidated income statement for the nine months ended September 30, 2014 includes an adjustment to decrease acquisition related costs by $11,732. |
(f) | The following adjustments were made to reflect Zonegran ® on a consistent reporting period: |
i. | For the nine months ended September 30, 2014: |
Six months | Plus: three | Nine months | ||||||||||
ended | months ended | ended | ||||||||||
Sep 30, 2014 | Mar 31, 2014 | Sep 30, 2014 | ||||||||||
(Unaudited) | (Unaudited) | (Unaudited) | ||||||||||
Revenue |
$ | 12,378 | $ | 4,903 | $ | 17,281 | ||||||
Cost of sales |
1,774 | 2,537 | 4,311 | |||||||||
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Gross profit |
10,604 | 2,366 | 12,970 | |||||||||
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Operating expenses |
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General and administrative |
1,393 | 601 | 1,994 | |||||||||
Selling and marketing |
334 | 232 | 566 | |||||||||
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Total operating expenses |
1,727 | 833 | 2,560 | |||||||||
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Operating income |
8,877 | 1,533 | 10,410 | |||||||||
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Other income and expense |
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Other (income) expense |
90 | (52 | ) | 38 | ||||||||
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Net Income (Loss) before tax |
8,787 | 1,585 | 10,372 | |||||||||
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Income taxes |
3,376 | 618 | 3,994 | |||||||||
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Net Income (Loss) |
$ | 5,411 | $ | 967 | $ | 6,378 | ||||||
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Exhibit 99.29
Concordia Healthcare Announces Changes to the Board of Directors, Management Team and Auditors
TORONTO, ONT. May, 25, 2015 Concordia Healthcare Corp. (Concordia or the Company) (TSX: CXR) (OTCQX: CHEHF), a diverse healthcare company focused on legacy pharmaceutical products and orphan drugs, today announced several key changes to the Companys board of directors (the Board ) and management team.
Board of Directors
The Company announced today that both Mr. Ronald Schmeichel and Mr. John Huss would not be standing for re-election at the Companys annual general meeting of shareholders scheduled for June 25, 2015 (the Meeting ).
I would like to thank Ron and John for the dedication and service they provided to Concordia during the past few years, stated Mark Thompson, Chief Executive Officer of Concordia. In particular, I would like to thank Ron for his leadership in assisting with the establishment of Concordia. Ron was instrumental in Concordias start-up financing and in taking the Company public. His guidance during that time was critical to Concordias success.
Ron Schmeichel stated, I am very proud to have served as the Chairman of Concordia while working alongside Mark Thompson to grow Concordia from a company with a market capitalization of approximately $30 million to almost $3 billion in two short years, and I look forward to focusing on building JJR Private Capitals other portfolio companies now that Concordia moves into a new phase of growth.
In their place, the Company is pleased to announce that Mr. Edward Borkowski and Ms. Rochelle Fuhrmann have been nominated for election as directors of the Company. Mr. Borkowski and Ms. Fuhrmann will join the Board effective June 25, 2015, subject to shareholder approval at the Meeting.
Mr. Borkowski has over 15 years of experience in executive financial positions in the pharmaceutical sector, and is currently the Chief Financial Officer of Amerigen Pharmaceuticals. Prior to joining Amerigen Pharmaceuticals, Mr. Borkowski held several executive level finance positions with various entities, notably as the Chief Financial Officer and Executive Vice President of Mylan N.V. Mr. Borkowski has an MBA in accounting from Rutgers University and a degree in Economics and Political Science from Allegheny College.
Ms. Fuhrmann has over 20 years of broad financial experience and was previously the Chief Financial Officer of Amneal Pharmaceuticals LLC. Prior to joining Amneal, Ms. Fuhrmann was Senior Vice President, Finance at Warner Chilcott plc, a specialty pharmaceuticals company, prior to its acquisition by Actavis, Inc. in 2013. She spent the early part of her career in telecommunications and public accounting having held various positions at AT&T and Coopers and Lybrand LLC (now PricewaterhouseCoopers LLP). Ms. Fuhrmann earned her certified public accountant designation (inactive) in 1996 and has a B.Sc. degree in accounting from the University of Rhode Island.
On behalf of the nominating and corporate governance committee and the board of directors as a whole, I am very pleased to announce the nomination of Edward and Rochelle to the board of directors. This nomination is an important part of several recent and ongoing pharmaceutical industry leadership and corporate governance enhancement initiatives that have been undertaken by the Board, stated Mark Thompson.
Upon conclusion of the Meeting, it is planned that Mr. Thompson will replace Mr. Schmeichel as the Chairman of the Board and Jordan Kupinsky will become Lead Independent Director of the Board.
Management Team
The Company is also pleased to announce that Mr. Adrian de Saldanha has been appointed the Chief Financial Officer of the Company, which will take effect immediately. In his role as Chief Financial Officer, Mr. de Saldanha will succeed Mr. Leith Tessy.
Mr. de Saldanha is a Chartered Professional Accountant (CPA, CA) with extensive experience as a senior finance executive in roles covering a variety of industries. Most recently Mr. de Saldanha was Chief Financial Officer at Syncordia Technologies and Healthcare Solutions, Inc., previous to which he was a Managing Vice President at OMERS Strategic Investments where his responsibilities included management of investments in entities involved in aviation, engineering and industrial services. Mr. de Saldanha also spent over seven years at Biovail Corporation (now Valeant Pharmaceuticals) in a number of senior finance roles including Interim Chief Financial Officer, Vice President Finance & Treasurer, Vice President Manufacturing Finance as well as Vice President, Controller at Biovail Pharmaceuticals Canada. Before joining Biovail, Mr. de Saldanha spent eight years at Molson Inc. in a number of progressively senior finance positions.
I am very pleased to welcome Adrian to the Concordia team and look forward to working with him as we take the Company through the next phase of its development. Adrians successful track record of overseeing company finances will provide valuable financial leadership and guidance to Concordia during its continued development, stated Mark Thompson.
