0001136261-18-000308.txt : 20181113 0001136261-18-000308.hdr.sgml : 20181113 20181109185803 ACCESSION NUMBER: 0001136261-18-000308 CONFORMED SUBMISSION TYPE: 10-Q PUBLIC DOCUMENT COUNT: 84 CONFORMED PERIOD OF REPORT: 20180930 FILED AS OF DATE: 20181113 DATE AS OF CHANGE: 20181109 FILER: COMPANY DATA: COMPANY CONFORMED NAME: PERNIX THERAPEUTICS HOLDINGS, INC. CENTRAL INDEX KEY: 0001024126 STANDARD INDUSTRIAL CLASSIFICATION: PHARMACEUTICAL PREPARATIONS [2834] IRS NUMBER: 330724736 STATE OF INCORPORATION: MD FISCAL YEAR END: 1231 FILING VALUES: FORM TYPE: 10-Q SEC ACT: 1934 Act SEC FILE NUMBER: 001-14494 FILM NUMBER: 181174408 BUSINESS ADDRESS: STREET 1: 10 NORTH PARK PLACE STREET 2: SUITE 201 CITY: MORRISTOWN STATE: NJ ZIP: 07960 BUSINESS PHONE: (862) 260-8457 MAIL ADDRESS: STREET 1: 10 NORTH PARK PLACE STREET 2: SUITE 201 CITY: MORRISTOWN STATE: NJ ZIP: 07960 FORMER COMPANY: FORMER CONFORMED NAME: GOLF TRUST OF AMERICA INC DATE OF NAME CHANGE: 19961002 10-Q 1 body10q.htm 10-Q Q3 2018 10-Q DOC


UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
Washington, DC 20549

FORM 10-Q

(Mark One)

 

þ

Quarterly report pursuant to section 13 or 15(d) of the Securities Exchange Act of 1934

For the quarterly period ended: September 30, 2018

o

Transition report pursuant to section 13 or 15(d) of the Securities Exchange Act of 1934

For the transition period from: _______ to _____________

001-14494
Commission File Number

PERNIX THERAPEUTICS HOLDINGS, INC.
(Exact name of Registrant as specified in its charter)

Maryland

 

33-0724736

(State or other jurisdiction of incorporation or organization)

 

(I.R.S. Employer Identification Number)

 

10 North Park Place, Suite 201, Morristown, NJ

 

07960

  (Address of principal executive offices) 

 

  (Zip Code)

(800) 793-2145
(Registrant's telephone number, including area code)

Indicate by check mark whether the Registrant (1) has filed all reports required to be filed by Section 13 or 15(d) of the Securities Exchange Act of 1934 during the preceding 12 months (or for such shorter period that the Registrant was required to file such report(s) and (2) has been subject to such filing requirements for the past 90 days. Yes    þ     No    o.

Indicate by check mark whether the Registrant has submitted electronically every Interactive Data File required to be submitted pursuant to Rule 405 of Regulation S-T (§232.405 of this chapter) during the preceding 12 months (or for such shorter period that the registrant was required to submit such files).  Yes    þ    No    o.

Indicate by check mark whether the registrant is a large accelerated filer, an accelerated filer, a non-accelerated filer, a smaller reporting company or an emerging growth company. See the definitions of "large accelerated filer," "accelerated filer," "smaller reporting company" and "emerging growth company" in Rule 12b-2 of the Exchange Act.

Large accelerated filer    o

Accelerated filer    o

Non-accelerated filer    þ

Smaller reporting company    þ

Emerging growth company    o

If an emerging growth company, indicate by check mark if the registrant has elected not to use the extended transition period for complying with any new or revised financial accounting standards provided pursuant to Section 13(a) of the Exchange Act.    o

Indicate by check mark whether the registrant is a shell company (as defined in Rule 12b-2 of the Exchange Act). YES  o    NO  þ

On November 6, 2018, there were 14,505,848 shares outstanding of the Registrant's common stock, par value $0.01 per share.



PERNIX THERAPEUTICS HOLDINGS, INC. AND SUBSIDIARIES

Quarterly Report on Form 10-Q
For the Three and Nine Months Ended September 30, 2018

INDEX

PART I. 

FINANCIAL INFORMATION

 

 

 

 

 

 

 

 

Item 1. 

Financial Statements (unaudited)

 

 

 

 

Condensed Consolidated Balance Sheets

 

 

3

 

 

Condensed Consolidated Statements of Operations

 

 

4

 

 

Condensed Consolidated Statements of Comprehensive (Loss) Gain

 

 

5

 

 

Condensed Consolidated Statements of Stockholders' Equity (Deficit)

 

 

6

 

 

Condensed Consolidated Statements of Cash Flows

 

 

7

 

 

Notes to Condensed Consolidated Financial Statements

 

 

8

 

Item 2. 

Management's Discussion and Analysis of Financial Condition and Results of Operations

 

 

37

 

Item 3.

Quantitative and Qualitative Disclosures About Market Risk

 

 

53

 

Item 4.

Controls and Procedures

 

 

53

 

 

 

 

 

 

 

PART II. 

OTHER INFORMATION

 

 

 

 

 

 

 

 

 

 

Item 1. 

Legal Proceedings

 

 

54

 

Item 1A. 

Risk Factors

 

 

54

 

Item 2. 

Unregistered Sales of Equity Securities and Use of Proceeds

 

 

92

 

Item 3.

Defaults upon Senior Securities

 

 

92

 

Item 4.

Mine Safety Disclosures

 

 

92

 

Item 5.

Other Information

 

 

92

 

Item 6.  

Exhibits

 

 

92

 

 

Signatures

 

 

94

 

 

 

2


PART I.   FINANCIAL INFORMATION

Item 1. Financial Statements.

PERNIX THERAPEUTICS HOLDINGS, INC. AND SUBSIDIARIES
Condensed Consolidated Balance Sheets

(In thousands, except share and per share data)
(Unaudited)

  

      September 30,     December 31,
      2018     2017
Current assets:            
     Cash and cash equivalents   $ 24,511    $ 32,820 
     Accounts receivable, net     66,443      45,317 
     Inventory, net     17,788      5,396 
     Prepaid expenses and other current assets     11,935      8,628 
     Income tax receivable     45      123 
          Total current assets     120,722      92,284 
             
Property and equipment, net     1,000      752 
Goodwill     17,572      12,100 
Intangible assets, net     133,649      96,606 
Other     1,827      2,263 
               Total assets   $ 274,770    $ 204,005 
Liabilities and Stockholders' Deficit            
Current liabilities:            
     Accounts payable   $ 11,302    $ 7,911 
     Accrued personnel expenses     5,181      5,748 
     Accrued allowances     71,698      56,309 
     Other accrued expenses     10,148      6,909 
     Interest payable     6,381      10,612 
     Treximet Secured Notes - current, net         3,664 
     Other liabilities - current     6,901      2,648 
          Total current liabilities     111,611      93,801 
             
Term loan     41,250     
Convertible notes - long-term, net     67,823      65,194 
Exchangeable notes - long-term, net     10,030      7,975 
Delayed draw term loan - long-term, net     37,805      27,248 
Derivative liability     54      93 
Contingent consideration     1,501      1,358 
Treximet Secured Notes - long-term, net     151,364      163,887 
Credit facility     14,185      14,185 
Deferred revenue     10,840     
Arbitration award         2,000 
Other liabilities - long-term     589      2,521 
          Total liabilities     447,052      378,262 
Commitments and contingencies (note 13)            
Stockholders' deficit:            
     Preferred stock, $0.01 par value; 8,500,000 and 10,000,000 shares authorized             
          at September 30, 2018 and December 31, 2017; no shares issued and
          outstanding at September 30, 2018 and December 31, 2017
       
     Series C convertible preferred stock, $0.01 par value, authorized 1,500,000 shares;             
          81,000 shares issued and outstanding at September 30, 2018        
     Common stock, $0.01 par value, 140,000,000 shares authorized, 13,957,733            
          and 11,841,173 shares issued and outstanding at September 30, 2018 and            
          December 31, 2017, respectively     140      119 
     Additional paid-in capital     274,458      261,158 
     Accumulated other comprehensive loss     85     
     Accumulated deficit     (479,476)     (435,534)
Total Pernix stockholders' deficit     (204,792)     (174,257)
Noncontrolling interests      32,510     
          Total stockholders' deficit     (172,282)     (174,257)
               Total liabilities and stockholders' deficit   $ 274,770    $ 204,005 

See accompanying notes to condensed consolidated financial statements.

3


PERNIX THERAPEUTICS HOLDINGS, INC. AND SUBSIDIARIES
Condensed Consolidated Statements of Operations

(In thousands, except per share data)
(Unaudited)

      Three Months Ended     Nine Months Ended
      September 30,     September 30,
      2018     2017     2018     2017
                         
Net revenues   $ 37,156    $ 40,469    $ 86,383    $ 104,527 
                         
Costs and operating expenses:                        
     Cost of product sales     11,823      10,580      26,353      31,113 
     Selling, general and administrative expense     31,872      20,226      67,412      59,519 
     Research and development expense     1,524      99      1,534      709 
     Depreciation and amortization expense     2,391      18,214      13,686      54,976 
     Change in fair value of contingent consideration         884      143      344 
     Loss from disposal and impairments of assets     75      25      75      25 
     Gain from legal settlement         (10,476)         (10,476)
     Restructuring costs     (2)     (97)     1,212      34 
          Total costs and operating expenses     47,683      39,455      110,415      136,244 
                         
Income (loss) from operations     (10,527)     1,014      (24,032)     (31,717)
                         
Other income (expense):                        
     Interest expense, net     (10,073)     (9,323)     (29,063)     (27,491)
     Gain on sale of assets             446     
     Change in fair value of derivative liability     18      46      39      (38)
     Gain from exchange of debt     137      14,650      137      14,650 
     Foreign currency transaction (loss) gain     (843)         (864)    
          Total other income (expense), net     (10,761)     5,373      (29,305)     (12,879)
                         
Income (loss) before income tax expense     (21,288)     6,387      (53,337)     (44,596)
Income tax expense     61      27      109      122 
Net income (loss)     (21,349)     6,360      (53,446)     (44,718)
Adjust: Net loss attributable to noncontrolling interests      9,504          9,504     
Net income (loss) attributable to common stockholders   $ (11,845)   $ 6,360    $ (43,942)   $ (44,718)
                         
Net income (loss) per common share attributable to common stockholders:                        
     Basic   $ (0.89)   $ 0.57    $ (3.55)   $ (4.31)
     Diluted   $ (0.89)   $ 0.42    $ (3.55)   $ (4.31)
                         
Weighted-average common shares outstanding:                        
     Basic     13,301      11,117      12,377      10,387 
     Diluted     13,301      16,520      12,377      10,387 

  See accompanying notes to condensed consolidated financial statements.

4


PERNIX THERAPEUTICS HOLDINGS, INC. AND SUBSIDIARIES
Condensed Consolidated Statements of Comprehensive Income (Loss)

(In thousands
(Unaudited)

      Three Months Ended     Nine Months Ended
      September 30,     September 30,
      2018     2017     2018     2017
                         
Net income (loss)   $ (21,349)   6,360    $ (53,446)   (44,718)
                         
Other comprehensive income (loss):                        
     Foreign currency translation adjustments     849          849     
     Unrealized gain during period, net of tax of $0 and $0, respectively                 33 
Comprehensive income (loss)     (20,500)     6,369      (52,597)     (44,685)
     Less: Comprehensive income attributable to noncontrolling interests     (764)         (764)    
Comprehensive income (loss) attributable to common stockholders   $ (21,264)   $ 6,369    $ (53,361)   $ (44,685)

  See accompanying notes to condensed consolidated financial statements.

5


PERNIX THERAPEUTICS HOLDINGS, INC. AND SUBSIDIARIES
Condensed Consolidated Statements of Stockholders' Equity (Deficit)

(In thousands)
(Unaudited)

      Series C
Convertible
Preferred Stock
  Common Stock     Additional Paid-In     Treasury     Accumulated     Accumulated
Other
Comprehensive
    Total Pernix
Stockholders'
    Noncontrolling     Total
Stockholders'
      Shares     Amount   Shares     Amount     Capital     Stock     Deficit     Loss     Deficit     interests     Deficit
Balance at December 31, 2016         10,016    100    244,309      (358,393)   (79)   (114,063)     (114,063)
Conversion of restricted stock units           44          (113)                   (112)         (112)
Issuance of Convertible Debt           1,100      11      12,499                  12,510          12,510 
Compensation expense on share-based awards                   2,491                  2,491          2,491 
Net proceeds from sale of shares           681          1,972                  1,979          1,979 
Other comprehensive loss                               79      79          79 
Net loss                           (77,141)         (77,141)         (77,141)
Balance at December 31, 2017           11,841      119      261,158        (435,534)         (174,257)         (174,257)
Capital Contribution - Nalpropion                                       41,250      41,250 
Treximet Secured Notes Conversion     81        1,855      18      11,558                  11,577          11,577 
Conversion of restricted stock units           71          (37)                 (36)         (36)
Compensation expense on share-based awards                   1,328                  1,328          1,328 
Net proceeds from sale of shares           191          451                  453          453 
Other comprehensive loss                               85      85      764      849 
Net loss                           (43,942)         (43,942)     (9,504)     (53,446)
Balance at September 30, 2018     81      13,958    140    274,458      (479,476)   85    (204,792)   32,510    (172,282)

  See accompanying notes to condensed consolidated financial statements.

6


PERNIX THERAPEUTICS HOLDINGS, INC. AND SUBSIDIARIES
Condensed Consolidated Statements of Cash Flows

(In thousands)
(Unaudited)

      Nine Months Ended
      September 30,
      2018     2017
Cash flows from operating activities:            
     Net loss   $ (53,446)   $ (44,718)
     Adjustments to reconcile net loss to net cash used in operating activities:            
          Depreciation     316      277 
          Amortization of intangibles     13,457      54,788 
          Amortization of deferred financing costs     2,839      2,376 
          Accretion expense     3,806      3,837 
          PIK interest      1,409     
          Amortization of acquisition related inventory step-up     2,239     
          Stock compensation expense     1,328      1,935 
          Unrealized foreign currency loss      737     
          Fair market value change in contingent consideration     143      344 
          Fair market value change in derivative liability     (39)     38 
          Gain from legal settlement         (10,476)
          Gain from exchange of debt     (137)     (14,650)
          Impairment of fixed assets      75      25 
          Gain on sale of assets     (446)    
          (Increase) decrease in operating assets, net of effects of acquisitions:            
               Accounts receivable     6,487      2,361 
               Income tax receivable     78      985 
               Inventory     3,556      (355)
               Prepaid expenses and other assets     (3,605)     6,605 
          Increase (decrease) in operating liabilities, net of effects of acquisitions:            
               Accounts payable and accrued expenses     (293)     (2,979)
               Accrued allowances     2,441      (2,707)
               Interest payable     (3,980)     (5,026)
               Other liabilities     (2,360)     (1,878)
                    Net cash used in operating activities     (25,395)     (9,218)
             
Cash flows from investing activities:            
     Acquisition of Orexigen, net of cash acquired     (69,225)    
     Proceeds from sale of non-core assets     446     
     Purchase of software and equipment     (139)     (5)
                    Net cash used in investing activities     (68,918)     (5)
             
Cash flows from financing activities:            
     Nalpropion - Capital Contribution      41,250     
     Proceeds from 2018 Term Loan     41,250     
     Net proceeds from Delayed Draw Term Loan     9,167      30,000 
     Payments on Treximet Secured Notes     (5,373)     (17,511)
     Payments of financing costs     (221)     (13,586)
     Net payments on credit facilities         185 
     Payments on mortgages and capital leases     (38)     (55)
     Proceeds from issuance of common stock, net of tax and costs     453      1,123 
     Shares withheld for the payment of taxes     (37)     (67)
     Stock issuance costs     (549)    
                    Net cash provided by financing activities     85,902      89 
Effect of exchange rate changes on cash and cash equivalents     102     
Net decrease in cash and cash equivalents     (8,309)     (9,134)
Cash and cash equivalents, beginning of period     32,820      36,375 
Cash and cash equivalents, end of period   $ 24,511    $ 27,241 

See accompanying notes to condensed consolidated financial statements.

7


PERNIX THERAPEUTICS HOLDINGS, INC. AND SUBSIDIARIES
NOTES TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS

(Unaudited)

Note 1. Company Overview

Pernix® Therapeutics Holdings, Inc. and subsidiaries (collectively, Pernix, the Company, we, our and us) is a specialty pharmaceutical company focused on the acquisition, development and commercialization of prescription drugs, primarily for the United States (U.S.) market. The Company is currently focused on the therapeutic areas of pain and neurology and has an interest in expanding into additional specialty segments. The Company promotes its branded products to health care professionals through its Pernix sales force and markets its generic portfolio through its wholly owned subsidiaries, Macoven™ Pharmaceuticals, LLC (Macoven) and Cypress Pharmaceuticals®, Inc. (Cypress).

The Company's branded products include Zohydro® ER with BeadTek® (Zohydro ER), an extended-release opioid agonist indicated for the management of pain severe enough to require daily, around-the-clock, long-term opioid treatment and for which alternative treatment options are inadequate, Treximet® a medication indicated for the acute treatment of migraine attacks with and without aura, and Silenor® a non-controlled substance and approved medication for the treatment of insomnia characterized by difficulty with sleep maintenance.

Subsequent Events

Departure of Angus Smith, Senior Vice President, Chief Business Officer and Principal Financial Officer

On October 26, 2018, Angus Smith notified the Company of his decision to resign as the Company's Senior Vice President, Chief Business Officer and Principal Financial Officer, effective as of November 23, 2018 (the "Effective Date"), to pursue other opportunities. Mr. Smith will continue in his current role through the Effective Date to assist with the transition of his responsibilities and other related matters.

The Company has designated Glenn Whaley, the Company's Vice President of Finance, Principal Accounting Officer and Corporate Controller, as principal financial officer of the Company to succeed Mr. Smith, effective as of the Effective Date. As of the Effective Date, Mr. Whaley's title will be Vice President of Finance, Principal Financial and Accounting Officer.

Nasdaq Deficiency Notices

On October 17, 2018, the Company received notice (the Minimum Market Value of Publicly Held Shares Notice) from the Nasdaq Stock Market LLC (Nasdaq) that the Company is not currently in compliance with the $15 million minimum market value of publicly held shares requirement of Nasdaq Listing Rule 5450(b)(3)(C). The Minimum Market Value of Publicly Held Shares Notice indicated that, consistent with Nasdaq Listing Rule 5810(c)(3)(D), the Company has until April 15, 2019 to regain compliance with the minimum market value of publicly held shares requirement by having the closing market value of publicly held shares, calculated by multiplying the closing bid price of the Company's common stock (Common Stock) by the Company's total shares outstanding (less any shares held by officers, directors or beneficial owners of 10% or more of the total shares outstanding ), meet or exceed $15 million for at least ten consecutive business days.

On October 19, 2018, the Company received notice (the Minimum Bid Price Notice) from Nasdaq that the Company is not currently in compliance with the $1.00 minimum closing bid price requirement of Nasdaq Listing Rule 5450(a)(1). The Minimum Bid Price Notice indicated that, consistent with Nasdaq Listing Rule 5810(c)(3)(A), the Company has until April 17, 2019 to regain compliance with the minimum bid price requirement by having the closing bid price of the Common Stock meet or exceed $1.00 per share for at least ten consecutive business days. If the Company does not regain compliance with the minimum bid price requirement by April 17, 2019, the Company may be eligible to transfer the listing of the Common Stock from the Nasdaq Global Market to the Nasdaq Capital Market if, at the time of such transfer, the Company meets the initial listing requirement for market value of publicly held shares ($1 million) and all other initial listing standards for the Nasdaq Capital Market (except for the minimum bid price requirement) and provides Nasdaq with written notice of its intention to cure the minimum bid price requirement deficiency. In response, Nasdaq may provide the

8


Company with an additional 180 day period to satisfy the minimum bid price requirement. However, if it appears to the Nasdaq staff that the Company will not be able to cure the deficiency, or if the Company is otherwise not eligible, Nasdaq will provide notice to the Company that the Common Stock will be subject to delisting pursuant to Nasdaq's delisting procedures.

The notices do not result in the immediate delisting of the Common Stock from the Nasdaq Global Market. If the Common Stock is delisted from the Nasdaq Global Market, the holders of the Convertible Notes (as defined in Note 10 below) and the Exchangeable Notes (as defined in Note 10 below) would have the right to require the Company (in the case of the Convertible Notes) or Pernix Ireland Pain Designated Activity Company (PIP DAC) (in the case of the Exchangeable Notes) to repurchase all of the Convertible Notes and Exchangeable Notes owned by such holders at a price equal to 100% of the principal amount thereof, plus any accrued and unpaid interest thereon, within 35 business days following the Company or PIP DAC giving notice to such holders of the delisting. The Company's or PIP DAC's failure to pay such amounts when due would result in a default under the indentures governing the Convertible Notes or the Exchangeable Notes, as the case may be, which would ripen into an event of default immediately under the indenture governing the Convertible Notes, and within five days of becoming due under the indenture governing the Exchangeable Notes. Further, an event of default under either of these indentures would result in a cross-default under the Delayed Draw Term Loan (as defined in Note 10 below) as well as the ABL Facility (as defined in Note 10 below), which could result in indebtedness outstanding under those instruments to become immediately due and payable. In addition, any acceleration of the debt under the Convertible Notes, the Exchangeable Notes, the Delayed Draw Term Loan or the ABL Facility would trigger an event of default under the indenture governing the Treximet Secured Notes (as defined in Note 10 below), which could result in such indebtedness becoming immediately due and payable.

Going Concern

As of October 17, 2018, the Company was not in compliance with certain Nasdaq Global Market listing requirements. The Company's outstanding 4.25% Convertible Notes (as defined in Note 10 below) in the principal amount of $78.2 million that contain redemption features in the event the Company was not able to maintain its Nasdaq Global Market listing. In addition, the Company's outstanding Exchangeable Notes (as defined in Note 10 below) in the principal amount of $36.1 million contain redemption features in the event the Company is not able to maintain any Nasdaq listing. These factors raise substantial doubt about the ability of the Company to continue as a going concern within one year after the date that these financial statements are issued. The Company continues to seek other sources of capital and alternatives. However, if the Company is unable to raise sufficient capital or maintain its Nasdaq listing to prevent the redemption of its outstanding indebtness, the Company will not have sufficient liquidity to fund its business operations for at least the next year following the date that the financial statements are issued. The financial statements do not include any adjustments relating to the recoverability and classification of recorded asset amounts or the amounts and classification of liabilities that might be necessary should the Company be unable to continue as a going concern.

Conversion of 0% Series C Perpetual Convertible Preferred Stock

On October 3, 2018, holders of 13,100 shares of the Company' 0% Series C Perpetual Convertible Preferred Stock (Convertible Preferred Stock) elected to convert such Convertible Preferred Stock into 548,115 shares of the Common Stock (see note 11, Stockholders' Equity).

Note 2. Basis of Presentation and Summary of Significant Accounting Policies

Basis of Presentation

The accompanying unaudited condensed consolidated financial statements included herein have been prepared by the Company in accordance with generally accepted accounting principles in the United States (GAAP) and under the rules and regulations of the United States Securities and Exchange Commission (SEC) for interim reporting. In management's opinion, the interim financial data presented includes all adjustments (consisting solely of normal recurring items) necessary for fair presentation. All intercompany accounts and transactions have been eliminated. Certain information required by GAAP has been condensed or omitted in accordance with rules and regulations of the SEC. Operating results for the three and nine months ended September 30, 2018 are not necessarily indicative of the results that may be expected for any future period or for the year ending December 31, 2018.

9


These unaudited condensed consolidated financial statements should be read in conjunction with the Company's audited consolidated financial statements and the notes thereto for the year ended December 31, 2017, included in Pernix's 2017 Annual Report on Form 10-K filed with the SEC.

The preparation of the unaudited condensed consolidated financial statements requires management to make estimates and assumptions relating to reporting of the assets and liabilities and the disclosure of contingent assets and liabilities to prepare these unaudited condensed consolidated financial statements and the reported amounts of revenues and expenses during the reporting period in conformity with GAAP. Significant estimates of the Company include: revenue recognition, sales allowances such as returns on product sales, government program rebates, customer coupon redemptions, wholesaler/pharmacy discounts, product service fees, rebates and chargebacks, sales commissions, amortization, stock-based compensation, the determination of fair values of assets and liabilities in connection with business combinations, and deferred income taxes. Actual results could differ from these estimates.

Certain prior period amounts have been reclassified to conform to the current period presentation including reclassifying capitalized debt issuance costs of approximately $1.5 million from "Prepaid expenses and other current assets" to the Company's long-term debt instruments within "Total liabilities" except for those related to revolving credit facilities. This reclassification had no effect on previously reported results of operations, financial position or cash flows.

Principles of Consolidation

The unaudited condensed consolidated financial statements include the accounts of the Company, its wholly owned subsidiaries, and variable interest entities (VIEs) for which the Company is the primary beneficiary. All significant intercompany balances and transactions have been eliminated in consolidation.

The Company evaluates its ownership, contractual, and other interests in entities that are not wholly owned to determine if these entities are VIEs, and, if so, whether the Company is the primary beneficiary of the VIE. In determining whether the Company is the primary beneficiary of a VIE and therefore required to consolidate the VIE, a qualitative approach is applied that determines whether the Company has both (1) the power to direct the activities of the VIE that most significantly impact the VIE's economic performance and (2) the obligation to absorb losses of, or the rights to receive benefits from, the VIE that could potentially be significant to that VIE. The Company will continuously assess whether it is the primary beneficiary of a VIE as changes to existing relationships or future transactions may result in the consolidation or deconsolidation of such VIE. During the three and nine months ended September 30, 2018, the Company's consolidated VIE includes Nalpropion™ Pharmaceuticals Inc. (Nalpropion), and the Company remains the primary beneficiary of Nalpropion (see note 4, Variable Interest Entity). The equity of Nalpropion held by investors other than the Company are treated as a noncontrolling interest in the condensed consolidated financial statements.

Recently Adopted Accounting Pronouncements

In May 2014, the Financial Accounting Standards Board (FASB) issued Accounting Standards Update (ASU) No. 2014-09, Revenue from Contracts with Customers (Topic 606) which supersedes nearly all existing revenue recognition guidance. Effective January 1, 2018, the Company adopted ASU No. 2014-09, Revenue from Contracts with Customers (ASC 606) and all the related amendments (new revenue standard) to all contracts using the modified retrospective method. No material differences were identified as compared to the Company's historical revenue recognition accounting and accordingly, the Company did not recognize a cumulative effect of applying the new revenue standard as an adjustment to the opening balance of retained earnings. The comparative information has not been restated and continues to be reported under the accounting standards in effect for those periods. The Company does not expect the adoption of the new revenue standard to have a material impact to the Company's net income on an ongoing basis.

The Company's new revenue recognition policy is as follows:

Revenue is recognized upon transfer of control of promised products or services to customers in an amount that reflects the consideration the Company expects to receive in exchange for those products or services. The Company generally enters into contracts to sell approved branded and generic pharmaceutical drugs.

10


  • Product Sales
  • Product sales revenue is recognized at the estimated consideration to be received when control has transferred to the customer, which is typically on delivery to the customer or, in the case of products that are subject to consignment agreements, when the customer removes product from the Company's consigned inventory location for shipment directly to a patient. Payment terms vary by customer and the products or services offered and is generally required in a term ranging from 30 to 90 days from date of shipment or satisfaction of the performance obligation.

  • Significant Judgments
  • Product sales contracts provide the customer with the right to return the product and also provide for a variety of discounts and allowances including, specialty distributor fees, wholesaler fees, prompt payment discounts, government rebates, government chargebacks, coupon programs and rebates under managed care plans which are accounted for as variable consideration. Returns are estimated through comparison of historical return data to their related sales on a production lot basis. Historical rates of return are determined for each product and are adjusted for known or expected changes in the marketplace specific to each product, when appropriate.

    Judgment is required to estimate the appropriate adjustments for variable consideration which is based on sales or invoice data, contractual terms, historical utilization rates, new information regarding changes in these programs regulations and guidelines that would impact the amount of the actual rebates, the Company's expectations regarding future utilization rates for these programs and channel inventory data.

  • Contract Balances
  • The timing of customer invoicing generally does not differ from the timing of revenue recognition. The Company records provisions for returns, specialty distributor fees, wholesaler fees, government rebates, coupon programs and rebates under managed care plans are included within current liabilities in the Company's consolidated balance sheets. Provision for prompt payment discounts are generally shown as a reduction in accounts receivable.

In May 2017, the FASB issued ASU 2017-09, Compensation-Stock Compensation (Topic 718): Scope of Modification Accounting, (ASU 2017-09). ASU 2017- 09 provides clarity and reduces both (1) diversity in practice and (2) cost and complexity when applying the guidance in Topic 718, to a change to the terms or conditions of a share-based payment award. ASU 2017-09 is effective for the interim and annual periods beginning after December 15, 2017. The Company adopted the provisions of ASU 2017-09 as of January 1, 2018. There was no material impact on the Company's condensed consolidated financial statements resulting from the adoption of this guidance.

In January 2017, the FASB issued ASU 2017-01, Business Combinations (Topic 805): Clarifying the Definition of a Business, which changes the definition of a business to assist entities with evaluating when a set of transferred assets and activities is deemed to be a business. Determining whether a transferred set constitutes a business is important because the accounting for a business combination differs from that of an asset acquisition. The definition of a business also affects the accounting for dispositions. Under the new standard, when substantially all of the fair value of assets acquired are concentrated in a single asset, or a group of similar assets, the assets acquired would not represent a business and business combination accounting would not be required. The new standard may result in more transactions being accounted for as asset acquisitions rather than business combinations. The standard is effective for interim and annual periods beginning after December 15, 2017 and shall be applied prospectively. The Company adopted ASU 2017-01 as of January 1, 2018, and there was no material impact on the Company's condensed consolidated financial statements resulting from the adoption of this guidance.

In August 2016, the FASB issued ASU 2016-15 Statement of Cash Flows - Classification of Certain Cash Receipts and Cash Payments, which provides updated guidance on eight classification issues related to the statement of cash flows: debt prepayments and extinguishment costs, settlement of zero-coupon bonds, contingent consideration payments made after a business combination, proceeds from the settlement of insurance claims, proceeds from the settlement of corporate-owned life insurance policies, distributions received from equity method investees, beneficial interests in securitization transactions and separately identifiable cash flows and application of the predominance principle. ASU 2016-15 is effective for interim and annual periods beginning after December 15, 2017. The Company adopted the provisions of ASU 2016-15 as of January 1, 2018. There was no material impact on the Company's results of operations resulting from the adoption of this guidance.

11


In January 2016, the FASB issued ASU 2016-01, Financial Instruments-Overall (Subtopic 825-10): Recognition and Measurement of Financial Assets and Financial Liabilities. The accounting standard primarily affects the accounting for equity investments, financial liabilities under the fair value option, and the presentation and disclosure requirements for financial instruments. In addition, it includes a clarification related to the valuation allowance assessment when recognizing deferred tax assets resulting from unrealized losses on available-for-sale debt securities. The accounting guidance is effective for annual reporting periods (including interim periods within those periods) beginning after December 15, 2017. The Company adopted ASU 2016-01 as of January 1, 2018, and there was no material impact on the Company's condensed consolidated financial statements resulting from the adoption of this guidance.

Recently Issued Accounting Standards, Not Adopted as of September 30, 2018

In August 2018, the FASB issued ASU No. 2018-13, Fair Value Measurement (Topic 820) - Disclosure Framework - Changes to the Disclosure Requirements for Fair Value Measurement, which is designed to improve the effectiveness of disclosures by removing, modifying and adding disclosures related to fair value measurements. ASU No. 2018-13 is effective for fiscal years beginning after December 15, 2019, including interim periods within those fiscal years; the ASU allows for early adoption in any interim period after issuance of the update. The Company is currently assessing the impact this ASU will have on its consolidated financial statements.

In March 2018, the FASB issued ASU No. 2018-05, Income Taxes (Topic 740): Amendments to SEC Paragraphs Pursuant to SEC Staff Accounting Bulletin No. 118 which allowed SEC registrants to record provisional amounts in earnings for the year ended December 31, 2017 due to the complexities involved in accounting for the enactment of the U.S. Tax Cuts and Jobs Act (TCJA) on December 22, 2017. The Company continues to analyze the TCJA, see Note 12, Income taxes for more information.

In February 2016, the FASB issued ASU no. 2016-02, Leases, which requires lessees to recognize assets and liabilities on the balance sheet for the rights and obligations created by all leases with terms of more than 12 months. The leasing standard will be effective for calendar year-end public companies beginning after December 15, 2018, and interim periods within those fiscal years. In July 2018, the FASB issued additional authoritative guidance providing companies with an optional prospective transition method to apply the provisions of this guidance. The Company will adopt the standard in the first quarter of 2019 and elect this transition method to apply the standard prospectively. While the Company is currently evaluating the impact of adoption of this ASU, the adoption is expected to result in a material increase in the assets and liabilities recorded on the condensed consolidated balance sheets.

Management does not believe that any other recently issued, but not yet effective, accounting standards if currently adopted would have a material effect on the Company's consolidated financial statements.

Significant Customers

The Company's customers consist of drug wholesalers, specialty pharmacies, retail drug stores, mass merchandisers and grocery store pharmacies in the United States. The Company primarily sells its products directly to large national drug wholesalers, which in turn resell the products to smaller or regional wholesalers, retail pharmacies, chain drug stores, and other third parties. The following tables list the Company's customers that individually comprised greater than 10% of total gross product sales for the three and nine months ended September 30, 2018 and 2017, or 10% of total accounts receivable as of September 30, 2018 and December 31, 2017.

      Three Months Ended     Nine Months Ended
      September 30,     September 30,
      2018     2017     2018     2017
                         
McKesson Corporation     39%     35%     35%     34%
AmerisourceBergen Drug Corporation     26%     29%     26%     30%
Cardinal Health, Inc.     25%     23%     24%     24%
     Total     90%     87%     85%     88%

12


Accounts Receivable, net:            
      September 30,     December 31,
      2018     2017
             
McKesson Corporation     37%     29%
Cardinal Health, Inc.     29%     31%
AmerisourceBergen Drug Corporation     27%     27%
     Total     93%     87%

Note 3. Business Combinations/Divestitures

Closing of Transactions Regarding Worldwide Rights to Contrave® (naltrexone HCl / bupropion HCl)

On April 17, 2018, PIP DAC entered into a commitment letter (the Commitment Letter) pursuant to which PIP DAC committed to provide Nalpropion with $7.5 million in debt and/or equity capital to fund Nalpropion's purchase of certain assets of Orexigen® Therapeutics, Inc. (Orexigen) on the terms and conditions contained in the Commitment Letter. Nalpropion is a special purpose vehicle jointly owned by PIP DAC and certain other co-investors. Nalpropion submitted a "stalking horse" bid to purchase certain assets of Orexigen, which filed a voluntary petition for relief under Chapter 11 of Title 11 of the United States Code, 11 U.S.C. §§ 101, et seq. in the United States Bankruptcy Court for the District of Delaware. On June 22, 2018, the Company announced that no other bids for Orexigen's assets were received by the court-approved bid deadline and, on July 27, 2018, Nalpropion acquired substantially all of the assets of Orexigen, including worldwide rights to Contrave® (Contrave), a prescription-only weight loss medication (the Orexigen Acquisition). The purchase price for the Orexigen Acquisition was $73.5 million with $5 million held back to cover potential indemnification claims. The Company, through PIP DAC, received two purchase options that will enable it to acquire up to 49.9% and 100% of Nalpropion at specified time periods and purchase prices.

Nalpropion financed the Orexigen acquisition utilizing capital sourced from PIP DAC and certain other co-investors, including the full amount of borrowing available, from its 2018 Term Loan facility as defined and as discussed in Note 10. PIP DAC provided capital of $7.35 million, and an incremental $1.82 million for working capital requirements via its existing delayed draw term loan facility, which is structured as a 50% loan and 50% equity contribution to Nalpropion. The co-investors contributed $66.15 million and an incremental $16.35 million for working capital requirements, which was structured as a 50% loan and 50% equity contribution to Nalpropion. PIP DAC and certain affiliates of the co-investors are lenders to Nalpropion under its 2018 Term Loan (see Note 10, Debt and Lines of Credit).

As Nalpropion qualifies as a VIE based on its governance structure and contractual relationship with the Company, the Company will therefore consolidate Nalpropion in its condensed consolidated financial statements since the Company has the power to direct activities that most significantly impact Nalpropion's economic performance (see Note 4, Variable Interest Entity). The Orexigen Acquisition has been accounted for as a business combination using the acquisition method of accounting under the provisions of Accounting Standards Codification ("ASC") 805, Business Combinations by Nalpropion.

Fair Value of Consideration Transferred

The following table indicates the consideration transferred to effect the Orexigen Acquisition:

      Preliminary
      Purchase
      Price
      Allocation
Cash consideration   $ 68,500 
Holdback     5,000 
Total consideration transferred   $ 73,500 

13


Assets Acquired and Liabilities Assumed

The following table summarizes the estimated fair values of the assets acquired and liabilities assumed as of the acquisition date. The following recognized amounts are provisional and subject to change:

  • amounts for intangible assets, property and equipment, certain liabilities, and other working capital balances pending finalization of the valuation; and

  • amount of goodwill pending the completion of the valuation of the assets acquired and liabilities assumed.
      Amounts
      Recognized
      as of the
      Acquisition
      Date
Cash and cash equivalents   $ 730 
Accounts receivable     27,700 
Inventory (a)     18,219 
Prepaids and other current assets      344 
Property and equipment     426 
Intangible assets (b)     50,500 
Goodwill (c)     5,472 
Accounts payable     (1,097)
Accrued allowances     (13,574)
Accrued personnel expense     (841)
Other liabilities - current     (1,877)
Deferred revenue     (12,502)
    $ 73,500 

_________________________

(a)

Includes an estimated fair value step-up adjustment to inventory of $5.6 million.

(b)

The following table summarizes the preliminary amounts and useful lives assigned to identifiable intangible assets:

 

      Preliminary      
      Intangible     Estimated
      Asset     Useful
      Valuation     Life
Acquired developed technologies   $ 44,800      10 years
Tradenames     4,800      12 years
Other     900      5 years
    $ 50,500       

 

(c)

Goodwill is calculated as the difference between the acquisition date fair value of the consideration transferred and the values assigned to the assets acquired and liabilities assumed. None of the goodwill is expected to be deductible for tax purposes. The goodwill recorded represents the following:

  • cost savings and operating synergies expected to result from utilizing the Company's shared services;
  • intangible assets that do not qualify for separate recognition (for instance, assembled workforce) and the residual amount paid not allocated to other net assets acquired.

Nalpropion will finalize these amounts as it obtains the information necessary to complete the measurement process. Any changes resulting from facts and circumstances that existed as of the acquisition date may result in retrospective adjustments to the provisional amounts recognized at the acquisition date. These changes could be significant. Nalpropion will finalize these amounts no later than one year from the acquisition date. To date, Nalpropion has incurred $3.9 million in transaction costs directly related to the Orexigen Acquisition, which includes expenditures for advisory, legal, valuation, accounting and other similar services. These costs have been expensed as acquisition-related costs and is included in selling, general and administrative expenses.

Pro Forma Information

The following table represents the consolidated financial information for the Company on a pro forma basis, assuming that the Orexigen Acquisition occurred as of January 1, 2017. The historical financial information has been adjusted to give effect to pro forma items that are directly attributable to the Orexigen Acquisition and are expected to have a continuing impact on the consolidated results. These items include, among others, adjustments to record the amortization of definite-lived intangible assets and interest expense. Additionally, the following table sets forth unaudited financial information and has been compiled from historical financial statements and other information, but is not necessarily indicative of the results that actually would have been achieved had the transactions occurred on the dates indicated or that may be achieved in the future.

14


      Three Months Ended     Nine Months Ended
      September 30,     September 30,
      2018     2017     2018     2017
Net revenues   $ 40,868    $ 59,372    $ 132,572    $ 165,931 
Net income (loss) attributable to Pernix     (22,371)     4,372      (59,890)     (55,574)
                         
Net income (loss) per share attributable to Pernix:                        
Basic   $ (1.68)   $ 0.39    $ (4.84)   $ (5.35)
Diluted   $ (1.68)   $ 0.30    $ (4.84)   $ (5.35)

Sale of Non-Core Assets

On May 29, 2018, the Company received proceeds of $446,000 from the sale of certain obsolete equipment and was recorded as a Gain on sale of assets line in the unaudited condensed consolidated statements of operations for the nine months ended September 30, 2018.

On November 6, 2017, the Company announced the sale of a non-core product, Cedax (ceftibuten capsules and ceftibuten for oral suspension), a third-generation cephalosporin antibiotic for the treatment of acute bacterial exacerbations of chronic bronchitis and middle ear infection, to SI Pharmaceuticals, LLC, for $2.0 million in gross cash proceeds. Cedax was discontinued by Pernix in 2016 and the Company did not generate any sales from this product in 2017.

Note 4. Variable Interest Entity

The Company evaluates its investment in Nalpropion in accordance with the variable interest model to determine whether it has a controlling financial interest in an investment. This evaluation is made as of the date on which the Company makes its initial investment, and subsequent evaluations are made if the structure of the investment changes. If the Company determines that Nalpropion is a VIE, then the Company evaluates whether Nalpropion is required to be consolidated. When the Company holds rights that give it the power to direct the activities of an entity that most significantly impact the entity's economic performance, combined with the obligation to absorb an entity's losses or the right to receive benefits, the Company consolidates a VIE. This determination may involve complex and subjective analyses.

As of September 30, 2018, the Company holds a variable interest in Nalpropion, for which the primary beneficiary of the VIE needs to be determined. The Company has concluded, based on its qualitative consideration of the relationship with Nalpropion and by virtue of the management agreement whereby the Company will assume responsibility for product distribution in the United States and managing Nalpropion, that the Company is the primary beneficiary of Nalpropion.

When the Company consolidates a VIE, it discloses the noncontrolling interest of investors other than the Company in its consolidated financial statements.

15


The following items of Nalpropion are included in the Company's condensed consolidated statement of operations for the three and nine months ended September 30, 2018:

    Three Months Ended September 30, 2018
    Pernix     Nalpropion     Eliminations (1)     Total Company
Net revenues incl. related party $ 20,544    $ 17,923    $ (1,311)   $ 37,156 
                       
Costs and operating expenses:                      
     Cost of product sales   6,470      6,664      (1,311)     11,823 
     Selling, general and administrative expense   14,857      17,015      -       31,872 
     Research and development expense       1,522      -       1,524 
     Depreciation and amortization expense   1,434      957      -       2,391 
     Other operating expenses   73      -       -       73 
          Total costs and operating expenses   22,836      26,158      (1,311)     47,683 
                -       -  
Income (loss) from operations   (2,292)     (8,235)     -       (10,527)
                       
Other income (expense):                      
     Interest expense, net   (9,409)     (664)           (10,073)
     Other, net   (83)     (1,661)     1,056      (688)
          Total other income (expense), net   (9,492)     (2,325)     1,056      (10,761)
                       
Income (loss) before income tax expense $ (11,784)   $ (10,560)   $ 1,056    $ (21,288)
                       
(1) Included in Eliminations are transactions Pernix and Nalpropion enter into with one another. Such transactions include the sale of 
     Contrave inventory from Nalpropion to Pernix and elimination of equity in earnings of Nalpropion. 

 

    Nine Months Ended September 30, 2018
    Pernix     Nalpropion     Eliminations (1)     Total Company
Net revenues incl. related party $ 69,771    $ 17,923    $ (1,311)   $ 86,383 
                       
Costs and operating expenses:                      
     Cost of product sales   21,000      6,664      (1,311)     26,353 
     Selling, general and administrative expense   50,397      17,015      -       67,412 
     Research and development expense   12      1,522      -       1,534 
     Depreciation and amortization expense   12,729      957      -       13,686 
     Other operating expenses   1,430      -       -       1,430 
          Total costs and operating expenses   85,568      26,158      (1,311)     110,415 
                       
Income (loss) from operations   (15,797)     (8,235)     -       (24,032)
                       
Other income (expense):                      
     Interest expense, net   (28,399)     (664)     -       (29,063)
     Other, net   363      (1,661)     1,056      (242)
          Total other income (expense), net   (28,036)     (2,325)     1,056      (29,305)
                       
Income (loss) before income tax expense $ (43,833)   $ (10,560)   $ 1,056    $ (53,337)
                       
(1) Included in Eliminations are transactions Pernix and Nalpropion enter into with one another. Such transactions include the sale of 
     Contrave inventory from Nalpropion to Pernix and elimination of equity in earnings of Nalpropion. 

16


The following assets and liabilities of Nalpropion are included in the Company's condensed consolidated balance sheet as of September 30, 2018.

    As of September 30, 2018
    Pernix     Nalpropion     Eliminations (1)     Total Company
Cash and cash equivalents (2) $ 18,202    $ 6,309    $ -     $ 24,511 
Accounts receivable, net (3)   58,907      7,536      -       66,443 
Inventory, net   4,174      13,614      -       17,788 
Related party receivable   5,841      38,305      (44,146)     -  
Other current assets   4,844      7,136      -       11,980 
Property and equipment, net   634      366      -       1,000 
Goodwill   12,100      5,472      -       17,572 
Intangible assets   84,047      49,602      -       133,649 
Investment in VIE   3,528      -       (3,528)     -  
Related party loan   4,584      -       (4,584)     -  
Other assets   1,827      -       -       1,827 
                -       -  
Total assets $ 198,688    $ 128,340    $ (52,258)   $ 274,770 
                       
Accounts payable and other accrued expenses $ 15,775    $ 10,856    $ -     $ 26,631 
Accrued allowances   54,543      17,155      -       71,698 
Interest payable   5,784      597      -       6,381 
Related party payable   38,305      5,841      (44,146)     -  
Other liabilities - current   5,806      1,095      -       6,901 
Long term debt excluding 2018 Term Loan   281,207      -       -       281,207 
2018 Term Loan   -       45,834      (4,584)     41,250 
Deferred revenue   -       10,840      -       10,840 
Other liabilities - long-term   2,144      -       -       2,144 
                       
Total liabilities   403,564    $ 92,218    $ (48,730)   $ 447,052 
                       
Total equity   (204,876)   $ 36,122    $ (36,038)   $ (204,792)
Noncontrolling interest   -       -       32,510      32,510 
                       
Total liabilities and equity $ 198,688    $ 128,340    $ (52,258)   $ 274,770 
                       
                       
(1) Included in Eliminations are transactions Pernix and Nalpropion enter into with one another. Such transactions may include the following:
     •   Operating transactions in accordance with a services agreement between Nalpropion and Pernix.
     •   Elimination of investments in Nalpropion.
     •   Elimination of investments in Nalpropion's earnings.
(2) Approximately $12.2 million of cash and cash equivalents related to Nalpropion is held by Pernix at September 30, 2018.
(3) Approximately $23.5 million of Pernix's accounts receivable, net includes accounts receivables related to sales of Contrave.

Note 5. Earnings per Share

Basic net income (loss) per common share is the amount of net income (loss) for the period divided by the weighted average shares of Common Stock outstanding during the reporting period. Diluted income (loss) per common share is the amount of income (loss) for the period plus interest expense on convertible debt divided by the sum of weighted average shares of Common Stock outstanding during the reporting period and weighted average shares that would have been outstanding assuming the issuance of common shares for all dilutive potential common shares.

17


The following table sets forth the computation of basic and diluted net income (loss) per share (in thousands except per share data):

      Three Months Ended     Nine Months Ended
      September 30,     September 30,
      2018     2017     2018     2017
Numerator:                         
     Net income (loss)   $ (11,845)   $ 6,360    $ (43,942)   $ (44,718)
                         
Denominator - Basic:                        
     Weighted-average common shares     13,301      11,117      12,377      10,387 
                         
Numerator - Diluted:                        
     Net income (loss)   $ (11,845)   $ 6,360    $ (43,942)   $ (44,718)
     Adjustment for interest, net of income tax effect     -       599      -       -  
     Net income (loss), adjusted   $ (11,845)   $ 6,959    $ (43,942)   $ (44,718)
                         
Denominator - Diluted:                        
     Weighted-average common shares     13,301      11,117      12,377      10,387 
     Effect of dilutive securities:                        
          Stock options, Awards and Warrants     -       246      -       -  
          Exchangeable notes     -       5,157      -       -  
     Dilutive potential common shares     -       5,403      -       -  
Weighted-average common shares, diluted     13,301      16,520      12,377      10,387 
                         
Basic income (loss) per share   $ (0.89)   $ 0.57    $ (3.55)   $ (4.31)
Diluted income (loss) per share   $ (0.89)   $ 0.42    $ (3.55)   $ (4.31)

The following table sets forth the potential common shares that could potentially dilute basic income per share in the future that were not included in the computation of diluted income (loss) per share because to do so would have been anti-dilutive for the periods presented (in thousands):

      Three Months Ended     Nine Months Ended
      September 30,     September 30,
      2018     2017     2018     2017
Treximet Secured Notes     27,238      -       27,238      -  
Exchangeable Notes     6,572      -       6,572      1,738 
Converible Preferred Stock     3,389      -       3,389      -  
Stock options and restricted stock units     1,511      370      1,511      562 
4.25% Convertible Notes     682      780      682      1,014 
Warrants         -           33 
Total potential dilutive effect     39,396      1,150      39,396      3,347 

Note 6. Fair Value Measurement

The Company's financial assets and liabilities are measured using inputs from the three levels of the fair value hierarchy. The three levels are as follows:

Level 1- Inputs are unadjusted quoted prices in active markets for identical assets or liabilities that the Company has the ability to access at the measurement date.

Level 2- Inputs are other than quoted prices included within Level 1 that are observable for the asset or liability, either directly or indirectly. Level 2 inputs include quoted prices for similar assets and liabilities in active markets, quoted prices for identical or similar assets or liabilities in markets that are not active, inputs other than quoted prices that are observable for the asset or liability (i.e., interest rates, yield curves, etc.), and inputs that are derived principally from or corroborated by observable market data by correlation or other means (market corroborated inputs).

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Level 3- Inputs are unobservable and reflect the Company's assumptions that market participants would use in pricing the asset or liability. The Company develops these inputs based on the best information available.

Summary of Assets Recorded at Fair Value

The Company's cash equivalents are classified within Level 1 of the fair value hierarchy because they are valued using quoted market prices or broker or dealer quotations for similar assets.

The Company had no financial assets that are required to be measured at fair value as of September 30, 2018 and December 31, 2017.

There were no transfers of assets or liabilities between Level 1 and Level 2 during the three and nine months ended September 30, 2018 and 2017.

The carrying amounts reflected in the unaudited condensed consolidated balance sheets for certain short-term financial instruments including accounts receivable, accounts payable, accrued expenses, and other liabilities approximate fair value due to their short-term nature.

Summary of Liabilities Recorded at Carrying Value and Fair Value

The 4.25% Convertible Notes, Exchangeable Notes, 2018 Term Loan, Delayed Draw Term Loan and the Treximet Secured Notes (each, as defined below in Note 10) are recorded at carrying value. The derivative liability and contingent consideration are recorded at fair value. The fair and carrying value of our debt instruments are detailed as follows (in thousands):

      As of September 30, 2018     As of December 31, 2017
      Fair     Carrying     Fair     Carrying
      Value     Value     Value     Value
4.25% Convertible Notes   $ 33,714    $ 67,823    $ 36,208    $ 65,194 
Exchangeable Notes     13,631      10,030      21,375      7,975 
2018 Term loan     41,250      41,250      -       -  
Delayed draw term loan     36,940      37,805      30,300      27,248 
Derivative liability     54      54      93      93 
Contingent consideration     1,501      1,501      1,358      1,358 
Treximet Secured Notes     132,335      151,364      139,201      167,551 
     Total   $ 259,425    $ 309,827    $ 228,535    $ 269,419 

4.25% Convertible Notes, Exchangeable Notes, 2018 Term Loan and Delayed Draw Term Loan

The fair values of the 4.25% Convertible Notes and the Exchangeable Notes were estimated using the (i) terms of the Convertible Notes and Exchangeable Notes; (ii) rights, preferences, privileges, and restrictions of the underlying security; (iii) time until any restriction(s) are released; (iv) fundamental financial and other characteristics of the Company; (v) trading characteristics of the underlying security (exchange, volume, price, dividend yield and volatility); (vi) prevailing interest rates; and (vii) precedent sale transactions. The fair value was determined using a convertible note model that incorporated these inputs, as the convertible notes are not listed on any securities exchange or quoted on an inter-dealer automated quotation system.

The Delayed Draw Term Loan and the 2018 Term Loan are classified within Level 3 of the fair value measurements hierarchy. The fair value of these instruments has been estimated using a discounted cash flow analysis based on incremental borrowing rate for similar borrowing arrangements. The carrying amount of the Nalpropion's 2018 Term Loan approximates fair value as the interest rate on the debt approximates the estimated borrowing rate currently available to Nalpropion.

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Given the nature and the variable interest rates under the ABL Facility (as defined below), the fair value of borrowings under this facility approximated their carrying value as of September 30, 2018.

Derivative Liability

The derivative liability is classified within Level 3 of the fair value measurements hierarchy and the fair value is determined using a "with and without" conversion scenario. Under this methodology, valuations are performed on the 4.25% Convertible Notes inclusive of all terms as well as for a convertible note that has identical terms and features but excluding the conversion option. The difference between the two valuations is equal to the fair value of the conversion option. Significant increases or decreases in these inputs would result in a significant change in the fair value of the derivative liability.

Contingent Consideration

The contingent consideration is classified within Level 3 of the fair value measurements hierarchy and the fair value is based on two components - a regulatory milestone and commercial milestone.

For the regulatory milestone, the expected regulatory earn out payment was discounted taking into account (a) the Company's cost of debt, (b) the expected timing of the payment and (c) subordinate nature of the earn out obligation.

The fair value of the commercial milestone was determined using a Monte Carlo simulation. This simulation assumed a risk-neutral framework, whereby future net revenue was simulated over the earn out period using the Geometric Brownian Motion. For each simulation path, the earn out payments were calculated based on the achievement of the revenue milestone and then were discounted to the valuation date. Significant increases or decreases in these unobservable inputs and/or the probability of achievement of these milestones would result in a significant change in the fair value of the contingent consideration.

Treximet Secured Notes

The Company's Treximet Secured Notes is classified within Level 3 of the fair value measurements hierarchy and the fair value was estimated using a discounted cash flow model.

Fair Value Measurements Using Significant Unobservable Inputs (Level 3)

For the Company's assets and liabilities measured at fair value on a recurring basis using significant unobservable inputs (Level 3), the following table provides a reconciliation of the beginning and ending balances for each category therein, and gains or losses recognized during the periods (in thousands).

      As of and for the     As of and for the
      Nine Months Ended     Nine Months Ended
      September 30, 2018     September 30, 2017
Derivative liability:            
Balance at beginning of year   93    230 
     Impairment due to partial conversion     -       (90)
     Remeasurement adjustments - loss (gains) included in earnings     (39)     38 
Ending Balance    54    178 
             
Contingent consideration:            
Balance at beginning of year   1,358    2,403 
     Remeasurement adjustments - loss (gains) included in earnings     143      344 
Ending Balance    1,501    2,747 

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Note 7. Inventory

Inventories are stated at the lower of cost or market. Inventories consist of the following (in thousands):

      September 30,     December 31,
      2018     2017
Raw materials   $ 4,297    $ 727 
Work-in-process     2,957      238 
Finished goods     11,524      5,889 
Inventory, gross     18,778      6,854 
Reserve for obsolescence     (990)     (1,458)
     Inventory, net   $ 17,788    $ 5,396 

As of September 30, 2018, $13.6 million of inventory related to the Company's consolidation of Nalpropion as a VIE is included in the Company's unaudited condensed consolidated balance sheets.

Note 8. Goodwill and Intangible Assets

Goodwill consists of the following (in thousands):

      Amount
Balance at December 31, 2016   $ 30,600 
     Impairment     (18,500)
Balance at December 31, 2017     12,100 
     Additions     5,472 
     Impairment     -  
Balance at September 30, 2018   $ 17,572 

The Company performs an impairment test of goodwill annually in the fourth quarter of each fiscal year unless there are triggering events that would require such analysis during an interim period. There were no triggering events during the nine months ended September 30, 2018. For the year ended December 31, 2017, the carrying value of the reporting unit exceeded its fair value by $18.5 million and accordingly an impairment charge of $18.5 million was recorded in 2017. The decline in the estimated fair value of the reporting unit resulted from management's review of its then-current forecast. As a result of this review, management lowered its forecast for Zohydro ER. The lower projected operating results reflected changes in assumptions related to revenue, market trends, cost structure, and other expectations about the anticipated short-term and long-term operating results of the business.

As of September 30, 2018, $5.5 million of goodwill related to the Company's consolidation of Nalpropion as a VIE is included in the Company's unaudited condensed consolidated balance sheets.

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Intangible assets consist of the following (dollars in thousands):

          As of September 30, 2018
      Weighted Average     Gross Carrying           Accumulated     Net Carrying
      Life Remaining     Amount     Impairment     Amortization     Amount
Unamortized intangible assets:                              
     In-process research and development     Indefinite   $ 11,000    $ -     $ -     $ 11,000 
Total unamortized intangible assets           11,000      -       -       11,000 
                               
Amortized intangible assets:                              
     Product licenses     4.8 years     2,846      -       (1,823)     1,023 
     Supplier contracts     2.6 years     583      -       (282)     301 
     Customer Lists     4.8 years     900      -       (32)     868 
     Tradename      11.8 years     4,800      -       (71)     4,729 
     Acquired developed technologies     12.7 years     409,486      -       (293,758)     115,728 
Total amortized intangible assets           418,615      -       (295,966)     122,649 
                               
Total intangible assets         $ 429,615    $ -     $ (295,966)   $ 133,649 

 

          As of December 31, 2017
      Weighted Average     Gross Carrying           Accumulated     Net Carrying
      Life Remaining     Amount     Impairment     Amortization     Amount
Unamortized intangible assets:                              
     In-process research and development     Indefinite   $ 11,000    $ -     $ -     $ 11,000 
Total unamortized intangible assets           11,000      -       -       11,000 
                               
Amortized intangible assets:                              
     Product licenses     5.4 years     2,846      -       (1,623)     1,223 
     Supplier contracts     3.3 years     583      -       (194)     389 
     Acquired developed technologies     13.7 years     364,686      -       (280,692)     83,994 
Total amortized intangible assets           368,115      -       (282,509)     85,606 
                               
Total intangible assets         $ 379,115    $ -     $ (282,509)   $ 96,606 

As of September 30, 2018, the weighted average remaining life for our definite-lived intangible assets in total was approximately 12.5 years.

In process research and development (IPR&D) will be amortized on a straight-line basis over its useful life once the receipt of regulatory approval is obtained.

Estimated amortization expense related to intangible assets with definite lives for each of the five succeeding years and thereafter is as follows (in thousands):

      Amount
2018 (October - December)   $ 2,642 
2019     10,567 
2020     10,480 
2021     10,385 
2022     10,346 
Thereafter     78,229 
Total   $ 122,649 

Amortization expense was $2.3 million and $13.5 million for the three months and nine months ended September 30, 2018, respectively, of which, $29,000 and $88,000 are included in cost of product sales in the unaudited condensed consolidated statements of operations for the three and nine months ended September 30, 2018, respectively.

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Amortization expense was $18.2 million and $54.8 million for the three and nine months ended September 30, 2017, respectively, of which, $30,000 and $88,000 are included in cost of product sales in the unaudited condensed consolidated statements of operations for the three and nine months ended September 30, 2017, respectively

As of September 30, 2018, $49.6 million of intangible assets related to the Company's consolidation of Nalpropion as a VIE is included in the Company's unaudited condensed consolidated balance sheets.

Note 9. Accrued Allowances

Accrued allowances consist of the following (in thousands):

      September 30,     December 31,
      2018     2017
Accrued returns allowance   $ 25,370    $ 21,681 
Accrued price adjustments     22,823      10,766 
Accrued managed care rebates     17,230      17,221 
Accrued government program rebates     6,275      6,641 
     Total   $ 71,698    $ 56,309 

As of September 30, 2018, $17.2 million of accrued allowances related to the Company's consolidation of Nalpropion as a VIE is included in the Company's unaudited condensed consolidated balance sheets.

Note 10. Debt and Lines of Credit

Debt, net of discounts and deferred financing costs, consists of the following (in thousands):

      As of September 30, 2018     As of December 31, 2017
      Principal     Note
Discount
    Deferred
Financing
Costs
    Net of Discount
and Deferred
Financing Costs
    Principal     Note
Discount
    Deferred
Financing
Costs
    Net of Discount
and Deferred
Financing Costs
4.25% Convertible Notes   $ 78,225    $ (8,828)   $ (1,574)   $ 67,823    $ 78,225    $ (11,060)   $ (1,971)   $ 65,194 
Exchangeable Notes     36,145      (22,913)     (3,202)     10,030      35,743      (24,363)     (3,405)     7,975 
Delayed Draw Term Loan     40,074      -       (2,269)     37,805      30,000      -       (2,752)     27,248 
Treximet Secured Notes - Long Term     154,515      -       (3,151)     151,364      166,697      -       (2,810)     163,887 
Treximet Secured Notes - Short Term     -       -       -       -       5,373      -       (1,709)     3,664 
2018 Term Loan     41,250      -       -       41,250      -       -       -       -  
ABL Facility     14,185      -       -       14,185      14,185      -       -       14,185 
     Total outstanding debt   $ 364,394    $ (31,741)   $ (10,196)   $ 322,457    $ 330,223    $ (35,423)   $ (12,647)   $ 282,153 
                                                 
     Less: Current portion of long-term debt                       -                         3,664 
     Long-term debt outstanding, net                     $ 322,457                      $ 278,489 

Convertible Notes:

4.25% Convertible Notes

On April 22, 2015, the Company issued $130.0 million aggregate principal amount 4.25% Convertible Notes. The 4.25% Convertible Notes mature on April 1, 2021, unless earlier converted, redeemed or repurchased. Interest on the 4.25% Convertible Notes is payable on April 1 and October 1 of each year, beginning October 1, 2015.

The 4.25% Convertible Notes are governed by the terms of an indenture, between the Company and Wilmington Trust, National Association, each of which were entered into on April 22, 2015. The Company may not redeem the 4.25% Convertible Notes prior to April 6, 2019. However, the holders may convert their 4.25% Convertible Notes at any time prior to the close of business on the business day immediately preceding January 1, 2021 only under certain circumstances. The effective interest rate on the 4.25% Convertible Notes, including debt issuance costs and bifurcated conversion option derivative (discussed below), is 10.4%.

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The Company is required to separate the conversion option in the 4.25% Convertible Notes under Accounting Standards Codification (ASC) 815, Derivatives and Hedging. During April 2015, the Company recorded the bifurcated conversion option valued at $28.5 million as a derivative liability, which created a discount on the debt. The derivative liability is marked to market through the other income (expense) section on the unaudited condensed consolidated statements of operations for each reporting period, while the discount created on the 4.25% Convertible Notes is accreted as interest expense over the life of the debt. The derivative liability is valued at $54,000 and $93,000 as of September 30, 2018 and December 31, 2017, respectively.

Interest expense was $1.7 million and $5.1 million for the three and nine months ended September 30, 2018, respectively, and $1.9 million and $6.9 million for the three and nine months ended September 30, 2017, respectively, related to the 4.25% Convertible Notes. Interest expense includes amortization of deferred financing costs and accretion of debt discount.

Change in fair value of derivative liability was a benefit of $18,000 and $39,000 for the three and nine months ended September 30, 2018, respectively, and a benefit of $46,000 and an expense of $38,000 for the three and nine months ended September 30, 2017, respectively. Accrued interest on the 4.25% Convertible Notes was approximately $1.7 million and $0.8 million as of September 30, 2018 and December 31, 2017, respectively.

As a result of the Exchangeable Notes transaction during the third quarter of 2017, the Company recorded $14.7 million as gain from exchange of debt for the three months ended September 30, 2017.

Exchangeable Notes

On July 20, 2017, the Company entered into an exchange agreement (the 2017 Exchange Agreement) with certain holders of its 4.25% Convertible Notes (Holders) pursuant to which $51.8 million of aggregate principal amount of its 4.25% Convertible Notes held by the Holders were exchanged for (i) $36.2 million aggregate principal amount of 4.25%/5.25% Exchangeable Senior Notes due 2022 (the Exchangeable Notes), issued by PIP DAC pursuant to an Indenture, dated July 21, 2017 (the Exchangeable Notes Indenture), among PIPL, the guarantors party thereto (the Guarantors), and Wilmington Trust, National Association, as Trustee and (ii) 1,100,498 shares of Common Stock.

The Exchangeable Notes issued under the Exchangeable Notes Indenture are guaranteed by the Company and each other subsidiary thereof. The Exchangeable Notes are senior, unsecured obligations of PIP DAC. Interest on the Exchangeable Notes will be paid in cash or a combination of cash and in-kind interest at PIP DAC's election. Interest paid in cash (the All Cash Method) will accrue at a rate of 4.25% per annum, while interest paid in a combination of cash and in-kind will accrue at a rate of 5.25% per annum, with 2.25% per annum (plus additional interest, if any) capitalized to the principal amount of the Exchangeable Notes, and the balance paid in cash. The maturity date of the Exchangeable Notes Indenture is July 15, 2022. The Exchangeable Notes initially are exchangeable into shares of Common Stock at an exchange price per share of $5.50 (the Exchange Price).

The 2017 Exchange Agreement allowed the Company to reduce the principal amount of its outstanding indebtedness through the exchange of the Holders' 4.25% Convertible Notes for a smaller principal amount of the Exchangeable Notes. The principal amount of the Exchangeable Notes may be reduced if the Holders thereof exchange their Exchangeable Notes for shares of Common Stock. The Exchangeable Notes Indenture will provide capacity to refinance up to an additional $25.0 million principal amount of the 4.25% Convertible Notes, which refinancing could also provide an opportunity to further reduce the principal amount of the Company's outstanding indebtedness.

The outstanding borrowings of the Exchangeable Notes were paid down by $500,000 in November 2017 with a portion of the proceeds from the sale of certain non-core assets. Interest expense was $1.0 million and $3.0 million for the three and nine months ended September 30, 2018, respectively, and $0.6 million for the three and nine months ended September 30, 2017, related to the Exchangeable Notes and included amortization of deferred financing costs and accretion of debt discount. During the first quarter of 2018, PIP DAC elected the PIK option in lieu of making scheduled interest payments. The election increased the principal due on the Exchangeable Notes by $402,000 as of September 30, 2018. Accrued interest on the Exchangeable Notes was approximately $396,000 and $675,000 as of September 30, 2018 and December 31, 2017, respectively.

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Term Facility:

On July 21, 2017 PIP DAC entered into a term loan credit agreement (the Delayed Draw Term Loan, the Term Facility or DDTL) with Cantor Fitzgerald Securities, as agent and the lenders party thereto to obtain the DDTL. $30.0 million under the DDTL was drawn on July 21, 2017 in connection with the closing of several refinancing transactions and the remaining $15.0 million will be available for subsequent draws for certain specified purposes, including to finance certain acquisitions, subject to conditions set forth in the DDTL credit agreement. The DDTL includes an incremental feature that allows PIP DAC, with the consent of the requisite lenders under the Term Facility, to obtain up to an additional $20.0 million in term loan commitments. Interest on the loans will accrue either in cash or a combination of cash and in kind interest, at PIP DAC's election. Cash interest will accrue at a rate of 7.50% per annum, while the combination of cash and in-kind interest will accrue at a rate of 8.50% per annum, with up to 4.00% per annum added to the principal amount of loans and the balance paid in cash. The DDTL will mature on July 21, 2022. During the first quarter of 2018, PIP DAC elected the PIK option in lieu of making scheduled interest payments. The election increased the principal due on the DDTL by $906,000 as of September 30, 2018.

On July 27, 2018, PIP DAC drew $9.2 million under the DDTL. The proceeds were used to fund the Company's investment in Nalpropion for Nalpropion's purchase of certain assets of Orexigen and for working capital requirements.

PIP DAC also entered into a mortgage debenture with Cantor Fitzgerald Securities as agent, pursuant to which PIP DAC's obligations under the DDTL will be secured by substantially all of the assets of PIP DAC and its future-acquired subsidiaries.

On August 1, 2018 the Company entered into an amendment of its Term Facility. These amendments were made to permit the exchange of the 12% Senior Secured Notes due 2020 (Treximet Secured Notes) for newly issued shares of Common Stock in the exchange transactions and equitization transaction (as defined below), and to amend certain terms of the Term Facility and the ABL Facility (collectively, the Credit Facilities), including (i) changes to permit the use of subsequent draws under the Term Facility for working capital or other general corporate purposes, and (ii) changes to the interest payment provisions under the Term Facility increasing the minimum percentage of interest that must be paid in cash to 6.00% per annum from 4.50% per annum.

Interest expense was approximately $1.0 million and $2.6 million for the three and nine months ended September 30, 2018 related to the DDTL and includes amortization of deferred financing costs. Accrued interest on the DDTL was approximately $624,000 and $484,000 as of September 30, 2018 and December 31, 2017, respectively.

Secured Notes:

Treximet Note Offering

On August 19, 2014, the Company issued $220.0 million aggregate principal amount of its Treximet Secured Notes pursuant to an Indenture (the August 2014 Indenture) dated as of August 19, 2014 among the Company, certain of its subsidiaries (the Treximet Guarantors) and U.S. Bank National Association (the August 2014 Trustee), as trustee and collateral agent.

On April 13, 2015, the Company amended the August 2014 Indenture to allow the Company to, among other things, incur up to $42.2 million of additional debt. On December 29, 2017, the Company and the August 2014 Trustee entered into a third supplemental indenture to amend the August 2014 Indenture to clarify the definition of "Net Sales", as such term is defined in the August 2014 Indenture and resulted in the deferral of $3.2 million of principal payments until maturity of the notes.

25


The Treximet Secured Notes mature on August 1, 2020 and bear interest at a rate of 12% per annum, payable in arrears on February 1 and August 1 of each year (each, a Payment Date), beginning on February 1, 2015. On each Payment Date, commencing August 1, 2015, the Company began paying installments of principal of the Treximet Secured Notes in an amount equal to 50% of net sales of Treximet for the two consecutive fiscal quarters immediately preceding such Payment Date (less the amount of interest paid on the Treximet Secured Notes on such Payment Date). At each month-end beginning with January 2015, the net sales of Treximet will be calculated, the monthly interest accrual amount will then be deducted from the net sales and this resulting amount will be recorded as the current portion of the Treximet Secured Notes. If the Treximet net sales less the interest due at the end of each six-month period does not result in any excess over the interest due, no principal payment must be paid at that time. The remaining balance outstanding on the Treximet Secured Notes will be due on the maturity date, which is August 1, 2020. As of September 30, 2018, the principal amount outstanding of the Treximet Secured Notes is $154.5 million and is classified as a non-current liability. As of December 31, 2017, the Company classified $5.4 million, of the Treximet Secured Notes as a current liability and $166.7 million as a non-current liability at December 31, 2017.

The Treximet Secured Notes are secured by a continuing first-priority security interest in substantially all of the assets of the Company and the Treximet Guarantors related to Treximet other than inventory and certain inventory related assets, including accounts arising from the sale of the inventory.

On August 1, 2018, the Company entered into an exchange agreement (2018 Exchange Agreement) with certain holders (Exchange Holders) of the Treximet Secured Notes for newly issued shares of Common Stock and shares of a newly created class of convertible preferred stock of the Company designated as Convertible Preferred Stock (Exchange Transactions).

The Exchange Transactions closed on August 1, 2018 and were as follows:

  • exchange of approximately $2.7 million aggregate principal amount of the Treximet Secured Notes for 1,204,586 shares of Common Stock which includes $0.2 million of accrued and unpaid interest on the Treximet Secured Notes;
  • exchange of $8.0 million principal amount of the Treximet Secured Notes plus $0.1 million of accrued and unpaid interest for 81,000 shares of Convertible Preferred Stock.

The 2018 Exchange Agreement affords certain Exchange Holders the right to exchange up to an additional $65.1 million aggregate principal amount of the Treximet Secured Notes plus accrued and unpaid interest, into additional Convertible Preferred Stock until February 1, 2020. The Company evaluated the transaction under ASC 470-50, Debtors Accounting for a Modification or Exchange of Debt Instruments and determined the inclusion of the conversion right was not substantive and therefore does not constitute a debt extinguishment.

On August 1, 2018, the Company entered into separate Equitization Exchange Agreements by and among Pernix and certain Equitization Holders of Treximet Secured Notes. Pursuant to the Equitization Exchange Agreements, the Company issued 650,190 shares of its Common Stock in exchange for approximately $1.5 million aggregate principal amount of Treximet Secured Notes held by such Equitization Holders plus $0.1 million of accrued and unpaid interest thereon (Equitization Transaction). This transaction closed on August 1, 2018.

As a result of the Exchange Transactions and Equitization Transaction, the Company recorded a net gain on early extinguishment of debt of $0.1 million.

Interest expense related to the Treximet Secured Notes was $5.2 million and $16.1 million for the three and nine months ended September 30, 2018, respectively, and was $5.6 million and $17.2 million for the three and nine months ended September 30, 2017, respectively. Interest expense includes amortization of deferred financing costs. Accrued interest on the Treximet Secured Notes was approximately $3.1 million and $8.6 million as of September 30, 2018 and December 31, 2017, respectively.

26


2018 Term Loan

On July 27, 2018, Nalpropion entered into a credit agreement (2018 Credit Agreement) with Wilmington Savings Fund Society, FSB, as administrative and collateral agent, and certain lenders including PIP DAC and certain affiliates of Highbridge Capital Management, LLC (Highbridge) and Whitebox Advisors LLC (Whitebox, and collectively, the Lenders) from time to time party thereto providing for $45.8 million principal amount of a three-year term loan (the 2018 Term Loan). Loans under the 2018 Term Loan bear interest at 8.0% per year and mature on July 27, 2021. PIP DAC provided $4.6 million of the total commitment under the credit facility established under the 2018 Credit Agreement (2018 Credit Facility). Nalpropion borrowed the full $45.8 million available under the 2018 Term Loan to partially fund the Orexigen Acquisition and for working capital requirements. As PIP DAC is one of the lenders under the 2018 Credit Facility and provided $4.6 million of the total commitment under the 2018 Credit Facility, the $4.6 million is eliminated in consolidation as the transaction is between affiliates. As of September 30, 2018, $41.3 million of borrowings under the 2018 Term Loan related to the Company's consolidation of Nalpropion as a VIE is included in the Company's unaudited condensed consolidated balance sheets.

The borrowings under the 2018 Credit Agreement are secured, subject to customary permitted liens and other agreed upon exceptions, by a perfected security interest in the intangible assets of Nalpropion. Nalpropion is permitted to make voluntary prepayments at any time without payment of a premium or penalty. Nalpropion is required to make mandatory prepayments of outstanding indebtedness under the 2018 Credit Agreement (without payment of a premium) with (a) net cash proceeds from certain non-ordinary course asset sales (subject to reinvestment rights and other exceptions), (b) casualty proceeds and condemnation awards (subject to reinvestment rights and other exceptions), and (c) 75% of the excess cash flow generated during a semi-annual period (commencing with the period subsequent to June 30, 2019), depending on certain factors as defined in the 2018 Credit Agreement.

The 2018 Credit Agreement contains certain negative covenants (subject to exceptions, materiality thresholds and other allowances) including, without limitation, negative covenants that limit Nalpropion's ability to incur additional debt, guarantee other obligations, grant liens on assets, make loans, acquisitions or other investments, dispose of certain assets, make optional payments in connection with or modify certain debt instruments, pay dividends or make other payments on capital stock, engage in mergers or consolidations, enter into arrangements that restrict Nalpropion's ability to pay dividends or grant liens, engage in transactions with affiliates, or change its fiscal year.

In addition, the 2018 Credit Agreement also contains customary events of default (with customary grace periods and materiality thresholds). Upon the occurrence of certain events of default, the obligations under the 2018 Credit Agreement may be accelerated and any remaining commitments thereunder may be terminated.

Interest expense related to the 2018 Term Loan was $0.7 million for the three months ended September 30, 2018 of which $0.1 million is due to the Company and is eliminated in consolidation. As of September 30, 2018, $0.6 million of accrued interest on the 2018 Term Loan related to the Company's consolidation of Nalpropion as a VIE is included in the Company's unaudited condensed consolidated balance sheets.

Credit Facility:

Cantor Fitzgerald

On July 21, 2017, Pernix and certain subsidiaries of Pernix as borrowers and guarantors (the ABL Borrowers) and PIP DAC, Pernix Ireland Limited, Pernix Holdco 1, LLC, Pernix Holdco 2, LLC and Pernix Holdco 3, LLC as additional guarantors (the ABL Guarantors), entered into an asset-based revolving credit agreement (the ABL Credit Agreement) with Cantor Fitzgerald Securities, as agent (the ABL Agent) and the lenders party thereto to obtain a five-year $40 million asset-based revolving credit facility (the ABL Facility). On April 23, 2018, the Company entered into an amendment, effective as of April 12, 2018, to modify the borrowing base formula which determines the Company's capacity to draw on the ABL Facility, which could increase such capacity. The amendment also removed concentration limits for accounts receivable due from individual customers or other account debtors that may be included in the borrowing base.

The ABL Borrowers' obligations under the ABL Credit Agreement are guaranteed by the ABL Borrowers and the ABL Guarantors are secured by, among other things, the ABL Borrowers' cash, inventory and accounts receivable, in each case pursuant to a guaranty and security agreement between the ABL Borrowers, ABL Guarantors and Cantor Fitzgerald Securities as agent. Borrowings under the ABL Credit Agreement bear interest at the rate of LIBOR plus 7.50%, payable monthly, in addition to a commitment fee on any undrawn commitments at a rate per annum of 0.25%, payable monthly. The ABL Credit Agreement contains representations and warranties, affirmative and negative covenants, and events of default applicable to the Company, the other ABL Borrowers, the ABL Guarantors and their respective subsidiaries that are customary for credit facilities of this type. The ABL Credit Agreement will mature on July 21, 2022.

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On August 1, 2018 the Company entered into an amendment of the ABL Facility. The amendment provides for certain changes to the borrowing base calculation under the ABL Facility that are intended to improve the Company's borrowing capacity under the ABL Facility and that will also permit the Company, among other things, to include Contrave inventory owned by the Company in the calculation of the borrowing base, and a reduction in the commitments under the ABL Facility from $40.0 million to $32.5 million.

Interest expense was $0.5 million and $1.5 million for the three and nine months ended September 30, 2018, respectively, and was $0.4 million for the three and nine months ended September 30, 2017, related to the ABL Credit Agreement and includes amortization of deferred financing costs. As of September 30, 2018, unamortized debt issuance costs of $0.6 million and $1.6 million are recorded on the unaudited consolidated balance sheets in Prepaid expenses and other currents assets and Other assets, respectively, and are being amortized to interest expense over the life of the agreement. As of December 31, 2017, $0.6 million and $2.1 million of unamortized debt issuance costs are recorded on the unaudited consolidated balance sheets in Prepaid expenses and other currents assets and Other assets, respectively.

Wells Fargo

On August 21, 2015, the Company entered into a credit agreement with Wells Fargo, as Administrative Agent and the lenders party thereto for a $50.0 million, three-year senior secured revolving credit facility (the Wells Fargo Credit Facility).

The ABL Facility entered into on July 21, 2017 replaced the Wells Fargo Credit Facility and the Company used the proceeds from the ABL Facility to repay the outstanding obligation of the Wells Fargo Credit Facility.

Interest expense including amortization of deferred financing costs related to the Wells Fargo Credit Facility amounted to $142,000 and $748,000, for the three and nine months ending September 30, 2017, respectively.

The following table represents the future maturity schedule of the outstanding debt and line of credit at September 30, 2018 (in thousands):

      Amount
2018 (October - December)   $ -  
2019     -  
2020     154,515 
2021     119,475 
2022     90,404 
Thereafter     -  
     Total maturities     364,394 
Less:      
     Note discount     (31,741)
     Deferred financing costs     (10,196)
Total outstanding debt, net   $ 322,457 

Note 11. Stockholders' Equity 

Convertible Preferred Stock

On August 1, 2018, in connection with the 2018 Exchange Agreement, the Company reclassified and designated 1,500,000 shares of the authorized but unissued preferred stock of the Company to the Convertible Preferred Stock. In connection with the Exchange Transactions, $8.0 million principal amount of the Treximet Secured Notes plus $100,000 of accrued and unpaid interest was exchanged for 81,000 shares of Convertible Preferred Stock. The Convertible Preferred Stock was recorded at fair value in the amount of $7.2 million, net of issuance costs of $0.5 million and is recorded to additional paid-in capital.

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Holders of Convertible Preferred Stock have the right to convert their shares of Convertible Preferred Stock, in whole or in part, into shares of Common Stock at any time on or after August 1, 2018 (the Initial Issue Date). The Company has the right, at its option, to automatically convert all shares of Convertible Preferred Stock into shares of Common Stock, subject to the satisfaction of certain specified conditions. Upon any conversion of an Exchange Holder's Convertible Preferred Stock, the Company will deliver shares of Common Stock, calculated by multiplying the number of shares of Convertible Preferred Stock by 41.841 shares of Common Stock per share of Convertible Preferred Stock (the Conversion Rate). The Conversion Rate is initially equal to the number of shares of Common Stock convertible into Common Stock at a price $0.01 above the consolidated closing bid price on the date immediately preceding Initial Issue Date, or $2.39 per share.

Subsequent to the Initial Issue Date, an Exchange Holder is not able to convert Convertible Preferred Stock into Common Stock to the extent that the Common Stock held by such Exchange Holder and its affiliates would exceed 4.985% of the Common Stock outstanding immediately after giving effect to the issuance of shares of Common Stock.

Moreover, at any time on or after the Initial Issue Date, the Company has the right to redeem the Convertible Preferred Stock, in whole or in part, at a redemption price equal to 100% of the liquidation preference of the shares to be redeemed, plus any accrued and unpaid dividends. Except as required by law or the Articles Supplementary, the Exchange Holders of Convertible Preferred Stock have no voting rights (other than with respect to certain matters regarding the Convertible Preferred Stock).

In accordance with the Articles Supplementary, the Company will not authorize, declare or pay regular or special dividends or other distributions (whether in the form of cash, shares, indebtedness or any other property or asset, but excluding any purchase, redemption or other acquisition of shares) on the shares of the Common Stock, unless simultaneously with the authorization, declaration or payment, it authorizes, declares or pays, as applicable, dividends or other distributions on the Convertible Preferred Stock.

On October 3, 2018, holders of 13,100 shares of the Company' 0% Series C Perpetual Convertible Preferred Stock elected to convert such Convertible Preferred Stock into 548,115 shares of the Company's Common Stock.

Controlled Equity Offering

On November 7, 2014, the Company entered into a controlled equity offering sales agreement (the Sales Agreement) with Cantor Fitzgerald & Co. (Cantor) pursuant to which the Company could issue and sell shares of its Common Stock having an aggregate offering price of up to one hundred million dollars, pursuant to an effective registration statement on Form S-3 (No. 333-200005), from time to time through Cantor, acting as agent. On November 22, 2017, the Company filed a registration statement on Form S-3 (No. 333-221717) to replace the previously-filed registration statement, which was subsequently declared effective by the SEC on December 18, 2017. The Company will pay Cantor a commission rate of 3.0% of the gross sales price per share of the Common Stock sold through Cantor as agent under the Sales Agreement.

During the nine months ended September 30, 2018, the Company sold 191,170 shares of Common Stock under the Sales Agreement at an average price of approximately $2.51 per share for gross proceeds of $480,000 and net proceeds of $453,000, after deducting commission and fees. During the nine months ended September 30, 2017, the Company sold 372,176 shares of Common Stock under the Sales Agreement at an average price of approximately $3.21 per share for gross proceeds of $1.2 million and net proceeds of $1.1 million, after deducting commission and fees. As of September 30, 2018, approximately $77.0 million of Common Stock remained available to be sold under this facility, subject to certain limitation to the extent the Company continues to have a public float of less than $75.0 million.

Noncontrolling Interest

Ownership interests in subsidiaries held by parties other than the Company are presented as non-controlling interest within stockholders' equity, separately from the equity held by the Company on the consolidated statements of stockholders' equity. Revenues, expenses, net income and other comprehensive income are reported in the condensed consolidated financial statements at the consolidated amounts, which includes amounts attributable to both the Company's interest and the non-controlling interests in Nalpropion. Net loss and other comprehensive loss is then attributed to the Company's interest and the non-controlling interests. Net loss to non-controlling interests is added to net loss in the consolidated statements of loss to determine net loss attributable to the Company's common shareholders (see unaudited condensed consolidated statements of stockholders' equity (deficit) for activity related to the noncontrolling interest).

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Warrants

As of September 30, 2018, the Company has approximately 4,380 outstanding Common Stock warrants assumed in connection with the acquisition of Somaxon Pharmaceuticals, Inc. (Somaxon) in March 2013, with exercise prices ranging from $83.73 to $258.51 and expiration dates ranging from August 2021 through December 2021.

Share-Based Compensation Plans

In November 2017, the Company's shareholders approved the 2017 Omnibus Incentive Plan (the 2017 Plan) for future equity awards granted by the Company. Subject to the adjustments described below, the maximum number of shares of  Common Stock that will be available for issuance under the 2017 Omnibus Incentive Plan will be equal to the sum of (i) one million (1,000,000) shares of Common Stock plus (ii) the number of shares of our Common Stock available for future awards under the 2015 Omnibus Incentive Plan and the 2009 Stock Incentive Plan as of November 15, 2017, plus (iii) the number of shares of Common Stock related to awards outstanding under such plans as of November 15, 2017 that terminate after such date by expiration or forfeiture, cancellation, or otherwise without the issuance of such shares of Common Stock. On May 22, 2018, the Company's stockholders approved an amendment to the 2017 Plan to increase the number of shares reserved under the 2017 Plan from 642,294 shares of Common Stock to 1,242,294 shares of Common Stock.

Stock-Based Compensation

Stock-based compensation expense is recognized, net of an estimated forfeiture rate, on a straight-line basis over the requisite service period, which is the vesting period.

The Company uses the Black-Scholes option pricing model to determine the fair value of its stock options. The weighted average fair value of stock options granted during the periods and the assumptions used to estimate those values using the Black-Scholes option pricing mode were as follows:

      Three Months Ended     Nine Months Ended
      September 30,     September 30,
      2018     2017     2018     2017
Weighted average expected stock price volatility     86.4%     88.0%     86.4%     87.6%
Estimated dividend yield     -     -     -     -
Risk-free interest rate     2.9%     2.0%     2.8%     2.0%
Expected life of option (in years)     6.3     6.2     6.3     6.2
Weighted average grant date fair value per option   $ 0.69   $ 2.15   $ 1.61   $ 2.15

The Company measures the grant date fair value of restricted stock units (RSUs) using the Company's closing Common Stock price on the grant date.

The accounting policy with respect to stock options and RSUs is described in the audited consolidated financial statements contained in the Company's Annual Report on Form 10-K for the year ended December 31, 2017.

Stock-based compensation expense was $0.4 million and $1.3 million for the three and nine months ended September 30, 2018, respectively and was $0.5 million and $1.9 million for the three and nine months ended September 30, 2017. Stock-based compensation expense for the periods presented is included within the selling, general and administrative expense in the unaudited condensed consolidated statements of operations.

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Stock Options

The following table shows the option activity, described above, during the nine months ended September 30, 2018 (shares and intrinsic value in thousands):

                  Weighted Average      
            Average     Remaining     Aggregate
            Exercise     Contractual Life     Intrinsic
      Shares     Price     (years)     Value
Options Outstanding at December 31, 2017     1,042    $ 13.80      8.8       
     Granted     556      2.17             
     Exercised     -       -              
     Cancelled     (228)     12.29             
     Expired     -       -              
Options outstanding at September 30, 2018     1,370    $ 9.34      8.7    $
Options vested and expected to vest as of September 30, 2018     895    $ 12.86      8.3    $
Options vested and exercisable as of September 30, 2018     339    $ 24.88      7.3    $

As of September 30, 2018, there was approximately $1.4 million of total unrecognized compensation cost related to non-vested stock options issued to employees and directors of the Company, which is expected to be recognized ratably over a weighted-average period of 2.0 years.

The total intrinsic value of options exercised during each of the three and nine months ended September 30, 2018 and 2017 was $0.

Options issued subsequent to January 2014 have a graded vesting schedule over either three or four years. The Company's stock option grants expire ten years from the date of grant.

Restricted Stock

The following table shows the Company's non-vested restricted stock activity during the nine months ended September 30, 2018 (shares in thousands):

            Weighted Average
            Grant Date Fair
      Shares     Value
Non-vested restricted stock outstanding at December 31, 2017     135    $ 3.17 
     Granted     62      2.46 
     Vested     (54)     3.25 
     Forfeited     (2)     2.60 
Non-vested restricted stock outstanding at September 30, 2018     141    $ 2.83 

The total fair value of RSUs vested in the nine months ended 2018 and 2017, were $177,000 and $220,000, respectively. As of September 30, 2018, there was $0.8 million total unrecognized compensation cost related to non-vested restricted stock issued to employees and directors of the Company which is expected to be recognized ratably over a weighted-average period of 1.97 years.