Mr. Thompson added, I would like to thank Leith for his hard work and dedication over the past two years and wish him the best in his future endeavours. Leith will remain available to the Company until September 1, 2015, to assist in the transition.
In addition, upon conclusion of the Meeting, it is planned that Mr. Thompson will relinquish his role as President of the Company and Mr. Wayne Kreppner will be promoted to the role of President, in addition to his role as Chief Operating Officer of the Company.
Waynes dedication and efforts have been the underpinning of Concordias operational success, stated Mr. Thompson. In his new role he will be able to provide additional leadership to the team and further enhance operational success going forward.
Finally, the Company announced that Mr. Arikit Mookerjee has joined as Chief Financial Officer of Concordia Pharmaceuticals Inc. ( CPI ), the Companys Barbados subsidiary. Prior to accepting this position with CPI, Mr. Mookerjee was a consultant for SMEC International Pty Limited, an Audit Director with PricewaterhouseCoopers LLP, and acted as the Group Financial Controller with Cordlife Limited a healthcare and stem-cell biotechnology firm.
Mr. Mookerjee brings a strong financial background and will provide leadership to Concordia Pharmaceuticals Inc, stated Mr. Thompson.
Change of Auditor
The Company announced today that the auditors, Collins Barrow Toronto LLP, Chartered Accountants (the Former Auditor ) are not being proposed for re-appointment at the Meeting. At the Meeting, Concordias shareholders will be asked to approve the appointment of PricewaterhouseCoopers LLP, as auditor of the Company. Subject to all applicable regulatory and shareholder approvals, effective upon conclusion of the Meeting, the Companys auditor will be PricewaterhouseCoopers LLP (the Successor Auditor ).
The Company advises that there were no reservations in the Auditors Reports for either of the Companys two most recently completed fiscal years nor for any period subsequent thereto for which an audit report was issued and preceding the date hereof.
In the opinion of the Companys audit committee and the Board, there were no reportable events as defined in National Instrument 52-102 - Continuous Disclosure Obligations ( NI-51-102 ).
The Companys audit committee and the Board have approved the resignation of the Former Auditor. Pursuant to NI 51-102, the notice of change of auditor, together with the letter from the Former Auditor and the letter from the Successor Auditor have been reviewed by the Companys audit committee and Board and have been filed on SEDAR accordingly.
FTC Consent Decree
On February 9, 2015, Concordia and its subsidiary, CPI, received a civil investigative demand ( CID ) from the United States Federal Trade Commission ( FTC ) regarding its attention deficit hyperactivity disorder product Kapvay ® . The CID is a request for documents and information relating to CPIs agreements with Par Pharmaceutical, Inc. ( Par ) with respect to Kapvay ® (the Par Agreements ). While Concordia maintains that the Par Agreements are lawful, it has negotiated the terms of a proposed settlement agreement with the FTC and expects to settle the FTC investigation. The proposed agreement with the FTC does not constitute an admission by Concordia that it has violated the law. Under the terms of the proposed settlement agreement, Concordia will be prohibited from enforcing the provision of the Par Agreements which entitle Concordia to a royalty payment corresponding to Pars sales of generic Kapvay ® and from entering any future agreement with a generic company that would prevent the marketing of an authorized generic version of a branded drug after all patents have expired on the drug. Concordia will also be subject to standard antitrust compliance and reporting requirements. The proposed settlement agreement is subject to initial acceptance by the FTC, publication of the settlements terms and a 30-day public comment period, and final acceptance by the FTC.
About Concordia
Concordia is a diverse healthcare company focused on legacy pharmaceutical products and orphan drugs. Concordias legacy pharmaceutical division, Concordia Pharmaceuticals Inc., consists of 23 high-margin products including Nilandron ® , for the treatment of metastatic prostate cancer; Dibenzyline ® , for the treatment of pheochromocytoma; Lanoxin ® , for the treatment of mild-to-moderate heart failure and atrial fibrillation; Plaquenil ® , for the treatment of lupus and rheumatoid arthritis, Donnatal ® for the treatment of irritable bowel syndrome and Zonegran ® (zonisamide) for treatment of partial seizures in adults with epilepsy. Concordias orphan drugs division, Concordia Laboratories Inc., manufactures Photofrin ® . Photofrin ® is marketed by Pinnacle Biologics, Inc. in the United States.
Concordia operates out of facilities in Oakville, Ontario; Bridgetown, Barbados; Kansas City, Missouri; Chicago, Illinois and Charlottesville, Virginia.
For more information, please visit www.concordiarx.com or contact:
Adam Peeler
TMX Equicom
416-815-0700 x 225
apeeler@tmxequicom.com
Notice regarding forward-looking statements:
This news release includes forward-looking statements regarding Concordia and its business, which may include, but are not limited to, the composition of the Board, shareholder approval for Board nominees, and the benefits to be provided to the Company by new management appointees. Often, but not always, forward-looking statements can be identified by the use of words such as plans, is expected, expects, scheduled, intends, contemplates, anticipates, believes, proposes, or variations (including negative and grammatical variations) of such words and phrases, or state that certain actions, events or results may, could, would, might or will be taken, occur or be achieved. Such statements are based on the current expectations of Concordias management, and are based on assumptions and subject to risks and uncertainties. Although Concordias management believes that the assumptions underlying these statements are reasonable, they may prove to be incorrect. The forward-looking events and circumstances discussed in this news release may not occur by certain specified dates or at all and could differ materially as a result of known and unknown risk factors and uncertainties affecting Concordia, including risks relating to the use of Concordias products to treat certain diseases, the pharmaceutical industry, the failure to obtain regulatory or shareholder approvals, economic factors, market conditions, the equity markets generally, risks associated with growth and competition, general economic and stock market conditions and many other factors beyond the control of Concordia. Although Concordia has attempted to identify important factors that could cause actual actions, events or results to differ materially from those described in forward-looking statements, there may be other factors that cause actions, events or results to differ from those anticipated, estimated or intended. No forward-looking statement can be guaranteed. Except as required by applicable securities laws, forward-looking statements speak only as of the date on which they are made and Concordia undertakes no obligation to publicly update or revise any forward-looking statement, whether as a result of new information, future events, or otherwise.
Exhibit 99.30
Concordia Healthcare Corp. works to expand treatment options for patients with rare cancers
Photodynamic therapy with PHOTOFRIN ® being studied in range of cancers
Oakville, ONTARIO, May 7, 2015 Concordia Healthcare Corp. (Concordia or the Company) (TSX: CXR) (OTCQX: CHEHF), a diverse healthcare company focused on legacy pharmaceutical products, orphan drugs, and medical devices for the diabetic population, today provided a clinical update on its orphan drug development program with Photodynamic Therapy (PDT) with PHOTOFRIN ® (porfimer sodium), a drug-device combination therapy.
Due to its ability to target cancer cells, PDT with PHOTOFRIN is being studied in a range of hard-to-treat, hard-to-reach cancers including adult and pediatric brain cancer, mesothelioma and cholangiocarcinoma (bile duct cancer).
As a drug-device combination treatment, photodynamic therapy with PHOTOFRIN has broad therapeutic applicability, said Mark Thompson, CEO of Concordia. Concordia has the commitment to fully realize the potential of this research program in the orphan disease space, potentially helping patients dealing with an unmet medical need.
Researchers at the Medical College of Wisconsin (MCW) are currently initiating a Phase 2 study of PDT with PHOTOFRIN in adults with recurrent high-grade gliomas , a diverse group of tumors of the brain and spinal cord that grow quickly and have the ability to spread through the brain aggressively making them very difficult to treat.
In the United States, the five-year survival rate for patients of all ages with all types of brain tumors is approximately 20 percent, with the scale skewed toward even poorer survival in patients with gliomas. Although surgery and radiotherapy are primary treatment options, surgery is rarely curative, and radiotherapy has little impact on overall survival. PDT allows investigators to target treatment directly into tumor areas near eloquent tissue the parts of the brain needed for important functions such as speech, walking, movement, and memory with the potential to improve the ability to treat and destroy all tumor cells while reducing potential long-term neurological consequences associated with surgery and radiation. The trial is expected to enroll 30 patients over a three-year period.
Previous PDT trials demonstrated increases in long-term survival including one trial in adult patients with recurrent glioblastoma with rates of 57 per cent (anaplastic astrocytoma) and 37 per cent (glioblastoma multiforme) beyond 36 months.
Harry T. Whelan, MD, the Bleser Professor of Neurology and Pediatrics and Hyperbaric Medicine at MCW, is the lead investigator for the study.
Patients with high-grade gliomas in particular have a very poor prognosis, said Dr. Whelan. Photodynamic therapy with PHOTOFRIN has the potential to add to the multi-modal approach of surgery and chemotherapy by providing another treatment option for patients with rare cancers for which there is no clear standard of care.
Dr. Whelan also is conducting a Phase 1 clinical trial of PDT with PHOTOFRIN in children and adolescents, from newborn to 18 years old, who have recurrent or progressive brain tumors. The primary objective of this study is to identify a maximum tolerated dose (MTD) and to characterize the side-effect profile of PHOTOFRIN in children with recurrent brain tumors. The trial is being conducted by the Childrens Hospital of Wisconsin Research Institute and MCW, one of the few centers in the United States with experience utilizing PDT technology for the treatment of brain tumors.
Other Clinical Trials with Photodynamic Therapy with PHOTOFRIN
Concordia is continuing to advance a broad clinical trial program using PDT with PHOTOFRIN. After reaching an agreement with the U.S. Food and Drug Administration in November 2013 to conduct a Phase 3 clinical trial in unresectable cholangiocarcinoma (CCA) per the conditions specified in a special protocol assessment or SPA (ClinicalTrials.gov identifier: NCT02082522), Concordia began initiating global clinical trial sites in August. Sites in North America, Europe and Korea have since been initiated and patient enrollment is underway in North American and Korea. The trial is expected to enroll 200 patients.
Concordias presence in Southeast Asia also includes its recent exclusive trademark license and product distribution agreement with Union Med. Limited (Union), a leader in providing hospitals throughout China with photodynamic therapies for cancerous and non-cancerous tumors. Under the distribution agreement, Union will import, clinically develop (if necessary), gain regulatory approval for, distribute, market and sell PHOTOFRIN throughout the Peoples Republic of China, Hong Kong, Macau and Taiwan.
Also, with support from an US$8 million National Cancer Institute grant, researchers at the Perelman School of Medicine at the University of Pennsylvania are enrolling patients in a Phase 2 trial to evaluate PDT with PHOTOFRIN for patients with epithelioid malignant pleural mesothelioma (MPM). Mesothelioma is a rare, aggressive and deadly cancer that most often manifests itself in the lining of the lungs and is caused almost exclusively by exposure to asbestos. The study expects to enroll 102 patients over four years.
About Photodynamic Therapy with PHOTOFRIN
PDT with PHOTOFRIN is a two-step cancer treatment process. PHOTOFRIN, a photosensitizing drug, is injected into the blood stream of patients where it accumulates in cancer cells. Immediately after surgical removal of the tumor, PHOTOFRIN is activated or turned on with laser light, which attacks any remaining cancer cells in nearby tissue. In addition to directly attacking cancer cells, PDT appears to shrink or attack tumors in two
other ways. The photosensitizer can damage blood vessels in the tumor, thereby preventing the cancer from receiving necessary nutrients. PDT also may modulate the immune system to attack the tumor cells.
PHOTOFRIN is indicated for the treatment of esophageal cancer, non-small-cell lung cancer and high-grade dysplasia in Barretts esophagus. PHOTOFRIN was granted orphan drug designation (ODD) by the FDA in 2001 for the ablation of High-Grade Dysplasia in Barretts Esophagus in patients who are not considered to be candidates for esophagectomy, in 2004 for cholangiocarcinoma (CCA), a rare cancer in the ducts that carry bile from the liver to the small intestine, and in 2011 as adjuvant therapy to surgery for the treatment of malignant pleural mesothelioma.