Note 12. Income Taxes

On December 22, 2017, the U.S. Tax Cuts and Jobs Act ("TCJA") was enacted reducing the corporate Federal tax rate from 35% to 21% effective for tax years beginning on or after January 1, 2018. ASC 740, Income Taxes, requires the effects of changes in tax laws to be recognized in the period in which the legislation is enacted. However, due to the complexity and significance of the TCJA's provisions and anticipated guidance from the U.S. Treasury and the Internal Revenue Service regarding the TCJA, the SEC staff issued Staff Accounting Bulletin 118, which allows companies to record the tax effects of the TCJA on a provisional basis based on a reasonable estimate, and then, if necessary, subsequently adjust such amounts during a limited measurement period as more information becomes available. The measurement period ends when a company has obtained, prepared, and analyzed the information necessary to finalize its accounting, but cannot extend beyond one year from enactment of the TCJA.

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Under the TCJA, the Corporate Alternative Minimum Tax ("AMT") was repealed. The Company's previously recorded AMT credits of approximately $0.2 million are now refundable subject to budgetary sequestration over a four-year period beginning in 2018, and the previously recorded valuation allowance for these AMT credits was reversed during the year ended December 31, 2017. The Company's Irish subsidiaries have accumulated deficits in earnings and profits and thus the Company will not be subject to the one-time transition tax.

The TCJA creates a new requirement that certain income (i.e., Global intangible low taxed income "GILTI") earned by foreign subsidiaries must be included currently in the gross income of the U.S. shareholder. Due to the complexity of the new GILTI tax rules, the Company is continuing to evaluate this provision of the Tax Act and the application of ASC 740. Under U.S. GAAP, the Company is permitted to make an accounting policy election to either treat taxes due on future inclusions in U.S. taxable income related to GILTI as a current-period expense when incurred or to factor such amounts into the Company's measurement of its deferred taxes. The Company has not yet completed its analysis of the GILTI tax rules and is not yet able to reasonably estimate the effect of this provision of the Tax Act or make an accounting policy election for the ASC 740 treatment of the GILTI tax. Therefore, the Company has not recorded any amounts related to potential GILTI tax in its consolidated financial statements and has not yet made a policy decision regarding whether to record deferred taxes on GILTI.

The Company reported an income tax expense of approximately $61,000 and $109,000 for the three and nine months ended September 30, 2018, respectively and an income tax expense of approximately $27,000 and $122,000 for the three and nine months ended September 30, 2017, respectively. The Company's effective tax rate was (0.2%) for the nine months ended September 30, 2018, compared to an estimated annual effective rate of (0.3%) for the nine months ended September 30, 2017.

Deferred income taxes reflect the net tax effects of temporary differences between the carrying amount of the assets and liabilities for financial reporting purposes and the amounts used for income tax purposes. All deferred tax assets were subject to a full valuation allowance as of December 31, 2017.

The Company evaluates the realizability of its U.S. net deferred tax assets based on all available evidence, both positive and negative, on a quarterly basis. The realization of net deferred tax assets is dependent on the Company's ability to generate sufficient future taxable income during periods prior to the expiration of tax attributes to fully utilize these assets. The Company weighed both positive and negative evidence and determined that due to recent losses there is a continued need for a full valuation allowance against all of the Company's deferred tax assets as of September 30, 2018 and December 31, 2017.

As of September 30, 2018, the Company's gross deferred tax assets are comprised primarily of U.S. Federal net operating losses and accruals, and its gross deferred tax liabilities are comprised primarily of differences in the financial statement and tax bases of intangible assets.

The Company files income tax returns with both federal and state-level taxing authorities in the U.S., and with the taxing authorities of various foreign jurisdictions. The associated tax filings remain subject to examination by applicable tax authorities for a certain length of time following the tax year to which those filings relate. The IRS audit of the Company's 2014 and 2015 Federal tax returns concluded during the quarter ended September 30, 2018, and there were no material impacts to the Company's income tax provision as a result.  The Company's 2016 and 2017 tax returns are subject to potential examination.

Note 13. Commitments and Contingencies

Legal Proceedings

Pernix Ireland Pain Limited (n/k/a Pernix Ireland Pain Designated Activity Company) and Pernix Therapeutics, LLC v. Actavis Laboratories FL, Inc. (Actavis), District of Delaware Case No. 16-138; Pernix Ireland Pain Limited and Pernix Therapeutics, LLC v. Alvogen Malta Operations, Ltd. (Alvogen), District of Delaware Case No. 16-139.

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PIP DAC is the owner of: (a) U.S. Patent No. 9,265,760 (the '760 Patent), issued on February 23, 2016, (b) U.S. Patent No. 9,326,982 (the '982 Patent), issued on May 3, 2016, (c) U.S. Patent No. 9,333,201 (the '201 Patent), issued on May 10, 2016, and (d) U.S. Patent No. 9,339,499 (the '499 Patent), issued on May 17, 2016 (collectively, the Pernix Zohydro ER Patents).  The Pernix Zohydro ER Patents are listed in the United States Food and Drug Administration's (FDA) Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations (the Orange Book) as covering Zohydro ER.  Pernix Therapeutics, LLC (Pernix LLC) is the sole distributor of Zohydro ER in the United States. Pernix LLC and PIP DAC (collectively for the purpose of this paragraph, Pernix) brought suit against Actavis and Alvogen in the District of Delaware on March 4, 2016, seeking declaratory judgment of infringement of the '760 Patent. The Complaints relating to the '760 Patent were served on March 7, 2016. Pernix filed and served First and Second Amended Complaints on May 13, 2016 and May 31, 2016 against Alvogen and Actavis, respectively, adding allegations of infringement with respect to the '982, '201, and '499 Patents.  Actavis Motion to Dismiss was completed on July 11, 2016.  United States Patent Nos. 9,421,200 (the '200 Patent) and 9,433,619 (the '619 Patent) issued on August 23, 2016 and September 5, 2016, respectively.  Pernix filed and served Second and Third Amended Complaints, against Alvogen and Actavis respectively, on October 12, 2016, adding allegations of infringement with respect to the '200 and '619 Patents.  Actavis and Alvogen filed their respective Answers on November 30, 2016, denying Pernix's infringement allegations and raising Counterclaims of non-infringement and invalidity as to each of the asserted patents.  Pernix and Actavis entered into a settlement agreement on January 29, 2018.  Under the terms of the agreement, Pernix will grant Actavis a license to begin selling a generic version of Zohydro ER on March 1, 2029, or earlier under certain circumstances.  Other details of the settlement are confidential.  The launch of Actavis's generic product is contingent upon Actavis receiving final approval from the FDA of its ANDA for a generic version of Zohydro ER. For the Alvogen case, trial testimony was heard from June 11-13, 2018, post-trial briefing was completed on July 12, 2018, and the trial concluded with the parties' closing arguments on July 25, 2018. The district court's trial decision was rendered on August 24, 2018, finding the asserted claims of the Zohydro ER Patents to be infringed by Alvogen's proposed generic Zohydro ER product and not to be invalid for anticipation under 35 U.S.C. § 102. The district court also found the asserted claims to be invalid for obviousness under 35 U.S.C. § 103 and as lacking adequate written description under 35 U.S.C. § 112. Pernix filed a Notice of Appeal on September 7, 2018, appealing the district court's decision that the asserted claims are invalid for obviousness and lacking adequate written description to the United States Court of Appeals for the Federal Circuit. Pernix's opening appellate brief is due no later than November 13, 2018, Alvogen's answering brief is due no later December 24, 2018 and Pernix's reply brief is due no later than January 7, 2019. Oral argument on the appeal is expected in the second quarter of 2019, with a written decision to follow thereafter.

Medicine to Go Pharmacies, Inc. v. Macoven Pharmaceuticals, LLC and Pernix Therapeutics Holdings, Inc., District Court of New Jersey Case No. 2:16-cv-07717.

On October 23, 2016, Medicine to Go Pharmacies, Inc. (Plaintiff) filed an action against Pernix and its subsidiary, Macoven and unidentified individuals seeking redress for sending allegedly unlawful advertisements to facsimile machines in violation of the Telephone Consumer Protection Act, 47 U.S.C. 227. On December 2, 2016, the Company filed its answers in defense of the allegations. The December 2013 fax campaign that is the subject of this litigation was administered by a third party, Odyssey Services, Inc. (Odyssey), which was not initially named as a defendant in this litigation. On June 22, 2017, the Company filed a third-party complaint against Odyssey, seeking indemnity and contribution for any amounts that the Company may be liable to pay to the Plaintiff. Odyssey answered the third-party complaint and, in addition, filed a counterclaim for indemnification against the Company, alleging that the Company, not Odyssey, was responsible for the content of the facsimiles transmitted, and thus is liable to Odyssey for any costs or judgments associated with this action. Odyssey also filed a motion for summary judgment, seeking to dismiss the third-party claims against it; the Company has moved for summary judgment to hold Odyssey liable to indemnify the Company.

A settlement conference was conducted by the Court on July 12, 2018 during which counsel for Plaintiff and the Company agreed in principle that for purposes of settlement the defendants will create a settlement fund and the Company will contribute a total of $1.2 million to said fund, which amount shall be final and includes any and all costs of the settlement, including payment of claims submitted by class members, class notice, settlement administration, Plaintiff's

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attorneys' fees and costs, and any incentive award to Plaintiff. Further, the Company will not oppose Plaintiff's request that a Rule 23(b)(3) settlement class consisting of all persons and entities with fax numbers who received a copy of the December 2013 "Dear Pharmacist" fax be certified by the Court and the Company will agree that any unclaimed amounts of the settlement fund shall be distributed to one or more cy pres organizations to be selected by the Parties and subject to the approval of the Court. Odyssey subsequently agreed to participate in the settlement and to contribute to the proposed settlement fund. Plaintiff filed its unopposed motion for preliminary approval of the settlement on October 12, 2018, and the Court approved the motion on October 29, 2018.  As a result, notice of the settlement will be sent to all potential class members, who may submit a claim. Class members will have until January 5, 2019 to submit a claim, object to the settlement, or exclude themselves from the settlement. On February 21, 2019, the Court will conduct a final hearing to determine whether to grant final approval of the settlement, which will release all claims against Pernix and Odyssey. If the Court grants final approval, the settlement monies will be distributed thereafter.

Opioids Litigation

Beginning in 2014 and continuing to the present, a number of pharmaceutical companies have been named in numerous lawsuits brought by certain state and local governments related to the marketing of opioid pain medications. The claims are generally based on alleged misrepresentations and/or omissions in connection with the sale and marketing of prescription opioid pain medications and/or an alleged failure to take adequate steps to prevent abuse and diversion. The suits generally seek penalties and/or injunctive and monetary relief. These cases are in early stages of litigation. In May 2018, the Company was notified that the State of Arkansas has named approximately 65 companies and individuals, including the Company, in an ongoing lawsuit relative to the marketing and sale of opioid pain medications. In September of 2018, the Company filed a motion to dismiss the Arkansas lawsuit. That motion is currently pending.

During the second quarter of 2018, the Company was also served with two additional lawsuits in which it was included as a defendant, both of which were filed in Philadelphia County, PA (UFCW Local 23 Health Fund v. Endo Pharmaceuticals, Inc., et al. and Iron Workers Dist. Council of Philadelphia & Vicinity, Benefit Fund v. Abbott Laboratories, Inc., et al.). These cases have since been transferred to Delaware County, PA, although the decision to transfer the cases is currently on appeal. At this time, the Company is unaware of whether it will be named in any of the other opioid pain medication lawsuits. 

The Company intends to vigorously defend against the claims asserted against it in these litigations but is unable to predict probable outcomes at this time.

Navigators Insurance Company v. Pernix Therapeutics Holdings, Inc. (U.S. District Court, Eastern District of PA)

On October 26, 2018, Navigators Insurance Company ("Navigators") initiated an insurance coverage declaratory judgment action against Pernix in the United States District Court for the Eastern District of Pennsylvania.  The action pertains to a dispute between the parties as to whether Navigators owes coverage under certain insurance policies for the defense and potential indemnity of Pernix in three lawsuits pending against Pernix: (1) UFCW, Local 23 and Employers Health Fund v. Endo Pharmaceuticals, Inc. et al., Case No. 180403485, filed in the Pennsylvania Court of Common Pleas, Philadelphia County ("UFCW Action"); (2) Iron Workers District Council of Philadelphia and Vicinity, Benefit Fund v. Abbott Laboratories, Inc. et al., Case No. 180502442, filed in the Pennsylvania Court of Common Pleas, Philadelphia County ("Iron Workers Action"); and (3) State of Arkansas, ex. rel. Scott Ellington et al. v. Purdue Pharma, L.P. et al., Case No. CV-2018-268, filed in the Circuit Court of Crittenden County, Arkansas ("Arkansas Action") (collectively, the "Underlying Actions"). 

The complaint alleges that Pernix requested that Navigators defend and indemnify it in the Underlying Actions under three policies Navigators issued to Pernix, all of which are effective from November 30, 2017 to November 30, 2018: a Products-Completed Operations Liability policy (the "Products Liability Policy"), a Commercial General Liability policy (the "CGL Policy"), and (3) a Commercial Umbrella Liability policy (the "Umbrella Policy") (collectively, the "Policies").  The complaint further alleges that, by letter dated October 23, 2018, Navigators: (1) disclaimed any duty to defend or indemnify Pernix in the UFCW Action and Iron Workers Action under the Policies; (2) disclaimed any duty to defend or indemnify Pernix in the Arkansas Lawsuit under the CGL and Umbrella Policies; (3) disclaimed any duty to defend or indemnify Pernix on Counts Three to Nine of the Arkansas Action under the Products Liability Policy; and (4) reserved the right to disclaim any duty to defend or indemnify Pernix on Counts One and Two of the Arkansas Action under the Products Liability Policy.  Navigators alleges that Pernix disputes the propriety of Navigator's disclaimers. 

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Navigators has asserted seven counts against Pernix.  Counts I through VI seek declarations that Navigators has no duty to defend or indemnify Pernix in the Underlying Actions under any of the Policies.  These counts contain allegations of the various provisions of the Policies on which Navigators relies.  Count VII is pled in the alternative and seeks a declaration that Navigators is entitled to allocation between covered and uncovered defense and indemnification costs to the extent that any counts of the Underlying Actions are covered by one or more of the Policies.

Pernix intends to vigorously contest these claims, and file a counterclaim that Navigators owes Pernix a duty to defend all of the Underlying Actions in full, and that any determination of the duty to indemnify at this point is premature.

Other Commitments and Contingencies

In July 2012 and January 2013, Somaxon settled two patent litigation claims with parties seeking to market generic equivalents of Silenor.  As of September 30, 2018, remaining payment obligations of the Company owed under these settlement agreements are $250,000. The balance is payable in the third quarter 2019 and is recorded in "other liabilities - current" on the Company's unaudited condensed consolidated balance sheets as of September 30, 2018.

During the first quarter of 2014, the Company settled all claims arising from certain actions by Cypress under the Texas Medicaid Fraud Prevention Act prior to its acquisition by the Company. As part of the settlement, the Company agreed to pay $12.0 million, payable in annual amounts of $2.0 million until the settlement is paid in full. As of September 30, 2018, the net present value of remaining payment obligations owed under this settlement agreement is $2.0 million and is recorded within other liabilities - current on the Company's unaudited condensed consolidated balance sheets as of September 30, 2018.

GlaxoSmithKline (GSK) Arbitration

Pursuant to Amendment No. 2, the Company agreed that if on or before September 30, 2019, the Company (x) redeems or repurchases its 4.25% Convertible Notes for greater than 31 cents for every one dollar of principal amount outstanding or (y) exchange such notes for new notes or similar instruments that have a face value providing such exchanging holders a recovery that is greater than 31 cents for every one dollar of 4.25% Convertible Notes exchanged by such holders, the Company shall, no later than five business days thereafter, distribute to GSK additional cash or notes, as applicable, equal to such excess recovery, but in no event to exceed $2.0 million.  GSK has agreed that for so long as the Company complies with the payment terms set forth in the Amendment No. 2, enforcement of the award will be stayed and GSK shall not seek to enforce or exercise any other remedies in respect of the award, and that the outstanding balance of the Award shall be unconditionally and irrevocably forgiven upon satisfaction of such terms.  As of September 30, 2018 and December 31, 2017, the Company has recorded $2.0 million as contingent consideration for the potential payment due by September 30, 2019 and is recorded in "other liabilities - current" and "Arbitration Award" on the Company's consolidated balance sheets, respectively. Also, the Company recorded $10.5 million as a gain from legal settlement for the year ended December 31, 2017 pursuant to Amendment No. 2 in the consolidated statements of operations and comprehensive loss.

Nalpropion Related Litigation

In April 2015, Orexigen and Takeda Pharmaceutical Company Limited (Takeda) received notification of a Paragraph IV certification for certain patents for Contrave which are listed in the Orange Book. The certification resulted from the filing by Actavis Laboratories FL, Inc. (Actavis) of an ANDA challenging such patents for Contrave. In June 2015, Orexigen and Takeda filed a lawsuit in the U.S. District Court for the District of Delaware against Actavis on the basis that Actavis' proposed generic products infringe certain patents for Contrave. Takeda held the NDA for Contrave and was a licensee of Orexigen's patents until August 2016, at which point the ownership of the NDA was transferred to Orexigen and Takeda's rights to the Orexigen patents were terminated. A bench trial took place in June 2017 and on October 13, 2017, the court issued an opinion finding that the claims of the three patents at issue (U.S. Patent Nos. 7,462,626, 7,375,111 and 8,916,195, which expire in 2024, 2025 and 2030, respectively) were valid and infringed. Actavis filed an appeal, which is pending in the U.S. Court of Appeals for the Federal Circuit (Federal Circuit Appeal), and filed its

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opening appeal brief on February 21, 2018. The Federal Circuit ordered that the appeal be stayed during Orexigen's pending bankruptcy proceedings. On July 27, 2018, Nalpropion acquired worldwide rights to Contrave, including the rights to the patents at issue. Nalpropion filed motions to substitute itself as a party in the appeal and to lift the stay. Those motions were granted on September 19, 2018, allowing the appeal to proceed. Nalpropion's answering was filed on September 28, 2018, and Acatvis's reply appeal brief is due on November 13, 2018. Oral argument is expected sometime in the first half of 2019. If Actavis is successful in the Federal Circuit Appeal, a generic version of Contrave could be launched prior to the expiration of one or more of the patents at issue, which would materially impact Nalpropion's and our financial condition and results of operations. Further, if Contrave infringes or is alleged to infringe intellectual property rights of third parties, we may be adversely affected.

Note 14. Restructuring

On January 4, 2018, the Company committed to and commenced a realignment plan to reduce operating costs and better align our workforce with the needs of our business in anticipation of the expiration of certain patents related to Treximet® (2018 Restructuring). The Company completed the realignment plan on January 5, 2018, resulting in a reduction of our workforce by 41 employees, the majority of which were associated with our sales force and commercial infrastructure. As of September 30, 2018, the Company has incurred $0.8 million in costs related to the 2018 Restructuring, consisting of $0.7 million related to employee termination benefits and $0.1 million related to contract termination costs.

On July 7, 2016, the Company announced a restructuring of its sales force and operations (2016 Restructuring). The 2016 Reorganization included a reduction of 54 sales positions, primarily from the Company's Neurology sales team and reduced its administrative staff by 6 employees. To date, the Company has incurred $2.8 million in costs related to the 2016 Restructuring, consisting of $1.4 million related to employee termination benefits and $1.4 million related to contract termination costs. All associated contract termination cost payments are expected to be made by 2020.

A summary of accrued restructuring costs, included as a component of accounts payable and accrued expenses on the unaudited condensed consolidated balance sheets, is as follows (in thousands):

      December 31,
2017
    Charges     Cash     Non-cash     September 30,
2018
2018 Restructuring    $ -     $ 774    $ (774)   $ -     $ -  
                               
      December 31,
2017
    Charges     Cash     Non-cash     September 30,
2018
2016 Restructuring     $ 265    $ 438    $ (277)   $ -     $ 426 

Note 15. Supplemental Cash Flow Information

Supplemental cash flow information is as follows (in thousands):

      Nine Months Ended
      September 30,
      2018     2017
             
     Cash (received) paid for income taxes, net   $ 29    $ (873)
     Cash paid for interest     24,984      25,920 
Supplemental disclosures of Non-cash Investing and Financing activities:            
     Conversion of Treximet Secured Notes and interest to Common Stock    $ 4,433    $
     Conversion of Treximet Secured Notes and interest to Convertible Preferred Stock      8,100     
     Amount added to principal of Delayed Draw Term Loan and Exchangeable notes for Payment-in-kind (PIK) interest     1,308     
     Conversion of 4.25% Convertible Notes     -       (51,775)
     Issuance of 1,100,498 shares in exchange transaction     -       3,775 
     Issuance of Exchangeable Notes     -       36,243 

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

The following discussion and analysis of our financial condition and results of operations should be read in conjunction with our unaudited condensed consolidated financial statements and the related notes included in "Part I-Item 1. Financial Statements" of this Quarterly Report on Form 10-Q and the condensed consolidated financial statements and notes thereto and Management's Discussion and Analysis of Financial Condition and Results of Operations contained in our Annual Report on Form 10-K for the year ended December 31, 2017. Some of the information contained in this discussion and analysis or set forth elsewhere in this Quarterly Report on Form 10-Q, including information with respect to our plans and strategy for our business and related financing, includes forward-looking statements that involve risks and uncertainties, including, but not limited to, those set forth under "Part I-Item1A. Risk Factors" of our Annual Report on Form 10-K for the year ended December 31, 2017, and "Part II-Item1A. Risk Factors" of our Quarterly Report on Form 10- Q for the three months ended March 31, 2018, our Quarterly Report on Form 10-Q for the three and six months ended June 30, 2018 and this Quarterly Report on Form 10-Q for the three and nine months ended September 30, 2018.

The discussion below contains forward-looking statements within the meaning of Private Securities Litigation Reform Act of 1995. For this purpose, any statements contained herein, other than statements of current or historical fact, including statements regarding our current expectations of our future growth, results of operations, financial condition, cash flows, performance and business prospects, and opportunities and any other statements about management's future expectations, beliefs, goals, plans or prospects, constitute forward-looking statements. We have tried to identify forward-looking statements by using words such as "anticipate," "believe," "could," "estimate," "expect," "intend," "may," "plan," "project," "should," "target," "will," "would" or other words that convey uncertainty of future events or outcomes to identify these forward-looking statements. Among the factors that could cause actual results to differ materially from those indicated in the forward-looking statements are risks and uncertainties inherent in our business including, without limitation: our ability to comply with the covenants under our indebtedness, including our outstanding note securities, and our Credit Facilities; the timing and results of our exploration of strategic alternatives to address our liquidity and capital structure; the rate and degree of market acceptance of, and our ability and our distribution and marketing partners' ability to obtain reimbursement for, any approved products; our ability to successfully execute our sales and marketing strategy, including to successfully recruit and retain sales and marketing personnel; our ability to obtain additional financing; our ability to maintain regulatory approvals for and the ability to continue to market our products and Contrave® (Contrave) in the United States; our ability to successfully manage Nalpropion; our ability to address any adverse impact on our net revenues caused by our ceasing to distribute the combination product isometheptene mucate, dichlorphenazone (IDA), and acetaminophen in compliance with United States Food and Drug Administration (FDA) requirements; the accuracy of our estimates regarding expenses, future revenues and capital requirements; our ability to manage our anticipated future growth; the ability of our products to compete with generic products as well as new products that may be developed by our competitors; our ability and our distribution and marketing partners' ability to comply with regulatory requirements regarding the sales, marketing and manufacturing of our products, the performance of our manufacturers, over which we have limited control; our ability to obtain and maintain intellectual property protection for our products; our ability to operate our business without infringing the intellectual property rights of others; loss of key scientific or management personnel; regulatory developments in the United States. and foreign countries; our ability to either acquire or develop and commercialize other product candidates in addition to our current products; our ability to regain compliance with the Nasdaq Global Market's continued listing rules; the outcome of any litigation to which we may be subject and other risks detailed above in "Part I-Item 1A. Risk Factors" of our Annual Report on Form 10-K for the year ended December 31, 2017 and "Part II-Item1A. Risk Factors" of this Quarterly Report on Form 10-Q for the three months ended March 31, 2018, our Quarterly Report on Form 10-Q for the three and six months ended June 30, 2018 and this Quarterly Report on Form 10-Q for the three and nine months ended September 30, 2018, as well as any amendments thereto reflected in subsequent filings with the SEC.

Although we believe that the expectations reflected in our forward-looking statements are reasonable, we cannot guarantee future results, events, levels of activity, performance or achievement. In addition, any forward-looking statements in this Quarterly Report on Form 10-Q represent our views only as of the date of this Quarterly Report on Form 10-Q and should not be relied upon as representing our views as of any subsequent date. We anticipate that subsequent events and developments may cause our views to change.

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However, while we may elect to update these forward-looking statements publicly at some point in the future, we specifically disclaim any obligation to do so unless required by law, whether as a result of new information, future events or otherwise. Our forward-looking statements do not reflect the potential impact of any acquisitions, mergers, dispositions, business development transactions, joint ventures or investments we may enter into or make in the future. 

Overview

We are a specialty pharmaceutical company focused on improving patients' lives by identifying, developing and commercializing differentiated products that address unmet medical needs. Our strategy is to continue to create shareholder value by:

  • growing sales of the existing products in our portfolio in various ways, including identifying new growth opportunities; and
  • acquiring additional marketed specialty products or products close to regulatory approval to leverage our existing expertise and infrastructure.

We target underserved segments, such as central nervous system (CNS) indications, including pain and neurology. We promote our core branded products to physicians through our sales forces. We market our generic products through our wholly owned subsidiaries, Macoven and Cypress.

Our branded products include Zohydro ER with BeadTek (hydrocodone bitartrate) (Zohydro ER), an extended-release opioid agonist indicated for the management of pain, Silenor, a non-controlled substance and approved medication indicated for the treatment of insomnia characterized by difficulty with sleep maintenance and Treximet, a medication indicated for the acute treatment of migraine attacks, with or without aura, in adults.

Quarterly Update

Departure of Angus Smith, Senior Vice President, Chief Business Officer and Principal Financial Officer

On October 26, 2018, Angus Smith notified the Company of his decision to resign as the Company's Senior Vice President, Chief Business Officer and Principal Financial Officer, effective as of November 23, 2018 (the "Effective Date"), to pursue other opportunities. Mr. Smith will continue in his current role through the Effective Date to assist with the transition of his responsibilities and other related matters.

The Company has designated Glenn Whaley, the Company's Vice President of Finance, Principal Accounting Officer and Corporate Controller, as principal financial officer of the Company to succeed Mr. Smith, effective as of the Effective Date. As of the Effective Date, Mr. Whaley's title will be Vice President of Finance, Principal Financial and Accounting Officer.

2018 Exchange Transactions

On August 1, 2018, we entered into an exchange agreement (2018 Exchange Agreement) with certain holders (Exchange Holders) of our outstanding 12% Senior Secured Notes due 2020 (Treximet Secured Notes) for newly issued shares of our common stock (Common Stock) and shares of a newly created class of our convertible preferred stock designated as 0% Series C Perpetual Convertible Preferred Stock (Convertible Preferred Stock) (Exchange Transactions).

The Exchange Transactions included the following transactions:

  • exchange of approximately $2.7 million aggregate principal amount of the Treximet Secured Notes for 1,204,586 shares of Common Stock which includes $0.2 million of accrued and unpaid interest on the Treximet Secured Notes;
  • exchange of $8.0 million principal amount of the Treximet Secured Notes plus $0.1 million of accrued and unpaid interest for 81,000 shares of Convertible Preferred Stock.

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These transactions closed on August 1, 2018. In addition, the 2018 Exchange Agreement affords the Exchange Holders the right to exchange up to an additional $65.1 million aggregate principal amount of the Treximet Secured Notes plus accrued and unpaid interest, until February 1, 2020.

In addition, on October 3, 2018, holders of 13,100 shares of the Convertible Preferred Stock elected to convert such Convertible Preferred Stock into 548,115 shares of our Common Stock.

The Equitization Exchange Agreements

On August 1, 2018, we entered into separate Equitization Exchange Agreements (the Equitization Exchange Agreements) with certain holders (each, an Equitization Holder, and collectively the Equitization Holders) of our Treximet Secured Notes. Pursuant to the Equitization Exchange Agreements, we issued 650,190 shares of our Common Stock in exchange for approximately $1.5 million aggregate principal amount of Treximet Secured Notes held by such Equitization Holders plus $0.1 million of accrued and unpaid interest thereon (Equitization Transaction). This transaction closed on August 1, 2018.

Amended ABL Facility and Term Facility

On August 1, 2018 we entered into an amendment of our revolving asset-based credit facility agreement by and among us, the guarantors and lenders party thereto and Cantor Fitzgerald Securities, as agent (the ABL Facility), as well as an amendment to our existing delayed draw term loan facility by and among PIP DAC, the lenders party thereto and Cantor Fitzgerald Securities, as agent (the Term Facility and together with the ABL Facility, the Credit Facilities). These amendments were made to permit the exchange of the Treximet Secured Notes into Common Stock in the Exchange Transactions and Equitization Transaction, and to amend certain terms of the Credit Facilities, including (i) certain changes to the borrowing base calculation under the ABL Facility that are intended to improve our borrowing capacity under the ABL Facility and that will also permit us, among other things, to include Contrave inventory owned by us in the calculation of the borrowing base, (ii) changes to permit the use of subsequent draws under the Term Facility for working capital or other general corporate purposes, (iii) a reduction in the commitments under the ABL Facility from $40.0 million to $32.5 million, and (iv) changes to the interest payment provisions under the Term Facility increasing the minimum percentage of interest that must be paid in cash to 6.00% per annum from 4.50% per annum.

Closing of Transactions Regarding Worldwide Rights to Contrave (naltrexone HCl / bupropion HCl)

On April 17, 2018, we entered into a Commitment Letter pursuant to which we committed to provide Nalpropion Pharmaceuticals, Inc. (Nalpropion) with $7.5 million in debt and/or equity capital to fund Nalpropion's purchase of certain assets of Orexigen Therapeutics, Inc. (Orexigen). Nalpropion is a special purpose corporation jointly owned by us and certain other co-investors. Nalpropion submitted a "stalking horse" bid to purchase certain assets of Orexigen, which filed a voluntary petition for relief under Chapter 11 of Title 11 of the United States Code, 11 U.S.C. §§ 101, et seq. in the United States Bankruptcy Court for the District of Delaware.

On April 23, 2018, pursuant to a confidential non-binding term sheet agreement between us and the co-investors in Nalpropion, Nalpropion entered into a "stalking horse" asset purchase agreement (Asset Purchase Agreement) to acquire certain assets of Orexigen, including worldwide rights to Contrave, a prescription-only weight-loss medication, for $75 million in cash.

On June 22, 2018, we announced that no other bids for Orexigen's assets were received by the court-approved bid deadline and on July 27, 2018, Nalpropion acquired substantially all the assets and assumed certain liabilities of Orexigen for approximately $73.5 million in cash. Pursuant to an amendment to the Asset Purchase Agreement that was entered into concurrent with closing of the transaction, the purchase price was reduced to $73.5 million and $5.0 million of the purchase price was held back by Nalpropion to cover potential indemnification claims. On July 27, 2018, we funded PIP DAC's contribution of 10% of the capital required to fund the purchase price for Orexigen of $7.35 million and an incremental $1.82 million for working capital requirements, via its existing Term Facility. The Company owns 10% of the equity and has one of three seats on the Board of Directors of Nalpropion. We determined Nalpropion qualifies as a Variable Interest Entity (VIE) based on its governance structure and contractual relationship with us, therefore we will consolidate Nalpropion in our consolidated financial statements since the we have the power to direct activities that most significantly impacts Nalpropion's economic performance.

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Zohydro ER with BeadTek 20MG

On March 28, 2018 we resumed distribution of the 20 mg dosage strength of Zohydro ER. While our supplier now believes that it has resolved its manufacturing issue, we will experience a temporary stock-out of the 20 mg dosage during the fourth quarter of 2018. We do not believe that this temporary stock-out will have a material impact on the overall prescription volume for Zohydro ER in the fourth quarter.

Launch of Treximet Authorized Generic

On February 14, 2018, four patents covering Treximet expired, enabling up to three generic competitors to enter the market. As of September 30, 2018, three competitors have entered the market. Concurrent with the launch of generics by third parties, we launched an authorized generic version of Treximet and we will also continue to distribute the branded versions of Treximet. We have one additional patent that covers Treximet which will expire in 2026 that we expect to prevent additional generic competitors from entering the market until that time. We expect that generic competition for Treximet will have a material adverse effect on our net revenues for the nine month period ending September 30, 2018 and fiscal year ending December 31, 2018 as compared to the corresponding periods of the fiscal year ending December 31, 2017.

Patent Litigation Concerning Zohydro ER

We announced on January 29, 2018 that we had entered into a settlement agreement with Actavis Laboratories FL (Actavis) resolving patent litigation related to Zohydro ER. The litigation has been pending in the U.S. District Court for the District of Delaware and resulted from Actavis's submission of an ANDA to the FDA seeking approval to market a generic version of Zohydro ER. Under the terms of the agreement, we will grant Actavis a license to begin selling a generic version of Zohydro ER on March 1, 2029, or earlier under certain circumstances.  Other details of the settlement are confidential.  The launch of Actavis's generic product is contingent upon Actavis receiving final approval from the FDA of its ANDA for a generic version of Zohydro ER. The settlement agreement also resolves a pending appeal related to a patent litigation between Recro Gainesville LLC and Actavis, which also relates to Actavis's proposed generic version of Zohydro ER. As required by law, the parties have submitted the settlement agreement to the U.S. Federal Trade Commission and the U.S. Department of Justice for review.

A patent litigation that we previously commenced against Alvogen Malta Operations Ltd. related to Alvogen's proposed generic version of Zohydro ER. For the Alvogen case, trial testimony was heard from June 11-13, 2018, post-trial briefing was completed on July 12, 2018, and the trial concluded with the parties' closing arguments on July 25, 2018. The district court's trial decision was rendered on August 24, 2018, finding the asserted claims of the Zohydro ER patents to be infringed by Alvogen's proposed generic Zohydro ER product and not to be invalid for anticipation under 35 U.S.C. § 102. The district court also found the asserted claims to be invalid for obviousness under 35 U.S.C. § 103 and as lacking adequate written description under 35 U.S.C. § 112. We filed a Notice of Appeal on September 7, 2018, appealing the district court's decision to the United States Court of Appeals for the Federal Circuit. Our opening appellate brief is due no later than November 13, 2018, Alvogen's answering brief is due no later December 24, 2018, and our reply brief is due no later than January 7, 2019. Oral argument on the appeal is expected in second quarter 2019, with a written decision to follow thereafter. Absent a reversal of the Court's decision, pursuant to a previous settlement agreement dated September 29, 2016, between Alvogen and Recro Gainsville LLC, Alvogen can launch a generic version of Zohydro® ER with BeadTek®, subject to final approval of an ANDA from the FDA, as early as October 1, 2019.

Sales Force Restructure

On January 4, 2018, we committed to and commenced a realignment plan to reduce operating costs and better align our workforce with the needs of our business in anticipation of the expiration of certain patents related to Treximet®. We completed the realignment plan on January 5, 2018, resulting in a reduction of our workforce by 41 employees, the majority of which were associated with our sales force and commercial infrastructure. In connection with this commercial reorganization, we expect to realize annualized cost savings of $7.0-$8.0 million beginning in the first quarter of 2018. We recorded a one-time charge of $0.8 million during the nine months ended September 30, 2018 as a result of this realignment.

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Adoption of New Accounting Guidance

Revenue Recognition

On January 1, 2018, we adopted the new accounting standard ASC 606, Revenue from Contracts with Customers (ASC 606) and all the related amendments to all contracts using the modified retrospective method. Upon adoption of ASC 606, we did not initially recognize a cumulative effect of applying the new revenue standard as an adjustment to the opening balance of retained earnings. The comparative information has not been restated and continues to be reported under the accounting standards in effect for those periods. We do not expect the adoption of the new revenue standard to have a material impact on our results of operations for the year ending December 31, 2018. See note 2, Basis of Presentation and Summary of Significant Accounting Policies to our unaudited condensed consolidated financial statements for more information.

Results of Operations

Comparison of Three Months Ended September 30, 2018 and 2017

The following table summarizes our results of operations for the three months ended September 30, 2018 and 2017 and includes the results of Nalpropion (in thousands):

      Three Months Ended            
      September 30,     Increase /      
      2018     2017     (Decrease)     Percent
Net revenues   $ 37,156    40,469    (3,313)     -8%
                         
Costs and operating expenses:                        
     Cost of product sales     11,823      10,580      1,243      12%
     Selling, general and administrative expense     31,872      20,226      11,646      58%
     Research and development expense     1,524      99      1,425      *
     Depreciation and amortization expense     2,391      18,214      (15,823)     -87%
     Loss from disposal and impairments of assets     75      25      50      200%
     Change in fair value of contingent consideration         884      (884)     *
     Gain from legal settlement         (10,476)     10,476      *
     Restructuring costs     (2)     (97)     95      *
Other income (expense):                        
     Interest expense     (10,073)     (9,323)     750      8%
     Change in fair value of derivative liability     18      46      (28)     *
     Gain from exchange of debt     137      14,650      (14,513)     *
     Foreign currency transaction gain (loss)     (843)         (843)     *
Income tax expense (benefit)     61      27      34      *
Net income attributable to noncontrolling interests      9,504          9,504      *

*    Comparison to prior period is not meaningful.

Net Revenues

Net revenues consist of net product sales and revenue from co-promotion and other revenue sharing arrangements or agreements. We recognize product sales net of estimated allowances for product returns, price adjustments (customer rebates, managed care rebates, service fees, chargebacks, coupons and other discounts), government program rebates (Medicaid, Medicare and other government sponsored programs) and prompt pay discounts. The factors that determine our net product sales are the level of demand for our products, unit sales prices, the applicable federal and supplemental government program rebates, contracted rebates, services fees, and chargebacks and other discounts that we may offer such as consumer coupon programs. In addition to our own product portfolio, we have entered into co-promotion agreements and other revenue sharing arrangements with various parties in return for a percentage of sales we generate or on sales they generate.

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The following table sets forth a summary of our net revenues for the three months ended September 30, 2018 and 2017 (in thousands):

      Three Months Ended            
      September 30,     Increase /      
      2018     2017     (Decrease)     Percent
Contrave   $ 16,418    $ -     $ 16,418      *
Treximet     3,369      19,802      (16,433)     -83%
Treximet AG     2,253      -       2,253      *
Zohydro ER     6,655      6,305      350      6%
Silenor     5,596      6,881      (1,285)     -19%
Other     2,586      7,372      (4,786)     -65%
     Net product revenues     36,877      40,360      (3,483)     -9%
Co-promotion and other revenue     279      109      170      156%
Total net revenues   $ 37,156    $ 40,469    $ (3,313)     -8%

*    Comparison to prior period is not meaningful.

Net revenues decreased $3.3 million or 8% during the three months ended September 30, 2018 compared to the three months ended September 30, 2017.

The increase in Contrave net revenues of $16.4 million during the three months ended September 30, 2018 is attributable to Nalpropion's acquisition of Orexigen, which closed on July 27, 2018.

Treximet brand net revenues decreased by $16.4 million, or 83%, during the three months ended September 30, 2018 compared to the three months ended September 30, 2017 due to the loss of exclusivity of Treximet in February 2018 resulting in generic competition. We expect that future Treximet brand revenues will continue to decrease year over year due to the loss of exclusivity. On February 15, 2018, we launched an authorized generic version of Treximet (Treximet AG).

Treximet AG net revenues were $2.3 million during the three months ended September 30, 2018 due to its launch on February 15, 2018. There were no sales of Treximet AG prior to its launch.

Zohydro ER net revenues increased by $0.4 million, or 6%, during the three months ended September 30, 2018 compared to the three months ended September 30, 2017. The increase was due to an increase in net price of $0.6 million (related to favorable gross to net accrual rates), partially offset by lower sales volume of $0.2 million.

Silenor net revenues decreased by $1.3 million, or 19%, during the three months ended September 30, 2018 compared to the three months ended September 30, 2017. The decrease was due to a decrease in net price of $1.6 million (primarily related to a $1.0 million favorable settlement with one of our customers in the prior year), partially offset by higher sales volume of $0.3 million.

Net product revenues - other decreased by $4.8 million, or 65%, during the three months ended September 30, 2018 compared to the three months ended September 30, 2017. The decrease was due primarily to discontinuation of products no longer sold of $3.7 million, including IDA.

Cost of Product Sales

Cost of product sales increased by $1.2 million, or 12%, during the three months ended September 30, 2018 compared to the three months ended September 30, 2017. There was a $5.4 million increase in costs of product sales which was attributable to Nalpropion's acquisition of Contrave and increased Zohydro ER, and Treximet AG product costs of $0.8 million and $0.3 million, respectively, due to increased volume. This increase was partially offset by a $3.3 million decrease reflecting lower Treximet brand sales as a result of generic competition, combined with a $2.0 million decrease in our other product revenue (primarily related to discontinued products).

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Selling, General and Administrative Expense

Selling, general and administrative expense increased by $11.7 million, or 58%, during the three months ended September 30, 2018 compared to the three months ended September 30, 2017.  The increase is attributable primarily to Nalpropion's acquisition of Orexigen which resulted in selling, general and administrative expenses of $17.1 million. This increase was partially offset by lower sales force related expenses of $2.6 million due to the restructuring announced in January 2018, lower marketing and selling expenditures of $1.0 million related primarily to Treximet due to the loss of exclusivity, $0.6 million of lower deal costs as well as $1.2 million of lower spend across numerous areas.

Research and Development Expense

Research and development expense increased by $1.4 million during the three months ended September 30, 2018 compared to the three months ended September 30, 2017 and is attributable primarily to Nalpropion's acquisition of Orexigen which incurred research and development costs of $1.5 million partially offset by discontinuation of certain Zohydro-related research projects.

Depreciation and Amortization Expense

Depreciation and amortization expense decreased by $15.8 million, or 87%, during the three months ended September 30, 2018 compared to the three months ended September 30, 2017. The decrease was related primarily to Treximet intangible assets becoming fully amortized upon the expiration of certain underlying patents and the loss of its exclusivity in February 2018, partially offset by increased depreciation and amortization expense of $1.0 million related to Nalpropion's acquisition of Orexigen.

Change in Fair Value of Contingent Consideration

For the acquisition of Zohydro ER, we initially recorded $14.2 million of contingent consideration. The fair value of the contingent consideration linked to FDA approval was $2.7 million and the fair value of the contingent consideration linked to achievement of the net sales target was $11.5 million. As of September 30, 2018, the current fair value of the contingent consideration was approximately $1.5 million. We recorded a benefit of $0 and $884,000 as change in fair value of contingent consideration in the three months ended September 30, 2018 and 2017, respectively.

Restructuring Costs

Restructuring costs were a benefit of $2,000 and $97,000 during the three months ended September 30, 2018 and 2017, respectively, due primarily to the 2016 initiatives to restructure our sales force and operations.

Interest Expense

Interest expense increased by $0.8 million, or 8%, during the three months ended September 30, 2018 compared to the three months ended September 30, 2017. The increase was related primarily to higher borrowings under the Delayed Draw Term Loan (DDTL), which was used to fund our investment in Nalpropion and an increase in borrowings under the 2018 Term Loan as a result of Nalpropion's acquisition of Orexigen. These increases were offset partially by reduced interest expense on our Treximet Secured Notes due to the lower principal balance.

Change in Fair Value of Derivative Liability

We are required to separate the conversion option in the 4.25% Convertible Senior Notes Due 2021 (4.25% Convertible Notes) under ASC 815, Derivatives and Hedging. We recorded the bifurcated conversion option valued at $28.5 million at issuance, as a derivative liability, which creates additional discount on the debt. The derivative liability is marked to market through the other income (expense) section on the unaudited condensed consolidated statements of operations for each reporting period. We recorded a benefit of $18,000 and $46,000 as change in fair value of derivative liability in other income (expense) in the three months ended September 30, 2018 and 2017, respectively.

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Gain from Exchange of Debt

During the three months ended September 30, 2018, certain holders of the Treximet Secured Notes exchanged a total of $4.4 million in principal and accrued interest for Common Stock under the 2018 Exchange Agreement and the Equitization Exchange Agreements, which resulted in an extinguishment of deferred financing fees of $0.3 million. In addition, certain holders of the Treximet Secured Notes exchanged $8.1 million in principal and accrued interest for $7.7 million of Convertible Preferred Stock and resulted in a gain on extinguishment of $0.4 million. The combined effect of these transactions resulted in a net $0.1 million gain from the exchange of the Treximet Secured Notes during the three months ended September 30, 2018.

We recorded a gain of $14.7 million during the three months ended September 30, 2017 related to the Exchange Agreement. In July 2017, certain holders of the 4.25% Convertible Notes exchanged $51.8 million in principal notes for $36.2 million of 4.25%/5.25% Exchangeable Senior Notes due 2022 (the Exchangeable Notes).

Net loss attributable to noncontrolling interests

In accordance with the accounting consolidation principles, we consolidated Nalpropion which neither we nor our subsidiaries owned 100%, into our consolidated financial statements. Net loss attributable to noncontrolling interests relates to the portion of the net loss of Nalpropion not attributable, directly or indirectly, to our ownership interests. We recognized $9.5 million during the three months ended September 30, 2018 as a result of the Nalpropion transaction.

Income Tax Expense

We reported an income tax expense of $61,000 and $27,000 for the three months ended September 30, 2018 and 2017, respectively.

Comparison of Nine Months Ended September 30, 2018 and 2017

The following table summarizes our results of operations for the nine months ended September 30, 2018 and 2017 and includes the results of Nalpropion (in thousands):

      Nine Months Ended            
      September 30,     Increase /      
      2018     2017     (Decrease)     Percent
Net revenues   $ 86,383    104,527    (18,144)     -17%
                         
Costs and operating expenses:                        
     Cost of product sales     26,353      31,113      (4,760)     -15%
     Selling, general and administrative expense     67,412      59,519      7,893      13%
     Research and development expense     1,534      709      825      116%
     Depreciation and amortization expense     13,686      54,976      (41,290)     -75%
     Change in fair value of contingent consideration     143      344      (201)     *
     Loss from disposal and impairments of assets     75      25      50      *
     Gain from legal settlement         (10,476)     10,476      *
     Restructuring costs     1,212      34      1,178      *
Other income (expense):                        
     Interest expense     (29,063)     (27,491)     1,572      6%
     Gain on sale of assets     446          (446)     *
     Change in fair value of derivative liability     39      (38)     77      *
     Gain from exchange of debt     137      14,650      (14,513)     *
     Foreign currency transaction gain     (864)         (864)     *
Income tax expense (benefit)     109      122      13      *
Net income attributable to noncontrolling interests      9,504          9,504      *

*    Comparison to prior period is not meaningful.

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The following table sets forth a summary of our net revenues for the nine months ended September 30, 2018 and 2017 (in thousands):

      Nine Months Ended            
      September 30,     Increase /      
      2018     2017     (Decrease)     Percent
Contrave   16,418    -     16,418      *
Treximet     17,221      50,412      (33,191)     -66%
Treximet AG     7,135      -       7,135      *
Zohydro ER     21,937      17,955      3,982      22%
Silenor     17,299      15,580      1,719      11%
Other     5,738      20,335      (14,597)     -72%
     Net product revenues     85,748      104,282      (18,534)     -18%
Co-promotion and other revenue     635      245      390      159%
Total net revenues   $ 86,383    $ 104,527    $ (18,144)     -17%

*    Comparison to prior period is not meaningful.

Net revenues decreased $18.1 million or 17% during the nine months ended September 30, 2018 compared to the nine months ended September 30, 2017.

The increase in Contrave net revenues of $16.4 million during the nine months ended September 30, 2018 was attributable to Nalpropion's acquisition of Orexigen which closed on July 27, 2018.

Treximet brand net revenues decreased by $33.2 million, or 66%, during the nine months ended September 30, 2018 compared to the nine months ended September 30, 2017 due to the loss of exclusivity of Treximet in February 2018 resulting in generic competition. We expect that future Treximet brand revenues will continue to decrease year over year due to the loss of exclusivity. On February 15, 2018, we launched Treximet AG.

Treximet AG net revenues were $7.1 million during the nine months ended September 30, 2018 due to its launch on February 15, 2018. There were no sales of Treximet AG prior to its launch.

Zohydro ER net revenues increased by $4.0 million, or 22%, during the nine months ended September 30, 2018 compared to the nine months ended September 30, 2017. The increase was due to an increase in net price of $1.8 million (primarily related to favorable gross to net accrual rates) and sales volume of $2.2 million.

Silenor net revenues increased by $1.7 million, or 11%, during the nine months ended September 30, 2018 compared to the nine months ended September 30, 2017. The increase was primarily due to an increase in sales volume of $2.1 million partially offset by a decrease in net price of $0.4 million (primarily related a $1.0 million favorable settlement with one of our customers in the prior year).

Net product revenues - other decreased by $14.6 million, or 72%, during the nine months ended September 30, 2018 compared to the nine months ended September 30, 2017. The decrease was due primarily to discontinuation of products no longer sold of $10.7 million, including IDA, and increased competitive and pricing pressures on our generics portfolio.

Cost of Product Sales

Cost of product sales decreased by $4.8 million, or 15%, during the nine months ended September 30, 2018 compared to the nine months ended September 30, 2017. The decrease in cost of product sales was due primarily to a $7.1 million decrease as a result of lower Treximet brand sales as a result of generic competition combined with $6.0 million decrease in our other product revenue (primarily related to discontinued products), partially offset by (i) a $5.4 million increase in costs of product sales attributable to Nalpropion's acquisition of Contrave and (ii) increased Zohydro ER, Treximet AG and Silenor product costs of $1.8 million, $0.6 million and $0.5 million, respectively due to increased volume.

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Selling, General and Administrative Expense

Selling, general and administrative expense increased by $8.0 million, or 13%, during the nine months ended September 30, 2018 compared to the nine months ended September 30, 2017.  The increase is attributable primarily to Nalpropion's acquisition of Orexigen which resulted in selling, general and administrative expenses of $17.1 million. The increase was partially offset by lower sales force related expenses of $7.1 million due to the restructuring announced in January 2018, lower marketing and selling expenditures of $2.7 million related primarily to Treximet due to the loss of exclusivity, as well as $1.7 million of lower spend across numerous areas, partially offset by higher legal fees of $2.4 million related primarily to patent defense and legal settlements.

Research and Development Expense

Research and development expense increased by $0.8 million during the nine months ended September 30, 2018 compared to the nine months ended September 30, 2017 and is attributable primarily to Nalpropion's acquisition of Orexigen which resulted in research and development costs of $1.5 million partially offset by discontinuation of certain Zohydro-related research projects.

Depreciation and Amortization Expense

Depreciation and amortization expense decreased by $41.3 million, or 75%, during the nine months ended September 30, 2018 compared to the nine months ended September 30, 2017. The decrease was related primarily to Treximet intangible assets becoming fully amortized upon the expiration of certain underlying patents and the loss of its exclusivity in February 2018, partially offset by increased depreciation and amortization expense of $1.0 million related to Nalpropion's acquisition of Orexigen.

Change in Fair Value of Contingent Consideration

For the acquisition of Zohydro ER, we initially recorded $14.2 million of contingent consideration. The fair value of the contingent consideration linked to FDA approval was $2.7 million and the fair value of the contingent consideration linked to achievement of the net sales target was $11.5 million. As of September 30, 2018, the current fair value of the contingent consideration was approximately $1.5 million. We recorded expense of $0.1 million and $0.3 million as change in fair value of contingent consideration in the nine months ended September 30, 2018 and 2017, respectively.

Restructuring Costs

Restructuring costs were $1.2 million and $34,000 during the nine months ended September 30, 2018 and 2017, respectively, due to the 2018 and 2016 initiatives to restructure our sales force and operations.

Interest Expense

Interest expense increased by $1.6 million, or 6%, during the nine months ended September 30, 2018 compared to the nine months ended September 30, 2017. The increase was related primarily to (i) increased borrowings under the DDTL which was used to fund our investment in Nalpropion (ii) higher average interest rates under our ABL Facility, and (iii) an increase in borrowings under the 2018 Term Loan as a result of Nalpropion's acquisition of Orexigen. These increases were offset partially by reduced interest expense on our Treximet Secured Notes due to the lower principal balance.

Change in Fair Value of Derivative Liability

We are required to separate the conversion option in the 4.25% Convertible Notes under ASC 815, Derivatives and Hedging. We recorded the bifurcated conversion option valued at $28.5 million at issuance, as a derivative liability, which creates additional discount on the debt. The derivative liability is marked to market through the other income (expense) section on the unaudited condensed consolidated statements of operations for each reporting period. We recorded a benefit of $39,000 and an expense of $38,000 as change in fair value of derivative liability in other income (expense) in the nine months ended September 30, 2018 and 2017, respectively.

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Gain from Exchange of Debt

During the nine months ended September 30, 2018, certain holders of the Treximet Secured Notes exchanged a total of $4.4 million in principal and accrued interest for Common Stock under the 2018 Exchange Agreement and the Equitization Exchange Agreements, which resulted in an extinguishment of deferred financing fees of $0.3 million. In addition, certain holders of the Treximet Secured Notes exchanged $8.1 million in principal and accrued interest for $7.7 million of Convertible Preferred Stock and resulted in a gain on extinguishment of $0.4 million. The combined effect of these transactions resulted in a net $0.1 million gain from the exchange of the Treximet Secured Notes during the nine months ended September 30, 2018.

We recorded a gain of $14.7 million during the nine months ended September 30, 2017 related to the Exchange Agreement. In July 2017, certain holders of the 4.25% Convertible Notes exchanged $51.8 million in principal notes for $36.2 million in Exchangeable Notes.

Net loss attributable to noncontrolling interests

In accordance with the accounting consolidation principles, we consolidated Nalpropion which neither we nor our subsidiaries owned 100%, into our consolidated financial statements. Net loss attributable to noncontrolling interests relates to the portion of the net loss of Nalpropion not attributable, directly or indirectly, to our ownership interests. We recognized $9.5 million during the nine months ended September 30, 2018 as a result of the Nalpropion transaction.

Income Tax Expense

We reported an income tax expense of $109,000 and $122,000 for the nine months ended September 30, 2018 and 2017, respectively.

Non-GAAP Financial Measures

To supplement our financial results determined by GAAP, we have disclosed in the table below adjusted earnings before interest, taxes, depreciation and amortization (EBITDA).

Adjusted EBITDA is a non-GAAP financial measure that excludes the impact of certain items and, therefore, has not been calculated in accordance with GAAP.  This non-GAAP financial measure excludes from net loss: interest expense; depreciation and amortization; income tax expense; inventory step-up amortization, selling, general and administrative adjustments; gain from sale of non-core assets; change in fair value of contingent consideration; loss from disposal and impairment of assets; gain from exchange of debt; change in fair value of derivative liability; restructuring costs; and foreign currency transactions.  In addition, from time to time in the future there may be other items that we may exclude for the purposes of our use of adjusted EBITDA; likewise, we may in the future cease to exclude items that we have historically excluded for the purpose of adjusted EBITDA.  We believe that adjusted EBITDA provides meaningful supplemental information regarding our operating results because it excludes or adjusts amounts that management and the board of directors do not consider part of core operating results or that are non-recurring when assessing the performance of the organization.  We believe that inclusion of adjusted EBITDA provides consistency and comparability with past reports of financial results and provides consistency in calculations by outside analysts reviewing our results.  Accordingly, we believe that adjusted EBITDA is useful to investors in allowing for greater transparency of supplemental information used by management.

We believe that these non-GAAP financial measures are helpful in understanding our past financial performance and potential future results, but there are limitations associated with the use of these non-GAAP financial measures. These non-GAAP financial measures are not prepared in accordance with GAAP, do not reflect a comprehensive system of accounting and may not be completely comparable to similarly titled measures of other companies due to potential

47


differences in the exact method of calculation between companies. Adjustment items that are excluded from our non-GAAP financial measures can have a material impact on net earnings. As a result, these non-GAAP financial measures have limitations and should not be considered in isolation from, or as a substitute for, net loss, cash flow from operations or other measures of performance prepared in accordance with GAAP. We compensate for these limitations by using these non-GAAP financial measures as a supplement to GAAP financial measures and by reconciling the non-GAAP financial measure to its most comparable GAAP financial measure. Investors are encouraged to review the reconciliations of the non-GAAP financial measure to its most comparable GAAP financial measure that is included below in this Quarterly Report on Form 10-Q.

Reconciliation of GAAP reported net loss to adjusted EBITDA is as follows (in thousands):

      Three Months Ended     Nine Months Ended
      September 30,     September 30,
      2018     2017     2018     2017
Net income (loss) attributable to common stockholders   $ (11,845)   $ 6,360    $ (43,942)   $ (44,718)
Add: Net loss attributable to noncontrolling interests     (9,504)         (9,504)    
Adjustments:                        
     Interest expense     10,073      9,323      29,063      27,491 
     Depreciation and amortization      2,422      18,243      13,773      55,064 
     Income tax expense     61      27      109      122 
EBITDA     (8,793)     33,953      (10,501)     37,959 
     Inventory step-up amortization(1)     2,239          2,239     
     Selling, general and administrative adjustments (2)     5,059      1,985      8,190      3,720 
     Gain from sale of non-core asset (3)             (446)    
     Change in fair value of contingent consideration (4)         884      143      344 
     Loss from disposal and impairment of assets (5)     75      25      75      25 
     Gain from exchange of debt (6)     (137)     (14,650)     (137)     (14,650)
     Change in fair value of derivative liability (7)     (18)     (46)     (39)     38 
     Restructuring costs (8)     (2)     (97)     1,212      34 
     Gain from legal settlement (9)         (10,476)         (10,476)
     Foreign currency transaction (gain) loss (10)     843          864     
Adjusted EBITDA   $ (734)   $ 11,578    $ 1,600    $ 16,994 

________________

(1)

Excludes inventory step-up amortization recorded as part of Nalpropion's acquisition of Orexigen.

(2)

Excludes deal costs of $4.6 million and $1.3 million; stock compensation expense of $0.4 million and $0.5 million; severance expense of $16,000 and $0.2 million; and litigation settlement expenses of $25,000 and $20,000 for the three months ended September 30, 2018 and 2017, respectively. Also excludes deal costs of $5.4 million and $1.5 million; stock compensation expense of $1.3 million and $1.9 million; severance expense of $0.1 million and $0.2 million; and arbitration and litigation settlement expenses of $1.3 million and $38,000 for the nine months ended September 30, 2018 and 2017, respectively.

(3)

Excludes the gain from the sale of certain obsolete equipment.

(4)

Excludes loss from change in fair value of contingent consideration related to the 2015 acquisition of Zohydro ER and is linked to the achievement of certain net sales targets. Any change in fair values between the reporting dates is recognized in the condensed consolidated statements of operations.

(5)

Excludes loss from impairment of other assets.

(6)

Excludes $0.1 million gain related to the Exchange Transaction and the Equitization Transaction in the three and nine months ended September 2018. For the three and nine months ended September 30, 2017, excludes a $14.7 million gain related to the July 2017 financing transactions in which certain holders of the 4.25% Convertible Notes exchanged $51.8 million in principal notes for $36.2 million in Exchangeable Notes.

(7)

Excludes changes in fair value of derivative liability consideration. We are required to separate the conversion option in the 4.25% Convertible Notes under ASC 815, Derivatives and Hedging. We recorded the bifurcated conversion option valued at $28.5 million at issuance, as a derivative liability, which created additional discount on the debt. The derivative liability is marked to market through the other income (expense) section on the condensed consolidated statements of operations for each reporting period.

(8)

Excludes the cost related to the initiative to restructure our sales force and operations for the three and nine months ended September 30, 2018 and 2017.

(9)

Excludes $10.5 million gain from Pernix and GSK amended settlement agreement resulting from Amendment NO. 2 to the Interim Settlement Agreement with GSK under which Pernix paid approximately $6.7 million to GSK (potentially up to $8.7 million), which is a reduction of up to approximately $14.5 million from the initial settlement agreement.

(10)

Excludes losses on foreign currency transactions primarily related to Nalpropion's operations.

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Liquidity and Capital Resources

The following table summarizes our liquidity and capital resources (amounts in thousands):

      September 30,     December 31,
      2018     2017
Cash and cash equivalents   $ 24,511    $ 32,820 
Total current assets     120,723      92,284 
Current debt (1)     -       3,664 
Arbitration award (2)     2,000      2,000 
Non-current debt (1)     322,457      278,489 
Stockholders' deficit   $ (172,282)   $ (174,257)

(1)

The table below lists the total Borrowings, the note discount, and the deferred financing costs that when combined equal the components of current and non-current book value of the debt listed on our condensed consolidated balance sheets at September 30, 2018 and December 31, 2017, respectively. See Note 10, Debt and Lines of Credit to our condensed consolidated financial statements.

As of September 30, 2018

      Total     Note     Deferred Financing     Book
      Borrowings     Discount     Costs (a)     Value
4.25% Convertible Notes   $ 78,225    $ (8,828)   $ (1,574)   $ 67,823 
Exchangeable Notes     36,145      (22,913)     (3,202)     10,030 
2018 Term Loan     41,250      -       -       41,250 
Delayed Draw Term Loan     40,074      -       (2,269)     37,805 
Treximet Secured Notes - Long Term     154,515      -       (3,151)     151,364 
Treximet Secured Notes - Short Term     -       -       -       -  
ABL Facility     14,185      -       -       14,185 
     Balance at September 30, 2018   $ 364,394    $ (31,741)   $ (10,196)   $ 322,457 

As of December 31, 2017

      Total     Note     Deferred Financing     Book
      Borrowings     Discount     Costs (a)     Value
4.25% Convertible Notes   $ 78,225    $ (11,060)   $ (1,971)   $ 65,194 
Exchangeable Notes     35,743      (24,363)     (3,405)     7,975 
Delayed Draw Term Loan     30,000      -       (2,752)     27,248 
Treximet Secured Notes - Long Term     166,697      -       (2,810)     163,887 
Treximet Secured Notes - Short Term     5,373      -       (1,709)     3,664 
ABL Facility     14,185      -       -       14,185 
     Balance at December 31, 2017 (a)   $ 330,223    $ (35,423)   $ (12,647)   $ 282,153 

__________________________

(a)

We reclassified capitalized debt issuance costs of approximately $1.5 million from "Prepaid expenses and other current assets" to our long-term debt instruments within "Total liabilities" except for those related to revolving credit facilities to conform to the current period presentation. This reclassification had no effect on previously reported results of operations, financial position or cash flows.

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(2) GSK Arbitration

Relates to obligations associated with our arbitration proceeding with GSK. We had been engaged in an arbitration proceeding with GSK relating to an alleged breach by us of a covenant contained in the Asset Purchase and Sale Agreement, dated May 13, 2014, by and among GSK and its affiliates and us pertaining to a pre-existing customer agreement. The parties entered into an interim settlement agreement (the Interim Settlement Agreement) in July 2015 under which we paid approximately $10.3 million to GSK and escrowed an additional amount of approximately $6.2 million. On January 31, 2017, the arbitration tribunal issued opinions in favor of GSK, awarding it damages and fees in the amount of approximately $35.0 million, plus interest (estimated to be approximately $2.0 to $5.0 million). On March 17, 2017, we entered into Amendment No.1 to the Interim Settlement Agreement with GSK whereby we agreed to establish a payment schedule for satisfaction of the current balance of the award.

On July 20, 2017, we and GSK entered into Amendment No. 2 to the Interim Settlement Agreement.  Amendment No. 2 superseded Amendment No. 1 and permitted payment by us to GSK of a reduced amount in full satisfaction of the remaining approximately $21.2 million unpaid portion of the award granted to GSK in the arbitration of certain matters previously disputed by the parties.  Pursuant to Amendment No. 2, we were obligated to make two fixed payments to GSK: (i) a payment of $3.45 million due on or before August 4, 2017 and (ii) a payment of $3.2 million due on or before December 31, 2017. Both of these payments were made as of December 31, 2017. Also pursuant to Amendment No. 2, we agreed that if on or before September 30, 2019, we (x) redeem or repurchase our 4.25% Convertible Notes for greater than 31 cents for every one dollar of principal amount outstanding or (y) exchange such notes for new notes or similar instruments that have a face value providing such exchanging holders a recovery that is greater than 31 cents for every one dollar of 4.25% Convertible Notes exchanged by such holders, we shall, no later than five business days thereafter, distribute to GSK additional cash or notes, as applicable, equal to such excess recovery, but in no event to exceed $2.0 million. GSK has agreed that for so long as we comply with the payment terms set forth in the Amendment No. 2, enforcement of the award will be stayed and GSK shall not seek to enforce or exercise any other remedies in respect of the award, and that the outstanding balance of the Award shall be unconditionally and irrevocably forgiven upon satisfaction of such terms. As of September 30, 2018, and December 31, 2017, we recorded $2.0 million as contingent consideration for the potential payment due by September 30, 2019 and is recorded in other liabilities - current and Arbitration award, respectively, on our condensed consolidated balance sheets Also, we recorded $10.5 million as gain from legal settlement for the year ended December 31, 2017 pursuant to Amendment No. 2 in the consolidated statements of operations and comprehensive loss.

During the nine months ended September 30, 2018 and 2017 we utilized cash from operations of $25.4 million and $9.2 million respectively.

As of September 30, 2018, we had cash and cash equivalents of $24.5 million and borrowing availability of $6.8 million under our ABL Facility.

We have an effective shelf registration statement on Form S-3 with the SEC, which covers the offering, issuance and sale of up to $150.0 million of our Common Stock, preferred stock, debt securities, warrants, subscription rights and units. The shelf registration statement includes a sales agreement prospectus covering the offering, issuance and sale of up to $10.0 million shares of our Common Stock that may be issued and sold under the Controlled Equity Offering Sales Agreement, dated November 7, 2014, between us and Cantor Fitzgerald & Co. as agent. We sold 191,170 and 680,926 shares of Common Stock under this controlled equity program during the nine months ended September 30, 2018 and the year ended December 31, 2017, respectively, for net proceeds of $453,000 and $2.0 million during the nine months ended September 30, 2018 and the year ended December 31, 2017, respectively.

As a result of the Exchange Transactions announced on August 1, 2018, the principal amount of our Treximet Secured Notes outstanding at September 30, 2018 was reduced by $12.2 million to $154.5 million, resulting in an annual interest savings of $1.5 million. The amendment to our Term Facility provides us with access to up to $5.8 million of the delayed draw feature for working capital purposes, further enhancing our liquidity. In addition, the ABL Facility amendment includes changes to the borrowing base calculation, which provides for, among other revisions, the inclusion of Contrave® inventory owned by us going forward. As such, we believe that this amendment will create additional borrowing capacity under the ABL Facility. 

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On July 27, 2018, we funded the contribution, which contribution was made by PIP DAC, our wholly owned subsidiary, of 10% of the capital, or $7.35 million, required to fund Nalpropion's acquisition of Orexigen and an incremental $1.8 million for working capital requirements, via our existing DDTL. On July 27, 2018, Nalpropion acquired substantially all the assets and assumed certain liabilities of Orexigen for approximately $73.5 million in cash.

Our future capital requirements will depend on many factors, including:

  • the level of product sales of our currently marketed products and any additional products that we may market in the future;
  • the extent to which we acquire or invest in products, businesses and technologies;
  • the level of inventory purchase commitments under supply, manufacturing, license and/or co-promotion agreements;
  • the scope, progress, results and costs of development activities for our current product candidates;
  • the costs, timing and outcome of regulatory review of our product candidates;
  • the number of, and development requirements for, additional product candidates that we pursue;
  • the costs of commercialization activities, including product marketing, sales and distribution;
  • the costs and timing of establishing manufacturing and supply arrangements for clinical and commercial supplies of our product candidates and products;
  • the extent to which we choose to establish collaboration, co-promotion, distribution or other similar arrangements for our marketed products and product candidates;
  • the costs of and any judgments resulting from legal proceedings;
  • the principal and interest payments due under the Treximet Secured Notes, 4.25% Convertible Notes and 4.25%/5.25% Exchangeable Senior Notes due 2022 (Exchangeable Notes), as applicable;
  • our ability to draw down on our Credit Facilities;
  • our obligations to make cash payments under our indebtedness; and
  • the costs of preparing, filing and prosecuting patent applications and maintaining, enforcing and defending claims related to intellectual property owned by or licensed to us.

Going Concern

As of October 17, 2018, we were not in compliance with certain Nasdaq Global Market listing requirements. Our outstanding 4.25% Convertible Notes in the principal amount of $78.2 million contain redemption features in the event we are not able to maintain our Nasdaq Global Market listing. In addition, our outstanding Exchangeable Notes in the principal amount of $36.1 million contain redemption features in the event we are not able to maintain any Nasdaq listing. These factors raise substantial doubt about our ability to continue as a going concern within one year after the date that these financial statements are issued. We continue to seek other sources of capital and alternatives, however, if we are unable to raise sufficient capital or maintain our Nasdaq listing to prevent the redemption of our outstanding indebtness, we will not have sufficient liquidity to fund our business operations for at least the next year following the date that the financial statements are issued.  The financial statements do not include any adjustments relating to the recoverability and classification of recorded asset amounts or the amounts and classification of liabilities that might be necessary should we be unable to continue as a going concern.

We are analyzing various strategic alternatives to proactively address our liquidity and capital structure in a constructive manner, including a range of potential strategic alternatives. These alternatives could include, among other things, the sale of part or all of our company, a merger with another party or other strategic transaction or a restructuring or recapitalization. Our Board of Directors has not made any decisions related to any strategic alternatives at this time. There can be no assurance that the exploration of strategic alternatives will result in the consummation of a transaction or other strategic alternative of any kind.

Nasdaq Deficiency Notices

On October 17, 2018, we received notice, or the Minimum Market Value of Publicly Held Shares Notice, from Nasdaq that we are not currently in compliance with the $15 million minimum market value of publicly held shares requirement of Nasdaq Listing Rule 5450(b)(3)(C). The Minimum Market Value of Publicly Held Shares Notice indicated that, consistent with Nasdaq Listing Rule 5810(c)(3)(D), we have until April 15, 2019 to regain compliance with the minimum market value of publicly held shares requirement by having the closing market value of publicly held shares, calculated by multiplying the closing bid price of the Common Stock by our total shares outstanding (less any shares held by officers, directors or beneficial owners of 10% or more of the total shares outstanding ), meet or exceed $15 million for at least ten consecutive business days.

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On October 19, 2018, we received notice, or the Minimum Bid Price Notice, from Nasdaq that we are not currently in compliance with the $1.00 minimum closing bid price requirement of Nasdaq Listing Rule 5450(a)(1). The Minimum Bid Price Notice indicated that, consistent with Nasdaq Listing Rule 5810(c)(3)(A), we have until April 17, 2019 to regain compliance with the minimum bid price requirement by having the closing bid price of the Common Stock meet or exceed $1.00 per share for at least ten consecutive business days. If we do not regain compliance with the minimum bid price requirement by April 17, 2019, we may be eligible to transfer the listing of the Common Stock from the Nasdaq Global Market to the Nasdaq Capital Market if, at the time of such transfer, we meet the initial listing requirement for market value of publicly held shares ($1 million) and all other initial listing standards for the Nasdaq Capital Market (except for the minimum bid price requirement) and provide Nasdaq with written notice of our intention to cure the minimum bid price requirement deficiency. In response, Nasdaq may provide us with an additional 180 day period to satisfy the minimum bid price requirement. However, if it appears to the Nasdaq staff that we will not be able to cure the deficiency, or if we are otherwise not eligible, Nasdaq will provide notice to us that the Common Stock will be subject to delisting pursuant to Nasdaq's delisting procedures.

The notices do not result in the immediate delisting of the Common Stock from the Nasdaq Global Market. We intend to monitor the closing bid price of the Common Stock and our market value of publicly held shares and consider our available options in the event that the closing bid price of the Common Stock remains below $1.00 per share or our market value of publicly held shares remains below $15 million, including seeking to transfer to the Nasdaq Capital Market. There can be no assurance that we will be able to regain compliance with the minimum bid price requirement, even if we transfer to the Nasdaq Capital Market for the additional 180-day compliance period with respect to the minimum bid price requirement, or market value of publicly held shares requirement or maintain compliance with the other listing requirements.

If the Common Stock is delisted from the Nasdaq Global Market, the holders of the Convertible Notes and the Exchangeable Notes would have the right to require the Company (in the case of the Convertible Notes) or PIP DAC (in the case of the Exchangeable Notes) to repurchase all of the Convertible Notes and Exchangeable Notes owned by such holders at a price equal to 100% of the principal amount thereof, plus any accrued and unpaid interest thereon, within 35 business days following the Company or PIP DAC giving notice to such holders of the delisting. The Company's or PIP DAC's failure to pay such amounts when due would result in a default under the indentures governing the Convertible Notes or the Exchangeable Notes, as the case may be, which would ripen into an event of default immediately under the indenture governing the Convertible Notes, and within five days of becoming due under the indenture governing the Exchangeable Notes. Further, an event of default under either of these indentures would result in a cross-default under the Delayed Draw Term Loan as well as the ABL Facility, which could result in indebtedness outstanding under those instruments to become immediately due and payable. In addition, any acceleration of the debt under the Convertible Notes, the Exchangeable Notes, the Delayed Draw Term Loan or the ABL Facility would trigger an event of default under the indenture governing the Treximet Secured Notes, which could result in such indebtedness becoming immediately due and payable.

Cash Flows

The following table provides information regarding our cash flows for the nine months ended September 30, 2018, and 2017 (in thousands).

      Nine Months Ended
      September 30,
      2018     2017
Operating activities   $ (25,395)   $ (9,218)
Investing activities     (68,918)     (5)
Financing activities     85,902     89
Effect of exchange rate changes on cash and cash equivalents     102     -
Net decrease in cash and cash equivalents   $ (8,309)   $ (9,134)

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Comparison of the Nine Months Ended September 30, 2018 and 2017

Net cash used in operating activities

Net cash used in operating activities during the nine months ended September 30, 2018 was $25.4 million, an increase of $16.2 million from cash used in operating activities during the nine months ended September 30, 2017 of $9.2 million. The cash used in operating activities includes the operating activities of Nalpropion during the nine months ended September 30, 2018 and was driven by the consolidated companies' net loss of $53.4 million. This use was partially offset by non-cash expenses totaling $25.7 million and net changes in operating assets/liabilities of $2.3 million. The $9.2 million used in operating activities during the nine months ended September 30, 2017 was driven primarily by a net loss of $44.7 million and net changes in operating assets/liabilities of $3.0 million. This use was partially offset by non-cash expenses totaling $38.5 million.

Net cash used in investing activities

Net cash used in investing activities during the nine months ended September 30, 2018 was $68.9 million compared to a use of $5,000 during the nine months ended September 30, 2017, resulting from the purchase of Orexigen by Nalpropion for cash consideration of $69.3 million.

Net cash provided by financing activities

Net cash provided by financing activities during the nine months ended September 30, 2018 was $85.9 million and primarily reflects the following activity:

  • 2018 Term Loan proceeds of $45.8 million of which $4.5 million was provided by the PIP DAC (eliminated in consolidation), and $41.3 million was provided by certain co-investors. The proceeds were used to fund Nalpropion's acquisition of Orexigen and for working capital requirements.
  • Capital contributions of $41.3 million from certain co-investors, which was used to fund Nalpropion's acquisition of Orexigen and for working capital requirements.
  • Proceeds of $9.2 million from the DDTL which were utilized to fund our investment in Nalpropion structured through a capital contribution to Nalpropion and as one of the lenders in the 2018 Term Loan credit agreement.
  • These proceeds were partially offset by a $5.4 million principal repayment of our Treximet Secured Notes.

Net cash provided by financing activities during the nine months ended September 30, 2017 was $0.1 million. Cash provided by financing activities for the nine months ended September 30, 2017 was primarily from the net proceeds from the DDTL of $30.0 million and the issuance of 372,000 shares under the Controlled Equity Offering Sales Agreement for $1.1 million. This cash provided by financing activities was partially offset primarily by principal payments on our Treximet Secured Notes of $17.5 million, and the payment of financing costs related to the debt restructuring that was completed in July 2017 of $13.6 million.

ITEM 3. QUANTITATIVE AND QUALITATIVE DISCLOSURES ABOUT MARKET RISK

Not applicable.

ITEM 4. CONTROLS AND PROCEDURES

We maintain "disclosure controls and procedures" within the meaning of Rule 13a-15(e) of the Securities Exchange Act of 1934, as amended (the Exchange Act). Our disclosure controls and procedures, or Disclosure Controls, are designed to ensure that information required to be disclosed by us in the reports we file under the Exchange Act, such as this Quarterly Report on Form 10-Q, is recorded, processed, summarized and reported within the time periods specified in the U.S. Securities and Exchange Commission's rules and forms. Our Disclosure Controls are also designed to ensure that such information is accumulated and communicated to our management, including our Chief Executive Officer and Principal Financial Officer, as appropriate, to allow timely decisions regarding required disclosure. In designing and evaluating our Disclosure Controls, management recognized that any controls and procedures, no matter how well designed and operated, can provide only reasonable assurance of achieving the desired control objectives, and management necessarily was required to apply its judgment in evaluating and implementing possible controls and procedures.

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Evaluation of Disclosure Controls and Procedures.  As of September 30, 2018, we evaluated the effectiveness of the design and operation of the Company's disclosure controls and procedures, which was done under the supervision and with the participation of our management, including our Chief Executive Officer and our Principal Financial Officer. Immediately following the Signatures section of this Quarterly Report on Form 10-Q are certifications of our Chief Executive Officer and Principal Financial Officer, which are required in accordance with Rule 13a-14 of the Exchange Act. This Controls and Procedures section includes the information concerning the controls evaluation referred to in the certifications and it should be read in conjunction with the certifications for a more complete understanding of the topics presented. Based on the controls evaluation, our Chief Executive Officer and Principal Financial Officer concluded that as of the date of their evaluation, our disclosure controls and procedures were effective to provide reasonable assurance that (a) the information required to be disclosed by us in the reports that we file or submit under the Exchange Act is recorded, processed, summarized and reported within the time periods specified in the SEC's rules and forms, and (b) such information is accumulated and communicated to our management, including our Chief Executive Officer and Principal Financial Officer, as appropriate, to allow timely decisions regarding required disclosure.

Change in Internal Control over Financial Reporting. There were no changes in our internal control over financial reporting (as defined in Rule 13a-15(f) and Rule 15d-15(f) under the Exchange Act) during our most recent fiscal quarter that have materially affected, or are reasonably likely to materially affect, our internal control over financial reporting.

PART II. OTHER INFORMATION

ITEM 1. LEGAL PROCEEDINGS

Information regarding legal proceedings is incorporated by reference herein from Legal Proceedings under Note 13, Commitments and Contingencies, to our unaudited condensed consolidated financial statements for the three and nine months ended September 30, 2018 and 2017 contained in Part I, Item 1 of this Quarterly Report on Form 10-Q.

ITEM 1A. RISK FACTORS

The risk factors below supplement the risk factors contained in Part I, Item 1A. of our Annual Report on Form 10-K for the year ended December 31, 2017, filed with the SEC on March 8, 2018; Part II, Item 1A. of our Quarterly Report on Form 10-Q for the quarterly period ended March 31, 2018, filed with the SEC on May 10, 2018; and Part II, Item 1A. of our Quarterly Report on Form 10-Q for the quarterly period ended June 30, 2018, filed with the SEC on August 9, 2018. The occurrence of any one or more of these risks could materially harm our business, operating results, financial condition and prospects. These risks and uncertainties could also cause actual results to differ materially and adversely from those expressed or implied by forward-looking statements that we make from time to time. Please see "Note Regarding Forward-Looking Statements" appearing at the beginning of this Quarterly Report on Form 10-Q.

Risks Related to our Business

Our board of directors has authorized us to explore alternatives to refinance or restructure our existing debt. If we fail to successfully complete a restructuring or refinancing of all of our existing debt, we may initiate Chapter 11 proceedings to implement a restructuring of our obligations.

We are in the process of analyzing various alternatives to address our liquidity and capital structure, including strategic and refinancing alternatives. We believe the consummation of a successful refinancing or restructuring of our existing debt is critical to our continued viability. If we fail to successfully complete a restructuring or refinancing of all of our existing debt, all or certain of our indebtedness may be accelerated and we may not be able to otherwise source adequate liquidity to fund our operations, meet our obligations (including our debt payment obligations) and continue as a going concern. There can be no assurance that these efforts will result in any such agreement, that any refinancing or restructuring that we pursue will be successful, or what the terms thereof would be.

Any refinancing or restructuring will likely be subject to a number of conditions, many of which will be outside of our control. We can make no assurances that any refinancing or restructuring that we pursue will be successful, or what the terms thereof would be or what, if anything, our existing debt and equity holders would receive in any resulting transaction, which will depend on our enterprise value, although we believe that any refinancing or restructuring would be highly dilutive to our existing equity holders and certain debt holders. In addition, we can make no assurances with respect to what the value of our debt and equity will be following the consummation of any refinancing or restructuring. The issuance and sale of substantial amounts of common stock or the announcement that such issuances and sales may occur could adversely affect the market price of our common stock.

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If an agreement is reached and we pursue a restructuring, it may be necessary for us to file a voluntary petition for relief under Chapter 11 of the United States Bankruptcy Code in order to implement this agreement through the confirmation and consummation of a plan of reorganization and/or one or more sale transactions approved by the bankruptcy court in the bankruptcy proceedings. We may also conclude that it is necessary to initiate Chapter 11 proceedings to implement a restructuring of our obligations even if we are unable to reach an agreement with our creditors and other relevant parties regarding the terms of a restructuring. If a plan of reorganization is implemented in a bankruptcy proceeding, it is likely that holders of claims and interests with respect to, or rights to acquire our equity securities, would likely be entitled to little or no recovery, and those claims and interests would likely be canceled for little or no consideration. If that were to occur, we anticipate that all, or substantially all, of the value of all investments in our common stock will be lost and that our equity holders would lose all or substantially all of their investment. It is also likely that our other stakeholders, including our secured and unsecured creditors, will receive substantially less than the amount of their claims. We have a significant amount of secured indebtedness that is senior to our unsecured indebtedness and a significant amount of total indebtedness that is senior to our existing common stock in our capital structure. As a result, we believe that seeking Bankruptcy Court protection under a Chapter 11 proceeding could result in a limited recovery for unsecured noteholders and debtholders and place equity holders at significant risk of losing all of their interests in us. The commencement of bankruptcy proceedings would also result in an event of default under the terms of our Treximet Secured Notes, the 4.25% Convertible Notes, the Exchangeable Notes, the Term Facility and the ABL Facility, thereby resulting in such indebtedness becoming immediately due and payable.

Our business operations and financial position could be adversely affected as a result of our substantial indebtedness and other payment obligations.

As of September 30, 2018, we had approximately $323.1 million aggregate principal amount of debt outstanding, consisting of:

  • approximately $36.1 million aggregate principal amount of our Exchangeable Notes, issued pursuant to an indenture, as amended by that certain first supplemental indenture, dated July 27, 2018, under which PIP DAC, (formerly known as Pernix Ireland Pain Ltd. (PIPL), is the issuer and we and our other subsidiaries are the guarantors with Wilmington Trust, National Association, as trustee;
  • approximately $78.2 million aggregate principal amount of our Convertible Notes;
  • approximately $154.5 million aggregate principal amount of our Treximet Secured Notes;
  • approximately $14.2 million outstanding under our ABL Facility; and
  • approximately $40.1 million aggregate principal amount outstanding under the Term Credit Agreement.

In addition, we have the ability to borrow up to an additional $5.8 million under the Term Credit Agreement for certain specified purposes, including future acquisitions, working capital or other general corporate purposes, subject to conditions set forth in the Term Credit Agreement and up to an additional approximately $18.3 million under the ABL Facility, subject to borrowing base capacity and the conditions set forth in the ABL Facility. In addition, the Term Credit Agreement includes an incremental feature that allows us, with the consent of the requisite lenders under the Term Credit Agreement, to obtain up to an additional $20.0 million in term loan commitments from new or existing lenders under the Term Credit Agreement that agree to provide such commitments. Our significant indebtedness and other payment obligations could have important consequences.  For example, it could:

  • make it difficult for us to satisfy our obligations under our outstanding notes and our other indebtedness and contractual and commercial commitments;
  • require us to seek Chapter 11 bankruptcy protection;
  • limit our flexibility in planning for, or reacting to, changes in our business and the industry in which we operate;
  • require us to dedicate a substantial portion of our cash flow from operations to payments on our indebtedness, thereby reducing the availability of our cash flow to fund working capital, capital expenditures and other general corporate purposes;
  • restrict us from making strategic acquisitions, entering new markets or exploiting business opportunities;
  • place us at a competitive disadvantage compared to our competitors that have proportionally less debt;
  • limit our ability to borrow additional funds and/or leverage our cost of borrowing; and
  • decrease our ability to compete effectively or operate successfully under adverse economic and industry conditions.

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In the event our capital resources are otherwise insufficient to meet future capital requirements and operating expenses, we may seek to finance our cash needs through public or private equity or debt financings, strategic relationships, including the divestiture of non-core assets, assigning receivables, milestone payments or royalty rights, or other arrangements. Securing additional financing will require a substantial amount of time and attention from our management and may divert a disproportionate amount of its attention away from our day-to-day activities, which may adversely affect our management's ability to conduct our day-to-day operations. In addition, we cannot guarantee that future financing will be available in sufficient amounts or on terms acceptable to us, if at all. If we are unable to raise additional capital when required or on acceptable terms, we may be required to:

  • sell our business or all or substantially all of our assets to one or more third parties;
  • significantly scale back or discontinue certain of our commercial activities;
  • seek Chapter 11 bankruptcy protection;
  • significantly delay, scale back or discontinue the development or commercialization of our products and product candidates;
  • seek collaborators for one or more of our current or future products or product candidates at an earlier stage than otherwise would be desirable or on terms that are less favorable than might otherwise be available; or
  • relinquish or license on unfavorable terms, our rights to technologies or product candidates that we otherwise would seek to develop or commercialize ourselves.

Additional equity or debt financing, or corporate collaboration and licensing arrangements, may not be permissible under the indentures governing our outstanding notes or the covenants in the Credit Facilities, or otherwise available on acceptable terms, if at all. Additional equity financing will be dilutive to stockholders, and debt financing, if available, may involve additional restrictive covenants. In addition, if we raise additional funds through collaborations or other strategic transactions, it may be necessary to relinquish potentially valuable rights to our potential products or proprietary technologies, or grant licenses on terms that are not favorable to us.

Potential restructuring transactions may impact our business, financial condition and operations.

In connection with our exploration of alternatives to refinance or restructure our existing debt, we expect to incur expenses associated with identifying and evaluating our alternatives. The process of exploring refinancing or restructuring alternatives may be disruptive to our business operations. The inability to effectively manage the process and any resulting agreement or transaction could materially and adversely affect our business, financial condition or results of operations.

If we undertake a Chapter 11 proceeding, our senior management would be required to spend a significant amount of time and effort focusing on such proceedings. This diversion of attention from other matters may materially adversely affect the conduct of our business, and, as a result, our financial condition and results of operations, particularly if the Chapter 11 proceedings are protracted. Bankruptcy Court protection also might make it more difficult to retain management and other key personnel necessary to the success and growth of our business. In addition, the longer a proceeding related to a Chapter 11 proceeding continues, the more likely it is that our customers and suppliers would lose confidence in our ability to reorganize our businesses successfully and would seek to establish alternative commercial relationships.

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If we are unable to regain compliance with the listing requirements of The Nasdaq Global Market, our common stock may be delisted from The Nasdaq Global Market which could have a material adverse effect on our financial condition and could make it more difficult for you to sell your shares.

Our common stock is listed on the Nasdaq Global Market, and we are therefore subject to its continued listing requirements, including requirements with respect to the market value of publicly-held shares, market value of listed shares, minimum bid price per share, and minimum stockholder's equity, among others, and requirements relating to board and committee independence. If we fail to satisfy one or more of the requirements, we may be delisted from the Nasdaq Global Market.

On October 17, 2018, we received notice, or the Minimum Market Value of Publicly Held Shares Notice, from Nasdaq that we are not currently in compliance with the $15 million minimum market value of publicly held shares requirement of Nasdaq Listing Rule 5450(b)(3)(C). The Minimum Market Value of Publicly Held Shares Notice indicated that, consistent with Nasdaq Listing Rule 5810(c)(3)(D), we have until April 15, 2019 to regain compliance with the minimum market value of publicly held shares requirement by having the closing market value of publicly held shares, calculated by multiplying the closing bid price of our common stock by our total shares outstanding (less any shares held by officers, directors or beneficial owners of 10% or more of the total shares outstanding ), meet or exceed $15 million for at least ten consecutive business days. The Minimum Market Value of Publicly Held Shares Notice had no immediate effect on the listing of our common stock and our common stock will continue to trade on the Nasdaq Global Market under the symbol "PTX" at this time.

On October 19, 2018, we received notice, or the Minimum Bid Price Notice, from Nasdaq that we are not currently in compliance with the $1.00 minimum closing bid price requirement of Nasdaq Listing Rule 5450(a)(1). The Minimum Bid Price Notice indicated that, consistent with Nasdaq Listing Rule 5810(c)(3)(A), we have until April 17, 2019 to regain compliance with the minimum bid price requirement by having the closing bid price of our common stock meet or exceed $1.00 per share for at least ten consecutive business days. If we do not regain compliance with the minimum bid price requirement by April 17, 2019, we may be eligible to transfer the listing of our common stock from the Nasdaq Global Market to the Nasdaq Capital Market if, at the time of such transfer, we meet the initial listing requirement for market value of publicly held shares ($1 million) and all other initial listing standards for the Nasdaq Capital Market (except for the minimum bid price requirement) and provide Nasdaq with written notice of our intention to cure the minimum bid price requirement deficiency. In response, Nasdaq may provide us an additional 180 day period to satisfy the minimum bid price requirement. However, if it appears to the Nasdaq staff that we will not be able to cure the deficiency, or if we are not eligible, Nasdaq will provide notice to us that our common stock will be subject to delisting as described below. The Minimum Bid Price Notice had no immediate effect on the listing of our common stock and our common stock will continue to trade on the Nasdaq Global Market under the symbol "PTX" at this time.