For additional information about PHOTOFRIN, please see full prescribing information available at www.PHOTOFRIN.com.
About Concordia
Concordia is a diverse healthcare company focused on legacy pharmaceutical products and orphan drugs. Concordias legacy pharmaceutical division, Concordia Pharmaceuticals Inc., consists of 23 products including Nilandron ® , for the treatment of metastatic prostate cancer; Dibenzyline ® , for the treatment of pheochromocytoma; Lanoxin ® , for the treatment of mild-to-moderate heart failure and atrial fibrillation; Plaquenil ® , for the treatment of lupus and rheumatoid arthritis, Donnatal ® for the treatment of irritable bowel syndrome and Zonegran ® (zonisamide) for treatment of partial seizures in adults with epilepsy. Concordias orphan division, Concordia Laboratories Inc., manufactures PHOTOFRIN. PHOTOFRIN is marketed by Pinnacle Biologics, Inc. in the United States.
Concordia operates out of facilities in Oakville, Ontario; Bridgetown, Barbados; Charlottesville, Virginia and has a specialty healthcare distribution (SHD) division that operates out of Kansas City, Missouri. Pinnacle Biologics Inc. is located in Chicago, Illinois.
Notice regarding forward-looking statements:
This press release includes forward-looking statements and information (forward-looking statements) regarding Concordia and its business, which may include, but are not limited to, statements with respect to the addition of new sites approved to enroll patients into clinical trials, the ability to enroll patients into clinical trials, the ability to obtain necessary approvals, the approval and development of PDT with PHOTOFRIN as a new treatment for certain forms of cancer, the acceleration of product development, the ability, potential and/or effectiveness of PDT with PHOTOFRIN to combat certain forms of cancer and reducing potential long term consequences associated with surgery and radiation, the ability of PDT with PHOTOFRIN to provide better or alternative treatment options, the ability and/or potential of PDT with PHOTOFRIN to prolong the life of anyone affected by certain forms of cancer, medical community support and requirements for new treatments such as PDT with PHOTOFRIN, the results and/or success of clinical trials, the ability to expand existing sales of Concordias products in certain markets, the receipt of approval to market and distribute Concordias products in certain markets, the outcomes and success of distribution arrangements, market opportunities for Concordias products, statements with respect to the relationship between Concordia and Union, the commercial potential of Concordias products, the potential of Concordias products to assist patients in dealing with unmet medical needs and other factors. Often, but not always, forward-looking statements can be identified by the use of words such as plans, is expected, expects, scheduled, intends, contemplates, anticipates, believes, proposes or variations (including negative and grammatical variations) of such words and phrases, or state that certain actions,
events or results may, could, would, might or will be taken, occur or be achieved. Such statements are based on the current expectations of Concordias management, and are based on assumptions and subject to risks and uncertainties. Although Concordias management believes that the assumptions underlying these statements are reasonable, they may prove to be incorrect. The forward-looking events and circumstances discussed in this release may not occur by certain specified dates or at all and could differ materially as a result of known and unknown risk factors and uncertainties affecting the Company, including risks regarding the pharmaceutical industry, the failure to comply with applicable laws, the failure to obtain regulatory approvals, risks associated with clinical trials (including, without limitation, in respect of patient enrollment into clinical trials), risks relating to the use of Concordias products to treat certain diseases, risks relating to distribution arrangements, risks relating to the markets in which Concordia operates and/or distributes its products, economic factors, market conditions, the equity markets generally, risks associated with growth and competition and many other factors beyond the control of Concordia. Although Concordia has attempted to identify important factors that could cause actual actions, events or results to differ materially from those described in forward-looking statements, there may be other factors that cause actions, events or results to differ from those anticipated, estimated or intended. No forward-looking statement can be guaranteed. Except as required by applicable securities laws, forward-looking statements speak only as of the date on which they are made and Concordia undertakes no obligation to publicly update or revise any forward-looking statement, whether as a result of new information, future events, or otherwise.
For more information, please visit www.concordiarx.com or contact:
Media:
Molly Watson
Ritz Communications
413-454-3926
molly.watson@ritzcommunications.com
Investors:
Adam Peeler
TMX Equicom
416-815-0700 x 225
apeeler@tmxequicom.com
Exhibit 99.31
Concordia Healthcare Corp. Announces Completion of Acquisition of Covis Pharma Commercial Assets for US$1.2 Billion
TORONTO, ONT. April, 21, 2015 - Concordia Healthcare Corp. (Concordia or the Company) (TSX: CXR) (OTCQX: CHEHF), a diverse healthcare company focused on legacy pharmaceutical products and orphan drugs, today announced that it has completed the previously announced acquisition by the Company of 18 products, being comprised of 12 branded products and five authorized generic contracts and a product distributed by a third party in Australia pursuant to the terms of a distribution agreement, from Covis Pharma S.à.r.l and Covis Injectables, S.à.r.l (collectively, Covis) for $1.2 billion in cash (the Acquisition). All financial references are in U.S. dollars unless otherwise noted.
The portfolio of products we acquired from Covis feature stable revenue, strong margins and free cash flow, said Mark Thompson, CEO of Concordia. These asset attributes strengthen our financial base, which should support our plans to continue building Concordia through organic growth and potentially more accretive, disciplined acquisitions.
The distinctive product portfolio Concordia has acquired includes branded pharmaceuticals, injectables and authorized generics that address life threatening and other serious medical conditions in various therapeutic areas including cardiovascular, central nervous system, oncology and acute care markets.
Key products are Nilandron ® , for the treatment of metastatic prostate cancer; Dibenzyline ® , for the treatment of pheochromocytoma; Lanoxin ® , for the treatment of mild-to-moderate heart failure and atrial fibrillation; and, Plaquenil ® , for the treatment of lupus and rheumatoid arthritis.
The Acquisition was structured as an all-cash transaction with a purchase price of $1.2 billion. The Company paid for the Acquisition through a mix of term loans, bonds and equity (as further described below). RBC Capital Markets acted as financial advisor to Concordia on the Acquisition.
Senior Notes due 2023
In connection with the Acquisition, Concordia also closed its previously announced private offering of $735,000,000 of its 7.00% Senior Notes due 2023 (the Notes). The Notes were priced at an issue price of 100.00% of their face amount to yield 7.00%.
The Notes were offered and sold to qualified institutional buyers pursuant to Rule 144A under the Securities Act of 1933, as amended (the Securities Act), and to certain non-U.S. persons, including persons resident in Canada, in accordance with Regulation S under the Securities Act and other applicable securities laws. The Notes will not be registered under the Securities Act or the securities laws of any state or any other jurisdiction and may not be offered or sold in the United States absent an effective registration statement or an applicable exemption from the registration requirements under the Securities Act and applicable state securities laws and foreign securities laws. Any offer or sale of the Notes in
Canada was made on a private placement basis in a manner that was exempt from the prospectus requirements of applicable Canadian securities laws.
The net proceeds of the offering of the Notes were used to partially fund (i) the purchase price for the Acquisition; and (ii) the fees and expenses incurred in connection with the Acquisition.
Equity Offering
On April 8, 2015, Concordia announced the closing of its short form prospectus offering, on a bought deal basis, of 4,329,428 subscription receipts (Subscription Receipts) of the Company, which included the exercise by the Underwriters (as defined below) of an over-allotment option of 15%, for aggregate gross proceeds of C$368,001,380 (the Offering). The Offering was completed at a price per Subscription Receipt of C$85.00 by a syndicate of underwriters led by RBC Capital Markets, as sole bookrunner and co-lead manager, and including GMP Securities L.P., as co-lead manager, and TD Securities Inc. (collectively, the Underwriters). Upon closing of the Offering, the Underwriters received payment for their expenses and 50% of their commission under the Offering. Upon closing of the Acquisition each holder of Subscription Receipts automatically received, without payment of additional consideration or further action, one Concordia common share in exchange for each Subscription Receipt held. It is expected that the Subscription Receipts will cease trading on or about the closing of the Acquisition and the underlying Concordia common shares will commence trading shortly thereafter.
Pursuant to the agreement governing the Subscription Receipts, certain proceeds from the Offering which had been held in escrow have been released from escrow on behalf of Concordia to fund a portion of the purchase price for the Acquisition and pay the balance of the Underwriters commission under the Offering. Sufficient funds to pay a dividend equivalent amount equal to $0.075 per Subscription Receipt (less applicable withholding taxes, if any), as a result of the dividends declared on each Common Share by Concordia with a record date of April 15, 2015, will continue to be held in escrow. Funds to pay such dividend equivalent amount will be released from escrow and paid concurrent with the payment of the Companys dividend to all holders of Common Shares on April 30, 2015. Any funds in excess of the amount required to satisfy the dividend equivalent amount will be remitted to the Company once such dividend equivalent amount is paid to the former holders of Subscription Receipts.
Credit Facility
Concurrent with the closing of the Acquisition, Concordia announced that it entered into a credit agreement (Credit Agreement) dated April 21, 2015, by and among the Company, certain of the Companys subsidiaries, the Royal Bank of Canada, Morgan Stanley Senior Funding, Inc., TD Securities (USA) LLC, GE Capital Markets, Inc., Fifth Third Bank and certain lenders party thereto (collectively, the Lenders). Pursuant to the terms of the Credit Agreement, the Lenders agreed to provide senior secured credit facilities in an aggregate principal amount of up to $700 million comprising: (i) a senior secured revolving credit facility (the Revolving Facility) in an aggregate principal amount of up to $125 million; and (ii) a senior secured term loan facility (the Term Facility) in an aggregate principal amount of $575 million (together, the Bank Facilities). All obligations of the Company under the Bank Facilities are guaranteed by all material subsidiaries of the Company and will be secured by first priority (subject to permitted liens) perfected security interests in the assets of the Company and the assets of and equity interests in its material subsidiaries. The Term Facility will mature on the seventh anniversary of the Acquisition date (unless extended by the lenders under the Term Facility) and the Revolving Facility will mature on the fifth anniversary of the Acquisition date (unless extended by the lenders under the Revolving Facility).
The funds made available to the Company under the Term Facility were used to partially fund (i) the purchase price for the Acquisition; (ii) the fees and expenses incurred in connection with the Acquisition; and (iii) the repayment and retirement of the Companys outstanding debt issued pursuant to the terms and provisions of the amended and restated senior secured credit facility with GE Capital Canada Finance Inc. and a syndicate of lenders dated September 30, 2014.
About Concordia
Concordia is a diverse healthcare company focused on legacy pharmaceutical products and orphan drugs. Concordias legacy pharmaceutical division, Concordia Pharmaceuticals Inc., consists of 23 products including Nilandron ® , for the treatment of metastatic prostate cancer; Dibenzyline ® , for the treatment of pheochromocytoma; Lanoxin ® , for the treatment of mild-to-moderate heart failure and atrial fibrillation; Plaquenil ® , for the treatment of lupus and rheumatoid arthritis, Donnatal ® for the treatment of irritable bowel syndrome and Zonegran ® (zonisamide) for treatment of partial seizures in adults with epilepsy.
Concordias specialty healthcare distribution (SHD) division, Complete Medical Homecare, distributes medical supplies targeting diabetes and related conditions.
Concordias orphan drugs division, Concordia Laboratories Inc., manufactures PHOTOFRIN ® . PHOTOFRIN ® is marketed by Pinnacle Biologics, Inc. in the United States.