If we fail to regain compliance with either the minimum market value of publicly held shares requirement or the minimum bid price requirement during the applicable compliance periods, we will receive notification from Nasdaq that our common stock is subject to delisting. At that time we may then appeal the delisting determination to a Hearings Panel. Such notification will have no immediate effect on our listing on the Nasdaq Global Market, nor will it have an immediate effect on the trading of our common stock pending such hearing. There can be no assurance, however, that we will be able to regain compliance with each of Nasdaq's minimum market value of publicly held shares requirement and Nasdaq's minimum bid price requirement. If we regain compliance with the Nasdaq's minimum market value of publicly held shares requirement and Nasdaq's minimum bid price requirement, there can be no assurance that we will be able to maintain compliance with the continued listing requirements for the Nasdaq Global Market, or that our common stock will not be delisted from the Nasdaq Global Market in the future. In addition, we may be unable to meet other applicable listing requirements of the Nasdaq Global Market, in which case our common stock could be delisted notwithstanding our ability to demonstrate compliance with the minimum market value of publicly held shares and the minimum bid price requirements.

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Delisting from the Nasdaq Global Market may adversely affect our ability to raise additional financing through the public or private sale of equity securities, may significantly affect the ability of investors to trade our securities and may negatively affect the value and liquidity of our common stock. Delisting also could have other negative results, including the potential loss of employee confidence, the loss of institutional investors or interest in business development opportunities. Moreover, a delisting of our common stock could result in an Event of Default under our outstanding debt securities.

If we are delisted from the Nasdaq Global Market and we are not able to list our common stock on another exchange, our Common Stock could be quoted on the OTC Bulletin Board or in the "pink sheets." As a result, we could face significant adverse consequences including, among others:

  • a limited availability of market quotations for our securities;
  • a determination that our common stock is a "penny stock" which will require brokers trading in our common stock to adhere to more stringent rules and possibly result in a reduced level of trading activity in the secondary trading market for our securities;
  • a limited amount of news and little or no analyst coverage for us;
  • we would no longer qualify for exemptions from state securities registration requirements, which may require us to comply with applicable state securities laws; and
  • a decreased ability to issue additional securities (including pursuant to short-form registration statements on Form S-3) or obtain additional financing in the future.

In addition, if the Common Stock is delisted from the Nasdaq Global Market, the holders of the Convertible Notes and the Exchangeable Notes would have the right to require the Company (in the case of the Convertible Notes) or PIP DAC (in the case of the Exchangeable Notes) to repurchase all of the Convertible Notes and Exchangeable Notes owned by such holders at a price equal to 100% of the principal amount thereof, plus any accrued and unpaid interest thereon, within 35 business days following the Company or PIP DAC giving notice to such holders of the delisting. The Company's or PIP DAC's failure to pay such amounts when due would result in a default under the indentures governing the Convertible Notes or the Exchangeable Notes, as the case may be, which would ripen into an event of default immediately under the indenture governing the Convertible Notes, and within five days of becoming due under the indenture governing the Exchangeable Notes. Further, an event of default under either of these indentures would result in a cross-default under the Delayed Draw Term Loan as well as the ABL Facility, which could result in indebtedness outstanding under those instruments to become immediately due and payable. In addition, any acceleration of the debt under the Convertible Notes, the Exchangeable Notes, the Delayed Draw Term Loan or the ABL Facility would trigger an event of default under the indenture governing the Treximet Secured Notes, which could result in such indebtedness becoming immediately due and payable.

If our common stock becomes subject to the penny stock rules, it would become more difficult to trade our shares.

The SEC has adopted rules that regulate broker-dealer practices in connection with transactions in penny stocks. Penny stocks are generally equity securities with a price of less than $5.00, other than securities registered on certain national securities exchanges or authorized for quotation on certain automated quotation systems, provided that current price and volume information with respect to transactions in such securities is provided by the exchange or system. If we do not retain a listing on the Nasdaq Global Market and if the price of our common stock is less than $5.00, our common stock will be deemed a penny stock. The penny stock rules require a broker-dealer, before a transaction in a penny stock not otherwise exempt from those rules, to deliver a standardized risk disclosure document containing specified information. In addition, the penny stock rules require that before effecting any transaction in a penny stock not otherwise exempt from those rules, a broker-dealer must make a special written determination that the penny stock is a suitable investment for the purchaser and receive (i) the purchaser's written acknowledgment of the receipt of a risk disclosure statement; (ii) a written agreement to transactions involving penny stocks; and (iii) a signed and dated copy of a written suitability statement. These disclosure requirements may have the effect of reducing the trading activity in the secondary market for our common stock, and therefore stockholders may have difficulty selling their shares.

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We may not be able to grow through acquisitions of businesses and assets, the formation of collaborations or other strategic alliances or the in-licensing of products or product candidates.

We have sought growth largely through acquisitions, including the acquisitions of the Zohydro ER product line in 2015, the rights to Treximet intellectual property in 2014, Pernix Sleep in 2013 and Cypress in 2012. As part of our strategy, we plan to pursue acquisitions of assets, businesses or strategic alliances and collaborations (including the in-licensing of products or product-candidates), to expand our existing technologies and operations, such as the July 2018 services agreement with Nalpropion pursuant to which we manage Nalpropion and exclusively distribute Contrave in the United States. However, the indentures governing the Exchangeable Notes, the Convertible Notes and the Treximet Secured Notes, and the Credit Facilities contain restrictive covenants, which include, among other things, restrictions on the incurrence of indebtedness, as well as certain consolidations, acquisitions, mergers, purchases or sales of assets and capital expenditures, subject to certain exceptions and permissions limited in scope and dollar value, among other things. For additional information, see the notes to our audited consolidated financial statements for the years ended December 31, 2017 and 2016 contained in Part II, Item 8 of our Annual Report on Form 10-K for the fiscal year ended December 31, 2017. Moreover, it cannot be assured that acquisitions will be available on terms attractive to us or that such acquisitions will be permissible under the indentures governing our outstanding notes and the covenants in the Credit Facilities or that we will be able to arrange financing on terms acceptable to us or to obtain timely federal and state governmental approvals on terms acceptable to us, or at all. 

We may be unable to successfully integrate newly acquired businesses or assets and realize the anticipated benefits of these acquisitions or other collaborations or strategic alliances.

Management has in the past devoted, and will in the future devote, significant attention and resources to integrating newly acquired businesses and assets and/or establishing functioning collaborations that leverage our capabilities in pursuit of developing and commercializing our products and product candidates. Potential integration process difficulties that we have encountered or may encounter in the future include the following:

  • the inability to successfully combine our businesses with any newly acquired business, to integrate any newly acquired assets into our existing product portfolio, and to meet our capital requirements following such acquisition, in a manner that permits us to achieve the cost savings or revenue enhancements anticipated to result from these acquisitions, which would result in the anticipated benefits of the acquisitions not being realized in the time frame currently anticipated or at all;
  • lost sales and customers as a result of certain of our customers deciding not to do business with us following the acquisition of a business or asset;
  • the additional complexities of integrating newly acquired businesses and assets with different core products and markets;
  • potential unknown liabilities and unforeseen increased expenses associated with an acquisition of a business or asset;
  • performance shortfalls as a result of the diversion of management's attention caused by integrating the operations of a newly acquired business or a newly acquired asset into the existing product portfolio;
  • our collaborative partners may not commit adequate resources to the development, marketing and distribution of any collaboration products, limiting our potential revenues from these products;
  • our collaborative partners may experience financial difficulties and may therefore be unable to meet their commitments to us;
  • our collaborative partners may pursue a competing product candidate developed either independently or in collaboration with others, including our competitors; and
  • our collaborative partners may terminate our relationship.

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With respect to potential collaborations or strategic alliances, our ability to reach a definitive agreement for any collaboration will depend, among other things, upon our assessment of the collaborator's resources and expertise, the terms and conditions of the proposed collaboration and the proposed collaborator's evaluation of a number of factors. If we are unable to reach agreements with suitable collaborators on a timely basis, on acceptable terms, or at all, we may have to reduce or delay our development or commercialization programs or initiatives.

For all these reasons, you should be aware that it is possible that integrating a newly acquired business or asset and/or the establishment of collaborations or other strategic alliances could result in the distraction of our management, the disruption of our ongoing business or inconsistencies in our products, standards, controls, procedures and policies, any of which could adversely affect our ability to maintain relationships with customers, vendors and employees or to achieve the anticipated benefits of the acquisitions, or could otherwise adversely affect our business and financial results.

Despite our significant level of indebtedness, we and our subsidiaries may still be able to incur substantially more debt, which could exacerbate the risks associated with our substantial leverage.

We may be able to incur substantial additional indebtedness in the future. Although certain of our agreements, including the Credit Facilities and the indentures governing the Exchangeable Notes, the Convertible Notes and the Treximet Secured Notes, limit our ability and the ability of our subsidiaries to incur additional indebtedness, these restrictions are subject to waiver and a number of qualifications and exceptions and, under certain circumstances, debt incurred following receipt of a waiver or in compliance with these restrictions could be substantial. Among other things, we have the ability to borrow up to an additional $5.8 million under the Term Credit Agreement for certain specified purposes, including future acquisitions, working capital or other general corporate purposes, subject to certain conditions set forth in the Term Credit Agreement, and approximately $18.3 million of additional funds under the ABL Facility, subject to borrowing base capacity and certain conditions set forth in the ABL Facility. In addition, the Term Credit Agreement includes an incremental feature that allows us, with the consent of the requisite lenders under the Term Credit Agreement, to obtain up to an additional $20 million in term loan commitments from new or existing lenders under the Term Credit Agreement that agree to provide such commitments. To the extent that we incur additional indebtedness, the risks associated with our substantial leverage described herein, including our possible inability to service our debt, would increase.

Our debt service obligations may adversely affect our cash flow.

A high level of indebtedness increases the risk that we may default on our debt obligations. We may not be able to generate sufficient cash flow to pay the interest on our debt, and future working capital, borrowings or equity financing may not be available to pay or refinance such debt. If we are unable to generate sufficient cash flow to pay the interest on our debt, we may have to delay or curtail our operations.

Our ability to generate cash flows from operations and to make scheduled payments on our indebtedness will depend on our future financial performance. Our future financial performance will be affected by a range of economic, competitive and business factors that we cannot control, such as those risks described in this section and in our other filings with the SEC. A significant reduction in operating cash flows resulting from changes in economic conditions, increased competition or other events beyond our control could increase the need for additional or alternative sources of liquidity and could have a material adverse effect on our business, financial condition, results of operations, prospects and our ability to service our debt and other obligations. If we are unable to service our indebtedness we will be forced to adopt an alternative strategy that may include actions such as reducing capital expenditures, selling assets, restructuring or refinancing our indebtedness or seeking additional equity capital, or seeking Chapter 11 Bankruptcy Court protection.

These alternative strategies may not be affected on satisfactory terms, if at all, and they may not yield sufficient funds to make required payments on our indebtedness.

If for any reason we are unable to meet our debt service and repayment obligations, we would be in default under the terms of the agreements governing our debt, which may allow our creditors at that time to declare outstanding indebtedness to be due and payable, which would in turn trigger cross-acceleration or cross-default rights between the relevant agreements.

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In addition, the borrowings under our credit facilities bear interest at variable rates and other debt we incur could likewise be variable-rate debt. If interest rates increase, our debt service obligations on the variable rate indebtedness would increase even though the amount borrowed thereunder remains the same, and our net income and cash flows, including cash available for servicing our indebtedness, would correspondingly decrease.

The indentures governing the Exchangeable Notes, the Convertible Notes and the Treximet Secured Notes and the covenants in the Credit Facilities and the articles supplementary authorizing the issuance of the Convertible Preferred Stock impose significant operating and/or financial restrictions on us and our subsidiaries that may prevent us from pursuing certain business opportunities and restrict our ability to operate our business.

The indentures governing the Exchangeable Notes, the Convertible Notes and the Treximet Secured Notes and the Credit Facilities contain covenants that restrict our and our subsidiaries' ability to take various actions, such as:

  • incur additional debt;
  • pay dividends and make distributions on, or redeem or repurchase, our capital stock;
  • make certain investments, purchase certain assets or other restricted payments;
  • sell assets, including in connection with sale-leaseback transactions;
  • create liens;
  • enter into transactions with affiliates;
  • make lease payments that exceed a specified amount; and
  • merge, consolidate or transfer all or substantially all of their assets.

In addition, the articles supplementary authorizing the issuance of our Convertible Preferred Stock prohibit us from authorizing, declaring or paying regular or special dividends or other distributions (whether in the form of cash, shares, indebtedness or any other property or asset, but excluding any purchase, redemption or other acquisition of shares) on the shares of our Common Stock, unless simultaneously with the authorization, declaration or payment, we authorize, declare or pay, as applicable, dividends or other distributions on the Convertible Preferred Stock.

In addition, the terms of the Treximet Secured Notes require us to maintain a minimum liquidity of $8.0 million at all times and the terms of the ABL Facility require us to maintain unrestricted minimum liquidity of $7.5 million at all times. In order to maintain minimum liquidity, we must maintain cash or the availability to borrow cash under the ABL Facility in a combined amount of no less than the minimum liquidity set forth in the Treximet Secured Notes indenture and the ABL Facility.

Upon the occurrence of a fundamental change, as described in the indenture governing the 4.25% Convertible Notes, holders of the 4.25% Convertible Notes may require us to repurchase for cash all or part of their 4.25% Convertible Notes at a repurchase price equal to 100% of the principal amount of the 4.25% Convertible Notes to be repurchased, plus accrued and unpaid interest. If a holder elects to convert its 4.25% Convertible Notes for shares in excess of the conversion cap, as described in the indenture governing the 4.25% Convertible Notes, we will be obligated to deliver cash in lieu of any share that was not delivered on account of such limitation. However, we may not have enough available cash or be able to obtain financing at the time we are required to make repurchases of the 4.25% Convertible Notes surrendered therefor in connection with a fundamental change or payments of cash on 4.25% Convertible Notes converted in excess of the conversion cap. In addition, our ability to repurchase the 4.25% Convertible Notes or to pay cash upon conversions of the 4.25% Convertible Notes may be limited by law, by regulatory authority or by agreements governing our indebtedness. Our failure to repurchase the 4.25% Convertible Notes at a time when the repurchase is required by the indenture or to pay any cash payable on future conversions of the 4.25% Convertible Notes as required by the indenture would constitute a default under the indenture. A default under the indenture could also lead to a default under agreements governing our other outstanding indebtedness. If the repayment of the related indebtedness were to be accelerated after any applicable notice or grace periods, we may not have sufficient funds to repay the indebtedness and repurchase the 4.25% Convertible Notes or make cash payments upon conversions as required by the indenture.

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Upon the occurrence of a fundamental change, as described in the indenture governing the Exchangeable Notes, holders of the Exchangeable Notes may require us to repurchase for cash all or part of Exchangeable Notes at a repurchase price equal to 100% of the capitalized principal amount of the Exchangeable Notes to be repurchased, plus accrued and unpaid interest. However, we may not have enough available cash or be able to obtain financing at the time we are required to make repurchases of the Exchangeable Notes surrendered therefor in connection with a fundamental change. In addition, our ability to repurchase the Exchangeable Notes or to pay cash upon conversions of the Exchangeable Notes may be limited by law, by regulatory authority or by agreements governing our indebtedness. Our failure to repurchase the Exchangeable Notes at a time when the repurchase is required by the indenture or to pay any cash payable on future conversions of the Exchangeable Notes as required by the indenture would constitute a default under the indenture. A default under the indenture could also lead to a default under agreements governing our other outstanding indebtedness. If the repayment of the related indebtedness were to be accelerated after any applicable notice or grace periods, we may not have sufficient funds to repay the indebtedness and repurchase the Exchangeable Notes or make cash payments upon conversions as required by the indenture.

Our ability to comply with these covenants will likely be affected by many factors, including events beyond our control, and we may not satisfy those requirements. Our failure to comply with our debt-related obligations could result in an event of default under the particular debt instrument, which could permit acceleration of the indebtedness under that instrument and, in some cases, the acceleration of our other indebtedness, in whole or in part.

These restrictions also limit our ability to plan for or react to market conditions, meet capital needs or otherwise restrict our activities or business plans and adversely affect our ability to finance our operations, enter into acquisitions including transactions, collaborations or other commercial transactions or to engage in other business activities that would be in our interest.

Our ability to borrow under the ABL Facility is limited by the amount of our borrowing base. Any negative impact on the elements of our borrowing base, such as accounts receivable and inventory or an imposition of a reserve against our borrowing base, which Cantor Fitzgerald Securities has the authority to do in its sole discretion, could reduce our borrowing capacity under the ABL Facility.

If we fail to attract and retain key personnel, we may be unable to successfully develop or commercialize our products.

Our success depends in part on our continued ability to attract, retain and motivate highly qualified managerial personnel. We are highly dependent upon our executive management team. The loss of the services of any members of our executive management team or other key personnel could delay or prevent the successful completion of some of our development and commercialization objectives.

Recruiting and retaining qualified sales and marketing personnel is critical to our success. We may not be able to attract and retain these personnel on acceptable terms given the competition among numerous pharmaceutical and biotechnology companies for similar personnel. In addition, we rely on consultants and advisors, including scientific and clinical advisors, to assist us in formulating our development and commercialization strategy. Our consultants and advisors may be employed by employers other than us and may have commitments under consulting or advisory contracts with other entities that may limit their availability to us.

Our management devotes substantial time to comply with public company regulations.

As a public company, we incur significant legal, accounting and other expenses. In addition, the Sarbanes-Oxley Act, as well as rules subsequently implemented by the SEC and the Nasdaq Global Market, imposes various requirements on public companies, including with respect to corporate governance practices. Moreover, these rules and regulations increase legal and financial compliance costs and make some activities more time-consuming and costly.

In addition, the Sarbanes-Oxley Act requires, among other things, that our management maintain adequate disclosure controls and procedures and internal control over financial reporting. In particular, we must perform system and process evaluation and testing of our internal control over financial reporting to allow management and, as applicable, our independent registered public accounting firm to report on the effectiveness of our internal control over financial reporting, as required by Section 404 of the Sarbanes-Oxley Act. Our compliance with Section 404 requires us to incur

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substantial accounting and related expenses and expend significant management efforts. If we are not able to comply with the requirements of Section 404 or if we or our independent registered public accounting firm identifies deficiencies in our internal control over financial reporting that are deemed to be material weaknesses, our financial reporting could be unreliable and misinformation could be disseminated to the public.

Any failure to develop or maintain effective internal control over financial reporting or difficulties encountered in implementing or improving our internal control over financial reporting could harm our operating results and prevent us from meeting our reporting obligations. Ineffective internal controls also could cause our stockholders and potential investors to lose confidence in our reported financial information, which would likely have a negative effect on the trading price of our Common Stock. In addition, investors relying upon this misinformation could make an uninformed investment decision and we could be subject to sanctions or investigations by the SEC, Nasdaq Global Market or other regulatory authorities, or to stockholder class action securities litigation.

Our July 2018 obtainment of the exclusive distribution rights in the United States to Contrave, the April 2015 acquisition of Zohydro ER and the August 2014 acquisition of the rights to Treximet intellectual property and our strategy of obtaining, through asset acquisitions and in-licenses, rights to other products and product candidates for our development pipeline and to proprietary drug delivery and formulation technologies for our life cycle management of current products may not be successful.

We obtained the rights to the exclusive distribution in the United States of Contrave in July 2018, and acquired the rights to Zohydro ER in April 2015 and Treximet intellectual property in August 2014 and from time to time we may seek to engage in additional strategic transactions with third parties to acquire rights to other pharmaceutical products, pharmaceutical product candidates in the late stages of development and proprietary drug delivery and formulation technologies. Because we do not have discovery and research capabilities, the growth of our business will depend in significant part on our ability to acquire or in-license additional products, product candidates or proprietary drug delivery and formulation technologies that we believe have significant commercial potential and are consistent with our commercial objectives. However, we may be unable to license or acquire suitable products, product candidates or technologies from third parties for a number of reasons.

The licensing and acquisition of pharmaceutical products, product candidates and related technologies is a competitive area. A number of more established companies are also pursuing strategies to license or acquire products, product candidates or drug delivery and formulation technologies, which may mean fewer suitable acquisition opportunities for us as well as higher acquisition prices. Many of our competitors have a competitive advantage over us due to their size, cash resources and greater clinical development and commercialization capabilities.

Other factors that may prevent us from licensing or otherwise acquiring suitable products, product candidates or technologies include:

  • we may be unable to license or acquire the relevant products, product candidates or technologies on terms that would allow us to make an appropriate return on investment;
  • companies that perceive us as a competitor may be unwilling to license or sell their product rights or technologies to us;
  • we may be unable to identify suitable products, product candidates or technologies within our areas of expertise;
  • we may have inadequate cash resources or may be unable to obtain financing to acquire rights to suitable products, product candidates or technologies from third parties; and
  • we may be restricted from licensing or otherwise acquiring suitable products due to restrictions contained in the indentures governing the Exchangeable Notes, the 4.25% Convertible Notes and the Treximet Secured Notes and the restrictions contained in the covenants in the Credit Facilities.

If we are unable to successfully identify and acquire rights to products, product candidates or proprietary drug delivery and formulation technologies and successfully integrate them into our operations, we may not be able to increase our revenues in future periods, which could result in significant harm to our financial condition, results of operations and development prospects.

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Our failure to adequately address the financial, operational or legal risks of any acquisitions or in-license arrangements could harm our business. Financial aspects of these transactions that could alter our financial position, reported operating results or stock price include:

  • use of cash resources;
  • higher than anticipated acquisition costs and expenses;
  • potentially dilutive issuances of equity securities;
  • the incurrence of debt and contingent liabilities, impairment losses or restructuring charges;
  • large write-offs and difficulties in assessing the relative percentages of in-process research and development expense that can be immediately written off as compared to the amount that must be amortized over the appropriate life of the asset; and
  • amortization expenses related to other intangible assets.

Operational risks that could harm our existing operations or prevent realization of anticipated benefits from these transactions include:

  • challenges associated with managing an increasingly diversified business;
  • disruption of our ongoing business;
  • difficulty and expense in assimilating the operations, products, technology, information systems or personnel of the acquired company or in-licensed product;
  • diversion of management's time and attention from other business concerns;
  • entry into a geographic or business market in which we have little or no prior experience;
  • inability to maintain uniform standards, controls, procedures and policies;
  • the assumption of known and unknown liabilities of the acquired business or asset, including intellectual property claims; and
  • subsequent loss of key personnel.

If we are unable to successfully manage our licensing or acquisitions, or distribution rights that we have obtained, our ability to develop and commercialize new products and continue to expand our product pipeline may be limited.

If we are unable to effectively train and equip our sales force to sell newly acquired, in-licensed and existing products, our ability to successfully commercialize our products will be harmed.

We have in the past made, and may in the future continue to make, acquisitions or in-licenses of pharmaceutical products. We have also experienced, and expect to continue to experience, turnover of some of our sales representatives that we hired or will hire, requiring us to train new sales representatives. The members of our sales force may have no prior experience promoting the pharmaceutical products that we own or may acquire or in-license in the future.  As a result, we expend significant time and resources to train our sales force to be credible and persuasive in convincing physicians to prescribe and pharmacists to dispense these pharmaceutical products. In addition, we must train our sales force to ensure that a consistent and appropriate message about our products and the products that we distribute is being delivered to our potential customers. Our sales representatives may also experience challenges promoting multiple products when they call on physicians and their office staff. In addition, prior to our obtaining the exclusive distribution rights in the United States to Contrave in July 2018, all of our products or the products we distributed related to underserved segments, such as central nervous system (CNS) indications, including pain, neurology, and psychiatry, as well as other specialty therapeutic areas. If we are unable to effectively train our sales force and equip them with effective materials relating to our pharmaceutical products, including medical and sales literature to help them inform and educate potential customers about the benefits of such products and their proper administration and label indication, our efforts to successfully market these pharmaceutical products could be put in jeopardy, which could have a material adverse effect on our financial condition, stock price and operations.

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Recent reductions in workforce associated with our realignment plan could disrupt the operation of our business, distract our management from focusing on revenue-generating efforts, result in the erosion of employee morale, and impair our ability to respond rapidly to growth opportunities in the future.

We completed a realignment plan in January 2018 that resulted in a workforce reduction of approximately 22%, primarily through a reduction of sales and commercial infrastructure positions. The employee reductions could result in an erosion of morale and affect the focus and productivity of our remaining employees, including those directly responsible for revenue generation and the management and administration of our finances, which in turn may adversely affect our revenue in the future or cause other administrative deficiencies. Additionally, employees directly affected by the reductions may seek future employment with our business partners, customers or competitors. We may face wrongful termination, discrimination, or other claims from employees affected by the reduction related to their employment and termination. We could incur substantial costs in defending ourselves or our employees against such claims, regardless of the merits of such actions. Furthermore, such matters could divert the attention of our employees, including management, away from our operations, harm productivity, harm our reputation and increase our expenses. We cannot assure you that our realignment plan will be successful, and we may need to take additional realignment efforts, including additional personnel reduction, in the future.

Risks Related to Commercialization

Treximet has become subject to competition from generic competitors, which will have a material adverse impact on our sales of Treximet and our results of operations.

We own, have applied for or hold licenses to patents. Our patent protection for our products extends for varying periods in accordance with the legal life of patents. The protection afforded is limited by the applicable terms of our patents and the availability of legal remedies in the United States. Following expiration of patents covering our products, other entities may be able to obtain approval to manufacture and market generic alternatives, which we expect would result in lower net revenue. For example, in August 2014, through our wholly owned subsidiary Pernix Ireland Limited (PIL), we acquired the U.S. intellectual property rights to Treximet from GSK. Treximet is covered by five patents in the U.S. Including six months of pediatric exclusivity, four of the patents expired on February 14, 2018, and one expires on April 2, 2026. Six companies filed Abbreviated New Drug Applications, or ANDAs, with the FDA, seeking approval to market a generic version of Treximet. Three of the ANDA filers are enjoined from engaging in the commercial manufacture, use, offer to sell, or sale in or importation into the United States of the proposed ANDA products prior to April 2, 2026. As of September 30, 2018, three competitors have entered the market. While we launched our own generic version of Treximet on February 15, 2018, the entry of generics into the market has and will continue to have a material adverse impact on our sales of Treximet and our results of operations.

The commercial success of our currently marketed products, products that we distribute and any additional products that we successfully commercialize will depend upon the degree of market acceptance by physicians, patients, healthcare payors and others in the medical community.

Any products that we bring to the market may not gain market acceptance by physicians, patients, healthcare payors and others in the medical community. If our products do not achieve an adequate level of acceptance, we may not generate significant product revenue and may not be profitable. The degree of market acceptance of our products depends on a number of factors, including:

  • the prevalence and severity of any side effect;
  • the efficacy and potential advantages over the alternative treatments;
  • the ability to offer our branded products for sale at competitive prices, including in relation to any generic products;
  • substitution of our branded products with generic equivalents at the pharmacy level;
  • relative convenience and ease of administration;
  • the willingness of the target patient population to try new therapies and of physicians to prescribe these therapies;
  • the strength of marketing and distribution support; and
  • sufficient third-party coverage or reimbursement.

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We face competition, which may result in others discovering, developing or commercializing products before or more successfully than us.

The industry in which we operate is highly competitive. Our competitors include large and small pharmaceutical companies, and other private and public research organizations. We face significant competition for our currently marketed products and products that we distribute, including significant price competition from products for the same therapeutic categories. Some of our currently marketed products and products that we distribute do not have patent protection and face or could face generic competition.

Some or all of our products may face competition from other branded and generic drugs approved for the same therapeutic indications, approved drugs used "off-label" for such indications and novel drugs in clinical development. As a result, our commercial opportunities could be reduced or eliminated if competitors develop and commercialize products that are more effective, safer, have fewer or less severe side effects, are more convenient or are less expensive than our products.

Our patent rights, or the patent rights held by certain of our commercial partners or licensors, may not adequately protect our products or product candidates if competitors develop products that compete with us without legally infringing our or our commercial partners' or licensors' patent rights. Further, our or our commercial partners' or licensors' patent rights may be subject to challenge by branded and generic competition.

The FDCA and FDA regulations and policies provide certain exclusivity incentives to manufacturers to develop generic versions of innovator products and 505(b)(2) New Drug Applications. A generic manufacturer may only be required to show that its proposed generic product has the same active pharmaceutical ingredient, dosage form, strength, route of administration and indication as, and is bioequivalent to, our brand-name product. The development costs for such generic products would be significantly less than those for our or our commercial partners' or licensors' brand-name products and could lead to the emergence of multiple lower-priced competitor products, which would substantially limit our or our commercial partners' or licensors' ability to obtain a return on the investments we have made in our brand-name products. Additionally, other branded competitors may obtain FDA or other regulatory approval for their product candidates more rapidly than we may obtain approval for our product candidates, and they may obtain periods of exclusivity under applicable laws that may delay our own product candidates' approval by the FDA.

Products in our portfolio that do not have patent protection are potentially at risk for generic competition. Additionally, products we sell through our distribution, collaborative or co-promotion arrangements may also face competition in the marketplace. The availability of a large number of branded prescription products, including drugs that are prescribed off-label, generic products and over-the-counter products could limit the demand for, and the revenue that we are able to generate from the sale of our products.

Some of our competitors have significantly greater financial, technical and human resources than we have and superior expertise in marketing and sales, research and development, manufacturing, preclinical testing, conducting clinical trials, obtaining regulatory approvals and marketing approved products and thus may be better equipped than us to discover, develop, manufacture and commercialize products. These competitors also compete with us in recruiting and retaining qualified management personnel and acquiring technologies. Many of our competitors have collaborative arrangements in our target markets with leading companies and research institutions. In many cases, products that compete with our products have already received regulatory approval or are in late-stage development, have well-known brand names, are distributed by large pharmaceutical companies with substantial resources and have achieved widespread acceptance among physicians and patients. Smaller or early stage companies may also prove to be significant competitors, particularly through collaborative arrangements with large and established companies.

We may face competition based on the safety and effectiveness of our products, the timing and scope of regulatory approvals, the availability and cost of supply, marketing and sales capabilities, reimbursement coverage, price, patent position and other factors. Our competitors may develop or commercialize more effective, safer or more affordable

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products, or products with more effective patent protection, than our products. Accordingly, our competitors may commercialize products more rapidly or effectively than we are able to, which would adversely affect our competitive position, our revenue and profit from existing products and anticipated revenue and profit from product candidates. If our products or product candidates are rendered noncompetitive, we may not be able to recover the expenses of developing and commercializing those products or product candidates.

Negative publicity regarding any of our products or product candidates could delay or impair our ability to market any such product, delay or prevent approval of any such product candidate and may require us to spend time and money to address these issues.

If any of our products or any similar products distributed by other companies prove to be, or are asserted to be, harmful to consumers and/or subject to FDA enforcement action, our ability to successfully market and sell our products could be impaired. Because of our dependence on patient and physician perceptions, any adverse publicity associated with illness or other adverse effects resulting from the use or misuse of our products or any similar products distributed by other companies could limit the commercial potential of our products and expose us to potential liabilities.

If we are unable to attract, hire and retain qualified sales and management personnel and successfully manage our sales and marketing programs and resources, or if our commercial partners do not adequately perform, the commercial opportunity for our products may be diminished.

We and any other commercialization partner we engage may not be able to attract, hire, train and retain qualified sales and sales management personnel in the future. If we or they are not successful in maintaining an effective number of qualified sales personnel, our ability to effectively market and promote our products may be impaired. Even if we are able to effectively maintain such sales personnel, their efforts may not be successful in commercializing our products.

In addition, a significant portion of the revenues that we might receive from sales of products that are the subject to commercial partnerships could largely depend upon the efforts our partners. The efforts of partners, in many instances, could likely be outside our control. If we are unable to maintain commercial partnerships or to effectively establish alternative arrangements for our products, our business could be adversely affected. In addition, despite arrangements with other partners, we still may not be able to cover all of the prescribing physicians for our products at the same level of reach and frequency as our competitors, and we ultimately may need to further expand our selling efforts in order to effectively compete.

From time to time, we compliment the efforts of our sales force with on-line and other non-personal promotional initiatives that target both physicians and patients. We also focus upon ensuring broad patient access to our products by negotiating agreements with leading commercial managed care organizations, or MCOs, and with government payors. Although our goal is to achieve sales through the efficient execution of our sales and marketing plans and programs, we may not be able to effectively generate prescriptions and achieve broad market acceptance for our products on a timely basis, or at all. 

A failure to maintain optimal inventory levels to meet commercial demand for our products could harm our reputation and subject us to financial losses.

Our product, Zohydro ER, contains a controlled substance that is regulated by the DEA under the Controlled Substances Act. DEA quota requirements applicable to Schedule I and II controlled substances limit the amount of controlled substance drug products a manufacturer can manufacture and the amount of API it can use to manufacture those products. We may experience difficulties obtaining raw materials needed to manufacture such product as a result of DEA regulations or we may experience manufacturing challenges in the future. If we are unsuccessful in obtaining quotas, unable to manufacture and release inventory on a timely and consistent basis, fail to maintain an adequate level of product inventory, or if inventory is destroyed or damaged or reaches its expiration date, patients might not have access to our product, our reputation and our brands could be harmed and physicians may be less likely to prescribe such product in the future, each of which could have a material adverse effect on our business, financial condition, results of operations and cash flows.

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In addition, Nalpropion is the exclusive supplier of Contrave to us and we are the exclusive distributor of Contrave in the U.S. Nalpropion is currently party to an agreement with Patheon Pharmaceuticals and Patheon Inc., (collectively, Patheon), pursuant to which Patheon has agreed to manufacture commercial quantities of Contrave tablet products for Nalpropion. If Patheon, or any alternative manufacturer retained by Nalpropion, fails to deliver the required commercial quantities of Contrave on a timely basis, pursuant to provided specifications and at commercially reasonable prices, Nalpropion may be unable to supply us with adequate inventory to meet distribution demand for Contrave in the United States, which would negatively impact our ability to generate revenue.

We and our contract manufacturers may not be able to obtain the regulatory approvals or clearances that are necessary to manufacture pharmaceutical products.

 Before approving a new drug, the FDA requires that the facilities in which the product will be manufactured be in compliance with Good Manufacturing Practices, or cGMP, requirements, which include, among other things, requirements relating to quality control and quality assurance, maintenance of records and documentation and utilization of qualified raw materials. To be successful, our products must be manufactured in compliance with cGMP during development and, following approval, in commercial quantities and at acceptable costs.

We and our contract manufacturers, and the contract manufacturers used by our commercial partners and licensors, must comply with these cGMP requirements. While we believe that we and our and Nalpropion's contract manufacturers currently meet these requirements, we cannot assure that the manufacturing facilities used to manufacture and package our products will continue to meet cGMP requirements or will be sufficient to manufacture all of our needs and/or the needs of our customers for commercial materials.

We and our and Nalpropion's contract manufacturers may also encounter problems with the following:

  • production yields;
  • possible facility contamination;
  • quality control and quality assurance programs;
  • shortages of qualified personnel;
  • compliance with FDA or other regulatory authorities' regulations, including the demonstration of purity and potency;
  • changes in FDA or other regulatory authorities' requirements;
  • production costs; and/or
  • development of advanced manufacturing techniques and process controls.

In addition, we and our and Nalpropion's contract manufacturers must register our and their manufacturing facilities with the FDA, and such manufacturing facilities are subject to FDA inspections to confirm continuing compliance with cGMP and other regulations. If we or our or Nalpropion's contract manufacturers fail to maintain regulatory compliance, the FDA may impose regulatory sanctions including, among other things, temporary or permanent refusal to permit us, Nalpropion or our or Nalpropion's contract manufacturers to continue manufacturing approved products. As a result, our business, financial condition and results of operations may be materially harmed. 

If we or third-party manufacturers fail to comply with regulatory requirements for Zohydro ER, the DEA may take regulatory actions detrimental to our business, resulting in temporary or permanent interruption of distribution, withdrawal of such product from the market or other penalties.

We, third-party manufacturers and our Zohydro with BeadTek product are subject to the Controlled Substances Act and DEA regulations thereunder. Accordingly, we must adhere to a number of requirements, which can include registration, record-keeping and reporting requirements; labeling and packaging requirements; security controls, procurement and manufacturing quotas; and certain restrictions on refills. Failure to maintain compliance with applicable requirements can result in enforcement action that could have a material adverse effect on our business, financial condition, results of operations and cash flows. The DEA may seek civil penalties, refuse to renew necessary registrations or initiate proceedings to revoke those registrations. In certain circumstances, violations could result in criminal proceedings.

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If the suppliers of Contrave fail to comply with stringent regulations applicable to pharmaceutical drug manufacturers, our partners may face delays in the further development or commercialization of Contrave.

Although naltrexone itself is not addictive, synthesis of naltrexone is a multi-step process with a natural opiate starting material that has the potential for abuse and is therefore regulated as a controlled substance under the federal Controlled Substances Act or applicable foreign equivalents. As such, manufacturers of naltrexone API must be registered with the DEA or applicable foreign equivalents. Manufacturers making naltrexone also must obtain annual quotas from the DEA for the opiate starting material. Because of the DEA-related requirements and modest current demand for naltrexone API, there currently exist a limited number of manufacturers of this API. Therefore, API costs for naltrexone are greater than for the other constituents of our product. Demand for Contrave may require amounts of naltrexone greater than the currently available worldwide supply or our or our partners' current forecasts for the supply to us of Contrave or its components. Any lack of sufficient quantities of naltrexone would limit our ability to continue to distribute Contrave in the United States and would limit our partners' ability to commercialize Contrave outside the United States and Europe.

Changes in laws, regulations and policies applicable to the market for opioid products, litigation and government investigations may adversely affect our business, financial condition and results of operations.

The manufacture, marketing, sale, promotion and distribution of Zohydro ER are subject to comprehensive government regulations. Changes in laws and regulations applicable to the market for opioid products, including Zohydro ER with BeadTek, could potentially affect our business. For instance, federal, state and local governments have recently given increased attention to the public health issue of opioid abuse.

At the federal level, the White House Office of National Drug Control Policy continues to coordinate efforts between the FDA, the DEA, and other agencies to address this issue. In 2017, the FDA requested that Endo International plc, or Endo, withdraw Opana ® ER, one of its opioid pain medications, from the market due to the public health consequences of abuse (even when taken at recommended doses) associated with the use of Endo's product. Endo voluntarily complied with the FDA's removal request. In publicly announcing the request, the FDA noted that it would take similar regulatory action with regard to other opioid products if the risks for abuse outweighed the product's potential benefits. The FDA also revised the "black-box" warnings required in the labeling of opioid paid medications, including Zohydro ER, that highlight the risk of misuse, abuse, addiction, overdose and death. The DEA continues its efforts to hold manufacturers, distributors, prescribers and pharmacies accountable through various enforcement actions, as well as the implementation of compliance practices for controlled substances. In addition, the Centers for Disease Control and Prevention (CDC), issued national, non-binding guidelines in 2016 relative to the prescribing of opioids. These guidelines included recommended considerations for primary care provider use when prescribing opioids, including specific considerations and cautionary information about opioid dosage increases and morphine milligram equivalents. Certain payors are, or are considering, adopting these CDC guidelines, as well as putting other restrictions on the prescribing of opioid pain medications. Additionally, DEA has taken regulatory action to reduce the yearly quotas available in the United States for opioids.

Federal activity includes the issuance of a Presidential commission's final recommendations on combating opioid abuse; the federal Department of Health and Human Services declaring the opioid crisis a national public health emergency; President Trump's establishing a commission to make recommendations regarding new laws and policies to combat opioid addiction and abuse; Mallinckrodt's $35.0 million settlement with the Justice Department regarding alleged failures related to suspicious order monitoring obligations; and the FDA's announced intention to extend to immediate-release opioids the Risk Evaluation and Mitigation Strategy, or REMS, currently imposed on extended-release opioids, such as Zohydro ER At the state and local level, a number of states and major cities have brought separate lawsuits against various pharmaceutical companies marketing and selling opioid based pain medications, alleging misleading or otherwise improper promotion of opioid drugs to physicians and consumers. In addition, the attorneys general from several states have announced the launch of a joint investigation into the marketing and sales practices of drug companies that manufacture opioid pain medications.

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On October 24, 2018, the Support for Patients and Communities Act (the Support Act) was signed into law to address opioid misuse and addiction in the United States. The Support Act amends several provisions of the Federal Food, Drug, and Cosmetic Act (FDCA) and the Controlled Substances Act (CSA) that have implications on manufacturers of opioids and other controlled substances. Key changes include additional FDA authority to order the cessation of distribution of controlled substances and to impose requirements on packaging and safe disposal systems. In addition, the Support Act includes CSA provisions relevant to suspicious order monitoring obligations that may impact the distribution of Zohydro.

These initiatives and other changes and potential changes in laws, regulations and policies, including those that have the effect of reducing the overall market for opioids or reducing the prescribing of opioids, could adversely affect our business, financial condition and results of operations.

Our ceasing the distribution of our combination drug product IDA will impact our net revenues. In the future, FDA could also request that we no longer market and distribute certain of our other DESI, OTC, medical foods and dietary supplement products.

Through our Macoven entity, Pernix distributed a combination product called IDA, which was originally approved by the FDA, in 1948 for safety only. The product's efficacy as an adjunct treatment for peptic ulcer disease, as well as other medical conditions, such as migraine headaches, was reviewed under the FDA's Drug Efficacy Study Implementation process, DESI notice 3265.

On October 20, 2017, we received a letter dated October 19, 2017 from the FDA asserting that IDA was subject to DESI 3265 and that any drug products identified in DESI 3265, including IDA, require an approved NDA or ANDA in order for them to continue to be distributed. Since we have not obtained an NDA or ANDA for IDA, the FDA directed that we should immediately cease distribution of IDA. While IDA has a long history of safe use, we complied with the FDA's request and confirmed with the FDA within the requested time frame that we ceased distribution of the product. For the year ended December 31, 2017, our net revenues from the sale of IDA were $14.9 million. As we will not have further revenues from the product in 2018, the discontinuance of the product will impact net revenues for the fiscal year ending December 31, 2018.

Additionally, it is possible that the FDA could in the future request that we no longer distribute certain of our DESI, OTC, medical foods and dietary supplement products, which could adversely affect our net revenues.

Product liability lawsuits against us could cause us to incur substantial liabilities and limit commercialization of any products that we may develop.

We face an inherent risk of product liability exposure related to the sale of our currently marketed products and any other products that we successfully develop, commercialize or distribute. For example, at the state and local level, a number of states and major cities have brought separate lawsuits against various pharmaceutical companies marketing and selling opioid based pain medications, alleging misleading or otherwise improper promotion of opioid drugs to physicians and consumers. In addition, the attorneys general from several states have announced the launch of a joint investigation into the marketing and sales practices of drug companies that manufacture opioid pain medications. In May 2018, we were notified that the Company was named in an ongoing lawsuit that has been brought by the State of Arkansas against various pharmaceutical companies that market and sell opioid based pain medications.  During the second quarter of 2018, we were also served with two additional lawsuits in which we were included as a defendant, both of which were filed in Philadelphia County, PA.  At this time, we are unaware of whether we will be named in any of the other lawsuits brought by other state and local governments or in the various investigations by attorneys general from several states.

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If we cannot successfully defend ourselves against claims that our products, product candidates or products that we distribute caused injuries, we could incur substantial liabilities. Regardless of merit or eventual outcome, liability claims may result in:

  • decreased demand for our products, products that we distribute or any products that we may develop;
  • injury to reputation;
  • withdrawal of clinical trial participants;
  • withdrawal of a product from the market;
  • costs to defend the related litigation;
  • substantial monetary awards to trial participants or patients;
  • diversion of management time and attention;
  • loss of revenue; and
  • the inability to commercialize any products that we may develop.

Some of the insurance companies that presently insure and that have insured Pernix could legally assert that they are not liable to respond to or to cover a claimed liability, including but not limited to the opioid litigation and further, may dispute whether their insurance contracts must legally respond to claimed liabilities against Pernix. Should any of these contingencies occur and should Pernix be denied access to insurance coverage, this could have a material adverse effect on our business, financial condition and results of operations and we may not have adequate funds available to cover such liabilities, as well as incurred legal defense costs.

On October 26, 2018, Navigators Insurance Company ("Navigators") initiated an insurance coverage declaratory judgment action against us in the United States District Court for the Eastern District of Pennsylvania seeking a decision that it does not owe us coverage under certain insurance policies for the defense and potential indemnity of us in three lawsuits pending against us: (1) UFCW, Local 23 and Employers Health Fund v. Endo Pharmaceuticals, Inc. et al., Case No. 180403485, filed in the Pennsylvania Court of Common Pleas, Philadelphia County ("UFCW Action"); (2) Iron Workers District Council of Philadelphia and Vicinity, Benefit Fund v. Abbott Laboratories, Inc. et al., Case No. 180502442, filed in the Pennsylvania Court of Common Pleas, Philadelphia County ("Iron Workers Action"); and (3) State of Arkansas, ex. rel. Scott Ellington et al. v. Purdue Pharma, L.P. et al., Case No. CV-2018-268, filed in the Circuit Court of Crittenden County, Arkansas ("Arkansas Action").

While we intend to vigorously contest these claims, and file a counterclaim that Navigators owes us a duty to defend all of the lawsuits in full, and that any determination of the duty to indemnify at this point is premature, it is uncertain whether we will prevail. Further, it is possible that other insurers could adopt a similar position to that taken by Navigators and/or assert other reasons for denying coverage relative to claims made against us, including the opioid litigation lawsuits.  Further, there may be instances where our existing insurance coverage will not respond to or cover a claimed liability or where our insurers may dispute whether their insurance contracts require them to legally respond to such claimed liabilities. It is also possible that the amount of insurance that we currently hold may not be adequate to cover all liabilities that we might incur. Should any of these contingencies occur and should we be denied access to insurance coverage, this could have a material adverse effect on our business, financial condition and results of operations and we may not have adequate funds available to cover such liabilities, as well as incurred legal defense costs.  

Finally, insurance coverage is increasingly expensive. We might not be able to maintain insurance coverage at a reasonable cost that will be adequate to satisfy any liability that may arise. Further, we might not be able to obtain insurance coverage for certain products and/or potential liabilities, including but not limited to our opioid products.

Seasonality may cause fluctuations in our financial results.

We generally experience some effects of seasonality due to patients resetting their deductible amounts in the beginning of the calendar year and reaching their deductible amounts during the year. Accordingly, sales of our products and associated revenue have generally decreased in the first quarter of each year and begin to increase during the remainder of the year. This seasonality may cause fluctuations in our financial results. In addition, other seasonality trends may develop and the existing seasonality that we experience may change. 

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Risks Related to Our Dependence on Third Parties

We may face delays in the development and commercialization of, or be unable to meet demand for, our products and may lose potential revenues if the manufacturers upon whom we rely fail to properly produce our products or in the volumes that we require on a timely basis, or to comply with stringent regulations applicable to pharmaceutical drug manufacturers.

We do not manufacture our products, and we do not currently plan to develop any capacity to do so. We rely on third parties to manufacture our products. The manufacture of pharmaceutical products requires significant expertise and capital investment, including the development of advanced manufacturing techniques and process controls. Manufacturers of pharmaceutical products often encounter difficulties in production, particularly in scaling up and validating initial production. These problems include difficulties with production costs and yields, quality control, including stability of the product and quality assurance testing, shortages of qualified personnel, as well as compliance with strictly enforced federal, state and foreign regulations.

Manufacturers may not perform as agreed or may terminate their agreements. Additionally, manufacturers may experience manufacturing difficulties due to resource constraints or as a result of labor disputes or unstable political environments. If manufacturers were to encounter any of these difficulties, or otherwise fail to comply with their contractual obligations, our ability to sell our products or any other product candidate that we commercialize would be jeopardized. Any delay or interruption in our ability to meet commercial demand for our products will result in the loss of potential revenues.

For example, due to a manufacturing issue with one of our suppliers, the 20 mg. strength of Zohydro ER was on back order until March 2018. During that time, we marketed and distributed other strengths of Zohydro ER, including the 10 mg., 15 mg., 30 mg., 40 mg. and 50 mg. strengths. While utilization of the 10 mg., 15 mg. and 30 mg. strengths increased in order to fulfill patient needs, the temporary stock-out of the 20 mg. strength impacted the overall prescription volume for Zohydro ER, which resulted in a loss of revenue. While the manufacturer of the product, Recro Pharma, Inc. (Recro), was able to reinitiate supply of the 20 mg. strength of Zohydro to us, Recro has continued to be confronted with manufacturing challenges with the 20 mg. strength. While Recro now believes that it has resolved its manufacturing issue, we will experience a temporary stock-out of the 20 mg. during the fourth quarter of 2018. We do not believe that this temporary stock-out will have a material impact on the overall prescription volume for Zohydro ER in the fourth quarter.  While, as noted, Recro believes that the manufacturing issue relative to the 20 mg. strength is now resolved, it is possible that this issue is not fully resolved or that additional manufacturing issues might arise in the future that could cause Recro to be unable to supply us with the 20 mg. strength of Zohydro on a short or long term basis, which could have a potentially material adverse impact on our results of operations. Additionally, it is possible that Recro could encounter a manufacturing issue that could cause it to be unable to deliver requested quantities of the other dosage strengths of Zohydro ER, which could have a potentially material adverse impact on our results of operations.

In addition, in connection with our acquisition of the rights to Treximet intellectual property in August 2014, we discovered short-term supply constraints for the product. While we believe that we have addressed this issue by securing another manufacturer, our failure to obtain sufficient supply of Treximet to meet anticipated demand in the future may result in a loss of revenue.

Prior to the closing of the acquisition of Orexigen's assets, Orexigen informed us that due to certain packaging defects caused by manufacturing services provided by its third party manufacturer, Patheon, Orexigen elected to conduct a Class III recall at the retail level. We believe Nalpropion has adequate inventory of the product to prevent any product shortages and the product manufacturer, Patheon, has been placed on legal notice of actual and potential claims, as well as any other damages that might be incurred. Nevertheless, future manufacturing issues with Patheon could cause product shortages that would negatively impact our results of operations.

All manufacturers of pharmaceutical products must comply with the FDA's current cGMP requirements enforced by the FDA through its facilities inspection program. The FDA is also likely to conduct inspections of our and our commercial partners' manufacturing facilities as part of their review of any NDAs we submit to the FDA. These cGMP requirements include, among other things, quality control, quality assurance and the maintenance of records and documentation. Manufacturers of our products may be unable to comply with these cGMP requirements and with other FDA, state and foreign regulatory requirements. Failure to comply with these requirements may result in fines and civil penalties, suspension of production, suspension or delay in product approval, product seizure or recall, or withdrawal of product approval. If the safety, efficacy, or quantities of our products are compromised due to our or our commercial partners' manufacturers' failure to adhere to applicable laws or for other reasons, we may not be able to obtain regulatory approval for or successfully commercialize our products.

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Moreover, our or our commercial partners' manufacturers and suppliers may experience difficulties related to their overall businesses and financial stability, which could result in delays or interruptions of our supply of our products. We do not have alternate manufacturing plans in place at this time. If we need to change to other manufacturers, the FDA must approve these manufacturers' facilities and processes in advance, which would require new testing and compliance inspections. Moreover, new manufacturers may have to be trained in or independently develop the processes necessary for production.

Any of these factors could adversely affect the commercial activities for our products and required approvals for any other product candidate that we develop, or entail higher costs or result in our being unable to effectively commercialize our products. Furthermore, if our or our commercial partners' manufacturers failed to deliver the required commercial quantities of raw materials, including bulk drug substance, or finished product on a timely basis and at commercially reasonable prices, we would likely be unable to meet demand for our products and we would lose potential revenues.

The concentration of our product sales to only a few wholesale distributors increases the risk that we will not be able to effectively distribute our products if we need to replace any of these customers, which would cause our sales to decline.

The majority of our sales are to a small number of pharmaceutical wholesale distributors, which in turn sell our products primarily to retail pharmacies, which ultimately dispense our products to the end consumers. For the year ended December 31, 2017, McKesson Corporation, Cardinal Health and AmerisourceBergen Drug Corporation accounted for 34%, 24% and 30%, respectively, of our total gross sales.  For the year ended December 31, 2016, McKesson Corporation, Cardinal Health and AmerisourceBergen Drug Corporation accounted for 36%, 26% and 31%, respectively, of our total gross sales.  

If any of these customers cease doing business with us or materially reduce the amount of product they purchase from us and we cannot conclude agreements with replacement wholesale distributors on commercially reasonable terms, we might not be able to effectively distribute our products through retail pharmacies. The possibility of this occurring is exacerbated by the recent significant consolidation in the wholesale drug distribution industry, including through mergers and acquisitions among wholesale distributors and the growth of large retail drugstore chains. As a result, a small number of large wholesale distributors control a significant share of the market.

Any collaboration arrangements that we enter into may not be successful, which could adversely affect our ability to develop and commercialize our product candidates.

We enter into collaboration arrangements from time to time on a selective basis. Our collaborations may not be successful. In the future, we might market certain branded and generic products in the U.S. pursuant to collaboration arrangements. The success of such collaboration arrangements may depend heavily on the efforts and activities of our collaborators. Collaborators generally have significant discretion in determining the efforts and resources that they will apply to these collaborations.

Disagreements between parties to collaboration arrangements regarding clinical development and commercialization matters can lead to delays in the development process or commercialization of applicable product candidates and, in some cases, termination of the collaboration arrangement. These disagreements can be difficult to resolve if neither of the parties has final decision-making authority.

Our business could suffer as a result of a failure to manage and maintain our distribution network with our wholesale customers.

We depend on the distribution abilities of our wholesale customers to ensure that our products are effectively distributed through the supply chain. If there are any interruptions in our customers' ability to distribute products through their distribution centers, our products may not be effectively distributed, which could cause confusion and frustration among pharmacists and lead to product substitution.

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To the extent that we conduct clinical trials, we plan to rely on third parties to conduct these trials and such third parties may not perform satisfactorily, including failing to meet established deadlines for the completion of such trials.

We do not plan to independently conduct clinical trials for product candidates that we might acquire in the future and, instead, would rely on third parties, such as contract research organizations, clinical data management organizations, medical institutions and clinical investigators. Reliance on these third parties for clinical development activities would reduce our control over these activities, although we would remain responsible for ensuring that clinical trials performed at our direction are conducted in accordance with approved investigational plans and approved clinical trial protocols. Moreover, the FDA requires compliance with good clinical practices for conducting, recording, and reporting the results of clinical trials to assure that data and reported results are credible and accurate and that the rights and confidentiality of trial participants are protected. Reliance on third parties does not relieve a sponsor of these responsibilities and requirements. Furthermore, these third parties could also have relationships with other entities, some of which may be our competitors. If these third parties do not successfully carry out their contractual duties, meet expected deadlines or conduct our clinical trials in accordance with regulatory requirements or our stated protocols, we might not be able to obtain, or may be delayed in obtaining, regulatory approvals for future product candidates and may not be able to, or may be delayed in our efforts to, successfully commercialize such product candidates. 

We are subject to various legal proceedings and business disputes that could have a material adverse impact on our business, financial condition and results of operations and could cause the market value of our Common Stock to decline.

We are subject to various legal proceedings and business disputes and additional claims may arise in the future. Current legal proceedings and disputes as well as those that may arise in the future may be complex and extended and may occupy the resources of our management and employees. These proceedings may also be costly to prosecute and defend and may involve substantial awards or damages payable by us if not found in our favor some or all of which may not be covered by our existing insurance coverage or might result in the granting of certain rights on unfavorable terms in order to settle such proceedings. Defending against or settling such claims and any unfavorable legal decisions, settlements or orders could have a material adverse effect on our business, financial condition and results of operations and could cause the market value of our Common Stock to decline.

Risks Related to Intellectual Property

If we are unable to obtain and maintain protection for the intellectual property relating to our products, the value of our products will be adversely affected.

Our success will depend in part upon our ability, as well as our partners, to obtain and maintain protection for the intellectual property covering or incorporated into the products that we market, distribute and/or sell.  The patent situation in the field of pharmaceuticals is highly uncertain and involves complex legal and scientific questions.  We rely upon patents, trademarks, trade secrets and confidentiality agreements to protect the products that we market, distribute and/or sell.

We may not be able to obtain additional patent rights relating to our products and pending patent applications to which we have rights may not issue as patents or may not issue in a form that will be advantageous to us.  Further, our patents and the patents of our commercial partners could be challenged, narrowed, invalidated, or held to be unenforceable, the cost of any type of patent proceeding could be substantial and the results of which could limit our ability to stop third party competitors from marketing competing products.  Moreover, some physicians may prescribe a competitive or similar product that is not approved by the FDA to treat patients with insomnia or weight-related problems in lieu of prescribing Silenor or Contrave, respectively, and we cannot guarantee that our intellectual property or that the intellectual property of our partners, will prevent or deter such "off-label" use. Our patent rights also may not afford us protection against all competitors. 

Our collaborators and licensors may not adequately protect our intellectual property rights.  Certain of these third parties may have the first right to maintain or defend our intellectual property rights and, although we may have the right to assume the maintenance and defense of our intellectual property rights if these third parties do not, our ability to maintain and defend our intellectual property rights may be compromised by the acts or omissions of these third parties. 

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If we are unable to successfully appeal the district court's August 24, 2018 trial decision that the asserted claims of the Zohydro ER patents are invalid for obviousness under 35 U.S.C. § 103 and for lacking adequate written description under 35 U.S.C. § 112, we will no longer be able to maintain protection for the intellectual property relating to Zohydro ER with BeadTek, generic competitors will likely enter the U.S. marketplace in 2019 and the value of this product will be materially adversely affected.

Pernix Therapeutics, LLC (Pernix LLC) is the sole distributor of Zohydro ER in the United States. Pernix LLC and PIP DAC (collectively for the purpose of this paragraph, Pernix) brought suit against Actavis and Alvogen in the District of Delaware on March 4, 2016, seeking declaratory judgment of infringement of the '760 Patent.  Pernix filed and served Second and Third Amended Complaints, against Alvogen and Actavis respectively, on October 12, 2016, adding additional allegations of infringement. 

Pernix and Actavis entered into a settlement agreement on January 29, 2018.  Under the terms of the agreement, Pernix will grant Actavis a license to begin selling a generic version of Zohydro ER on March 1, 2029, or earlier under certain circumstances.  Other details of the settlement are confidential.  The launch of Actavis's generic product is contingent upon Actavis receiving final approval from the FDA of its ANDA for a generic version of Zohydro ER. For the Alvogen case, trial testimony was heard from June 11-13, 2018, post-trial briefing was completed on July 12, 2018, and the trial concluded with the parties' closing arguments on July 25, 2018. The district court's trial decision was rendered on August 24, 2018, finding the asserted claims of the Zohydro ER Patents to be infringed by Alvogen's proposed generic Zohydro ER product and not to be invalid for anticipation under 35 U.S.C. § 102. The district court also found the asserted claims to be invalid for obviousness under 35 U.S.C. § 103 and as lacking adequate written description under 35 U.S.C. § 112. Pernix filed a Notice of Appeal on September 7, 2018, appealing the district court's decision that the asserted claims are invalid for obviousness and lacking adequate written description to the United States Court of Appeals for the Federal Circuit. Pernix's opening appellate brief is due no later than November 13, 2018, Alvogen's answering brief is due no later December 24, 2018 and Pernix's reply brief is due no later than January 7, 2019. Oral argument on the appeal is expected in the second quarter of 2019, with a written decision to follow thereafter.

Should our appeal be unsuccessful, and upon Alvogen receiving final approval from the FDA of its ANDA for a generic version of Zohydro ER, Alvogen may be in a position to begin selling a generic version of Zohydro ER as early as October 1, 2019. Other generic competitors may enter the U.S. market thereafter. The entry of generic competitors will likely have a materially adverse impact upon the value of this product and our gross revenues.

Trademark protection of our products may not provide us with a meaningful competitive advantage.

We use trademarks on our marketed, branded products and believe that having distinctive marks is an important factor in marketing those products and maintaining good will.  Distinctive marks may also be important for any additional products that we successfully develop and/or commercially market.  However, even though we register, maintain, monitor and defend our trademarks as necessary, we generally do not rely on our marks to provide a meaningful competitive advantage over other products.  We believe that efficacy, safety, convenience, price, the level of competition and the availability of reimbursement from government and other third-party payors are likely to continue to be more important factors in the commercial success of our products. 

If we fail to comply with the obligations included in our intellectual property licenses with third parties, we could lose license rights that are important to our business.

We have acquired rights to products and product candidates under license and co-promotion agreements with third parties and expect to enter into additional licenses and co-promotion agreements in the future.  Our existing licenses impose, and we expect that future licenses will impose, various development and commercialization, purchase commitment, royalty, sublicensing, patent protection and maintenance, insurance and other similar obligations on us.

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If we fail to comply with our obligations under a license agreement, the licensor may have the right to terminate the license in whole, terminate the exclusive nature of the license or bring a claim against us for damages.  Any such termination or claim could prevent or impede our ability to market any product that is covered by the license agreement.  Even if we contest any such termination or claim and are ultimately successful, our business could suffer.  In addition, upon any termination of a license agreement, our market position could be impacted if we were legally required to provide a licensor with a license to use any related intellectual property that we developed.

If we are unable to protect the confidentiality of our proprietary information and know-how, the value of our technology and products could be adversely affected.

In addition to patents and trademarks, we rely upon trade secrets, technical know-how and continuing technological innovation to develop and maintain our competitive position.  We require our relevant persons, such as employees, consultants and other third parties, including vendors (when appropriate), to execute confidentiality and/or assignment-of-inventions agreements with us.

These agreements may be breached, and in some instances, we may not have an appropriate remedy available for breach of the agreements.  Furthermore, our competitors may independently develop substantially equivalent proprietary information and techniques, reverse engineer our information and techniques, or otherwise gain access to our proprietary technology.  If we are unable to protect the confidentiality of our proprietary information and know-how, competitors may be able to use this information to develop products that compete with our products, which could adversely impact our business.

If we infringe or are alleged to infringe intellectual property rights of third parties, it may adversely affect our business.

Our development and commercialization activities, as well as any product candidates or products resulting from these activities, may infringe or be claimed to infringe one or more claims of an issued patent or pending patent application which we do not hold a license or other rights.  Third parties may own or control these patents or patent applications and could bring claims against us or our collaborators that would cause us to incur substantial expenses and, if successful against us, could cause us to pay substantial damages.  Further, if a patent infringement suit were brought against us or our collaborators, we or our collaborators could be forced to stop or delay development, manufacturing or sales of the product or product candidate that is the subject of the suit.

If any relevant claims of third-party patents that we are alleged to infringe are upheld as valid and enforceable in any litigation or administrative proceeding, we or our potential future collaborators could be prevented from commercializing a product, or maybe required to obtain licenses from the patent owners of each such patent, or to redesign our products, and could be liable for damages.  There can be no assurance that such licenses would be available or, if available, would be available on acceptable terms, or that we would be successful in any attempt to redesign our products.  Even if we or our collaborators were able to obtain a license, the rights may be nonexclusive, which could result in our competitors gaining access to the same intellectual property.  Ultimately, we could be prevented from commercializing a product, or be forced to cease some aspect of our business operations. An adverse determination in a judicial or administrative proceeding, failure to redesign, or failure to obtain necessary licenses could prevent us or our future collaborators from manufacturing and selling our products and would have a material adverse effect on our business. 

There has been substantial litigation and other proceedings regarding patents and other intellectual property rights in the pharmaceutical and biotechnology industries.  The cost to us of any patent litigation or other proceedings, even if resolved in our favor, could be substantial.  Some of our competitors may be able to sustain the costs of such litigation or proceedings more effectively than we can because of their substantially greater financial resources.  Uncertainties resulting from the initiation and continuation of patent litigation or other proceedings could have a material adverse effect on our ability to compete in the marketplace.  Patent litigation and other proceedings may also absorb significant management time.

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Risks Related to Our Financial Position

We may need substantial additional funding and may be unable to raise capital when needed, which would force us to delay, reduce or eliminate our product development programs, commercialization efforts or acquisition strategy.

We make significant investments in our currently-marketed products for sales, marketing, and distribution. We have used, and expect to continue to use, revenue from sales of our marketed products and products we distribute to fund acquisitions (at least partially), for development costs and to establish and expand our sales and marketing infrastructure.

Our future capital requirements will depend on many factors, including:

  • our ability to restructure our existing debt;
  • our ability to successfully integrate the operations of newly acquired businesses and assets and/or in-licensed products or product candidates into our product portfolio;
  • our ability to successfully establish and maintain collaborations or other strategic alliances;
  • the level of product sales from our currently marketed or distributed products and any additional products that we may market or distribute in the future;
  • the extent to which we acquire or invest in products, businesses and technologies;
  • the scope, progress, results and costs of clinical development activities for our product candidates;
  • the costs, timing and outcome of regulatory review of our product candidates;
  • the number of, and development requirements for, additional product candidates that we pursue;
  • the costs of commercialization activities, including product marketing, sales and distribution;
  • the extent to which we choose to establish additional collaboration, co-promotion, distribution or other similar arrangements for our products and product candidates; and
  • the costs of preparing, filing and prosecuting patent applications and maintaining, enforcing and defending intellectual property related claims.

We intend to obtain any additional funding that we require through public or private equity or debt financings, strategic relationships, including the divestiture of non-core assets, assigning receivables, milestone payments or royalty rights, or other arrangements. We cannot assure such funding will be available on reasonable terms, or at all. Additional equity financing will be dilutive to stockholders, and debt financing, if available, may involve restrictive covenants. In addition, if we raise additional funds through collaborations or other strategic transactions, it may be necessary to relinquish potentially valuable rights to our potential products or proprietary technologies, or we may have to grant licenses on terms that are not favorable to us.

If efforts to raise additional funds are unsuccessful, we may be required to delay, scale-back or eliminate plans or programs relating to our business, relinquish some or all rights to our products or renegotiate less favorable terms with respect to such rights than we would otherwise agree to accept or we may have to cease operating as a going concern. In addition, if we do not meet our payment obligations to third parties as they come due, we may be subject to litigation claims. Even if we were successful in defending against these potential claims, litigation could result in substantial costs and be a distraction to management and might result in unfavorable results that could further adversely impact our financial condition

If we are unable to continue as a going concern, we may have to liquidate our assets and may receive less than the value at which those assets are carried on our financial statements, and it is likely that investors will lose all or a part of their investments.

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If the estimates that we make, or the assumptions upon which we rely, in preparing our financial statements prove inaccurate, our future financial results may vary from expectations.

Our financial statements have been prepared in accordance with GAAP. The preparation of our financial statements requires us to make estimates and judgments that affect the reported amounts of our assets, liabilities, stockholders' equity, revenues and expenses, the amounts of charges accrued by us and related disclosure of contingent assets and liabilities. We base our estimates on historical experience and on various other assumptions that we believe to be reasonable under the circumstances. For example, at the same time we recognize revenues for product sales, we also record an adjustment, or decrease, to revenue for estimated charge backs, rebates, discounts, vouchers and returns, which management determines on a product-by-product basis as its best estimate at the time of sale based on each product's historical experience adjusted to reflect known changes in the factors that impact such reserves.  For new products, these sales adjustments may be estimated based upon information available on any similar products in the marketplace or specific information provided by business partners or if management is not able to derive a reasonable estimate for the adjustments, gross revenue can be deferred and recognized as the product is prescribed.

Actual sales allowances may vary from our estimates for a variety of reasons, including unanticipated competition, regulatory actions or changes in one or more of our contractual relationships. We cannot assure you, therefore, that there may not be material fluctuations between our estimates and the actual results.

Our ability to utilize our net operating loss carryforwards and certain other tax attributes may be limited.

As of December 31, 2017, we had net operating losses (NOLs) of approximately $396.5 million for federal income tax purposes. Subject to applicable limitations, these NOLs may be used to offset future taxable income, to the extent we generate any taxable income, and thereby reduce our future federal income taxes otherwise payable.

Under Section 382 of the Internal Revenue Code (the Code), if a corporation undergoes an "ownership change" as defined in that section, the corporation's ability to use its pre-change NOLs and other pre-change tax attributes to offset its post-change income may become subject to significant limitations. In general terms, an ownership change occurs if there is a greater than 50 percentage point increase in the amount of the corporation's stock owned by certain stockholders during a three year testing period. An ownership change may be triggered by the purchase and sale, redemption, or new issuance of stock. $366.5 million of our NOLs are already subject to limitation under Section 382 of the Code. We may experience an ownership change in the future as a result of shifts in our stock ownership, which may result from, among other things, issuances of Common Stock, including upon the exercise by the holders of our existing convertible debt securities and any convertible debt securities we may offer in the future of the conversion rights under such instruments, and upon the exercise of stock options and other equity compensation awards. If a future ownership change were to be triggered, our ability to use some or all of our remaining NOLs could be significantly limited. Further, depending on the level of our taxable income, all or a portion of our NOLs may expire unutilized, which could prevent us from offsetting future taxable income by the entire amount of our current and future NOLs.

Additionally, on December 22, 2017, the U.S. government enacted comprehensive tax legislation commonly referred to as the Tax Cuts and Jobs Act (the Tax Act). The Tax Act contains significant changes to corporate taxation and modifies several existing laws around NOLs, including a limitation on the deduction for NOLs to 80 percent of current year taxable income as well as an indefinite carryover period for NOLs. Both provisions are applicable for losses arising in tax years beginning after December 31, 2017. For these reasons, even if we generate taxable income in the future, our ability to utilize our NOLs may be limited, potentially significantly so.

If we fail to meet all applicable continued listing requirements of the Nasdaq Global Market and it determines to delist our Common Stock, the market liquidity and market price of our Common Stock could decline.

If we fail to meet all applicable listing requirements of the Nasdaq Global Market and it determines to delist our Common Stock, trading, if any, in our shares may continue to be conducted on an over-the-counter market, such as the OTCQX, OTCQB or the OTC Pink. Delisting of our shares would result in limited release of the market price of those shares and limited analyst coverage and could restrict investors' interest and confidence in our securities. Also, a delisting could have

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a material adverse effect on the trading market and prices for our shares and our ability to issue additional securities or to secure additional financing. In addition, if our shares were not listed and the trading price of our shares was less than $5.00 per share, our shares could be subject to Rule 15g-9 under the Exchange Act which, among other things, requires that broker/dealers satisfy special sales practice requirements, including making individualized written suitability determinations and receiving a purchaser's written consent prior to any transaction. In such case, our securities could also be deemed to be a "penny stock" under the Securities Enforcement and Penny Stock Reform Act of 1990, which would require additional disclosure in connection with trades in those shares, including the delivery of a disclosure schedule explaining the nature and risks of the penny stock market. Such requirements could severely limit the liquidity of our securities and our ability to raise additional capital.

If significant business or product announcements by us or our competitors cause fluctuations in our stock price, an investment in our stock may suffer a decline in value.

The market price of our Common Stock may be subject to substantial volatility as a result of announcements by us or other companies in our industry, including our collaborators. Announcements that may subject the price of our Common Stock to substantial volatility include but are not limited to announcements regarding:

  • our operating results, including the amount and timing of sales of our products and our ability to successfully integrate the operations of newly acquired businesses or products;
  • the availability and timely delivery of a sufficient supply of our products;
  • the safety and quality of our products or those of our competitors;
  • our licensing and collaboration agreements and the products or product candidates that are the subject of those agreements;
  • the results of discoveries, preclinical studies and clinical trials by us or our competitors;
  • the acquisition of technologies, product candidates or products by us or our competitors;
  • the development of new technologies, product candidates or products by us or our competitors;
  • regulatory actions with respect to our product candidates or products or those of our competitors; and
  • significant acquisitions, strategic partnerships, joint ventures or capital commitments by us or our competitors.

The holders of our debt obligations and preferred stock, if any, will have priority over our Common Stock with respect to payment in the event of liquidation, dissolution or winding up and with respect to the payment of interest and dividends.

In any liquidation, dissolution or winding up of the Company, our Common Stock would rank below all claims of our note holders and other creditors as well as the claims of the Convertible Preferred Stock and any preferred stock issued subsequent to the date hereof. As of August 1, 2018, we had approximately $323.1million aggregate principal amount of debt outstanding, consisting of approximately (i) $36.1 million aggregate principal amount of our Exchangeable Notes, (ii) $78.2 million aggregate principal amount of our 4.25% Convertible Notes, (iii) $154.5 million aggregate principal amount of our Treximet Secured Notes, and (iv) approximately $54.3 million outstanding under our Credit Facilities. In addition, on August 1, 2018 we also issued 81,000 shares of the Convertible Preferred Stock and we are authorized, under our articles of incorporation, to issue up to an additional 1,000,000 shares of our Series B Junior Participating Stock and up to 7,500,000 shares of preferred stock, with designations, rights and preferences as they may determine. Accordingly, our Board has in the past and may in the future, without stockholder approval, issue shares of preferred stock with dividend, liquidation, conversion, voting or other rights that could adversely affect the voting power or other rights of the holders of our Common Stock.

In the event of our liquidation, dissolution or winding up, holders of our Common Stock would not be entitled to receive any payment or other distribution of assets upon our liquidation, dissolution or winding up until after all of our obligations to our note holders and other creditors were satisfied and holders of senior equity securities, including holders of our Convertible Preferred Stock, had received any payment or distribution due to them.

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Because we do not anticipate paying any cash dividends on our capital stock in the foreseeable future, capital appreciation, if any, will be your sole source of gain.

We did not make any distributions for the years ended December 31, 2017 and 2016. We are currently investing in our promoted products lines and do not anticipate paying dividends in the foreseeable future. We currently intend to retain all of our future earnings, if any, to finance the growth and development of our business. In addition, the terms of the Credit Facilities, the indentures governing the Exchangeable Notes, the 4.25% Convertible Notes and the Treximet Secured Notes and the articles supplementary authorizing the issuance of the Convertible Preferred Stock prohibit us from paying dividends. As a result, capital appreciation, if any, of our Common Stock will be your sole source of gain for the foreseeable future.

Sales of a substantial number of shares of our Common Stock or equity-linked securities could cause our stock price to fall.

Sales of a substantial number of shares of our Common Stock or equity-linked securities in the public market or the perception that these sales might occur, could depress the market price of our Common Stock and could impair our ability to raise capital through the sale of additional equity or equity-linked securities. We are unable to predict the effect that sales may have on the prevailing market price of our Common Stock.

Exchange of the Exchangeable Notes and conversion of the Convertible Preferred Stock and the 4.25% Convertible Notes may dilute the ownership interest of existing stockholders and could have an adverse impact upon the prevailing market price of our Common Stock.

Subject to certain contractual restrictions, holders of the Exchangeable Notes and the Convertibles Notes are entitled to exchange or convert, respectively, the Exchangeable Notes or the 4.25% Convertible Notes for shares of our Common Stock at their option at any time prior to the close of business on the second scheduled trading day immediately preceding the maturity date of the Exchangeable Notes or the 4.25% Convertible Notes, respectively. In addition, holders of the Convertible Preferred Stock, subject to certain contractual restrictions, have the right to convert their shares of Convertible Preferred Stock for shares of our Common Stock at their option. On October 3, 2018, holders of 13,100 shares of the Convertible Preferred Stock elected to convert such Convertible Preferred Stock into 548,115 shares of our Common Stock. Further, the 2018 Exchange Agreement affords certain Exchange Holders the right to exchange up to an additional $65.1 million aggregate principal amount of the Treximet Secured Notes plus accrued and unpaid interest, into additional Convertible Preferred Stock until February 1, 2020. We have the right, at our option, to automatically convert all shares of the Convertible Preferred Stock into shares of Common Stock, subject to the satisfaction of certain specified conditions. The exchange of some or all of the Exchangeable Notes or the conversion of some or all of the 4.25% Convertible Notes or shares of the Convertible Preferred Stock will dilute the ownership interests of existing stockholders. If holders of the Exchangeable Notes were to exchange all of the outstanding Exchangeable Notes (not taking into account the potential for capitalization of interest or additional interest or changes to the exchange price), we would need to deliver approximately 6,571,746 shares of our Common Stock to settle the exchange, which would result in significant dilution to existing stockholders. If holders of the 4.25% Convertible Notes were to exchange all of the outstanding 4.25% Convertible Notes, we would need to deliver approximately 682,413 shares of our Common Stock to settle the conversion, which would result in additional dilution to existing stockholders. If holders of the Convertible Preferred Stock were to convert all of the outstanding shares of Convertible Preferred Stock (assuming the Exchange Holders exercise their right to exchange the entire $65.1 million aggregate principal amount of the Treximet Secured Notes plus accrued and unpaid interest as of September 30, 2018), and not giving effect to any applicable ownership limitations on such conversions, we would need to deliver approximately 30,627,615 shares of our Common Stock to settle the conversions, which would result in additional dilution to existing stockholders. Sales in the public market of shares of our Common Stock issued upon exchange or conversion could have an adverse impact upon the prevailing market price of our Common Stock.

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Future issuances of preferred stock may adversely affect the market price for our Common Stock.

Additional issuances and sales of preferred stock, or the perception that such issuances and sales could occur, may cause prevailing market prices for our Common Stock to decline and may adversely affect our ability to raise additional capital in the financial markets at times and prices favorable to us.

Our operating results are likely to fluctuate from period to period.

We anticipate that there may be fluctuations in our future operating results. Potential causes of future fluctuations in our operating results may include:

  • period-to-period fluctuations in financial results due to seasonal demands for certain of our products;
  • unanticipated potential product liability or patent infringement claims;
  • new or increased competition from generics;
  • the introduction of technological innovations or new commercial products by competitors;
  • changes in the availability of reimbursement to the patient from third-party payers for our products;
  • the entry into, or termination of, key agreements, including key strategic alliance agreements;
  • the initiation of litigation to enforce or defend any of our intellectual property rights;
  • the loss of key employees;
  • the results of pre-clinical testing, IND application, and potential clinical trials of some product candidates;
  • regulatory changes;
  • the results and timing of regulatory reviews relating to the approval of product candidates;
  • the results of clinical trials conducted by others on products that would compete with our products and product candidates;
  • failure of any of our products or product candidates to achieve commercial success;
  • general and industry-specific economic conditions that may affect research and development expenditures;
  • future sales of our Common Stock; and
  • changes in the structure of health care payment systems resulting from proposed healthcare legislation or otherwise.

Our stock price is subject to fluctuation, which may cause an investment in our stock to suffer a decline in value.

The market price of our Common Stock may fluctuate significantly in response to factors that are beyond our control. The stock market in general has recently experienced extreme price and volume fluctuations. The market prices of securities of pharmaceutical and biotechnology companies have been extremely volatile and have experienced fluctuations that often have been unrelated or disproportionate to the operating performance of these companies. These broad market fluctuations could result in extreme fluctuations in the price of our Common Stock, which could cause a decline in the value of our Common Stock.

If we become subject to unsolicited public proposals from activist stockholders, we may experience significant uncertainty that would likely be disruptive to our business and increase volatility in our stock price.

Public companies, particularly those in volatile industries such as the pharmaceutical industry, have been the target of unsolicited public proposals from activist stockholders. The unsolicited and often hostile nature of these public proposals can result in significant uncertainty for current and potential licensors, suppliers, patients, physicians and other constituents, and can cause these parties to change or terminate their business relationships with the targeted company. Companies targeted by these unsolicited proposals from activist stockholders may not be able to attract and retain key personnel as a result of the related uncertainty. In addition, unsolicited proposals can result in stockholder class action lawsuits. The review and consideration of an unsolicited proposal as well as any resulting lawsuits can be a significant distraction for management and employees, and may require the expenditure of significant time, costs and other resources. 

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If we were to receive unsolicited public proposals from activist stockholders, we may encounter all of these risks and, as a result, may be delayed in executing our core strategy. We could be required to spend substantial resources on the evaluation of the proposal as well as the review of other opportunities that never come to fruition. If we were to receive any of these unsolicited public proposals, the future trading price of our Common Stock is likely to be even more volatile than in the past, and could be subject to wide price fluctuations based on many factors, including uncertainty associated with the proposals.

We may become involved in securities or other class action litigation that could divert management's attention and harm our business.

The stock market has from time to time experienced significant price and volume fluctuations that have affected the market prices for the common stock of pharmaceutical and biotechnology companies. These broad market fluctuations may cause the market price of our common stock to decline. In the past, following periods of volatility in the market price of a particular company's securities, securities class action litigation has often been brought against that company. Any securities or other class action litigation asserted against us could have a material adverse effect on our business.

Risks Related to Regulatory Matters

If we are not able to obtain required regulatory approvals, we will not be able to commercialize our product candidates and our ability to generate increased revenue will be materially impaired. 

Product candidates and the activities associated with their development and commercialization, including their testing, manufacture, safety, efficacy, recordkeeping, labeling, storage, approval, advertising, promotion, sale and distribution, are subject to comprehensive regulation by the FDA, the DEA and other regulatory agencies in the United States. Should we acquire or develop a product candidate, the failure to obtain regulatory approval would prevent us from commercializing the product candidate. Securing FDA approval requires the submission of extensive preclinical and clinical data and supporting information for each therapeutic indication to establish the product candidate's safety and efficacy. Securing FDA approval also requires the submission of information about the product manufacturing process to, and inspection of manufacturing facilities by, the FDA. Additionally, it is possible that future product candidates may not be effective, may be only moderately effective, or may have undesirable or unintended side effects, toxicities or other characteristics that may preclude our obtaining regulatory approval or prevent or limit commercial use.

The process of obtaining regulatory approvals is expensive, often takes many years, if approval is obtained at all, and can vary substantially based upon a variety of factors, including the type, complexity and novelty of the product candidates involved and the nature of the disease or condition to be treated. Changes in regulatory approval policies during the development period, changes in or the enactment of additional statutes or regulations, or changes in the regulatory review process for a product application may cause delays in the approval of, or rejection of, an application. The FDA has substantial discretion in the approval process and may refuse to accept any application or may decide that our data is insufficient for approval and require additional preclinical, clinical or other studies. The FDA may decline to approve one or more of our product candidates for many reasons, including:

  • disagreement with the design or implementation of our clinical trials;
  • failure to demonstrate that a product candidate is safe and effective for its proposed indication;
  • failure of clinical trial results to meet the level of statistical significance required for approval;
  • failure to demonstrate that a product candidate's clinical and other benefits outweigh its safety risks;
  • disagreement with our interpretation of data from preclinical studies or clinical trials;
  • insufficiency of data collected from clinical trials of a product candidate to support the submission and filing of an NDA or other submission or to obtain regulatory approval;
  • disapproval of the manufacturing processes or facilities of third-party manufacturers with whom we contract for clinical and commercial supplies; and
  • changes in approval policies or regulations that render our preclinical and clinical data insufficient for approval.

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In addition, varying interpretations of the data obtained from preclinical and clinical testing could delay, limit or prevent regulatory approval of a product candidate. Any regulatory approval ultimately obtained may be limited or subject to restrictions or post-approval commitments that render the approved product not commercially viable.

Any pharmaceutical product for which we currently have marketing approval could be subject to restrictions or withdrawal from the market and we may be subject to penalties if we fail to comply with regulatory requirements or if we experience unanticipated problems with our products.

Any FDA approved products are subject to continued requirements of and review by the FDA. These requirements include submissions of safety and other post-marketing information and reports, registration requirements, cGMP requirements relating to quality control, quality assurance and corresponding maintenance of records and documents, requirements regarding the distribution of samples to physicians and recordkeeping. Even after a product receives FDA approval, that approval may be subject to limitations on the indicated uses for which the product may be marketed, or to requirements for costly post-marketing testing and surveillance to monitor the safety or efficacy of the product. Later discovery of previously unknown problems with our products, manufacturers, or manufacturing processes or failure to comply with regulatory requirements may result in administrative and judicial actions such as:

  • withdrawal of the products from the market;
  • restrictions on the marketing or distribution of such products;
  • requirements to place additional warnings on the labels for such products;
  • requirements to develop a REMS for such products or, if a REMS is already in place, to incorporate additional requirements under the REMS;
  • requirements to conduct additional post-market studies;
  • restrictions on the manufacturers or manufacturing processes;
  • warning letters;
  • refusal to approve pending applications or supplements to approved applications that we submit;
  • recalls;
  • fines;
  • suspension or withdrawal of regulatory approvals;
  • refusal to permit the import or export of our products;
  • product seizure;
  • injunctions or the imposition of civil or criminal penalties; or
  • private lawsuits alleging harm caused to subjects or patients.

For example, even though U.S. regulatory approval has been obtained for Contrave, which we have the exclusive right to distribute in the United States from Nalpropion, the FDA has imposed restrictions on its indicated uses and marketing and has imposed ongoing requirements for post-marketing studies and other activities. Nalpropion also is required to conduct a number of post-marketing studies, including a series of studies in obese pediatric patients to evaluate the safety and efficacy of Contrave for weight management in pediatric populations and a group of short-term trials, including a single-dose pharmacokinetic study in renal and hepatic impairment and a placebo-controlled cardiovascular outcomes clinical trial (the "CVOT"). We cannot assure you that the CVOT proposal to be submitted by Nalpropion will satisfy the FDA's post-marketing requirements related to cardiovascular outcomes or that the FDA will not require Nalpropion to conduct additional studies during or after the CVOT.

Any issues relating to these restrictions or post-marketing requirements (including any additional studies which the FDA may require or a delay in conducting the post- marketing required studies) for our products, or for Contrave, could have an adverse impact on product market acceptance, as well as our ability to market, sell and/or distribute (as applicable) such potentially impacted product in the United States and to generate revenue.

In addition, the FDA strictly regulates labeling, advertising and promotion of marketed products. A pharmaceutical product that receives FDA approval may only be promoted for FDA-approved indications and in accordance with the FDA-approved labeling. We may be subject to enforcement and other liability if we inappropriately promote our products.

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Our sales depend on payment and reimbursement from third-party payors, and a reduction in the payment rate or reimbursement could result in decreased use or sales of our products.

Our sales of currently marketed products and products that we distribute and our ability to commercialize our products depends substantially on the availability of sufficient coverage and reimbursement from third-party payors, including U.S. governmental payors such as the Medicare and Medicaid programs, MCOs and private insurers. All of Pernix's promoted products are generally well covered by managed care and private insurance plans. Generally, the status or tier within managed care formularies, which are lists of approved products developed by MCOs, varies but coverage is similar to other products within the same class of drugs. However, the position of any of our branded products that requires a higher patient copayment may make it more difficult to expand the current market share for such product. In some cases, MCOs may require additional evidence that a patient had previously failed another therapy, additional paperwork or prior authorization from the MCO before approving reimbursement for a branded product. Some Medicare Part D plans also cover some or all of our products, but the amount and level of coverage varies from plan to plan. We also participate in the Medicaid Drug Rebate program with the Centers for Medicare & Medicaid Services (CMS) and submit all of our covered products for inclusion in this program. Coverage of our products under individual state Medicaid plans varies from state to state.

Additionally, our covered products are made available under the 340B Drug Pricing Program, which is codified as Section 340B of the Public Health Service Act. The 340B program requires participating manufacturers to agree to charge statutorily defined covered entities no more than the 340B "ceiling price" for the manufacturer's covered outpatient drugs. Details of the 340B program, our reliance on payment and reimbursement from third-party payors, and a reduction in the payment rate or reimbursement are discussed in the Business section under the heading "Pharmaceutical Pricing and Reimbursement" in Part I, Item 1, of our most recent Annual Report on Form 10-K.

There have been, there are, and we expect there will continue to be federal and state legislative and administrative proposals that could limit the amount that government health care programs will pay to reimburse the cost of pharmaceutical and biologic products. For example, the Medicare Prescription Drug Improvement and Modernization Act of 2003, or MMA, created a new Medicare benefit for prescription drugs. The Deficit Reduction Act of 2005 significantly reduced reimbursement for drugs under the Medicaid program. More recently, there have been proposals to impose federal rebates on Medicare Part D drugs, requiring federally-mandated rebates on all drugs dispensed to Medicare Part D enrollees or on only those drugs dispensed to certain groups of lower income beneficiaries. Legislative or administrative acts that reduce reimbursement or result in us owing additional rebates for our products could adversely impact our business.

Details of changes under Health Care Reform, as well as current uncertainties arising as a result of Trump administration and Congressional initiatives, are discussed in the Business section under the heading "Effects of Legislation on the Pharmaceutical Industry" in Part I, Item 1, of our most recent Annual Report on Form 10-K.

In addition, private insurers, such as MCOs, may adopt their own reimbursement reductions in response to federal or state legislation. Any reduction in reimbursement for our products could materially harm our results of operations. In addition, we believe that the increasing emphasis on managed care in the United States has and will continue to put pressure on the price and usage of our products, which may adversely impact our product sales. Furthermore, when a new product is approved, governmental and private coverage for that product and the amount for which that product will be reimbursed are uncertain. We cannot predict the availability or amount of reimbursement for our product candidates, and current reimbursement policies for marketed products and products that we distribute may change at any time.

The MMA established a voluntary prescription drug benefit, called Part D, which became effective in 2006 for all Medicare beneficiaries. We cannot be certain that our currently marketed products and products that we distribute will continue to be, or any of our product candidates still in development will be, included in the Medicare prescription drug benefit. Even if our products are included, the private health plans that administer the Medicare drug benefit can limit the number of prescription drugs that are covered on their formularies in each therapeutic category and class. In addition, private managed care plans and other government agencies continue to seek price discounts. Because many of these same private health plans administer the Medicare drug benefit, they have the ability to influence prescription decisions for a

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larger segment of the population. In addition, certain states have proposed or adopted various programs under their Medicaid programs to control drug prices, including price constraints, restrictions on access to certain products and bulk purchasing of drugs.