Concordia operates out of facilities in Oakville, Ontario; Bridgetown, Barbados; Kansas City, Missouri; Chicago, Illinois and Charlottesville, Virginia
Notice regarding forward-looking statements:
This release includes forward-looking statements regarding Concordia and its business, which may include, but are not limited to, statements with respect to the Acquisition, the impact of the Acquisition on Concordias financial performance (including with respect to its revenues), Concordias intentions regarding organic growth and accretive acquisitions, Concordias growth and other factors. Often, but not always, forward-looking statements can be identified by the use of words such as plans, is expected, expects, scheduled, intends, contemplates, anticipates, believes, proposes or variations (including negative and grammatical variations) of such words and phrases, or state that certain actions, events or results may, could, would, might or will be taken, occur or be achieved. Such statements are based on the current expectations of Concordias management, and are based on assumptions and subject to risks and uncertainties. Although Concordias management believes that the assumptions underlying these statements are reasonable, they may prove to be incorrect. The forward-looking events and circumstances discussed in this release may not occur by certain specified dates or at all and could differ materially as a result of known and unknown risk factors and uncertainties affecting Concordia, including risks relating to the use of Concordias products to treat certain diseases, the pharmaceutical industry, the failure to obtain regulatory approvals, risks associated with the acquisition of pharmaceutical products including the Acquisition, economic factors, market conditions, acquisition opportunities, the inability to complete acquisitions, the equity markets generally, risks associated with growth and competition, general economic and stock market conditions and many other factors beyond the control of Concordia. Although Concordia has attempted to identify important factors that could cause actual actions, events or results to differ materially from those described in forward-looking statements, there may be other factors that cause actions, events or results to differ from those anticipated, estimated or intended. No forward-looking statement can be guaranteed. Except as required by applicable securities laws, forward-looking statements speak only as of the date on which they are
made and Concordia undertakes no obligation to publicly update or revise any forward-looking statement, whether as a result of new information, future events, or otherwise.
For more information, please visit www.concordiarx.com or contact:
Adam Peeler
TMX Equicom
416-815-0700 x 225
apeeler@tmxequicom.com
Exhibit 99.32
Concordia Healthcare Corp. Provides Corporate Update
TORONTO February 12, 2015 Concordia Healthcare Corp., (Concordia) (TSX: CXR) (OTCQX: CHEHF), today provided a corporate update on various matters, including its Phase 3 clinical trial to treat a rare form of bile duct cancer.
Concordia enrolls first Korean patient in Phase 3 bile duct cancer trial
Concordia announced today it has enrolled its first patient in its Phase 3 bile duct cancer trial in Korea. The OPUS trial is a global O pen-label, multicenter, randomized Phase 3 S tudy that will evaluate the efficacy and safety of P hotodynamic therapy (PDT) with PHOTOFRIN ® (porfimer sodium) for injection as treatment for U nresectable, advanced perihilar cholangiocarcinoma (CCA) Bismuth type III/IV. Cholangiocarcinoma or bile duct cancer, is a rare disease with a poor prognosis.
The trial is expected to enroll 200 patients from North America, Switzerland, Germany, and South Korea. In addition to sites in North America and Europe, five sites have been initiated in South Korea. Concordia announced in November that Thomas Jefferson University in Philadelphia, PA enrolled the first U.S. patient in the trial.
The global scope of this trial, which extends from South Korea to Europe to the U.S. and Canada, plus the support of all our investigators in moving quickly to qualify sites and begin enrolling patients, is critical to finding what we hope will be an effective treatment for this deadly orphan disease, said Mark Thompson, CEO of Concordia.
Concordias presence in Southeast Asia also includes its recent exclusive trademark license and product distribution agreement with Union Med. Limited (Union), a leader in providing hospitals throughout China with photodynamic therapies for cancerous and non-cancerous tumors. Under the Distribution Agreement, Union will import, clinically develop (if necessary), gain regulatory approval for, distribute, market and sell PHOTOFRIN throughout the Peoples Republic of China, Hong Kong, Macau and Taiwan.
Cholangiocarcinoma is a rare disease with only about 4,000 to 5,000 new cases diagnosed annually in the United States; however it is more prevalent in Southeast Asia, mostly because a parasitic infection that can cause bile duct cancer is much more common there i . Because the bile duct is located deep inside the body, early tumors cannot be seen or felt by healthcare providers during routine physical exams, leading to diagnosis only after symptoms appear and the disease has advanced. There are currently no approved, effective therapies available and as a result, most people with perihilar CCA have about a two percent chance of surviving at least five years ii .
There remains an urgent, unmet need for treatments for individuals diagnosed with bile duct cancer, a rare cancer that is much more prevalent in Southeast Asia than in other parts of the world. The breadth of data collected from study sites in Southeast Asia, plus those in Europe and the U.S., will help differentiate Photodynamic Therapy with PHOTOFRIN as a treatment well-suited to those individuals with rare, hard-to-treat or hard-to-reach cancers, said Young Koog Cheon, M.D., Ph.D., professor, Digestive Disease Center, Konkuk University School of Medicine, Seoul, Korea.
PHOTOFRIN is indicated for the treatment of esophageal cancer, non-small-cell lung cancer and high-grade dysplasia in Barretts esophagus. PHOTOFRIN was granted orphan drug designation (ODD) by the FDA in 2001 for the ablation of High-Grade Dysplasia in Barretts Esophagus in patients who are not considered to be candidates for esophagectomy, in 2004 for cholangiocarcinoma, a rare cancer in the ducts that carry bile from the liver to the small intestine, and in 2011 as adjuvant therapy to surgery for the treatment of malignant pleural mesothelioma.
For additional information about PHOTOFRIN, please see full prescribing information available at www.PHOTOFRIN.com .
About the trial
The U.S. Food and Drug Administration has agreed to allow Concordia to conduct the Phase 3 clinical trial per the conditions agreed to in a special protocol assessment or SPA (ClinicalTrials.gov identifier: NCT02082522). An SPA is an agreement with the FDA that the proposed trial design, clinical endpoints and analyses of results of just one trial are acceptable to support regulatory approval.
Concordia to present at RBC Healthcare Conference
Concordia also announced today that Mark Thompson, Chief Executive Officer, will present at the 2015 RBC Capital Markets Global Healthcare Conference in New York City.
Concordia is scheduled to present at the New York Palace Hotel on February 24, 2015 at 4:05 pm ET.
A webcast of Concordias presentation will be available on the Investors/Events section of the Companys website at www.concordiarx.com.