With respect to Nalpropion, there is also continued uncertainty outside of the U.S., as to the extent that governmental authorities may establish favorable coverage and reimbursement levels for Contrave. The ability of Nalpropion to secure favorable coverage and reimbursement levels outside of the U.S. is important to its revenue projections and thus its ability to be successful could impact our results of operations.

If we acquire and market additional products to the market, these products may not be considered cost-effective and reimbursement to the patient may not be available or sufficient to allow us to sell our product candidates on a competitive basis to a sufficient patient population. We may need to conduct expensive pharmacoeconomic trials in order to demonstrate the cost-effectiveness of our products and product candidates.

If we fail to comply with our reporting and payment obligations under the Medicaid Drug Rebate program or other governmental pricing programs, we could be subject to additional reimbursement requirements, penalties, sanctions and fines, which could have a material adverse effect on our business, financial condition, results of operations and growth prospects.

We participate in and have certain price reporting obligations to the Medicaid Drug Rebate program and other governmental pricing programs.

Under the Medicaid Drug Rebate program, we are required to pay a rebate to each state Medicaid program for our covered outpatient drugs that are dispensed to Medicaid beneficiaries and paid for by a state Medicaid program as a condition of having federal funds being made available to the states for our drugs under Medicaid and Medicare Part B (we currently do not market any Part B drugs). Those rebates are based on pricing data reported by us on a monthly and quarterly basis to the CMS the federal agency that administers the Medicaid Drug Rebate program. These data include the average manufacturer price and, in the case of innovator products, the best price for each drug which, in general, represents the lowest price available from the manufacturer to any entity in the United States in any pricing structure, calculated to include all sales and associated rebates, discounts and other price concessions.

Health Care Reform made significant changes to the Medicaid Drug Rebate program, such as expanding rebate liability from fee-for-service Medicaid utilization to include the utilization of Medicaid MCOs as well and changing the definition of average manufacturer price. Health Care Reform also increased the minimum Medicaid rebate; changed the calculation of the rebate for certain innovator products that qualify as line extensions of existing drugs; and capped the total rebate amount at 100% of the average manufacturer price. Finally, Health Care Reform requires pharmaceutical manufacturers of branded prescription drugs to pay a branded prescription drug fee to the federal government.

On February 1, 2016, CMS issued final regulations to implement the changes to the Medicaid Drug Rebate program under Health Care Reform, which became effective on April 1, 2016. The issuance of regulations and coverage expansion by various governmental agencies relating to the Medicaid Drug Rebate program has and will continue to increase our costs and the complexity of compliance, has been and will be time-consuming to implement, and could have a material adverse effect on our results of operations, particularly if CMS challenges the approach we take in our implementation of the final rule.

Federal law requires that any company that participates in the Medicaid Drug Rebate program also participate in the Public Health Service's 340B drug pricing program in order for federal funds to be available for the manufacturer's drugs under Medicaid and Medicare Part B. The 340B program requires participating manufacturers to agree to charge no more than the 340B "ceiling price" for the manufacturer's covered outpatient drugs to a variety of community health clinics and other entities that receive health services grants from the Public Health Service, as well as hospitals that serve a disproportionate share of low-income patients. Health Care Reform expanded the list of covered entities to include certain free-standing cancer hospitals, critical access hospitals, rural referral centers and sole community hospitals. The 340B ceiling price is calculated using a statutory formula based on the average manufacturer price and rebate amount for the

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covered outpatient drug as calculated under the Medicaid Drug Rebate program. Changes to the definition of average manufacturer price and the Medicaid rebate amount under Health Care Reform and CMS's final regulations implementing those changes also could affect our 340B ceiling price calculations and negatively impact our results of operations.

Health Care Reform obligates the Secretary of HHS, to create regulations and processes to improve the integrity of the 340B program. On January 5, 2017, HRSA issued a final regulation regarding the calculation of 340B ceiling price and the imposition of civil monetary penalties on manufacturers that knowingly and intentionally overcharge covered entities. The effective date of the regulation has been delayed until July 1, 2018. Implementation of this final rule and the issuance of any other final regulations and guidance could affect our obligations under the 340B program in ways we cannot anticipate. In addition, legislation may be introduced that, if passed, would further expand the 340B program to additional covered entities or would require participating manufacturers to agree to provide 340B discounted pricing on drugs used in the inpatient setting.

Pricing and rebate calculations vary across products and programs, are complex, and are often subject to interpretation by us, governmental or regulatory agencies and the courts. In the case of our Medicaid pricing data, if we become aware that our reporting for a prior quarter was incorrect, or has changed as a result of recalculation of the pricing data, we are obligated to resubmit the corrected data for up to three years after those data originally were due. Such restatements and recalculations increase our costs for complying with the laws and regulations governing the Medicaid Drug Rebate program and could result in an overage or underage in our rebate liability for past quarters. Price recalculations also may affect the ceiling price at which we are required to offer our products under the 340B drug discount program.

We are liable for errors associated with our submission of pricing data. In addition to retroactive rebates and the potential for 340B program refunds, if we are found to have knowingly submitted any false price information to the government, we may be liable for civil monetary penalties. Our failure to submit the required price data on a timely basis could also result in a civil monetary penalty for each day the information is late beyond the due date. Such failure also could be grounds for CMS to terminate our Medicaid drug rebate agreement, pursuant to which we participate in the Medicaid program. In the event that CMS terminates our rebate agreement, federal payments may not be available under Medicaid or Medicare Part B for our covered outpatient drugs.

CMS and the Office of the Inspector General have pursued manufacturers that were alleged to have failed to report these data to the government in a timely manner. Governmental agencies may also make changes in program interpretations, requirements or conditions of participation, some of which may have implications for amounts previously estimated or paid. We cannot assure you that our submissions will not be found by CMS to be incomplete or incorrect.

Federal law requires that for a company to be eligible to have its products paid for with federal funds under the Medicaid and Medicare Part B programs as well as to be purchased by certain federal agencies and grantees, it also must participate in the Department of Veterans Affairs, (VA), Federal Supply Schedule, (FSS), pricing program. To participate, we are required to enter into an FSS contract with the VA, under which we must make our innovator "covered drugs" available to the "Big Four" federal agencies - the VA, the Department of Defense, or DoD, the Public Health Service (PHS), and the Coast Guard - at pricing that is capped pursuant to a statutory federal ceiling price, (FCP), formula set forth in Section 603 of the Veterans Health Care Act of 1992, or VHCA. The FCP is based on a weighted average non-federal average manufacturer price (Non-FAMP), which manufacturers are required to report on a quarterly and annual basis to the VA. If a company misstates Non-FAMPs or FCPs it must restate these figures. In 2017, the civil monetary penalties for the knowing provision of false information in connection with a Non-FAMP filing was $181,071 for each item of false information. This penalty amount has not yet been updated for 2018.

FSS contracts are federal procurement contracts that include standard government terms and conditions, separate pricing for each product, and extensive disclosure and certification requirements. All items on FSS contracts are subject to a standard FSS contract clause that requires FSS contract price reductions under certain circumstances where pricing is reduced to an agreed "tracking customer." Further, in addition to the "Big Four" agencies, all other federal agencies and some non-federal entities are authorized to access FSS contracts. FSS contractors are permitted to charge FSS purchasers other than the Big Four agencies "negotiated pricing" for covered drugs that is not capped by the FCP; instead, such pricing is negotiated based on a mandatory disclosure of the contractor's commercial "most favored customer" pricing. We offer the same price to the Big 4 and other government agencies on our FSS contract.

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In addition, pursuant to regulations issued by the DoD TRICARE Management Activity, now the Defense Health Agency, to implement Section 703 of the National Defense Authorization Act for Fiscal Year 2008, each of our covered drugs is listed on a Section 703 Agreement under which we have agreed to pay rebates on covered drug prescriptions dispensed to TRICARE beneficiaries by TRICARE network retail pharmacies. Companies are required to list their innovator products on Section 703 Agreements in order for those products to be eligible for DoD formulary inclusion. The formula for determining the rebate is established in the regulations and our Section 703 Agreement and is based on the difference between the annual Non-FAMP and the FCP (as described above, these price points are required to be calculated by us under the VHCA).

Our relationships with customers and payors are subject to applicable fraud and abuse and other healthcare laws and regulations, which could expose us to criminal sanctions, civil penalties, contractual damages, reputational harm, and diminished profits and future earnings.

Healthcare providers, payors and others play a primary role in the recommendation and prescription of our products. Our arrangements with third-party payors and customers exposes us to broadly applicable fraud and abuse and other healthcare laws and regulation that may constrain the business or financial arrangements and relationships through which we market, sell and distribute our products. Applicable federal and state healthcare laws and regulations, include but are not limited to, the following:

  • The federal healthcare anti-kickback statute prohibits, among other things, any person or entity from knowingly and willfully soliciting, offering, receiving or paying remuneration, directly or indirectly, in cash or in kind, to induce or reward either the referral of an individual for, or the purchase, lease, order or arranging for or recommendation of, any good or service, for which payment may be made, in whole or in part, under federal healthcare programs such as Medicare and Medicaid. The term "remuneration" has been broadly interpreted to include anything of value. The government can establish a violation of the anti-kickback statute without proving that a person or entity had actual knowledge of the statute or specific intent to violate. Some courts, as well as certain governmental guidance, have interpreted the scope of the anti-kickback statute to cover any situation where one purpose of the remuneration is to induce referrals of federal health care program business, even if there are other legitimate reasons for the remuneration. In addition, the government may assert that a claim including items or services resulting from a violation of the anti-kickback statute constitutes a false or fraudulent claim for purposes of the False Claims Act. The anti-kickback statute has been applied by government enforcement officials to a number of common business arrangements in the pharmaceutical industry. There are a number of statutory exceptions and regulatory safe harbors protecting some common activities from prosecution. Those exceptions and safe harbors are drawn narrowly. Failure to meet all of the requirements of the exception or safe harbor does not make the conduct per se illegal, but the legality of the arrangements will be evaluated based on the totality of the facts and circumstances. However, there are no safe harbors for many common practices, such as educational and research grants or product support and patient assistance programs. We seek to comply with the available statutory exceptions and safe harbors whenever possible, but our practices may not in all cases meet all of the criteria for safe harbor protection from anti-kickback liability.

  • The federal False Claims Act imposes civil penalties, and provides for whistleblower or qui tam actions, against individuals or entities for, among other things, knowingly presenting, or causing to be presented claims for payment of government funds that are false or fraudulent or knowingly making, or using or causing to be made or used a false record or statement material to a false or fraudulent claim to avoid, decrease, or conceal an obligation to pay money to the federal government. In recent years, several pharmaceutical and other health care companies have faced enforcement actions under the False Claims Act for, among other things, allegedly submitting false or misleading pricing information to government health care programs and providing free product to customers with the expectations that the customers will bill federal programs for the product. Federal enforcement agencies have also showed increased interest in pharmaceutical companies' product and patient assistance programs, including reimbursement and co-pay support services. Other companies have faced

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    enforcement actions for causing false claims to be submitted because of the company's marketing the product for unapproved uses. False Claims Act liability is potentially significant because the statute provides for treble damages and mandatory penalties of $11,181 to $22,363 per false claim or statement. Because of the potential for large monetary damages and penalties, pharmaceutical manufacturers often resolve allegations without admissions of liability for significant and material amounts. Companies may be required to enter into corporate integrity agreements with the government to avoid exclusion from federal health care programs. Corporate integrity agreements impose substantial costs on companies to ensure compliance. There are also federal criminal statutes that prohibit making or presenting a false or fictitious or fraudulent claim to the federal government.

  • The Foreign Corrupt Practices Act and similar anti-bribery laws in countries outside of the U.S., such as the U.K. Bribery Act of 2010, prohibit companies and their intermediaries from making, or offering or promising to make, improper payments for the purpose of obtaining or retaining business or otherwise seeking favorable treatment.

  • The Health Insurance Portability and Accountability Act of 1996, or HIPAA, imposes criminal and civil liability for executing a scheme to defraud any healthcare benefit program. HIPAA also prohibits knowingly and willfully falsifying, concealing or covering up a material fact or making any materially false, fictitious or fraudulent statement or representation, or making or using any false writing or document knowing the same to contain any materially false, fictitious or fraudulent statement or entry in connection with the delivery of or payment for healthcare benefits, items or services.

  • The Open Payments program imposes annual reporting requirements on manufacturers of drugs, devices, or biologics for which payment is available under Medicare, Medicaid or the State Children's Health Insurance Program, of certain payments and other transfers of value to physicians and teaching hospitals made during the preceding calendar year, and any ownership and investment interests held by physicians. Failure to submit required information may result in civil monetary penalties of up to an aggregate of $150,000 per year (and up to an aggregate of $1.0 million per year for "knowing failures") for all payments, transfers of value or ownership or investment interests not appropriately reported. Manufacturers must submit reports by the 90th day of each calendar year.

  • Analogous state laws and regulations, such as state anti-kickback and false claims laws, may apply to sales or marketing arrangements and claims involving healthcare items or services reimbursed by non-governmental third party payors, including private insurers. Several states require pharmaceutical companies to report expenses relating to the marketing and promotion of pharmaceutical products in those states and to report gifts and payments to individual health care providers in those states. Some states also prohibit certain marketing-related activities, including providing gifts, meals or other items to certain health care providers. Some states restrict the ability of manufacturers to offer co-pay support to patients for certain prescription drugs. Other states and cities require identification or licensing of state representatives. Some states require pharmaceutical manufacturers to implement compliance programs or marketing codes that are consistent with the May 2003 Office of Inspector General Compliance Program Guidance for Pharmaceutical Manufacturers, and/or the voluntary PhRMA Code.

We, as well as many other pharmaceutical companies, sponsor prescription drug coupons and other product support agreements to help ensure that financial need does not limit a patient's access to our products. Co-pay coupon programs and other product and patient assistance programs have received negative publicity related to their use to promote branded pharmaceutical products over less costly generics and as a strategy to increase drug prices by shielding patients from those price increases. In recent years, other pharmaceutical manufacturers were named in class action lawsuits that challenged co-pay programs under a variety of federal and state laws. The Office of Inspector General for the HHS has issued additional guidance related to co-pay and patient assistance programs, and other government enforcement agencies have initiated investigations into and pursued enforcement actions related to other manufacturers' product and patient support programs. We cannot be certain whether our product and patient support programs will be named in any future similar lawsuits or become subject to government scrutiny. 

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We attempt to ensure that our business arrangements with third parties comply with applicable healthcare laws and regulations, utilizing the expertise of outside experts. However, it is possible that governmental authorities might conclude that our business practices do not comply with current or future statutes, regulations or case law involving applicable fraud and abuse or other healthcare laws and regulations. If our past or present operations, including activities conducted by our sales team or agents, would be found to be in violation of any of these laws or any other governmental regulations that may apply to us, we may be subject to significant civil, criminal and administrative penalties, damages, imprisonment, fines, exclusion from federal health care programs such as Medicare and Medicaid, and the curtailment or restructuring of our operations. If any of the physicians or other providers or entities with whom we do business are found to be not in compliance with applicable laws, they may be subject to criminal, civil or administrative sanctions, including exclusions from government funded healthcare programs.

Many aspects of these laws have not been definitively interpreted by the regulatory authorities or the courts and their provisions are open to a variety of subjective interpretations and remain subject to change. This increases the risk of potential violations. Any action against us for violation of these laws, even if we successfully defend against it, could cause us to incur significant legal expenses, divert our management's attention from the operation of our business and damage our reputation.

If we fail to comply with data protection laws and regulations, we could be subject to government enforcement actions (which could include civil or criminal penalties), private litigation and/or adverse publicity, which could negatively affect our operating results and business.

We are subject to data protection laws and regulations (i.e., laws and regulations that address privacy and data security). In the United States, numerous federal and state laws and regulations, including state data breach notification laws, state health information privacy laws, and federal and state consumer protection laws (e.g., Section 5 of the Federal Trade Commission Act), govern the collection, use, disclosure, and protection of health-related and other personal information. Failure to comply with data protection laws and regulations could result in government enforcement actions and create liability for us (which could include civil and/or criminal penalties), private litigation and/or adverse publicity that could negatively affect our operating results and business. In addition, we may obtain health information from third parties (e.g., healthcare providers who prescribe our products) that are subject to privacy and security requirements under HIPAA, as amended by the Health Information Technology for Economic and Clinical Health Act. Although we are not directly subject to HIPAA-other than potentially with respect to providing certain employee benefits - we could be subject to criminal penalties if we knowingly obtain or disclose individually identifiable health information maintained by a HIPAA-covered entity in a manner that is not authorized or permitted by HIPAA. HIPAA generally requires that healthcare providers and other covered entities obtain written authorizations from patients prior to disclosing protected health information of the patient (unless an exception to the authorization requirement applies). If authorization is required and the patient fails to execute an authorization, or the authorization fails to contain all required provisions, then we may not be allowed access to and use of the patient's information and our research efforts could be impaired or delayed. Furthermore, use of protected health information that is provided to us pursuant to a valid patient authorization is subject to the limits set forth in the authorization (e.g., for use in research and in submissions to regulatory authorities for product approvals). In addition, HIPAA does not replace federal, state, international or other laws that may grant individuals even greater privacy protections.

Also, the European Parliament has adopted the General Data Protection Regulation (GDPR), which became effective on May 25, 2018. This regulation replaces the EU's 1995 data protection directive and is now the single EU standard across all member states. The GDPR takes a broad view of the types of information that are deemed covered as personal identification information and contains provisions that require businesses to protect such personal data and the privacy of EU citizens for transactions that occur within EU member states. The GDPR also regulates the exportation of personal data outside of the EU. Non-compliance with the GDPR could result in significant penalties. Many companies, including our company, continue to assess the requirements of the GDPR against current business practices in order to maintain continuing compliance with this regulation.

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Risks Related to our Management of Nalpropion

We have limited experience managing companies for third parties and our management efforts may not be successful.

We, through our services agreement with Nalpropion, are responsible for distributing Contrave, a weight- loss product, in the United States. We are also responsible, through this services agreement, for overseeing the operations of Nalpropion (including overseeing the legal function and financial operations of Nalpropion), which operates in a therapeutic area that we have not previously serviced. We may be unable to adapt our current operations to appropriately service Nalpropion or this market and we may ultimately be unable to realize the anticipated benefits of Nalpropion's acquisition of Contrave and our agreement with Nalpropion. If we are unable to comply with our obligations under the services agreement with Nalpropion, Nalpropion may terminate the services agreement, which may have a material adverse effect on our business. In addition, we may have not discovered during the due diligence process all known and unknown factors regarding Contrave that could produce unintended and unexpected consequences for Nalpropion and us. Undiscovered factors could cause us to incur potentially material financial liabilities and prevent both Nalpropion and us from achieving the expected benefits from the transaction within our desired time frames, if at all. Additionally, Nalpropion is subject to certain restrictive covenants under the agreement governing its credit facilities, which may limit or disrupt its ability to manage or conduct its business.

The non-renewal or termination of our services agreement with Nalpropion would result in us losing rights to distribute Contrave and may adversely affect our financial performance and business.

Under the terms of the service agreement with Nalpropion, we will derive income from providing services to Nalpropion for a management fee and a percentage of the revenue generated by Nalpropion. As a result, we will incorporate into our annual financial guidance certain revenue expectations premised upon Nalpropion using a certain level of our services and generating a certain level of revenue. The initial term of our services agreement with Nalpropion is two years, subject to automatic renewals of consecutive one-year terms unless Nalpropion elects not to renew the services agreement at least 90 days prior to the end of the then current term. In addition, either party may terminate the services agreement for material breach after an opportunity to cure and Nalpropion may terminate the services agreement (i) at any time by providing at least 120 days prior written notice or (ii) no earlier than 120 days after the date on which we replace certain members of our management team without appointing replacements satisfactory to Nalpropion. Pursuant to the terms of the stockholders agreement among us, Nalpropion and the other stockholders named therein, we have the option to acquire up to 49.9% and 100% of the outstanding capital stock of Nalpropion at specified time periods and purchase prices, provided, however, both such purchase options terminate in connection with the non-renewal or termination of our services agreement with Nalpropion.

In the event Nalpropion exercised its non-renewal or termination rights under the services agreement, we would no longer be entitled to the exclusive U.S. distributor rights for Contrave (subject to a non-exclusive right to sell any inventory of Contrave we held at the time of such non-renewal or termination for a period not to exceed six months) and would also lose the option to exercise our option to purchase the capital stock of Nalpropion. Such non-renewal or early termination of the services agreement and the loss of our exclusive distributorship rights to Contrave and our option to purchase, respectively, could adversely affect our financial performance and we may be unable to recoup the transaction or business expenses we have incurred or expect to incur in connection with our transaction with Nalpropion. In addition, early termination of the services agreement may harm our business and results of operations as we may have failed to pursue other beneficial opportunities due to the focus of management on the management of Nalpropion prior to realizing all of the anticipated benefits of our transaction with Nalpropion.

Certain members of our executive management team, including our Chief Executive Officer, Chief Legal & Compliance Officer and Chief Business Officer and Principal Financial Officer, may dedicate inadequate time and attention to our Company.

Pursuant to the services agreement with Nalpropion, John A. Sedor, our Chairman of the Board and Chief Executive Officer, Kenneth R. Pińa, our Senior Vice President, Chief Legal & Compliance Officer and Corporate Secretary, and Angus W. Smith, our Senior Vice President, Chief Business Officer and Principal Financial Officer, will serve as officers

90


of Nalpropion and will allocate a portion of their time of employment with the Company to performing services for Nalpropion. Each of these individuals will allocate their time between our affairs and the affairs of Nalpropion. This situation presents the potential for conflicts of interest in determining the respective percentages of the time that these individuals devote to our affairs and the affairs of Nalpropion. In addition, if the affairs of Nalpropion require these members of our management team to devote more substantial amounts of their time to those affairs in the future, their ability to devote sufficient time to our affairs may be limited and could negatively impact our business.

A variety of risks associated with operating Nalpropion's business and distributing its product, Contrave, in the United States could have a material adverse impact upon the business and financial condition of Nalpropion and consequently materially adversely affect our business and financial condition.

We, through our services agreement with Nalpropion, are responsible for distributing Contrave in the United States and overseeing the operations of Nalpropion. Our business and financial condition could therefore be materially adversely affected by a variety of risks associated with managing Nalpropion's business and distributing Contrave in the United States, including the following:

  • While the constituent drugs that make up Contrave, bupropion and naltrexone, have post-marketing safety records and while these constituent drugs have been tested in combination in the clinical trials of Contrave to date, the safety of the combined use of the constituents of Contrave is not yet fully known, and any future clinical trials may produce side effects not observed to date. Undesirable side effects caused by Contrave could cause regulatory authorities to, among other things, (i) withdraw or limit their approval to market Contrave, (ii) require additional labeling statements, such as an additional "boxed" warning with Contrave or an additional contraindication statement; (iii) require Nalpropion to change the way Contrave is distributed or administrated; and/or (iv) require Nalpropion to conduct additional clinical trials. In addition, even though we are only the distributor of Contrave in the United States and are not directly responsible for the marketing of the product, it is possible that we could be named as a defendant in product liability lawsuits that are brought relative to Contrave due to our management of Nalpropion and indirect commercial activities relative to Contrave. While Nalpropion is responsible to defend and indemnify us in such instances and while our liability to Nalpropion for any errors or omissions on the part of our personnel under the services agreement is limited to no more than $6 million, it is possible that Nalpropion might not have the insurance proceeds or assets to adequately protect us from such liabilities.
  • While Nalpropion has placed contractual limitations and requirements in place with its vendors, we do not control the actions of Nalpropion's manufacturers and other third-party agents, including third party distributors outside of the United States, although we and Nalpropion may potentially be liable for their actions. Violations of laws by such third parties may result in civil or criminal sanctions, which could include monetary fines, criminal penalties, and disgorgement of past profits, which could have a material adverse impact upon the business and financial condition of Nalpropion and consequently on our business and financial condition.
  • Nalpropion's market opportunity for Contrave may be limited by the relatively small number of issued U.S. patents and foreign patents that it owns or in-licenses. Moreover, Contrave may face additional competition outside of the United States as a result of a lack of patent enforcement in foreign countries and off-label use of other dosage forms of the generic components in Contrave which could have a material adverse impact upon the business and financial condition of Nalpropion and consequently on our business and financial condition.

Nalpropion's market opportunity for Contrave may be limited by challenges to its issued U.S. patents. Further, restrictions on patent rights relating to Contrave may limit Nalpropion's ability to prevent third parties from competing against Contrave. Should Nalpropion be unsuccessful in defending against such legal challenges, it could have a material adverse impact upon the business and financial condition of Nalpropion and consequently on our business and financial condition. For example, in April 2015, Orexigen and Takeda Pharmaceutical Company Limited (Takeda) received notification of a Paragraph IV certification for certain patents for Contrave which are listed in the Orange Book. The certification resulted from the filing by Actavis Laboratories FL, Inc. (Actavis) of an ANDA challenging such patents for Contrave.

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In June 2015, Orexigen and Takeda filed a lawsuit in the U.S. District Court for the District of Delaware against Actavis on the basis that Actavis' proposed generic products infringe certain patents for Contrave. Takeda held the NDA for Contrave and was a licensee of Orexigen's patents until August 2016, at which point the ownership of the NDA was transferred to Orexigen and Takeda's rights to the Orexigen patents were terminated. A bench trial took place in June 2017 and on October 13, 2017, the court issued an opinion finding that the claims of the three patents at issue (U.S. Patent Nos. 7,462,626, 7,375,111 and 8,916,195, which expire in 2024, 2025 and 2030, respectively) were valid and infringed. Actavis filed an appeal, which is pending in the U.S. Court of Appeals for the Federal Circuit (Federal Circuit Appeal), and filed its opening appeal brief on February 21, 2018. The Federal Circuit ordered that the appeal be stayed during Orexigen's pending bankruptcy proceedings. On July 27, 2018, Nalpropion acquired worldwide rights to Contrave, including the rights to the patents at issue. Nalpropion filed motions to substitute itself as a party in the appeal and to lift the stay. Those motions were granted on September 19, 2018, allowing the appeal to proceed. Nalpropion's answering was filed on September 28, 2018, and Acatvis's reply appeal brief is due on November 13, 2018. Oral argument is expected sometime in the first half of 2019. If Actavis is successful in the Federal Circuit Appeal, a generic version of Contrave could be launched prior to the expiration of one or more of the patents at issue, which would materially impact Nalpropion's and our financial condition and results of operations. Further, if Contrave infringes or is alleged to infringe intellectual property rights of third parties, we may be adversely affected.

ITEM 2. UNREGISTERED SALES OF EQUITY SECURITIES AND USE OF PROCEEDS

On October 3, 2018, holders of 13,100 shares of the Company' 0% Series C Perpetual Convertible Preferred Stock elected to convert such Convertible Preferred Stock into 548,117 shares of the Common Stock. The issuance of Common Stock upon the conversion of the Convertible Preferred Stock was made in reliance upon the exemption from the registration requirements in Section 3(a)(9) of the Securities Act.

Other than as set forth above or as previously disclosed on our Current Reports on Form 8-K filed with the SEC, we did not issue any unregistered equity securities during the three months ended September 30, 2018.

ITEM 3. DEFAULTS UPON SENIOR SECURITIES

None.

ITEM 4. MINE SAFETY DISCLOSURES

Not applicable.

ITEM 5. OTHER INFORMATION

None.

ITEM 6.EXHIBITS

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EXHIBIT INDEX

Exhibit No.

 

Description

     

3.1 *

 

Articles Supplementary for 0% Series C Perpetual Convertible Preferred Stock.

 

10.1 *+

 

Stockholders Agreement, dated July 27, 2018, by and among Nalpropion Pharmaceuticals, Inc., 1992 MSF International Ltd., 1992 Tactical Credit Master Fund, L.P., 1992 Master Fund Co-Invest SPC3, Whitebox Caja Blanca Fund, LP, Whitebox Multi-Strategy Partners, L.P., Whitebox Asymmetric Partners, L.P., and Pernix Ireland Pain Designated Activity Company.

 

10.2 *

 

Services Agreement, dated July 27, 2018, between Nalpropion Pharmaceuticals, Inc. and Pernix Therapeutics, LLC.

 

10.3

 

Exchange Agreement, dated August 1, 2018, by and among Pernix Therapeutics Holdings, Inc., Deerfield Management L.P. and certain of its affiliates (incorporated by reference to Exhibit 10.1 to the Registrant's Current Report on Form 8-K filed on August 1, 2018).

 

10.4

 

Equitization Exchange Agreement, dated August 1, 2018, by and among Pernix Therapeutics Holdings, Inc. and 1992 Tactical Credit Master Fund, L.P. (incorporated by reference to Exhibit 10.2 to the Registrant's Current Report on Form 8-K filed on August 1, 2018).

 

10.5

 

Equitization Exchange Agreement, dated August 1, 2018, by and among Pernix Therapeutics Holdings, Inc. and 1992 MSF International Ltd. (incorporated by reference to Exhibit 10.3 to the Registrant's Current Report on Form 8-K filed on August 1, 2018).

 

10.6 *

 

Amendment No. 3 to the ABL Facility, August 1, 2018, by and among Pernix, the guarantors and lenders party thereto and Cantor Fitzgerald Securities, as agent.

 

10.7*

 

Amendment No. 2 to the Term Facility, dated August 1, 2018, by and among PIP DAC, the lenders party thereto and Cantor Fitzgerald Securities, as agent.

 

10.8 *

 

First Supplemental Indenture, dated July 27, 2018, between Pernix Therapeutics Holdings, Inc. and Wilmington Trust, National Trust Association, as Trustee.

     

31.1*

 

Certification of the Registrant's Chief Executive Officer pursuant to Section 302 of the Sarbanes-Oxley Act of 2002.

 

 

 

31.2*

 

Certification of the Registrant's Principal Financial Officer pursuant to Section 302 of the Sarbanes-Oxley Act of 2002.

 

 

 

32.1*

 

Certification of the Registrant's Chief Executive Officer and Principal Financial Officer pursuant to Section 906 of the Sarbanes-Oxley Act of 2002.

 

 

 

101*

 

Attached as Exhibit 101 to this report are the following items formatted in XBRL (Extensible Business Reporting Language):

 

 

(i) Condensed Consolidated Balance Sheets as of September 30, 2018 and December 31, 2017;

 

 

(ii) Condensed Consolidated Statements of Operations for the Three and Nine Months Ended September 30, 2018 and 2017;

   

(iii) Condensed Consolidated Statements of Comprehensive Income (Loss) for the Three and Nine Months Ended September 30, 2018 and 2017;

   

(iv) Condensed Consolidated Statements of Stockholders' Equity (Deficit) for the Nine Months Ended September 30, 2018 and for the year ended December 31, 2017;

 

 

(v) Condensed Consolidated Statements of Cash Flows for the Nine Months Ended September 30, 2018 and 2017; and

 

 

(vi) Notes to Condensed Consolidated Financial Statements.

_______________________

*   Filed herewith.

 + Confidential treatment requested as to portions of the exhibit (indicated by asterisks). Confidential materials omitted and filed separately with the Securities and Exchange Commission.

93


SIGNATURES

Pursuant to the requirements of the Securities Exchange Act of 1934, the Registrant has duly caused this report to be signed on its behalf by the undersigned thereunto duly authorized.

  

PERNIX THERAPEUTICS HOLDINGS, INC.

  

  

  

  

  

Date: November 9, 2018

By:

/s/ JOHN SEDOR

  

  

  

John Sedor

  

  

  

Chairman and Chief Executive Officer
(Principal Executive Officer)

  

  

  

  

  

Date: November 9, 2018

By:

/s/ ANGUS SMITH

  

  

  

Angus Smith
Senior Vice President and Chief Business Officer and Principal Financial Officer

  

  

  

(Principal Financial Officer)

 

  

 

 

 

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EX-3.1 2 exh3-1.htm ARTICLES SUPPLEMENTARY FOR 0% SERIES C PERPETUAL CONVERTIBLE PREFERRED STOCK Section 1

PERNIX THERAPEUTICS HOLDINGS, INC.

ARTICLES SUPPLEMENTARY ESTABLISHING AND FIXING THE
PREFERENCES, RIGHTS AND LIMITATIONS OF
0% SERIES C PERPETUAL CONVERTIBLE PREFERRED STOCK

Pernix Therapeutics Holdings, Inc., a Maryland corporation (the “Corporation”), hereby certifies to the State Department of Assessments and Taxation of Maryland (the “SDAT”) that:

FIRST:  Pursuant to the authority conferred upon the Board of Directors of the Corporation (the “Board of Directors”) by Article IV of the articles of incorporation of the Corporation (the “Articles of Incorporation”) and Section 2-208 of the Maryland General Corporation Law (the “MGCL”), the Board of Directors (a) has reclassified and designated 1,500,000 shares of the authorized but unissued Preferred Stock of the Corporation, par value $0.01 per share (the “Preferred Stock”) as a series of Preferred Stock designated as “0% Series C Perpetual Convertible Preferred Stock”, with the following preferences, conversion or other rights, voting powers, restrictions, limitations as to dividends, qualifications, or terms or conditions of redemption and (b) has authorized the filing of these Articles Supplementary (the “Articles Supplementary”) with the SDAT containing the information determined by the Board of Directors.

SECOND:  The preferences, conversion and other rights, voting powers, restrictions, limitations as to dividends, qualifications and terms and conditions of redemption as established by the Board of Directors for the 0% Series C Perpetual Convertible Preferred Stock which, upon any restatement of the Articles of Incorporation, shall become part of Article IV of the Articles of Incorporation (or any successor provision thereto), with any necessary or appropriate renumbering or relettering of the sections or subsections hereof, are as follows:

Section 1.  Designation and Number of Shares.  Pursuant to the Articles of Incorporation, a series of Preferred Stock, designated as the “0% Series C Perpetual Convertible Preferred Stock” (the “Perpetual Convertible Preferred Stock”), is hereby established.  The par value of the Perpetual Convertible Preferred Stock is $0.01 per share.  The number of shares of Perpetual Convertible Preferred Stock constituting such series shall be 1,500,000.  Such number of shares may be decreased by resolution of the Board of Directors, subject to the terms and conditions hereof; provided that no decrease shall reduce the number of shares of the Perpetual Convertible Preferred Stock to a number less than the number of shares then outstanding.  Capitalized terms used but not defined herein shall have the meanings ascribed to them in the Articles of Incorporation.

Section 2.  General Matters; Ranking.  Each share of the Perpetual Convertible Preferred Stock shall be identical in all respects to every other share of the Perpetual Convertible Preferred Stock.  The Perpetual Convertible Preferred Stock, with respect to rights upon the liquidation, winding-up or dissolution of the Corporation, shall rank (i) senior to all Junior Stock, (ii) on a parity with all Parity Preferred Stock and (iii) junior to all Senior Stock and the Corporation’s existing and future indebtedness.



Section 3.  Standard Definitions.  As used herein with respect to the Perpetual Convertible Preferred Stock:

Affiliate means, with respect to any Person, any other Person that directly or indirectly through one or more intermediaries controls, is controlled by or is under common control with, the Person in question.  As used herein, the term “control means the possession, direct or indirect, of the power to direct or cause the direction of the management and policies of a Person, whether through ownership of voting securities, by contract or otherwise.

Articles Supplementary” shall have the meaning set forth in the recitals.

Articles of Incorporation” shall have the meaning set forth in the recitals.

Average VWAP” per share of the Common Stock over a specified period means the arithmetic average of the VWAPs per share of the Common Stock for each Trading Day in such period.  Whenever any provision of these Articles Supplementary requires the Corporation or the Board of Directors (including any authorized committee thereof) to calculate the VWAP per share of Common Stock over a span of multiple days, the Board of Directors (or an authorized committee thereof) shall make appropriate adjustments to account for any adjustment to the Conversion Rate that becomes effective, or any event requiring an adjustment to the Conversion Rate where the Ex-Dividend Date, Effective Date or expiration date, as the case may be, of the event occurs, at any time during the period when the VWAPs are to be calculated.

Beneficial Ownership Limitation” shall have the meaning set forth in Section 24.

Board of Directors” shall have the meaning set forth in the recitals.

Business Day” means any day other than a Saturday or Sunday or other day on which commercial banks in New York City are authorized or required by law or executive order to close.

Bylaws” means the Amended and Restated Bylaws of the Corporation, as they may be further amended or restated from time to time.

Capital Stock” means, for any entity, any and all shares, interests or other equivalents of or interests in (however designated) stock issued by that entity and does not include convertible or exchangeable debt securities.

Change of Control” shall have the meaning set forth in Section 15(a)(v).

close of business” means 5:00 p.m., New York City time.

Closing Sale Price” per share of Common Stock means, on any date of determination, the closing sale price (or if no closing sale price is reported, the average of the bid and ask prices or, if more than one in either case, the average of the average bid and the average ask prices) on that date as reported in composite transactions for the principal U.S. national or regional securities exchange on which the Common Stock is traded.  If the Common Stock is not listed for trading on a U.S. national or regional securities exchange on the relevant date, the “Closing Sale Price” shall be the last quoted bid price for the Common Stock in the over-the-counter market on the relevant date as reported by OTC Markets Group Inc. or a similar organization.  If


2


the Common Stock is not so quoted, the “Closing Sale Price” shall be the average of the mid-point of the last bid and ask prices for the Common Stock on the relevant date from each of at least three nationally recognized independent investment banking firms selected by the Corporation for this purpose.

Code” means the U.S. Internal Revenue Code of 1986, as amended.

Common Stock” means the common stock, par value $0.01 per share, of the Corporation, subject to ‎Section 15.

Conversion Agent” means Computershare Trust Company, N.A., the Corporation’s duly appointed conversion agent for the Perpetual Convertible Preferred Stock, and any successor appointed under ‎Section 16.

Conversion Date” means each of (i) the last Trading Day of the Mandatory Conversion Measurement Period (in respect of any Mandatory Conversion) and (ii) any Optional Conversion Date (in respect of an Optional Conversion).

Conversion Obligation” means the amount and kind of consideration due upon an Optional Conversion or a Mandatory Conversion as described in Section 10.

Conversion Price” means as of any time, $100 divided by the Conversion Rate as of such time.

Conversion Rate” means, initially, 41.8410 shares of Common Stock per share of Perpetual Convertible Preferred Stock, subject to adjustment as provided in ‎Section 14.

Corporation” shall have the meaning set forth in the recitals.

Effective Date” means the first date on which shares of the Common Stock trade on the applicable exchange or in the applicable market, regular way, reflecting the relevant share split or share combination, as applicable.

Election Notice” shall have the meaning set forth in Section 15(e).

Event” shall have the meaning set forth in Section 9(a).

Exchange Act” shall mean the Securities Exchange Act of 1934, as amended, and the rules and regulations thereunder.

Exchange Agreement” means that certain Exchange Agreement among the Corporation and certain affiliates of Deerfield Partners, L.P., dated as of August 1, 2018.

Ex-Dividend Date” means, with respect to any issuance, dividend or distribution, the first date on which shares of the Common Stock trade on the applicable exchange or in the applicable market, regular way, without the right to receive the issuance, dividend or distribution in question, from the Corporation or, if applicable, from the seller of Common Stock on such exchange or market (in the form of due bills or otherwise) as determined by such exchange or market.


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Holder” means each person in whose name shares of the Perpetual Convertible Preferred Stock are registered, who shall be treated by the Corporation and the Registrar as the absolute owner of those shares of Perpetual Convertible Preferred Stock for the purpose of making payment and settling conversions and for all other purposes.

Initial Issue Date” shall mean August 1, 2018.

Junior Stock” means (i) the Common Stock and (ii) each other class or series of capital stock of the Corporation established after the Initial Issue Date, the terms of which do not expressly provide that such class or series ranks either (x) senior to the Perpetual Convertible Preferred Stock as to priority of payment of dividends and other distributions or rights upon voluntary or involuntary liquidation, winding-up or dissolution or (y) on a parity with the Perpetual Convertible Preferred Stock as to priority of payment of dividends and other distributions and rights upon voluntary or involuntary liquidation, winding-up or dissolution.

Liquidation Preference” shall have the meaning set forth in Section 5(a).

Mandatory Conversion” shall have the meaning set forth in Section 10(b).

Mandatory Conversion Condition” shall have the meaning set forth in Section 10(c).

Mandatory Conversion Date” means the last Trading Day of the Mandatory Conversion Measurement Period.

Mandatory Conversion Measurement Period” shall have the meaning set forth in Section 10(c).

Mandatory Conversion Settlement Amount” means a number of shares of Common Stock equal to the product of (i) the number of shares of Perpetual Convertible Preferred Stock to be converted, and (ii) the Conversion Rate on the Mandatory Conversion Date.

Market Disruption Event” means (a) a failure by the primary U.S. national or regional securities exchange or market on which the Common Stock is listed or admitted for trading to open for trading during its regular trading session or (b) the occurrence or existence prior to 1:00 p.m. New York City time, on any Scheduled Trading Day for the Common Stock for more than one half-hour period in the aggregate during regular trading hours of any suspension or limitation imposed on trading (by reason of movements in price exceeding limits permitted by the relevant stock exchange or otherwise) in the Common Stock or in any options contracts or futures contracts relating to the Common Stock.

Notice of Conversion” shall have the meaning set forth in Section 11(b)(i).

Observation Period” means, with respect to any Optional Redemption of any share of Perpetual Convertible Preferred Stock, the 20 consecutive Trading Day Period beginning on, and including, the 23rd Scheduled Trading Day immediately preceding the Redemption Date.

Officer” means the Chief Executive Officer, the Chief Financial Officer, the Chairman of the Board, any Executive Vice President or any Senior Vice President of the Corporation.


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Officer’s Certificate” means a certificate of the Corporation, signed by any duly authorized Officer of the Corporation.

open of business” means 9:00 a.m., New York City time.

Optional Conversion” shall have the meaning set forth in ‎Section 10(a).

Optional Conversion Date” shall have the meaning set forth in ‎Section 11(b).

Optional Redemption” shall have the meaning set forth in ‎Section 7(a).

Parity Preferred Stock” means any class or series of capital stock of the Corporation, the terms of which expressly provide that such class or series shall rank on a parity with the Perpetual Convertible Preferred Stock as to the priority of payment of dividends and other distributions and rights upon voluntary or involuntary liquidation, winding-up or dissolution.

Perpetual Convertible Preferred Stock” shall have the meaning set forth in ‎Section 1.

Person” means any individual, partnership, firm, corporation, limited liability company, business trust, joint stock company, trust, unincorporated association, joint venture, governmental authority or other entity of whatever nature.

Preferred Stock” shall have the meaning set forth in the recitals.

Record Datemeans, with respect to any dividend, distribution or other transaction or event in which the holders of Common Stock (or other applicable security) have the right to receive any cash, securities or other property or in which the Common Stock (or such other security) is exchanged for or converted into any combination of cash, securities or other property, the date fixed for determination of holders of the Common Stock (or such other security) entitled to receive such cash, securities or other property (whether such date is fixed by the Board of Directors (or an authorized committee thereof), by statute, by the Articles of Incorporation (including these Articles Supplementary), by the Bylaws or otherwise).

Redemption Date” shall have the meaning set forth in ‎Section 7(b).

Redemption Notice” shall have the meaning set forth in ‎Section 7(b).

Redemption Price” means, for each share of Perpetual Convertible Preferred Stock to be redeemed pursuant to ‎Section 7(a), 100% of the Liquidation Preference of such share, plus any accrued and unpaid dividends.

Redemption Settlement Date” means, with respect to any Optional Redemption, the relevant Redemption Date.

Reference Property” shall have the meaning set forth in ‎Section 15(a).

Registrar” shall initially mean Computershare Trust Company, N.A., the Corporation’s duly appointed registrar for the Perpetual Convertible Preferred Stock and any successor appointed under ‎Section 16.


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Reorganization Event” shall have the meaning set forth in ‎Section 15(a).

Rule 144” means Rule 144 as promulgated under the Securities Act.

Scheduled Trading Day” means a day that is scheduled to be a Trading Day.

SEC” means the U.S. Securities and Exchange Commission.

Securities Act” means the Securities Act of 1933, as amended, and the rules and regulations promulgated thereunder.

Senior Stock” means each class or series of capital stock of the Corporation established after the Initial Issue Date, the terms of which expressly provide that such class or series shall rank senior to the Perpetual Convertible Preferred Stock as to priority of payment of dividends and other distributions or rights upon voluntary or involuntary liquidation, winding-up or dissolution.

Specified Dollar Amount” means the cash amount per share of Perpetual Convertible Preferred Stock to be received in respect of the Redemption Price upon an Optional Redemption for which Redemption Combination Settlement applies as specified (or deemed to be specified) in the Redemption Notice for such Optional Redemption.

Subsidiary” means, with respect to any Person, any corporation, association, partnership or other business entity of which more than 50% of the total voting power of shares of capital stock or other interests (including partnership interests) entitled (without regard to the occurrence of any contingency) to vote in the election of directors, managers, general partners or trustees thereof is at the time owned or controlled, directly or indirectly, by (i) such Person; (ii) such Person and one or more Subsidiaries of such Person; or (iii) one or more Subsidiaries of such Person.

Trading Day” means a day on which (x) there is no Market Disruption Event and (y) trading in the Common Stock generally occurs (and at least one share of the Common Stock has traded) on The NASDAQ Global Select Market or, if the Common Stock is not then listed on The NASDAQ Global Select Market, on the principal other U.S. national or regional securities exchange on which the Common Stock is then listed or, if the Common Stock is not then listed on a U.S. national or regional securities exchange, on the principal other market on which the Common Stock is then listed or admitted for trading, except that if the Common Stock is not so listed or admitted for trading, “Trading Day” means a Business Day.

Transfer Agent” shall initially mean Computershare Trust Company, N.A., the Corporation’s duly appointed transfer agent for the Perpetual Convertible Preferred Stock and any successor appointed under ‎Section 16.

unit of Reference Property” shall have the meaning set forth in ‎Section 15(a).

VWAP” per share of Common Stock on any Trading Day means the per share volume-weighted average price as displayed on Bloomberg page “PTX <Equity> AQR” (or its equivalent successor if such page is not available) in respect of the period from 9:30 a.m. to 4:00 p.m., New York City time, on such Trading Day; or, if such price is not available, “VWAP


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means the market value per share of Common Stock on such Trading Day as determined, using a volume-weighted average method, by a nationally recognized independent investment banking firm retained by the Corporation for this purpose.  The “VWAP” shall be determined without regard to after-hours trading or any other trading outside of the regular trading session trading hours.

Section 4.  Dividends. (a) The Corporation shall not authorize, declare or pay regular or special dividends or other distributions (whether in the form of cash, shares, indebtedness or any other property or asset, but excluding any purchase, redemption or other acquisition of shares) on the shares of the Common Stock, unless simultaneously with the authorization, declaration or payment,  it authorizes, declares or pays, as applicable, dividends or other distributions on the Perpetual Convertible Preferred Stock as set forth in this Section 4.  The amount of such dividends or other distributions payable per share of Perpetual Convertible Preferred Stock shall equal the product of the Conversion Rate on the date the Corporation announces the dividend or other distribution payable on the Common Stock times the amount of such dividend or other distribution per share of Common Stock.  To the extent provided under Maryland law, any dividend on the Perpetual Convertible Preferred Stock of the Corporation authorized and declared under this Section 4 shall be a liability of the Corporation enforceable by the holder of the Perpetual Convertible Preferred Stock.

(b) The Corporation shall not commence, support or approve any tender offer, share purchase or similar transaction available to all or substantially all holders of the Common Stock, unless such tender offer, share purchase or similar transaction is also simultaneously made on the same terms to the Holders of Perpetual Convertible Preferred Stock, allowing such Holders to participate and receive, in exchange for such Holders’ shares of Perpetual Convertible Preferred Stock, the consideration such Holders would have received had they tendered a number of shares of Common Stock equal to the Conversion Rate times the number of shares of Perpetual Convertible Preferred Stock so exchanged.

Section 5.  Liquidation, Dissolution or Winding Up.  

(a)Upon any liquidation (voluntary or otherwise), dissolution or winding up (including by way of merger, consolidation, reorganization or sale of all or substantially all of the assets) of the Corporation, no distribution shall be made to the holders of Junior Stock unless, prior thereto, the Holders shall have received an amount of cash equal to $100 per share of Perpetual Convertible Preferred Stock (the “Liquidation Preference”), plus any declared and unpaid dividends. 

(b)If, upon the voluntary or involuntary liquidation, winding-up or dissolution of the Corporation, the amounts payable with respect to (1) the Liquidation Preference and any accrued and unpaid dividends on the Perpetual Convertible Preferred Stock and (2) the liquidation preference of, and the amount of accrued and unpaid dividends (if any) to, but excluding, the date fixed for liquidation, dissolution or winding up, on, all Parity Preferred Stock are not paid in full, the Holders and all holders of any Parity Preferred Stock shall share equally and ratably in any distribution of the Corporation’s assets in proportion to the respective liquidation preferences and amounts equal to the accrued and unpaid dividends to which they are entitled. 

(c)After the payment to any Holder of the full amount of the Liquidation Preference and any accrued and unpaid dividends for each of such Holder’s shares of Perpetual Convertible  


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Preferred Stock, such Holder as such shall have no right or claim to any of the remaining assets of the Corporation in respect of such Holder’s shares of Perpetual Convertible Preferred Stock.

(d)In determining whether a distribution (other than upon voluntary or involuntary liquidation, dissolution or winding up of the affairs of the Corporation) by dividend, redemption or other acquisition of shares of stock of the Corporation or otherwise is permitted under the MGCL, no effect shall be given to amounts that would be needed, if the Corporation were to be dissolved at the time of the distribution, to satisfy the preferential rights upon dissolution of Holders of the Perpetual Convertible Preferred Stock. 

Section 6. No Maturity.  The Perpetual Convertible Preferred Stock has no maturity date.

Section 7.  Optional Redemption. Notwithstanding anything herein to the contrary, the Corporation may redeem the Perpetual Convertible Preferred Stock (each, an “Optional Redemption”) on or after the Initial Issue Date, in whole or in part, at the Redemption Price, payable as described in ‎Section 7(d).  No distribution by redemption or other acquisition of shares of Perpetual Convertible Preferred Stock may be made unless permitted under the provisions of the MGCL pertaining to distributions.  Any such Optional Redemption in part shall be for an integral number of shares of Perpetual Convertible Preferred Stock.

(a) In case the Corporation exercises its Optional Redemption right to redeem all or, as the case may be, any part of the Perpetual Convertible Preferred Stock pursuant to ‎Section 7(a), it shall fix a date for redemption, which must be a Business Day (each, a “Redemption Date”) and it shall deliver by electronic mail an irrevocable notice of such Optional Redemption (a “Redemption Notice”) not less than 45 nor more than 60 calendar days prior to the Redemption Date to each Holder; provided the Corporation may not exercise its redemption right from any period following the entry into any transaction or agreement that would result in a Reorganization Event until the later of (A) the conclusion of the Reorganization Event and (B) the date on which Holders of Perpetual Convertible Preferred Stock electing to receive the Reorganization Event consideration have been paid the Reorganization Event consideration.   

(i)The Redemption Notice, if delivered in the manner herein provided, shall be conclusively presumed to have been duly given, whether or not the Holders receive such notice.   

(ii)Each Redemption Notice shall specify: 

(A)the Redemption Date; 

(B)the Redemption Price; 

(C)that on the Redemption Settlement Date, the Redemption Price will become due and payable upon each share of Perpetual Convertible Preferred Stock;  

(D)(1) that Holders may surrender their Perpetual Convertible Preferred Stock for conversion at any time on or after the Initial Issue Date prior to the close of business on the Scheduled Trading Day immediately preceding the  


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Redemption Date; (2) the procedures a converting Holder must follow to convert its Perpetual Convertible Preferred Stock; and (3) the Conversion Rate; and

(E)in case the Perpetual Convertible Preferred Stock is to be redeemed in part only, the number of shares of Perpetual Convertible Preferred Stock to be redeemed. 

A Redemption Notice shall be irrevocable.

(iii)If fewer than all of the outstanding shares of Perpetual Convertible Preferred Stock are to be redeemed pursuant to ‎Section 7(a), the Transfer Agent shall select the shares of Perpetual Convertible Preferred Stock to be redeemed (which such number shall be an integer) by lot, on a pro rata basis or by another method the Transfer Agent considers to be fair and appropriate (or as required by the procedures of the Transfer Agent, if applicable).  If any Perpetual Convertible Preferred Stock selected for partial redemption is submitted for conversion in part after such selection, the shares of Perpetual Convertible Preferred Stock submitted for conversion shall be deemed (so far as may be possible) to be the portion selected for redemption. 

(iv)On and after the Redemption Settlement Date, upon surrender of a share certificate representing any Perpetual Convertible Preferred Stock redeemed in part, the Corporation shall execute and instruct the Registrar and Transfer Agent to countersign and deliver to the Holder thereof, at the expense of the Corporation, a certificate evidencing a number of shares of Perpetual Convertible Preferred Stock equal to the unredeemed portion thereof, or, if the Perpetual Convertible Preferred Stock is held in book-entry form, the Corporation shall cause the Transfer Agent and Registrar to reduce the number of shares of Perpetual Convertible Preferred Stock represented by the global certificate by making a notation on Schedule I attached to the global certificate.  

(b)If any Redemption Notice has been given in respect of any Perpetual Convertible Preferred Stock in accordance with ‎Section 7(b), the Perpetual Convertible Preferred Stock to be redeemed shall become due and payable on the Redemption Settlement Date at the place or places stated in the Redemption Notice and at the applicable Redemption Price.  Upon the payment of the Redemption Price, (i) the Perpetual Convertible Preferred Stock to be redeemed will cease to be outstanding and (ii) all other rights of the Holders in respect of the Perpetual Convertible Preferred Stock to be redeemed will terminate (other than the right to receive the Redemption Price). 

(c)Upon any Optional Redemption of any share of Perpetual Convertible Preferred Stock, the Corporation shall pay to the Holder of such share, in respect of each share being redeemed, an amount, in cash out of funds legally available for such distribution, equal to the Redemption Price per share of Perpetual Convertible Preferred Stock. 

(d)The Corporation shall pay the consideration due in respect of any Optional Redemption on the relevant Redemption Settlement Date.  

(e)No sinking fund is provided for the Perpetual Convertible Preferred Stock. 


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Section 8.  Voting Rights.  Holders shall not have any voting rights except as set forth in Section 9 or as otherwise from time to time specifically required by Maryland law.

Section 9.  Changes Affecting Perpetual Convertible Preferred Stock.  

(a)So long as any shares of Perpetual Convertible Preferred Stock are outstanding, the Corporation shall not, without first obtaining the affirmative vote or written consent of the Holders of at least a majority of the total number of shares of Perpetual Convertible Preferred Stock then outstanding, voting as a separate class: 

(i)amend, alter or repeal (A) these Articles Supplementary or (B) any other provision of the Articles of Incorporation, in the case of Clause (B) in any manner that would adversely affect in any respect the preferences, conversion or other rights (including repurchase rights), voting powers, restrictions, limitations as to dividends, qualifications, or terms or conditions of redemption of the Perpetual Convertible Preferred Stock, in each case, including whether by recapitalization, reorganization, reclassification, merger, consolidation, transfer or conveyance of all or substantially all of its assets or otherwise (an “Event”); provided however, with respect to the occurrence of any of the foregoing Events, so long as the Perpetual Convertible Preferred Stock remains outstanding with the terms thereof unchanged or the Holders receive stock of the successor with substantially identical powers, preferences, privileges and rights as the Perpetual Convertible Preferred Stock, taking into account that, upon the occurrence of such Event, the Corporation may not be the surviving entity, the occurrence of such Event shall not be deemed to adversely affect such powers, preferences, privileges or rights of the Perpetual Convertible Preferred Stock, and in such case such Holders shall not have any voting rights with respect to the occurrence of any such Event, and, provided further, that the creation or issuance, or any increase in the amounts authorized, of any class or series of Junior Stock or Parity Preferred Stock that the Corporation may issue shall not be deemed to adversely affect the powers, preferences, privileges or rights of the Perpetual Convertible Preferred Stock;  

(ii)designate or issue any Senior Stock, or create, authorize or issue any obligation or security convertible into or evidencing the right to purchase any such stock; or  

(iii)enter into, amend or alter any provision of any agreement or other instrument binding upon the Corporation or any of its subsidiaries in a manner that could reasonably be expected to be material and adverse to the powers, preferences, privileges or rights of the Perpetual Convertible Preferred Stock under these Articles Supplementary. 

(b)On each matter on which Holders are entitled to vote, each share of Perpetual Convertible Preferred Stock will be entitled to one vote. 

(c)To the extent permitted by Maryland law, the Holders shall have exclusive voting rights on any Articles of Incorporation amendment that would alter the contract rights, as expressly set forth in the Articles of Incorporation, of only the Perpetual Convertible Preferred Stock. 


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(d)The Corporation shall not, by amendment of its Articles of Incorporation or through any reorganization, transfer of assets, consolidation, merger, dissolution, issue or sale of securities, or any other voluntary action, avoid or seek to avoid the observance or performance of any of the terms to be observed or performed hereunder by the Corporation, but shall at all times in good faith assist in the carrying out of all the provisions of these Articles Supplementary of Perpetual Convertible Preferred Stock and in the taking of all such action as may be necessary or appropriate in order to protect the rights of the Holders against impairment. 

(e)Without the consent or action of the Holders, so long as such action is made pursuant to an amendment to the Corporation’s Articles of Incorporation duly adopted in accordance with Maryland law, and does not adversely affect in any respect any of the preferences, conversion or other rights (including repurchase rights), voting powers, restrictions, limitations as to dividends, qualifications, or terms or conditions of redemption of the Perpetual Convertible Preferred Stock, a majority of the entire Board of Directors may change the name or other designation or the par value of such stock of the Corporation. 

Section 10.  Conversion of Perpetual Convertible Preferred Stock.

(a)Conversion Privilege.  Holders shall have the right to convert their shares of Perpetual Convertible Preferred Stock, in whole or in part (but in no event less than one share of Perpetual Convertible Preferred Stock), at any time on or after the Initial Issue Date (“Optional Conversion”), as described in this Section 10 and subject to satisfaction of the conversion procedures set forth in ‎Section 11, in each case, for the amount and kind of consideration as described in this Section 10. 

(b)Mandatory Conversion at Option of Corporation.  So long as the Mandatory Conversion Condition (as defined in Section 10(c) hereto) has been satisfied, the Corporation shall have the right, at the option of the Corporation, to automatically convert all shares of Perpetual Convertible Preferred Stock (unless previously converted at the option of the Holder in accordance with Section 10(a) or redeemed by the Corporation pursuant to Section 7), at any time on or after the Initial Issue Date, for the amount and kind of consideration as described in Section 10(d) (“Mandatory Conversion”).  The Mandatory Conversion shall be effective on the Mandatory Conversion Date. 

(c)Conditions to Mandatory Conversion.  The Mandatory Conversion Condition shall be satisfied if the Closing Sale Price for the Common Stock exceeds 150% of the Conversion Price for each Trading Day during any ten consecutive Trading Day period following the Initial Issue Date (such period, the “Mandatory Conversion Measurement Period” and such condition, the “Mandatory Conversion Condition”). 

(d)Settlement Upon Conversion.  Subject to this Section 10(d), upon conversion of any share of Perpetual Convertible Preferred Stock, the Corporation shall deliver to the converting Holder, shares of Common Stock, together with cash, if applicable, in lieu of delivering any fractional share of Common Stock in accordance with ‎Section 13, as set forth in this Section 10(d), in satisfaction of its Conversion Obligation. 

(i)The Corporation shall satisfy its Conversion Obligation in connection with Optional Conversions made pursuant to Section 10(a) by delivering to the converting Holder of Perpetual Convertible Preferred Stock being converted a number of shares of  


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Common Stock equal to the product of (1) the number of shares of Perpetual Convertible Preferred Stock to be converted, and (2) the Conversion Rate on the Optional Conversion Date.

(ii)The Corporation shall satisfy its Conversion Obligation in connection with Mandatory Conversions made pursuant to Section 10(b) by delivering to the converting Holder of Perpetual Convertible Preferred Stock being converted a number of shares of Common Stock equal to the Mandatory Conversion Settlement Amount for such converting Holder. 

Section 11.  Conversion Procedures.

(a)If the Corporation exercises its Mandatory Conversion right pursuant to Section 10(b), any outstanding shares of Perpetual Convertible Preferred Stock so converted shall automatically convert in accordance with Section 10(b) on the Mandatory Conversion Date.  The Person or Persons entitled to receive any shares of Common Stock issuable on the Mandatory Conversion Date shall be treated for all purposes as the record holder(s) of such shares of Common Stock immediately following delivery by the Corporation of the Notice of Conversion (as defined below). 

(b)To effect an Optional Conversion pursuant to Section 10(a), any Holder who holds shares of Perpetual Convertible Preferred Stock must: 

(i)complete and sign a conversion notice in the form attached to the stock certificate hereto in Exhibit A (the “Notice of Conversion”); and  

(ii)deliver via electronic mail to asmith@pernixtx.com and kpina@pernixtx.com during regular business hours, the completed and executed Notice of Conversion to the Corporation. 

The Optional Conversion shall be effective on the date on which a Holder has delivered the Notice of Conversion to the Corporation (such date, the “Optional Conversion Date”); provided that if a Holder so indicates in a Notice of Conversion delivered in connection with the consummation of a Reorganization Event or any tender offer, share purchase or similar transaction available to all or substantially all with respect to the Common Stock, then such Notice of Conversion shall not become effective until the date on which such Reorganization Event, tender offer, share purchase or similar transaction closes or becomes effective.  Any Holder shall be treated for all purposes as the record holder(s) of such shares of Common Stock upon the delivery of the Notice of Conversion and upon such delivery shall be deemed not to hold the shares of Perpetual Convertible Stock being converted. The Holders shall not be required to physically surrender certificates upon the delivery of the Notice of Conversion for such conversion to be effective.

Except as set forth in ‎‎Section 15(a), the Corporation shall pay or deliver, as the case may be, the consideration due in respect of the Conversion Obligation for any Optional Conversion on the second Business Day immediately following the last Trading Day of the relevant Observation Period (or such earlier date as comprises the standard settlement period on the Corporation’s primary trading market with respect to the Common Stock).  A Holder shall not be required to pay any transfer or similar taxes or duties relating to the issuance or delivery of any


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Common Stock if such Holder exercises its conversion rights, but such Holder shall be required to pay any transfer or similar tax or duty that may be payable relating to any transfer involved in the issuance or delivery of any Common Stock in a name other than the name of such Holder.  A certificate representing the shares of Common Stock, if any, issuable upon conversion shall be issued and delivered to the converting Holder.

Execution and delivery of a Notice of Conversion with respect to a partial conversion shall have the same effect as cancellation of the original certificate(s) representing such Perpetual Convertible Preferred Stock and issuance of a certificate representing such remaining Perpetual Convertible Preferred Stock.  In accordance with the preceding sentence, upon the written request of the Holder and the surrender of certificate(s) representing Perpetual Convertible Preferred Stock, the Corporation shall, within three Trading Days of such request, deliver to the Holder certificate(s) (as specified by the Holder in such request) representing such remaining Perpetual Convertible Preferred Stock.

 

(c)In the event that a Holder shall not by written notice designate the name in which any shares of Common Stock to be issued upon conversion of such Perpetual Convertible Preferred Stock should be registered or, if applicable, the address to which the certificate or certificates representing such shares of Common Stock should be sent, the Corporation shall be entitled to register such shares, and make such payment, in the name of the Holder as shown on the records of the Corporation and, if applicable, to send the certificate or certificates representing such shares of Common Stock to the address of such Holder shown on the records of the Corporation. 

(d)Shares of Perpetual Convertible Preferred Stock shall cease to be outstanding on the applicable Optional Conversion Date or Mandatory Conversion Date, subject to the right of Holders of such shares to receive the cash payable and/or the shares of Common Stock issuable upon conversion of such shares of Perpetual Convertible Preferred Stock to which they are entitled pursuant to Section 10. 

(e)Not later than two Business Days after the applicable Conversion Date, the Corporation shall electronically transfer the shares of Common Stock by crediting the account of the applicable Holder’s broker through its Deposit Withdrawal Agent Commission system.  

(f)Nothing herein shall limit a Holder’s right to pursue any other remedies available to it hereunder, at law or in equity including, without limitation, a decree of specific performance and/or injunctive relief with respect to the Corporation’s failure to timely deliver certificates representing shares of Common Stock upon conversion of the shares of Perpetual Convertible Preferred Stock as required pursuant to the terms hereof; provided, however, that the Holder shall not be entitled to both (i) require the reissuance of the shares of Perpetual Convertible Preferred Stock submitted for conversion for which such conversion was not timely honored and (ii) receive the number of shares of Common Stock that would have been issued if the Corporation had timely complied with its delivery requirements under this Agreement. 

Section 12.  Reservation of Common Stock.   The Corporation shall at all times reserve and keep available out of its authorized and unissued Common Stock of the Corporation, solely for issuance upon the conversion, or redemption of shares of Perpetual Convertible Preferred Stock as herein provided, free from any preemptive or other similar rights, a number of


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shares of Common Stock equal to the applicable Conversion Rate multiplied by the number of shares of Perpetual Convertible Preferred Stock.

(a)All shares of Common Stock delivered upon any conversion or redemption of the Perpetual Convertible Preferred Stock shall be duly authorized, validly issued, fully paid and non-assessable, free and clear of all liens, claims, security interests and other encumbrances (other than liens, charges, security interests and other encumbrances created by the Holders). 

(b)Prior to the delivery of any securities that the Corporation shall be obligated to deliver upon conversion of the Perpetual Convertible Preferred Stock, the Corporation shall use reasonable best efforts to comply with all U.S. federal and state laws and regulations thereunder requiring the registration of such securities with, or any approval of or consent to the delivery thereof by, any governmental authority; provided that this ‎Section 12(d) shall not obligate the Corporation to register the offer and sale of such securities under the Securities Act or any other applicable securities laws.  Assuming the Holder to which the shares of Common Stock is to be issued is not as of the date of issuance, and for a period of three months prior to the date of issuance has not been, an Affiliate of the Corporation (which the Corporation shall assume (and the applicable Holder shall be deemed to represent) unless such Holder has otherwise advised the Corporation in writing), the shares of Common Stock will be freely tradeable by such Holder without restriction or limitation (including volume limitation), pursuant to Rule 144 under the Securities Act, and will not contain or be subject to any legend or stop transfer instructions restricting the sale or transferability thereof. 

Section 13.  Fractional Shares.   No fractional shares of Common Stock shall be issued as a result of any conversion or redemption of shares of Perpetual Convertible Preferred Stock.

(a)In lieu of any fractional share of Common Stock otherwise issuable in respect of the aggregate number of shares of Perpetual Convertible Preferred Stock that are redeemed pursuant to Section 7 or converted pursuant to ‎Section 10, as the case may be, the Corporation shall pay an amount in cash (computed to the nearest cent) equal to the product of (i) that same fraction and (ii) the VWAP per share of the Common Stock on the last Trading Day of the relevant Observation Period (in the case of a redemption of the Perpetual Convertible Preferred Stock) or on the Conversion Date (in the case of a conversion of the Perpetual Convertible Preferred Stock). 

(b)If more than one share of the Perpetual Convertible Preferred Stock is surrendered for conversion or redemption at one time by or for the same Holder, the number of full shares of Common Stock issuable upon conversion or redemption thereof, as the case may be, shall be computed on the basis of the aggregate number of shares of the Perpetual Convertible Preferred Stock so surrendered. 

Section 14.  Adjustments to the Conversion Rate.  The Conversion Rate shall be adjusted from time to time by the Corporation if any of the following events occurs, except that the Corporation shall not make any adjustments to the Conversion Rate if Holders of the Perpetual Convertible Preferred Stock participate, at the same time and upon the same terms as holders of the Common Stock and solely as a result of holding the Perpetual Convertible Preferred Stock, in any of the transactions described in this ‎Section 14, without having to convert their Perpetual Convertible Preferred Stock, as if they held a number of shares of Common Stock


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equal to the Conversion Rate, multiplied by the number of shares of Perpetual Convertible Preferred Stock held by such Holder.

(a)If the Corporation effects a share split or share combination, the Conversion Rate shall be adjusted based on the following formula: 

CR' = CR0 X OS'

       OS0

where,

CR0=the Conversion Rate in effect immediately prior to the open of business on the Effective Date of such share split or share combination, as applicable; 

CR'=the Conversion Rate in effect immediately after the close of business on such Record Date or immediately after the open of business on such effective date, as applicable; 

OS0=the number of shares of Common Stock outstanding immediately prior to the close of business on such record date or immediately prior to the open of business on such effective date, as applicable; and 

OS'=the number of shares of Common Stock outstanding immediately after giving effect to such share split or share combination. 

Any adjustment made under this ‎Section 14(a) shall become effective immediately after the close of business on the Record Date for such dividend or distribution, or immediately after the open of business on the Effective Date for such share split or share combination, as applicable.  If any dividend or distribution of the type described in this ‎Section 14(a) is declared but not so paid or made, the Conversion Rate shall be immediately readjusted, effective as of the date the Board of Directors (or an authorized committee thereof) determines not to pay such dividend or distribution, to the Conversion Rate that would then be in effect if such dividend or distribution had not been declared.

(b)Except as stated herein, the Corporation shall not adjust the Conversion Rate for the issuance of shares of the Common Stock or any securities convertible into or exchangeable for shares of the Common Stock or the right to purchase shares of the Common Stock or such convertible or exchangeable securities. 

(c)Notwithstanding anything to the contrary in this ‎Section 14, the Conversion Rate shall not be adjusted: 

(i)upon the issuance of any shares of Common Stock pursuant to any present or future plan providing for the reinvestment of dividends or interest payable on the Corporation’s securities and the investment of additional optional amounts in shares of Common Stock under any plan; 

(ii)upon the issuance of any shares of Common Stock or options or rights to purchase those shares pursuant to any present or future employee, director or consultant  


15


benefit plan or program of or assumed by the Corporation or any of the Corporation’s Subsidiaries;

(iii)upon the issuance of any shares of the Common Stock pursuant to any option, warrant, right or exercisable, exchangeable or convertible security not described in clause ‎(ii) of this subsection and outstanding as of the Initial Issue Date; 

(iv)upon the repurchase of any shares of Common Stock pursuant to an open-market repurchase program or other buy-back transaction; 

(v)solely for a change in the par value of the Common Stock;  

(vi)upon any dividend or distribution on the Common Stock that is a regular, quarterly dividend, whether payable in cash, shares of Common Stock or a combination of cash and shares of Common Stock (including at the election of a holder of the Common Stock); or 

(vii)for unpaid dividends, whether accumulated or declared, if any. 

(d)All calculations and other determinations under this ‎Section 14 shall be made by the Board of Directors (or an authorized committee thereof) and shall be made to the nearest one-ten thousandth (1/10,000th) of a share of Common Stock.  The Corporation shall not adjust the Conversion Rate pursuant to this ‎‎Section 14 unless the adjustment would result in a change of at least 1% in the then-effective Conversion Rate. However, the Corporation shall carry forward any adjustment that it would otherwise have had to make and take that adjustment into account in any subsequent adjustment.  Notwithstanding the foregoing, all such carried-forward adjustments shall be made with respect to the Perpetual Convertible Preferred Stock (i) in connection with any subsequent adjustment to the Conversion Rate of at least 1%, (ii) on each Conversion Date related to the conversion of Perpetual Convertible Preferred Stock and (iii) on each Trading Day of any Observation Period related to the redemption of Perpetual Convertible Preferred Stock. 

(e)Whenever the Conversion Rate is adjusted as herein provided, the Corporation shall promptly prepare a notice of such adjustment of the Conversion Rate setting forth the adjusted Conversion Rate, the method of calculation thereof in reasonable detail and the date on which each adjustment becomes effective and shall mail such notice of such adjustment of the Conversion Rate to each Holder in the manner set forth in ‎Section 18.  Failure to deliver such notice shall not affect the legality or validity of any such adjustment. 

(f)For purposes of this ‎Section 14, the number of shares of Common Stock at any time outstanding shall not include shares of Common Stock held in the treasury of the Corporation so long as the Corporation does not pay any dividend or make any distribution on shares of Common Stock held in the treasury of the Corporation, but shall include shares of Common Stock issuable in respect of scrip certificates issued in lieu of fractions of shares of Common Stock. 

(g)Whenever any provision of these Articles Supplementary requires the Corporation to calculate the Average VWAPs over a span of multiple days (including an Observation Period), the Board of Directors (or an authorized committee thereof) shall in good faith make appropriate adjustments to each to account for any adjustment to the Conversion Rate that becomes effective,  


16


or any event requiring an adjustment to the Conversion Rate where the Ex-Dividend Date, Effective Date or expiration date, as the case may be, of the event occurs, at any time during the period when the Average VWAPs are to be calculated.

(h)If the Corporation has a stockholder rights plan in effect upon conversion of the Perpetual Convertible Preferred Stock, each share of Common Stock, if any, issued upon such conversion shall be entitled to receive the appropriate number of rights, if any, and the certificates representing the Common Stock issued upon such conversion shall bear such legends, if any, in each case as may be provided by the terms of any such stockholder rights plan, as the same may be amended from time to time. 

(i)Notwithstanding anything to the contrary herein, the Corporation may delay the settlement of any conversion of the Perpetual Convertible Preferred Stock to the extent necessary to calculate the amount of consideration due upon conversion in connection with any adjustment of the Conversion Rate pursuant to this ‎Section 14 (including, for the avoidance of doubt, to calculate any readjustment of the Conversion Rate pursuant to this ‎Section 14), and, in respect of any such delay, the Corporation shall be deemed not to have breached its obligation to deliver the consideration due upon conversion by the date specified in ‎Section 11(b). 

Section 15.  Reorganization Events.  

(a)In the case of: 

(i)any recapitalization, reclassification or change of the Common Stock (other than changes resulting from a subdivision or combination),  

(ii)any consolidation, merger, combination or similar transaction involving the Corporation,  

(iii)any sale, lease or other transfer to a third party of the consolidated assets of the Corporation and the Corporation’s Subsidiaries substantially as an entirety,  

(iv)any statutory share exchange,  

(v)a “person” or “group” within the meaning of Section 13(d) of the Exchange Act, other than the Corporation, its wholly owned Subsidiaries and the employee benefit plans of the Corporation and its wholly owned Subsidiaries, becomes the direct or indirect “beneficial owner,” as defined in Rule 13d-3 under the Exchange Act, of the Common Stock representing more than 50% of the voting power of the Common Stock (a “Change of Control”), or 

(vi)any transaction having the same effect as any transaction set forth in clauses (i)-(v). 

in each case whether directly or indirectly in one or more related transactions, as a result of which the Common Stock would be converted into, or exchanged for, stock, other securities, other property or assets (including cash or any combination thereof) (any such event, a “Reorganization Event”), then, at and after the effective time of such Reorganization Event, the right to convert each share of Perpetual Convertible Preferred Stock at the Conversion Rate shall


17


be changed into a right to convert such share into the kind and amount of shares of stock, other securities or other property or assets (including cash or any combination thereof) that a holder of a number of shares of Common Stock equal to the Conversion Rate immediately prior to such Reorganization Event would have owned or been entitled to receive (the “Reference Property,” with each “unit of Reference Property” meaning the kind and amount of Reference Property that a holder of one share of Common Stock is entitled to receive) upon such Reorganization Event, without regard to the Beneficial Ownership Limitation; provided, however, that at and after the effective time of the Reorganization Event (A) the number of shares of Common Stock otherwise deliverable upon conversion of the Perpetual Convertible Preferred Stock in accordance with Section 11 shall instead be deliverable in the amount and type of Reference Property that a holder of that number of shares of Common Stock would have received in such Reorganization Event and (B) the VWAP shall be calculated based on the value of a unit of Reference Property. In the case of a Change of Control, the parties (other than the Corporation, its wholly owned Subsidiaries, and any employee benefit plan of the Corporation and its wholly owned subsidiaries), as a condition of effecting the Change of Control shall make all necessary provisions such that, following the Change of Control and for so long thereafter as the Perpetual Convertible Preferred Stock remains outstanding, the holders of the Perpetual Convertible Preferred Stock shall have the right to obtain the applicable amount of Refereince Property upon exercise of the conversion right.

If Holders of Common Stock are given any choice as to the securities, cash or property to be received in a Reorganization Event, then the Holders shall be given the same choice as to the Reference Property it receives upon any conversion of the Perpetual Convertible Preferred Stock following such Reorganization Event.

(b)The above provisions of this Section 15 shall similarly apply to successive Reorganization Events and the provisions of this Section 15 shall apply to any Reference Property. 

(c)The Corporation (or any successor thereto) shall, as soon as reasonably practicable (but in any event within 3 calendar days) after the occurrence of any Reorganization Event, provide written notice to the Holders of such occurrence and of the kind and amount of the stock, other securities, other property or assets that constitute the Reference Property.  Failure to deliver such notice shall not affect the operation of this ‎Section 15. 

(d)The Corporation shall not enter into or consummate any transaction or become a party to any agreement, in each case, with respect to any transaction that would constitute a Reorganization Event, unless its terms require that any successor or surviving entity comply with the provisions of Section 15(a) and insuring that the Perpetual Convertible Preferred Stock (or any such replacement security) will receive the Reference Property upon conversion (without giving effect to the Beneficial Ownership Limitation) and as applicable, be similarly adjusted upon any subsequent transaction analogous to a Reorganization Event. 

(e)Following the announcement of the entry into a transaction that will result in a Reorganization Event, a Holder of the Perpetual Convertible Preferred Stock may (i) effect an Optional Conversion or (ii) elect prior to the consummation of the Reorganization Event to receive, at the same time as the Holders of the Common Stock, the amount of Reference Property with respect to each share of Perpetual Convertible Preferred Stock subject to such election that such Holders would have received had they held a number of shares of Common Stock equal to  


18


the Conversion Rate immediately prior to such Reorganization Event (in the case of clause (ii), without giving effect to the Beneficial Ownership Limitation).  To make the election described in clause (ii) above, any Holder who holds shares of Perpetual Convertible Preferred Stock must complete and sign an election notice in the form attached to the stock certificate hereto in Exhibit A (the “Election Notice”) and deliver via electronic mail to asmith@pernixtx.com and kpina@pernixtx.com during regular business hours, the completed and executed Election Notice to the Corporation.

Section 16.  Transfer Agent, Registrar and Conversion Agent.  The duly appointed Transfer Agent, Registrar and Conversion Agent for the Perpetual Convertible Preferred Stock shall be Computershare Trust Company, N.A..  The Corporation may, in its sole discretion, remove the Transfer Agent, Registrar or Conversion Agent in accordance with the agreement between the Corporation and the Transfer Agent, Registrar or Conversion Agent, as the case may be; provided that if the Corporation removes Computershare Trust Company, N.A., the Corporation shall appoint a successor transfer agent, registrar or conversion agent, as the case may be, who shall accept such appointment prior to the effectiveness of such removal.  Upon any such removal or appointment, the Corporation shall send notice thereof by first-class mail, postage prepaid, to the Holders.

Section 17.  Record Holders.  To the fullest extent permitted by applicable law, the Corporation and the Transfer Agent may deem and treat the Holder of any shares of Perpetual Convertible Preferred Stock as the true and lawful owner thereof for all purposes.

Section 18.  Notices.  All notices or communications in respect of the Perpetual Convertible Preferred Stock shall be sufficiently given if given in writing and delivered in person or by first class mail, postage prepaid, electronic mail or if given in such other manner as may be permitted in these Articles Supplementary, in the Articles of Incorporation or the Bylaws and by applicable law.

Section 19.  No Preemptive Rights.  The Holders shall have no preemptive or preferential rights to purchase or subscribe to any stock, obligations, warrants or other securities of the Corporation of any class.  

Section 20.  Other Rights.  The shares of the Perpetual Convertible Preferred Stock shall not have any preferences, conversion or other rights (including, but not limited to, any relative, participating, optional or other special rights), voting powers, restrictions, limitations as to dividends, qualifications, or terms or conditions of redemption thereof, other than as set forth herein or in the Articles of Incorporation or as provided by applicable law.

Section 21.  Stock Certificates.

(a)Shares of Perpetual Convertible Preferred Stock shall be represented by stock certificates substantially in the form set forth as Exhibit A hereto. 

(b)Stock certificates representing shares of the Perpetual Convertible Preferred Stock shall be signed by an authorized Officer of the Corporation and attested by the Secretary, any assistant secretary, the Treasurer or any assistant treasurer, in accordance with the Bylaws and applicable Maryland law, by manual or facsimile signature. 


19


(c)If any Officer of the Corporation who has signed a stock certificate no longer holds that office at the time the Transfer Agent and Registrar countersigns the stock certificate, the stock certificate shall be valid nonetheless. 

Section 22. Replacement Certificates.  If physical certificates are issued, and any of the Perpetual Convertible Preferred Stock certificates shall be mutilated, lost, stolen or destroyed, the Corporation shall, at the expense of the Holder, issue, in exchange and in substitution for and upon cancellation of the mutilated Perpetual Convertible Preferred Stock certificate, or in lieu of and substitution for the Perpetual Convertible Preferred Stock certificate lost, stolen or destroyed, a new Perpetual Convertible Preferred Stock certificate of like tenor and representing an equivalent Liquidation Preference of shares of Perpetual Convertible Preferred Stock, but only upon receipt of evidence of such loss, theft or destruction of such Perpetual Convertible Preferred Stock certificate and indemnity, if requested, reasonably satisfactory to the Corporation and the Transfer Agent.  

Section 23.  Transfer Restrictions.  Holders shall not be permitted to transfer any shares of the Perpetual Convertible Preferred Stock to any Person unless the Person to whom such shares are transferred is an Affiliate of the transferring Holder.  As used in this Section 23, the term “transfer” encompasses any sale, pledge, transfer or other disposition whatsoever of any Perpetual Convertible Preferred Stock.  

Each stock certificate evidencing the Perpetual Convertible Preferred Stock (and every security issued in exchange therefor or substitution thereof, except any shares of Common Stock issued upon conversion or redemption thereof) shall bear a legend in substantially the following form:

THE SHARES REPRESENTED BY THIS CERTIFICATE ARE SUBJECT TO RESTRICTIONS ON TRANSFER OF SHARES AS SET FORTH IN ARTICLE FOUR OF THE CHARTER OF PERNIX THERAPEUTICS HOLDINGS, INC. (THE “CORPORATION”), AS SUPPLEMENTED BY SECTION 23 OF THE ARTICLES SUPPLEMENTARY THAT HAVE BEEN FILED IN RESPECT TO THE CLASS OF PREFERRED STOCK OF WHICH SUCH SHARES ARE A PART, AND THE SHARES REPRESENTED BY THIS CERTIFICATE MAY NOT BE SOLD, PLEDGED, TRANSFERRED OR OTHERWISE DISPOSED OF UNLESS SUCH TRANSFER IS MADE TO AN AFFILIATE OF THE HOLDER IN COMPLIANCE WITH THE PROVISIONS OF THE CHARTER OF THE CORPORATION. 

IN CONNECTION WITH ANY TRANSFER, THE HOLDER WILL DELIVER TO THE TRANSFER AGENT SUCH CERTIFICATES AND OTHER INFORMATION AS THE TRANSFER AGENT MAY REASONABLY REQUIRE TO CONFIRM THAT THE TRANSFER COMPLIES WITH THE FOREGOING RESTRICTIONS. 

Section 24.  Provisions Relating To Ownership Limit.  Notwithstanding anything herein to the contrary, the Corporation shall not effect any conversion, including any Mandatory Conversion, of the Perpetual Convertible Preferred Stock, and a Holder shall not have the right to convert any portion of the Perpetual Convertible Preferred Stock, to the extent that, after giving effect to an attempted conversion set forth on the applicable Notice of Conversion, such Holder (together with such Holder’s Affiliates, and any other person or entity whose beneficial ownership of Common Stock would be aggregated with the Holder’s for purposes of Section


20


13(d) of the Exchange Act and the applicable regulations of the Commission, including any “group” of which the Holder is a member) would beneficially own a number of shares of Common Stock in excess of the Beneficial Ownership Limitation (as defined below).  For purposes of the foregoing sentence, the number of shares of Common Stock beneficially owned by such Holder and its Affiliates shall include the number of shares of Common Stock issuable upon conversion of the Perpetual Convertible Preferred Stock subject to the Notice of Conversion with respect to which such determination is being made, but shall exclude the number of shares of Common Stock which are issuable upon (A) conversion of the remaining, unconverted Perpetual Convertible Preferred Stock beneficially owned by such Holder or any of its Affiliates, and (B) exercise or conversion of the unexercised or unconverted portion of any other securities of the Corporation subject to a limitation on conversion or exercise analogous to the limitation contained herein (including any warrants) beneficially owned by such Holder or any of its Affiliates.  Except as set forth in the preceding sentence, for purposes of this Section 24, beneficial ownership shall be calculated in accordance with Section 13(d) of the Exchange Act and the rules and regulations promulgated thereunder.  In addition, a determination as to any “group” status as contemplated above shall be determined in accordance with Section 13(d) of the Exchange Act and the rules and regulations promulgated thereunder.  For purposes of this Section 24, in determining the number of outstanding shares of Common Stock, a Holder may rely on the number of outstanding shares of Common Stock as stated in the most recent of the following: (A) the Corporation’s most recent periodic or annual filing with the Commission, as the case may be, (B) a more recent public announcement by the Corporation that is filed with the Commission or (C) a more recent notice by the Corporation or the Corporation’s transfer agent to the Holder setting forth the number of shares of Common Stock then outstanding.  Upon the written request of a Holder ( which may be via electronic mail), the Corporation shall within two Trading Days thereof, confirm in writing via electronic mail to such Holder the number of shares of Common Stock then outstanding.  In any case, the number of outstanding shares of Common Stock shall be determined after giving effect to any actual conversion or exercise of securities of the Corporation, including Perpetual Convertible Preferred Stock, by such Holder or its Affiliates since the date as of which such number of outstanding shares of Common Stock was last publicly reported.  The “Beneficial Ownership Limitation shall be 4.985% of the number of shares of the Common Stock outstanding immediately after giving effect to the issuance of shares of Common Stock issuable upon conversion of Perpetual Convertible Preferred Stock held by the applicable Holder.

Section 25.  Miscellaneous.   The Corporation shall pay any and all stock transfer and documentary stamp taxes that may be payable in respect of any issuance or delivery of shares of Perpetual Convertible Preferred Stock or shares of Common Stock or other securities issued on account of Perpetual Convertible Preferred Stock pursuant hereto or certificates representing such shares or securities.  The Corporation shall not, however, be required to pay any such tax that may be payable in respect of any transfer involved in the issuance or delivery of shares of Common Stock or other securities in a name other than that in which the shares of Perpetual Convertible Preferred Stock with respect to which such shares or other securities are issued or delivered were registered, and shall not be required to make any such issuance or delivery unless and until the Person otherwise entitled to such issuance or delivery has paid to the Corporation the amount of any such tax or has established, to the satisfaction of the Corporation, that such tax has been paid or is not payable.


21


(a)The Liquidation Preference shall be subject to equitable adjustment whenever there shall occur a stock split, combination, reclassification or other similar event involving the Perpetual Convertible Preferred Stock.  Such adjustments shall be determined in good faith by the Corporation and submitted by the Corporation to the Transfer Agent. 

(b)All shares of Perpetual Convertible Preferred Stock redeemed or otherwise acquired in any manner by the Corporation shall be retired and shall be restored to the status of authorized but unissued Preferred Stock, without designation as to series or class. 

THIRD:  The 0% Series C Perpetual Convertible Preferred Stock has been re-classified and designated by the Board of Directors under the authority contained in the Articles of Incorporation.

FOURTH:  These Articles Supplementary have been approved by the Board of Directors in the manner and by the vote required by law.

FIFTH:  The undersigned acknowledges these Articles Supplementary to be the corporate act of the Corporation and, as to all matters or facts required to be verified under oath, the undersigned acknowledges that, to the best of his knowledge, information and belief, these matters and facts are true in all material respects and that this statement is made under the penalties of perjury.


22


IN WITNESS WHEREOF, these Articles Supplementary are executed on behalf of the Corporation by its Officer and attested to on this 1st day of August, 2018.

 

ATTEST:

PERNIX THERAPEUTICS HOLDINGS, INC.

 /s/ Kenneth R. Piña

By:

/s/ Angus Smith

Name:Kenneth R. Piña 

 

Name:  Angus Smith

Title:Senior Vice President 

 

Title:   Chief Financial Officer

 

 

 

 



Exhibit A

[FORM OF FACE OF PERPETUAL CONVERTIBLE PREFERRED STOCK CERTIFICATE]

THE SHARES REPRESENTED BY THIS CERTIFICATE ARE SUBJECT TO RESTRICTIONS ON TRANSFER OF SHARES AS SET FORTH IN ARTICLE FOUR OF THE CHARTER OF PERNIX THERAPEUTICS HOLDINGS, INC. (THE “CORPORATION”), AS SUPPLEMENTED BY SECTION 23 OF THE ARTICLES SUPPLEMENTARY THAT HAVE BEEN FILED IN RESPECT TO THE CLASS OF PREFERRED STOCK OF WHICH SUCH SHARES ARE A PART, AND THE SHARES REPRESENTED BY THIS CERTIFICATE MAY NOT BE SOLD, PLEDGED, TRANSFERRED OR OTHERWISE DISPOSED OF UNLESS SUCH TRANSFER IS MADE TO AN AFFILIATE OF THE HOLDER IN COMPLIANCE WITH THE PROVISIONS OF THE CHARTER OF THE CORPORATION.

IN CONNECTION WITH ANY TRANSFER, THE HOLDER WILL DELIVER TO THE TRANSFER AGENT SUCH CERTIFICATES AND OTHER INFORMATION AS THE TRANSFER AGENT MAY REASONABLY REQUIRE TO CONFIRM THAT THE TRANSFER COMPLIES WITH THE FOREGOING RESTRICTIONS.


A-1

 

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Certificate Number [__] Number of Shares of Perpetual Convertible Preferred Stock [_____] 

CUSIP [__]
ISIN [__]

PERNIX THERAPEUTICS HOLDINGS, INC.

0% Series C Perpetual Convertible Preferred Stock
(par value $0.01 per share)
(Liquidation Preference as specified below)

PERNIX THERAPEUTICS HOLDINGS, INC., a Maryland corporation (the “Corporation”), hereby certifies that [_______] (the “Holder”), is the registered owner of [_______] fully paid and non-assessable shares of the Corporation’s designated 0% Series C Perpetual Convertible Preferred Stock, with a par value of $0.01 per share and a Liquidation Preference of $100.00 per share (the “Perpetual Convertible Preferred Stock”).  The shares of Perpetual Convertible Preferred Stock are transferable in accordance with the terms of the Articles Supplementary (as defined below) on the books and records of the Registrar, in person or by a duly authorized attorney, upon surrender of this certificate duly endorsed and in proper form for transfer.  The designations, rights, privileges, restrictions, preferences and other terms and provisions of the Perpetual Convertible Preferred Stock represented hereby are and shall in all respects be subject to the provisions of the Articles Supplementary establishing the 0% Series C Perpetual Convertible Preferred Stock of Pernix Therapeutics Holdings, Inc. dated August 1, 2018 as the same may be amended from time to time (the “Articles Supplementary”).  Capitalized terms used herein but not defined shall have the meaning given them in the Articles Supplementary.  The Corporation will provide a copy of the Articles Supplementary to the Holder without charge upon written request to the Corporation at its principal place of business. In the case of any conflict between this Certificate and the Articles Supplementary, the provisions of the Articles Supplementary shall control and govern.

Reference is hereby made to the provisions of the Perpetual Convertible Preferred Stock set forth on the reverse hereof and in the Articles Supplementary, which provisions shall for all purposes have the same effect as if set forth at this place.

Upon receipt of this executed certificate, the Holder is bound by the Articles Supplementary and is entitled to the benefits thereunder.

Unless the Transfer Agent and Registrar have properly countersigned, these shares of Perpetual Convertible Preferred Stock shall not be entitled to any benefit under the Articles Supplementary or be valid or obligatory for any purpose.


A-2

 

#91111382v13

SC1:4708444.3A


IN WITNESS WHEREOF, this certificate has been executed on behalf of the Corporation by an Officer of the Corporation and attested this [__] of [______] [____].

ATTEST:

PERNIX THERAPEUTICS HOLDINGS, INC.

 

 

By:

 

Name:

 

Name:

Title:

 

Title:

 

 

 

 


A-3

 

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COUNTERSIGNATURE

These are shares of Perpetual Convertible Preferred Stock referred to in the within-mentioned Articles Supplementary.

Dated: [_______], [____]

Computershare Trust Company, N.A., as Registrar and Transfer Agent

By:

 

Name:

Title:


A-4

 

 

SC1:4708444.3A


[FORM OF REVERSE OF CERTIFICATE FOR PERPETUAL CONVERTIBLE PREFERRED STOCK]

The shares of Perpetual Convertible Preferred Stock shall be convertible and are subject to redemption at the option of the Corporation in the manner and accordance with the terms set forth in the Articles Supplementary.

The Corporation shall furnish without charge to each Holder who so requests a summary of the authority of the Board of Directors to determine variations for future series within a class of stock and the designations, limitations, preferences and relative, participating, optional or other special rights of each class or series of share capital issued by the Corporation and the qualifications, limitations or restrictions of such preferences and/or rights.


A-5

 

SC1:4708444.3A


NOTICE OF CONVERSION

(To be Executed by the Holder
in order to Convert the Perpetual Convertible Preferred Stock)

The undersigned hereby irrevocably elects (unless otherwise indicated below) to convert (the “Conversion”) [_______] shares of 0% Series C Perpetual Convertible Preferred Stock (the “Perpetual Convertible Preferred Stock”), of Pernix Therapeutics Holdings, Inc. (hereinafter called the “Corporation”), represented by stock certificate No(s). [______] (the “Perpetual Convertible Preferred Stock Certificates”), into common stock, par value $0.01 per share, of the Corporation (the “Common Stock”), according to the conditions of the Articles Supplementary establishing the Perpetual Convertible Preferred Stock (the “Articles Supplementary”), as of the date written below.  If Common Stock is to be issued in the name of a person other than the undersigned, the undersigned shall pay all transfer taxes payable with respect thereto, if any.

Capitalized terms used but not defined herein shall have the meanings ascribed thereto in or pursuant to the Articles Supplementary.

Date of Conversion: 

Number of Shares of Perpetual Convertible Preferred Stock to be Converted: 

Signature: 

Name: 

Address:2* 

Fax No.: 

 

If the undersigned’s election is contingent on the closing or effectiveness of a Reorganization Event, tender offer, share repurchase or similar transaction, so indicate below:

 

 


* Address where Common Stock and any other payments or certificates shall be sent by the Corporation. 


1

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ELECTION NOTICE

(To be Executed by the Holder
in order to make the election described in Section 15(e)(ii) of the Articles Supplementary referred to below)

With respect to [_______] shares of 0% Series C Perpetual Convertible Preferred Stock (the “Perpetual Convertible Preferred Stock”), of Pernix Therapeutics Holdings, Inc. (hereinafter called the “Corporation”), represented by stock certificate No(s). [______] (the “Perpetual Convertible Preferred Stock Certificates”), the undersigned makes the election described in Section 15(e)(ii) of the Articles Supplementary establishing the Perpetual Convertible Preferred Stock (the “Articles Supplementary”), as of the date written below.

Capitalized terms used but not defined herein shall have the meanings ascribed thereto in or pursuant to the Articles Supplementary.

Date of election: 

Number of Shares of Perpetual Convertible Preferred Stock

subject to the election: 

Signature: 

Name: 

Address:3* 

Fax No.: 

 


* Address where Reference Property shall be sent by the Corporation. 


2

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SC1:4708444.3A


 

ASSIGNMENT

FOR VALUE RECEIVED, the undersigned assigns and transfers the shares of Perpetual Convertible Preferred Stock evidenced hereby to:

 

 

(Insert assignee’s social security or taxpayer identification number, if any)

 

 

(Insert address and zip code of assignee)

and irrevocably appoints:

 

 

as agent to transfer the shares of Perpetual Convertible Preferred Stock evidenced hereby on the books of the Transfer Agent. The agent may substitute another to act for him or her.

Date:

Signature:

(Sign exactly as your name appears on the other side of this Certificate)

Signature Guarantee:


3

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EX-10.1 3 exh10-1.htm STOCKHOLDERS AGREEMENT, DATED JULY 27, 2018, BY AND AMONG NALPROPION PHARMACEUTICALS, INC., .

Exhibit 10.1

[***] Certain information in this document has been omitted and filed separately with the Securities and Exchange Commission. Confidential treatment has been requested with respect to the omitted portions.


STOCKHOLDERS AGREEMENT

 

 

among

 

 

 

NALPROPION PHARMACEUTICALS, INC.

 

 

 

and

 

 

 

the Stockholders named herein

 

 

dated as of

 

July 27, 2018


 


[***] Certain information in this document has been omitted and filed separately with the Securities and Exchange Commission. Confidential treatment has been requested with respect to the omitted portions.


Stockholders Agreement

 

This Stockholders Agreement (as amended, modified, supplemented or restated from time to time, this “Agreement”), dated as of July 27, 2018, is entered into by and among Nalpropion Pharmaceuticals, Inc., a Delaware corporation (the “Company”), 1992 MSF International Ltd., 1992 Tactical Credit Master Fund, L.P., 1992 Master Fund Co-Invest SPC3 (collectively with 1992 MSF International Ltd. and 1992 Tactical Credit Master Fund, L.P., and each of their respective Permitted Transferees, the “1992 Funds”), Whitebox Caja Blanca Fund, LP, Whitebox Multi-Strategy Partners, L.P., Whitebox Asymmetric Partners, L.P. (collectively with Whitebox Caja Blanca Fund, LP and Whitebox Multi-Strategy Partners, L.P., and each of their respective Permitted Transferees, the “Whitebox Funds”), Pernix Ireland Pain Designated Activity Company (together with its Permitted Transferees, “Pernix”) and each other Person who after the date hereof acquires securities of the Company and agrees to become a party to, and bound by, this Agreement. The 1992 Funds, the Whitebox Funds, Pernix, and each other Person who after the date hereof acquires securities of the Company and agrees to become a party to, and bound by, this Agreement, in accordance with its terms and their respective Permitted Transferees, are each referred to herein as a “Stockholder” and, collectively, the “Stockholders”.  

 

RECITALS

WHEREAS, the Company and the Stockholders desire to enter into this Agreement to set forth their understanding and agreement as to the shares of capital stock and other securities of the Company held by the Stockholders, including all matters relating to the funding, activities and management of the Company and ownership and transfer of such shares of capital stock and other securities of the Company.

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, the parties hereto agree as follows:

ARTICLE I 

DEFINITIONS 

Section 1.01    Definitions. When used in this Agreement with initial capital letters, the following terms have the meanings specified or referred to in this Section 1.01:  

 

1992 Funds” has the meaning set forth in the Preamble.

ABL Facility Debt” has the meaning set forth in the Credit Agreement.

Affiliate” means, with respect to any Person, any other Person who, directly or indirectly (including through one or more intermediaries), controls, is controlled by, or is 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, “control,” when used with respect to any specified Person, shall mean the power, direct or indirect, to direct or cause the direction of the management


 


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and policies of such Person, whether through ownership of voting securities or partnership or other ownership interests, by contract or otherwise; and the terms “controlling” and “controlled” shall have correlative meanings.  Notwithstanding the foregoing, (i) neither the Company nor any of the Company Subsidiaries shall be deemed to be an Affiliate of the Stockholders and (ii) a Person who is a director of one or more portfolio companies which are Affiliates of the 1992 Funds or the Whitebox Funds shall not be deemed an Affiliate of the 1992 Funds or the Whitebox Funds, as applicable, solely as a result of such directorship.

Agreement” has the meaning set forth in the Preamble.

Applicable Law” means all applicable provisions of (a) constitutions, treaties, statutes, laws (including the common law), rules, regulations, decrees, ordinances, codes, proclamations, declarations or orders of any Governmental Authority; (b) any consents or approvals of any Governmental Authority; and (c) any orders, decisions, advisory or interpretative opinions, injunctions, judgments, awards, decrees of, or agreements with, any Governmental Authority.

Applicable ROFR Rightholder Exercise Notice” has the meaning set forth in Section 4.03(d)(ii).

Applicable ROFR Rightholder Option Period” has the meaning set forth in Section 4.03(d)(ii).

Applicable ROFR Rightholders” has the meaning set forth in Section 4.03(a).

beneficial owner” has the meaning given to such term under Rule 13d-3 under the Exchange Act). The term “beneficial ownership” and “beneficially owns” shall have correlative meanings.

Board” has the meaning set forth in Section 2.01(a)(i).

Budget” has the meaning set forth in Section 5.03(d).

Business” has the meaning set forth in the Services Agreement.

Business Day” means a day other than a Saturday, Sunday or other day on which commercial banks in the City of New York are authorized or required to close.

Capital Stock” means the Common Stock and any other class or series of capital stock or other equity securities of the Company, whether authorized as of or after the date hereof.

CEO” has the meaning set forth in Section 2.01(a)(i)(B).

Certificate of Incorporation” means the Amended and Restated Certificate of Incorporation of the Company, as filed on July 27, 2018 with the Secretary of State of the State of Delaware and as amended, modified, supplemented or restated from time to time.


 


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Change in Control” means: (a) the sale, lease, transfer, exclusive license or other disposition, in a single transaction or series of related transactions of all or substantially all of the consolidated assets of the Company and the Company Subsidiaries; (b) an event or series of events, the result of which is that (i) any Person or group of Persons (other than Pernix, the 1992 Funds or the Whitebox Funds) acquires or otherwise becomes the beneficial owner of more than fifty percent (50%) of the Capital Stock or (ii) the 1992 Funds cease to hold collectively at least 50.1% of the Capital Stock (other than as a result of Pernix exercising its rights under Section 4.07); or (c) a merger, consolidation or similar transaction in which (i) the Company is a constituent party or (ii) a Company Subsidiary is a constituent party where, immediately after the consummation of the transaction, Pernix, the 1992 Funds and the Whitebox Funds own, directly or indirectly, less than fifty percent (50%) of the then outstanding voting securities having the power to elect the Board (or other governing body) of the ultimate parent entity resulting from such transaction.  For purposes of the preceding sentence, beneficial ownership shall include an interest resulting from ownership of the voting securities of one or more corporations or other business entities which own the Company, either directly or through one or more subsidiary corporations or other business entities.

Closing Date” means July 27, 2018.

Common Stock” means shares of Common Stock of the Company, $0.001 par value per share.

Company” has the meaning set forth in the Preamble.

Company Opportunity” has the meaning set forth in Section 5.01(a).

Company Competitor” means any Person, other than a Stockholder, engaged, directly or indirectly, in whole or in part, in the same or similar business as the Company, including those engaged in the Business.

Company Securities” means, at any time, the issued and outstanding Capital Stock at such time, and the Debt Commitments funded or committed at such time.

Company Subsidiary” means a Subsidiary of the Company.

Confidential Information” has the meaning set forth in Section 5.02(a).

Credit Agreement” means that certain Credit Agreement, entered into as of July 27, 2018, by and among the lenders identified on the signature pages thereof, Wilmington Savings Fund Society, FSB, as administrative agent and collateral agent for each member of the Lender Group (as defined in the Credit Agreement), the Company, as Borrower, and the Guarantors (as defined in the Credit Agreement) from time to time party hereto, and the other Subsidiaries of the Company from time to time party thereto.

Debt Commitments” means the Loans under the Credit Agreement and any additional loans or debt securities funded to the Company from and after the Closing date by a Stockholder.  For purposes of this Agreement, the term “Closing Debt Commitments” means the Loans, in the


 


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aggregate principal amount equal to $45,833,500 funded or committed by Pernix, the 1992 Funds and the Whitebox Funds to the Company as of the Closing Date under the Credit Agreement.

Delaware Act” means the General Corporation Law of the State of Delaware, Title 8, Chapter 1, and any successor statute, as it may be amended from time to time.

Director” has the meaning set forth in Section 2.01(a)(i).

Dispute” has the meaning set forth in Section 8.13.

Disqualification Event” has the meaning set forth in Section 2.02(e).

Disqualified Designee” has the meaning set forth in Section 2.02(e).

Distributions” means, with respect to any Stockholder, (i) any dividends or distributions paid on such Stockholder’s shares of Capital Stock, (ii) any repayments to such Stockholders of the principal amount of the Debt Commitments and (iii) any proceeds received in connection with the repurchase of any Equity Commitments.

Drag-along Notice” has the meaning set forth in Section 4.05(c).

Drag-along Sale” has the meaning set forth in Section 4.05(a).

Drag-along Stockholder” has the meaning set forth in Section 4.05(a).

Dragging Stockholder” has the meaning set forth in Section 4.05(a).

Exchange Act” means the Securities Exchange Act of 1934, as amended, or any successor federal statute, and the rules and regulations thereunder, which shall be in effect at the time.

Equity Commitment” has the meaning set forth under the definition of “Invested Amount”.

Excluded Issuance” means: (a) a grant of Capital Stock to any existing or prospective Directors, officers or other employees, consultants or service providers of the Company or any Company Subsidiary pursuant to any equity based incentive plans  or other compensation agreement approved by the Board; (b) the issuance of Capital Stock to a Person as consideration in any bona fide acquisition (including via a merger, consolidation or other business combination) by the Company or any Company Subsidiary of any equity interests, assets, properties or business of such Person; (c) the commencement of any Public Offering; (d) any subdivision of Capital Stock (by a split of Capital Stock or otherwise), payment of stock dividend pro rata, reclassification, reorganization or any similar recapitalization; (e) the issuance of Capital Stock to a Person as consideration in the formation of a bona fide joint venture, strategic alliance or other commercial relationship with such Person (including such Persons that are customers, suppliers and strategic partners of the Company or any Company Subsidiary) relating to the operation of the Company’s or any Company Subsidiary’s business and not for the primary purpose of raising equity capital; or (f) the issuance of Capital Stock to a lessor or a vendor in connection with an office lease or


 


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equipment lease or similar equipment financing transaction in which the Company or any Company Subsidiary obtains from such lessor or vendor the use of such office space or equipment for its business.

Exercising Applicable ROFR Rightholder” has the meaning set forth in Section 4.03(d)(iiii).

Exercising Applicable ROFR Rightholder Exercise Notice” has the meaning set forth in Section 4.03(d)(iii).

Exercising Applicable ROFR Rightholder Notice” has the meaning set forth in Section 4.03(d)(iii).

Exercising Applicable ROFR Rightholder Option Period” has the meaning set forth in Section 4.03(d)(iii).

“Expenditure means any payments or other financial commitments to a third party made by or on behalf of the Company or any Subsidiary.

Fair Market Value” of any asset as of any date means the purchase price that a willing buyer having all relevant knowledge would pay a willing seller for such asset in an arm’s length transaction, as determined in good faith by the Board based on such factors as the Board, in the exercise of its reasonable business judgment, considers relevant.

Family Members” has the meaning set forth in Section 4.02(b).

First Purchase Option Purchase Price” means, for any Company Securities Transferred pursuant to Section 4.06(a) as of any particular time, an amount equal to (a) the Purchase Percentage, multiplied by (b) an amount equal to (i) the Invested Amount, multiplied by (ii) [***], minus (iii) the total amount of Distributions to the Stockholders as of such time, plus (iv) the total amount of accrued and unpaid interest on the Debt Commitments.

Fiscal Year” means the calendar year, unless the Company is required to have a taxable year other than the calendar year, in which case Fiscal Year shall be the period that conforms to its taxable year.

Fully Electing Tag-Along Stockholder” has the meaning set forth in Section 4.04(d)(ii).

Fully Exercising Stockholder” has the meaning set forth in Section 3.01(d).

GAAP” means United States generally accepted accounting principles in effect from time to time.

Governmental Authority” means any federal, state, local or foreign government or political subdivision thereof, or any agency or instrumentality of such government or political subdivision, or any self-regulated organization or other non-governmental regulatory authority or quasi-governmental authority (to the extent that the rules, regulations or orders of such


 


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organization or authority have the force of law), or any arbitrator, court or tribunal of competent jurisdiction.

HB Director” has the meaning set forth in Section 2.01(a)(i)(A).

HB/WB Director” has the meaning set forth in Section 2.01(a)(i)(C).

Independent Director” means a Person who is not: (1) an officer or employee of (a) the Company or (b) any Affiliate of the Company or (2) an Affiliate or an officer or employee of (w) any advisor to the Company under an advisory agreement, (x) any lessee or management company operating any property of the Company, (y) any Company Subsidiary, or (z) any Stockholder.

Invested Amount” means, as of any particular time, the sum of: (i) each Stockholder’s total equity capital contribution to the Company at such time (the “Equity Commitment”), plus (ii) the total principal amount of the Debt Commitments funded by each Stockholder to the Company at such time, in each case inclusive of all capital contributions and Debt Commitments made from the Closing Date through such date, without deduction for any Distributions.  

Issuance Notice” has the meaning set forth in Section 3.01(b).

Joinder Agreement” means the Joinder Agreement to this Agreement in form and substance attached hereto as Exhibit A.

Loans” has the meaning set forth in the Credit Agreement.

Mediation Request” has the meaning set forth in Section 8.13.

New Securities” means any authorized but unissued shares of Capital Stock or any debt securities evidencing debt for borrowed money except for ABL Facility Debt.

Offered Stock” has the meaning set forth in Section 4.03(a).

Offering Stockholder” has the meaning set forth in Section 4.03(a).

Officer” means those employees of the Company who have been specifically appointed by the Company Board, through formal resolutions, as officers of the Company or any of its Subsidiaries.  

Other Business” has the meaning set forth in Section 5.1(a).

Over-allotment Exercise Period” has the meaning set forth in Section 3.01(d).

Over-allotment Notice” has the meaning set forth in Section 3.01(d).

Permitted Transfer” means a Transfer of Capital Stock carried out pursuant to Section 4.02.


 


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Permitted Transferee” means a recipient of a Transfer made in accordance with Article IV of this Agreement.

Pernix” has the meaning set forth in the Preamble.

Pernix Director” has the meaning set forth in Section 2.01(a)(i)(B).

Pernix Promote” has the meaning set forth in Section 5.05(a)(iii).

Person” means an individual, corporation, partnership, joint venture, limited liability company, Governmental Authority, unincorporated organization, trust, association or other entity.

Pre-emptive Acceptance Notice” has the meaning set forth in Section 3.01(c).

Pre-emptive Exercise Period” has the meaning set forth in Section 3.01(c).

Pre-emptive Pro Rata Portion” means, for any Stockholder as of any particular time, a fraction determined by dividing (a) the number of shares of Capital Stock owned by such Stockholder immediately prior to such time by (b) the aggregate number of shares of Capital Stock owned by all of the Stockholders immediately prior to such time.

Prospective Purchaser” has the meaning set forth in Section 3.01(b).

Prospective Transferee” has the meaning set forth in Section 4.03(b).

Public Offering” means any underwritten public offering pursuant to a registration statement filed in accordance with the Securities Act.

Purchase Percentage” means, as of any particular time, the percentage equivalent of the following fraction, (i) the numerator of which is the number of shares of Capital Stock Transferred to Pernix as of such time pursuant to Section 4.07(a) or Section 4.07(b), as applicable, and (ii) the denominator of which is the total number of shares of Capital Stock issued and outstanding at such time.

Related Agreements” has the meaning set forth in Section 8.06.

Related Fund” means any Person (other than a natural person) that is administered, advised or managed by (a) a Stockholder, (b) an Affiliate of a Stockholder or (c) an entity or an Affiliate of an entity that administers, advises or manages a Stockholder.

Remaining New Securities” has the meaning set forth in Section 3.01(d).

Representative” means, with respect to any Person, any and all directors, officers, employees, consultants, financial advisors, counsel, accountants and other agents of such Person.

ROFR Notice” has the meaning set forth in Section 4.03(c).


 


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ROFR Pro Rata Portion” means, for any Applicable ROFR Rightholder, a fraction determined by dividing (a) the number of shares of Capital Stock owned by such Applicable ROFR Rightholder immediately prior to such time by (b) the aggregate number of shares of Capital Stock owned by all of the Applicable ROFR Rightholders immediately prior to such time.

Sale Proceeds” has the meaning set forth in Section 5.05(a).

Second Purchase Option Purchase Price” means, for any Company Securities Transferred pursuant to Section 4.07(b) as of any particular time, an amount equal to (a) the Purchase Percentage, multiplied by (b) an amount equal to (i) the Invested Amount, multiplied by (ii) [***], minus (iii) the total amount of Distributions to the Stockholders as of such time, plus (iv) the total amount of accrued and unpaid interest on the Debt Commitments.

Securities Act” means the Securities Act of 1933, as amended, or any successor federal statute, and the rules and regulations thereunder, which shall be in effect at the time.

Selling Stockholder” means (a) during any time Pernix beneficially owns less than 49.9% of the Capital Stock, the 1992 Funds and/or the Whitebox Funds, as applicable, and (b) during any time Pernix beneficially owns 49.9% or more of the Capital Stock, Pernix.

Services” has the meaning set forth in the Services Agreement.

Services Agreement” means the Services Agreement dated as of the date hereof between the Company, and Pernix Therapeutics, LLC.

Stockholder” has the meaning set forth in the Preamble.

Stockholders Schedule” has the meaning set forth in Section 2.06.

Subsidiary” means, with respect to any Person, any other Person of which a majority of the outstanding shares or other equity interests having the power to vote for directors or comparable managers are owned, directly or indirectly, by the first Person.

Subsidiary Board” has the meaning set forth in Section 2.01(b).

Tag-along Exercise Notice” has the meaning set forth in Section 4.04(d)(i).

Tag-along Exercise Period” has the meaning set forth in Section 4.04(d)(i).

Tag-along Notice” has the meaning set forth in Section 4.04(c).

Tag-along Pro Rata Portion” means, for any Selling Stockholder or Tag-along Stockholder a fraction determined by dividing (a) the number of shares of Capital Stock owned by such Stockholder immediately prior to such time by (b) the number of shares of Capital Stock owned by the Selling Stockholder and all of the Tag-along Stockholders timely electing to participate in the applicable Tag-along Sale pursuant to Section 4.04(d)(i) immediately prior to such time.


 


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Tag-along Sale” has the meaning set forth in Section 4.04(a).

Tag-along Stock” has the meaning set forth in Section 4.04(a).

Tag-along Stockholder” means (a) during any time Pernix beneficially owns less than 49.9% of the Capital Stock, Pernix, and (b) during any time Pernix beneficially owns 49.9% or more of the Capital Stock, the 1992 Funds and the Whitebox Funds.

Transfer” means to, directly or indirectly (including pursuant to a derivative transaction or through the transfer of any equity interests in any direct or indirect company holding Company Securities (but excluding, with respect to Pernix, any transfers of any equity interests in Pernix Therapeutics Holdings, Inc.) or through the issuance and redemption by any such company of its securities), sell, transfer, assign, pledge, encumber, hypothecate or similarly dispose of, either voluntarily or involuntarily, by operation of law or otherwise, or to enter into any contract, option or other arrangement or understanding with respect to the sale, transfer, assignment, pledge, encumbrance, hypothecation or similar disposition of, any Company Securities owned by a Person or any interest (including a beneficial interest) in any Company Securities owned by a Person. “Transfer”, when used as a noun, shall have a correlative meaning.

Transfer Offer” has the meaning set forth in Section 4.03(a).

Transferee” means a recipient of, or proposed recipient of, a Transfer, including a Permitted Transferee or a Prospective Transferee.

Trigger Event” has the meaning set forth in Section 5.05(a).

Whitebox Funds” has the meaning set forth in the Preamble.

Section 1.02 Interpretation. For purposes of this Agreement: (a) the words “include,” “includes” and “including” shall be deemed to be followed by the words “without limitation”; (b) the word “or” is not exclusive; and (c) the words “herein,” “hereof,” “hereby,” “hereto” and “hereunder” refer to this Agreement as a whole. The definitions given for any defined terms in this Agreement shall apply equally to both the singular and plural forms of the terms defined. Whenever the context may require, any pronoun shall include the corresponding masculine, feminine and neuter forms. Unless the context otherwise requires, references herein: (x) to Articles, Sections, Exhibits and Schedules mean the Articles and Sections of, and Exhibits and Schedules attached to, this Agreement; (y) to an agreement, instrument or other document means such agreement, instrument or other document as amended, supplemented and modified from time to time to the extent permitted by the provisions thereof; and (z) to a statute means such statute as amended from time to time and includes any successor legislation thereto and any regulations promulgated thereunder. This Agreement shall be construed without regard to any presumption or rule requiring construction or interpretation against the party drafting an instrument or causing any instrument to be drafted. The Exhibits and Schedules referred to herein shall be construed with, and as an integral part of, this Agreement to the same extent as if they were set forth verbatim herein.


 


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ARTICLE II

MANAGEMENT

 

Section 2.01 Board Composition.

 

(a)Board Composition. Each Stockholder shall vote all voting securities owned by such Stockholder or over which such Stockholder has voting control, and shall take all other necessary or desirable actions within his, her or its control (including in his, her or its capacity as a stockholder, director, member of a board committee, officer of the Company or otherwise), and the Company shall take all necessary or desirable actions within its control, to ensure that:  

(i)for so long as Pernix beneficially owns Company Securities, and during any time Pernix beneficially owns less than 49.9% of the Capital Stock, the number of directors constituting the board of directors of the Company (each a “Director” and, collectively, the “Board”) is fixed and remains at all times at three (3) Directors, consisting of:  

(A)one (1) individual designated by the 1992 Funds (the “HB Director”), who shall initially be Jonathan Segal;  

(B)one (1) individual designated by Pernix (the “Pernix Director”), who shall initially be John Sedor and who shall serve as the Company’s Chairman and Chief Executive Officer (“CEO”); and 

(C)one (1) individual designated by the mutual agreement of the 1992 Funds and the Whitebox Funds (the “HB/WB Director”), who shall initially be Jake Mercer. 

(ii)during any time Pernix beneficially owns 49.9% or more of the Capital Stock but less than 100%, the number of Directors constituting the Board is fixed and remains at all times at five (5) Directors, consisting of:  

(A)two Pernix Directors, one of whom will serve as the Company’s Chairman and CEO; 

(B)one HB Director;  

(C)one HB/WB Director; and  

(D)one (1) individual who is an Independent Director designated by the mutual agreement of the 1992 Funds, the Whitebox Funds and Pernix (the “Independent Director”). 

The Stockholder or Stockholders entitled to designate a Director pursuant to this Section 2.01(a)(i) shall no longer be entitled to designate such Director if such Stockholder (together with its Permitted Transferees) ceases to hold at least fifty percent (50%) of the Company Securities  


 


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held by such Stockholder or Stockholders as of the Closing Date.  To the extent that any of clauses (A) through (C) of Section 2.01(a)(i) or clauses (A) through (D) of Section 2.01(a)(ii) above shall not be applicable, any Director who would otherwise have been designated in accordance with the terms thereof shall instead be voted upon by all the stockholders of the Company entitled to vote thereon in accordance with, and pursuant to, the Certificate of Incorporation of the Company.

(b)Subsidiary Board Composition. At all times, the composition of any board of directors of any Company Subsidiary (each, a “Subsidiary Board”) shall consist of at least three (3) Directors (subject to applicable law) and shall be as determined by the Board.  Initially, the Subsidiary Boards shall consist of four (4) Directors, who shall initially be John Sedor, Kenneth Piña, Angus Smith and Joseph Behan.  

Section 2.02  Removal Resignation; Vacancies.

(a)Removal. An HB Director may be removed at any time as a Director (with or without cause) upon, and only upon, the written request of the 1992 Funds.  A Pernix Director may be removed at any time as a Director (with or without cause) upon, and only upon, the written request of Pernix.  An HB/WB Director may be removed at any time as a Director (with or without cause) upon, and only upon, the joint written request of the 1992 Funds and the Whitebox Funds.  An Independent Director may be removed at any time as a Director (with or without cause) upon, and only upon, the unanimous written request of the 1992 Funds, the Whitebox Funds and Pernix.  Each Stockholder shall vote all shares of Capital Stock owned by such Stockholder or over which such Stockholder has voting control, and shall take all other necessary or desirable actions within his, her or its control (including in his, her or its capacity as a stockholder, director, member of a board committee, officer of the Company or otherwise), and the Company shall take all necessary or desirable actions within its control, to remove or replace such Director upon, and only upon, such written request of the applicable Stockholder or Stockholders entitled to designate such Director pursuant to Section 2.01(a) of this Agreement. Except as provided in the preceding sentence, unless the applicable Stockholders entitled to designate such Director pursuant to Section 2.01(a) of this Agreement shall otherwise consent in writing or such Stockholder or Stockholders shall no longer be entitled to designate such Director pursuant to Section 2.01(a), no other Stockholder shall take any action to cause the removal of a Director.  To the extent a Stockholder or Stockholders are no longer entitled to designate a Director pursuant to Section 2.01(a), the removal of such Director (with or without cause) appointed by such Stockholder pursuant to Section 2.01(a) shall instead be effected in accordance with, and pursuant to, the Certificate of Incorporation and the Bylaws of the Company.  

(b)Resignation. A Director may resign at any time from the Board by delivering his written resignation to the Board. Any such resignation shall be effective upon receipt thereof unless it is specified to be effective at some other time or upon the occurrence of some other event. The Board’s acceptance of a resignation shall not be necessary to make it effective. 


 


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(c)Vacancies. In the event that a vacancy is created on the Board at any time due to the death, disability, retirement, resignation or removal of a Director, then the Stockholder or Stockholders entitled to designate such Director pursuant to Section 2.01(a) of this Agreement shall have the right to designate an individual to fill such vacancy and the Company and each Stockholder (whether in his, her or its capacity as a stockholder, director, member of a board committee, officer of the Company or otherwise) hereby agree to take such actions as may be necessary or desirable within his, her or its control (including, in the case of a Stockholder, by voting all shares of Capital Stock owned by such Stockholder or over which such Stockholder has voting control) to ensure the election or appointment of such designee to fill such vacancy on the Board. In the event that the Stockholder or Stockholders entitled to designate such Director pursuant to Section 2.01(a) of this Agreement shall fail to designate in writing a representative to fill a vacant Director position on the Board, and such failure shall continue for more than thirty (30) days after notice from the Company to the Stockholder or Stockholders entitled to designate such Director pursuant to Section 2.01(a) of this Agreement with respect to such failure, then the vacant position shall be filled by an individual designated by the Directors then in office; provided, that such individual shall be removed from such position if the Stockholder or Stockholders entitled to designate such Director pursuant to Section 2.01(a) of this Agreement so directs and simultaneously designates a new Director. To the extent a Stockholder or Stockholders are no longer entitled to designate a Director pursuant to Section 2.01(a), filling a vacancy on the Board caused by the death, disability, retirement, resignation or removal of a Director appointed by such Stockholder shall instead be effected in accordance with, and pursuant to, the Certificate of Incorporation and the Bylaws of the Company.  

(d)No Liability for Election of Recommended Directors. No Stockholder, nor any Affiliate of any Stockholder, shall have any liability as a result of designating a person for election as a Director for any act or omission by such designated person in his or her capacity as a Director of the Company, nor shall any Stockholder have any liability as a result of voting for any such designee in accordance with the provisions of this Agreement. 

(e)No “Bad Actor” Designees. Each Person with the right to designate or participate in the designation of a Director as specified above hereby represents and warrants to the Company that, to such Person’s knowledge, none of the “bad actor” disqualifying events described in Rule 506(d)(1)(i)-(viii) under the Securities Act (each, a “Disqualification Event”), is applicable to such Person’s initial designee named above except, if applicable, for a Disqualification Event as to which Rule 506(d)(2)(ii) or (iii) or (d)(3) is applicable. Any Director designee to whom any Disqualification Event is applicable, except for a Disqualification Event to which Rule 506(d)(2)(ii) or (iii) or (d)(3) is applicable, is hereinafter referred to as a “Disqualified Designee”. Each Person with the right to designate or participate in the designation of a Director as specified above hereby covenants and agrees (A) not to designate or participate in the designation of any Director designee who, to such Person’s knowledge, is a Disqualified Designee and (B) that in the event such Person becomes aware that any individual previously designated by any such Person is or has become a Disqualified Designee, such Person shall as promptly as  


 


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practicable take such actions as are necessary to remove such Disqualified Designee from the Board and designate a replacement designee who is not a Disqualified Designee.

Section 2.03 Board of Directors.   

(a)Powers.  Except as reserved to the Stockholders by law, by the Certificate of Incorporation or by this Agreement, the business of the Company shall be managed under the direction of the Board, who shall have and may exercise and delegate all of the powers of the Company. 

(b)Meetings of the Board. 

(i)Generally. The Board shall meet at least quarterly, or more often as determined by the Board, at such time and at such place as the Board may designate. Meetings of the Board may be held either in person or by means of telephone or video conference or other communications device that permits all Directors participating in the meeting to hear each other, at the offices of the Company or such other place (either within or outside the State of Delaware) as may be determined from time to time by the Board. To the extent reasonably practical unless otherwise unanimously consented to by the Directors, written notice of each meeting of the Board shall be given to each Director by electronic mail at least 48 hours prior to each such meeting.  Any lawful business may be transacted at a meeting of the Board, notwithstanding the fact that the nature of the business may not have been specified in the notice or waiver of notice of the meeting.  

(ii)Special Meetings. Special meetings of the Board shall be held on the call of the CEO or any one or more Directors upon at least 72 hours’ written notice given by electronic mail if the meeting is to be held in person or 48 hours’ written notice given by electronic mail if the meeting is to be held by telephone communications or video conference to the Directors, or upon such shorter notice as may be unanimously approved by all Directors. Any Director may waive such notice as to himself or herself. 

(iii)Quorum Requirements. For so long as Pernix beneficially owns Company Securities, and during any time Pernix beneficially owns less than 49.9% of the Capital Stock, the presence of all Directors then in office is required for a quorum. During any time Pernix beneficially owns 49.9% or more of the Capital Stock, the presence of the greater of four of Directors then in office or a majority of the Directors then in office shall constitute a quorum, provided that the presence of at least (A) one Pernix Director and (B) one HB Director or one HB/WB Director shall be required for a quorum. If a quorum is not achieved at a first duly called meeting, such meeting may be postponed to a time no earlier than 48 hours after written notice of such postponement has been given to the Directors and, at such second call, a quorum shall be deemed present as long as a majority of the Directors then in office are present. 


 


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(iv)Action at Meeting.  Any motion adopted by vote of the majority of the Directors then in office shall be the act of the Board, except where a different vote is required by Applicable Law, by the Certificate of Incorporation or by this Agreement.   

(v)Action Without Meeting.  Any action by the Board may be taken without a meeting if all of the Directors consent to the action in writing and the consents are filed with the records of the Board meetings.  Such consent shall be treated for all purposes as a vote of the Directors at a meeting. 

(vi)Restrictions on the Authority of the Board.  

(A)Notwithstanding anything to the contrary in this Agreement, none of the following actions may be taken by the Company, directly or indirectly, without the approval of the Stockholders holding more than 50% of the shares of Capital Stock: 

(1) a Change in Control;  

(2) the determination of a “reasonably acceptable” executive for the purposes of the Key Man provisions; provided, however, that Pernix shall not be entitled to vote as to whether such replacement executive is reasonably acceptable; and 

(3) the entering into, modification (subject to Section 2.03(b)(vi)(C)(2)) or renewal of the Service(s) Agreement in accordance with its terms; provided, however, that Pernix shall not be entitled to vote on the entering into, modification (subject to Section 2.03(b)(vi)(C)(2)) or renewal of the Service(s) Agreement. 

(B)Notwithstanding anything to the contrary in this Agreement, none of the following actions may be taken by the Company, directly or indirectly, without the approval of the Stockholders holding more than 50% of the shares of Capital Stock, unless and until Pernix beneficially owns 49.9% or more of the Capital Stock: 

(1) the issuance of any shares of Capital Stock or any security or obligation that is by its terms, directly or indirectly, convertible into or exchangeable or exercisable for shares of Capital Stock, and any option, warrant or other right to subscribe for, purchase or acquire shares of Capital Stock; 

(2) the making of any distributions of cash or property to the Stockholders, in their capacities as such, or the redemption, purchase, or other acquisition for consideration of any shares of  


 


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Capital Stock, other than as permitted in the Company’s Certificate of Incorporation, Bylaws, this Agreement, the Credit Agreement or other organizational document of the Company;

(3) the granting of registration rights to any Person, other than as expressly set forth in Exhibit B to this Agreement; 

(4) the formation of any Company Subsidiaries other than a wholly-owned Company Subsidiary or the sale of any equity interests of any Company Subsidiary to any person other than a wholly-owned Company Subsidiary; 

(5) the entering into, renewal or modification of any joint venture, partnership or similar arrangement; 

(6) the sale, transfer or other disposition of material assets of the Company and the Company Subsidiaries involving an aggregate consideration equal to or greater than $5 million or the commencement of a process to explore or consummate a Change in Control, other than as permitted in the Credit Agreement;  

(7) the creation, incurrence or assumption of any pledge, mortgage, lien, charge, security interest or any other material encumbrance of any kind upon any of the Company’s or the Company Subsidiaries’ properties or assets, or the acquisition of any property of any character subject to or upon any mortgage, conditional sale agreement or other title retention agreement, or sale, assignment, pledge or other disposition of any accounts or notes receivable or contract rights, except (i) encumbrances incurred in connection with purchase money financing or lease of personal property, solely with respect to the property leased or purchased; (ii) liens for taxes, assessments, governmental charges, levies or claims suffered by the Company or any Company Subsidiary which such Person is contesting in good faith; (iii) other liens, charges, pledges, deposits and encumbrances incidental to the conduct of the business of the Company and its Subsidiaries which are not incurred in connection with the borrowing of money or the obtaining of advances or credits and which do not in the aggregate exceed $5 million; (iv) under customary ABL arrangements with a borrowing capacity which does not in the aggregate exceed $30 million; and (v) under the Credit Agreement;  

(8) the entering into, renewal or modification of any agreement other than in the ordinary course of business involving a commitment by the Company, or any Company Subsidiary or  


 


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Affiliate of the Company (other than the Stockholders and their Affiliates) in any twelve month period of an amount in excess of $5 million, other than (i) the Credit Agreement, (ii) the Services Agreement or (iii) any agreement between the Company or any of its Subsidiaries, on the one hand, and the Company or any of its Subsidiaries, on the other hand;

(9) the incurrence, creation, or assumption of any indebtedness, except (i) current liabilities and accounts payable (other than indebtedness for borrowed money) incurred in the ordinary course of business; (ii) indebtedness secured by, or incurred in connection with, purchases or leases of equipment or other personal property acquired or leased; (iii) indebtedness of the Company to any wholly-owned Company Subsidiary; and (iv) customary ABL arrangements with a borrowing capacity which does not in the aggregate exceed $30 million; or (v) indebtedness under the Credit Agreement; and 

(10) the purchase, lease, license, exchange or other acquisition (including by merger, consolidation, acquisition of stock or acquisition of assets) by the Company of any assets involving an aggregate consideration equal to or greater than $5 million, except as permitted by the Services Agreement. 

During any time Pernix beneficially owns 49.9% or more of the Capital Stock, unless otherwise required by Applicable Law, the actions set forth in this Section 2.03(b)(vi)(B) may be taken by the Company, with the approval of the Board. 

(C)Notwithstanding anything to the contrary in this Agreement, none of the following actions may be taken by the Company, directly or indirectly, without the unanimous approval of all of the Stockholders: 

(1) the purchase, lease, license, exchange or other acquisition (including by merger, consolidation, acquisition of stock or acquisition of assets) by the Company of any assets involving an aggregate consideration equal to or greater than $10 million;  

(2) any modification of the Services Agreement(s), the Certificate of Incorporation, Bylaws, this Agreement or other organizational document of the Company or any other action, in each case, which may have a disproportionate adverse economic effect on any Stockholder, in their capacity as such; provided, however, that the exercise of preemptive rights, in accordance with the terms of Article III of this Agreement, shall not be deemed to have a disproportionate adverse economic effect on any Stockholders that choose to or not to exercise such rights; 


 


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(3) the entering into any new activity or business, other than the development and commercialization of pharmaceutical products designed for weight loss;  

(4) the entering into or becoming a party to any transaction with any Affiliate, Director, officer, or employee of the Company or any “associate” (as defined in Rule 12b-2 promulgated under the Exchange Act) of any such Person, except for (i) the Credit Agreement and (ii) the Services Agreement, and, in each case, any agreements or instruments contemplated thereunder;  

(5) the liquidation or dissolution of the Company;  

(6) any change to the size of the Board (except as permitted under Section 2.01(a)); 

(7) any distributions that are not made pro rata to the Stockholders, or any repurchases or repayments of any indebtedness of the Company held by Stockholders that are not made pro rata to the Stockholders, in each case based on their ownership of shares of Capital Stock, other than as expressly provided for in the Company’s Certificate of Incorporation, Bylaws, this Agreement or other organizational document of the Company; and 

(8) any entry into any contract that restricts the ability of any Stockholder or any of their Affiliates (other than the Company and its Subsidiaries) to compete in any business or geography.  

Section 2.04   Compensation; No Employment. 

(a)     Compensation of Directors. The Company and each Stockholder acknowledges and agrees that:

(i)No Director that is an Affiliate of or is employed by a Stockholder shall receive compensation for service as a Director to the Company or any Company Subsidiary.  An Independent Director may receive compensation for service as a Director to the Company as determined by the Board, in an amount up to $150,000 per annum or as otherwise approved by the Board. Directors (whether or not an Affiliate of, employed by or a representative of, any Stockholder) shall be reimbursed by the Company for all reasonable travel and out-of-pocket expenses incurred in the performance of Company duties as a Director, including attendance in person at meetings of the Board or the board of any Company Subsidiary (or any committees thereof), pursuant to such policies as from time to time established by the Board.  


 


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(vii)Nothing contained in this Section 2.04 shall be construed to preclude any Director from serving the Company or any Company Subsidiary in any other capacity and receiving reasonable compensation for such services provided such other arrangements are expressly approved by the Board. 

(b)  No Right of Employment Conferred. This Agreement does not, and is not intended to, confer upon any Director any rights with respect to continued employment by the Company, and nothing herein should be construed to have created any employment agreement with any Director.

Section 2.05   Committees. The Company and each Stockholder acknowledges and agrees that the Board may, by resolution, designate from among the Directors one or more committees, each of which shall be comprised of one or more Directors, one of which shall be a Pernix Director and one of which shall be the HB Director or the HB/WB Director. Any such committee, to the extent provided in the resolution forming such committee, shall have and may exercise the authority of the Board, subject to the limitations set forth in the Delaware Act. The Board may dissolve any committee or remove any member of a committee at any time.

Section 2.06   Schedule of Stockholders.  The Board shall maintain a schedule of all Stockholders, their respective mailing addresses and their Invested Amount, the number of shares of Capital Stock held by them, and the Debt Commitments and Equity Commitments funded by them (the “Stockholders Schedule”), and shall update the Stockholders Schedule upon the issuance or Transfer of any Company Securities to any new or existing Stockholders. A copy of the Stockholders Schedule as of the execution of this Agreement is attached hereto as Schedule A.

Section 2.07 Stockholder Meetings.  At the request of any of the 1992 Funds, the Whitebox Funds or Pernix, the Board shall call special meetings of stockholders.

ARTICLE III 

PRE-EMPTIVE RIGHT 

Section 3.01  Pre-emptive Right.

 

(a)Issuance of New Securities. The Company hereby grants to each Stockholder a right to purchase its Pre-emptive Pro Rata Portion (subject to its over-allotment option in Section 3.01(d) below) of any New Securities that the Company may from time to time propose to issue or sell to any party; provided, that the provisions of this Section 3.01 shall not apply to any Excluded Issuance. 

(b)Additional Issuance Notices. The Company shall give written notice (an “Issuance Notice”) of any proposed issuance or sale of New Securities described in Section 3.01(a) to each Stockholder within five (5) Business Days following any meeting of the Board at which any such issuance or sale is approved. The Issuance Notice shall, if applicable, be accompanied by a written offer from any prospective purchaser seeking to  


 


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purchase the applicable New Securities (a “Prospective Purchaser”) and shall set forth the material terms and conditions of the proposed issuance or sale, including:

(i)the number and description of New Securities proposed to be issued; 

(ii)the proposed issuance date, which shall be at least thirty (30) days from the date of the Issuance Notice; 

(iii)the proposed purchase price per share of New Securities and all other material terms of the offer or sale; and 

(iv) if the consideration to be paid by the Prospective Purchaser includes non-cash consideration, the Fair Market Value thereof.

The Issuance Notice shall also be accompanied by a current copy of a capitalization table or other stockholders ledger of the Company indicating each Stockholder’s Pre-emptive Pro Rata Portion of any New Securities.

(c)Exercise of Pre-emptive Rights. Each Stockholder shall for a period of ten (10) Business Days following the receipt of an Issuance Notice (the “Pre-emptive Exercise Period”) have the right, but not the obligation, to elect irrevocably to purchase all or any portion of its Pre-emptive Pro Rata Portion of any New Securities on the terms and conditions, including the purchase price, set forth in the Issuance Notice by delivering a written notice to the Company (a “Pre-emptive Acceptance Notice”) specifying the number of New Securities it desires to purchase up to its Pre-emptive Pro Rata Portion. The delivery of a Pre-emptive Acceptance Notice by a Stockholder shall be a binding and irrevocable offer by such Stockholder to purchase the New Securities described therein. The failure of a Stockholder to deliver a Pre-emptive Acceptance Notice by the end of the Pre-emptive Exercise Period shall constitute a waiver of its rights under this Section 3.01(c) with respect to the purchase of such New Securities, but shall not affect its rights with respect to any future issuances or sales of New Securities. 

(d)Over-allotment. No later than five (5) Business Days following the expiration of the Pre-emptive Exercise Period, the Company shall give written notice (the “Over-allotment Notice”) to each Stockholder specifying the number of New Securities that each Stockholder has agreed to purchase (including, for the avoidance of doubt, where such number is zero) and the aggregate number of remaining New Securities, if any, not elected to be purchased by the Stockholders pursuant to Section 3.01(c) (the “Remaining New Securities”). Each Stockholder exercising its rights to purchase its Pre-emptive Pro Rata Portion of the New Securities in full (a “Fully Exercising Stockholder”) shall have a right of over-allotment such that if there are any Remaining New Securities, such Fully Exercising Stockholder may purchase all or any portion of its pro rata portion of the Remaining New Securities, based on the relative Pre-emptive Pro Rata Portions of all Fully Exercising Stockholders. Each Fully Exercising Stockholder shall elect to purchase its allotment of Remaining New Securities by giving written notice to the Company specifying  


 


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the number of Remaining New Securities it desires to purchase within five (5) Business Days of receipt of the Over-allotment Notice (the “Over-allotment Exercise Period”).

(e)Sales to the Prospective Purchaser. Following the expiration of the Pre-emptive Exercise Period and, if applicable, the Over-allotment Exercise Period, the Company shall be free to complete the proposed issuance or sale of New Securities described in the Issuance Notice with respect to which Stockholders declined to exercise the pre-emptive right set forth in this Section 3.01 on terms no less favorable to the Company than those set forth in the Issuance Notice (except that the amount of New Securities to be issued or sold by the Company may be reduced); provided, that: (i) such issuance or sale is closed within twenty (20) Business Days after the expiration of the Pre-emptive Exercise Period and, if applicable, the Over-allotment Exercise Period (subject to the extension of such twenty (20) Business Day period for a reasonable time not to exceed forty (40) Business Days to the extent reasonably necessary to obtain any third-party approvals); and (ii) for the avoidance of doubt, the price at which the New Securities are sold to the Prospective Purchaser is at least equal to or higher than the purchase price described in the Issuance Notice. In the event the Company has not sold such New Securities within such time period, the Company shall not thereafter issue or sell any New Securities without first again offering such securities to the Stockholders in accordance with the procedures set forth in this Section 3.01. 

(f)Prior Offer.  Notwithstanding the foregoing provisions of this Section 3.01, the Company may proceed with the issuance of New Securities without first following the procedures in Sections 3.01(a)-(e) if the Board unanimously and in good faith determines that exigent circumstances exist which make it advisable and in the best interests of the Company and the Stockholders to issue the New Securities without first following the procedures in Sections 3.01(a)-(e); provided that (i) the Prospective Purchasers of such New Securities agree in writing to take such New Securities subject to the provisions of Section 3.01(a), and (ii) within ten (10) Business Days following the issuance of such New Securities, the Company or the Prospective Purchasers of the New Securities undertake steps substantially similar to those in Sections 3.01(a)-(e) to offer to all Stockholders the right to purchase from the Company or the Prospective Purchasers of the New Securities their applicable Pre-Emptive Pro Rata Portion of such New Securities or equivalent at the same price and terms applicable to the Prospective Purchasers’ purchase thereof so as to achieve substantially the same effect from a dilution protection standpoint as if the procedures set forth above in this Section 3.01 had been followed prior to the issuance of such New Securities. 

(g)Closing of the Issuance. The closing of any purchase by any Stockholder shall be consummated concurrently with the consummation of the issuance or sale described in the Issuance Notice. Upon the issuance or sale of any New Securities in accordance with this Section 3.01, the Company shall deliver the New Securities in certificated form, free and clear of any liens (other than those arising hereunder and those attributable to the actions of the purchasers thereof), and the Company shall so represent and warrant to the purchasers thereof, and further represent and warrant to such purchasers that such New Securities shall be, upon issuance thereof to such purchasers and after  


 


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payment therefor, duly authorized, validly issued, fully paid and non-assessable. Each Stockholder shall deliver to the Company the purchase price for the New Securities purchased by it by certified or bank check or wire transfer of immediately available funds. Each party to the purchase and sale of New Securities shall take all such other actions as may be reasonably necessary to consummate the purchase and sale including, without limitation, entering into such additional agreements as may be necessary or appropriate.

ARTICLE IV

TRANSFER

 

Section 4.01  General Restrictions on Transfer. 

 

(a)General. Each Stockholder acknowledges and agrees that such Stockholder (and any Permitted Transferee of such Stockholder) shall not Transfer any Company Securities, except in accordance with the provisions of this Article IV or otherwise with the written approval of all Stockholders.  

(b)Transfer Restrictions. Notwithstanding any other provision of this Agreement, each Stockholder agrees that it will not, directly or indirectly, Transfer any Company Securities: 

(i)except as permitted under the Securities Act and other applicable federal or state securities or blue sky laws, and then, if requested by the Company, only upon delivery to the Company of a written opinion of counsel in form and substance satisfactory to the Company to the effect that such Transfer may be effected without registration under the Securities Act; 

(ii)if such Transfer would cause the Company or any of the Company Subsidiaries to be required to register as an investment company under the Investment Company Act of 1940, as amended; or 

(iii)if such Transfer would cause the assets of the Company or any of the Company Subsidiaries to be deemed “Plan Assets” as defined under the Employee Retirement Income Security Act of 1974 or its accompanying regulations or result in any “prohibited transaction” thereunder involving the Company or any Company Subsidiary. 

(c)Transfers by Pernix.  

(i)For so long as Pernix Therapeutics Holdings, Inc., and/or one or more of its Subsidiaries is party to the Services Agreement, Pernix shall not transfer any Company Securities without the prior written consent of the Stockholders, except:  

(A)pursuant to Section 4.02; 


 


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(B)upon the exercise of a tag-along right as a Tag-along Stockholder pursuant to Section 4.04; or  

(C)when required of a Drag-along Stockholder pursuant to Section 4.05. 

(ii)If none of Pernix Therapeutics Holdings, Inc. or any of its Subsidiaries are party to the Services Agreement, Pernix shall not transfer any Company Securities without the prior written consent of the Stockholders, except: 

(A)as permitted pursuant to Section 4.02; or 

(B)during any time Pernix beneficially owns less than 49.9% of the Capital Stock, (1) in strict accordance with the restrictions, conditions and procedures described in the other provisions of this Section 4.01 and Section 4.03; (2) upon the exercise of a tag-along right as a Tag-along Stockholder pursuant to Section 4.04; or (3) when required of a Drag-along Stockholder pursuant to Section 4.05; and  

(C)during any time Pernix beneficially owns 49.9% or more of the Capital Stock, in strict accordance with the restrictions, conditions and procedures described in the other provisions of this Section 4.01 and Section 4.03, Section 4.04 and Section 4.05, as applicable.   

(d)Transfers by the 1992 Funds and the Whitebox Funds.  The 1992 Funds and the Whitebox Funds shall not Transfer any Company Securities except: 

(i)as permitted pursuant to Section 4.02;  

(ii)during any time Pernix beneficially owns less than 49.9% of the Capital Stock, in strict accordance with the restrictions, conditions and procedures described in the other provisions of this Section 4.01 and Section 4.03, Section 4.04 and Section 4.05, as applicable; and 

(iii)during any time Pernix beneficially owns 49.9% or more of the Capital Stock, in strict accordance with the restrictions, conditions and procedures described in the other provisions of this Section 4.01 and Section 4.03; (2) upon the exercise of a tag-along right as a Tag-along Stockholder pursuant to Section 4.04; or (3) when required of a Drag-along Stockholder pursuant to Section 4.05. 

(e)Transfers of Company Securities. The Stockholders acknowledge and agree that, until the expiration or earlier termination of the Credit Agreement, the shares of Capital Stock issued to each Stockholder as of the date hereof and the Closing Debt Commitments will be “stapled” and shall only be transferred by such Stockholders proportionately as between the shares of Capital Stock and the Closing Debt Commitments (e.g. if a Stockholder Transfers 5% of its shares of Capital Stock, the Stockholder must  


 


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Transfer 5% of its Closing Debt Commitments in the same transaction to the same transferee).

(f)Joinder Agreement. Except with respect to any Transfer pursuant to a Public Offering or a Drag-along Sale, no Transfer of Company Securities pursuant to any provision of this Agreement shall be deemed completed until the Transferee shall have entered into a Joinder Agreement. 

(g)Transfers in Violation of this Agreement. Any Transfer or attempted Transfer of any Company Securities in violation of this Agreement, including any failure of a Transferee, as applicable, to enter into a Joinder Agreement pursuant to Section 4.01(f) above, shall be null and void, no such Transfer shall be recorded on the Company’s books and the purported Transferee in any such Transfer shall not be treated (and the Stockholder proposing to make any such Transfer shall continue be treated) as the owner of such Company Securities for all purposes of this Agreement. 

Section 4.02  Permitted Transfers. Subject to Section 4.01 above, including the requirement to enter into a Joinder Agreement pursuant to Section 4.01(f) above, the provisions of Section 4.03, Section 4.04 and Section 4.05 shall not apply to any of the following Transfers by any Stockholder of any Company Securities:

(a)With respect to the 1992 Funds and the Whitebox Funds (i) to any Related Fund, provided that all provisions of this Agreement shall apply to the 1992 Funds, the Whitebox Funds, such Related Fund, and such Company Securities as if such Transfer had not occurred, or (ii) to any Person, provided that, in the case of any 1992 Funds, from and after the Closing Date, the 1992 Funds have not Transferred in the aggregate (including as a result of the presently contemplated Transfer), more than ten percent (10%) of the Company Securities owned by the 1992 Funds in the aggregate as of the Closing Date, and, in the case of any Whitebox Fund, from and after the Closing Date, the Whitebox Funds have not Transferred in the aggregate (including as a result of the presently contemplated Transfer) more than ten percent (10%) of the Company Securities owned by the Whitebox Funds in the aggregate as of such date; provided, however, that the Company Securities deemed Transferred by a Stockholder under this Section 4.02(a) will be reduced by the number of additional Company Securities purchased or acquired by such Stockholder following the date of this Agreement; and 

(h)With respect to Pernix, to any direct or indirect wholly-owned Subsidiary of Pernix Therapeutics Holdings, Inc.  

Section 4.03 Right of First Refusal.

(a)Offered Stock. Subject to the terms and conditions specified in Section 4.01Section 4.02, this Section 4.03 and Section 4.04, if a Stockholder (the “Offering Stockholder”) receives a bona fide offer from any Person (a “Prospective Transferee”) that the Offering Stockholder desires to accept (a “Transfer Offer) to Transfer all or any portion of any Company Securities it owns (the “Offered Stock”), each other Stockholder  


 


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shall have a right of first refusal with respect to such Transfer. Each time an Offering Stockholder receives a Transfer Offer for any Offered Stock from a Prospective Transferee, the Offering Stockholder shall first make an offering of the Offered Stock to each Stockholder other than the Offering Stockholder (the “Applicable ROFR Rightholders”), all in accordance with the following provisions of this Section 4.03, prior to Transferring such Offered Stock to the Prospective Transferee.  For any particular Transfer Offer, this right of first refusal and the terms and conditions set forth in this Section 4.03 shall be applied separately on a class-by-class and series-by-series basis for each class or series of Offered Stock, as applicable, with the Debt Commitments and the Capital Stock treated as separate classes of Offered Stock in any Transfer Offer, subject to Section 4.01(e).

(b)Offered Stock Transfer Exceptions. Notwithstanding anything herein to the contrary, the right of first refusal in Section 4.03(a) shall not apply to any Transfer Offer or Transfer of Company Securities that are: 

(i)permitted by and made in accordance with Section 4.02; 

(ii)are proposed to be made by a Dragging Stockholder or required to be made by a Drag-along Stockholder pursuant to Section 4.05; 

(iii)are made by a Tag-along Stockholder upon the exercise of its tag-along right pursuant to Section 4.04 after the Applicable ROFR Rightholders have declined to exercise their rights in full under this Section 4.03; or 

(iv)made pursuant to a Public Offering. 

(c)Offer Notice. 

(i)The Offering Stockholder shall, within five (5) Business Days of receipt of the Transfer Offer, give written notice (a “ROFR Notice) to each Applicable ROFR Rightholder stating that it has received a Transfer Offer for the Offered Stock and specifying: 

(A)the number of shares of each class or series of Offered Stock to be Transferred by the Offering Stockholder; 

(B)the proposed date, time and location of the closing of the Transfer, which shall not be less than twenty (20) Business Days from the date of the ROFR Notice; 

(C)the purchase price per share of each class or series of Offered Stock (which shall be payable solely in cash) and the other material terms and conditions of the Transfer Offer; and 

(D)the name of the Prospective Transferee who has offered to purchase such Offered Stock. 


 


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(ii)The ROFR Notice shall constitute the Offering Stockholder’s offer to Transfer all of the Offered Stock to the Applicable ROFR Rightholders in accordance with the provisions of this Section 4.03, which offer shall be irrevocable until the end of the Applicable ROFR Rightholder Option Period described in Section 4.03(d)(ii); 

(iii)By delivering the ROFR Notice, the Offering Stockholder represents and warrants to each Applicable ROFR Rightholder that: 

(A)the Offering Stockholder has full right, title and interest in and to the Offered Stock described in the ROFR Notice; 

(B)the Offering Stockholder has all the necessary power and authority and has taken all necessary action to Transfer the Offered Stock described in the ROFR Notice as contemplated by this Section 4.03; and 

(C)the Offered Stock described in the ROFR Notice is free and clear of any and all liens other than those arising as a result of or under the terms of this Agreement. 

(d)Exercise of Right of First Refusal; Over-Allotment Option. 

(i)Upon receipt of the ROFR Notice, each Applicable ROFR Rightholder shall have the right to purchase the Offered Stock on the terms and purchase price(s) set forth in the ROFR Notice. The Applicable ROFR Rightholders shall have the right to purchase all (but not less than all) of their respective ROFR Pro Rata Portions of the Offered Stock, in accordance with the procedures set forth in Section 4.03(d)(ii). The Applicable ROFR Rightholders may only exercise their right to purchase the Offered Stock if, after giving effect to all elections made under this Section 4.03(d), no less than all of the Offered Stock will be purchased by the Applicable ROFR Rightholders. 

(ii)For a period of ten (10) Business Days following the receipt of a ROFR Notice (such period, the “Applicable ROFR Rightholder Option Period”), each Applicable ROFR Rightholder shall have the right to elect to purchase all (but not less than all) of its ROFR Pro Rata Portion of the Offered Stock by delivering a written notice to the Company and the Offering Stockholder (an “Applicable ROFR Rightholder Exercise Notice) specifying its desire to purchase its ROFR Pro Rata Portion of the Offered Stock, on the terms and applicable purchase price(s) set forth in the ROFR Notice. The Applicable ROFR Rightholder Exercise Notice shall be binding upon delivery and irrevocable by the Applicable ROFR Rightholder. 

(iii)If the Applicable ROFR Rightholders pursuant to Section 4.03(d)(ii) do not, in the aggregate, elect to purchase all of the Offered Stock, each Applicable ROFR Rightholder electing pursuant to Section 4.03(d)(ii) to purchase  


 


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its entire ROFR Pro Rata Portion of the Offered Stock (each, an “Exercising Applicable ROFR Rightholder) shall have the right to purchase all or any portion of the remaining Offered Stock not elected to be purchased by the Applicable ROFR Rightholders. As promptly as practicable following the Applicable ROFR Rightholder Exercise Period, the Offering Stockholder shall deliver a written notice to each Exercising Applicable ROFR Rightholder (an “Exercising Applicable ROFR Rightholder Notice”) stating the number of shares of remaining Offered Stock available for purchase following the Applicable ROFR Rightholder Exercise Period. For a period of ten (10) Business Days following the receipt of an Exercising Applicable ROFR Rightholder Notice (such period, the “Exercising Applicable ROFR Rightholder Option Period”), each Exercising Applicable ROFR Rightholder shall have the right to elect to purchase all or any portion of the remaining Offered Stock by delivering a written notice to the Company and the Offering Stockholder (an “Exercising Applicable ROFR Rightholder Exercise Notice”) specifying the number of additional remaining Offered Stock it desires to purchase on the terms and applicable purchase price set forth in the ROFR Notice. The Exercising Applicable ROFR Rightholder Exercise Notice shall be binding upon delivery and irrevocable by the Exercising Applicable ROFR Rightholder.

(iv)The failure of any Applicable ROFR Rightholder to deliver an Applicable ROFR Rightholder Exercise Notice, respectively, by the end of the Applicable ROFR Rightholder Option Period, respectively, shall constitute a waiver of the applicable rights of first refusal under this Section 4.03 with respect to the Transfer of the Offered Stock, but shall not affect their respective rights with respect to any future Transfers. 

(e)Allocation of Offered Stock. Upon the expiration of the Applicable ROFR Rightholder Option Period or, if applicable, the expiration of the Exercising Applicable ROFR Rightholder Option Period, the Offered Stock shall be allocated for purchase among the Exercising Applicable ROFR Rightholders, as follows: 

(i)First, to each Exercising Applicable ROFR Rightholder having elected pursuant to Section 4.03(d)(ii) to purchase its entire ROFR Pro Rata Portion of the Offered Stock, such Applicable ROFR Rightholder’s ROFR Pro Rata Portion of such Offered Stock; and 

(ii)Second, the balance, if any, not allocated under clause (i) above shall be allocated to those Exercising Applicable ROFR Rightholders electing pursuant to Section 4.03(d)(iii) to purchase a number of remaining Offered Stock exceeding their respective ROFR Pro Rata Portions, in an amount, with respect to each such Exercising Applicable ROFR Rightholder, that is equal to the lesser of: 

(A)the number of such remaining Offered Stock that such Exercising Applicable ROFR Rightholder elected to purchase in excess of its applicable ROFR Pro Rata Portion; and 


 


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(B)the product of (1) the number of the remaining Offered Stock not allocated under Section 4.03(e)(i) multiplied by (2) a fraction, the numerator of which is the number of such remaining Offered Stock that such Exercising Applicable ROFR Rightholder was permitted to purchase pursuant to Section 4.03(e)(i), and the denominator of which is the aggregate number of such remaining Offered Stock that all Exercising Applicable ROFR Rightholders were permitted to purchase pursuant to Section 4.03(e)(i) 

provided, that if following the allocation under this Section 4.03(e)(ii) there are any remaining unallocated shares of remaining Offered Stock, those shares shall be allocated to those Exercising Applicable ROFR Rightholders who have not yet been allocated their full share election of such remaining Offered Shares made pursuant to Section 4.03(d)(iv) pro rata based on the number of remaining shares of Offered Stock elected to be purchased by those Exercising Applicable ROFR Rightholders until either no Offered Stock remains or until such time as all Exercising Applicable ROFR Rightholders have been permitted to purchase all Offered Stock that they elected to purchase. 

(f)Consummation of Sale to the Applicable ROFR Rightholders. In the event that the Applicable ROFR Rightholders shall have, in the aggregate, exercised their respective rights to purchase any of the Offered Stock, then the Offering Stockholder shall sell such Offered Stock to the Applicable ROFR Rightholders, and the Applicable ROFR Rightholders shall purchase such Offered Stock, within sixty (60) days following the expiration of the Applicable ROFR Rightholder Option Period or, if applicable, the Exercising Applicable ROFR Rightholder Option Period (either of which period may be extended for a reasonable time not to exceed ninety (90) days to the extent reasonably necessary to obtain required approvals or consents from any Governmental Authority). Each Stockholder shall take all actions as may be reasonably necessary to consummate the sale contemplated by this Section 4.03(f), including, without limitation, entering into agreements and delivering certificates and instruments and consents as may be deemed necessary or appropriate. At the closing of any sale and purchase pursuant to this Section 4.03(f), the Offering Stockholder shall deliver to the participating Applicable ROFR Rightholders certificates (if any) representing the Offered Stock to be sold, free and clear of any liens or encumbrances (other than those contained in this Agreement), accompanied by evidence of transfer and all necessary transfer taxes paid and stamps affixed, if necessary, against receipt of the purchase price therefor from such Applicable ROFR Rightholders by certified or official bank check or by wire transfer of immediately available funds. 

(g)Sale to Proposed Purchaser. In the event that the Applicable ROFR Rightholders shall not have collectively elected to purchase all of the Offered Stock, then, provided that the Offering Stockholder has also complied with the provisions of Section 4.04 and Section 4.01, to the extent applicable, the Offering Stockholder may Transfer such Offered Stock not elected to be purchased by the Applicable ROFR Rightholders, at a price per share not less than that specified in the ROFR Notice and on other terms and conditions which are not materially more favorable in the aggregate to the Prospective Transferee than  


 


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those specified in the ROFR Notice, but only to the extent that such Transfer occurs within ninety (90) days after expiration of the Applicable ROFR Rightholder Option Period or, if applicable, the Exercising Applicable ROFR Rightholder Option Period. Any Offered Stock not Transferred within such 90-day period will be subject to the provisions of this Section 4.03 upon subsequent Transfer.

Section 4.04  Tag-along Right. 

(a)Participation on Sale of Stock. Subject to the terms and conditions specified in Section 4.01 and Section 4.03, if a Selling Stockholder proposes to Transfer any Company Securities (the Tag-along Stock”) to any Person, each Tag-along Stockholder shall be permitted to participate in such sale (a “Tag-along Sale”) on the terms and conditions set forth in this Section 4.04.  This participation right and the terms and conditions set forth in this Section 4.04 shall be applied separately on a class-by-class and series-by-series basis for each class or series of Tag-along Stock, as applicable, with the Company Securities and shares of Capital Stock treated as separate classes of Tag-along Stock in any Tag-along Sale, subject to Section 4.01(e). 

(b)Tag-along Sale Exceptions. Notwithstanding anything herein to the contrary, the provisions of this Section 4.04 shall not apply to any Transfer of Tag-along Stock that is: 

(i)permitted by and made in accordance with Section 4.02;  

(ii)made to any Applicable ROFR Rightholder pursuant to the exercise of the rights set forth in Section 4.03; or 

(iii)proposed to be made by a Dragging Stockholder or required to be made by a Drag-along Stockholder pursuant to Section 4.05.  

(c)Tag-along Notice. The Selling Stockholder shall deliver to the Company and each other Tag-along Stockholder a written notice (a “Tag-along Notice”) of the proposed Tag-along Sale within (i) five (5) Business Days following the expiration of the Applicable ROFR Rightholder Option Period or, if applicable, the Exercising Applicable ROFR Rightholder Option Period, in the event that the Applicable ROFR Rightholders shall not have, in the aggregate, exercised their respective rights to purchase all of the Offered Stock pursuant to Section 4.03, or (ii) twenty (20) Business Days prior to the consummation of any Tag-along Sale which was not subject to Section 4.03.  

The Tag-along Notice shall make reference to the Tag-along Stockholders’ rights hereunder and shall describe in reasonable detail:

(i)The number of shares of each class or series of Tag-along Stock the Selling Stockholder proposes to Transfer; 

(ii)The identity of the Prospective Transferee(s); 


 


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(iii)The proposed date, time and location of the closing of the Tag-along Sale, which shall not be less than twenty (20) Business Days from the date of the Tag-along Notice;  

(iv)The purchase price per share of each class or series of Tag-along Stock (which shall be payable solely in cash) and the other material terms and conditions of the Transfer; and 

(v)A copy of any form of agreement proposed to be executed in connection therewith. 

(d)Exercise of Tag-along Right. 

(i) Each Tag-along Stockholder may exercise its right to participate in the Tag-along Sale on the terms described in the Tag-along Notice by delivering to the Selling Stockholder a written notice (a “Tag-along Exercise Notice”) stating its election to do so no later than ten (10) Business Days after receipt of the Tag-along Notice (the “Tag-along Exercise Period”). The election of each Tag-along Stockholder set forth in a Tag-along Exercise Notice shall be irrevocable, and, to the extent the offer in the Tag-along Notice is accepted, such Tag-along Stockholder shall be bound and obligated to consummate the Transfer on the terms and conditions set forth in this Section 4.04. If one or more Tag-along Stockholders elects pursuant to a Tag-along Exercise Notice and this Section 4.04(d)(i) to participate in the Tag-along Sale, the number of each applicable class or series of Tag-along Stock that the Selling Stockholder may sell in the Tag-along Sale shall be correspondingly reduced in accordance with Section 4.04(d)(ii). 

(ii)The Selling Stockholder and each Tag-along Stockholder timely electing to participate in the Tag-along Sale pursuant to Section 4.04(d)(i) shall have the right to Transfer in the Tag-along Sale the number of Tag-along Stock set out in the applicable Tag-along Notice, equal to the product of (A) the aggregate number of Tag-along Stock set out in the Tag-along Notice and (B) such Stockholder’s Tag-along Pro Rata Portion of Tag-along Stock. Any Tag-along Stockholder may elect to sell in the Tag-along Sale less than the number of Company Securities calculated pursuant to this Section 4.04(d)(ii) of Tag-along Stock, in which case the Selling Stockholder shall have the right to sell the applicable Tag-along Stock not elected to be sold by a Tag-along Stockholder. 

(e)Waiver. Each Tag-along Stockholder who does not deliver a Tag-along Exercise Notice in compliance with Section 4.04(d)(i) shall be deemed to have waived all of such Tag-along Stockholder’s rights to participate in the Tag-along Sale with respect to the Company Securities owned by such Tag-along Stockholder, and the Selling Stockholder shall (subject to the rights of any other participating Tag-along Stockholder) thereafter be free to sell to the prospective Transferee the Tag-along Stock identified in the Tag-along Notice at a per share price that is no greater than the per share price set forth in the Tag-along Notice and on other terms and conditions which are not materially more  


 


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favorable to the Selling Stockholder than those set forth in the Tag-along Notice, without any further obligation to the non-accepting Tag-along Stockholders.

(f)Conditions of Sale. 

(i)Each Stockholder participating in the Tag-along Sale shall receive the same consideration per share of each class or series of Tag-along Stock, after deduction of such Stockholder’s proportionate share of the related expenses in accordance with Section 4.04(h) below; provided, that, the aggregate consideration payable in the Tag-along Sale shall be allocated among the applicable classes or series of Tag-along Stock in accordance with the liquidation preferences and other priorities of the applicable classes or series of Tag-along Stock. In addition, no Transfer of any Tag-along Stock by the Selling Stockholder in the Tag-along Sale shall occur unless the prospective Transferee simultaneously purchases the Company Securities elected to be sold by the Tag-along Stockholders pursuant to Section 4.04(d)(i) and if any such Transfer is in violation of this Section 4.04, it shall be null and void in accordance with the provisions of Section 4.01(e) hereof.  

(ii)Each Tag-along Stockholder shall execute the applicable purchase agreement, if any, and shall make or provide the same representations, warranties, covenants and indemnities as the Selling Stockholder makes or provides in connection with the Tag-along Sale; provided, that each Tag-along Stockholder shall only be obligated to make representations and warranties that relate specifically to a Stockholder (as opposed to the Company and its business) with respect to the Tag-along Stockholder’s title to and ownership of the applicable Company Securities, authorization, execution and delivery of relevant documents, enforceability of such documents against the Tag-along Stockholder, and other similar representations and warranties made by the Selling Stockholder, and shall not be obligated to make any of the foregoing representations and warranties with respect to any other Stockholder or their Company Securities; provided, further, that all indemnities and other obligations shall be made by the Selling Stockholder and each Tag-along Stockholder severally and not jointly and severally (A) with respect to breaches of representations, warranties and covenants made by the Selling Stockholder and the Tag-along Stockholders relating to the Company and its business, if any, pro rata based on the aggregate consideration received by the Selling Stockholder and each Tag-along Stockholder in the Tag-along Sale, and (B) in an amount not to exceed for the Selling Stockholder or any Tag-along Stockholder, the net proceeds received by the Selling Stockholder and each such Tag-along Stockholder in connection with the Tag-along Sale, as applicable, plus the amount of any consideration forfeited by the Selling Stockholder or such Tag-along Stockholder, as applicable, to which it is entitled but has not yet received (including, without limitation, as a result of an escrow agreement, earn-out or similar arrangement). 

(g)Cooperation. Subject to Section 4.04(g)(ii), each Tag-along Stockholder shall take all actions as may be reasonably necessary to consummate the Tag-along Sale,  


 


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including, without limitation, entering into agreements and delivering certificates and instruments (including stock certificates evidencing the applicable shares of Capital Stock, duly endorsed in blank or accompanied by stock powers or other instruments of transfer duly executed in blank), in each case, consistent with the agreements being entered into and the certificates and instruments being delivered by the Selling Stockholder.

(h)Expenses. The fees and expenses of the Selling Stockholder incurred in connection with a Tag-along Sale and for the benefit of all Tag-along Stockholders (it being understood that costs incurred by or on behalf of a Selling Stockholder for its sole benefit will not be considered to be for the benefit of all Tag-along Stockholders), to the extent not paid or reimbursed by the Company or the prospective Transferee, shall be shared by the Selling Stockholder and all the participating Tag-along Stockholders on a pro rata basis, based on the aggregate consideration received by each such Stockholder; provided, that no Tag-along Stockholder shall be obligated to make any out-of-pocket expenditure prior to the consummation of the Tag-along Sale. 

(i)Consummation of Sale. Subject to the requirements and conditions of this Section 4.04 and the other applicable provisions of this Agreement, including Section 4.01 hereof, the Selling Stockholder shall have sixty (60) days following the expiration of the Tag-along Exercise Period in which to consummate the Tag-along Sale, on terms not more favorable to the Selling Stockholder than those set forth in the Tag-along Exercise Notice (which 60-day period may be extended for a reasonable time not to exceed ninety (90) days to the extent reasonably necessary to obtain required approvals or consents from any Governmental Authority). If at the end of such period the Selling Stockholder has not completed the Tag-along Sale, the Selling Stockholder may not then effect a Transfer that is subject to this Section 4.04 without again fully complying with the provisions of this Section 4.04. At the closing of the Tag-along Sale, each of the Tag-along Stockholders timely electing to participate in the Tag-along Sale pursuant to Section 4.04(d)(i) shall enter into the agreements and deliver the certificates and instruments, in each case, required by Section 4.04(g) and Section 4.04(h) against payment therefor directly to the Tag-along Stockholder of the portion of the aggregate consideration to which each such Tag-along Stockholder is entitled in the Tag-along Sale in accordance with the provisions of this Section 4.04.  

(j)Transfers in Violation of the Tag-along Right. If the Selling Stockholder sells or otherwise Transfers to the prospective Transferee any of its Company Securities in breach of this Section 4.04, then each Tag-along Stockholder shall have the right to sell to the Selling Stockholder, and the Selling Stockholder undertakes to purchase from each Tag-along Stockholder, the number of each class or series of Company Securities or that such Tag-along Stockholder would have had the right to sell to the prospective Transferee pursuant to this Section 4.04 for a per share amount and form of consideration and upon the terms and conditions on which the prospective Transferee bought such shares from the Selling Stockholder, but without indemnity being granted by any Tag-along Stockholder to the Selling Stockholder; provided, that nothing contained in this Section 4.04(k) shall preclude any Stockholder from seeking alternative remedies against such Selling Stockholder as a result of its breach of this Section 4.04. The Selling Stockholder shall also  


 


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reimburse each Tag-along Stockholder for any and all reasonable and documented out-of-pocket fees and expenses, including reasonable legal fees and expenses, incurred pursuant to the exercise or the attempted exercise of the Tag-along Stockholder’s rights under this Section 4.04(k).

Section 4.05  Drag-along Rights. 

(a)Participation. If, during any time Pernix beneficially owns less than 49.9% of the Capital Stock, the 1992 Funds and the Whitebox Funds and their Permitted Transferees (such Stockholder(s), the “Dragging Stockholder”), proposes to consummate, in one transaction or a series of related transactions, a Change in Control involving (i) a sale of all or substantially all of the consolidated assets of the Company and the Company Subsidiaries, (ii) a merger, consolidation, recapitalization, or reorganization of the Company involving 100% of the Capital Stock, or (iii) the Transfer of 100% of the Capital Stock (a “Drag-along Sale”), the Dragging Stockholder shall have the right, after delivering the Drag-along Notice in accordance with Section 4.05(c) and subject to compliance with Section 4.05(b) and Section 4.05(d), to require that each other Stockholder (each, a “Drag-along Stockholder”) participate in such Drag-along Sale on substantially the same terms and conditions as the Dragging Stockholder and in the manner set forth in Section 4.05(b). 

(b)Sale of Stock; Sale of Assets. Subject to compliance with Section 4.05(d): 

(i)If the Drag-along Sale is structured as a Change in Control involving the Transfer of Capital Stock, each Drag-along Stockholder shall sell and Transfer, all of their shares of Capital Stock.  

(ii)If the Drag-along Sale is structured as a sale of all or substantially all of the consolidated assets of the Company and the Company Subsidiaries or as a merger, consolidation, recapitalization, or reorganization of the Company or other transaction requiring the consent or approval of the Stockholders, then notwithstanding anything to the contrary in this Agreement, each Drag-along Stockholder shall (A) vote (in person, by proxy or by written consent, as requested) all of its voting securities in favor of the Drag-along Sale (and any related actions necessary to consummate such sale) and otherwise consent to and raise no objection to such Drag-along Sale and such related actions and (B) refrain from taking any actions to exercise, and shall take all actions to waive, any dissenters’, appraisal or other similar rights that it may have in connection with such transaction.  

(c)Drag-along Notice. The Dragging Stockholder shall exercise its rights pursuant to this Section 4.05 by delivering a written notice (the “Drag-along Notice”) to the Company and each Drag-along Stockholder no more than ten (10) Business Days after the execution and delivery by all of the parties thereto of the definitive agreement entered into with respect to the Drag-along Sale and, in any event, no later than twenty (20) Business Days prior to the closing date of such Drag-along Sale. The Drag-along Notice  


 


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shall make reference to the Dragging Stockholders’ rights and obligations hereunder and shall describe in reasonable detail:

(i)The name(s) of the purchaser; 

(ii)The proposed date, time and location of the closing of the Drag-along Sale; 

(iii)The proposed amount of consideration in the Drag-along Sale, including, if applicable, the purchase price per Company Security to be sold and the other material terms and conditions of the Drag-along Sale; and 

(iv)A copy of any form of agreement proposed to be executed in connection therewith. 

(d)Conditions of Sale. The obligations of the Drag-along Stockholders in respect of a Drag-along Sale under this Section 4.05 are subject to the satisfaction of the following conditions: 

(i)The consideration to be received by each Drag-along Stockholder shall be the same form and amount of consideration to be received by the Dragging Stockholder per Company Security and the terms and conditions of such sale shall, except as otherwise provided in Section 4.05(d)(iii), be the same as those upon which the Dragging Stockholder sells its Company Securities; provided, that this Section 4.05(d)(i) condition shall be deemed satisfied even if only Stockholders qualifying as “accredited investors” (as defined in Rule 501 of Regulation D promulgated under the Securities Act), to the exclusion of Stockholders who either do not qualify as accredited investors or would otherwise cause the registration under applicable federal securities laws of securities issued to such Stockholder in the Drag-along Sale, receive securities of the purchaser in the Drag-along Sale, so long as the Dragging Stockholder and each Drag-along Stockholder receive the same value (as determined in good faith by the Board), whether in cash or such securities, as of the closing of the Drag-along Sale with respect to each such Stockholder’s applicable Company Security; 

(ii)If the Dragging Stockholder or any Drag-along Stockholder is given an option as to the form and amount of consideration to be received, the same option shall be given to all Drag-along Stockholders; provided, that this Section 4.05(d)(ii) condition shall be deemed satisfied even if only Stockholders qualifying as “accredited investors” (as defined in Rule 501 of Regulation D promulgated under the Securities Act), to the exclusion of Stockholders who either do not qualify as accredited investors or would otherwise cause the registration under applicable federal securities laws of securities issued to such Stockholder in the Drag-along Sale, receive an option to receive securities of the purchaser in the Drag-along Sale, so long as the Dragging Stockholder and each Drag-along Stockholder receive the same value (as determined in good faith by the Board), whether in cash or such  


 


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securities, as of the closing of the Drag-along Sale with respect to each such Stockholder’s applicable Company Security;

(iii)Each Drag-along Stockholder shall execute the applicable purchase agreement (and any related ancillary agreements entered into by the Dragging Stockholder in connection with the Drag-along Sale) and make or provide the same representations, warranties, covenants, indemnities (directly to the third-party purchaser and/or indirectly pursuant to a contribution agreement, as required by the Dragging Stockholder), purchase price adjustments, escrows and other obligations as the Dragging Stockholder makes or provides in connection with the Drag-along Sale.  Notwithstanding the foregoing, Pernix shall not be required to agree to any non-compete, non-solicit or any other restrictive covenant in connection with the Drag-along Sale, except to the extent provided for in the Services Agreement on the same terms as the Services Agreement; and 

(iv)if the Dragging Stockholder enters into any negotiation or transaction for which Rule 506 under the Securities Act (or any similar rule then in effect) may be available with respect to such negotiation or transaction (including a merger, consolidation, recapitalization or other reorganization), each Drag-along Stockholder who is not an “accredited investor” (as defined in Rule 501 of Regulation D promulgated under the Securities Act) shall, at the request of the Company, appoint a “purchaser representative” (as defined in Rule 501 of Regulation D promulgated under the Securities Act) designated by the Company, the fees and expenses of which shall be borne by the Dragging Stockholder. 

(e)Cooperation. Each Drag-along Stockholder shall take all actions as may be reasonably necessary to consummate the Drag-along Sale, including, without limitation, entering into agreements and delivering certificates and instruments, in each case, consistent with the agreements being entered into and the certificates being delivered by the Dragging Stockholder. 

(f)Fees and Expenses. The fees and expenses of the Dragging Stockholder (either directly or indirectly by the Company and any Company Subsidiary) incurred in connection with a Drag-along Sale and for the benefit of all Drag-along Stockholders, to the extent not paid or reimbursed by the Company, any Company Subsidiary or the purchaser, shall be shared by the Dragging Stockholder and all the Drag-along Stockholders on a pro rata basis, based on the aggregate consideration received by each such Stockholder in the Drag-along Sale. 

(g)Consummation of Sale. The Dragging Stockholder shall have ninety (90) days following the date of the Drag-along Notice in which to consummate the Drag-along Sale, on the terms set forth in the Drag-along Notice (which 90-day period may be extended for a reasonable time not to exceed one-hundred and twenty (120) days to the extent reasonably necessary to obtain required approvals or consents from any Governmental Authority). If at the end of such period the Dragging Stockholder has not completed the  


 


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Drag-along Sale, the Dragging Stockholder may not then exercise its rights under this Section 4.05 without again fully complying with the provisions of this Section 4.05.

Section 4.06   Pernix Purchase Option.

(a)[***], Pernix may elect from time to time, at its sole discretion, for all other Stockholders to Transfer Company Securities to Pernix for an aggregate amount for each such Transfer equal to the First Purchase Option Purchase Price; provided that (w) in no event shall such other Stockholders be required to Transfer Company Securities to Pernix under this Section 4.06(a) that would result in Pernix owning more than 49.9% of the Capital Stock at any time prior to [***], (x) any such Transfer of Company Securities shall be made by the Stockholders (other than Pernix) on a pro rata basis, (y) Section 4.01(e) shall apply, and (z) the First Purchase Option Purchase Price shall be distributed among the Stockholders (other than Pernix) on a pro rata basis (based on their proportionate ownership of the Company Securities), or as otherwise mutually agreed by the Stockholders (other than Pernix).  

(b)[***], Pernix may elect, at its sole discretion, for all other Stockholders to Transfer Company Securities to Pernix for an aggregate amount equal to the Second Purchase Option Purchase Price; provided that (x) in no event shall such other Stockholders be required to Transfer Company Securities to Pernix under this Section 4.06(b) unless such Transfer is for 100% of the Company Securities held by each of such other Stockholders at such time and (y) the Second Purchase Option Purchase Price shall be distributed among the Stockholders (other than Pernix) on a pro rata basis (based on their proportionate ownership of the Company Securities), or as otherwise mutually agreed by the Stockholders (other than Pernix).  

(c)In connection with Pernix’s exercise of the purchase options under Section 4.06, each Stockholder (including Pernix) shall be required to pay a pro rata portion (based on each Stockholder’s proportionate ownership of the Capital Stock as of immediately prior to the exercise of the purchase option under this Section 4.06) of, or the Stockholders shall cause the Company to pay, any amounts that may become payable as a result of or in connection with the exercise of such purchase option under any management incentive plan of the Company then in effect.   

(d)Notwithstanding anything to the contrary herein, Pernix’s right to purchase Company Securities from the other Stockholders pursuant to this Section 4.06 shall terminate upon the termination or expiration of the Services Agreement for any reason in accordance with its terms. 

(e)An example of the calculation of Pernix’s purchase options under this Section 4.06 is set forth on Exhibit C hereto.  