Notification from the United States Federal Trade Commission (FTC)
Concordia also announced that its subsidiary, Concordia Pharmaceuticals Inc. (CPI), received a civil investigative demand (CID) from the FTC regarding its attention deficit hyperactivity disorder (ADHD) product Kapvay ® . The CID is a request for documents and information regarding CPIs agreements with respect to Kapvay. CPI intends to provide information to the FTC in accordance with the request.
About Concordia
Concordia is a diverse healthcare company focused on legacy pharmaceutical products, orphan drugs, and medical devices for the diabetic population. Concordias legacy pharmaceutical division, Concordia Pharmaceuticals Inc., consists of the following products: ADHD-treatment Kapvay ® (clonidine extended release tablets), Head Lice treatment Ulesfia ® (benzyl alcohol) Lotion, Asthma-related medication
Orapred ODT ® (prednisolone sodium phosphate orally disintegrating tablets), Irritable Bowel Syndrome treatment Donnatal ® (belladonna alkaloids, phenobarbital) and Zonegran ® (zonisamide) for treatment of partial seizures in adults with epilepsy. Concordias specialty healthcare distribution (SHD) division, Complete Medical Homecare, distributes medical supplies targeting diabetes and related conditions. Concordias orphan division, Concordia Laboratories Inc., manufactures PHOTOFRIN. PHOTOFRIN is marketed by Pinnacle Biologics, Inc. in the United States.
Concordia operates out of facilities in Oakville, Ontario; Lenexa, Kansas; Chicago, Illinois; Bridgetown, Barbados; and Charlottesville, Virginia.
Notice regarding forward-looking statements:
This press release includes forward-looking statements regarding Concordia and its business, which may include, but are not limited to, statements with respect to the addition of new sites approved to enroll patients into the clinical trial, the ability to enroll patients into the clinical trial, the ability to obtain necessary approvals, the approval and development of PDT with PHOTOFRIN as a new treatment for certain forms of cancer, the acceleration of product development, the ability, potential and/or effectiveness of PDT with PHOTOFRIN to combat certain forms of cancer, the ability of PHOTOFRIN to provide better treatment options, the ability and/or potential of PDT with PHOTOFRIN to prolong the life of anyone affected by certain forms of cancer, medical community support and requirements for new treatments such as PDT with PHOTOFRIN, the results and/or success of clinical trials, the ability to expand existing sales of Concordias products in certain markets, the receipt of approval to market and distribute Concordias products in certain markets, the outcomes and success of distribution arrangements, market opportunities for Concordias products, statements with respect to the relationship between Concordia and Union, the FTC investigation, the outcomes of the FTC investigation, compliance with applicable laws and other factors. Often, but not always, forward-looking statements can be identified by the use of words such as plans, is expected, expects, scheduled, intends, contemplates, anticipates, believes, proposes or variations (including negative and grammatical variations) of such words and phrases, or state that certain actions, events or results may, could, would, might or will be taken, occur or be achieved. Such statements are based on the current expectations of Concordias management, and are based on assumptions and subject to risks and uncertainties. Although Concordias management believes that the assumptions underlying these statements are reasonable, they may prove to be incorrect. The forward-looking events and circumstances discussed in this release may not occur by certain specified dates or at all and could differ materially as a result of known and unknown risk factors and uncertainties affecting the company, including risks regarding the pharmaceutical industry, regulatory investigations, the failure to comply with applicable laws, the failure to obtain regulatory approvals, risks associated with clinical trials (including, without limitation, in respect of patient enrollment into clinical trials), risks relating to the use of Concordias products to treat certain diseases, risks relating to distribution arrangements, risks relating to the markets in which Concordia operates and/or distributes its products, economic factors, market conditions, the equity markets generally, risks associated with growth and competition and many other factors beyond the control of Concordia. Although Concordia has attempted to identify important factors that could cause actual actions, events or results to differ materially from those described in forward-looking statements, there may be other factors that cause actions, events or results to differ from those anticipated, estimated or intended. No forward-looking statement can be guaranteed. Except as required by applicable securities laws, forward-looking statements speak only as of the date on which they are made and Concordia undertakes no obligation to publicly update or revise any forward-looking statement, whether as a result of new information, future events, or otherwise.
Please visit www.concordiarx.com or contact:
Media:
Molly Watson
Ritz Communications
413-454-3926
molly.watson@ritzcommunications.com
Investors:
Adam Peeler
TMX Equicom
416-815-0700 x 225
apeeler@tmxequicom.com
i | What Are the Key Statistics about Bile Duct Cancer? What Are the Key Statistics about Bile Duct Cancer? American Cancer Society, 1 Nov. 2014. Web. 08 Jan. 2015. |
ii | SEER Stat Fact Sheet: Cancer of the Liver and Intrahepatic Bile Duct (SEER 18 2004-2010, All Races, Both Sexes by SEER Summary Stage 2000). National Cancer Institute. Retrieve 8 January 2015 from http://seer.cancer.gov/statfacts/html/livibd.html |
Exhibit 99.33
Concordia Healthcare Corp. Announces Change to Board of Directors
TORONTO, ONT. December 22, 2014 - Concordia Healthcare Corp. (Concordia or the Company) (TSX: CXR) (OTCQX: CHEHF), a diverse healthcare company focused on legacy pharmaceutical products, orphan drugs, and medical devices for the diabetic population, today announced that Paul Manning has resigned from the Board of Directors of the Company, effective January 2, 2015.
Mr. Manning will remain with the Company in an advisory role.
We are grateful to Paul for his contributions and wish him success in his future endeavors, said Ron Schmeichel, Non-Executive Chairman of the Board.
Mr. Manning served on Concordias Board of Directors since May 15, 2014, when the Company, through its subsidiary, acquired Donnatal ® , an adjunctive therapy in the treatment of irritable bowel syndrome (IBS) and acute enterocolitis, from a privately held specialty pharmaceutical company carrying on business as Revive Pharmaceuticals. Mr. Manning was the founder of Revive Pharmaceuticals.