ARTICLE V

CONVENANTS


 


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Section 5.01  Other Business Activities..  The parties hereto, including the Company, expressly acknowledge and agree that: (i) the 1992 Funds, the Whitebox Funds, the HB Directors, and the HB/WB Directors and their Affiliates, and, subject to its obligations in Section 5.03 of the Services Agreement, Pernix, the Pernix Directors and their Affiliates are permitted to have, and may presently or in the future have, investments or other business or strategic relationships, ventures, agreements or other arrangements with entities other than the Company or any Company Subsidiary that are engaged in the business of the Company or any Company Subsidiary, or that are or may be competitive with the Company or any Company Subsidiary (any such other investment or relationship, an “Other Business”); (ii) none of the 1992 Funds and the Whitebox Funds and their Affiliates and, subject to its obligations in Section 5.03 of the Services Agreement, Pernix and its Affiliates, will be prohibited by virtue of such Person’s investment in the Company from pursuing and engaging in any Other Business; (iii) none of the 1992 Funds, the Whitebox Funds, the HB Directors, and the HB/WB Directors, or their Affiliates, or, subject to its obligations in Section 5.03 of the Services Agreement, Pernix, the Pernix Directors or their Affiliates, will be obligated to inform the Company or any other Stockholder of any opportunity, relationship or investment in any Other Business (a “Company Opportunity”) or to present any Company Opportunity to the Company, and the Company hereby renounces any interest in any Company Opportunity and any expectancy that a Company Opportunity will be offered to it; (iv) nothing contained herein shall limit, prohibit or restrict any HB Director or HB/WB Director, or, subject to Pernix’s obligations in Section 5.03 of the Services Agreement, any Pernix Director, from serving on the board of directors or other governing body or committee of any Other Business; and (v) no other Stockholder will acquire, be provided with an option or opportunity to acquire, or be entitled to any interest or participation in any Other Business as a result of the participation therein of any of the 1992 Funds and the Whitebox Funds and their Affiliates or Pernix and its Affiliates. The parties hereto expressly authorize and consent to the involvement of the 1992 Funds and the Whitebox Funds and their Affiliates, and, subject to its obligations in Section 5.03 of the Services Agreement, Pernix and its Affiliates, in any Other Business; provided, that any transactions between the Company and/or the Company Subsidiaries and an Other Business will be on terms no less favorable to the Company and/or the Company Subsidiaries than would be obtainable in a comparable arm’s-length transaction and shall be subject to Section 2.03(b)(vi)(c)(4). The parties hereto expressly waive, to the fullest extent permitted by Applicable Law, any rights to assert any claim that such involvement breaches any fiduciary or other duty or obligation owed to the Company or any Stockholder or to assert that such involvement constitutes a conflict of interest by such Persons with respect to the Company any Stockholder.  Nothing herein shall limit the parties’ obligations under Section 5.02.

 

Section 5.02   Confidentiality.

 

(a)Each Stockholder acknowledges that during the term of this Agreement, it may have access to and become acquainted with trade secrets, proprietary information and confidential information belonging to the Company, the Company Subsidiaries and their Affiliates that are not generally known to the public, including, but not limited to, information concerning business plans, financial statements and other information provided pursuant to this Agreement, operating practices and methods, expansion plans,  


 


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strategic plans, marketing plans, contracts, customer lists or other business documents which the Company treats as confidential, in any format whatsoever (including oral, written, electronic or any other form or medium) (collectively, “Confidential Information”). In addition, each Stockholder acknowledges that: (i) the Company has invested, and continues to invest, substantial time, expense and specialized knowledge in developing its Confidential Information; (ii) the Confidential Information provides the Company with a competitive advantage over others in the marketplace; and (iii) the Company would be irreparably harmed if the Confidential Information were disclosed to competitors or made available to the public. Without limiting the applicability of any other agreement to which any Stockholder is subject, no Stockholder shall, directly or indirectly, disclose or use (other than solely for the purposes of such Stockholder monitoring and analyzing his investment in the Company or performing its duties as a Director, officer, employee, or consultant of the Company) at any time, including, without limitation, use for personal, commercial or proprietary advantage or profit, either during such Stockholder’s association or employment with the Company or thereafter, any Confidential Information of which such Stockholder is or becomes aware. Each Stockholder in possession of Confidential Information shall take all appropriate steps to safeguard such information and to protect it against disclosure, misuse, espionage, loss and theft.

(b)Nothing contained in Section 5.02(a) shall prevent any Stockholder from disclosing Confidential Information: (i) upon the order of any court or administrative agency; (ii) upon the request or demand of any regulatory agency or authority having jurisdiction over such Stockholder; (iii) to the extent compelled by legal process or required or requested pursuant to subpoena, interrogatories or other discovery requests; (iv) as, on the advice of such Stockholder’s counsel, is necessary or advisable to comply with Applicable Law (including securities laws) or rules or regulations of any nationally recognized United States or foreign securities exchange, (v) to the extent necessary in connection with the exercise of any remedy under this Agreement; (vi) to such Stockholder’s Representatives who, in the reasonable judgment of such Stockholder, need to know such Confidential Information and agree to be bound by the provisions of this Section 5.02 as if a Stockholder; (vii) to any potential Permitted Transferee in connection with a proposed Transfer of shares of Capital Stock from such Stockholder or (viii) in connection with a proposed Transfer of shares of Capital Stock from such Stockholder or a Change in Control pursuant to Section 4.03, Section 4.04, or Section 4.05 to a Proposed Transferee as long as such Proposed Transferee agrees to be bound by the provisions of this Section 5.02 as if a Stockholder and enters into a confidentiality agreement in form and substance reasonably acceptable to the Company and such Confidential Information may be made available to such potential Proposed Transferee via a restricted website; provided, that in the case of clause (i), (ii) (iii) or (iv), such Stockholder shall provide the Company with prompt written notice of any such requirement so long as it is not legally prohibited from doing so, so that the Company may seek a protective order or other appropriate remedy and/or waive compliance with this Agreement.  If, in the absence of a protective order or other remedy or the receipt of a waiver from the Company, such Stockholder is nonetheless required to disclose any of the Confidential Information, such Stockholder may, without liability hereunder, disclose only that portion of the Confidential  


 


[***] Certain information in this document has been omitted and filed separately with the Securities and Exchange Commission. Confidential treatment has been requested with respect to the omitted portions.


Information which such Stockholder is required to disclose, provided, that such Stockholder will reasonably cooperate with the Company, at the Company’s sole expense, in obtaining an appropriate protective order or other reliable assurance that confidential treatment will be accorded the Confidential Information.

(c)The restrictions of Section 5.02(a) shall not apply to Confidential Information that: (i) is or becomes generally available to the public other than as a result of a disclosure by a Stockholder in violation of this Agreement; (ii) is or becomes available to a Stockholder or any of its Representatives on a non-confidential basis prior to its disclosure to the receiving Stockholder and any of its Representatives in compliance with this Agreement; (iii) is or has been independently developed or conceived by such Stockholder without use of, reliance on or reference to the Confidential Information; or (iv) becomes available to the receiving Stockholder or any of its Representatives on a non-confidential basis from a source other than the Company, any other Stockholder or any of their respective Representatives; provided, that such source is not known by the recipient of the Confidential Information to be bound by a confidentiality agreement or other duty with the disclosing Stockholder or any of its Representatives. 

(d)Notwithstanding anything in this Agreement to the contrary, in no event shall any Stockholder disclose any Confidential Information to any Company Competitor. 

Section 5.03  Financial Statements. The Company shall furnish to each Stockholder the following reports:

(a)Annual Financial Statements. As soon as available, and in any event within one hundred twenty (120) days after the end of each Fiscal Year, audited consolidated balance sheets of the Company and any Company Subsidiaries as at the end of each such Fiscal Year and audited consolidated statements of income, cash flows and stockholders’ equity for such Fiscal Year, in each case setting forth in comparative form the figures for the previous Fiscal Year and for the Budget for such Fiscal Year, accompanied by the certification of independent certified public accountants of recognized national standing selected by the Board, certifying to the effect that, except as set forth therein, such financial statements have been prepared in accordance with GAAP, and fairly present in all material respects the financial condition of the Company and Company Subsidiaries as of the dates thereof and the results of their operations and changes in their cash flows and stockholders’ equity for the periods covered thereby. 

(b)Quarterly Financial Statements. As soon as available, and in any event within forty-five (45) days after the end of each quarterly accounting period in each Fiscal Year (other than the last fiscal quarter of the Fiscal Year), unaudited consolidated balance sheets of the Company and Company Subsidiaries as at the end of each such fiscal quarter and for the current Fiscal Year to date and unaudited consolidated statements of income, cash flows and stockholders’ equity for such fiscal quarter and for the current  Fiscal Year to date, in each case setting forth in comparative form the figures for the corresponding periods of the previous Fiscal Year and for the Budget for such Fiscal Year, all in  


 


[***] Certain information in this document has been omitted and filed separately with the Securities and Exchange Commission. Confidential treatment has been requested with respect to the omitted portions.


reasonable detail and all prepared in accordance with GAAP, consistently applied (subject to normal year-end audit adjustments and the absence of notes thereto), and certified by the principal financial or accounting officer of the Company.

(c)Monthly Financial Statements. As soon as available, and in any event within thirty (30) days after the end of each monthly accounting period in each fiscal quarter (other than the last month of the fiscal quarter), unaudited consolidated balance sheets of the Company and Company Subsidiaries as at the end of each such monthly period and unaudited consolidated statements of income, cash flows for each such monthly period, all in reasonable detail and all prepared in accordance with GAAP, consistently applied (subject to normal year-end audit adjustments and the absence of notes thereto). 

(d)Budget. Not later than fifteen (15) days prior to the commencement of each calendar year, a business plan and quarterly and annual operating budgets for the Company and Company Subsidiaries for the upcoming Fiscal Year, including capital and operating expense budgets, cash flow projections, and profit and loss projections, all itemized in reasonable detail shall be submitted to the Board for its approval (the “Budget”), and as promptly as practicable upon preparation thereof (but in any event, no later than ten (10) Business Days thereafter), any other significant budgets prepared by the Company and any revisions of the Budget or such other budgets; provided that the time frame for preparing the Budget for the remainder of the 2018 calendar year shall be as set forth in the Services Agreement.  

(e)Election to Receive Information.  At any time, a Stockholder may elect not to receive, or participate in, the distribution of any information that the Stockholder otherwise has a right to receive pursuant to this Section 5.03; provided that the election not to receive any specified information will not be a waiver of such Stockholder’s right to receive any other information required or permitted to be distributed to the Stockholders. 

Section 5.04 Inspection Rights. Upon reasonable notice from a Stockholder, the Company shall, and shall cause its directors, officers and employees to, afford each Stockholder and its Representatives reasonable access during normal business hours to (i) the Company’s and the Company Subsidiaries’ properties, offices, plants and other facilities, (ii) the corporate, financial and similar records, reports and documents of the Company and the Company Subsidiaries, including, without limitation, all books and records, minutes of proceedings, internal management documents, reports of operations, reports of adverse developments, copies of any management letters and communications with stockholders, and to permit each Stockholder and its Representatives to examine such documents and make copies thereof, and (iii) the Company’s and the Company Subsidiaries’ officers, senior employees and public accountants, and to afford each Stockholder and its Representatives the opportunity to discuss and advise on the affairs, finances and accounts of the Company and the Company Subsidiaries with their officers, senior employees and public accountants (and the Company hereby authorizes said accountants to discuss with such Stockholder and its Representatives such affairs, finances and accounts).

Section 5.05   Distributions


 


[***] Certain information in this document has been omitted and filed separately with the Securities and Exchange Commission. Confidential treatment has been requested with respect to the omitted portions.


(a) Each of the Company and each Stockholder hereby agrees that upon (x) a Change in Control involving (i) a sale of all or substantially all of the consolidated assets of the Company and the Company Subsidiaries, (ii) a merger, consolidation, recapitalization, or reorganization of the Company involving 100% of the Capital Stock, or (iii) the Transfer of 100% of the Capital Stock, (y) a Drag-along Sale or (z) a dissolution, liquidation or winding of the Company (each of the events in clauses (x), (y) and (z), a “Trigger Event”), any net proceeds received by the Company from third parties and/or any distributions from the Company (the “Sale Proceeds”), whether in the form of cash, securities or other types of assets, shall be distributed in the following manner, and each Stockholder hereby agrees to take all action, provide all approvals and execute all agreements, including any purchase or acquisition agreement, in order to cause the Sale Proceeds to be distributed in the following manner:

(i)(A) all indebtedness for borrowed money of the Company shall be repaid, and (B) (1) each Stockholder’s Debt Commitments minus (2) all Distributions received by such Stockholder with respect to such Debt Commitments prior to such time plus (3) the amount of accrued and unpaid interest on its Debt Commitments (to the extent the Sale Proceeds are insufficient to make the payment pursuant to this clause (i)(B), then each Stockholder shall receive its ratable share of the Sale Proceeds); in each case, in the order of priority of such indebtedness, including the Debt Commitments, shall be repaid; 

(ii)each Stockholder shall receive an amount equal to (A) its Equity Commitment minus (B) all Distributions with respect to such Equity Commitments received by such Stockholder prior to such time (excluding, for the avoidance of doubt, any Distributions deducted in clause (i)(B)(2)) plus (C) the amount of the Pernix Promote paid with respect to any Distributions deducted pursuant to the foregoing clause (ii)(B); provided that (x) for the avoidance of doubt, if the foregoing number is a negative number with respect to any Stockholder, such Stockholder shall not receive an amount pursuant to this clause (ii) and such negative number shall be added to the total amount of the Sale Proceeds for purposes of clause (iii) below and (y) to the extent the Sale Proceeds are insufficient to make such payment, then each Stockholder shall receive its ratable share of the remaining Sale Proceeds after deducting the amount in clause (i) above; 

(iii)Pernix shall receive 10% of the remaining Sale Proceeds after deducting the amounts in clauses (i) and (ii) above (the “Pernix Promote”); and 

(iv)each Stockholder (including Pernix) shall receive its ratable share of the remaining Sale Proceeds after deducting the amounts in clause (i) and (ii) above and the Pernix Promote on a pro rata basis. 

(b)    Each of the Company and each Stockholder hereby agrees to discuss in good faith an appropriate payment to be made to Pernix in the event of a Change of Control that does not constitute a Trigger Event, and appropriate modifications to Section 5.05(a) in connection therewith.


 


[***] Certain information in this document has been omitted and filed separately with the Securities and Exchange Commission. Confidential treatment has been requested with respect to the omitted portions.


(c)   Each of the Company and each Stockholder hereby agrees that, prior to a Trigger Event, at such time that (A) each Stockholder has received an amount equal to its Invested Amount from Distributions and (B) all indebtedness of the Company has been repaid, including the Debt Commitments and all accrued and unpaid interest on such Debt Commitments, then notwithstanding anything to the contrary herein, (1) Pernix shall receive 10% of any subsequent Distribution, and (2) each Stockholder (including Pernix) shall receive its ratable share of any such remaining Distribution, after deducting the amount in clause (1), on a pro rata basis.

(d)  Pernix hereby agrees that, to the extent that at such time it is entitled to receive the Pernix Promote, Pernix or its Affiliate is in default of any obligation to make payment to the Company pursuant to the Services Agreement, as finally determined in accordance with Section 8.11, then the Company shall have the right to set off against the Pernix Promote any such defaulted payments under the Services Agreement.

(e)  Pernix’s right to receive the Pernix Promote pursuant to this Section 5.05 shall terminate upon the date that is the six-month anniversary of the date of the termination or expiration of the Services Agreement for any reason in accordance with its terms; provided that nothing in this Section 5.05(e) shall impair or affect Pernix’s rights pursuant to this Section 5.05 if the Company or any Stockholder has, prior to such termination or expiration of the Services Agreement, entered into a definitive agreement that would result in a Trigger Event occurring upon the consummation of the transactions contemplated by such agreement. 

(f)   An example of the calculation of distributions in accordance with the provisions of this Section 5.05 is set forth on Exhibit C hereto.

 

ARTICLE VI

REPRESENTATIONS AND WARRANTIES

 

Section 6.01 Representations and Warranties. Each Stockholder, severally and not jointly, represents and warrants to the Company that:

 

(a)For each such Stockholder that is not an individual, such Stockholder is a corporation duly organized, validly existing and in good standing under the laws of its jurisdiction of formation.  

(b)Such Stockholder has full capacity or organizational power and authority to execute and deliver this Agreement, to perform its obligations hereunder and to consummate the transactions contemplated hereby. The execution and delivery of this Agreement, the performance of its obligations hereunder and the consummation of the transactions contemplated hereby have been duly authorized by all requisite action of such Stockholder. Such Stockholder has duly executed and delivered this Agreement.  


 


[***] Certain information in this document has been omitted and filed separately with the Securities and Exchange Commission. Confidential treatment has been requested with respect to the omitted portions.


(c)This Agreement constitutes the legal, valid and binding obligation of such Stockholder, enforceable against such Stockholder in accordance with its terms except as enforceability may be limited by applicable bankruptcy, insolvency, reorganization, moratorium or similar laws affecting the enforcement of creditors’ rights generally and by general equitable principles (whether enforcement is sought by proceedings in equity or at law). The execution, delivery and performance of this Agreement and the consummation of the transactions contemplated hereby, require no action by or in respect of, or filing with, any Governmental Authority. 

(d)The execution, delivery and performance by such Stockholder of this Agreement and the consummation of the transactions contemplated hereby do not (i) conflict with or result in any violation or breach of any provision of any of the organizational documents of such Stockholder; (ii) conflict with or result in any violation or breach of any provision of any Applicable Law or (iii) require any consent or other action by any Person under any provision of any material agreement or other instrument to which the Stockholder is a party. 

(e)Except for this Agreement, such Stockholder has not entered into or agreed to be bound by any other agreements or arrangements of any kind with any other party with respect to any Capital Stock, including agreements or arrangements with respect to the acquisition or disposition of any such shares of Capital Stock or any interest therein or the voting of any shares of Capital Stock. 

ARTICLE VII

REGISTRATION RIGHTS

 

Rights and obligations of the Company and the Stockholders with respect to registration of shares of Common Stock shall be as set forth on Exhibit B. 

ARTICLE VIII

MISECLLANEOUS

Section 8.01  Further Assurances. In connection with this Agreement and the transactions contemplated hereby, the Company and each Stockholder hereby agrees, at the request of the Company or any other Stockholder, to execute and deliver such additional documents, instruments, conveyances and assurances and to take such further actions as may be required to carry out the provisions hereof and give effect to the transactions contemplated hereby. 

Section 8.02   Notices. All notices, requests, consents, claims, demands, waivers and other communications hereunder shall be in writing and shall be deemed to have been given: (a) when delivered by hand (with written confirmation of receipt); (b) when received by the addressee if sent by a nationally recognized overnight courier (receipt requested); (c) on the date receipt is confirmed relative to a communication sent by facsimile or e-mail (with confirmation of transmission) if sent during normal business hours of the recipient, and on the next Business


 


[***] Certain information in this document has been omitted and filed separately with the Securities and Exchange Commission. Confidential treatment has been requested with respect to the omitted portions.


Day if sent after normal business hours of the recipient; or (d) on the third day after the date mailed, by certified or registered mail, return receipt requested, postage prepaid. Such communications must be sent to the respective parties at the addresses set forth on the signature page hereto (or at such other address for a party as shall be specified in a notice given in accordance with this Section 8.02).

Section 8.03   Headings. The headings in this Agreement are inserted for convenience or reference only and are in no way intended to describe, interpret, define, or limit the scope, extent or intent of this Agreement or any provision of this Agreement.

Section 8.04    Severability. If any term or provision of this Agreement is held to be invalid, illegal or unenforceable under Applicable Law in any jurisdiction, such invalidity, illegality or unenforceability shall not affect any other term or provision of this Agreement or invalidate or render unenforceable such term or provision in any other jurisdiction. Upon such determination that any term or other provision is invalid, illegal or unenforceable, the parties hereto shall negotiate in good faith to modify this Agreement so as to effect the original intent of the parties as closely as possible in a mutually acceptable manner in order that the transactions contemplated hereby be consummated as originally contemplated to the greatest extent possible.

Section 8.05   Entire Agreement.

(a)This Agreement, together with the Certificate of Incorporation, the Services Agreement and any Joinder Agreements executed after the date hereof (collectively, the “Related Agreements”), and all related Exhibits and Schedules hereto and thereto constitutes the sole and entire agreement of the parties to this Agreement with respect to the subject matter contained herein and therein, and supersedes all prior and contemporaneous understandings, agreements, representations and warranties, both written and oral, with respect to such subject matter. 

(f)In the event of an inconsistency or conflict between the provisions of this Agreement and any provisions of any Related Agreement with respect to the subject matter herein, the terms of this Agreement shall control. 

Section 8.06. Successors and Assigns; Assignment. Subject to the rights and restrictions on Transfers set forth in this Agreement, this Agreement shall be binding upon and shall inure to the benefit of the parties hereto and their respective permitted successors and permitted assigns.

Section 8.07   No Third-party Beneficiaries. This Agreement is for the sole benefit of the parties hereto (and their respective heirs, executors, administrators, successors and assigns) and nothing herein, express or implied, is intended to or shall confer upon any other Person, including any creditor of the Company, any legal or equitable right, benefit or remedy of any nature whatsoever under or by reason of this Agreement.

Section 8.08  Amendment. Subject to Section 2.03(b)(vi)(c)(2), no provision of this Agreement may be amended or modified except by an instrument in writing executed by


 


[***] Certain information in this document has been omitted and filed separately with the Securities and Exchange Commission. Confidential treatment has been requested with respect to the omitted portions.


the Company and Stockholders holding at least 66.67% of the shares of Capital Stock subject to this Agreement; provided that any amendment that disproportionately reduces or eliminates any rights of, or disproportionately increases or adds any obligations of, any Stockholder hereunder shall require the written consent of such Stockholder.

Section 8.09 Waiver. No waiver by any party of any of the provisions hereof shall be effective unless explicitly set forth in writing and signed by the party so waiving. No waiver by any party shall operate or be construed as a waiver in respect of any failure, breach or default not expressly identified by such written waiver, whether of a similar or different character, and whether occurring before or after that waiver. No failure to exercise, or delay in exercising, any right, remedy, power or privilege arising from this Agreement shall operate or be construed as a waiver thereof, nor shall any single or partial exercise of any right, remedy, power or privilege hereunder preclude any other or further exercise thereof or the exercise of any other right, remedy, power or privilege. For the avoidance of doubt, nothing contained in this Section 8.09 shall diminish any of the explicit and implicit waivers described in this Agreement, including in Section 4.03(d)(iv), Section 4.05(b)(ii), Section 4.04(e) and Section 8.11 hereof.

Section 8.10  Governing Law. All issues and questions concerning the application, construction, validity, interpretation and enforcement of this Agreement shall be governed by and construed in accordance with the internal laws of the State of Delaware, without giving effect to any choice or conflict of law provision or rule (whether of the State of Delaware or any other jurisdiction).

Section 8.11  Submission to Jurisdiction. The parties hereby agree that any suit, action or proceeding seeking to enforce any provision of, or based on any matter arising out of or in connection with, this Agreement or the transactions contemplated hereby, whether in contract, tort or otherwise, shall be brought in the United States District Court for the District of Delaware or in the Court of Chancery of the State of Delaware (or, if such courts lack subject-matter jurisdiction, in the Superior Court of the State of Delaware), so long as one of such courts shall have subject-matter jurisdiction over such suit, action or proceeding, and that any case of action arising out of this Agreement shall be deemed to have arisen from a transaction of business in the State of Delaware.

Each of the parties hereby irrevocably consents to the exclusive jurisdiction of such courts (and of the appropriate appellate courts therefrom) in any such suit, action or proceeding and irrevocably waives, to the fullest extent permitted by law, any objection that it may now or hereafter have to the laying of the venue of any such suit, action or proceeding in any such court or that any such suit, action or proceeding which is brought in any such court has been brought in an inconvenient form. Service of process, summons, notice or other document by certified or registered mail to the address set forth in Section 8.02 shall be effective service of process for any suit, action or other proceeding brought in any such court.

Section 8.12  Waiver of Jury Trial. Each party hereto hereby acknowledges and agrees that any controversy which may arise under this Agreement is likely to involve complicated and difficult issues and, therefore, each such party irrevocably and unconditionally waives any right it


 


[***] Certain information in this document has been omitted and filed separately with the Securities and Exchange Commission. Confidential treatment has been requested with respect to the omitted portions.


may have to a trial by jury in respect of any legal action arising out of or relating to this Agreement or the transactions contemplated hereby.

Section 8.13  Dispute Resolution.  Any and all claims, disputes or controversies arising out of, in connection with or relating to this Agreement (the “Dispute”) shall, at the written request of a party (a “Mediation Request”), be submitted to a neutrally positioned Person mutually agreed upon by the parties.  The mediation shall be held in (a) New York, NY or (b) such other place as the parties may mutually agree upon in writing. The parties shall have thirty (30) days from receipt by a party of a Mediation Request to agree on a mediator.  If no mediator has been agreed upon by the parties within thirty (30) days of receipt by a party of a Mediation Request, then Section 8.11 shall apply.  All mediation pursuant to this clause shall be confidential and shall be treated as compromise and settlement negotiations for purposes of applicable rules of evidence, and no oral or documentary representations made by the parties during such mediation shall be admissible for any purpose in any subsequent proceedings.  Live witness testimony shall not be taken.  Except as required by Applicable Law, none of the Parties nor their representatives may disclose the existence, content or results of any mediation hereunder without the prior written consent of the other parties.  If any of the Dispute has not been resolved within sixty (60) days of the appointment of a mediator, or within ninety (90) days after receipt by a party of a Mediation Request (whichever occurs sooner), or within such longer period as the parties may agree to in writing, then the Dispute shall be submitted to litigation in accordance with Section 8.11.

Section 8.14  Equitable Remedies. Each party hereto acknowledges that a breach or threatened breach by such party of any of its obligations under this Agreement would give rise to irreparable harm to the other parties, for which monetary damages would not be an adequate remedy, and hereby agrees that in the event of a breach or a threatened breach by such party of any such obligations, each of the other parties hereto shall, in addition to any and all other rights and remedies that may be available to them in respect of such breach, be entitled to equitable relief, including a temporary restraining order, an injunction, specific performance and any other relief that may be available from a court of competent jurisdiction (without any requirement to post bond).

Section 8.15  Remedies Cumulative. The rights and remedies under this Agreement are cumulative and are in addition to and not in substitution for any other rights and remedies available at law or in equity or otherwise.

Section 8.16 Counterparts. This Agreement may be executed in counterparts, each of which shall be deemed an original, but all of which together shall be deemed to be one and the same agreement. A signed copy of this Agreement delivered by facsimile, e-mail or other means of electronic transmission shall be deemed to have the same legal effect as delivery of an original signed copy of this Agreement.

Section 8.17  Legend. In addition to any other legend required by Applicable Law, all certificates representing issued and outstanding Capital Stock shall bear a legend substantially in the following form:


 


[***] Certain information in this document has been omitted and filed separately with the Securities and Exchange Commission. Confidential treatment has been requested with respect to the omitted portions.


THE SHARES REPRESENTED BY THIS CERTIFICATE ARE SUBJECT TO A STOCKHOLDERS AGREEMENT AMONG THE COMPANY AND ITS STOCKHOLDERS, A COPY OF WHICH IS ON FILE AT THE PRINCIPAL EXECUTIVE OFFICE OF THE COMPANY. NO TRANSFER, SALE, ASSIGNMENT, PLEDGE, HYPOTHECATION OR OTHER DISPOSITION OF THE SHARES REPRESENTED BY THIS CERTIFICATE MAY BE MADE EXCEPT IN ACCORDANCE WITH THE PROVISIONS OF SUCH STOCKHOLDERS AGREEMENT.

THE SHARES REPRESENTED BY THIS CERTIFICATE HAVE NOT BEEN REGISTERED UNDER THE SECURITIES ACT OF 1933, AS AMENDED, OR UNDER ANY OTHER APPLICABLE SECURITIES LAWS AND MAY NOT BE TRANSFERRED, SOLD, ASSIGNED, PLEDGED, HYPOTHECATED OR OTHERWISE DISPOSED EXCEPT (A) PURSUANT TO A REGISTRATION STATEMENT EFFECTIVE UNDER SUCH ACT AND LAWS, OR (B) PURSUANT TO AN EXEMPTION FROM REGISTRATION THEREUNDER.

Section 8.18 Stock Split.  All references to amounts of Capital Stock in this Agreement shall be appropriately adjusted to reflect any dividend, split, combination or other recapitalization affecting the Capital Stock occurring after the date of this Agreement.

Section 8.19 Additional Stockholders.  Notwithstanding anything to the contrary contained herein, if the Company issues additional shares of Capital Stock after the date hereof, any purchaser of such shares of Capital Stock shall become a party to this Agreement by executing and delivering an additional counterpart signature page to this Agreement and thereafter shall be deemed a “Stockholder” for all purposes hereunder.

Section 8.20 Termination.  

(a)Date of Termination.  This Agreement shall terminate upon the earliest of: 

(i)the consummation of a Public Offering; 

(ii)the consummation of a Drag-along Sale or a Change in Control involving a sale of all or substantially all of the consolidated assets of the Company and the Company Subsidiaries or as a merger, consolidation, recapitalization, or reorganization of the Company or a Transfer of 100% of the Capital Stock of the Company; 

(iii)the date on which none of the Stockholders beneficially owns any Capital Stock or Pernix beneficially owns all of the Capital Stock;  

(iv)the dissolution, liquidation, or winding up of the Company; or 

(v)upon the unanimous agreement of the Stockholders. 


 


[***] Certain information in this document has been omitted and filed separately with the Securities and Exchange Commission. Confidential treatment has been requested with respect to the omitted portions.


(b)  Effect of Termination. The termination of this Agreement shall terminate all further rights and obligations of the Stockholders under this Agreement except that such termination shall not effect:

(vi)the existence of the Company; 

(vii)the rights which any Stockholder may have by operation of Applicable Law as a stockholder of the Company; or 

(viii)the rights contained herein which, but their terms are intended to survive termination of this Agreement. 

(c)  Survival. The following provisions shall survive the termination of this Agreement: this Section 8.20(c) and Section 5.02, Section 8.02, Section 8.10, Section 8.11, Section 8.12, Section 8.13, Section 8.14, and Section 8.15.

[signature page follows]

IN WITNESS WHEREOF, the parties hereto have caused this Agreement to be executed as of the date first written above by their respective officers thereunto duly authorized.

 

The Company:

 

Nalpropion Pharmaceuticals, Inc.

 

 

By: /s/ John A. Sedor 

Name: John A. Sedor

Title: Chief Executive Officer

 

 


 


[***] Certain information in this document has been omitted and filed separately with the Securities and Exchange Commission. Confidential treatment has been requested with respect to the omitted portions.


 

1992 MSF INTERNATIONAL LTD.

By: Highbridge Capital Management, LLC, as trading manager

 

By: /s/ Jonathan Segal 

Name:  Jonathan Segal

Title:  Managing Director

 

 

 

 

1992 TACTICAL CREDIT MASTER FUND, L.P.

By: Highbridge Capital Management, LLC, as trading manager

 

 

 

By: /s/ Jonathan Segal 

Name:  Jonathan Segal

Title:  Managing Director

 

 

 

 

1992 MASTER FUND CO-INVEST SPC3

FOR AND ON BEHALF OF SERIES 3 SEGREGATED PORTFOLIO

By: Highbridge Capital Management, LLC, as trading manager

 

 

By: /s/ Jonathan Segal 

Name:  Jonathan Segal

Title:  Managing Director

 

 

 

 


[Signature Page to Stockholders Agreement] 

 

 


[***] Certain information in this document has been omitted and filed separately with the Securities and Exchange Commission. Confidential treatment has been requested with respect to the omitted portions.



[Signature Page to Stockholders Agreement] 

 

 


[***] Certain information in this document has been omitted and filed separately with the Securities and Exchange Commission. Confidential treatment has been requested with respect to the omitted portions.


 

WHITEBOX CAJA BLANCA FUND, LP

 

 

By: /s/ Mark Strefling 

Name:  Mark Strefling

Title:  Chief Executive Officer

 

 

 

 

 

WHITEBOX MULTI-STRATEGY PARTNERS, L.P.

 

 

By: /s/ Mark Strefling 

Name:  Mark Strefling

Title:  Chief Executive Officer

 

 

 

 

 

WHITEBOX ASYMMETRIC PARTNERS, L.P.

 

 

By: /s/ Mark Strefling 

Name:  Mark Strefling

Title:  Chief Executive Officer

 

 

 

 

 

 


[Signature Page to Stockholders Agreement] 

 

 


[***] Certain information in this document has been omitted and filed separately with the Securities and Exchange Commission. Confidential treatment has been requested with respect to the omitted portions.


 

PERNIX IRELAND PAIN DESIGNATED ACTIVITY COMPANY

 

 

By: /s/ Kenneth R. Pina 

Name:  Kenneth R. Pina

Title:  Director

 

Address:  3 Burlington Road

   Dublin 4 Ireland 

 

 

 


[Signature Page to Stockholders Agreement] 

 

 


[***] Certain information in this document has been omitted and filed separately with the Securities and Exchange Commission. Confidential treatment has been requested with respect to the omitted portions.


Schedule A

Stockholders Schedule

Holder Name and Address

Invested Amount

Debt Commitments

Number of Shares of Capital Stock

 

 

 

 

1992 MSF International Ltd.

$25,000,000.00

$12,500,000.00

125,000

 

 

 

 

1992 Tactical Credit Master Fund, L.P.

$15,635,000.00

$7,817,500.00

78,175

 

 

 

 

1992 Master Fund Co-Invest SPC3 for and on behalf of Series 3 Segregated Portfolio

$26,865,000.00

$13,432,500.00

134,325

 

 

 

 

Whitebox Caja Blanca Fund, LP

$2,000,000.00

$1,000,000.00

10,000

 

 

 

 

Whitebox Multi-Strategy Partners, L.P.

$6,890,000.00

$3,445,000.00

34,450

 

 

 

 

Whitebox Asymmetric Partners, L.P.

$6,110,000.00

$3,055,000.00

30,550

 

 

 

 

Pernix Ireland Pain Designated Activity Company

$9,167,000.00

$4,583,500.00

45,835.00

 

 

 

 

TOTAL

$91,667,000.00

$45,833,500.00

458,335.00


 


[***] Certain information in this document has been omitted and filed separately with the Securities and Exchange Commission. Confidential treatment has been requested with respect to the omitted portions.


Exhibit A

Joinder

Reference is hereby made to the Stockholders Agreement, dated July 27, 2018, as amended from time to time (the “Stockholders Agreement”), among Nalpropion Pharmaceuticals, Inc. (the “Company”) and the Stockholders named therein. Pursuant to and in accordance with Section 4.01(f) of the Stockholders Agreement, the undersigned hereby acknowledges that it has received and reviewed a complete copy of the Stockholders Agreement and agrees that upon execution of this Joinder, such Person shall become a party to the Stockholders Agreement and shall be fully bound by, and subject to, all of the covenants, terms and conditions of the Stockholders Agreement as though an original party thereto and shall be deemed, and is hereby admitted as, a Stockholder for all purposes thereof and entitled to all the rights incidental thereto.  Capitalized terms used herein without definition shall have the meanings ascribed thereto in the Stockholders Agreement.

IN WITNESS WHEREOF, the parties hereto have executed this Agreement as of [DATE]. 

 

Stockholder:

 

 

______________________________________

 

By:___________________________________

Name:

Title:

 

 

 

Company:

 

Nalpropion Pharmaceuticals, Inc.

 

By:___________________________________

Name:

Title:

 

 


 


[***] Certain information in this document has been omitted and filed separately with the Securities and Exchange Commission. Confidential treatment has been requested with respect to the omitted portions.


Exhibit B

Registration Rights

1.Defined Terms. All capitalized terms used but not defined in this Exhibit B shall have the meanings given to them in the Stockholders Agreement.  As used in this Exhibit B, the following terms shall have the following meanings: 

Commission” means the Securities and Exchange Commission or any other federal agency administering the Securities Act and the Exchange Act at the time.

Controlling Person” has the meaning set forth in Section 5(g).

Demand Registration” has the meaning set forth in Section 2(b).

DTCDRS” has the meaning set forth in Section 5(r).

Inspectors” has the meaning set forth in Section 5(h).

IPO” means an initial public offering of the Common Stock pursuant to an effective Registration Statement filed under the Securities Act (other than a registration (i) pursuant to a Registration Statement on Form S-8 (or other registration solely relating to an offering or sale to employees or directors of the Company pursuant to any employee stock plan or other employee benefit arrangement), (ii) pursuant to a Registration Statement on Form S-4 (or similar form that relates to a transaction subject to Rule 145 under the Securities Act or any successor rule thereto), or (iii) in connection with any dividend or distribution reinvestment or similar plan).

Long-Form Registration” has the meaning set forth in Section 2(a).

Piggyback Registration” has the meaning set forth in Section 3(a).

Piggyback Registration Statement” has the meaning set forth in Section 3(a).

Piggyback Shelf Registration Statement” has the meaning set forth in Section 3(a).

Piggyback Shelf Takedown” has the meaning set forth in Section 3(a).

Prospectus” means the prospectus or prospectuses included in any Registration Statement (including, without limitation, a prospectus that includes any information previously omitted from a prospectus filed as part of an effective Registration Statement in reliance on Rule 430A under the Securities Act or any successor rule thereto), as amended or supplemented by any prospectus supplement, including any Shelf Supplement, with respect to the terms of the offering of any portion of the Registrable Securities covered by such Registration Statement and by all other amendments and supplements to the prospectus, including post-effective amendments and all material incorporated by reference in such prospectus or prospectuses.

Records” has the meaning set forth in Section 5(h).


 


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Registrable Securities” means (a) any shares of Common Stock beneficially owned by the Stockholders, and (b) any shares of Common Stock issued or issuable with respect to any shares described in subsection (a) above by way of a stock dividend or stock split or in exchange for or upon conversion of such shares or otherwise in connection with a combination of shares, distribution, recapitalization, merger, consolidation, other reorganization or other similar event with respect to the Common Stock (it being understood that, for purposes of this Agreement, a Person shall be deemed to be a holder of Registrable Securities whenever such Person has the right to then acquire or obtain from the Company any Registrable Securities, whether or not such acquisition has actually been effected). As to any particular Registrable Securities, such securities shall cease to be Registrable Securities when (i) the Commission has declared a Registration Statement covering such securities effective and such securities have been disposed of pursuant to such effective Registration Statement, (ii) such securities are sold under circumstances in which all of the applicable conditions of Rule 144 under the Securities Act are met or (iii) such securities have ceased to be outstanding.

Registration Date” means the date on which the Company becomes subject to Section 13(a) or Section 15(d) of the Exchange Act.

Registration Statement” means any registration statement of the Company, including the Prospectus, amendments and supplements (including Shelf Supplements) to such registration statement, including post-effective amendments, all exhibits and all material incorporated by reference in such registration statement.

Requesting Stockholders” has the meaning set forth in Section 2(a).

Rule 144” means Rule 144 under the Securities Act or any successor rule thereto.

Selling Expenses” means all underwriting discounts, selling commissions and stock transfer taxes applicable to the sale of Registrable Securities, and fees and disbursements of counsel for any holder of Registrable Securities, except for the reasonable fees and disbursements of counsel for the holders of Registrable Securities required to be paid by the Company pursuant to Section 6.

Shares” means the shares of Common Stock held by the Stockholders.

Shelf Registration” has the meaning set forth in Section 2(c).

Shelf Registration Statement” has the meaning set forth in Section 2(c).

Shelf Supplement” has the meaning set forth in Section 2(d).

Shelf Takedown” has the meaning set forth in Section 2(d).

Shelf Takedown Notice” has the meaning set forth in Section 2(d).

Short-Form Registration” has the meaning set forth in Section 2(b).


 


[***] Certain information in this document has been omitted and filed separately with the Securities and Exchange Commission. Confidential treatment has been requested with respect to the omitted portions.


2.Demand Registration. 

(a)At any time after 180 days after the IPO, each of Pernix, each 1992 Fund and each Whitebox Fund (the “Requesting Stockholders”) may request registration under the Securities Act of all or any portion of their Registrable Securities pursuant to a Registration Statement on Form S-1 or any successor form thereto (each, a “Long-Form Registration”). Each request for a Long-Form Registration shall specify the number of Registrable Securities requested to be included in the Long-Form Registration. Upon receipt of any such request, the Company shall promptly (but in no event later than ten (10) days following receipt thereof) deliver notice of such request to all other Stockholders holding Registrable Securities who shall then have ten (10) days from the date such notice is given to notify the Company in writing of their desire to be included in such registration. The Company shall prepare and file with (or confidentially submit to) the Commission a Registration Statement on Form S-1 or any successor form thereto covering all of the Registrable Securities that the Requesting Stockholders have requested to be included in such Long-Form Registration within sixty (60) days after the date on which the initial request is given and shall use its reasonable efforts to cause such Registration Statement to be declared effective by the Commission as soon as practicable thereafter. The Company shall not be required to effect a Long-Form Registration more than three (3) times for the holders of Registrable Securities as a group; provided, that a Registration Statement shall not count as a Long-Form Registration requested under this Section 2(a) unless and until it has become effective and the Stockholders requesting such registration are able to register and sell at least fifty percent (50%) of the Registrable Securities requested to be included in such registration. 

(b)After the IPO, the Company shall use its reasonable efforts to qualify and remain qualified to register the offer and sale of securities under the Securities Act pursuant to a Registration Statement on Form S-3 or any successor form thereto. At such time as the Company shall have qualified for the use of a Registration Statement on Form S-3 or any successor form thereto, the Requesting Stockholders shall have the right to request an unlimited number of registrations under the Securities Act of all or any portion of their Registrable Securities pursuant to a Registration Statement on Form S-3 or any similar short-form Registration Statement (each, a “Short-Form Registration” and, collectively with each Long-Form Registration and Shelf Registration (as defined below), a “Demand Registration”). Each request for a Short-Form Registration shall specify the number of Registrable Securities requested to be included in the Short-Form Registration. Upon receipt of any such request, the Company shall promptly (but in no event later than ten (10) days following receipt thereof) deliver notice of such request to all other Stockholders holding Registrable Securities who shall then have ten (10) days from the date such notice is given to notify the Company in writing of their desire to be included in such registration. The Company shall prepare and file with (or confidentially submit to) the Commission a Registration Statement on Form S-3 or any successor form thereto covering all of the Registrable Securities that the Stockholders have requested to be included in such Short-Form Registration within sixty (60) days after the date on which the initial request is given and shall use its reasonable efforts to cause such Registration Statement to be declared effective by the Commission as soon as practicable thereafter. 

(c)At such time as the Company shall have qualified for the use of a Registration Statement on Form S-3 or the then appropriate form for an offering to be made on a delayed or  


 


[***] Certain information in this document has been omitted and filed separately with the Securities and Exchange Commission. Confidential treatment has been requested with respect to the omitted portions.


continuous basis pursuant to Rule 415 under the Securities Act or any successor rule thereto (a “Shelf Registration Statement”), the Stockholders shall have the right to request registration under the Securities Act of all or any portion of their Registrable Securities for an offering on a delayed or continuous basis pursuant to Rule 415 under the Securities Act or any successor rule thereto (a “Shelf Registration”). Each request for a Shelf Registration shall specify the number of Registrable Securities requested to be included in the Shelf Registration. Upon receipt of any such request, the Company shall promptly (but in no event later than ten (10) days following receipt thereof) deliver notice of such request to all other Stockholders holding Registrable Securities who shall then have ten (10) days from the date such notice is given to notify the Company in writing of their desire to be included in such registration. The Company shall prepare and file with (or confidentially submit to) the Commission a Shelf Registration Statement covering all of the Registrable Securities that the Stockholders have requested to be included in such Shelf Registration within forty-five (45) days after the date on which the initial request is given and shall use its reasonable efforts to cause such Shelf Registration Statement to be declared effective by the Commission as soon as practicable thereafter.

(d)The Company shall not be obligated to effect any Long-Form Registration within 180 days after the effective date of a previous Long-Form Registration, Shelf Takedown, or a previous Piggyback Registration in which the Stockholders holding Registrable Securities were permitted to register the offer and sale under the Securities Act, and actually sold, at least fifty percent (50%) of the shares of Registrable Securities requested to be included therein. The Company may postpone for up to sixty (60) days the filing or effectiveness of a Registration Statement for a Demand Registration or a supplement for the purpose of effecting an offering pursuant to Rule 415 under the Securities Act or any successor rule thereto (a “Shelf Takedown”) if the Board determines in its reasonable good faith judgment that such Demand Registration or Shelf Takedown would (i) materially interfere with a significant acquisition, corporate organization, financing, securities offering or other similar transaction involving the Company; (ii) require premature disclosure of material information that the Company has a bona fide business purpose for preserving as confidential; or (iii) render the Company unable to comply with requirements under the Securities Act or Exchange Act; provided, that in such event the Stockholders holding two thirds of the Registrable Securities initiating such Demand Registration or Shelf Takedown shall be entitled to withdraw such request and, if such request for a Demand Registration is withdrawn, such Demand Registration shall not count as one of the permitted Demand Registrations hereunder and the Company shall pay all registration expenses in connection with such registration. The Company may delay a Demand Registration or Shelf Takedown hereunder only twice in any period of 12 consecutive months. 

(e)If the Stockholders holding Registrable Securities initially requesting a Demand Registration or Shelf Takedown elect to distribute the Registrable Securities covered by their request in an underwritten offering, they shall so advise the Company as a part of their request made pursuant to Section 2(a), Section 2(b), Section 2(c) or Section 2(d), and the Company shall include such information in its notice to the other Stockholders holding Registrable Securities. The Stockholders holding two thirds of the Registrable Securities initially requesting the Demand Registration or Shelf Takedown shall select the investment banking firm or firms to act as the managing underwriter or underwriters in connection with such offering. 


 


[***] Certain information in this document has been omitted and filed separately with the Securities and Exchange Commission. Confidential treatment has been requested with respect to the omitted portions.


(f)The Company shall not include in any Demand Registration or Shelf Takedown any securities which are not Registrable Securities without the prior written consent of the Stockholders holding two-thirds of the Registrable Securities included in such Demand Registration or Shelf Takedown, which consent shall not be unreasonably withheld or delayed. If a Demand Registration or Shelf Takedown involves an underwritten offering and the managing underwriter of the requested Demand Registration or Shelf Takedown advises the Company and the Stockholders holding Registrable Securities in writing that in its reasonable and good faith opinion the number of shares of Common Stock proposed to be included in the Demand Registration or Shelf Takedown, including all Registrable Securities and all other shares of Common Stock proposed to be included in such underwritten offering, exceeds the number of shares of Common Stock which can be sold in such underwritten offering and/or the number of shares of Common Stock proposed to be included in such Demand Registration or Shelf Takedown would adversely affect the price per share of the Common Stock proposed to be sold in such underwritten offering, the Company shall include in such Demand Registration or Shelf Takedown (i) first, the shares of Common Stock that the Stockholders holding Registrable Securities propose to sell, and (ii) second, the shares of Common Stock proposed to be included therein by any other Persons (including shares of Common Stock to be sold for the account of the Company and/or other holders of Common Stock) allocated among such Persons in such manner as they may agree. If the managing underwriter determines that less than all of the Registrable Securities proposed to be sold can be included in such offering, then the Registrable Securities that are included in such offering shall be allocated pro rata among the respective Stockholders on the basis of the number of Registrable Securities owned by each such Stockholder. 

3.Piggyback Registration. 

(a)Whenever the Company proposes to register the offer and sale of any shares of its Common Stock under the Securities Act (other than a registration (i) pursuant to a Registration Statement on Form S-8 (or other registration solely relating to an offering or sale to employees or directors of the Company pursuant to any employee stock plan or other employee benefit arrangement), (ii) pursuant to a Registration Statement on Form S-4 (or similar form that relates to a transaction subject to Rule 145 under the Securities Act or any successor rule thereto), or (iii) in connection with any dividend or distribution reinvestment or similar plan), whether for its own account or for the account of one or more stockholders of the Company and the form of Registration Statement (a “Piggyback Registration Statement”) to be used may be used for any registration of Registrable Securities (a “Piggyback Registration”), the Company shall give prompt written notice (in any event no later than twenty (20) days prior to the filing of such Registration Statement) to the holders of Registrable Securities of its intention to effect such a registration and, subject to Section 3(b) and Section 3(c), shall include in such registration all Registrable Securities with respect to which the Company has received written requests for inclusion from the holders of Registrable Securities within ten (10) days after the Company's notice has been given to each such holder. A Piggyback Registration shall not be considered a Demand Registration for purposes of Section 2. If any Piggyback Registration Statement pursuant to which holders of Registrable Securities have registered the offer and sale of Registrable Securities is a Registration Statement on Form S-3 or the then appropriate form for an offering to be made on a delayed or continuous basis pursuant to Rule 415 under the Securities Act or any successor rule thereto (a “Piggyback Shelf Registration Statement”), such holder(s) shall have the right, but  


 


[***] Certain information in this document has been omitted and filed separately with the Securities and Exchange Commission. Confidential treatment has been requested with respect to the omitted portions.


not the obligation, to be notified of and to participate in any offering under such Piggyback Shelf Registration Statement (a “Piggyback Shelf Takedown”).

(b)If a Piggyback Registration or Piggyback Shelf Takedown is initiated as a primary underwritten offering on behalf of the Company and the managing underwriter advises the Company and the holders of Registrable Securities (if any holders of Registrable Securities have elected to include Registrable Securities in such Piggyback Registration or Piggyback Shelf Takedown) in writing that in its reasonable and good faith opinion the number of shares of Common Stock proposed to be included in such registration or takedown, including all Registrable Securities and all other shares of Common Stock proposed to be included in such underwritten offering, exceeds the number of shares of Common Stock which can be sold in such offering and/or that the number of shares of Common Stock proposed to be included in any such registration or takedown would adversely affect the price per share of the Common Stock to be sold in such offering, the Company shall include in such registration or takedown (i) first, the shares of Common Stock that the Company proposes to sell; (ii) second, the shares of Common Stock requested to be included therein by holders of Registrable Securities, allocated pro rata among all such holders on the basis of the number of Registrable Securities owned by each such holder or in such manner as they may otherwise agree; and (iii) third, the shares of Common Stock requested to be included therein by holders of Common Stock other than holders of Registrable Securities, allocated among such holders in such manner as they may agree. 

(c)If a Piggyback Registration or Piggyback Shelf Takedown is initiated as an underwritten offering on behalf of a holder of Common Stock other than Registrable Securities, and the managing underwriter advises the Company in writing that in its reasonable and good faith opinion the number of shares of Common Stock proposed to be included in such registration or takedown, including all Registrable Securities and all other shares of Common Stock proposed to be included in such underwritten offering, exceeds the number of shares of Common Stock which can be sold in such offering and/or that the number of shares of Common Stock proposed to be included in any such registration or takedown would adversely affect the price per share of the Common Stock to be sold in such offering, the Company shall include in such registration or takedown (i) first, the shares of Common Stock requested to be included therein by the holder(s) requesting such registration or takedown and by the holders of Registrable Securities, allocated pro rata among all such holders on the basis of the number of shares of Common Stock other than the Registrable Securities (on a fully diluted, as converted basis) and the number of Registrable Securities, as applicable, owned by all such holders or in such manner as they may otherwise agree; and (ii) second, the shares of Common Stock requested to be included therein by other holders of Common Stock, allocated among such holders in such manner as they may agree. 

(d)If any Piggyback Registration or Piggyback Shelf Takedown is initiated as a primary underwritten offering on behalf of the Company, the Company shall select the investment banking firm or firms to act as the managing underwriter or underwriters in connection with such offering. 

4.Lock-up Agreement. Each holder of Registrable Securities agrees that in connection with an IPO, and upon the request of the managing underwriter in such offering, such holder shall not, without the prior written consent of such managing underwriter, during the 180 days prior to the  


 


[***] Certain information in this document has been omitted and filed separately with the Securities and Exchange Commission. Confidential treatment has been requested with respect to the omitted portions.


effective date of such registration and until the date specified by such managing underwriter (such period not to exceed 180 days in the case of an IPO or 90 days in the case of any registration under the Securities Act other than an IPO), (a) offer, pledge, sell, contract to sell, grant any option or contract to purchase, purchase any option or contract to sell, hedge the beneficial ownership of or otherwise dispose of, directly or indirectly, any shares of Common Stock or any securities convertible into, exercisable for or exchangeable for shares of Common Stock held immediately before the effectiveness of the Registration Statement for such offering/(whether such shares or any such securities are then owned by the holder or are thereafter acquired), or (b) enter into any swap or other arrangement that transfers to another, in whole or in part, any of the economic consequences of ownership of such securities, whether any such transaction described in clause (a) or (b) above is to be settled by delivery of Common Stock or such other securities, in cash or otherwise. The foregoing provisions of this Section 4 shall not apply to sales of Registrable Securities to be included in such offering pursuant to Section 2(a), Section 2(b), Section 2(c), Section 2(d) or Section 3(a), and shall be applicable to the holders of Registrable Securities only if all officers and directors of the Company and all stockholders owning more than 1% of the Company's outstanding Common Stock are subject to the same restrictions. Each holder of Registrable Securities agrees to execute and deliver such other agreements as may be reasonably requested by the Company or the managing underwriter which are consistent with the foregoing or which are necessary to give further effect thereto. Notwithstanding anything to the contrary contained in this Section 4, each holder of Registrable Securities shall be released, pro rata, from any lock-up agreement entered into pursuant to this Section 4 in the event and to the extent that the managing underwriter or the Company permit any discretionary waiver or termination of the restrictions of any lock-up agreement pertaining to any officer, director or holder of greater than 1% of the outstanding Common Stock.

5.Registration Procedures. If and whenever the holders of Registrable Securities request that the offer and sale of any Registrable Securities be registered under the Securities Act or any Registrable Securities be distributed in a Shelf Takedown pursuant to the provisions of this Agreement, the Company shall use its reasonable efforts to effect the registration of the offer and sale of such Registrable Securities under the Securities Act in accordance with the intended method of disposition thereof, and pursuant thereto the Company shall as soon as practicable and as applicable: 

(a)subject to Section 2(a) Section 2(b) and Section 2(c), prepare and file with the Commission a Registration Statement covering such Registrable Securities and use its reasonable efforts to cause such Registration Statement to be declared effective; 

(b)in the case of a Long-Form Registration or a Short-Form Registration, prepare and file with the Commission such amendments, post-effective amendments and supplements to such Registration Statement and the Prospectus used in connection therewith as may be necessary to keep such Registration Statement effective for a period of not less than 120 days, or if earlier, until all of such Registrable Securities have been disposed of and to comply with the provisions of the Securities Act with respect to the disposition of such Registrable Securities in accordance with the intended methods of disposition set forth in such Registration Statement; 


 


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(c)at least ten (10) business days before filing such Registration Statement, Prospectus or amendments or supplements thereto with the Commission, furnish to one counsel selected by holders of two-thirds of such Registrable Securities copies of such documents proposed to be filed, which documents shall be subject to the review, comment and approval of such counsel; 

(d)notify each selling holder of Registrable Securities, promptly after the Company receives notice thereof, of the time when such Registration Statement has been declared effective or a supplement, including a Shelf Supplement, to any Prospectus forming a part of such Registration Statement has been filed with the Commission; 

(e)furnish to each selling holder of Registrable Securities such number of copies of the Prospectus included in such Registration Statement (including each preliminary Prospectus) and any supplement thereto, including a Shelf Supplement (in each case including all exhibits and documents incorporated by reference therein),and such other documents as such seller may request in order to facilitate the disposition of the Registrable Securities owned by such seller; 

(f)use its reasonable efforts to register or qualify such Registrable Securities under such other securities or “blue sky” laws of such jurisdictions as any selling holder reasonably requests and do any and all other acts and things which may be reasonably necessary or advisable to enable such holders to consummate the disposition in such jurisdictions of the Registrable Securities owned by such holders; provided, that the Company shall not be required to qualify generally to do business, subject itself to general taxation or consent to general service of process in any jurisdiction where it would not otherwise be required to do so but for this Section 5(f); 

(g)notify each selling holder of such Registrable Securities, at any time when a Prospectus relating thereto is required to be delivered under the Securities Act, of the happening of any event that would cause the Prospectus included in such Registration Statement to contain an untrue statement of a material fact or omit any fact necessary in order to make the statements made therein, in light of the circumstances under which they were made, not misleading, and, at the request of any such holder, the Company shall prepare a supplement or amendment to such Prospectus so that, as thereafter delivered to the purchasers of such Registrable Securities, such Prospectus shall not contain an untrue statement of a material fact or omit to state any fact necessary to make the statements therein, in light of the circumstances under which they were made, not misleading; 

(h)make available for inspection by any selling holder of Registrable Securities, any underwriter participating in any disposition pursuant to such Registration Statement and any attorney, accountant or other agent retained by any such holder or underwriter (collectively, the “Inspectors”), all financial and other records, pertinent corporate documents and properties of the Company (collectively, the “Records”), and cause the Company's officers, directors and employees to supply all information reasonably requested by any such Inspector in connection with such Registration Statement; 

(i)provide a transfer agent and registrar (which may be the same entity) for all such Registrable Securities not later than the effective date of such registration; 


 


[***] Certain information in this document has been omitted and filed separately with the Securities and Exchange Commission. Confidential treatment has been requested with respect to the omitted portions.


(j)use its reasonable efforts to cause such Registrable Securities to be listed on each securities exchange on which the Common Stock is then listed or, if the Common Stock is not then listed, on a national securities exchange selected by the holders of two-thirds of such Registrable Securities; 

(k)in connection with an underwritten offering, enter into such customary agreements (including underwriting and lock-up agreements in customary form) and take all such other customary actions as the holders of such Registrable Securities or the managing underwriter of such offering reasonably request in order to expedite or facilitate the disposition of such Registrable Securities (including, without limitation, making appropriate officers of the Company available to participate in “road show” and other customary marketing activities (including one-on-one meetings with prospective purchasers of the Registrable Securities)); 

(l)otherwise use its best to comply with all applicable rules and regulations of the Commission and make available to its stockholders an earnings statement (in a form that satisfies the provisions of Section 11(a) of the Securities Act and Rule 158 under the Securities Act or any successor rule thereto) no later than thirty (30) days after the end of the 12-month period beginning with the first day of the Company's first full fiscal quarter after the effective date of such Registration Statement, which earnings statement shall cover said 12-month period, and which requirement will be deemed to be satisfied if the Company timely files complete and accurate information on Forms 10-K, 10-Q and 8-K under the Exchange Act and otherwise complies with Rule 158 under the Securities Act or any successor rule thereto;  

(m)furnish to each selling holder of Registrable Securities and each underwriter, if any, with (i) a written legal opinion of the Company's outside counsel, dated the closing date of the offering, in form and substance as is customarily given in opinions of the Company's counsel to underwriters in underwritten registered offerings; and (ii) on the date of the applicable Prospectus, on the effective date of any post-effective amendment to the applicable Registration Statement and at the closing of the offering, dated the respective dates of delivery thereof, a “comfort” letter signed by the Company's independent certified public accountants in form and substance as is customarily given in accountants' letters to underwriters in underwritten registered offerings; 

(n)without limiting Section 5(f), use its reasonable efforts to cause such Registrable Securities to be registered with or approved by such other governmental agencies or authorities as may be necessary by virtue of the business and operations of the Company to enable the holders of such Registrable Securities to consummate the disposition of such Registrable Securities in accordance with their intended method of distribution thereof; 

(o)notify the holders of Registrable Securities promptly of any request by the Commission for the amending or supplementing of such Registration Statement or Prospectus or for additional information; 

(p)advise the holders of Registrable Securities, promptly after it shall receive notice or obtain knowledge thereof, of the issuance of any stop order by the Commission suspending the effectiveness of such Registration Statement or the initiation or threatening of any proceeding for  


 


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such purpose and promptly use its reasonable efforts to prevent the issuance of any stop order or to obtain its withdrawal at the earliest possible moment if such stop order should be issued;

(q)permit any holder of Registrable Securities which holder, in its sole and exclusive judgment, might be deemed to be an underwriter or a “controlling person” (within the meaning of Section 15 of the Securities Act and Section 20 of the Exchange Act) (a “Controlling Person”) of the Company, to participate in the preparation of such Registration Statement and to require the insertion therein of language, furnished to the Company in writing, which in the reasonable judgment of such holder and its counsel should be included; 

(r)cooperate with the holders of the Registrable Securities to facilitate the timely preparation and delivery of certificates representing the Registrable Securities to be sold pursuant to such Registration Statement or Rule 144 free of any restrictive legends and representing such number of shares of Common Stock and registered in such names as the holders of the Registrable Securities may reasonably request a reasonable period of time prior to sales of Registrable Securities pursuant to such Registration Statement or Rule 144; provided, that the Company may satisfy its obligations hereunder without issuing physical stock certificates through the use of The Depository Trust Company's Direct Registration System (the “DTCDRS”); 

(s)not later than the effective date of such Registration Statement, provide a CUSIP number for all Registrable Securities and provide the applicable transfer agent with printed certificates for the Registrable Securities which are in a form eligible for deposit with The Depository Trust Company; provided, that the Company may satisfy its obligations hereunder without issuing physical stock certificates through the use of the DTCDRS; 

(t)take no direct or indirect action prohibited by Regulation M under the Exchange Act; provided, that, to the extent that any prohibition is applicable to the Company, the Company will take all reasonable action to make any such prohibition inapplicable; and 

(u)otherwise use its reasonable efforts to take all other steps necessary to effect the registration of such Registrable Securities contemplated hereby. 

6.Expenses. All expenses (other than Selling Expenses) incurred by the Company in complying with its obligations pursuant to this Agreement and in connection with the registration and disposition of Registrable Securities shall be paid by the Company, including, without limitation, all (i) registration and filing fees (including, without limitation, any fees relating to filings required to be made with, or the listing of any Registrable Securities on, any securities exchange or over-the-counter trading market on which the Registrable Securities are listed or quoted); (ii) underwriting expenses (other than fees, commissions or discounts); (iii) expenses of any audits incident to or required by any such registration; (iv) fees and expenses of complying with securities and “blue sky” laws (including, without limitation, fees and disbursements of counsel for the Company in connection with “blue sky” qualifications or exemptions of the Registrable Securities); (v) printing expenses; (vi) messenger, telephone and delivery expenses; (vii) fees and expenses of the Company's counsel and accountants; (viii) Financial Industry Regulatory Authority, Inc. filing fees (if any); and (ix) fees and expenses of one counsel for the holders of Registrable Securities participating in such registration as a group (selected by, in the  


 


[***] Certain information in this document has been omitted and filed separately with the Securities and Exchange Commission. Confidential treatment has been requested with respect to the omitted portions.


case of a registration under Section 2(a), the holders of two-thirds of the Registrable Securities initially requesting such registration, and, in the case of all other registrations hereunder, the holders of a majority of the Registrable Securities included in the registration). In addition, the Company shall be responsible for all of its internal expenses incurred in connection with the consummation of the transactions contemplated by this Agreement (including, without limitation, all salaries and expenses of its officers and employees performing legal or accounting duties) and the expense of any annual audits. All Selling Expenses relating to the offer and sale of Registrable Securities registered under the Securities Act pursuant to this Agreement shall be borne and paid by the holders of such Registrable Securities, in proportion to the number of Registrable Securities included in such registration for each such holder.

7.Indemnification. 

(a)The Company shall indemnify and hold harmless, to the fullest extent permitted by law, each holder of Registrable Securities, such holder's officers, directors, managers, members, partners, stockholders and Affiliates, each underwriter, broker or any other Person acting on behalf of such holder of Registrable Securities and each other Controlling Person, if any, who controls any of the foregoing Persons, against all losses, claims, actions, damages, liabilities and expenses, joint or several, to which any of the foregoing Persons may become subject under the Securities Act or otherwise, insofar as such losses, claims, actions, damages, liabilities or expenses arise out of or are based upon any untrue or alleged untrue statement of a material fact contained in any Registration Statement, Prospectus, preliminary Prospectus, free writing prospectus (as defined in Rule 405 under the Securities Act or any successor rule thereto) or any amendment thereof or supplement thereto or any omission or alleged omission of a material fact required to be stated therein or necessary to make the statements therein (in the case of a Prospectus, preliminary Prospectus or free writing prospectus, in light of the circumstances under which they were made) not misleading; and shall reimburse such Persons for any legal or other expenses reasonably incurred by any of them in connection with investigating or defending any such loss, claim, action, damage or liability, except insofar as the same are caused by or contained in any information furnished in writing to the Company by such holder expressly for use therein or by such holder's failure to deliver a copy of the Registration Statement, Prospectus, preliminary Prospectus, free writing prospectus (as defined in Rule 405 under the Securities Act or any successor rule thereto) or any amendments or supplements thereto (if the same was required by applicable law to be so delivered) after the Company has furnished such holder with a sufficient number of copies of the same prior to any written confirmation of the sale of Registrable Securities. This indemnity shall be in addition to any liability the Company may otherwise have. 

(b)In connection with any registration in which a holder of Registrable Securities is participating, each such holder shall furnish to the Company in writing such information as the Company reasonably requests for use in connection with any such Registration Statement or Prospectus and, to the extent permitted by law, shall indemnify and hold harmless, the Company, each director of the Company, each officer of the Company who shall sign such Registration Statement, each underwriter, broker or other Person acting on behalf of the holders of Registrable Securities and each Controlling Person who controls any of the foregoing Persons against any losses, claims, actions, damages, liabilities or expenses resulting from any untrue or alleged untrue statement of material fact contained in the Registration Statement, Prospectus, preliminary  


 


[***] Certain information in this document has been omitted and filed separately with the Securities and Exchange Commission. Confidential treatment has been requested with respect to the omitted portions.


Prospectus, free writing prospectus (as defined in Rule 405 under the Securities Act or any successor rule thereto) or any amendment thereof or supplement thereto or any omission or alleged omission of a material fact required to be stated therein or necessary to make the statements therein (in the case of a Prospectus, preliminary Prospectus or free writing prospectus, in light of the circumstances under which they were made) not misleading, but only to the extent that such untrue statement or omission is contained in any information so furnished in writing by such holder; provided, that the obligation to indemnify shall be several, not joint and several, for each holder and shall not exceed an amount equal to the net proceeds (after underwriting fees, commissions or discounts) actually received by such holder from the sale of Registrable Securities pursuant to such Registration Statement. This indemnity shall be in addition to any liability the selling holder may otherwise have.

(c)Promptly after receipt by an indemnified party of notice of the commencement of any action involving a claim referred to in this Section 7, such indemnified party shall, if a claim in respect thereof is made against an indemnifying party, give written notice to the latter of the commencement of such action. The failure of any indemnified party to notify an indemnifying party of any such action shall not (unless such failure shall have a material adverse effect on the indemnifying party) relieve the indemnifying party from any liability in respect of such action that it may have to such indemnified party hereunder. In case any such action is brought against an indemnified party, the indemnifying party shall be entitled to participate in and to assume the defense of the claims in any such action that are subject or potentially subject to indemnification hereunder, jointly with any other indemnifying party similarly notified to the extent that it may wish, with counsel reasonably satisfactory to such indemnified party, and after written notice from the indemnifying party to such indemnified party of its election so to assume the defense thereof, the indemnifying party shall not be responsible for any legal or other expenses subsequently incurred by the indemnified party in connection with the defense thereof; provided, that, if (i) any indemnified party shall have reasonably concluded that there may be one or more legal or equitable defenses available to such indemnified party which are additional to or conflict with those available to the indemnifying party, or that such claim or litigation involves or could have an effect upon matters beyond the scope of the indemnity provided hereunder, or (ii) such action seeks an injunction or equitable relief against any indemnified party or involves actual or alleged criminal activity, the indemnifying party shall not have the right to assume the defense of such action on behalf of such indemnified party without such indemnified party's prior written consent (but, without such consent, shall have the right to participate therein with counsel of its choice) and such indemnifying party shall reimburse such indemnified party and any Controlling Person of such indemnified party for that portion of the fees and expenses of any counsel retained by the indemnified party which is reasonably related to the matters covered by the indemnity provided hereunder. If the indemnifying party is not entitled to, or elects not to, assume the defense of a claim, it shall not be obligated to pay the fees and expenses of more than one counsel for all parties indemnified by such indemnifying party with respect to such claim, unless in the reasonable judgment of any indemnified party a conflict of interest may exist between such indemnified party and any other of such indemnified parties with respect to such claim. In such instance, the conflicting indemnified parties shall have a right to retain one separate counsel, chosen by the holders of a majority of the Registrable Securities included in the registration, at the expense of the indemnifying party. 


 


[***] Certain information in this document has been omitted and filed separately with the Securities and Exchange Commission. Confidential treatment has been requested with respect to the omitted portions.


(d)If the indemnification provided for hereunder is held by a court of competent jurisdiction to be unavailable to an indemnified party with respect to any loss, claim, damage, liability or action referred to herein, then the indemnifying party, in lieu of indemnifying such indemnified party hereunder, shall contribute to the amounts paid or payable by such indemnified party as a result of such loss, claim, damage, liability or action in such proportion as is appropriate to reflect the relative fault of the indemnifying party on the one hand and of the indemnified party on the other in connection with the statements or omissions which resulted in such loss, claim, damage, liability or action as well as any other relevant equitable considerations; provided, that the maximum amount of liability in respect of such contribution shall be limited, in the case of each holder of Registrable Securities, to an amount equal to the net proceeds (after underwriting fees, commissions or discounts) actually received by such seller from the sale of Registrable Securities effected pursuant to such registration. The relative fault of the indemnifying party and of the indemnified party 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 indemnifying party or by the indemnified party, whether the violation of the Securities Act or any other similar federal or state securities laws or rule or regulation promulgated thereunder applicable to the Company and relating to action or inaction required of the Company in connection with any applicable registration, qualification or compliance was perpetrated by the indemnifying party or the indemnified party and the parties' relative intent, knowledge, access to information and opportunity to correct or prevent such statement or omission. The parties agree that it would not be just and equitable if contribution pursuant hereto were determined by pro rata allocation or by any other method or allocation which does not take account of the equitable considerations referred to herein. No Person guilty or liable 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. 

8.Participation in Underwritten Registrations. No Person may participate in any registration hereunder which is underwritten unless such Person (a) agrees to sell such Person's securities on the basis provided in any underwriting arrangements approved by the Person or Persons entitled hereunder to approve such arrangements and (b) completes and executes all questionnaires, powers of attorney, indemnities, underwriting agreements and other documents required under the terms of such underwriting arrangements. 

9.Rule 144 Compliance. With a view to making available to the holders of Registrable Securities the benefits of Rule 144 and any other rule or regulation of the Commission that may at any time permit a holder to sell securities of the Company to the public without registration, the Company shall: 

(a)make and keep public information available, as those terms are understood and defined in Rule 144, at all times after the Registration Date; 

(b)use reasonable efforts to file with the Commission in a timely manner all reports and other documents required of the Company under the Securities Act and the Exchange Act, at any time after the Registration Date; and 


 


[***] Certain information in this document has been omitted and filed separately with the Securities and Exchange Commission. Confidential treatment has been requested with respect to the omitted portions.


(c)furnish to any holder so long as the holder owns Registrable Securities, promptly upon request, a written statement by the Company as to its compliance with the reporting requirements of Rule 144 and of the Securities Act and the Exchange Act, a copy of the most recent annual or quarterly report of the Company, and such other reports and documents so filed or furnished by the Company as such holder may reasonably request in connection with the sale of Registrable Securities without registration. 

10.Preservation of Rights. The Company shall not (a) grant any registration rights to third parties which are more favorable than or inconsistent with the rights granted hereunder, or (b) enter into any agreement, take any action, or permit any change to occur, with respect to its securities that violates or subordinates the rights expressly granted to the holders of Registrable Securities in this Agreement. 

11.Remedies. Each holder of Registrable Securities, in addition to being entitled to exercise all rights granted by law, including recovery of damages, shall be entitled to specific performance of its rights under this Agreement. The Company acknowledges that monetary damages would not be adequate compensation for any loss incurred by reason of a breach by it of the provisions of this Agreement and the Company hereby agrees to waive the defense in any action for specific performance that a remedy at law would be adequate. 


 


[***] Certain information in this document has been omitted and filed separately with the Securities and Exchange Commission. Confidential treatment has been requested with respect to the omitted portions.


Exhibit C

 

Pernix Promote (Sale Proceeds Example):

 

A.On the Closing Date, the total Invested Amount is $100M, allocated as set forth below: 

 

Stockholder

Debt Commitment

Equity Contribution

1992 Funds

$37,500,000

$37,500,000

Whitebox Funds

$7,500,000

$7,500,000

Pernix

$5,000,000

$5,000,000

 

On the one year anniversary of the Closing Date, a Trigger Event occurs.  There have been $20M of Distributions with respect to the Debt Commitments and there is no other outstanding indebtedness of the Company.  The Trigger Event results in net proceeds to the Company of $200M.  

 

The proceeds are payable to the Stockholders as follows:

 

1.First, each Stockholder’s Debt Commitments minus the amount of Distributions with respect to such Debt Commitments plus the amount of accrued and unpaid interest would be paid as follows: $50M - $20M + $0 = $30M.  This example assumes no accrued and unpaid interest.   

 

Stockholder

Sale Proceeds Distributed

1992 Funds

$22,500,000

Whitebox Funds

$4,500,000

Pernix

$3,000,000

 

In addition, all other indebtedness of the Company would be repaid, in the case of such indebtedness and the Debt Commitments, in the applicable order of priority.

 

2.Second, each Stockholder’s Equity Commitments minus the amount of Distributions with respect to such Equity Commitments plus the amount of any Pernix Promote paid with respect to such Distribution would be paid as follows: $50M - $0 + $0 = $50M 

 

Stockholder

Sale Proceeds Distributed

1992 Funds

$37,500,000

Whitebox Funds

$7,500,000

Pernix

$5,000,000

 

3.Third, Pernix would receive 10% of the remaining Sale Proceeds calculated as follows: $200M - $30M - $50M = $120M * .1 = $12M  

 

4.Third, the remaining Sale Proceeds would be distributed to the Stockholders pro rata based on their percentage ownership of the Company Securities, calculated as follows:  $200M - $30M - $50M - $12M =  $108M 

 

Stockholder

Sale Proceeds Distributed

1992 Funds

$81,000,000

Whitebox Funds

$16,200,000

Pernix

$10,800,000


 


[***] Certain information in this document has been omitted and filed separately with the Securities and Exchange Commission. Confidential treatment has been requested with respect to the omitted portions.


Pernix Promote (Distributions Example):

 

A.On the Closing Date, the total Invested Amount is $100M, allocated as set forth below: 

 

Stockholder

Debt Commitment

Equity Contribution

1992 Funds

$37,500,000

$37,500,000

Whitebox Funds

$7,500,000

$7,500,000

Pernix

$5,000,000

$5,000,000

 

The Company repays the Invested Amounts (and accrued interest on the Debt Commitments) and subsequently begins to make quarterly Distributions with respect to the Capital Stock in an amount of $1M per quarter.  The Distributions payable to each Stockholder would be calculated as follows:

 

Stockholder

Distribution

Pernix Promote ($1M * .1)

$100,000

Distribution Remaining

$900,000

1992 Funds ($900K * .75)

$675,000

Whitebox Funds ($900K *.15)

$135,000

Pernix ($900K *.10)

$90,000


 


[***] Certain information in this document has been omitted and filed separately with the Securities and Exchange Commission. Confidential treatment has been requested with respect to the omitted portions.


Pernix Purchase Option Example:

 

[***]


 

EX-10.2 4 exh10-2.htm SERVICES AGREEMENT, DATED JULY 27, 2018, BETWEEN NALPROPION PHARMACEUTICALS, INC. AND PERNIX THERAPEUTICS, LLC .

EXECUTION VERSION 


SERVICES AGREEMENT

dated as of

July 27, 2018

between

NALPROPION PHARMACEUTICALS, INC.

and

PERNIX THERAPEUTICS, LLC


#90879273v29



TABLE OF CONTENTS

 

PAGE

ARTICLE 1 Definitions1 

Section 1.01 .  Definitions1 

Section 1.02 .  Other Definitional and Interpretive Provisions7 

ARTICLE 2 Services8 

Section 2.01 .  Services8 

Section 2.02 .  Third Party Providers10 

Section 2.03 .  General Standard of Service11 

Section 2.04 .  Compliance with Applicable Legal Requirements11 

Section 2.05 .  Business Plan and Budget11 

Section 2.06 .  Company Approval11 

Section 2.07 .  Reports11 

Section 2.08 .  Force Majeure12 

Section 2.09 .  Limitations13 

Section 2.10 .  Cooperation; Further Actions14 

Section 2.11 .  Systems Access14 

Section 2.12 .  Policies and Procedures15 

Section 2.13 .  Outstanding Accounts Receivable15 

ARTICLE 3 Distribution16 

Section 3.01 .  Appointment as Exclusive Distributor16 

Section 3.02 .  Supply of Product17 

Section 3.03 .  Intellectual Property Matters20 

Section 3.04 .  Regulatory Matters23 

Section 3.05 .  Cross-Territory Sales25 

ARTICLE 4 Fees; Payments25 

Section 4.01 .  Fees for Services25 

Section 4.02 .  Invoicing and Payments.26 

ARTICLE 5 Other Agreements29 

Section 5.01 .  Confidentiality29 

Section 5.02 .  Safeguards29 

Section 5.03 .  Noncompetition29 

ARTICLE 6 Indemnification; Limitation of Liability30 

Section 6.01 .  Indemnification30 

Section 6.02 .  Warranties31 

Section 6.03 .  Procedures32 

Section 6.04 .  Limitation of Liability: Exclusion of Damages34 

Section 6.05 .  Insurance34 


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ARTICLE 7 Term; Termination of Services34 

Section 7.01 .  Term34 

Section 7.02 .  Termination35 

Section 7.03 .  Effect of Termination37 

ARTICLE 8 Miscellaneous38 

Section 8.01 .  Notices38 

Section 8.02 .  Amendments; Waivers39 

Section 8.03 .  Expenses39 

Section 8.04 .  Independent Contractor Status39 

Section 8.05 .  Successors and Assigns39 

Section 8.06 .  Governing Law39 

Section 8.07 .  Mediation38 

Section 8.08 .  Jurisdiction38 

Section 8.09 .  Waiver of Jury Trial39 

Section 8.10 .  Counterparts; Third Party Beneficiaries39 

Section 8.11 .  Entire Agreement39 

Section 8.12 .  Severability39 

Section 8.13 .  Specific Performance40 

Section 8.14 .  Set off and Recoupment40 

Section 8.15 .  No Commingling40 

 

Schedule I Company Trademarks 

 

Schedule IIServices 

 

Schedule IIIBoard Approvals 

 

Schedule IVFunds Flow 


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SERVICES AGREEMENT

SERVICES AGREEMENT (this “Agreement”) dated as of July 27, 2018 between Nalpropion Pharmaceuticals, Inc., a Delaware corporation (the “Company”), and Pernix Therapeutics, LLC, a Louisiana limited liability company (“Pernix”).  The Company and Pernix are sometimes individually referred to herein as a “Party” and are sometimes collectively referred to herein as the “Parties.”

W I T N E S S E T H :

WHEREAS, the Company desires to appoint Pernix to perform the Services (as defined below), and Pernix desires to perform the Services, in each case in accordance with the terms and conditions contained in this Agreement.

WHEREAS, the Company is entering into this Agreement in reliance upon the unique skills, experience and expertise of Pernix and its senior managers in the pharmaceutical industry and in the expectation that Pernix’s current officers and senior managers will be available to perform the Services in their respective roles as the initial executive officers of the Company.

WHEREAS, each of the foregoing is a material inducement to the Company in entering into this Agreement with Pernix.

NOW, THEREFORE, for good and valuable consideration, the parties hereto agree as follows:

 

ARTICLE 1 

DEFINITIONS 

Section 1.01.  Definitions.

 

(b)The following terms, as used herein, have the following meanings: 

Affiliate” means, with respect to any Person, any other Person directly or indirectly controlling, controlled by, or under common control with such Person, at the time during the period for which the determination of affiliation is being made.  For purposes of this definition, “control” when used with respect to any Person means the power to direct the management and policies of such Person, directly or indirectly, whether through the ownership of voting securities, by contract or otherwise, and the terms “controlling” and “controlled” have correlative meanings.  For the purposes of this Agreement, in no event shall (i) the Company or any of its Subsidiaries be deemed to be an Affiliate of Pernix, the Pernix Parent or any of their respective Subsidiaries or (ii) Pernix, the Pernix Parent or any of their respective Subsidiaries be deemed to be an Affiliate of the Company or any of its Subsidiaries.  Notwithstanding anything herein to the contrary, for the purposes of this Agreement and solely as between the Parties hereto, any Company Officer, including John A. Sedor, Kenneth R. Piña and Angus W. Smith, shall be deemed to be an Affiliate of Pernix and a Pernix Employee and not an Affiliate of  


#90879273v29



the Company or a Company Employee, regardless of whether such Person is also an officer, director, employee or consultant of the Company or any of its Subsidiaries.

Allocated Compensation” means, with respect to any Corporate Service, the portion of the aggregate compensation (including base salary, wages, commissions, incentive compensation, retirement benefits and employee or welfare benefits) attributable to a Pernix Employee involved in providing such Corporate Service in accordance with the internal budgeting practices of Pernix or its Subsidiaries to the extent consistent with GAAP (other than, in all cases, equity or equity-based compensation), to the extent related to the provision of such Corporate Service to the Company, allocated based on the actual time spent by such Pernix Employee in performing such Corporate Services as evidenced by the contemporaneous written time sheets completed in good faith by such Pernix Employees and maintained by Pernix (subject to Section 2.01(a) and (b) in the case of Company Officers to which the Parties have agreed on a deemed allocation of time dedicated to Corporate Services). 

Allocated Costs” means, with respect to any Corporate Service, without duplication, the (i) Allocated Compensation and (ii) Allocated Overhead. 

Allocated Overhead” means, with respect to any Corporate Service, the portion of the aggregate overhead expenses (including costs associated with office space, connectivity, licenses, setup, utilities and maintenance) attributable to any Pernix Employee involved in providing such Corporate Service in accordance with the internal budgeting practices of Pernix or its Subsidiaries, to the extent related to the provision of such Corporate Service to the Company, allocated based on the actual time spent by such Pernix Employee in performing such Corporate Services as evidenced by the contemporaneous written time sheets completed in good faith by such Pernix Employees and maintained by Pernix (subject to Section 2.01(a) and (b) in the case of Company Officers to which the Parties have agreed on a deemed allocation of time dedicated to Corporate Services), but in all cases shall exclude any overhead expenses related to under-utilized capacity.  

Applicable Law” means, with respect to any Person, any transnational, domestic or foreign federal, state or local law (statutory, common or otherwise), constitution, treaty, convention, ordinance, code, rule, regulation, order, injunction, judgment, decree, ruling or other similar requirement enacted, adopted, promulgated or applied by a Governmental Authority that is binding upon or applicable to such Person. 

Business Day” means a day, other than Saturday, Sunday or other day on which commercial banks in New York, New York are authorized or required by Applicable Law to close.

Capital Stock” has the meaning set forth in the Stockholders Agreement.

Change in Control” has the meaning set forth in the Stockholders Agreement.


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Company Board” means the board of directors of the Company.

Company Employee” means any employee of the Company or one of its Subsidiaries.

Company Intellectual Property” means any and all Intellectual Property Rights owned or controlled by the Company or any of its Subsidiaries, including, if any, the Pernix Product IP.

Company Patents” means all Patents included in the Company Intellectual Property.

Company Trademarks” means the Trademarks included in the Company Intellectual Property and set forth on Schedule I.

“Credit Agreement” has the meaning set forth in the Stockholders Agreement.

FDA” means the U.S. Food and Drug Administration or its successor.

GAAP” means U.S. generally acceptable accounting practices, applied on a consistent basis by the applicable Party.

Governmental Authority” means any transnational, domestic or foreign federal, state or local governmental, regulatory or administrative authority, department, court, agency or official, including any political subdivision thereof.

Intellectual Property Rights” means (i) inventions, whether or not patentable, reduced to practice or made the subject of one or more pending patent applications, (ii) national and multinational statutory invention registrations, patents and patent applications (including all reissues, divisions, continuations, continuations-in-part, extensions and reexaminations thereof) registered or applied for in the Territory and all other nations throughout the world, all improvements to the inventions disclosed in each such registration, patent or patent application (“Patents”), (iii) trademarks, service marks, trade dress, logos, domain names, trade names and corporate names (whether or not registered) in the Territory and all other nations throughout the world, including all variations, derivations, combinations, registrations and applications for registration of the foregoing and all goodwill associated therewith (“Trademarks”), (iv) copyrights (whether or not registered) and registrations and applications for registration thereof in the Territory and all other nations throughout the world, including all derivative works, moral rights, renewals, extensions, reversions or restorations associated with such copyrights, now or hereafter provided by law, regardless of the medium of fixation or means of expression, (v) computer software (including source code, object code, firmware, operating systems and specifications), (vi) trade secrets and, whether or not confidential, business information (including pricing and cost information, business and marketing plans and customer and supplier lists) and know-how (including manufacturing and production processes and techniques and research and development information), (vii) industrial designs (whether or


3

 

 

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not registered), (viii) databases and data collections, (ix) copies and tangible embodiments of any of the foregoing, in whatever form or medium, (x) all rights to obtain and rights to apply for patents, and to register trademarks and copyrights, (xi) all rights in all of the foregoing provided by treaties, conventions and common law and (xii) all rights to sue or recover and retain damages and costs and attorneys’ fees for past, present and future infringement or misappropriation of any of the foregoing.

Logistics Provider” means the third party logistics provider engaged by Pernix from time to time to provide distribution and cash-to-order services for the Product and other products.

Net Sales” means, with respect to any period of time after the date hereof, the gross amounts invoiced for sales of the Product during such period, by, in the case of Net Sales in the Territory, Pernix, its Affiliates and/or its sublicensees to third parties not Affiliated to Pernix for use in the Territory and, in the case of Net Sales outside the Territory, the Company and its Affiliates to third parties not Affiliated to the Company for use outside of the Territory, minus any (i) trade, cash or quantity discounts or commercial rebates; (ii) redemption costs related to patient discount, loyalty and co-pay assistance programs; (iii) fees to wholesalers, retailers or distributors for inventory management programs or pursuant to distribution agreements; (iv) discounts, rebates, chargebacks and other price concessions, along with associated administrative fees, paid under managed care contracts; (v) deductions with respect to returns, recalls and rejections; (vi) price reductions or rebates imposed by Governmental Authorities; (vii) chargebacks granted to drug wholesalers or their customers in cases where there are not direct shipments to such customers; and (viii) sales, transfer, goods, services, value-added, gross receipt or similar taxes, duties, fees, charges or assessments (including any such taxes required to be withheld excluding in all cases taxes on income) (the “Taxes”) levied on, imposed or measured by the invoiced amount for the Product, as adjusted for rebates and refunds, to the extent not paid by a third party (the items in clauses (i) through (viii), the “Net Sales Deductions”).  For the avoidance of doubt, Net Sales Deductions shall be accrued in accordance with GAAP, as an estimate in the month in which the related Products are sold with reconciliations for actual deductions and credits performed on a quarterly basis until all such amounts have been finally reconciled, regardless of the number of quarters such final reconciliation requires.

Net Sales Deductions” has the meaning set forth in the definition of Net Sales.

Orange Book” means the FDA publication entitled “Approved Drug Products with Therapeutic Equivalence Evaluations” or any replacement thereof established or approved by the FDA.

Patents” has the meaning set forth in the definition of Intellectual Property Rights.

Pernix Employee” means any employee of Pernix or one of its Subsidiaries.


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Pernix Parent” means Pernix Therapeutics Holdings, Inc., a Maryland corporation or such successor Person with the power to direct the management and policies of Pernix, directly or indirectly, whether through the ownership of voting securities, by contract or otherwise.

Pernix Product Arrangements” means any and all rights and benefits relating to the commercialization of the Product under any agreement, understanding or arrangement to which Pernix, its Affiliate or its sublicensees is a party.

“Pernix Promote” has the meaning set forth in the Stockholders Agreement.

Person” means an individual, corporation, partnership, limited liability company, association, trust or other entity or organization, including a Governmental Authority.

Product” means (i) the Company’s proprietary fixed dose formulation of bupropion hydrochloride and naltrexone hydrochloride, each in a sustained release formulation, also known as Contrave® or Mysimbaä; provided that this shall be limited to the brand version of this product sold under the Company Trademark “Contrave” and approved under New Drug Application No. 200063, until such time that the Company Board approves the launch of generic version of this product in accordance with Schedule III, in which case such generic version shall also be deemed to be the Product hereunder and (ii) subject to Company Board approval as set forth in Schedule III, any future Company product with a fixed dose formulation of bupropion hydrochloride and naltrexone hydrochloride.

Pro Rata Share” means, with respect to any period of time, a percentage, determined by dividing the ex-factory sales volume of Product distributed by Pernix for use in the Territory during such period of time by the ex-factory sales volume of all products distributed by Pernix for use in the Territory (including the Product, but excluding any Zohydro ER to the extent the amounts relating to the warehousing and distribution of such Zohydro ER has been excluded from the calculation in Section 4.01(b)(ii)) during such period of time.

Regulatory Approvals” means all approvals and authorizations necessary for the development, distribution, importation, manufacture, production, use, storage, packaging, bottling, transport, reimbursement, clinical testing, marketing, offer for sale, sale or other commercialization of the Product for one or more indications in a country or regulatory jurisdiction, and satisfaction of all applicable regulatory and notification requirements.

Regulatory Materials” means all regulatory applications, submissions, notifications, registrations, and other filings made to or with a Governmental Authority in connection with the development, distribution, importation, manufacture, production, use, storage, packaging, bottling, transport, reimbursement, clinical testing, marketing, offer for sale, sale or other commercialization of the Product.


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Stockholders Agreement” means the Amended and Restated Stockholders Agreement among the Company, Highbridge Capital Management, LLC, Pernix Ireland Pain Designated Activity Company and Whitebox Advisors, LLC, dated as of the date hereof, as hereafter amended from time to time.

Subsidiary means, with respect to any Person, any entity of which securities or other ownership interests having ordinary voting power to elect a majority of the board of directors or other persons performing similar functions are at the time directly or indirectly owned by such Person.  For the purposes of this Agreement, in no event shall the Company be deemed to be a Subsidiary of Pernix, Pernix Parent or any of their respective Subsidiaries.

Taxes” has the meaning set forth in the definition of Net Sales.

Territory” means the United States of America (including its territories and possessions).

Trademarks” has the meaning set forth in the definition of Intellectual Property Rights.

“Trigger Event” has the meaning set forth in the Stockholders Agreement.

(c)Each of the following terms is defined in the Section set forth opposite such term: 

Term

Section

Agreement

Preamble

At Will Termination Notice

7.02(b)(i)

At Will Termination Right

7.02(b)(i)

Business

5.03(a)(i)

Business Plan and Budget

2.05

Company

Preamble

Company CEO

2.01(a)(i)

Company Indemnitees

6.01(b)

Company Officers

2.01(a)(i)

Company Third Party Provider

2.11

Confidential Information

5.01

Corporate Services

2.01(a)

Corporate Services Fee Cap

4.01(a)(iii)

Corporate Services Fees

4.01(a)(i)

Corporate Services Taxes

4.01(a)(ii)

Damages

6.01(a)

Departed Key Men

7.02(b)(ii)

Dispute

8.07

Distribution Service

3.01(a)

Expenses

4.01(b)


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Fees

4.01(a)(ii)

Force Majeure Event

2.08

Indemnified Party

6.03(a)

Indemnifying Party

6.03(a)

Initial Term

7.01

Key Man Termination Right

7.02(b)(ii)

Management Fee

4.01(a)(iii)

Mediation Request

8.07

Monthly Company Payment

4.02(c)

Monthly Company Statement

4.02(c)

Monthly Deduction Reimbursements

4.02(a)

Monthly ex-U.S. Net Sales

4.02(b)

Monthly ex-U.S. Net Sales Payment

4.02(b)

Monthly U.S. Net Sales

4.02(a)

Monthly U.S. Net Sales Payment

4.02(a)

Non-Renewal Notice

7.01

Non-Renewal Right

7.01

Order Forecast

‎3.02(c)

Parties

Preamble

Party

Preamble

Pernix

Preamble

Pernix Indemnitees

6.01(a)

Pernix Party

2.02

Pernix Product IP

3.03(a)(i)

Pernix Third Party Provider

2.02

Prosecution Activities

3.03(a)(vi)

Purchase Order

3.02(d)

Replacement Key Men

7.02(b)(ii)

Representatives

5.01

Services

2.01(b)

Subsequent Term

7.01

Term

7.01

Terminating Party

7.02(a)

Territory Infringement

3.03(c)

Third Party Claim

6.03(a)

Third Party Manufacturer

3.02(g)(ii)

Third Party Manufacturing Agreement

3.02(g)(ii)

Transfer Price

3.02(e)

 

Section 1.02.   Other Definitional and Interpretive Provisions.   The words “hereof,” “herein” and “hereunder” and words of like import used in this Agreement shall refer to this Agreement as a whole and not to any particular provision of this Agreement.  The captions herein are included for convenience of reference only and shall be ignored in


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the construction or interpretation hereof.  References to Articles, Sections and Schedules are to Articles, Sections and Schedules of this Agreement unless otherwise specified.  All Schedules attached hereto or referred to herein are hereby incorporated in and made a part of this Agreement as if set forth in full herein.  Any capitalized terms used in any Schedule but not otherwise defined therein shall have the meaning as defined in this Agreement.  Any singular term in this Agreement shall be deemed to include the plural, and any plural term the singular.  Whenever the words “include,” “includes” or “including” are used in this Agreement, they shall be deemed to be followed by the words “without limitation,” whether or not they are in fact followed by those words or words of like import.  “Writing,” “written” and comparable terms refer to printing, typing and other means of reproducing words (including electronic media) in a visible form.  References to any statute shall be deemed to refer to such statute as amended or supplemented from time to time, including through the promulgation of applicable rules or regulations.  References to any agreement or contract are to that agreement or contract as amended, modified or supplemented from time to time in accordance with the terms hereof and thereof.  References to any Person include the successors and permitted assigns of that Person.  References from or through any date mean, unless otherwise specified, from and including or through and including, respectively.  References to one gender include all genders.  References to “$” or “Dollars” shall mean United States Dollars.  The term “or” is not exclusive.

ARTICLE 2 

SERVICES 

Section 2.01.  Services.

 

(a)During the Term, and subject to the terms and conditions set forth herein, Pernix shall perform and be responsible for the provision of services (the “Corporate Services”) necessary for the management and operations of the Company as set forth in the Business Plan and Budget (as defined in Section 2.05 below), as well as all of the following:  

 

(i)Pernix shall provide Pernix Employees to serve as officers of the Company (such Pernix Employees in such capacity, the “Company Officers”), and, as of the date hereof, Pernix has provided John A. Sedor to serve as Chief Executive Officer of the Company (the “Company CEO”) and Kenneth R. Piña to serve as Executive Vice President of the Company, including overseeing the Company’s legal function and Angus W. Smith to serve as Executive Vice President of the Company, including overseeing the Company’s financial operations.  The Company Officers will provide, as part of the Corporate Services, oversight and management of the operations of the Company.  Consistent with Pernix’s responsibilities hereunder for the provision of the Corporate Services, Company Officers each shall have the roles, responsibilities and authorities as set forth in the foregoing and by the Company Board from time to time and in accordance with Delaware corporate law; provided that, for the avoidance of doubt, as between Pernix and the Company, any actions or inactions of such Company Officers in  


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their capacity as officers of the Company shall be imputed to Pernix as Pernix Employees performing Services and thereby Pernix’s responsibility to the extent set forth in Section 2.03 and subject to Sections 6.01 and 6.04; provided, that notwithstanding the foregoing, for the avoidance of doubt, each Company Officer in his capacity as an officer of the Company shall be entitled to (A) the benefit of any indemnification, exculpation and expense reimbursement provisions applicable to officers of the Company to the extent set forth in any organizational document of the Company, and (B) coverage under any director and officer liability insurance policy to the extent the Company has obtained such policies for its officers.  It is agreed by the Parties that John A. Sedor, Kenneth R. Piña and Angus W. Smith shall be deemed, for all purposes under this Agreement including calculation of the Fees, to allocate 30% of the time of their employment with Pernix to the performance of the Corporate Services hereunder; provided that from time to time the Company Board may request for supporting documents on the amount of time actually spent by each such person on the Services and, to the extent materially more or less than 30%, the Parties shall discuss in good faith equitable adjustments to such percentage.

(ii) Pernix shall also provide, or cause one or more of its Affiliates to provide, to the Company, and the Company shall receive, specific services set forth in Schedule II to be provided directly by Pernix (or a Pernix Third Party Provider as set forth in Section 2.02), unless otherwise expressly approved by the Company Board.  

(iii)Pernix shall provide such additional services as “Corporate Services” as expressly provided herein, including under Sections 2.05, 2.07, 2.09(b), 2.11, 3.03, 3.04 and 6.05.  

(iv)Subject to Schedule III, Pernix shall oversee and advise on the engagement of third party service providers by the Company as necessary and appropriate for the management and operations of the Company, it being understood that any such third party providers shall not be deemed to be Pernix Third Party Providers, and that the fees, costs and expenses of such third party providers shall be paid directly by the Company to such providers and shall not be deemed to be Expenses hereunder.  

(v)If, from time to time, the Company Board or, if the Fees for the requested service do not exceed $100,000 per year, the Company CEO, requests that Pernix perform specific services that go beyond the services set forth in this Section 2.01(a) and Pernix so agrees, upon mutual written agreement of the Parties (including mutual written agreement as to any change to the Corporate Services Fee Cap (as defined below) provided that, for the avoidance of doubt, only the Company Board, and not the Company CEO, may approve on the Company's behalf a change in the Corporate Services Fee Cap), Pernix shall provide such additional service as agreed to between the Company Board and Pernix, including,  


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but not limited to those set forth in the Business Plan and Budget, and such additional service shall be a Corporate Service hereunder for all purposes.

(b) It is understood that Pernix shall not have any obligation to provide, and the Company shall not have any obligation to accept, any services hereunder other than the Corporate Services set forth in Section 2.01(a) unless mutually agreed between the Parties in writing; and the Distribution Service (as defined below) (the Corporate Services and the Distribution Service collectively, the “Services”).  For the avoidance of doubt, the Parties acknowledge that all services and functions which are not specifically set forth on Schedule II hereof or the Business Plan and Budget or otherwise delegated to Pernix as Services to be performed by Pernix, including, as of the date hereof, all matters relating to the advertising, promotion and marketing of products of the Company, shall remain the responsibility of the Company, subject in all cases to the overall supervision and management of the Company Officers (in such capacity) as part of the Corporate Services.

(c) In order to facilitate performance of the Corporate Services by Pernix, at Pernix’s request and with the approval of the Company Board in each instance, the Company may in the future appoint, upon the request and consent of Pernix, other Pernix Employees as successors to, or replacements for Company Officers as of the date hereof, and all such persons shall be deemed to provide Services hereunder as Company Officers with the amount of their time deemed allocated to the Services to be mutually agreed by the Parties; provided that (i) Pernix shall remain responsible for ensuring that its obligations with respect to such Services, including the general standard of service described below under Section 2.03, are satisfied with respect to all Services provided by Company Officers and (ii) for the avoidance of doubt, nothing in this Section 2.01(c) shall require Pernix to seek the Company Board’s consent to allocate Pernix Employees to perform Services (other than the Service to act as a Company Officer) in accordance with the terms and conditions and limitations of this Agreement.  Notwithstanding anything herein to the contrary, during the Term, Company Officers may be removed from their respective positions only for cause by the Company Board and in the event of such removal or the resignation, death or incapacity of such named individuals, Pernix may designate replacement Company Officers reasonably acceptable to the Company Board.  Notwithstanding anything herein to the contrary, and for the avoidance of doubt, Company Officers shall serve as officers of the Company only during the Term and Pernix shall cause each Company Officer to resign from all positions held with the Company and any of its Subsidiaries upon the request of the Company Board, and each Company Officer may be removed from such positions by the Company Board without cause and in its sole discretion, on and after expiration or any termination of this Agreement.

(d)  By entering into this Agreement, the Company does not delegate to Pernix any of the powers, duties and responsibilities required to be retained by the Company under Applicable Law (including ownership of all certificates and licenses issued by any Governmental Authority for operation of the Company and its business), if any.  The Company shall be the owner and holder of all Regulatory Approvals required for the operation of the Company and its business, including commercialization of the Product.  


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(e) Notwithstanding anything to the contrary herein, Pernix shall not, and shall cause the Pernix Parties to not, take any of the actions that require the approval of the Company Board in the Company’s organizational documents, including the Stockholders’ Agreement, or by Applicable Law, without the prior written authorization of the Company Board.  Without limiting the foregoing, the actions set forth on Schedule III shall require approval of the Company Board.  Notwithstanding the provisions of this Section 2.01(e), Pernix shall be entitled, at its discretion, to decline to take any action relating to the operation of the Company without first receiving the express written approval of such action by the Company Board.  For the avoidance of doubt, when performing Services to implement any action approved by the Company Board, Pernix shall continue to have the same obligations hereunder with respect to such Services described below under Section 2.03.

Section 2.02.  Third Party Providers. In providing, or otherwise making available, the Services to the Company, Pernix may use Pernix Employees or employ the services of contractors, subcontractors, vendors or other third-party providers (each, a “Pernix Third Party Provider”); provided that Pernix shall remain responsible for ensuring that its obligations described below under Section 2.03 are satisfied with respect to all Services provided by any Pernix Third Party Provider engaged pursuant to this Section 2.02.  Each of Pernix, its Subsidiaries and any Pernix Employee (including any Company Officer) or Pernix Third Party Provider used by Pernix to provide the Services shall be referred to as a “Pernix Party.”

Section 2.03. General Standard of Service.  Pernix shall provide the Services (i) in accordance with the standards and practices for the performance of similar services by Pernix and its Affiliates in the conduct of their own business and (ii) in a manner consistent with Applicable Law.  Pernix shall not be responsible for any inability to provide a Service or any delay in doing so to the extent that such inability or delay is the result of the failure of the Company (excluding any Company Officer) to timely provide the information, access or other cooperation necessary for Pernix to provide such Service.  Pernix’s obligation to provide the Services in accordance with the standards set forth in this Section 2.03 shall be subject to Pernix’s right to supplement, modify, substitute or otherwise alter any of the Services from time to time provided or otherwise made available by a Pernix Party solely to the extent necessary to be generally consistent with supplements, modifications, substitutions or alterations made for similar services provided or otherwise made available by such Pernix Party to Pernix and its Affiliates for their own business or as required by Applicable Law.  Pernix shall promptly notify the Company Board of any material supplements, modifications, substitutions or alterations of the Services made pursuant to this Section 2.03.

Section 2.04. Compliance with Applicable Legal Requirements.  The Parties will comply, and will cause their Affiliates and their respective employees to comply, with all Applicable Law in the performance of this Agreement.

Section 2.05.  Business Plan and Budget.  During the first sixty (60) days of the term of this Agreement, the Company Officers shall oversee, as part of the Corporate


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Services, the preparation by the Company of a business plan and budget for the operation of the Company and the commercialization of the Product for the remainder of the 2018 calendar year and, starting from November of each year, such planned budget for the subsequent calendar year (each such business plan and budget, a “Business Plan and Budget”) to be presented to the Company Board for its approval by December 15th of each year.  Once the Business Plan and Budget has been approved by the Company Board, Pernix shall in good faith perform the Services as set forth herein and/or in the Business Plan and Budget to implement the Business Plan and Budget and shall consult with the Company Board concerning any material changes to the Business Plan and Budget.

Section 2.06.  Company Approval.  For the purposes of this Agreement, only the Company Board shall have the authority to act on the Company’s behalf with respect to the Company’s rights and obligations hereunder.  Notwithstanding the foregoing, the Company Board shall have the right to the extent permitted by Applicable Law, the governance documents of the Company and the Stockholders Agreement, to delegate by an expressed written resolution of the Company Board, all or a portion of its authority under this Section 2.06 to one or more officers of the Company (including Company Officers) or members of the Company Board.

Section 2.07. Reports.

(a)As part of the Corporate Services, a delegate of Pernix (which delegate shall be one or more of the following Pernix Employees unless otherwise approved by the Company Board: John A. Sedor, Kenneth R. Piña and Angus W. Smith) shall be available for (i) any duly called meeting of the Company Board (which may be held as often as deemed necessary by the Company Board) and (ii) non-meeting conference calls with the Company Board as and when requested by the Company Board (but no more than once per month for the first six (6) calendar months after the date hereof and then no more than once every three months thereafter) for the purpose of informing the Company Board of the performance of the Company and the Product against the Business Plan and Budget and any other matters relevant to the operation of the Company, including Pernix’s performance hereunder.  The Company Officers shall oversee the development, preparation and submission by the Company of written reports to the Company Board relative to financial or operational matters of a scope and detail as requested by the Board on a periodic basis (which may be as often as requested by the Company Board) as requested by the Company Board. 

(b)The Company Officers shall oversee the development, preparation and submission by the Company of monthly, quarterly and annual reports to the Company Board and shareholders that contain customary financial information in respect of the Company that are required to be delivered under the Stockholders Agreement, the Credit Agreement and otherwise requested by the Company Board.  Notwithstanding anything within this Agreement to the contrary, all financial books and records of the Company shall remain the property of the Company and any disclosure in violation of this Agreement shall be cause for termination pursuant to Section 7.02(a)(i). 


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Section 2.08.   Force Majeure.  Neither Party shall be liable to the other Party for any delays or any failure to perform under this Agreement to the extent caused by matters or events occurring that are beyond the reasonable control of such first Party (each, a “Force Majeure Event”), including strikes, lockouts or other labor difficulties, fires, floods, acts of God, extremes of weather, earthquakes, tornadoes or similar occurrences, riot, insurrection or other hostilities, embargo or fuel or energy shortage, personnel resignations, third party supply chain and production delays, or unfavorable changes in managed care and other third party contractual relationships (subject to Section 2.02 with respect to Pernix Parties).  Any delays in performance or failures to perform caused by such occurrences shall not be deemed to be a breach or failure to perform under this Agreement.  Each Party shall promptly notify the other Party upon learning of the occurrence of a Force Majeure Event that may lead to a delay in performance or failure to perform by such Party under this Agreement and (i) such first Party shall use its commercially reasonable efforts to mitigate and eliminate such Force Majeure Event in order to resume performance; provided that such first Party will have no obligations to incur any additional costs or liabilities to do so, and (ii) the other Party shall have no obligation hereunder with respect to the obligations that such first Party is unable to perform due to the Force Majeure Event.

Section 2.09.   Limitations.

(a)Pernix represents that is currently has and shall use reasonable best efforts to maintain during the Term the resources and capabilities to perform the Services as currently contemplated and set forth in Schedule II in accordance with this Agreement.  Subject to the foregoing, in providing the Services, subject to Pernix’s obligations to comply with the terms of this Agreement (including meeting the general standard of service described under Section 2.03), no Pernix Party shall be obligated to: (i) hire any additional employees, (ii) maintain the employment of any specific employee or (iii) purchase, lease or license any additional equipment, hardware, Intellectual Property Rights or software.  Notwithstanding the foregoing, should Pernix and/or the Company Board determine that additional employees or equipment, hardware, Intellectual Property Rights or software are needed to perform the Corporate Services, the Company Board and Pernix shall hold good faith discussions as the necessity and most efficient manner to provide them and what, if any, alteration to the Fees and Expenses would be appropriate under such circumstances.  A Pernix Party shall not be obligated to provide any Service that such Pernix Party’s independent auditor concludes will result in material deficiencies with such Pernix Party’s internal financial controls in connection with the keeping of its financial books and records or the preparation of its financial statements, unless such deficiencies can be avoided by a commercially reasonable change in the manner in which such Service is provided, in which case such Pernix Party shall perform such Service in such a manner as to avoid such deficiencies with no liability hereunder. 

(b)All labor matters relating to Pernix Employees (including Pernix Employees in their capacities as Company Officers) shall be within the exclusive control of Pernix (or its applicable Affiliate), and the Company and its Subsidiaries shall not take any action  


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affecting such matters (except as permitted under Section 2.01(c) with respect to the removal of Pernix Employees in their capacities as Company Officers).  Nothing in this Agreement is intended to transfer the employment of any Pernix Employee to the Company or any of its Subsidiaries (including Pernix Employees in their capacities as Company Officers).  All Pernix Employees (including Pernix Employees in their capacities as Company Officers) will be deemed for all compensation, employee benefits, tax and social security contribution purposes to be employees of Pernix (or its applicable Affiliate) and not employees of the Company or any of its Subsidiaries.  All Company Employees will be deemed for all compensation, employee benefits, tax and social security contribution purposes to be employees of the Company (or its applicable Subsidiary) and not employees of Pernix or any of its Affiliates; provided that, as part of the Corporate Services, Pernix shall be responsible for day to day management and administration of Company Employees, including, authority through the Company Officers to hire, terminate and set the compensation of Company Employees.  In providing the Corporate Services, the Pernix Employees (including Pernix Employees in their capacities as Company Officers) will be under the direction, control and supervision of Pernix or its Affiliate and not of the Company or any of its Subsidiaries (subject to the right of the Company Board to remove Pernix Employees in their capacities as Company Officers as permitted by Section 2.01(c)).  For the avoidance of doubt, Company Officers shall not be entitled to receive compensation directly from the Company (excluding, for the avoidance of doubt, the Fees) in respect to the Services except to the extent expressly approved by the Company Board and Pernix.

Section 2.10.  Cooperation; Further Actions.

(a)Each Party shall use its commercially reasonable efforts to cooperate with and assist the other Party in obtaining (i) any third-party consents or amendments or (ii) any licenses or sublicenses with respect to the Intellectual Property Rights, software or data, in each of clauses (i) and (ii) necessary for the performance of the Services by Pernix; provided that, neither Party shall be required to pay any money or other consideration (unless, in the case of Pernix, such money is fully reimbursed by the Company as Fees or Expenses), grant any other accommodation to any Person or initiate any litigation against any Person.  Notwithstanding anything herein to the contrary, to the extent that any such consent, amendment, license or sublicense is not obtained, (A) Pernix shall not be required to provide the applicable Service and (B) the Parties will cooperate in good faith to enter into arrangements that do not require such consent, amendment, license or sublicense and are reasonably acceptable to both Parties under which the Company would obtain the benefit and bear the burden of such Service to the same extent (or as nearly as practicable) as if such consent, amendment, license or sublicense were obtained. 

(b)Pernix acknowledges and agrees that as part of the Corporate Services the Company Officers will oversee all Company Third Party Providers and Company Employees who will be reporting directly or indirectly to Company Officers who are Pernix Employees.  Notwithstanding anything herein to the contrary, the Company shall not be responsible for any inability or delay in the performance of any obligation hereunder to the extent that such inability or delay is the result of the failure of the Company Officers to  


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timely and fully perform the foregoing Services in accordance with this Agreement necessary for the Company to perform such obligations hereunder.

Section 2.11.  Systems Access.  The Company Officers, as part of the Corporate Services, shall oversee the Company Employees and any contractors, subcontractors or vendors of, or third party providers of services to, the Company (each, a “Company Third Party Provider”) in): (i) not attempting to obtain access to, use or interfere with any information technology systems of Pernix or any of its Affiliates, or any data owned, used or processed by Pernix or any of its Affiliates, except to the extent granted by Pernix in connection with receipt by the Company of the Services, (ii) not permitting access to or the use of information technology systems of Pernix or any of its Affiliates by a third party other than as authorized by Pernix and (iii) not disabling, damaging or erasing or disrupting or impairing the normal operation of the information technology systems of Pernix or any of its Affiliates; provided that so long as the Company Officers meet their obligations in performing such Corporate Services in accordance with Section 2.03, nothing in this Section 2.11 shall eliminate the liability of the Company to Pernix to the extent set forth in Article 6 in the event that any of the Company Employees or any Company Third Party Providers take the actions set forth in the foregoing.  To the extent deemed necessary by Pernix, the Company shall use its commercially reasonable efforts to: (A) provide Pernix and each other Pernix Party with access to the Company’s information technology systems, as well as any data owned, used or processed by Pernix or any of its Affiliates, and (B) permit access to, or the use of, information technology systems of the Company by a third party as authorized by Pernix, except in either case to the extent so doing would violate Applicable Law or otherwise not comply with any obligation of the Company including its contractual obligations to third parties.

Section 2.12. Policies and Procedures.

(a)Each Party shall, and shall use its commercially reasonably efforts to cause its employees, officers, directors, advisors and representatives and any contractors to, comply with the internal policies, procedures, rules and regulations of the other Party (as may be updated from time to time in the ordinary course of business) that have been provided to such Party that are applicable to (i) the use of the other Party’s information technology systems, computers, networks, telephone systems, software, data, equipment or other facilities in connection with the provision of the Services or (ii) such Party’s  conduct while on the other Party’s premises or utilizing the other Party’s facilities in connection with the Services, in each case to the extent such policies, procedures, rules or regulations are generally applicable to such Party’s own organization. 

(b)During any period in which Pernix is required to consolidate the results of the Company under U.S. generally accepted accounting practices or Applicable Law, the Company shall, and shall use its commercially reasonable efforts to cause the Company Employees and Company Third Party Providers to, comply, at Pernix’s expense, with and subject to any reasonable accommodations requested by the Company to protect its Confidential Information (including Intellectual Property Rights) the reasonable requests of Pernix Employees and Pernix Third Party Providers for information and  


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assistance and the policies and procedures of Pernix that Pernix, in Pernix’s good faith reasonable judgment, determines that the Company should comply with to ensure that Pernix can satisfy its obligations under Applicable Law.

Section 2.13. Outstanding Accounts Receivable.

 As part of the Corporate Services, Pernix shall have the sole right to, and shall have the responsibility to, collect all accounts receivable of the Company on its behalf that are accrued and outstanding as of the date hereof; provided that (i) Pernix shall pay over to the Company all amounts collected on such accounts receivable within five (5) Business Days of Pernix’s receipt of any such accounts receivable, minus, any (A) accruals or reserves for returns, chargebacks or wholesaler fees to the extent related to such accounts receivables as determined by Pernix in its reasonable discretion which shall be timely paid when due by Pernix on the Company’s behalf and (B) other deductions or expenses that Pernix will be responsible for paying under this Agreement  to the extent such deductions or expenses are expressly permitted to be offset against amounts collected on such accounts receivable as set forth in the Business Plan and Budget or as otherwise expressly approved by the Company Board (or its delegee pursuant to Section 2.06), and (ii) Pernix may delegate the collection of such accounts receivable to a Pernix Third Party Provider as set forth in Section 2.02.  Within thirty (30) days after the end of each calendar month, Pernix shall deliver to the Company a schedule setting forth Pernix’s collections for the prior month and itemizing in detail any deductions made from such collections pursuant to this Section 2.13.  The Company’s right of audit set forth in Section 4.02(f) shall apply to Pernix’s collection activities under this Section 2.13.

ARTICLE 3

DISTRIBUTION

 

Section 3.01. Appointment as Exclusive Distributor

.  

(a)Subject to the terms and conditions set forth herein, the Company hereby appoints Pernix as, and Pernix hereby accepts the appointment as, the exclusive distributor of the Product in the Territory during the Term, and the Company hereby grants to Pernix the exclusive rights to, and Pernix hereby accepts the exclusive responsibilities to, offer for sale, sell, import, warehouse, distribute, accept and fill orders for, invoice, collect cash and record sales of, and process returns for, the Product for use in the Territory, all in a manner consistent with the Product’s Regulatory Approval in the Territory, during the Term (the “Distribution Service”).  In furtherance of the foregoing, and subject to the terms and conditions set forth herein, the Company, on behalf of itself and its Subsidiaries, hereby grants to Pernix, during the Term, an  exclusive (even as to the Company and its Subsidiaries), royalty-free, fully paid-up, sublicensable (solely in accordance with Section 3.01(d)), non-transferable (except in accordance with Section 8.05) license under the Company Intellectual Property to use, sell, offer to sell, import, and distribute the Product for use in the Territory and to use the Company Trademarks in the Territory, all of the foregoing solely to the extent necessary for Pernix to perform the Distribution Service, in  


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a manner consistent with Applicable Law (including the Product’s Regulatory Approval in the Territory) and this Agreement.

(b)The Company reserves the right to practice reasonable quality control with regard to the use of the Company Trademarks by Pernix and its sublicensees and Pernix shall, and shall cause its sublicensees to, adhere to such quality, appearance, distinctiveness and other standards with respect to the use of the Company Trademarks with respect to the Product as the Company may reasonably require from time to time.  Any use of the Company Trademarks by Pernix or its sublicensees inures to the benefit of the Company. 

(c)The Company shall not, and shall ensure that its Affiliates do not, during the term of this Agreement, offer for sale, sell, import or distribute the Product for use in the Territory without the prior written consent of Pernix. 

(d)Pernix shall have the right to grant sublicenses of any and all of its rights under this Agreement to Pernix Parent and any of Pernix Parent’s current Subsidiaries existing as of the date hereof and, with the prior approval of the Company Board in each instance, any third party in connection with the use, sale, offer for sale, importation, or distribution of the Product in the Territory or otherwise in connection with the Distribution Service.  Pernix shall remain responsible and liable to the Company for the performance of each of its sublicensees’ obligations under any sublicense granted under this Agreement. 

(e)Except as expressly provided in this Agreement, as agreed to in writing by the Parties or (iii) solely to the extent necessary for Pernix to perform the Corporate Services, no license or other right, title or interest in or to any Intellectual Property Rights is granted to either Party under this Agreement, whether by implication, estoppel or otherwise. 

Section 3.02. Supply of Product

.  The Company shall supply (or cause to be supplied) exclusively to Pernix for sale for use in the Territory in connection with the Distribution Services, and Pernix shall purchase exclusively from the Company, Pernix’s, its Affiliates’ and its sublicensees’ requirements of the Product for sale in the Territory in connection with the Distribution Services, in accordance with the following terms:

(f)General.  Product to be supplied to Pernix hereunder as part of the Distribution Service shall be sourced by the Company from one or more Third Party Manufacturers.  As part of the Corporate Services, Pernix shall be managing the Company’s Product supply chain with the Third Party Manufacturers.  Pernix shall manage the Company’s supply chain in the Territory in compliance with the Regulatory Approvals and Third Party Manufacturing Agreements consistent with the then current Business Plan and Budget, and the Company Officers shall oversee the Company Employees in their management of the Company’s supply chain outside the Territory. 

(g)Existing Product Inventory.  Notwithstanding the foregoing, any Product inventory owned by the Company existing as of the date hereof and in its possession shall be provided to Pernix for use in connection with the Distribution Services and no Transfer  


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Price (as defined in Section 3.02(d) below) shall be due on such Product; provided however that if the Company owes outstanding payment obligations to any Third Party Manufacturers in respect of such Product, Pernix shall pay such outstanding obligations; and provided further that Pernix shall pay to the Company any Monthly U.S. Net Sales Payment due on such Product.

(h)Forecasts. From time to time, Pernix shall prepare forecasts of its anticipated orders of the Product in connection with the Distribution Service (the “Order Forecast”) that correspond and are consistent with forecasts to be prepared by the Company (as overseen by the Company Officers) and submitted to Third Party Manufacturers in compliance with the applicable Third Party Manufacturing Agreements.   

(i)Orders.  From time to time, Pernix shall order Products from the Company by submitting binding purchase orders (a “Purchase Order”) that correspond and are consistent with Product purchase obligations of the Company to Third Party Manufacturers in compliance with the applicable Third Party Manufacturing Agreements, including purchase orders to be prepared by the Company (as overseen by the Company Officers) to such Third Party Manufacturers under such applicable Third Party Manufacturing Agreements.   

(j)Transfer Price.  The cost of each unit of the Product set forth in a Purchase Order shall be the Company’s actual per unit cost to purchase such unit from the applicable Third Party Manufacturer (which for the avoidance of doubt shall include manufacturing and supply costs of such Product including costs of active pharmaceutical ingredients and other raw materials excluding the costs of any active pharmaceutical ingredients and other raw materials owned by the Company as of the date hereof unless the Company owes outstanding payment obligations to any Third Party Manufacturers in respect of such active pharmaceutical ingredients and other raw materials which in all such cases Pernix shall pay such outstanding obligations as part of the cost of such unit of such Product) (the “Transfer Price”).  The total Transfer Price for the Products delivered to Pernix by a Third Party Manufacturer pursuant to this Section 3.02(d) shall be payable by Pernix to the Company no later than two (2) Business Days prior to the date that the Company is required to pay such Third Party Manufacturer for such Products. 

(k)Delivery.  All Products ordered by Pernix pursuant to an accepted Purchase Order shall be shipped in accordance with the applicable Third Party Manufacturing Agreement and risk, and title to such Products shall pass to Pernix upon acceptance of delivery; provided, that Pernix shall only reject such Products on a basis and within a time period that would permit the Company to properly and timely reject such Products and return them to the Third Party Manufacturer in accordance with the terms of the applicable Third Party Manufacturing Agreement. 

(l)Third Party Manufacturers.  

(i)Notwithstanding anything to the contrary herein, Pernix acknowledges and agrees that:  


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(A)all Product to be supplied to Pernix hereunder shall be sourced by the Company from one or more Third Party Manufacturers;  and,  

(B) terms of supply of Product to Pernix from the Company shall be no more favorable to Pernix than the terms of supply of Product to the Company from the applicable Third Party Manufacturer; and,  

(C)the Company’s obligations hereunder to supply Product to Pernix shall be limited in all cases to using reasonable best efforts to perform the Company’s obligations and enforce the Company’s rights under applicable Third Party Manufacturing Agreements; it being understood that Pernix has no duty to perform the Distribution Service to the extent the Company does not perform pursuant to this Section 3.02(d)(i)(A); and  

(D)In the event the Company incurs obligations pursuant to Third Party Manufacturing Agreements approved by Pernix to purchase Product, Pernix shall have corresponding obligations to the Company to purchase such Product; and  

(E)any liability of the Company to Pernix or remedy of Pernix (whether arising under contract, tort or otherwise) for failure to supply Product hereunder shall in no event exceed the contractual remedy, if any, that the Company may have against any applicable Third Party Manufacturer for such failure under the applicable Third Party Manufacturing Agreement; it being understood that Pernix has no duty to perform the Distribution Service to the extent the Company does not perform pursuant to this Section 3.02(d)(i)(C).  

(ii)In connection with the Distribution Services, Pernix shall have the right to approve (such approval not to be unreasonably withheld, delayed or conditioned) the terms of any manufacturing agreement (“Third Party Manufacturing Agreement”) between the Company and any third party manufacturer (the “Third Party Manufacturer”) in the Territory, and Pernix hereby approves all such Third Party Manufacturers and all such Third Party Manufacturing Agreements existing as of the date hereof.  In accordance with and subject to the terms of the applicable Third Party Manufacturing Agreement, the Company shall use reasonable best efforts, at Pernix’s reasonable request, to: (x) conduct audits of any Third Party Manufacturer, exercise any audit rights that the Company may have under such Third Party Manufacturing Agreement and disclose the results of such audits to Pernix; (y) cause any Third Party Manufacturers to promptly correct any deficiencies discovered in or other adverse findings from any such audits; and (z) use reasonable best efforts to enforce the terms of any Third Party Manufacturing Agreement against any Third Party Manufacturer. 


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(m)Recalls.  In the event that any Governmental Authority issues, requests or recommends a recall or market withdrawal or takes similar action in connection with the Product in the Territory, or in the event that the Company Board and/or Pernix determines that an event, incident or circumstance has occurred that may result in the need for a recall or market withdrawal of the Product in the Territory, Pernix and the Company shall consult with each other as to how best to proceed, it being understood and agreed that the final decision as to any recall or withdrawal of any Product shall be made by the Company Board; provided, however, that Pernix shall not be prohibited hereunder from taking any action (including initiating any recall or withdrawal) that it reasonably believes to be required or appropriate to take by Applicable Law after providing prior written notice of such action to the Company Board.  The Company shall bear all reasonable costs in connection with such recall or withdrawal; provided, however, nothing in this Section 3.02(h) is intended to affect the Parties’ respective rights and obligations under Article 6 with respect to indemnification.   

(i)An illustrative flow chart with respect to the distribution of Products in the Territory is attached hereto as Schedule IV. 

Section 3.03. Intellectual Property Matters.

(a)Ownership of Product Intellectual Property Rights.  

(i)The Parties hereby acknowledge and agree that the Company shall own all right, title and interest in and to the Intellectual Property Rights made or conceived or reduced to practice, in whole or in part, by Pernix, any Affiliate of Pernix and/or any and all of the Pernix Parties during the term of and in performance of the Services pursuant to this Agreement that solely relate to the Product or the Business (collectively, the “Pernix Product IP”).  For no additional consideration, Pernix, on behalf of itself its Affiliates and the Pernix Parties, hereby irrevocably agrees to assign, and does hereby assign, to the Company all right, title and interest in and to the Pernix Product IP, and acknowledges and agrees that the Pernix Product IP is the sole and exclusive property of the Company. 

(ii)Pernix shall further reasonably assist the Company, at the Company’s expense, to further evidence, record and perfect the foregoing assignments set forth in Section 3.03(a)(i) above, and to perfect, obtain and maintain, any Pernix Product IP. 

(iii)Pernix shall, and shall cause its Affiliates and Pernix Parties to, maintain reasonable written records (in such format as may be reasonably specified by the Company) of any conception, development or reduction to practice of Pernix Product IP, and all such written records shall be available and provided to the Company in the manner as requested by the Company.  To the extent such records solely relate to the Pernix Product IP, all such records shall be the sole and exclusive property of the Company. 


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(iv)If Pernix Product IP is based on, incorporates, or is an improvement or derivative of, or cannot be reasonably and fully practiced, made, used, reproduced, distributed and otherwise exploited without using or violating Intellectual Property Rights of Pernix, Pernix hereby grants the Company and its successors a perpetual, irrevocable, worldwide royalty-free, non-exclusive, freely sublicensable and assignable right and license to exploit and exercise all such Intellectual Property Rights in support of the Company’s exercise or exploitation of Pernix Product IP (including any modifications, improvements and derivatives of any of the same); provided that, in the event and to the extent any royalties or other fees become payable by Pernix to third parties as a result of such exercise or exploitation by the Company of the Intellectual Property Rights licensed under this Section 3.03(a)(iv), the Company shall reimburse Pernix for such royalties and fees. 

(v)Pernix shall cause each of the Pernix Affiliates and Pernix Employees to, and shall use reasonable best efforts to cause Pernix Third Party Providers and any other Pernix Parties to, execute and deliver to Pernix or the Company (upon request by the Company) an agreement assigning all of such party’s right, title and interest (if any) in and to the Pernix Product IP consistent with this Section 3.03(a) so that sole and exclusive ownership therein resides in the Company after giving effect to the assignment set forth under Section 3.03(a)(i) above and providing Pernix sufficient rights to grant the license to the Company set forth in Section 3.30(a)(iv).  

(vi)During the Term, subject to Pernix’s exclusive rights in connection with the Distribution Services, Pernix hereby agrees that the Company shall have the first opportunity to review and exploit any business opportunities that relate to the Product and or the Business offered to Pernix or any of its Affiliates (including the Company Officers in their capacity as such).  Such opportunities shall be promptly disclosed to the Company Board from time to time for its consideration. 

(b)Subject to the terms and conditions of this Agreement, during the Term, Pernix shall have the sole and exclusive right (including exercising such right as so directed by the Company Board) to prepare, file, prosecute, maintain and defend (including in connection with any interferences, reissue proceedings, reexaminations, requests for patent term extensions, inter partes reviews, post-grant reviews, derivation proceedings, oppositions or declaratory judgment actions) the Company Patents in the Company’s name, for its benefit and at the Company’s expense (such activities, the “Prosecution Activities”).  In connection with the foregoing, Pernix shall, as part of the Corporate Services, manage Prosecution Activities in accordance with the Business Plan and Budget, subject to any approval rights of the Company Board as set forth in Schedule III.  Notwithstanding the foregoing, any legal counsel engaged to perform Prosecution Activities shall be engaged on behalf of the Company by Pernix.  Each Party shall provide all reasonable cooperation and assistance requested by the other Party in connection with the Prosecution Activities, including by providing any necessary powers of attorney and executing any other required document or instrument for such Prosecution Activities.  Without limiting the generality  


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of the foregoing, each Party shall provide the other Party with all information necessary or desirable to enable such Party to comply with the duty of candor and duty of disclosure requirements of any patent authority.  Pernix agrees that at least one Pernix Employee (initially anticipated to be Erika Senska) shall manage such Prosecution Activities as part of the Corporate Services subject to any approval rights of the Company Board.

(c)If a Party becomes aware of any infringement, threatened infringement or alleged infringement of any of the Company Patents in the Territory (“Territory Infringement”), it shall promptly notify the other Party in writing of such Territory Infringement, including any evidence in the notifying Party’s possession demonstrating such Territory Infringement.  Any “patent certification” filed in the Territory under 21 U.S.C. §355(b)(2) or 21 U.S.C. §355(j)(2) that claims that infringement of a Company Patent will not arise from the manufacture, use or sale of a Product in the Territory by a third party or that any claim of a Company Patent in the Territory is invalid or unenforceable shall be deemed a Territory Infringement hereunder and a Party shall provide the other Party written notice of any such filed certification promptly upon the notifying Party  becoming aware thereof. 

(d)Subject to the terms and conditions or this Agreement, during the Term, Pernix shall have the sole and exclusive right, but not the obligation (unless so directed by the Company Board), to bring an appropriate suit or other action against any Person engaged in any Territory Infringement on behalf and for the benefit of the Company.  Notwithstanding anything herein to the contrary, Pernix shall not exercise the foregoing right by commencing any action or threating any action without the express approval of the Company Board as set forth in Schedule III.  Pursuant to the above, if the Company decides to bring such a suit or other action, then Pernix shall manage matters related to such suit or action, subject to the approval rights of the Company Board, and the management of any such suit shall be a Corporate Service hereunder.  Notwithstanding the foregoing, any legal counsel engaged to represent the Company in such suit or action shall be engaged on behalf of the Company by Pernix.  For the avoidance of doubt, and notwithstanding anything herein to the contrary, Pernix or any other Pernix Party (including any Company Officer) shall not settle any claim, suit or action for Territory Infringement without the express prior approval of the Company Board.  Any recoveries resulting from any claim or action for Territory Infringement shall be shall be first applied to reimbursing the Company for its costs and expenses in connection with such claim or action and the remainder shall be retained by the Company 

(a)During the Term, Pernix shall make recommendations to the Company Board relative to decisions regarding which, if any, of the Company Patents to submit to the FDA for listing in the Orange Book for any Product that is not so listed as of the date hereof.  As part of the Corporate Services, Pernix shall maintain with the FDA correct and complete listings of all Company Patents applicable to the Product.  Notwithstanding anything herein to the contrary, Pernix shall act in accordance with Schedule III. 


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(b)With respect to the matters under this Section 3.03, the Company and Pernix shall discuss promptly after the date hereof entering into a Joint Defense and Common Interest Agreement in a form to be mutually agreed. 

(c)Nothing in this Section 3.03 shall limit Pernix’s obligations with respect to the Corporate Services as expressly set forth in this Agreement. 

Section 3.04.  Regulatory Matters.

(a)Subject to Pernix’s performance of the Services and its responsibility for the operations of the Company as set forth herein, the Company under the oversight and supervision of Pernix (through the Company Officers) shall have responsibility and decision making-authority for its regulatory activities, including communications and filings with any Governmental Authorities, with respect to the Product in and out of the Territory.  As such pertains to the Corporate Services provided by Pernix, the Company shall promptly share with Pernix any written correspondence and/or communications of any kind that it receives from a Governmental Authority, including but not limited to copies of any and all Regulatory Materials and Regulatory Approvals (including all correspondence with Governmental Authorities) and keep Pernix promptly informed of the submission to Governmental Authorities of any significant Regulatory Materials, meetings with Governmental Authorities, and its receipt of, or any material changes to existing, Regulatory Approvals, in the case of this clause (ii), for the Product, whether in or outside the Territory.  In connection with obtaining and maintaining the Regulatory Approvals in the Territory in connection with the Distribution Service, Pernix shall have the right to reference during the Term any and all of the data submitted in support of the Regulatory Materials and Regulatory Approvals, including any Company Intellectual Property.  The Company shall be the legal owner of the Regulatory Approvals associated with the Product in the Territory.  At times and upon agreement by the Parties, as part of the Corporate Services, the Company may appoint Pernix as its agent with respect to such Regulatory Materials and Regulatory Approvals, including the right to file Regulatory Materials or take any other actions required by (or advisable under) Applicable Law or this Agreement in respect of the Product in the Territory on behalf of the Company. 

(b)Pernix and its Affiliates shall have the responsibility in the Territory for complying with all Applicable Laws, regulatory filings and reporting requirements required to be undertaken by Pernix acting as a distributor of the Product in the Territory. Pernix shall promptly notify the appropriate, designated persons within the Company of any report of an adverse drug reaction/experience concerning the Product to the extent known by Pernix.  Pernix shall cooperate with the Company as necessary to report such adverse drug reaction/experience when so required as a distributor of the Product under Applicable Laws.  Pernix shall also promptly notify the appropriate, designated persons within the Company of any material complaints related to the Product of which the applicable personnel of Pernix becomes aware regarding problems with the Product other than those associated with adverse drug reactions/experiences.  Subject to the foregoing, the Company shall be responsible for the timely reporting of all relevant adverse drug reactions/experiences, Product quality, Product complaints and safety data relating to the  


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Product to the appropriate Governmental Authorities in and outside of the Territory, all in accordance with Applicable Law and requirements of Governmental Authorities in the Territory or the applicable jurisdiction outside of the Territory, as the case may be.  As such pertains to the Corporate Services provided by Pernix, the Company shall promptly share all such reports with Pernix, and in all cases shall use its commercially reasonably efforts to provide such reports to Pernix before or simultaneous to the issuance of such reports to Governmental Authorities.

(c)The Company shall use its commercially reasonable efforts to obtain and maintain all Regulatory Approvals in the Territory.  The Company shall be responsible for all Product-related communications with any Governmental Authority in or outside of the Territory regarding the Product, unless previously agreed between the Company and Pernix. 

(d)Each Party shall keep the other Party reasonably informed in writing in a timely manner of any information that such Party receives that (i) raises any material concerns regarding the safety or efficacy of the Product; (ii) indicates or suggests a potential material liability of either Party to third parties (including Governmental Authorities) in connection with the Product; (iii) is reasonably likely to lead to a recall or market withdrawal of the Product; or (iv) relates to the Product and is reasonably likely to have a material impact on a Regulatory Approval or the commercialization of the Product. 

(e)At the request of designated persons within the Company, Pernix will supply distribution information and other information reasonably requested by the Company, for the purposes of inclusion into the Company’s Annual Report to FDA. 

(f)Pernix shall ensure that the Distribution Service activities of Pernix, its Affiliates, Pernix Parties and sublicensees related to the Product shall be compliant with Applicable Laws.  Pernix shall ensure that Pernix, its Affiliates, Pernix Parties and sublicensees shall not use any Promotional Materials not expressly approved for Pernix’s use by the Company Board (or its delegee).  “Promotional Materials” means all sales representative training materials and all written, printed, graphic, electronic, audio or video matter, including, but not limited to, journal advertisements, sales aids, formulary binders, reprints, direct mail, direct-to-consumer advertising, Internet postings, broadcast advertisements and sales reminder aids (for example, scratch pads, pens and other such items), used or intended for use by in connection with any promotion, distribution, marketing, advertising, importation, use, offer for sale, or sale of the Product.  

(g)Pernix and the Company agree to promptly notify the other Party in the event they or any of their respective Affiliates receive any communication or notice from the FDA with respect to the Product or an inspection of the facility where the Product is manufactured, and each Party shall promptly provide a copy of such communications to the extent applicable to the Product to the other.  The Parties shall cooperate in good faith in responding to any such FDA inquiry or in making any report to the FDA with respect to the Product, but in all cases the Company shall have final authority for regulatory decisions concerning the Product and responsibility for all communications with the FDA.   


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(h)Nothing in this Section 3.04 shall limit Pernix’s obligations with respect to the Corporate Services as expressly set forth in this Agreement.   

Section 3.05.   Cross-Territory Sales.  The Company shall not, and shall not authorize any third party to, sell, distribute or otherwise commercialize the Product within the Territory.  Except as authorized under this Agreement (including in connection with the Corporate Services), (i) Pernix shall not directly or indirectly solicit, sell, distribute, ship, consign, or otherwise transfer the Product outside of the Territory and (ii) the Company shall not directly or indirectly solicit, sell, distribute, ship, consign, or otherwise transfer the Product within the Territory.

Section 3.06.    No Conflict. To the fullest extent permitted by Applicable Law, each Party acknowledges and agrees, on behalf of itself and its Affiliates, that the enforcement by Pernix of its rights under Section 3.01, Section 3.02 and ‎Section 3.05, in and of itself, shall in no event be deemed to be (i) a breach of any fiduciary duty owed to the Company by any Pernix Employee (including any Company Officer or any designee of Pernix on the Company Board), whether pursuant to this Agreement, the Stockholders Agreement or otherwise, or (ii) a breach by Pernix under this Agreement of its obligations with respect to the Corporate Services; provided that this Section 3.06 shall not in and of itself limit Pernix’s obligations to perform the Corporate Services or the Company's rights to enforce Pernix's obligations hereunder.

ARTICLE 4 

FEES; PAYMENTS

 

Section 4.01.  Fees for Services.

 

(a)In consideration for the Services provided hereunder during each calendar month, the Company shall pay to Pernix in accordance with Section 4.02: the Allocated Costs for each Corporate Service provided during such calendar month (the “Corporate Services Fees”), with respect to any Corporate Service provided during such calendar month, any Taxes (the “Corporate Services Taxes” and, together with the Corporate Services Fees, the “Fees”), and the amounts payable to Pernix set forth in Section 4.02(a) and Section 4.02(b) (the “Management Fee”); provided that in no event shall the aggregate amount of the Corporate Services Fees paid by the Company to Pernix in any calendar year (pro-rated for any partial calendar year) exceed from the date hereof until December 31, 2023, $6 million, and from January 1, 2024 until the expiration or termination of this Agreement, $4 million (each such amount in clauses (A) and (B), the “Corporate Services Fee Cap”); provided, further that it is understood and agreed between the Parties that the Corporate Services Fee Cap was determined based on the size of the Company and its business as of the date hereof and, accordingly, if the size of the Company and its business shall increase in any material respect after the date hereof, the Parties shall negotiate in good faith to adjust upwards the Corporate Services Fee Cap, and Pernix shall have no liability hereunder to increase the amount of its resources used in the provision of the Corporate Services hereunder to accommodate any material increase  


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in the size of the Company and its business from the date hereof until the Corporate Services Fee Cap has been increased.  

(b)In addition to the Fees, the Company shall pay to Pernix substantially consistent with the then current Business Plan and Budget approved by the Company Board for each Corporate Service the direct and documented out-of-pocket expenses and costs incurred to third parties not Affiliates of Pernix (excluding for the avoidance of doubt Allocated Costs) that relate to the provision of such Corporate Service that are reasonably incurred by Pernix in performing such Corporate Service, including the out-of-pocket expenses and costs incurred by Pernix or any of its Subsidiaries from a Pernix Third Party Provider that are reasonably attributable to the delivery of such Corporate Service and the Pro Rata Share of any amount payable pursuant to any invoice received by Pernix from the Logistics Provider (excluding any such amounts Pernix pays to the Logistics Provider specifically for the warehousing and distribution of Zohydro ER) (collectively, clauses (i) and (ii), the “Expenses”). 

Section 4.02.  Invoicing and Payments.

(a)Within twenty-five (25) days after the end of each calendar month, Pernix shall deliver to the Company a schedule setting forth Pernix’s calculation of (i) the Net Sales in the Territory for such calendar month (the “Monthly U.S. Net Sales”), (ii) an amount equal to (A) 95% of the Monthly U.S. Net Sales for such calendar month minus (B) the aggregate price paid by Pernix to the Company or Third Party Manufacturers during such calendar month for Products pursuant to Section 3.02 (the “Monthly U.S. Net Sales Payment”), which Monthly U.S. Net Sales Payment shall be payable by Pernix to the Company; provided that if Pernix shall adjust its calculation of the Monthly U.S. Net Sales for any calendar month subsequent to the Monthly Reconciliation for such calendar month, then, (A) if the adjusted Monthly U.S. Net Sales is higher than the original Monthly U.S. Net Sales, an amount equal to 95% of such excess shall be payable by Pernix to the Company and (B) if the original Monthly U.S. Net Sales is higher than the adjusted Monthly U.S. Net Sales, Pernix shall deduct from the Monthly U.S. Net Sales Payment for such calendar month an amount equal to 95% of such excess, and (iii) the Net Sales Deductions that the Company will be required to pay related to the Monthly U.S. Net Sales for such month (the “Monthly Deduction Reimbursements”), which Monthly Deduction Reimbursement shall be payable by Pernix to the Company; provided that if a Monthly Deduction Reimbursement is in excess of or less than the actual amounts of Net Sales Deductions that the Company is required to pay, then the Parties shall work together in good faith to ensure that the Company has sufficient funds to make such Net Sales Deductions or apply such excess to future Monthly Deduction Reimbursements, as applicable.   

(b)Within twenty-five (25) days after the end of each calendar month, the Company shall deliver to Pernix a schedule setting forth the Company’s calculation of (i) the Net Sales (excluding Net Sales in the Territory) for such calendar month (the “Monthly ex-U.S. Net Sales”), and (ii) an amount equal to 5% of the Monthly ex-U.S. Net Sales for such calendar month (the “Monthly ex-U.S. Net Sales Payment”), which  


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Monthly ex-U.S. Net Sales Payment shall be payable by the Company to Pernix; provided that if the Company shall adjust its calculation of the Monthly ex-U.S. Net Sales for any calendar month subsequent to the Monthly Reconciliation for such calendar month, then, (A) if the adjusted Monthly ex-U.S. Net Sales is higher than the original Monthly ex-U.S. Net Sales, an amount equal to 5% of such excess shall be payable by the Company to Pernix and (B) if the original Monthly ex-U.S. Net Sales is higher than the adjusted Monthly ex-U.S. Net Sales, the Company shall deduct from the Monthly ex-U.S. Net Sales Payment for such calendar month an amount equal to 5% of such excess.  

(c)Within twenty-five (25) days after the end of each calendar month, Pernix shall deliver to the Company a statement (the “Monthly Company Statement”) setting forth the Fees and Expenses payable by the Company during such calendar month (the “Monthly Company Payment”), together with reasonable supporting documentation that will enable the Company to verify the Fees and Expenses then due; provided that if Pernix shall adjust its calculation of the Monthly Company Payment for any calendar month subsequent to the Monthly Reconciliation, (i) if the adjusted Monthly Company Payment is higher than the original Monthly Company Payment, then an amount equal to such excess shall be payable by the Company to Pernix and (ii) if the original Monthly Company Payment is higher than the adjusted Monthly Company Payment, then the Company shall be entitled to deduct from the Monthly Company Payment for such calendar month an amount equal to such excess.  

(d)On or as soon as is reasonably practicable after the 30th day of each month in which this Agreement is in effect, Pernix shall prepare, or cause to be prepared, a settlement and reconciliation (the “Monthly Reconciliation”) of all amounts due by the Company to Pernix and Pernix to the Company pursuant to Sections 4.02(a), 4.02(b) and 4.02(c).  Such statement shall net the aggregate amount due to Pernix from the Company and from the Company to Pernix, in each case, as shown on the Monthly Reconciliation, against each other and calculate whether a net amount (the “Monthly Net Payment”) is due from Pernix to the Company or from the Company to Pernix.  Within five (5) business days after such statement is issued, the Party which is determined to owe the Monthly Net Payment shall make such Monthly Net Payment to the other.  For the avoidance of doubt, it is expressly understood that such Monthly Net Payment shall be the sole manner of settling, satisfying and paying all amounts due from one party to the other party under this Article 4 except for indemnification which may become due pursuant to Section 6.01 hereof or a payment in connection with termination due pursuant to Section 7.01 or 7.02 hereof or as provided under Section 4.02(f) with respect to a Party’s audit rights.  

(e)If the applicable Party fails to pay any amount set forth in this Section 4.02 on or before the applicable payment date, from and after such payment date, in addition to any and all other remedies available hereunder, the other Party has the right to set off, recoup and apply any such unpaid amounts against any amounts payable by such other Party to the first Party under this Agreement. 

(f)Pernix shall maintain complete and accurate records in all material respects of Fees and Expenses and Monthly U.S. Net Sales for a period of at least three (3) years  


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following the end of the calendar year in which such Fees and Expenses were incurred and such Monthly U.S. Net Sales were generated.  The Company shall maintain complete and accurate records in all material respects of Monthly ex-U.S. Net Sales for a period of at least three (3) years following the end of the calendar year in which such Monthly ex-U.S. Net Sales were generated.  Each Party shall have the right to have an independent public accounting firm (provided that such independent public accounting firm is not compensated on a contingency basis), reasonably acceptable to the other Party, audit such records solely to confirm the accuracy of the amounts of, with respect to the Company’s audit right, Fees and Expenses and Monthly U.S. Net Sales and, with respect to Pernix’s audit right, Monthly ex-U.S. Net Sales.  Such audit may be exercised during normal business hours no more than once in any calendar year upon at least thirty (30) days prior written notice to the Party being audited.  The records of the audited Party shall be considered Confidential Information of such Party under Section 5.01 below.  Such accounting firm shall enter into a reasonable and standard written non-disclosure agreement with the audited Party and shall disclose to the Party requesting the audit only information relating to the accuracy of, with respect to the Company, Fees and Expenses and Monthly U.S. Net Sales and with respect to Pernix, Monthly ex-U.S. Net Sales.  Such accountants shall deliver concurrently to the Parties a detailed final written audit report (setting forth, among other things, the miscalculations, if any, identified by the audit) within thirty (30) days of completion of the audit.  If the audit discloses an overpayment by a Party, the Party who received such overpayment shall promptly pay the other Party the amount of such overpayment, within thirty (30) days of the audit report.  The Party requesting the audit shall bear the full cost of such audit unless such review discloses a discrepancy in the amounts under review of more than five (5) percent (5%) from the amounts originally reported by the Party being audited, in which case, the Party under audit shall reimburse the other Party the documented fees and costs of such audit.

ARTICLE 5

OTHER AGREEMENTS

 

Section 5.01.  Confidentiality.    During the Term and for one year after the expiration or termination of this Agreement, each Party shall hold, and cause its employees, officers, directors, advisors and representatives (collectively, “Representatives”) to hold, in confidence, unless compelled to disclose by judicial or administrative process, by the listing rules of a stock exchange or by other requirements of Applicable Law, all documents and information concerning the other Party provided to it pursuant to this Agreement (“Confidential Information”), except that Confidential Information shall not include any information that (i) is or becomes generally available to the public (other than as a result of a breach of this Section 5.01), (ii) is or becomes available to the receiving party or any of its Representatives from a third party not known by such party or such Representative to be bound by a confidentiality agreement or any legal, fiduciary or other obligation restricting disclosure of such information (iii) previously known on a non-confidential basis by the receiving party or any of its Representatives or (iv) is, with respect to information of the Company, known or used in the businesses of Pernix and its Subsidiaries more broadly than in the business of the Company; provided that Pernix may use or


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disclose Confidential Information of the Company to the extent necessary to perform the Services in accordance with the terms of this Agreement.

 

Section 5.02. Safeguards. Each Party agrees to establish and maintain administrative, physical and technical safeguards, information technology and data security procedures and other protections against the destruction, loss, unauthorized access or alteration of the other Party’s Confidential Information which are no less rigorous than those otherwise maintained for its own Confidential Information.

 

Section 5.02. Noncompetition

 

(a)Pernix agrees that, during the Term and for one (1) year after the expiration or termination of this Agreement, neither it nor any of its Affiliates shall: 

(i)engage, either directly or indirectly, as a principal or for its own account or solely or jointly with others, or as stockholders in any corporation or joint stock association, in any business that competes with the business of the Company, which shall be defined as the development, manufacture, and/or commercialization of any drug product, device or other therapy designed and/or used, alone or in combination as an adjunct or otherwise, for or in connection with weight management and/or weight loss and/or treatment of obesity (the “Business”); provided that nothing herein shall prohibit the acquisition by Pernix or any of its Affiliates of a diversified company having not more than ten percent 10% of its sales attributable to the Business; or 

(vii)employ or solicit for employment any current Company Employee; provided that nothing in this Section 5.03 shall prohibit Pernix or any of its Subsidiaries from (A) conducting any general solicitations for employment, such as any newspaper or Internet help wanted advertisement, directly or through any agent (including placement and recruiting agencies) that is not directed at current Company Employees, or (B) hiring any Company Employee whose employment with the Company or its Subsidiary has ceased. 

(b)   The Company agrees that, during the Term, neither it nor any of its Subsidiaries shall employ or solicit for employment any current Pernix Employee; provided that nothing in this Section 5.03 shall prohibit the Company or any of its Subsidiaries from (i) conducting any general solicitations for employment, such as any newspaper or Internet help wanted advertisement, directly or through any agent (including placement and recruiting agencies) that is not directed at current Pernix Employees, or (ii) hiring any Pernix Employee whose employment with Pernix or its Subsidiary has ceased.

ARTICLE 6

INDEMNIFICATION; LIMITATION OF LIABILITY

 

Section 6.01.  Indemnification.


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(a)The Company agrees to indemnify and hold harmless Pernix, any other Pernix Party, their respective Affiliates and its and their respective Representatives (collectively, the “Pernix Indemnitees”) from and against any damage, loss, liability and expense, including but not limited to reasonable expenses of investigation and reasonable attorneys’ fees and expenses in connection with any action, suit or proceeding, whether involving a Third Party Claim (as defined below) or a claim solely between the Parties (collectively, “Damages”), asserted against or incurred by any Pernix Indemnitee as a result or arising out of (i) the Services supplied by any Pernix Party under this Agreement, provided that the Company shall not be responsible for any Damages for which Pernix is required to indemnify a Company Indemnitee (as defined below) pursuant to Section 6.01(b),  (ii) any claim by any third party that the use, marketing, promotion, offering for sale, sale, distribution, importation or other exploitation of the Product infringes, misappropriates or otherwise violates any Intellectual Property Rights of any third party, provided that if there is a final non-appealable decision by a court that such Damages resulted from or arose from the gross negligence, knowing and willful misconduct by, fraudulent conduct by or breach of Applicable Law by, a Pernix Party, then Pernix shall reimburse the Company for any amounts paid by the Company to Pernix under this clause (ii) and the Company shall have no further obligation under this clause (ii) for such matter, or (iii) the Company’s failure to make payment when due under this Agreement. 

(b)Pernix agrees to indemnify and hold harmless the Company, its Affiliates and its and their respective Representatives (collectively, the “Company Indemnitees”) from and against any and all Damages asserted against or incurred by any Company Indemnitee as a result or arising out of (i) the Services supplied by any Pernix Party under this Agreement, but only to the extent such Damages result from or arise out of the gross negligence of, knowing and willful misconduct by, fraudulent conduct by or breach of Applicable Law by, a Pernix Party, or (ii) Pernix’s failure to make payment when due under this Agreement. 

Section 6.02.  Warranties.

(a)Each Party hereby represents, warrants and covenants to the other Party that:  

(i)Such Party is a business entity duly organized and validly existing under the laws of the jurisdiction in which it is formed. 

(ii)Such Party (A) has the power and authority to enter into this Agreement and to perform its obligations hereunder, and (B) has taken all necessary corporate action on its part to authorize the execution and delivery of this Agreement and the performance of its obligations hereunder. 

(iii)This Agreement has been duly executed and delivered on behalf of such Party, and constitutes a legal, valid, binding obligation, enforceable against such Party in accordance with its terms. 


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(iv)All necessary consents, approvals and authorizations of all Governmental Authorities and other Persons required to be obtained by such Party in connection with its execution, delivery and performance of this Agreement have been obtained. 

(v)The execution and delivery of this Agreement and the performance of such Party’s obligations hereunder (A) do not violate any provisions of the organizational documents of such Party, (B) do not conflict with or violate any requirement of Applicable Laws, and (C) do not conflict with, or constitute a default under, any material contractual obligation of such Party. 

(viii)Neither Party nor its Subsidiaries (A) has been debarred by the FDA or other governmental agency or is the subject of any FDA or other governmental agency debarment investigation or proceeding, (B) has employed or engaged any Person debarred by the FDA or other governmental agency, or any Person which is the subject of any FDA or other governmental agency debarment investigation or proceeding, and (C) has employed or engaged any Person which has been excluded from participating in the Medicare program or any other similar program of a governmental agency or has been subject to sanction pursuant to 42 U.S.C. § 1320a 7a or § 1320a 8 or been convicted of a criminal offense under 42 U.S.C. § 1320a 7b, in the conduct of the activities described above.  

(b)  Except to the extent expressly set forth in this Agreement, neither Party makes, and no Party is relying on, any warranty, express or implied, with respect to the Services and each Party hereby specifically disclaims any implied warranty of reasonable care or workmanlike effort.

Section 6.03.  Procedures

(a)The party seeking indemnification under Section 6.01 (the “Indemnified Party”) shall give prompt notice in writing to the Party against whom indemnity is to be sought (the “Indemnifying Party”) of the assertion of any claim or the commencement of any suit, action or proceeding by any third party (“Third Party Claim”) in respect of which indemnity may be sought under such Section.  Such notice shall set forth in reasonable detail such Third Party Claim and the basis for indemnification (taking into account the information then available to the Indemnified Party).  The failure to so notify the Indemnifying Party shall not relieve the Indemnifying Party of its obligations hereunder, except to the extent such failure shall have materially and adversely prejudiced the Indemnifying Party. 

(b)The Indemnifying Party shall be entitled to participate in the defense of any Third Party Claim and, subject to the limitations set forth in this Section, shall be entitled to control and appoint lead counsel for such defense, in each case at its own expense; provided that prior to assuming control of such defense, the Indemnifying Party must acknowledge that it would have an indemnity obligation for the alleged Damages resulting from such Third Party Claim as provided under this Article 6; and provided further that  


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any Third Party Claim relating to any alleged infringement, misappropriation or other violation of any third-party Intellectual Property Right shall be solely controlled by Pernix, who will act under and at the direction of the Company Board so long as there is no conflict between the Company’s rights and interests and Pernix’s rights and interests; and in the case of any conflict, the Company shall assume control of such defense and Pernix shall be entitled to participate in the defense and employ separate counsel of its choice for such purpose, in which case the fees and expenses of such separate counsel shall be borne by Pernix.

(c)The Indemnifying Party shall not be entitled to assume or maintain control of the defense of any Third Party Claim and shall pay the reasonable fees and expenses of counsel retained by the Indemnified Party if (i) the Indemnifying Party does not deliver the acknowledgment referred to in Section 6.03(b) within thirty (30) days of receipt of notice of the Third Party Claim pursuant to Section 6.03(a), (ii) the Third Party Claim relates to or arises in connection with any criminal proceeding, action, indictment, allegation or investigation, (iii) the Indemnified Party reasonably believes an adverse determination with respect to the Third Party Claim would be materially detrimental to the reputation or future business prospects of the Indemnified Party or any of its Subsidiaries, or (iii) the Third Party Claim seeks an injunction or equitable relief against the Indemnified Party or any of its Affiliates. 

(d)If the Indemnifying Party shall assume the control of the defense of any Third Party Claim in accordance with the provisions of this Section 6.03, the Indemnifying Party shall obtain the prior written consent of the Indemnified Party (which shall not be unreasonably withheld, conditioned or delayed) before entering into any settlement of such Third Party Claim, if the settlement does not expressly unconditionally release the Indemnified Party and its Affiliates from all liabilities and obligations with respect to such Third Party Claim or the settlement imposes injunctive or other equitable relief against the Indemnified Party or any of its Affiliates. 

(e)In circumstances where the Indemnifying Party is controlling the defense of a Third Party Claim, the Indemnified Party shall be entitled to participate in the defense of any Third Party Claim and to employ separate counsel of its choice for such purpose, in which case the fees and expenses of such separate counsel shall be borne by the Indemnified Party; provided that the Indemnifying Party shall pay the reasonable fees and expenses of such separate counsel if representation of both the Indemnifying Party and the Indemnified Party by the same counsel would create a conflict of interest. 

(f)Each Party shall cooperate, and cause their respective Affiliates to cooperate, in the defense or prosecution of any Third Party Claim and shall furnish or cause to be furnished such records, information and testimony, and attend such conferences, discovery proceedings, hearings, trials or appeals, as may be reasonably requested in connection therewith. 

(g)In the event an Indemnified Party has a claim for indemnity under Section 6.01 against an Indemnifying Party that does not involve a Third Party Claim, the  


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Indemnified Party agrees to give prompt, written notice of such claim to the Indemnifying Party.  Such notice shall set forth in reasonable detail such claim and the basis for indemnification (taking into account the information then available to the Indemnified Party).  The failure to so notify the Indemnifying Party shall not relieve the Indemnifying Party of its obligations hereunder, except to the extent such failure shall have materially and adversely prejudiced the Indemnifying Party.  If the Indemnifying Party does not notify the Indemnified Party within thirty (30) days following the receipt of a written notice with respect to any such claim that the Indemnifying Party disputes its indemnity obligation to the Indemnified Party for any Damages with respect to such claim, such Damages shall be conclusively deemed a liability of the Indemnifying Party and the Indemnifying Party shall promptly pay to the Indemnified Party any and all Damages arising out of such claim.  If the Indemnifying Party has timely disputed its indemnity obligation for any Damages with respect to such claim, the Parties shall proceed in good faith to negotiate a resolution of such dispute and, if not resolved through negotiations, such dispute shall be resolved by binding arbitration pursuant to the terms set forth in ‎Section 8.07.

Section 6.04. Limitation of Liability: Exclusion of Damages.

(a)TO THE MAXIMUM EXTENT PERMITTED BY APPLICABLE LAW, NO PARTY WILL BE LIABLE FOR ANY (I) PUNITIVE, SPECIAL, CONSEQUENTIAL, EXEMPLARY OR TREBLED DAMAGES (IN EACH CASE, EXCEPT TO THE EXTENT PAYABLE TO A THIRD PARTY IN RESPECT OF A THIRD PARTY CLAIM BASED ON A FINAL JUDGMENT OF A COURT OF COMPETENT JURISDICTION) OR (II) LOST PROFITS, DIMINUTION IN VALUE, MULTIPLE-BASED OR OTHER DAMAGES CALCULATED BASED ON A MULTIPLE OF ANOTHER FINANCIAL MEASURE, IN EACH CASE, ARISING OUT OF OR RELATING TO THIS AGREEMENT EVEN IF THE OTHER PARTY HAD BEEN ADVISED OF THE POSSIBILITY OF SUCH DAMAGES. 

(b)NOTWITHSTANDING ANY OTHER PROVISION CONTAINED IN THIS AGREEMENT, BUT SUBJECT TO SECTION 8.13, IN NO EVENT WILL EITHER PARTY, THE PERNIX INDEMNITEES OR THE COMPANY INDEMNITEES BE LIABLE UNDER THIS AGREEMENT, INCLUDING FOR ANY AND ALL CLAIMS ARISING OUT OF OR IN CONNECTION WITH THIS AGREEMENT, WHETHER SUCH LIABILITY ARISES FROM ANY CLAIM BASED UPON CONTRACT, WARRANTY, TORT, FAILURE OF ESSENTIAL PURPOSE, TRADE USAGE OR OTHERWISE, EXCEPT WITH RESPECT TO AMOUNTS PAYABLE BY SUCH PARTY UNDER SECTION 6.01. 

(c)NOTWITHSTANDING ANYTHING ELSE HEREIN TO THE CONTRARY, THE MAXIMUM AGGREGATE LIABILITY OF PERNIX TO THE COMPANY UNDER OR IN CONNECTION WITH THIS AGREEMENT, EXCLUDING ANY SUCH LIABILITY PURSUANT TO SECTION 6.01(B)(II), SHALL NOT EXCEED AND SHALL BE LIMITED TO THE FEES ACTUALLY RECEIVED BY PERNIX HEREUNDER OR $6 MILLION, WHICHEVER IS LOWER. 


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Section 6.05. Insurance. Pernix shall be responsible for providing Risk Management services to the Company, including but not limited to securing insurance, as part of the Corporate Services. 

ARTICLE 7

TERM; TERMINATION OF SERVICES 

 

Section 7.01.  Term. This Agreement shall commence on the date hereof and shall remain in effect until the two-year anniversary of the date hereof (the “Initial Term”), unless earlier terminated by the Parties as provided in Section 7.02; provided that upon the expiration of the Initial Term, this Agreement shall automatically be renewed and remain in effect for consecutive one-year terms (each such subsequent term, a “Subsequent Term” and each of the Initial Term and each Subsequent Term, a “Term”) unless the Company elects not to renew this Agreement by providing written notice to Pernix (the “Non-Renewal Notice”) at least ninety (90) days prior to the end of the then-current Term (the “Non-Renewal Right”); provided, further that upon any exercise of the Non-Renewal Right, the Company shall pay to Pernix by wire transfer of immediately available funds payable to the order of Pernix pursuant to wire transfer instructions specified by Pernix an amount equal to $4,000,000 within thirty (30) Business Days after the expiration of the Term; provided, further that, if at any time Pernix holds at least 35% of the Capital Stock, then, notwithstanding anything to the contrary herein, the Company may not exercise the Non-Renewal Right without the prior written consent of Pernix.

 

Section 7.02. Termination.

 

(a)This Agreement may be terminated by either Party (the “Terminating Party”) upon written notice to the other Party, if: 

(i)the other Party materially fails to perform or otherwise materially breaches this Agreement and such failure or breach is not cured, to the reasonable satisfaction of the Terminating Party, within forty-five (45) days of written notice thereof specifying such failure or breach; provided that in no event shall the Company be permitted to terminate this Agreement pursuant to this Section 7.02(a)(i) based only on (A) a failure by Pernix to perform this Agreement relating to or arising from a Force Majeure Event or (B) any suspension of any Service pursuant to Section 2.13 or Section 7.02(c) or (d); or 

(ii)the other Party fails to perform its obligations hereunder as a result of a Force Majeure Event for any period aggregating one hundred and twenty (120) days or more within any three hundred and sixty (360) day period; or 

(iii)the other Party makes a general assignment for the benefit of creditors or becomes insolvent, or a receiver is appointed for, or a court approves reorganization or arrangement proceedings on, such Party. 

(b)  The Company may elect to terminate this Agreement:


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(iv)at any time by providing written notice to Pernix (the “At Will Termination Notice”) at least one hundred and twenty (120) days prior to the date of termination (the “At Will Termination Right”); provided that upon any exercise of the At Will Termination Right, the Company shall pay to Pernix by wire transfer of immediately available funds payable to the order of Pernix pursuant to wire transfer instructions specified by Pernix an amount equal to $5,000,000 within thirty (30) Business Days after the effective date of the termination of this Agreement in accordance with this Section 7.02(b)(i); or 

(v)As the Company is entering into this Agreement and the shareholders of the Company are investing in the Company in reliance upon the unique skills, experience and expertise of Pernix and its current officers and senior managers in the pharmaceutical industry and in the expectation that Pernix’s current officers and senior managers will remain in such capacity and become the initial officers and manage of the Company, at any time after the date that is one hundred and twenty (120) days after the date on which any two of John A. Sedor, Kenneth R. Piña or Angus W. Smith are (A) no longer employed by Pernix or a Subsidiary thereof or (B) not holding substantially the same or more senior position as such individual holds at Pernix or a Subsidiary thereof as of the date hereof (such two individuals meeting the conditions in clauses (A) or (B), the “Departed Key Men”), in each case by providing written notice to Pernix (the “Key Man Termination Right”); provided that the Company may not exercise the Key Man Termination Right if Pernix has during such one hundred and twenty (120) day period (x) replaced the Departed Key Men with executives reasonably acceptable to the Company, acting reasonably, or (y) appointed executives reasonably acceptable to the Company, acting reasonably, in substantially the same or more senior positions held by the Departed Key Men as of the date hereof (such two executives who replace the Departed Key Men or who are appointed to substantially the same or more senior positions held by the Departed Key Men as of the date hereof, the “Replacement Key Men”); provided, further that if there are Replacement Key Men pursuant to the preceding proviso, then any such Replacement Key Men shall be substituted for the Departed Key Men in the first sentence of this Section 7.02(b)(ii), mutatis mutandis. 

(c)  The Company Board may, after consultation with Pernix, at any time, and from time to time, during the Term and for any reason, terminate, upon written notice to Pernix, Pernix’s obligations to provide any one or more of the Services (and the scope of any applicable licenses or rights of Pernix hereunder shall be automatically adjusted accordingly), subject to equitable payments to Pernix for costs and payments incurred by Pernix for such Services that cannot be cancelled on short notice; provided that for the avoidance of doubt, the Management Fee shall continue to be payable by the Company pursuant to Article 4 so long as this Agreement remains in effect.

(d) If the performance of any Service causes or would reasonably be expected to cause Pernix to violate any Applicable Law, then Pernix may immediately upon providing


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written notice of such fact to the Company suspend performance of such Service without any liability under this Agreement; provided that, following delivery of such notice, the Parties will cooperate in good faith to promptly amend this Agreement to the extent necessary either (i) to eliminate such violation of Applicable Law (ii) or to determine if such Service can be provided in a different manner that does not violate Applicable Law, in each case while as nearly as possible accomplishing the purpose of the intended Service in a mutually satisfactory manner.  If the Parties are unable to agree upon such an amendment to this Agreement within thirty (30) days of such notification, then Pernix may at its option (i) seek binding arbitration relative to such an amendment or (ii) terminate its obligation with respect to such Service upon written notice to the Company and, for the avoidance of doubt, such termination shall relieve each Party from any liability or payment obligation under this Agreement with respect to such Service that has not yet accrued prior to such termination.

(e)  This Agreement shall terminate automatically and without further notice upon the consummation of a Trigger Event or a Change in Control; and, in the event that the amount of the Pernix Promote is less than $5,000,000, the Company shall pay to Pernix by wire transfer of immediately available funds payable to the order of Pernix pursuant to wire transfer instructions specified by Pernix an amount equal to $5,000,000 less the amount of the Pernix Promote received or receivable by Pernix within thirty (30) Business Days after the effective date of the termination of this Agreement in accordance with this Section 7.02(e); provided, however, that if the amount of the Pernix Promote is equal to or greater than $5,000,000, the Company shall only be obligated to pay Pernix the Pernix Promote.

Section 7.03.  Effect of Termination.

(a)Upon the expiration or the termination of this Agreement or any Service pursuant to Section 7.01 or Section 7.02, Pernix shall have no further obligation to provide the terminated Services (or any Services, in the case of termination of this Agreement in its entirety) and neither the Company nor Pernix shall have any obligation to pay any Fees relating to such Services or make any other payments hereunder; provided that notwithstanding such termination, each Party shall remain liable to the other Party for all Fees, Expenses and other payments that were accrued or incurred prior to the effective date of such termination and Sections 3.03(a)(i), 3.03(a)(iv), 4.02(f), 5.01, 5.03, and Articles 6, 7 and 8 and Article 1 to the extent applicable to any of the foregoing Sections and Articles shall survive any such termination indefinitely. 

(b)Upon the expiration of this Agreement pursuant to Section 7.01 or the termination of this Agreement pursuant to Section 7.02(a)(i), 7.02(a)(iii) or Section 7.02(b), upon request of the Company, Pernix will provide one or more of the Service(s) as the Company deems reasonably necessary or desirable for an orderly transition to the Company for a period of time mutually agreed between the Parties at Pernix’s reasonable and documented cost (including all Fees and Expenses (as applicable)) on the same terms as such Service was provided during the calendar month immediately prior to the expiration or termination of this Agreement; provided that in no event shall any such Service(s) be  


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provided for more than nine (9) months after the expiration or termination of this Agreement.

(c)Upon expiration or termination of this Agreement, all rights and licenses granted to Pernix under this Agreement shall immediately terminate without further notice, provided that, subject to the Company’s rights under Section 7.03(d) below, Pernix shall have the non-exclusive right for six (6) months after such termination or expiration to sell any remaining Product inventory Pernix has on hand as of the date of expiration or termination so long as Pernix makes the applicable payments to the Company hereunder, including under Sections 3.02 and 4.02(a) hereof.  

(d)Upon expiration or any termination of this Agreement, the Company shall have the right, upon written notice to Pernix, to (i) cancel any then outstanding Pernix purchase orders for Product without liability to the Company; (ii) fulfill any then outstanding Pernix purchase orders for Product; and/or (iii) purchase from Pernix all unopened Product in Pernix’s inventory that is in good and resellable condition for the cost Pernix paid for such Product or such lesser price as mutually agreed. 

(e)Upon expiration or termination of this Agreement, for no additional consideration, the Company shall be, at the Company’s election on a case by case basis, subrogated to all of the Pernix Product Arrangements to the extent permitted under such Pernix Product Arrangements.  Pernix shall take such actions and execute such instruments as reasonably requested by the Company to facilitate such subrogation.  To the extent that any such Pernix Product Arrangement is not assignable to the Company, Pernix shall take such steps as necessary to allow the Company to obtain and enjoy the benefits of such Pernix Product Arrangements in the form of a license or other right to the extent Pernix has the right and ability to do so at the Company’s sole cost.  During the Term, Pernix shall use its commercially reasonable efforts to ensure that all Pernix Product Arrangements are assignable to the Company at its election at the Company’s sole cost.  

ARTICLE 8

MISCELLANEOUS

 

Section 8.01. Notices. All notices, requests, demands, claims and other communications hereunder shall be in writing.  Any such notice, request, demand, claim or other communication hereunder shall be deemed duly given or made upon receipt when it shall be delivered by hand, certified or registered mail, electronic mail or facsimile to the Party to which it is addressed at such Party’s address specified below, or at such other address as such Party shall have designated by notice in accordance with this Section 8.01:


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if to the Company, to:

Nalpropion Pharmaceuticals, Inc.
c/o Pernix Therapeutics Holdings, Inc.
10 North Park Place
Morristown, NJ 07960
Attn: Secretary of the Board of Directors
Telephone: 973-775-9271
Email: jsedor@pernixtx.com

with copies to:

Highbridge Capital Management, LLC

40 West 57th Street, 32nd Floor

New York, NY 10019

Attn:  Jonathan Segal

Telephone:

Email:  jonathan.segal@highbridge.com

 

and

 

Whitebox Advisors LLC

3033 Excelsior Boulevard

Suite 300

Minneapolis, MN 55416

Attn:  Jake Mercer

Telephone:

Email:  jmercer@whiteboxadvisors.com

 

if to Pernix, to:

Pernix Therapeutics, LLC

c/o Pernix Therapeutics Holdings, Inc.
10 North Park Place
Morristown, NJ 07960
Attn: Chief Legal Officer
Telephone: 973-775-9271  
Email: kpina@pernixtx.com


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Section 8.02.  Amendments; Waivers.  To be effective, any amendment or waiver under this Agreement must be in writing and be signed by the Party against whom enforcement of the same is sought.  Neither the failure of any Party to exercise any right, power or remedy provided under this Agreement or to insist upon compliance by the other Party with its obligations hereunder, nor any custom or practice of the Parties at variance with the terms hereof shall constitute a waiver by such Party of its right to exercise any such right, power or remedy or to demand such compliance.

 

Section 8.03. Expenses. Except as otherwise expressly provided in this Agreement, each Party will bear its respective fees and expenses incurred in connection with the preparation, negotiation, execution and performance of this Agreement and the transactions contemplated herein, including all fees and expenses of its lawyers, consultants and other agents.  Further, in the event of a dispute, each Party will bear its respective fees and expenses incurred in connection with undertaking a binding arbitration proceeding and shall share equally the costs of such arbitration proceeding.

 

Section 8.04.  Independent Contractor Status. Nothing in this Agreement shall constitute or be deemed to constitute a partnership or joint venture between the Parties. Neither Party is now, nor shall it be made by this Agreement, an agent, employee or legal representative of the other Party or any of its Affiliates for any purpose pursuant to this Agreement.  Each Party is and shall be an independent contractor in the performance of Services hereunder and nothing herein shall be construed to be inconsistent with this status.

 

Section 8.05.   Successors and Assigns.  The provisions of this Agreement shall be binding upon and inure to the benefit of the Parties and their respective successors and permitted assigns.  Neither this Agreement nor any right, remedy, obligation or liability arising hereunder or by reason hereof nor any of the documents executed in connection herewith may be assigned by any Party without the consent of the other Party, which consent may be granted or withheld in the discretion of such other Party; provided that, Pernix may assign this Agreement to any of Pernix Parent’s current Subsidiaries existing as of the date hereof, without the prior written consent of the Company; provided, further that (i) Pernix shall remain liable and responsible to the Company for the performance and observance of all such duties and obligations by such Subsidiary and (ii) Section 7.02(b)(ii) shall remain in force and effect notwithstanding any such assignment.

 

Section 8.06.  Governing Law. This Agreement and any claims arising out of this Agreement shall be governed by and construed in accordance with the law of the State of Delaware, without regard to the conflicts of law rules of such state.


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Section 8.07.  Mediation. Any and all claims, disputes or controversies arising out of, in connection with or relating to this Agreement (the “Dispute”) shall, at the written request of a Party (a “Mediation Request”), be submitted to a neutrally positioned Person to act as mediator as mutually agreed by the Parties.  The mediation shall be held in (a) New York, NY or (b) such other place as the Parties may mutually agree in writing. The Parties shall have thirty (30) days from receipt by a Party of a Mediation Request to agree on a mediator.  If no mediator has been agreed upon by the Parties within thirty (30) days of receipt by a Party of a Mediation Request, then Section 8.08 shall apply.  All mediation pursuant to this clause shall be confidential and shall be treated as compromise and settlement negotiations for purposes of applicable rules of evidence, and no oral or documentary representations made by the Parties during such mediation shall be admissible for any purpose in any subsequent proceedings.  Live witness testimony shall not be taken.  Except as required by Applicable Law, neither Party nor its representatives may disclose the existence, content or results of any mediation hereunder without the prior written consent of both Parties.  If any of the Dispute has not been resolved within sixty (60) days of the appointment of a mediator, or within ninety (90) days after receipt by a Party of a Mediation Request (whichever occurs sooner), or within such longer period as the Parties may agree to in writing, then the Dispute shall be submitted to litigation in accordance with Section 8.08.

 

Section 8.08. Jurisdiction. The Parties irrevocably agree that any Dispute not resolved pursuant to Section 8.07 shall be under the exclusive jurisdiction of the Court of Chancery of the State of Delaware; provided, however, that if jurisdiction is not then available in the Court of Chancery of the State of Delaware, then any such legal action or proceeding may be brought in any federal court located in the State of Delaware or any other Delaware state court.  Each of the Parties agrees not to commence any action, suit or proceeding relating to the Dispute except in the courts described above in Delaware, other than actions in any court of competent jurisdiction to enforce any judgment, decree or award rendered by any such court in Delaware as described herein.  Each of the Parties further agrees that notice as provided herein shall constitute sufficient service of process and the Parties further waive any argument that such service is insufficient.  Each of the parties hereby irrevocably and unconditionally waives, and agrees not to assert, by way of motion or as a defense, counterclaim or otherwise, in any action or proceeding arising out of or relating to this Agreement or the transactions contemplated by this Agreement, (a) any claim that it is not personally subject to the jurisdiction of the courts in Delaware as described herein for any reason, (b) that it or its property is exempt or immune from jurisdiction of any such court or from any legal process commenced in such courts (whether through service of notice, attachment prior to judgment, attachment in aid of execution of judgment, execution of judgment or otherwise) and (c) that (i) the suit, action or proceeding in any such court is brought in an inconvenient forum, (ii) the venue of such suit, action or proceeding is improper or (iii) this Agreement, or the subject matter hereof, may not be enforced in or by such courts.


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Section 8.09. WAIVER OF JURY TRIAL.  EACH PARTY HEREBY IRREVOCABLY WAIVES, TO THE FULLEST EXTENT PERMITTED BY APPLICABLE LAW, ANY RIGHT TO TRIAL BY JURY OF ANY ACTION, SUIT OR PROCEEDING (I) ARISING UNDER THIS AGREEMENT, OR (II) IN ANY WAY CONNECTED WITH OR RELATED OR INCIDENTAL TO THE DEALINGS OF THE PARTIES IN RESPECT OF THIS AGREEMENT OR ANY OF THE TRANSACTIONS CONTEMPLATED BY THIS AGREEMENT, IN EACH CASE WHETHER NOW EXISTING OR HEREAFTER ARISING, AND WHETHER IN CONTRACT, TORT, EQUITY OR OTHERWISE. EACH PARTY HEREBY AGREES AND CONSENTS THAT ANY SUCH ACTION, SUIT OR PROCEEDING SHALL BE DECIDED BY COURT TRIAL WITHOUT A JURY AND THAT THE PARTIES MAY FILE A COPY OF THIS AGREEMENT WITH ANY COURT AS WRITTEN EVIDENCE OF THE CONSENT OF THE PARTIES TO THE IRREVOCABLE WAIVER OF THEIR RIGHT TO TRIAL BY JURY.

 

Section 8.10. Counterparts; Third Party Beneficiaries.  This Agreement may be executed in two or more counterparts, each of which shall be deemed to constitute an original of the same Agreement, and all of which together shall constitute one single Agreement.  A complete set of counterparts shall be made available to each Party.  No Person not a party to this Agreement shall have rights under this Agreement as a third-party beneficiary or otherwise.

 

Section 8.11.  Entire Agreement. This Agreement and the Stockholders Agreement constitutes the entire agreement between the Parties with respect to the subject matter hereof and thereof and supersedes all prior agreements and understandings, both oral and written, between the Parties with respect to the subject matter hereof and thereof.

 

Section 8.12.  Severability.  If any term or other provision of this Agreement is held by a court of competent jurisdiction to be invalid, illegal or unenforceable in any respect, such invalidity, illegality or unenforceability shall not affect any other provision of this Agreement, and this Agreement shall be construed as if such invalid, illegal or unenforceable provision had not been included herein.

 

Section 8.13.  Specific Performance. The Parties agree that irreparable damage would occur in the event that any of the provisions of this Agreement were not performed by them in accordance with the terms hereof or were otherwise breached and that each Party shall be entitled to seek an injunction or injunctions to prevent breaches of the provisions of this Agreement and to enforce specifically the provisions of this Agreement (without any requirement to post any bond or other security in connection with seeking such relief), in addition to any other remedy at law or equity.

 

Section 8.14. Set off and Recoupment. Following a default on a payment obligation hereunder, the Parties agree that such defaulted payment obligations shall be subject to set off or recoupment to the maximum extent permitted by applicable law.


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Section 8.15.  No Commingling.  In the event that the Company Board determines that it is not in the best interest of the Company to co-mingle any assets of the Company with assets of Pernix, it shall notify Pernix and the Company Officers and Pernix and the Company shall take reasonable steps to limit such commingling as soon as practicable and take reasonable steps to cause such commingling to cease within 90 days.

[Signature Page Follows]


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

 

NALPROPION PHARMACEUTICALS, INC.

By:

/s/ John A. Sedor

 

Name:JOHN A. SEDOR 

 

Title:CHAIRMAN AND CHIEF EXECUTIVE OFFICER 

 

PERNIX THERAPEUTICS, LLC

By:

/s/ Kenneth R. Piña

 

Name:KENNETH R. PIÑA 

 

Title:SENIOR VICE PRESIDENT AND CORPORATE SECRETARY 

 


[Signature Page to Services Agreement]

 

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Schedule I

Company Trademarks

1.CONTRAVE 

2.OREXIGEN THERAPEUTICS 

3.All Trademarks (as such term is defined in the Asset Purchase Agreement dated as of April 23, 2018 between Orexigen Therapeutics, Inc. and the Company (the “APA”)) in the Territory set forth on Schedule 2.1(d) of the APA 


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Schedule II

List of Corporate Services

Pernix will provide senior management oversight for all of key functions of the Company.  Pernix will provide services to support most corporate functions, as requested specifically by the Company Board, as approved in the Company’s Business Plan and Budget; and as otherwise mutually agreed in writing.  The scope of oversight, services and support to be provided by Pernix shall include, but not be limited to, the following corporate functions:

 

oSales  

oMarketing 

oSales Operations 

oSales Training 

oTrade Relations 

oGovernment Affairs and Contracting 

oManaged Markets 

oPatient Access Programming 

oSupply Chain and Technical Operations 

oRegulatory Affairs  

oQuality Assurance  

oPharmacovigilance/Drug Safety 

oLegal Affairs  

oCorporate Secretarial and Governance Services 

oContract Management Support 

oRisk Management and Insurance 

oHuman Resources  

oCorporate Finance and Financial Reporting  

oMedical Affairs 

oResearch and Development 

oCompliance, Quality Control and Clinical Affairs 


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Schedule III

List of Actions Requiring Company Board Approval

The following actions, whether performed by the Company or Pernix pursuant to the Services Agreement concerning the Company, its business and/or assets will require the Company Board's prior approval unless the Company Board, to the extent permitted by Applicable Law, the governance documents of the Company and the Stockholders Agreement, has to the extent permitted by Applicable Law, the governance documents of the Company and the Stockholders Agreement, delegated by an expressed written resolution of the Company Board, such authority to the Company CEO or other Company Officers:

·Actions which require the approval of the Company Board under Delaware General Corporation Law. 