Donnatals performance has exceeded our expectations and Paul played an important role in the integration of this asset into our diverse and growing portfolio of legacy pharmaceuticals, said Mark Thompson, CEO of Concordia.
The Board of Directors will determine if it is preferable to fill the vacancy before the next annual meeting of shareholders and, if so, will follow established nominating procedures.
About Concordia
Concordia is a diverse healthcare company focused on legacy pharmaceutical products, orphan drugs, and medical devices for the diabetic population. Concordias legacy pharmaceutical division, Concordia Pharmaceuticals Inc., consists of the following products: ADHD-treatment Kapvay ® (clonidine extended release tablets), head lice treatment Ulesfia ® (benzyl alcohol) Lotion, asthma-related medication Orapred ODT ® (prednisolone sodium phosphate orally disintegrating tablets), irritable bowel syndrome treatment Donnatal ® (belladonna alkaloids, phenobarbital) and Zonegran ® (zonisamide) for treatment of partial seizures in adults with epilepsy. Concordias specialty healthcare distribution (SHD) division, Complete Medical Homecare, distributes medical supplies targeting diabetes and related conditions. Concordias orphan drugs division, Concordia Laboratories Inc., manufactures PHOTOFRIN ® . PHOTOFRIN ® is marketed by Pinnacle Biologics, Inc. in the United States.
Concordia operates out of facilities in Oakville, Ontario; Bridgetown, Barbados; Lenexa, Kansas; Chicago, Illinois and Charlottesville, Virginia.
Notice regarding forward-looking statements:
This release includes forward-looking statements regarding Concordia and its business, which may include, but are not limited to, the performance of Concordias assets, the revenue-generating capabilities and/or potential of Concordias assets, Concordias financial strength, the continued and/or expected profitability of Concordias products and/or services, Concordias growth, the acquisition of additional products and/or assets (including orphan drugs and legacy products) and other factors. Often, but not always, forward-looking statements can be identified by the use of words such as plans, is expected, expects, scheduled, intends, contemplates, anticipates, believes, proposes or variations (including negative and grammatical variations) of such words and phrases, or state that certain actions, events or results may, could, would, might or will be taken, occur or be achieved. Such statements are based on the current expectations of Concordias management, and are based on assumptions and subject to risks and uncertainties. Although Concordias management believes that the assumptions underlying these statements are reasonable, they may prove to be incorrect. The forward-looking events and circumstances discussed in this release may not occur by certain specified dates or at all and could differ materially as a result of known and unknown risk factors and uncertainties affecting Concordia, including risks relating to the use of Concordias products to treat certain diseases, the pharmaceutical industry, the failure to obtain regulatory approvals, risks associated with the acquisition of pharmaceutical products, economic factors, market conditions, acquisition opportunities, the inability to complete acquisitions, the equity markets generally, risks associated with growth and competition and many other factors beyond the control of Concordia. Although Concordia has attempted to identify important factors that could cause actual actions, events or results to differ materially from those described in forward-looking statements, there may be other factors that cause actions, events or results to differ from those anticipated, estimated or intended. No forward-looking statement can be guaranteed. Except as required by applicable securities laws, forward-looking statements speak only as of the date on which they are made and Concordia undertakes no obligation to publicly update or revise any forward-looking statement, whether as a result of new information, future events, or otherwise.
For more information, please visit www.concordiarx.com or contact:
Adam Peeler
TMX Equicom
416-815-0700 x 225
apeeler@tmxequicom.com
Exhibit 99.34
|
Collins Barrow Toronto LLP | |
Collins Barrow Place | ||
11 King Street West | ||
Suite 700, Box 27 | ||
Toronto, Ontario | ||
M5H 4C7 Canada | ||
T. 416.480.0160 | ||
F. 416.480.2646 | ||
www.collinsbarrow.com |
May 20, 2015
Ontario Securities Commission
Alberta Securities Commission
British Columbia Securities Commission
The Manitoba Securities Commission
Financial and Consumer Services Commission New Brunswick
Office of the Superintendent of Securities Service Newfoundland and Labrador
Nova Scotia Securities Commission
Office of the Superintendent of Securities Prince Edward Island
Autorité des marchés financiers (Quebec)
Financial and Consumer Affairs Authority of Saskatchewan
PWC Canada LLP
Dear Sir/Mesdames:
RE: Notice of Change of Auditors |
||
Concordia Healthcare Corp. (the Corporation) (the Notice) |
We have read the Notice of Change of Auditor dated May 15, 2015 from the Corporation (the Notice), delivered to us in accordance with National Instrument 51-102 and, based on our knowledge of the information at this time, we agree with each statement contained in the Notice.
Yours very truly,
Licensed Public Accountants
Chartered Professional Accountants
cc: | Board of Directors of the Corporation |
Mark Thompson, President and Chief Executive Officer
Leith Tessy, Chief Financial Officer and Secretary-Treasurer
This office is independently owned and operated by Collins Barrow Toronto LLP The Collins Barrow trademarks are used under License. |
|
|
Exhibit 99.35
May 20, 2015
Ontario Securities Commission
Alberta Securities Commission
British Columbia Securities Commission
The Manitoba Securities Commission
New Brunswicks Financial and Consumer Services Commission
Office of the Superintendent of Securities Services Newfoundland and Labrador
Nova Scotia Securities Commission
Prince Edward Islands Office of the Superintendent of Securities
Autorité des marchés financiers (Quebec)
Financial and Consumer Affairs Authority of Saskatchewan
Collins Barrow Toronto LLP, Chartered Accountants
Dear Sirs/Madames:
We have read the statements made by Concordia Healthcare Corp. in the attached copy of change of auditor notice dated May 15, 2015, which we understand will be filed pursuant to Section 4.11 of National Instrument 51-102.
We agree with the statements in the change of auditor notice dated May 15, 2015.
Yours very truly,
Ross Sinclair
Partner
Audit and Assurance
RS:chk
Encls.
cc: | Board of Directors of Concordia Healthcare Corp. |
Mark Thompson, President and Chief Executive Officer
Leith Tessy, Chief Financial Officer and Secretary Treasurer