·Actions which require the approval of the Company Board under the Services Agreement. 

·Actions which require the approval of the Company Board under the Certificate of Incorporation and the Bylaws of the Company. 

·Adoption of each annual Business Plan and Budget of the Company.  

·Unbudgeted operating expenditures exceeding the budgeted amount(s) in the then current Business Plan and Budget approved by the Company Board by $1 million individually or in the aggregate.  

·Unbudgeted capital expenditures exceeding the budgeted amount(s) in the then current Business Plan and Budget approved the Company Board by $1 million, individually or in the aggregate. 

·Other than operating and capital expenditures, material strategic or operational deviations from the then current Business Plan and Budget approved by the Company Board. 

·Any sale, license, transfer, or other disposition of any asset of the Company with a value in excess of $1 million or a sale, license, transfer or other disposition of the Company’s Intellectual Property Rights, other than inventory in the ordinary course of business.   

·Other than trade payables of the Company as incurred in the ordinary course of business consistent with the then current Business Plan and Budget approved by the Company Board, any unbudgeted  indebtedness in excess of $1 million, or guaranteeing any indebtedness in excess of $1 million, or granting any material lien or security interest in respect of any such indebtedness. 

·Other than trade payables as incurred in the ordinary course of business consistent with the then current Business Plan and Budget approved by the Company Board,, any intercompany indebtedness between the Company and/or one or more of its Subsidiaries.  


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·The Board should receive prior notice of and the right to approve or disallow the following actions related to Intellectual Property Rights:  

oMaterial deviation from the prosecution plan and budget included in the then current Business Plan and Budget approved by the Company Board.  

oAbandoning or ceasing the prosecution or maintenance of any of the Company's material rights in any material Patents, Trademarks or other Intellectual Property Rights (including failure to file a continuing patent application after allowance of any patent application).  

oCommencing or settling any administrative proceeding, including threat of action, concerning the Company's rights in material Patents, Trademarks or other Intellectual Property Rights.  

oIssuance of any legal opinion concerning Company's rights in material Patents, Trademarks or other Intellectual Property Rights or the Company's business or products.  

oCommencing or settling any claim or action, including threat of claim or action, alleging infringement, misappropriation or similar claim of the Company's material Intellectual Property Rights.  

oSettling any material claim or action, including threat of claim or action, alleging infringement, misappropriation or similar claim of a third party's Intellectual Property Rights.  

·Developing, manufacturing or commercializing any product other than the brand product sold under the Trademark  Contrave or Mysimba and approved under NDA #200063, (including any generic product),or the granting of a license or authorization to do the foregoing to a third party.  

·Entering into, materially amending, terminating or not renewing any material agreements that: (i) grants any party the right to develop, manufacture, market or sell the Company's product(s), (ii) licenses or secures rights in any Intellectual Property Rights integral to such products (other than ordinary course non-exclusive licenses for commercially available, off-the-shelf software granted by third parties to the Company in the ordinary course of business), (iii) contains any non-competition or non-solicitation covenants that are not considered customary and within the scope of conduct deemed to be in the ordinary course of business, (iv) involve a governmental entity and are not considered within the scope of conduct deemed to be in the ordinary course of business, (iv) which cannot be terminated within 120 days without resulting in a cost or penalty of $50,000 or more, or (iv) which the Company will be committed to spend or is expected to receive, in the aggregate, more than $1 million annually.  

·The following actions related to the regulatory matters:  

oMaterial deviation from the regulatory plan and budget included in the then current Business Plan and Budget approved by the Company Board. 


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oSponsoring, commencing or authorizing any clinical studies for the Company’s products that are not included in the Company’s Business Plan and Budget. 

oThe filing of material regulatory submissions, material amendments and/or supplements, as well as termination and non-renewal notifications, with respect to the Company's products.  

·Review and approval of the Company’s annual risk management and insurance program and subsequent review and approval of any material modifications to any existing and previously Board approved insurance coverage (except for the planned renewal of existing policies on terms not materially different from those in effect).  

·Commencing or settling any material lawsuit, litigation or other legal proceeding with an actual or estimated monetary value in excess of $500,000 or that does not expressly and unconditionally release the Company or which restricts the Company's business in any material respect. 

·Hiring, terminating, or changing the compensation of any of the Company's employees with titles of Senior Vice President or above or creating any new benefits for employees not contemplated in the then current Business Plan and Budget approved by the Company Board.  

·Creating any non wholly-owned subsidiary of the Company or joint venture or similar arrangements, or acquiring any debt securities, equity securities, or any other ownership or similar interest (or any right or option to acquire any such interest) in any other person. 

·Subject to the Stockholders Agreement, issuing, selling or otherwise transferring any debt securities, equity securities, or any other ownership or similar interest (or any right or option to acquire any such interest) in the Company.  

·Entering into any agreement or arrangement to share with a third party profits, losses, revenues, costs or liabilities of the Company.  

·Changing the principal business of the Company, entering new lines of business, or exiting the current line of business

·Engaging the Company's outside auditors. 

·Subject to Section 2.12(b), approving the Company’s consolidated financial statements. 

·Making any material change to any accounting or tax policies of the Company. 

·Filing a voluntary petition in bankruptcy or similar proceeding, or consenting to the appointment of a receiver for the Company.  

·Issuing any press release or public statement on behalf of the Company or with respect to its products relative to a material development, other than in the ordinary course. .   

References to the “Company” and to “Pernix” shall include the respective Affiliates of each.


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EX-10.6 5 exh10-6.htm AMENDMENT NO. 3 TO THE ABL FACILITY, AUGUST 1, 2018, BY AND AMONG PERNIX, THE GUARANTORS AND LENDERS PARTY THERETO

EXECUTION VERSION


AMENDMENT NO. 3 (ABL CREDIT AGREEMENT)

AMENDMENT NO. 3 dated as of August 1, 2018 (this “Amendment”) to the Credit Agreement dated as of July 21, 2017 (as amended, restated, amended and restated or otherwise modified prior to the date hereof, the “Credit Agreement”) by and among Pernix Therapeutics Holdings, Inc., a Maryland corporation (“Parent”), Pernix Therapeutics, LLC, a Louisiana limited liability company (“Therapeutics”), PERNIX SLEEP, INC., a Delaware corporation (“Sleep”), Cypress Pharmaceuticals, Inc., a Mississippi corporation (“Cypress”), GAINE, INC., a Delaware corporation (“Gaine”), Respicopea Inc., a Delaware corporation (“Respicopea”), Macoven Pharmaceuticals, L.L.C., a Louisiana limited liability company (“Macoven”) and Hawthorn Pharmaceuticals, Inc., a Mississippi corporation  (“Hawthorn”, and together with Parent, Therapeutics, Sleep, Cypress, Gaine, Respicopea and Macoven, collectively, jointly and severally, the “Borrowers”, and individually, each a “Borrower”), each other Loan Party, the lenders party thereto and Cantor Fitzgerald Securities, as administrative agent for the lenders (the “Agent”).

W I T N E S S E T H :

WHEREAS, Parent and the Borrowers have requested that the Agent and the Lenders amend the Credit Agreement as set forth herein.

NOW, THEREFORE, the parties hereto agree as follows:

Section 1. &NBSP;Defined Terms; References. &NBSP;Unless otherwise specifically defined herein, each term used herein that is defined in the Credit Agreement has the meaning assigned to such term in the Credit Agreement. Each reference to “hereof”, “hereunder”, “herein” and “hereby” and each other similar reference and each reference to “this Agreement” and each other similar reference contained in the Credit Agreement shall, after this Amendment becomes effective, refer to the Credit Agreement as amended hereby.

Exchange” means the exchange of a certain portion of Parent’s outstanding 12% Senior Secured Notes due 2020 (the “Notes”) for shares of common stock in Parent pursuant to the terms of those certain Exchange Agreements dated as of the date hereof by and among Parent and, respectively, 1992 MSF International Ltd. and 1992 Tactical Credit Master Fund, L.P., in each case in the form attached hereto as Exhibit B.

Section 2.  Amendments to Credit Agreement.  Each of the parties hereto agrees that, effective on the Amendment Effective Date, the Credit Agreement shall be amended as follows:

2.1The following new defined terms be added to Schedule 1.1 in the appropriate alphabetical order to read as follows: 

Amendment No. 3 (ABL Credit Agreement)” means the document titled “Amendment No. 3 (ABL Credit Agreement)” dated on or about August 1 2018 by and among, among others, Parent, the Borrowers, each other Loan Party identified therein and the Agent.


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Amendment No. 3 Effective Date” means the “Amendment Effective Date” as defined in the Amendment No. 3 (ABL Credit Agreement).

Contrave Assets” means any pharmaceutical products based upon or incorporating Bupropion Hydrochloride and/or Naltrexone Hydrochloride, also known as CONTRAVE.

2.2Clause (b)(i) of the definition of “Borrowing Base” contained in Schedule 1.1 therein is hereby amended and restated to read in its entirety as follows: 

(i) $15,000,000,

2.3Clause (b)(iii) of the definition of “Borrowing Base” contained in Schedule 1.1 therein is hereby amended and restated to read in its entirety as follows: 

(iii) the product of 100% multiplied by the amount calculated pursuant to clause (a)(i) above, minus

2.4The definition of “Eligible Accounts” contained in Schedule 1.1 therein is hereby amended by (i) deleting “or” at the end of sub-clause (p) therein, (ii) replacing “.” with “, or” at the end of clause (q) therein, and (iii) inserting a new sub-clause (r) immediately following sub-clause (q) as follows: 

(r)Accounts arising from the sale or distribution of the Contrave Assets and/or due to the Nalpropion JV. 

2.5 Sub-clause (j) of the definition of “Eligible Inventory” contained in Schedule 1.1 therein is hereby amended and restated to read in its entirety as follows: 

(j) it is subject to third party trademark, patent, copyright, licensing or other proprietary rights, unless Agent is satisfied that (1) such Inventory can be freely sold by Agent on and after the occurrence of an Event of a Default despite such third party rights, and (2) no change of control or other event has arisen under the terms of any applicable agreement that would permit the owner, licensor or grantor of any such trademark, patent, copyright, licensing or other proprietary rights to terminate the rights of Borrowers with respect thereto; provided, however, that (i) Inventory consisting of the Khedezla product in an amount not to exceed $750,000 in the aggregate shall not be ineligible pursuant to this clause (j), and (ii) the Inventory that constitutes, or is used in the manufacturing or distribution of, the Contrave Assets, shall constitute Eligible Inventory so long as Agent is reasonably satisfied that such Inventory can be freely sold by Agent on and after the occurrence of an Event of Default (it being understood that Agent (at the direction of the Required Lenders) confirms that it is satisfied in respect to  free salability of the Contrave Assets Inventory based on the facts and circumstances which exist as of Amendment No. 3 Effective Date);

2.6 Sub-clause (p) of the definition of “Eligible Inventory” contained in Schedule 1.1 therein is hereby amended and restated to read in its entirety as follows: 

(p) other than in the case of any item in the Inventory constituting, or used in the manufacturing or distribution of, the Contrave Assets, it was acquired in connection with a Permitted Acquisition or the Orexigen Transaction, until the completion of an appraisal and field examination (or such other diligence as Agent shall require) of such Inventory, in each case,


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reasonably satisfactory to Agent (which appraisal and field examination may be conducted prior to the closing of such Permitted Acquisition or the Orexigen Transaction).

2.7The definition of “Maximum Revolver Amount” contained in Schedule 1.1 therein is hereby amended and restated to read in its entirety as follows: 

Maximum Revolver Amount” means $32,500,000, decreased or increased by the amount of reductions or increases, as the case may be, in the Revolver Commitments made in accordance with Section 2.4(c) or 2.14, as applicable, of the Agreement. 

2.8Section 6.6(a)(i) of the Credit Agreement is hereby amended by (i) deleting “and” at the end of sub-clause (G) therein, (ii) replacing “or” with “and/or” at the end of clause (H) therein, and (iii) inserting a new sub-clause (I) immediately following sub-clause (I) as follows: 

(I) with respect to the Treximet Note Purchase Debt, payments of principal on the Treximet Note Purchase Debt made solely by exchanging such Treximet Note Purchase Debt for shares of Qualified Equity Interests without any payment of cash (other than in respect of fractional shares in an amount not to exceed $50,000).

2.9Schedule C-1 in the Credit Agreement is amended and restated in its entirety in the form of Schedule C-1 attached hereto. Notwithstanding anything set forth in the Loan Documents, the Agent, the Borrowers, and each of the Lenders hereto agree that the Commitments shall be as set forth in Schedule C-1 attached hereto. 

Section 3. &NBSP;Representations and Warranties, Covenants and Acknowledgements. To induce the Agent and Lenders to enter into this Amendment:

(a) the Borrowers and each other Loan Party represents and warrants that (i) as of the date hereof and after giving effect to the amendments hereto, all of the representations and warranties made or deemed to be made under the Credit Agreement and the other Loan Documents are true and correct, except to the extent that such representations and warranties expressly relate to an earlier date in which case such representations and warranties shall have been true and correct on and as of such earlier date, (ii) as of the date hereof and after giving effect to the amendments hereto, there exists no Default or Event of Default under the Credit Agreement or any of the other Loan Documents, (iii) it has the power and is duly authorized to enter into, deliver and perform this Amendment, (iv) this Amendment and each of the other Loan Documents is the legal, valid and binding obligation of each Loan Party, enforceable against each Loan Party in accordance with its terms, except to the extent enforcement may be limited under applicable bankruptcy, insolvency, reorganization, receivership, moratorium, or similar laws affecting creditors’ rights generally and the equitable discretion of the court;  

(b)each Loan Party hereby reaffirms each of the agreements, covenants, and undertakings set forth in the Credit Agreement and each other Loan Document executed in connection therewith or pursuant to, as amended and modified hereby, to which it is a party; and 

(c)Each Loan Party acknowledges and agrees that this Amendment shall be deemed a Loan Document for all purposes under the Credit Agreement. 


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Section 4.  Effectiveness. &NBSP;This Amendment shall become effective on the first date on which each of the following conditions have been satisfied (the “Amendment Effective Date”): (x) when the Agent shall have received (i) from each of the Loan Parties, the Required Lenders and the Agent an executed counterpart hereof signed by such party or facsimile or other written confirmation that such party has signed a counterpart hereof and (ii) the fully executed Amendment No. 2 to the 2017 Term Facility, dated as of the date hereof, in the form attached hereto as Exhibit A and (y) substantially simultaneously therewith, the Exchange shall have been consummated.

Section 5. &NBSP;Reaffirmation of Guaranty. &NBSP;&NBSP;Each Guarantor, for value received, hereby expressly acknowledges and agrees to the Borrower’s execution and delivery of this Amendment, to the performance by each of the Borrowers of its agreements and obligations hereunder and to the consents, amendments and waivers set forth herein. The Amendment, the performance or consummation of any transaction or matter contemplated under the Amendment and all consents, amendments and waivers set forth herein, shall not limit, restrict, extinguish or otherwise impair such Guarantor’s liability to the Agent or Lenders with respect to the payment and other performance obligations of such Guarantor pursuant to the Guaranty and Security Agreement. Each Guarantor hereby ratifies, confirms and approves its obligations under the Guaranty and Security Agreement and acknowledges that it is unconditionally liable to the Agent and Lenders for the full and timely payment of the obligations under the Guaranty and Security Agreement.

Section 6.  Counterparts. &NBSP;This Amendment may be signed in any number of counterparts, each of which shall be an original, with the same effect as if the signatures thereto and hereto were upon the same instrument. Delivery of an executed signature page of this Amendment by facsimile, email or other electronic transmission shall be effective as delivery of a manually executed counterpart to this Amendment.

Section 7. &NBSP;Amendment, Modification and Waiver. This Amendment may not be amended, modified or waived except by an instrument or instruments in writing signed and delivered on behalf of each of the parties hereto.

Section 8.  Severability.  If any provision of this Amendment is held to be illegal, invalid or unenforceable in any jurisdiction, the legality, validity and enforceability of the remaining provisions or obligations, or of such provision or obligation in any other jurisdiction, of this Amendment and the other Loan Documents shall not be affected or impaired thereby.

Section 9.  Headings.  Section and Subsection headings in this Amendment are included herein for convenience of reference only and shall not constitute a part of this Amendment for any other purpose or be given any substantive effect.

Section 10.  Governing Law; Waiver of Jury Trial.  Section 12 of the Credit Agreement is hereby incorporated herein by reference mutatis mutandis.

SECTION 11.  Fees and Expenses.  Borrowers and the Guarantors hereby reconfirm their respective obligations pursuant to the Credit Agreement to pay and reimburse the Agent and the Lenders for all reasonable costs and expenses (including, without limitation, reasonable and documented fees of counsel to the Agent and Lenders) incurred in connection with the negotiation, preparation, execution and delivery of this Agreement and all other documents and instruments delivered in connection herewith.

[Remainder of this page intentionally left blank]


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IN WITNESS WHEREOF, the parties hereto have caused this Amendment to be duly executed as of the date first above written.

 

BORROWERS:

PERNIX THERAPEUTICS HOLDINGS, INC.

 

 

By:

/s/ Kenneth R. Pina

 

 

 

Name:Kenneth R. Pina 

 

 

 

Title:   Corporate Secretary

 

MACOVEN PHARMACEUTICALS, L.L.C.

By:

/s/ John A. Sedor

 

Name:John A. Sedor 

 

Title:Manager 

 

PERNIX THERAPEUTICS, LLC

By:

/s/ John A. Sedor

 

Name:John A. Sedor 

 

Title:Manager 

 

CYPRESS PHARMACEUTICALS, INC.

By:

/s/ Kenneth R. Pina

 

Name:Kenneth R. Pina 

 

Title:Senior Vice President & Corporate Secretary 

 

GAINE, INC.

By:

/s/ Kenneth R. Pina

 

Name:Kenneth R. Pina 

 

Title:Senior Vice President & Corporate Secretary 


[Signature Page to ABL Amendment No. 3]

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RESPICOPEA INC.

By:

/s/ Kenneth R. Pina

 

Name:Kenneth R. Pina 

 

Title: Senior Vice President & Corporate Secretary 

 

HAWTHORN PHARMACEUTICALS, INC.

By:

/s/ Kenneth R. Pina

 

Name:Kenneth R. Pina 

 

Title:Senior Vice President & Corporate Secretary 

 

PERNIX SLEEP, INC.

By:

/s/ Kenneth R. Pina

 

Name:Kenneth R. Pina 

 

Title:Senior Vice President & Corporate Secretary 


[Signature Page to ABL Amendment No. 3]

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GUARANTORS:

PERNIX IRELAND DESIGNATED ACTIVITY COMPANY

 

 

By:

/s/ Angus Smith

 

 

 

Name:Angus Smith 

 

 

 

Title:Director 

 

PERNIX IRELAND LIMITED

By:

/s/ Angus Smith

 

Name:Angus Smith 

 

Title:Director 

 

PERNIX HOLDCO 1, LLC

 

By: Pernix Therapeutics, LLC

Its: Sole Member and Sole Manager

 

By:

/s/ John A. Sedor

 

Name:John A. Sedor 

 

Title:Manager 

 

PERNIX HOLDCO 2, LLC

 

By: Cypress Pharmaceuticals, Inc.

Its: Sole Member and Sole Manager

 

By:

/s/ Kenneth R. Pina

 

Name:Kenneth R. Pina 

 

Title:Corporate Secretary 

 

PERNIX HOLDCO 3, LLC

 

By: Pernix Therapeutics Holdings, Inc.

Its: Sole Member and Sole Manager

 

By:

/s/ Kenneth R. Pina

 

Name:Kenneth R. Pina 

 

Title:Corporate Secretary 


[Signature Page to ABL Amendment No. 3]

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LENDERS:

1992 MSF INTERNATIONAL LTD.

 

 

BY: HIGHBRIDGE CAPITAL MANAGEMENT, LLC, AS TRADING MANAGER,

 

 

 

 

By:

 

 

/s/ Jonathan Segal

 

 

 

Name:Jonathan Segal 

 

 

 

Title:Managing Director 

 

 

 

 

 

 

By:

/s/ Jason Hempel

 

 

 

Name:Jason Hempel 

 

 

 

Title:Managing Director 

 

 

 

 

1992 TACTICAL CREDIT MASTER FUND, L.P.

 

 

BY: HIGHBRIDGE CAPITAL MANAGEMENT, LLC, AS TRADING MANAGER,

 

 

 

 

By:

 

 

/s/ Jonathan Segal

 

 

 

Name:Jonathan Segal 

 

 

 

Title:Managing Director 

 

 

 

 

 

 

By:

/s/ Jason Hempel

 

 

 

Name:Jason Hempel 

 

 

 

Title:Managing Director 


[Signature Page to ABL Amendment No. 3]

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CANTOR FITZGERALD SECURITIES, as Agent

By:

/s/ James Buccola

 

Name:James Buccola 

 

Title:Head of Fixed Income 


[Signature Page to ABL Amendment No. 3]

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EXHIBIT A – AMENDMENT NO. 2 TO 2017 TERM FACILITY


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EXHIBIT B – EXCHANGE AGREEMENTS


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SCHEDULE C-1 – COMMITMENTS

 

Lender

 

Revolver Commitment

Total Commitment

 

1992 MSF International Ltd

$23,400,00

$23,400,00

1992 Tactical Credit Master Fund, L.P.

$9,100,000

$9,100,000

All Lenders

$32,500,000

 

 

$32,500,000


#91143783v7

EX-10.7 6 exh10-7.htm AMENDMENT NO. 2 TO THE TERM FACILITY, DATED AUGUST 1, 2018, BY AND AMONG PIP DAC, THE LENDERS PARTY THERETO

EXECUTION VERSION


AMENDMENT NO. 2 (TERM LOAN CREDIT AGREEMENT)

AMENDMENT NO. 2 dated as of August 1, 2018 (this “Amendment”) to the Credit Agreement dated as of July 21, 2017 (the “Credit Agreement”) among PERNIX IRELAND PAIN DESIGNATED ACTIVITY COMPANY (f/k/a Pernix Ireland Pain Limited), a designated activity company organized under the laws of the Republic of Ireland (the “Borrower”), the lenders party thereto and Cantor Fitzgerald Securities, as administrative agent for the lenders (the “Agent”).

W I T N E S S E T H :

WHEREAS, the Borrower has requested that the Agent and the Lenders amend the Credit Agreement as set forth herein.

NOW, THEREFORE, the parties hereto agree as follows:

SECTION 1. Defined Terms; References. Unless otherwise specifically defined herein, each term used herein that is defined in the Credit Agreement has the meaning assigned to such term in the Credit Agreement. Each reference to “hereof”, “hereunder”, “herein” and “hereby” and each other similar reference and each reference to “this Agreement” and each other similar reference contained in the Credit Agreement shall, after this Amendment becomes effective, refer to the Credit Agreement as amended hereby.

Exchange” means the exchange of a certain portion of Parent’s outstanding 12% Senior Secured Notes due 2020 (the “Notes”) for shares of common stock in Parent pursuant to the terms of those certain Exchange Agreements dated as of the date hereof by and among Parent and, respectively, 1992 MSF International Ltd. and 1992 Tactical Credit Master Fund, L.P., in each case in the form attached hereto as Exhibit B.

SECTION 2. Amendments to Credit Agreement.  Each of the parties hereto agrees that, effective on the Amendment Effective Date, the Credit Agreement shall be amended as follows:

2.1Section 2.6(d)(ii) of the Credit Agreement is hereby amended and restated to read in its entirety as follows: 

(ii)The Borrower may, at its sole discretion (an “Interest Election”), elect to pay interest on the Loans in respect of any Interest Payment Date, (A) entirely in cash (“Cash Interest”) or  (B) partly as Cash Interest and partly by adding the amount of such interest up to a maximum amount of 2.50% per annum to the outstanding principal amount of the Loans (“PIK Interest”, and the amount of any such PIK Interest added to the principal of the Loans on any Interest Payment Date as required by the relevant Interest Election(s), the “Additional PIK Principal”) (with Cash Interest and Additional PIK Principal to be allocated pro rata among the Lenders in proportion to the aggregate principal amount of the portion of the Loan held by each Lender). 

2.2[Reserved.] 


2.3Section 6.6(a)(i) of the Credit Agreement is hereby amended by (i) deleting “or” at the end of sub-clause (F) therein, (ii) replacing “.” with “, and/or” at the end of clause (G) therein, and (iii) inserting a new sub-clause (H) immediately following sub-clause (G) as follows: 

(H) with respect to the Treximet Note Purchase Debt, payments of principal on the Treximet Note Purchase Debt made solely by exchanging such Treximet Note Purchase Debt for shares of Qualified Equity Interests without any payment of cash (other than in respect of fractional shares in an amount not to exceed $50,000).

2.4Schedule 3.2 to the Credit Agreement is hereby amended and restated in its entirety as set out in Schedule 1 attached hereto.  

2.5Schedule 5.17 to the Credit Agreement is hereby amended and restated in its entirety as set out in Schedule 2 attached hereto.  

SECTION 3. Representations and Warranties, Covenants and Acknowledgements. To induce the Agent and Lenders to enter into this Amendment:

(a) the Borrower and each other Loan Party represents and warrants that (i) as of the date hereof and after giving effect to the amendments hereto, all of the representations and warranties made or deemed to be made under the Credit Agreement and the other Loan Documents are true and correct, except to the extent that such representations and warranties expressly relate to an earlier date in which case such representations and warranties shall have been true and correct on and as of such earlier date, (ii) as of the date hereof and after giving effect to the amendments hereto, there exists no Default or Event of Default under the Credit Agreement or any of the other Loan Documents, (iii) it has the power and is duly authorized to enter into, deliver and perform this Amendment, (iv) this Amendment and each of the other Loan Documents is the legal, valid and binding obligation of each Loan Party, enforceable against each Loan Party in accordance with its terms, except to the extent enforcement may be limited under applicable bankruptcy, insolvency, reorganization, receivership, moratorium, or similar laws affecting creditors’ rights generally and the equitable discretion of the court;  

(b)each Loan Party hereby reaffirms each of the agreements, covenants, and undertakings set forth in the Credit Agreement and each other Loan Document executed in connection therewith or pursuant to, as amended and modified hereby, to which it is a party; and 

(c)Each Loan Party acknowledges and agrees that this Amendment shall be deemed a Loan Document for all purposes under the Credit Agreement. 

SECTION 4 Effectiveness. This Amendment shall become effective on the first date when each of the following conditions have been satisfied (the “Amendment Effective Date”) (x) the Agent shall have received from each of the Loan Parties, the Required Lenders and the Agent (i) an executed counterpart hereof signed by such party or facsimile or other written confirmation that such party has signed a counterpart hereof and (ii) the fully executed Amendment No. 3 to the 2017 ABL Facility, dated as of the date hereof, in the form attached hereto as Exhibit A and (y) substantially simultaneously therewith, the Exchange shall have been consummated.


SECTION 5. Counterparts. This Amendment may be signed in any number of counterparts, each of which shall be an original, with the same effect as if the signatures thereto and hereto were upon the same instrument. Delivery of an executed signature page of this Amendment by facsimile, email or other electronic transmission shall be effective as delivery of a manually executed counterpart to this Amendment.

SECTION 6. Amendment, Modification and Waiver. This Amendment may not be amended, modified or waived except by an instrument or instruments in writing signed and delivered on behalf of each of the parties hereto.

SECTION 7.  Severability.  If any provision of this Amendment is held to be illegal, invalid or unenforceable in any jurisdiction, the legality, validity and enforceability of the remaining provisions or obligations, or of such provision or obligation in any other jurisdiction, of this Amendment and the other Loan Documents shall not be affected or impaired thereby.

SECTION 8.  Headings.  Section and Subsection headings in this Amendment are included herein for convenience of reference only and shall not constitute a part of this Amendment for any other purpose or be given any substantive effect.

SECTION 9.  Governing Law; Waiver of Jury Trial.  Section 12 of the Credit Agreement is hereby incorporated herein by reference mutatis mutandis.

SECTION 10.  Fees and Expenses.  Borrower hereby reconfirm their respective obligations pursuant to the Credit Agreement to pay and reimburse the Agent and the Lenders for all reasonable costs and expenses (including, without limitation, reasonable and documented fees of counsel to the Agent and Lenders) incurred in connection with the negotiation, preparation, execution and delivery of this Agreement and all other documents and instruments delivered in connection herewith.

[Remainder of this page intentionally left blank]



IN WITNESS WHEREOF, the parties hereto have caused this Amendment to be duly executed as of the date first above written.

 

 

BORROWER:

PERNIX IRELAND PAIN DESIGNATED ACTIVITY COMPANY

 

By:

/s/ Angus Smith

 

 

Name: Angus Smith   

 

 

Title:Director 


[SIGNATURE PAGE - DDTL AMENDMENT NO. 2]



LENDERS:

1992 MSF INTERNATIONAL LTD.

 

 

BY: HIGHBRIDGE CAPITAL MANAGEMENT, LLC, AS TRADING MANAGER,

 

 

By:

/s/ Jonathan Segal

 

 

 

Name:Jonathan Segal 

 

 

 

Title:Managing Director 

 

 

 

 

 

 

By:

/s/ Jason Hempel

 

 

 

Name:Jason Hempel 

 

 

 

Title:Managing Director 

 

 

1992 TACTICAL CREDIT MASTER FUND, L.P.

 

 

BY: HIGHBRIDGE CAPITAL MANAGEMENT, LLC, AS TRADING MANAGER,

 

 

By:

/s/ Jonathan Segal

 

 

 

Name:Jonathan Segal 

 

 

 

Title:Managing Director 

 

 

 

 

 

 

By:

/s/ Jason Hempel

 

 

 

Name:Jason Hempel 

 

 

 

Title:Managing Director 


[SIGNATURE PAGE - DDTL AMENDMENT NO. 2]



CANTOR FITZGERALD SECURITIES, as Agent

By:

/s/ James Buccola

 

Name:James Buccola 

 

Title:Head of Fixed Income 


[SIGNATURE PAGE - DDTL AMENDMENT NO. 2]



SCHEDULE 1 – AMENDED AND RESTATED SCHEDULE 3.2

Schedule 3.2

The obligation of each Lender to make each Subsequent Loan provided for hereunder is subject to the fulfillment of each of the following conditions precedent (the making of such extensions of credit by a Lender being conclusively deemed to be its satisfaction or waiver of the conditions precedent):

i.If the proceeds of such Subsequent Loan are being used, directly or indirectly, to acquire any Equity Interests of any Person or any other assets (whether pursuant to a Permitted Acquisition or other acquisition permitted by the Agreement): 

ii.Agent shall have received the results of a search of the Uniform Commercial Code filings (or equivalent filings) and judgment filings and the results of federal tax lien searches made with respect to the acquired assets (including Target and its Subsidiaries) are contemplated to be so acquired) and, if applicable, the Acquisition Subsidiary in the states (or other jurisdictions) of formation of such Persons and in which the chief executive office of each such Person is located, and in such other jurisdictions as may be reasonably required by Agent or Required Lenders, together with copies of the financing statements (or similar documents) disclosed by such search, and accompanied by evidence satisfactory to the Agent and Required Lenders that the Liens indicated in any such financing statement (or similar document) would constitute Permitted Liens or have been or will be contemporaneously with the funding of the initial extension of credit released or terminated. 

iii.Immediately after giving effect to the Borrowing of such Subsequent Loan, the consummation of such acquisition and the transactions related thereto, the Target, its Subsidiaries and, if applicable, the Acquisition Subsidiary shall not be obligated on any Indebtedness other than Permitted Indebtedness. 

iv.Borrower shall have delivered to Agent a copy of the definitive sale and purchase agreement related to such acquisition (the “Acquisition Agreement”) and any related documents reasonably requested by Agent or the Required Lenders. 

v.Such acquisition shall be consummated pursuant to the terms of the Acquisition Agreement in all material respects, substantially concurrently with the funding of such Subsequent Loan, without giving effect to any amendments, express consents or express waivers by the Borrower thereto or modifications to the provisions thereof that are adverse to the interests of Lender Group without the prior written consent of the Required Lenders. 

vi.Agent shall have received due diligence information relating to the Target, its Subsidiaries and, if applicable, the Acquisition Subsidiary, to  




the extent available to the Borrower or required in connection with Section 5.11 of the Agreement.

vii.Agent shall have received each of the following documents, in form and substance reasonably satisfactory to the Required Lenders, duly executed and delivered, and each such document shall be in full force and effect: 

viii.supplements to the Security Agreement or other Additional Document(s) required pursuant to Section 5.11 or 5.12 of the Agreement, executed by the Acquisition Subsidiary (if applicable), the Target and each of its Subsidiaries that is required to become a Guarantor pursuant to Section 5.11, ‎5.12 and/or 5.17 of the Agreement, 

ix.duly executed short form security agreements with respect to the Intellectual Property owned by the Acquisition Subsidiary (if applicable), Target and each of its Subsidiaries that are required to become a Guarantor pursuant to Section 5.11, 5.12 and/or 5.17 of the Agreement, in appropriate form for filing in the United States and, upon reasonable request of the Agent, in additional applicable jurisdictions, and in a format reasonable acceptable to the Agent,  

x.a completed Perfection Certificate for the Acquisition Subsidiary (if applicable), the Target and its Subsidiaries or otherwise with respect to the acquired assets, and 

xi.executed counterparts of each other Loan Document required to perfect the Agent’s security interest in the Collateral duly executed by an Authorized Person of the Acquisition Subsidiary (if applicable), Target and each of its Subsidiaries party thereto. 

xii.Agent shall have received proper financing statements (Form UCC-1 or the equivalent) for filing under the Code or other appropriate filing offices of each jurisdiction as may be necessary to perfect the security interests granted by the Acquisition Subsidiary (if applicable), the Target and its Subsidiaries. 

xiii.Agent shall have received a certificate from the Secretary of the Acquisition Subsidiary (if applicable), the Target and each of its Subsidiaries that are required to become Loan Parties pursuant to the Agreement (i) attesting to the resolutions of its Board of Directors authorizing its execution, delivery, and performance of the Loan Documents to which it is a party, (ii) authorizing its Authorized Persons to execute the same, and (iii) attesting to the incumbency and signatures of such Authorized Persons.  

xiv.Agent shall have received copies of the Governing Documents of the Acquisition Subsidiary (if applicable), the Target and each of its  




Subsidiary, as amended, modified, or supplemented to the relevant Funding Date, which Governing Documents shall be certified by the Secretary of such Person and with respect to Governing Documents of a Person that are charter documents, certified as of a recent date (not more than 30 days prior to the Funding Date) by the appropriate government official.

xv.To the extent customary in the relevant jurisdiction of organization, Agent shall have received a certificate of good standing (or equivalent, to the extent the concept is applicable) with respect to the Acquisition Subsidiary (if applicable), the Target and each of its Subsidiaries, such certificate to be issued by the relevant authority of the jurisdiction of organization of such Person. 

xvi.Agent shall have received opinions of the Loan Parties’ and/or Target’s counsel pursuant to Section 5.11 and/or 5.12 of the Agreement with respect to the Acquisition Subsidiary (if applicable), the Target and each of its Subsidiaries in form and substance reasonably satisfactory to Agent and the Required Lenders. 

xvii.Borrower shall have otherwise complied with Section 5.11 and 5.12 of the Agreement to the extent applicable (without giving effect to the post acquisition time period for taking such actions following the acquisition). 

xviii.Agent shall have received at least two (2) Business Days prior to the Funding Date, all documentation and other information with respect to the Acquisition Subsidiary (if applicable), Target and its Subsidiaries reasonably requested by Agent in writing at least ten (10) Business Days prior to the Funding Date, required under applicable “know your customer” and anti-money laundering rules and regulations, including the USA PATRIOT Act. 

xix.The Acquired Cash Flow Ratio, after giving pro forma effect to such Permitted Acquisition or other acquisition shall be greater than 1.50 to 1.00. 

1.The proceeds of such Subsequent Loan shall be used in accordance with Section 5.17 of the Agreement, and, if such Subsequent Loan is being incurred for the purposes set forth in clause (i) of the introductory paragraph of Schedule 5.17, such proceeds shall be applied substantially concurrently with the funding of such Subsequent Loan or funded into a blocked account subject to a Control Agreement over which Agent has a first lien security interest, pending application of such proceeds in accordance with the terms of the Agreement and, if applicable, the applicable Acquisition Agreement. 

i.Borrower shall have paid all Lender Group Expenses incurred in connection with such Subsequent Loan, the Permitted Acquisition (if applicable) and the transactions related thereto to the extent invoiced at least two (2) Business Days prior to the Funding Date. 




ii.Agent shall have received a duly executed Notice of Borrowing with respect to such Subsequent Loan, executed by an Authorized Person of the Borrower and in accordance with the requirements of the Agreement, which shall, among other things, specify in reasonable detail the proposed use of proceeds thereof. 

Agent shall have received a certificate duly signed by an Authorized Person of the Borrower confirming the satisfaction of the conditions set forth in this Schedule 3.2.




SCHEDULE 2 – AMENDED AND RESTATED SCHEDULE 5.17

 

Schedule 5.17

Subsequent Loans – Use of Proceeds

Unless otherwise approved by the Required Lenders prior to the funding of a Subsequent Loan, the proceeds of each Subsequent Loan made after the Closing Date shall only be used (i) for the following purposes in connection with a Permitted Acquisition where the Acquired Cash Flow Ratio of the Target of such Permitted Acquisition, after giving pro forma effect thereto, is greater than 1.50 to 1.00 or (ii) for working capital or other general corporate purposes not in contravention of any applicable Law or of any Loan Document, including for the purposes of making Restricted Payments or Permitted Investments:

 

i.The Purchase Price required to be paid by any Loan Party or Subsidiary (including any upfront, milestone or royalty payments made to the seller or licensor) or the refinancing of such Target’s existing indebtedness, in each case in connection with the consummation of such Permitted Acquisition, and related reasonable transaction fees and expenses. 

ii.In connection with any new product of any Loan Party or Subsidiary acquired pursuant to such Permitted Acquisition: 

(a)Marketing expenses associated with such new product, including any pre-marketing activities such as market research; 

(b)Selling expenses associated with such new product, including all costs related to any incremental headcount required to support the product(s), the cost of sales force training and any incremental sales analytics expenses (including but not limited to sales force automation and data expenses);  

(c)Research and development expenses associated with such new product, including any post-market requirements;  

(d)Manufacturing expenses associated with such new product, including the cost of validation and scale-up;  

(e)Costs associated with the supply chain for such new product, including the cost of third-party logistics providers, audit of any third-party manufacturing sites, and technology transfer expenses; and/or 

(f)Post-closing capital needs relating to such new product to (i) fund inventory purchases and (ii) fund other working capital needs; provided, however, that amounts requested pursuant to this clause (ii) shall not exceed $500,000. 




iii.Interest expense and any fees pursuant to the Agreement associated with the Subsequent Loan incurred in connection with such Permitted Acquisition. 




EXHIBIT A – AMENDMENT NO. 3 TO THE 2017 ABL AGREEMENT




EXHIBIT B – EXCHANGE AGREEMENTS


EX-10.8 7 exh10-8.htm FIRST SUPPLEMENTAL INDENTURE, DATED JULY 27, 2018, BETWEEN PERNIX THERAPEUTICS HOLDINGS, INC. AND WILMINGTON TRUST,

 

 

 

 

PERNIX IRELAND PAIN DESIGNATED ACTIVITY COMPANY,

as Issuer,

the GUARANTORS party hereto

AND

WILMINGTON TRUST, NATIONAL ASSOCIATION

as Trustee


FIRST SUPPLEMENTAL INDENTURE


Dated as of July 27, 2018

 

4.25%/5.25% Exchangeable Senior Notes due 2022



THIS FIRST SUPPLEMENTAL INDENTURE (this “Supplemental Indenture”), entered into as of July 27, 2018, among Pernix Ireland Pain Designated Activity Company (f/k/a Pernix Ireland Pain Limited), a designated activity company organized under the laws of the Republic of Ireland (the “Issuer”), the guarantors party to the Indenture (as defined below) (the “Guarantors”) and Wilmington Trust, National Association, as trustee (the “Trustee”).

RECITALS

WHEREAS, the Issuer, the Guarantors and the Trustee entered into the Indenture, dated as of July 21, 2017 (the “Indenture”), relating to the Issuer’s 4.25%/5.25% Exchangeable Senior Notes due 2022 (the “Notes”);

WHEREAS, the Issuer intends to enter into an arrangement whereby it, in partnership with Highbridge Capital Management, LLC on behalf of various funds which it manages or advises (“HB”) and Whitebox Advisors, LLC, on behalf of various funds which it manages or advises (“WB”) will form a jointly owned special purpose entity, to be known as Nalpropion Pharmaceuticals, Inc. (or one or more other special purpose entities formed by HB, WB and the Issuer, and such entities’ successors and assigns (“Nalpropion”)) for the purpose of acquiring some or all of the assets of Orexigen Therapeutics, Inc., a Delaware corporation, and in connection therewith has requested that certain terms of the Indenture be amended as set forth herein;

WHEREAS, Section 10.02 of the Indenture provides that the Issuer and the Trustee may from time to time amend or supplement certain terms of the Indenture with the consent of Holders of not less than a majority in principal amount of the outstanding  Notes (the “Required Holders”);

WHEREAS, the written consent of the Required Holders pursuant to Section 8.01(a) of the Indenture has been obtained with respect to the proposed amendments set forth herein;

WHEREAS, in accordance with Section 10.02 of the Indenture, the Issuer desires, by this Supplemental Indenture, to amend the Indenture as set forth herein;

AGREEMENT

NOW, THEREFORE, in consideration of the premises and mutual covenants herein contained and intending to be legally bound, the parties to this Supplemental Indenture hereby agree as follows:

SECTION 1.  The Indenture is hereby amended as follows:

(a) By the addition of the following definitions in the appropriate alphabetical order to Section 1.01 of the Indenture as follows:

First Supplemental Indenture Effective Date” means July 27, 2018.

Nalpropion JV” has the meaning set forth in the definition of “Orexigen Investment”.



Nalpropion Asset Purchase Agreement” means that certain Asset Purchase Agreement, dated as of April 23, 2018, between Orexigen Therapeutics, Inc., as seller, and the Nalpropion JV, as purchaser, as in effect on the First Supplemental Indenture Effective Date and as thereafter may be amended, restated, supplemented or modified from time to time in accordance with Section 4.25 of the Indenture.

Nalpropion Documents” means, collectively, the Nalpropion Asset Purchase Agreement, the Nalpropion Governance Documents, the Nalpropion Services Agreement and the Nalpropion Stockholders Agreement.  

Nalpropion Governance Documents” means the bylaws and certificate of incorporation of the Nalpropion JV, as in effect on the First Supplemental Indenture Effective Date and as thereafter may be amended, restated, supplemented or modified from time to time in accordance with Section 4.25 of the Indenture.

Nalpropion Services Agreement” means that certain services agreement, dated as of July 13, 2018, between Pernix Therapeutics and Nalpropion JV, as in effect on the First Supplemental Indenture Effective Date and as thereafter may be amended, restated, supplemented or modified from time to time in accordance with Section 4.25 of the Indenture.

Nalpropion Stockholders Agreement” means that certain stockholders agreement dated as of July 13, 2018 among Nalpropion JV, 1992 MSF International Ltd., 1992 Tactical Credit Master Fund, L.P., 1992 Master Fund Co-Invest SPC3, Whitebox Caja Blanca Fund, LP, Whitebox Multi-Strategy Partners, L.P., Whitebox Asymmetric Partners, L.P., the Issuer and each other equity holder of Nalpropion JV that becomes party thereto, as in effect on the First Supplemental Indenture Effective Date and as thereafter may be amended, restated, supplemented or modified from time to time in accordance with Section 4.25 of the Indenture.

Orexigen Acquisition” means the acquisition by the Nalpropion JV of some or all of the assets of Orexigen Therapeutics, Inc., a Delaware corporation, in accordance with the terms of the Nalpropion Asset Purchase Agreement.

Orexigen Investment” means any Investment by Holdings or any of its Subsidiaries made (i) (x) in accordance with the Nalpropion Governance Documents to create and form Nalpropion Pharmaceuticals, Inc. (the “Nalpropion JV”) for the purpose of consummating the Orexigen Acquisition in accordance with the Nalpropion Asset Purchase Agreement and (y) to create and/or form any pass-through entities, blocker entities or other holding companies connection therewith, (ii) for the purpose of consummating the Orexigen Acquisition in accordance with the Nalpropion Asset Purchase Agreement, including, without


3


limitation, the use of proceeds of Debt incurred under the Delayed Draw Term Loan Facility or other Investments to permit the Nalpropion JV to consummate the Orexigen Acquisition in accordance with the Nalpropion Asset Purchase Agreement (including, without limitation, loans to the Nalpropion JV, the proceeds of which shall constitute part of the consideration for the Orexigen Acquisition), (iii) to enable Pernix Therapeutics to fulfill its obligations under the Nalpropion Services Agreement, or (iv) to purchase additional Equity Interests or other ownership interests in the Nalpropion JV in accordance with the Nalpropion Stockholders Agreement.

Orexigen Transaction” means any transaction between Holdings or any of its Subsidiaries, on the one hand, and the Nalpropion JV, on the other hand, pursuant to the Nalpropion Services Agreement and any management or other fees or payment or reimbursement obligations or similar arrangements provided for therein (including any “true up” payment provisions).

Pernix Therapeutics” means Pernix Therapeutics, LLC, a Louisiana limited liability company.

(b) By amending and restating the definition of “Permitted Business” in Section 1.01 of the Indenture as follows:

Permitted Business” means (x) any of the businesses in which the Credit Parties and their Subsidiaries are engaged on the Issue Date, (y) any business related or complementary thereto, and (z) any business pursuant to the Orexigen Investment or any Orexigen Transaction. 

(c) By amending the definition of “Permitted Investments” in Section 1.01 of the Indenture by (i) deleting “and” at the end of clause (m) therein, (ii) replacing “.” with “; and” at the end of clause (n) therein, and (ii) adding immediately after clause (n):

(o) any Orexigen Investment; 

(d) By replacing clause (d)(4) of Section 4.15, “Limitations on Transactions with Affiliates,” of the Indenture as follows: 

(4) any transaction or agreement entered into in connection with the Orexigen Acquisition, Orexigen Investment or any Orexigen Transaction; 

(e) By amending Section 4.25, “Material Contracts,” of the Indenture to add the following new clause (c): 

(c) Other than as consented to by the Required Holders, each Credit Party will not, and each Credit Party will not permit any of its Subsidiaries to amend, change or modify any Nalpropion Document if the effect of such amendment, change or modification, individually or in the aggregate, (x) would amend, modify, change and/or add any material  


4


obligation of the Issuer or any of its Subsidiaries thereunder in a manner adverse to the interests of the Holders or (y) could reasonably be expected to be materially adverse to the interests of the Holders.

(f) By amending Section 4.27 of the Indenture as follows: 

Section 4.27. Restrictive Agreements. Except as provided in the following sentence, each Credit Party will not, and each Credit Party will not permit any of its Subsidiaries to, create or otherwise cause or suffer to exist or become effective any consensual encumbrance or restriction of any kind in any case on the ability of any Subsidiary of any Credit Party to: (A) pay or make Restricted Distributions to any Credit Party; (B) pay any Debt owed to any Credit Party; (C) make loans or advances to any Credit Party; or (D) transfer any of its property or assets to any Credit Party. Notwithstanding the immediately prior sentence, each Credit Party and each of the Credit Parties’ Subsidiaries may create, cause or suffer to exist or become effective any such consensual encumbrance or restriction provided by (a) this Indenture, (b) the Treximet Indenture, (c) the Existing Notes Indenture, (d) any agreement entered into to refinance all or any part of the Notes (but only to the extent the consensual encumbrances or restrictions contained therein that limit the actions described in (A) – (D) above are no more restrictive with respect to such actions than this Indenture if less than all of the Notes will be refinanced), (e) the ABL Facility Agreement and any other agreement entered into in connection with an ABL Facility, (f) the Delayed Draw Term Loan Agreement and any other agreement entered into in connection with the Delayed Draw Term Loan Facility (or any portion thereof), (g) any instrument governing Debt or Capital Stock of a Person acquired by any Credit Party or any of the Credit Parties’ Subsidiaries as in effect at the time of (and not in anticipation of) such acquisition, which encumbrance or restriction is not applicable to any Person, or the properties or assets of any Person, other than the Person and/or any of its Subsidiaries, or the property or assets of the Person and/or any of its Subsidiaries, so acquired, (h) any instrument governing Debt incurred in connection with a Permitted Acquisition, (i)(x) customary non-assignment and similar provisions in contracts, leases and licenses entered into in the Ordinary Course of Business, (y) net worth provisions in leases and other agreements and (z) provisions restricting cash or other deposits in agreements entered into by each Credit Party or any Subsidiary of such Credit Party in the Ordinary Course of Business, (j) mortgage financings, purchase money obligations and Capital Lease Obligations that impose restrictions on the property owned or leased, (k) any agreement for the sale or other disposition permitted by this Indenture of the Capital Stock or all or substantially all of the property and assets of a Subsidiary of any Credit Party that restricts distributions by that Subsidiary pending its sale or other disposition, (l) Permitted Liens, (m) restrictions on cash or other deposits or net worth imposed by customers or suppliers or required by insurance, surety or bonding companies, in each case, under contracts entered into in the Ordinary Course of Business, (n) customary encumbrances or restrictions contained in agreements in connection with Swap Contracts or Bank


5


Product Obligations permitted under this Indenture, (o) customary provisions contained in leases or licenses of intellectual property and other agreements, in each case, entered into in the Ordinary Course of Business, (p) any Nalpropion Document, or (q) any consensual encumbrance or restriction of any kind existing under any agreement that extends, renews, refinances, replaces, amends, modifies, restates or supplements the agreements containing the encumbrances or restrictions in the foregoing clauses (a) through (p), or in this clause (q) (provided, that the terms and conditions of any such consensual encumbrance or restriction of any kind that limit the actions described in (A) –  (D) above are no more restrictive than those under or pursuant to the agreement so extended, renewed, refinanced, replaced, amended, modified, restated or supplemented).

SECTION 2. Capitalized terms used herein and not otherwise defined herein are used as defined in the Indenture.

SECTION 3.  This Supplemental Indenture shall become effective on the date when the Trustee shall have received: (i) from each of the Credit Parties an executed counterpart hereof signed by such party or facsimile, (ii) a duly executed Officers’ Certificate and Opinion of Counsel as required by the Indenture, (iii) a fully executed copy of Amendment No. 2 to the ABL Facility Agreement, dated as of the date hereof, in the form attached hereto as Exhibit A, and (iv) a fully executed copy of Amendment No. 1 to the Delayed Draw Term Loan Agreement, dated as of the date hereof, in the form attached hereto as Exhibit B.

SECTION 4.  This Supplemental Indenture shall be governed by and construed in accordance with the laws of the State of New York.

SECTION 5. This Supplemental Indenture may be signed in various counterparts which together will constitute one and the same instrument.

SECTION 6. This Supplemental Indenture is an amendment supplemental to the Indenture and the Indenture and this Supplemental Indenture will henceforth be read together. The Indenture is hereby incorporated herein, and except as specifically modified herein, the Indenture, as amended, restated, supplemented or otherwise modified by this Supplemental Indenture is in all respects ratified and confirmed, and all the terms, conditions and provisions in the Indenture and the Notes shall remain in full force and effect.

SECTION 7. The Trustee shall not be responsible for and makes no representation as to the validity or adequacy of this Supplemental Indenture, and is not responsible for any recital or statement herein.

[Remainder of Page Intentionally Blank]


6


IN WITNESS WHEREOF, the parties hereto have caused this Supplemental Indenture to be duly executed as of the date first above written.

PERNIX IRELAND PAIN DESIGNATED ACTIVITY COMPANY, as Issuer

By:

/s/ Kenneth R. Piña

 

Name:Kenneth R. Piña 

 

Title:Director 

 

PERNIX THERAPEUTICS HOLDINGS, INC., as Guarantor

By:

/s/ Kenneth R. Piña

 

Name:Kenneth R. Piña 

 

Title:Senior Vice President &  

            Corporate Secretary

 

PERNIX THERAPEUTICS LLC, as Guarantor

By:

/s/ John A. Sedor

 

Name:John A. Sedor 

 

Title:Manager 

 

PERNIX MANUFACTURING LLC, as Guarantor

By:

/s/ John A. Sedor

 

Name:John A. Sedor 

 

Title:Manager 

 

CYPRESS PHARMACEUTICALS, INC.,  as Guarantor

By:

/s/ Kenneth R. Piña

 

Name:Kenneth R. Piña 

 

Title:Senior Vice President & Corporate Secretary 



 

PERNIX SLEEP, INC., as Guarantor

By:

/s/ Kenneth R. Piña

 

Name:Kenneth R. Piña 

 

Title:Senior Vice President & Corporate Secretary 

 

GAINE, INC., as Guarantor

By:

/s/ Kenneth R. Piña

 

Name:Kenneth R. Piña 

 

Title:Senior Vice President & Corporate Secretary 

 

RESPICOPEA INC., as Guarantor

By:

/s/ Kenneth R. Piña

 

Name:Kenneth R. Piña 

 

Title:Senior Vice President & Corporate Secretary 

 


 

MACOVEN PHARMACEUTICALS, L.L.C., as Guarantor

By:

/s/ John A. Sedor

 

Name:John A. Sedor 

 

Title:Manager 

 

HAWTHORN PHARMACEUTICALS, INC., as Guarantor

By:

/s/ Kenneth R. Piña

 

Name:Kenneth R. Piña 

 

Title:Senior Vice President & Corporate Secretary 



 

PERNIX IRELAND LIMITED, as Guarantor

By:

/s/ Kenneth R. Piña

 

Name:Kenneth R. Piña 

 

Title:Director 

 

PERNIX HOLDCO 1, LLC, as Guarantor

By: Pernix Therapeutics, LLC
Its: Sole Member and Sole Manager

By:

/s/ John A. Sedor

 

Name:John A. Sedor 

 

Title:Manager 

 

PERNIX HOLDCO 2, LLC, as Guarantor

By: Cypress Pharmaceuticals, Inc.
Its: Sole Member and Sole Manager

By:

/s/ Kenneth R. Piña

 

Name:Kenneth R. Piña 

 

Title:Senior Vice President &  

            Corporate Secretary

 

PERNIX HOLDCO 3, LLC, as Guarantor

By: Pernix Therapeutics Holdings, Inc.
Its: Sole Member and Sole Manager

By:

/s/ Kenneth R. Piña

 

Name:Kenneth R. Piña 

 

Title:Senior Vice President &            

            Corporate Secretary



WILMINGTON TRUST, NATIONAL ASSOCIATION, as Trustee

By:

/s/ Lynn M. Steiner

 

Name:Lynn M. Steiner 

 

Title:  Vice President



Exhibit A

 

Amendment No. 2 to ABL Facility Agreement



Exhibit B

 

Amendment No. 1 to Delayed Draw Term Loan Agreement


EX-31.1 8 exh31-1.htm CEO 302 CERTIFICATE Q3 2018 10-Q Exhibit 31.1

EXHIBIT 31.1

CERTIFICATION

I, John Sedor, certify that:

1. I have reviewed this Quarterly Report on Form 10-Q of Pernix Therapeutics Holdings, Inc.;

2. Based on my knowledge, this report does not contain any untrue statement of a material fact or omit to state a material fact necessary to make the statements made, in light of the circumstances under which such statements were made, not misleading with respect to the period covered by this report;

3. Based on my knowledge, the financial statements, and other financial information included in this report, fairly present in all material respects the financial condition, results of operations and cash flows of the Registrant as of, and for, the periods presented in this report;

4. The Registrant's other certifying officer and I are responsible for establishing and maintaining disclosure controls and procedures (as defined in Exchange Act Rules 13a-15(e) and 15d-15(e)) and internal control over financial reporting (as defined in Exchange Act Rules 13a-15(f) and 15d-15(f)) for the Registrant and have:

(a) Designed such disclosure controls and procedures, or caused such disclosure controls and procedures to be designed under our supervision, to ensure that material information relating to the Registrant, including its consolidated subsidiaries, is made known to us by others within those entities, particularly during the period in which this quarterly report is being prepared;

(b) Designed such internal control over financial reporting, or caused such internal control over financial reporting to be designed under our supervision, to provide reasonable assurance regarding the reliability of financial reporting and the preparation of financial statements for external purposes in accordance with generally accepted accounting principles;

(c) Evaluated the effectiveness of the Registrant's disclosure controls and procedures and presented in this quarterly report our conclusions about the effectiveness of the disclosure controls and procedures, as of the end of the period covered by this report based on such evaluation; and

(d) Disclosed in this report any change in the Registrant's internal control over financial reporting that occurred during the Registrant's most recent fiscal quarter (the Registrant's fourth fiscal quarter in the case of an Annual Report) that has materially affected, or is reasonably likely to materially affect, the Registrant's internal control over financial reporting; and

5. The Registrant's other certifying officer and I have disclosed, based on our most recent evaluation of internal control over financial reporting, to the Registrant's auditors and the audit committee of the Registrant's board of directors (or persons performing the equivalent functions):

(a) All significant deficiencies and material weaknesses in the design or operation of internal control over financial reporting which are reasonably likely to adversely affect the Registrant's ability to record, process, summarize and report financial information; and

(b) Any fraud, whether or not material, that involves management or other employees who have a significant role in the Registrant's internal control over financial reporting.

 

 

 

 

November 9, 2018

 

/s/ JOHN SEDOR

 

 

 

John Sedor

 

 

 

Chairman and Chief Executive Officer
(Principal Executive Officer)

 

 


EX-31.2 9 exh31-2.htm CFO 302 CERTIFICATE Q3 2018 10-Q Exhibit 31.2

EXHIBIT 31.2

CERTIFICATION

I, Angus Smith, certify that:

1. I have reviewed this Quarterly Report on Form 10-Q of Pernix Therapeutics Holdings, Inc.;

2. Based on my knowledge, this report does not contain any untrue statement of a material fact or omit to state a material fact necessary to make the statements made, in light of the circumstances under which such statements were made, not misleading with respect to the period covered by this report;

3. Based on my knowledge, the financial statements, and other financial information included in this report, fairly present in all material respects the financial condition, results of operations and cash flows of the Registrant as of, and for, the periods presented in this report;

4. The Registrant's other certifying officer and I are responsible for establishing and maintaining disclosure controls and procedures (as defined in Exchange Act Rules 13a-15(e) and 15d-15(e)) and internal control over financial reporting (as defined in Exchange Act Rules 13a-15(f) and 15d-15(f)) for the Registrant and have:

(a) Designed such disclosure controls and procedures, or caused such disclosure controls and procedures to be designed under our supervision, to ensure that material information relating to the Registrant, including its consolidated subsidiaries, is made known to us by others within those entities, particularly during the period in which this quarterly report is being prepared;

(b) Designed such internal control over financial reporting, or caused such internal control over financial reporting to be designed under our supervision, to provide reasonable assurance regarding the reliability of financial reporting and the preparation of financial statements for external purposes in accordance with generally accepted accounting principles;

(c) Evaluated the effectiveness of the Registrant's disclosure controls and procedures and presented in this quarterly report our conclusions about the effectiveness of the disclosure controls and procedures, as of the end of the period covered by this quarterly report based on such evaluation; and

(d) Disclosed in this quarterly report any change in the Registrant's internal control over financial reporting that occurred during the Registrant's most recent fiscal quarter (the Registrant's fourth fiscal quarter in the case of an Annual Report) that has materially affected, or is reasonably likely to materially affect, the Registrant's internal control over financial reporting; and

5. The Registrant's other certifying officer and I have disclosed, based on our most recent evaluation of internal control over financial reporting, to the Registrant's auditors and the audit committee of the Registrant's board of directors (or persons performing the equivalent functions):

(a) All significant deficiencies and material weaknesses in the design or operation of internal control over financial reporting which are reasonably likely to adversely affect the Registrant's ability to record, process, summarize and report financial information; and

(b) Any fraud, whether or not material, that involves management or other employees who have a significant role in the Registrant's internal control over financial reporting.

November 9, 2018

 

/s/ ANGUS SMITH

 

 

 

Angus Smith

 

 

 

Senior Vice President and Chief Business Officer and Principal Financial Officer
(Principal Financial Officer)

 

 


EX-32.1 10 exh32-1.htm 906 CERTIFICATE Q3 2018 10-Q Exhibit 32.1

EXHIBIT 32.1

CERTIFICATION UNDER SECTION 906
OF THE SARBANES-OXLEY ACT OF 2002

Pursuant to 18 U.S.C. Section 1350, as adopted pursuant to Section 906 of the Sarbanes-Oxley Act of 2002, each of the undersigned certifies that this periodic report fully complies with the requirements of section 13(a) or 15(d) of the Securities Exchange Act of 1934, as amended; and that information contained in this periodic report fairly presents, in all material respects, the financial condition and results of operations of Pernix Therapeutics Holdings, Inc. for the periods covered by this periodic report.

Date: November 9, 2018

 

/s/ JOHN SEDOR

 

 

 

John Sedor

 

 

 

Chairman and Chief Executive Officer
(Principal Executive Officer)

 

 

 

 

 

Date: November 9, 2018

 

/s/ ANGUS SMITH

 

 

 

Angus Smith
Senior Vice President and Chief Business Officer and Principal Financial Officer

 

 

 

(Principal Financial Officer)

 

 


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Period, Weighted Average Grant Date Fair Value Share-based Compensation Arrangement by Share-based Payment Award, Equity Instruments Other than Options, Forfeitures, Weighted Average Grant Date Fair Value Restructuring Reserve Payments for Restructuring EX-101.PRE 17 ptx-20180930_pre.xml XBRL TAXONOMY EXTENSION PRESENTATION LINKBASE DOCUMENT XML 18 R1.htm IDEA: XBRL DOCUMENT v3.10.0.1
Document and Entity Information - shares
9 Months Ended
Sep. 30, 2018
Nov. 06, 2018
Document Information [Line Items]    
Entity Registrant Name PERNIX THERAPEUTICS HOLDINGS, INC.  
Entity Central Index Key 0001024126  
Document Type 10-Q  
Document Period End Date Sep. 30, 2018  
Amendment Flag false  
Current Fiscal Year End Date --12-31  
Entity Small Business true  
Is Entity's Reporting Status Current? Yes  
Entity Filer Category Non-accelerated Filer  
Entity Emerging Growth Company false  
Entity Common Stock, Shares Outstanding   14,505,848
Document Fiscal Period Focus Q3  
Document Fiscal Year Focus 2018  
XML 19 R2.htm IDEA: XBRL DOCUMENT v3.10.0.1
CONDENSED CONSOLIDATED BALANCE SHEETS (USD $) - USD ($)
$ in Thousands
Sep. 30, 2018
Dec. 31, 2017
Current assets:    
Cash and cash equivalents $ 24,511 $ 32,820
Accounts receivable, net 66,443 45,317
Inventory, net 17,788 5,396
Prepaid expenses and other current assets 11,935 8,628
Income tax receivable 45 123
Total current assets 120,722 92,284
Property and equipment, net 1,000 752
Goodwill 17,572 12,100
Intangible assets, net 133,649 96,606
Other 1,827 2,263
Total assets 274,770 204,005
Current liabilities:    
Accounts payable 11,302 7,911
Accrued personnel expenses 5,181 5,748
Accrued allowances 71,698 56,309
Other accrued expenses 10,148 6,909
Interest payable 6,381 10,612
Treximet Secured Notes - current, net 0 3,664
Other liabilities - current 6,901 2,648
Total current liabilities 111,611 93,801
Term loan 41,250 0
Convertible notes - long-term, net 67,823 65,194
Exchangeable notes - long-term, net 10,030 7,975
Delayed draw term loan - long-term, net 37,805 27,248
Derivative liability 54 93
Contingent consideration 1,501 1,358
Treximet Secured Notes - long-term, net 151,364 163,887
Credit facility 14,185 14,185
Deferred revenue 10,840 0
Arbitration award 0 2,000
Other liabilities - long-term 589 2,521
Total liabilities 447,052 378,262
Commitments and contingencies (note 13)
Stockholders' deficit:    
Preferred stock 1 0
Common stock, $0.01 par value, 140,000,000 shares authorized, 13,957,733 and 11,841,173 shares issued and outstanding at September 30, 2018 and December 31, 2017, respectively 140 119
Additional paid-in capital 274,458 261,158
Accumulated other comprehensive loss 85 0
Accumulated deficit (479,476) (435,534)
Total Pernix stockholders' deficit (204,792) (174,257)
Noncontrolling interests 32,510 0
Total stockholders' deficitty (172,282) (174,257)
Total liabilities and stockholders' deficit $ 274,770 $ 204,005
XML 20 R3.htm IDEA: XBRL DOCUMENT v3.10.0.1
CONDENSED CONSOLIDATED BALANCE SHEETS (USD $) (Parenthetical) - $ / shares
Sep. 30, 2018
Dec. 31, 2017
Stockholders Equity    
Common stock par value $ 0.01 $ 0.01
Common stock shares authorized 140,000,000 140,000,000
Common stock shares issued 13,957,733 11,841,173
Common stock shares outstanding 13,957,733 11,841,173
Preferred Stock    
Stockholders Equity    
Preferred stock, par value $ 0.01 $ 0.01
Preferred stock, shares authorized 8,500,000 10,000,000
Preferred stock, shares issued 0 0
Preferred stock, shares outstanding 0 0
Series C Convertible Preferred Stock [Member]    
Stockholders Equity    
Preferred stock, par value $ 0.01  
Preferred stock, shares authorized 1,500,000  
Preferred stock, shares issued 81,000  
Preferred stock, shares outstanding 81,000  
XML 21 R4.htm IDEA: XBRL DOCUMENT v3.10.0.1
CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS (Unaudited) (USD $) - USD ($)
shares in Thousands, $ in Thousands
3 Months Ended 9 Months Ended
Sep. 30, 2018
Sep. 30, 2017
Sep. 30, 2018
Sep. 30, 2017
Income Statement [Abstract]        
Net revenues $ 37,156 $ 40,469 $ 86,383 $ 104,527
Costs and operating expenses:        
Cost of product sales 11,823 10,580 26,353 31,113
Selling, general and administrative expense 31,872 20,226 67,412 59,519
Research and development expense 1,524 99 1,534 709
Depreciation and amortization expense 2,391 18,214 13,686 54,976
Change in fair value of contingent consideration 0 884 143 344
Loss from disposal and impairments of assets 75 25 75 25
Gain from legal settlement 0 (10,476) 0 (10,476)
Restructuring costs (2) (97) 1,212 34
Total costs and operating expenses 47,683 39,455 110,415 136,244
Income (loss) from operations (10,527) 1,014 (24,032) (31,717)
Other income (expense):        
Interest expense (10,073) (9,323) (29,063) (27,491)
Gain on sale of assets 0 0 446 0
Change in fair value of derivative liability 18 46 39 (38)
Gain from exchange of debt 137 14,650 137 14,650
Foreign currency transaction gain (843) 0 (864) 0
Total other expense, net (10,761) 5,373 (29,305) (12,879)
Income (loss) before income tax expense (21,288) 6,387 (53,337) (44,596)
Income tax expense 61 27 109 122
Net income (loss) (21,349) 6,360 (53,446) (44,718)
Adjust: Net loss attributable to noncontrolling interests 9,504 0 9,504 0
Net income (loss) attributable to common stockholders $ (11,845) $ 6,360 $ (43,942) $ (44,718)
Net income (loss) per common share attributable to common stockholders:        
Basic $ (0.89) $ 0.57 $ (3.55) $ (4.31)
Diluted $ (0.89) $ 0.42 $ (3.55) $ (4.31)
Weighted-average common shares outstanding:        
Basic 13,301 11,117 12,377 10,387
Diluted 13,301 16,520 12,377 10,387
XML 22 R5.htm IDEA: XBRL DOCUMENT v3.10.0.1
CONDENSED CONSOLIDATED STATEMENTS COMPREHENSIVE INCOME (LOSS) (USD $) - USD ($)
$ in Thousands
3 Months Ended 9 Months Ended
Sep. 30, 2018
Sep. 30, 2017
Sep. 30, 2018
Sep. 30, 2017
Income Statement [Abstract]        
Net income (loss) $ (21,349) $ 6,360 $ (53,446) $ (44,718)
Other comprehensive income (loss):        
Foreign currency translation adjustments 849 0 849 0
Unrealized gain during period, net of tax of $0 and $0, respectively 0 9 0 33
Comprehensive income (loss) (20,500) 6,369 (52,597) (44,685)
Less: Comprehensive income attributable to noncontrolling interest (764) 0 (764) 0
Comprehensive income (loss) attributable to common stockholders $ (21,264) $ 6,369 $ (53,361) $ (44,685)
XML 23 R6.htm IDEA: XBRL DOCUMENT v3.10.0.1
CONDENSED CONSOLIDATED STATEMENTS OF STOCKHOLDERS' EQUITY (DEFICIT) - USD ($)
shares in Thousands, $ in Thousands
Series C Convertible Preferred Stock
Common Stock
Additional Paid-In Capital
Treasury Stock
Retained Earnings (Deficit)
Accumulated Other Comprehensive Loss
Total Pernix Stockholder' Deficit
Noncontrolling Interest
Total
Beginning Balance, Amount at Dec. 31, 2016 $ 0 $ 100 $ 244,309 $ 0 $ (358,393) $ (79) $ (114,063) $ 0 $ (114,063)
Beginning Balance, Shares at Dec. 31, 2016 0 10,016              
Conversion of restricted stock units, Amount $ 0 $ 1 (113) 0 0 0 (112) 0 (112)
Conversion of restricted stock units, Shares 0 44              
Compensation expense on share-based awards $ 0 $ 0 2,491 0 0 0 2,491 0 2,491
Issuance of convertible debt, Amount 0 $ 11 12,499 0 0 0 12,510 0 $ 12,510
Issuance of convertible debt, Shares   1,100              
Issuance of common stock upon the exercise of stock options, Shares                 0
Net proceeds from sale of shares, Amount 0 $ 7 1,972 0 0 0 1,979 0 $ 1,979
Net proceeds from sale of shares, Shares   681              
Other comprehensive loss 0 $ 0 0 0 0 79 79 0 79
Net loss 0 0 0 0 (77,141) 0 (77,141) 0 (77,141)
Ending Balance, Amount at Dec. 31, 2017 $ 0 $ 119 261,158 0 (435,534) 0 (174,257) 0 (174,257)
Ending Balance, Shares at Dec. 31, 2017 0 11,841              
Capital Contribution - Nalpropion, Amount $ 0 $ 0 0 0 0 0 0 41,250 41,250
Capital Contribution - Nalpropion, Shares 0 0              
Treximet Secured Notes Conversion, Amount $ 1 $ 18 11,558 0 0 0 11,577 0 11,577
Treximet Secured Notes Conversion, Shares 81 1,855              
Conversion of restricted stock units, Amount $ 0 $ 1 (37) 0 0 0 (36) 0 (36)
Conversion of restricted stock units, Shares   71              
Compensation expense on share-based awards 0 $ 0 1,328 0 0 0 1,328 0 1,328
Net proceeds from sale of shares, Amount 0 $ 2 451 0 0 0 453 0 453
Net proceeds from sale of shares, Shares   191              
Other comprehensive loss 0 $ 0 0 0 0 85 85 764 849
Net loss 0 0 0 0 (43,942) 0 (43,492) (9,504) (43,942)
Ending Balance, Amount at Sep. 30, 2018 $ 1 $ 140 $ 274,458 $ 0 $ (479,476) $ 85 $ (204,792) $ 32,510 $ (172,282)
Ending Balance, Shares at Sep. 30, 2018 81 13,958              
XML 24 R7.htm IDEA: XBRL DOCUMENT v3.10.0.1
CONDENSED CONSOLIDATED STATEMENTS OF CASH FLOWS (Unaudited) (USD $) - USD ($)
$ in Thousands
9 Months Ended
Sep. 30, 2018
Sep. 30, 2017
Cash flows used in operating activities:    
Net loss $ (53,446) $ (44,718)
Adjustments to reconcile net loss to net cash used in operating activities:    
Depreciation 316 277
Amortization of intangibles 13,457 54,788
Amortization of deferred financing costs 2,839 2,376
Accretion expense 3,806 3,837
PIK Interest 1,409 0
Amortization of acquisition related inventory step-up 2,239 0
Stock compensation expense 1,328 1,935
Unrealized foreign currency loss 737 0
Fair market value change in contingent consideration 143 344
Fair market value change in derivative liability (39) 38
Gain from legal settlement 0 (10,476)
Gain from exchange of debt (137) (14,650)
Impairment of fixed assets 75 25
Gain on sale of assets (446) 0
(Increase) decrease in operating assets, net of effects of acquisitions:    
Accounts receivable 6,487 2,361
Income tax receivable 78 985
Inventory 3,556 (355)
Prepaid expenses and other assets (3,605) (6,605)
Increase (decrease) in operating liabilities, net of effects of acquisitions:    
Accounts payable and accrued expenses (293) (2,979)
Accrued allowances 2,441 (2,707)
Interest payable (3,980) (5,026)
Other liabilities (2,360) (1,878)
Net cash used in operating activities (25,395) (9,218)
Cash flows from investing activities:    
Acquisition of Orexigen, net of cash acquired (69,225) 0
Proceeds from sale of non-core assets 446 0
Purchase of software and equipment (139) (5)
Net cash used in investing activities (68,918) (5)
Cash flows from financing activities:    
Nalpropion - Capital Contribution 41,250 0
Proceeds from 2018 Term Loan 41,250 0
Net proceeds from Delayed Draw Term Loan 9,167 30,000
Payments on Treximet Secured Notes (5,373) (17,511)
Payment on financing costs (221) (13,586)
Net payments on credit facilities 0 185
Payments on mortgages and capital leases (38) (55)
Proceeds from issuance of common stock, net of tax and costs 453 1,123
Shares withheld for the payment of taxes (37) (67)
Stock issuance costs (549) 0
Net cash provided by financing activities 85,902 89
Effect of exchange rate changes on cash and cash equivalents 102 0
Net decrease in cash and cash equivalents (8,309) (9,134)
Cash and cash equivalents, beginning of period 32,820 36,375
Cash and cash equivalents, end of period $ 24,511 $ 27,241
XML 25 R8.htm IDEA: XBRL DOCUMENT v3.10.0.1
1. Company Overview
9 Months Ended
Sep. 30, 2018
Organization, Consolidation and Presentation of Financial Statements [Abstract]  
1. Company Overview

Note 1. Company Overview

Pernix® Therapeutics Holdings, Inc. and subsidiaries (collectively, Pernix, the Company, we, our and us) is a specialty pharmaceutical company focused on the acquisition, development and commercialization of prescription drugs, primarily for the United States (U.S.) market. The Company is currently focused on the therapeutic areas of pain and neurology and has an interest in expanding into additional specialty segments. The Company promotes its branded products to health care professionals through its Pernix sales force and markets its generic portfolio through its wholly owned subsidiaries, Macoven™ Pharmaceuticals, LLC (Macoven) and Cypress Pharmaceuticals®, Inc. (Cypress).

The Company's branded products include Zohydro® ER with BeadTek® (Zohydro ER), an extended-release opioid agonist indicated for the management of pain severe enough to require daily, around-the-clock, long-term opioid treatment and for which alternative treatment options are inadequate, Treximet® a medication indicated for the acute treatment of migraine attacks with and without aura, and Silenor® a non-controlled substance and approved medication for the treatment of insomnia characterized by difficulty with sleep maintenance.

Subsequent Events

Departure of Angus Smith, Senior Vice President, Chief Business Officer and Principal Financial Officer

On October 26, 2018, Angus Smith notified the Company of his decision to resign as the Company's Senior Vice President, Chief Business Officer and Principal Financial Officer, effective as of November 23, 2018 (the "Effective Date"), to pursue other opportunities. Mr. Smith will continue in his current role through the Effective Date to assist with the transition of his responsibilities and other related matters.

The Company has designated Glenn Whaley, the Company's Vice President of Finance, Principal Accounting Officer and Corporate Controller, as principal financial officer of the Company to succeed Mr. Smith, effective as of the Effective Date. As of the Effective Date, Mr. Whaley's title will be Vice President of Finance, Principal Financial and Accounting Officer.

Nasdaq Deficiency Notices

On October 17, 2018, the Company received notice (the Minimum Market Value of Publicly Held Shares Notice) from the Nasdaq Stock Market LLC (Nasdaq) that the Company is not currently in compliance with the $15 million minimum market value of publicly held shares requirement of Nasdaq Listing Rule 5450(b)(3)(C). The Minimum Market Value of Publicly Held Shares Notice indicated that, consistent with Nasdaq Listing Rule 5810(c)(3)(D), the Company has until April 15, 2019 to regain compliance with the minimum market value of publicly held shares requirement by having the closing market value of publicly held shares, calculated by multiplying the closing bid price of the Company's common stock (Common Stock) by the Company's total shares outstanding (less any shares held by officers, directors or beneficial owners of 10% or more of the total shares outstanding ), meet or exceed $15 million for at least ten consecutive business days.

On October 19, 2018, the Company received notice (the Minimum Bid Price Notice) from Nasdaq that the Company is not currently in compliance with the $1.00 minimum closing bid price requirement of Nasdaq Listing Rule 5450(a)(1). The Minimum Bid Price Notice indicated that, consistent with Nasdaq Listing Rule 5810(c)(3)(A), the Company has until April 17, 2019 to regain compliance with the minimum bid price requirement by having the closing bid price of the Common Stock meet or exceed $1.00 per share for at least ten consecutive business days. If the Company does not regain compliance with the minimum bid price requirement by April 17, 2019, the Company may be eligible to transfer the listing of the Common Stock from the Nasdaq Global Market to the Nasdaq Capital Market if, at the time of such transfer, the Company meets the initial listing requirement for market value of publicly held shares ($1 million) and all other initial listing standards for the Nasdaq Capital Market (except for the minimum bid price requirement) and provides Nasdaq with written notice of its intention to cure the minimum bid price requirement deficiency. In response, Nasdaq may provide the Company with an additional 180 day period to satisfy the minimum bid price requirement. However, if it appears to the Nasdaq staff that the Company will not be able to cure the deficiency, or if the Company is otherwise not eligible, Nasdaq will provide notice to the Company that the Common Stock will be subject to delisting pursuant to Nasdaq's delisting procedures.

The notices do not result in the immediate delisting of the Common Stock from the Nasdaq Global Market. If the Common Stock is delisted from the Nasdaq Global Market, the holders of the Convertible Notes (as defined in Note 10 below) and the Exchangeable Notes (as defined in Note 10 below) would have the right to require the Company (in the case of the Convertible Notes) or Pernix Ireland Pain Designated Activity Company (PIP DAC) (in the case of the Exchangeable Notes) to repurchase all of the Convertible Notes and Exchangeable Notes owned by such holders at a price equal to 100% of the principal amount thereof, plus any accrued and unpaid interest thereon, within 35 business days following the Company or PIP DAC giving notice to such holders of the delisting. The Company's or PIP DAC's failure to pay such amounts when due would result in a default under the indentures governing the Convertible Notes or the Exchangeable Notes, as the case may be, which would ripen into an event of default immediately under the indenture governing the Convertible Notes, and within five days of becoming due under the indenture governing the Exchangeable Notes. Further, an event of default under either of these indentures would result in a cross-default under the Delayed Draw Term Loan (as defined in Note 10 below) as well as the ABL Facility (as defined in Note 10 below), which could result in indebtedness outstanding under those instruments to become immediately due and payable. In addition, any acceleration of the debt under the Convertible Notes, the Exchangeable Notes, the Delayed Draw Term Loan or the ABL Facility would trigger an event of default under the indenture governing the Treximet Secured Notes (as defined in Note 10 below), which could result in such indebtedness becoming immediately due and payable.

Going Concern

As of October 17, 2018, the Company was not in compliance with certain Nasdaq Global Market listing requirements. The Company's outstanding 4.25% Convertible Notes (as defined in Note 10 below) in the principal amount of $78.2 million that contain redemption features in the event the Company was not able to maintain its Nasdaq Global Market listing. In addition, the Company's outstanding Exchangeable Notes (as defined in Note 10 below) in the principal amount of $36.1 million contain redemption features in the event the Company is not able to maintain any Nasdaq listing. These factors raise substantial doubt about the ability of the Company to continue as a going concern within one year after the date that these financial statements are issued. The Company continues to seek other sources of capital and alternatives. However, if the Company is unable to raise sufficient capital or maintain its Nasdaq listing to prevent the redemption of its outstanding indebtness, the Company will not have sufficient liquidity to fund its business operations for at least the next year following the date that the financial statements are issued. The financial statements do not include any adjustments relating to the recoverability and classification of recorded asset amounts or the amounts and classification of liabilities that might be necessary should the Company be unable to continue as a going concern.

Conversion of 0% Series C Perpetual Convertible Preferred Stock

On October 3, 2018, holders of 13,100 shares of the Company' 0% Series C Perpetual Convertible Preferred Stock (Convertible Preferred Stock) elected to convert such Convertible Preferred Stock into 548,115 shares of the Common Stock (see note 11, Stockholders' Equity).

 

 

 

XML 26 R9.htm IDEA: XBRL DOCUMENT v3.10.0.1
2. Basis of Presentation and Summary of Significant Accounting Policies
9 Months Ended
Sep. 30, 2018
Accounting Policies [Abstract]  
2. Basis of Presentation and Summary of Significant Accounting Policies

Note 2. Basis of Presentation and Summary of Significant Accounting Policies

Basis of Presentation

The accompanying unaudited condensed consolidated financial statements included herein have been prepared by the Company in accordance with generally accepted accounting principles in the United States (GAAP) and under the rules and regulations of the United States Securities and Exchange Commission (SEC) for interim reporting. In management's opinion, the interim financial data presented includes all adjustments (consisting solely of normal recurring items) necessary for fair presentation. All intercompany accounts and transactions have been eliminated. Certain information required by GAAP has been condensed or omitted in accordance with rules and regulations of the SEC. Operating results for the three and nine months ended September 30, 2018 are not necessarily indicative of the results that may be expected for any future period or for the year ending December 31, 2018.

These unaudited condensed consolidated financial statements should be read in conjunction with the Company's audited consolidated financial statements and the notes thereto for the year ended December 31, 2017, included in Pernix's 2017 Annual Report on Form 10-K filed with the SEC.

The preparation of the unaudited condensed consolidated financial statements requires management to make estimates and assumptions relating to reporting of the assets and liabilities and the disclosure of contingent assets and liabilities to prepare these unaudited condensed consolidated financial statements and the reported amounts of revenues and expenses during the reporting period in conformity with GAAP. Significant estimates of the Company include: revenue recognition, sales allowances such as returns on product sales, government program rebates, customer coupon redemptions, wholesaler/pharmacy discounts, product service fees, rebates and chargebacks, sales commissions, amortization, stock-based compensation, the determination of fair values of assets and liabilities in connection with business combinations, and deferred income taxes. Actual results could differ from these estimates.

Certain prior period amounts have been reclassified to conform to the current period presentation including reclassifying capitalized debt issuance costs of approximately $1.5 million from "Prepaid expenses and other current assets" to the Company's long-term debt instruments within "Total liabilities" except for those related to revolving credit facilities. This reclassification had no effect on previously reported results of operations, financial position or cash flows.

Principles of Consolidation

The unaudited condensed consolidated financial statements include the accounts of the Company, its wholly owned subsidiaries, and variable interest entities (VIEs) for which the Company is the primary beneficiary. All significant intercompany balances and transactions have been eliminated in consolidation.

The Company evaluates its ownership, contractual, and other interests in entities that are not wholly owned to determine if these entities are VIEs, and, if so, whether the Company is the primary beneficiary of the VIE. In determining whether the Company is the primary beneficiary of a VIE and therefore required to consolidate the VIE, a qualitative approach is applied that determines whether the Company has both (1) the power to direct the activities of the VIE that most significantly impact the VIE's economic performance and (2) the obligation to absorb losses of, or the rights to receive benefits from, the VIE that could potentially be significant to that VIE. The Company will continuously assess whether it is the primary beneficiary of a VIE as changes to existing relationships or future transactions may result in the consolidation or deconsolidation of such VIE. During the three and nine months ended September 30, 2018, the Company's consolidated VIE includes Nalpropion™ Pharmaceuticals Inc. (Nalpropion), and the Company remains the primary beneficiary of Nalpropion (see note 4, Variable Interest Entity). The equity of Nalpropion held by investors other than the Company are treated as a noncontrolling interest in the condensed consolidated financial statements.

Recently Adopted Accounting Pronouncements

In May 2014, the Financial Accounting Standards Board (FASB) issued Accounting Standards Update (ASU) No. 2014-09, Revenue from Contracts with Customers (Topic 606) which supersedes nearly all existing revenue recognition guidance. Effective January 1, 2018, the Company adopted ASU No. 2014-09, Revenue from Contracts with Customers (ASC 606) and all the related amendments (new revenue standard) to all contracts using the modified retrospective method. No material differences were identified as compared to the Company's historical revenue recognition accounting and accordingly, the Company did not recognize a cumulative effect of applying the new revenue standard as an adjustment to the opening balance of retained earnings. The comparative information has not been restated and continues to be reported under the accounting standards in effect for those periods. The Company does not expect the adoption of the new revenue standard to have a material impact to the Company's net income on an ongoing basis.

The Company's new revenue recognition policy is as follows:

Revenue is recognized upon transfer of control of promised products or services to customers in an amount that reflects the consideration the Company expects to receive in exchange for those products or services. The Company generally enters into contracts to sell approved branded and generic pharmaceutical drugs.

  • Product Sales

Product sales revenue is recognized at the estimated consideration to be received when control has transferred to the customer, which is typically on delivery to the customer or, in the case of products that are subject to consignment agreements, when the customer removes product from the Company's consigned inventory location for shipment directly to a patient. Payment terms vary by customer and the products or services offered and is generally required in a term ranging from 30 to 90 days from date of shipment or satisfaction of the performance obligation.

  • Significant Judgments

Product sales contracts provide the customer with the right to return the product and also provide for a variety of discounts and allowances including, specialty distributor fees, wholesaler fees, prompt payment discounts, government rebates, government chargebacks, coupon programs and rebates under managed care plans which are accounted for as variable consideration. Returns are estimated through comparison of historical return data to their related sales on a production lot basis. Historical rates of return are determined for each product and are adjusted for known or expected changes in the marketplace specific to each product, when appropriate.

Judgment is required to estimate the appropriate adjustments for variable consideration which is based on sales or invoice data, contractual terms, historical utilization rates, new information regarding changes in these programs regulations and guidelines that would impact the amount of the actual rebates, the Company's expectations regarding future utilization rates for these programs and channel inventory data.

  • Contract Balances

The timing of customer invoicing generally does not differ from the timing of revenue recognition. The Company records provisions for returns, specialty distributor fees, wholesaler fees, government rebates, coupon programs and rebates under managed care plans are included within current liabilities in the Company's consolidated balance sheets. Provision for prompt payment discounts are generally shown as a reduction in accounts receivable.

In May 2017, the FASB issued ASU 2017-09, Compensation-Stock Compensation (Topic 718): Scope of Modification Accounting, (ASU 2017-09). ASU 2017- 09 provides clarity and reduces both (1) diversity in practice and (2) cost and complexity when applying the guidance in Topic 718, to a change to the terms or conditions of a share-based payment award. ASU 2017-09 is effective for the interim and annual periods beginning after December 15, 2017. The Company adopted the provisions of ASU 2017-09 as of January 1, 2018. There was no material impact on the Company's condensed consolidated financial statements resulting from the adoption of this guidance.

In January 2017, the FASB issued ASU 2017-01, Business Combinations (Topic 805): Clarifying the Definition of a Business, which changes the definition of a business to assist entities with evaluating when a set of transferred assets and activities is deemed to be a business. Determining whether a transferred set constitutes a business is important because the accounting for a business combination differs from that of an asset acquisition. The definition of a business also affects the accounting for dispositions. Under the new standard, when substantially all of the fair value of assets acquired are concentrated in a single asset, or a group of similar assets, the assets acquired would not represent a business and business combination accounting would not be required. The new standard may result in more transactions being accounted for as asset acquisitions rather than business combinations. The standard is effective for interim and annual periods beginning after December 15, 2017 and shall be applied prospectively. The Company adopted ASU 2017-01 as of January 1, 2018, and there was no material impact on the Company's condensed consolidated financial statements resulting from the adoption of this guidance.

In August 2016, the FASB issued ASU 2016-15 Statement of Cash Flows - Classification of Certain Cash Receipts and Cash Payments, which provides updated guidance on eight classification issues related to the statement of cash flows: debt prepayments and extinguishment costs, settlement of zero-coupon bonds, contingent consideration payments made after a business combination, proceeds from the settlement of insurance claims, proceeds from the settlement of corporate-owned life insurance policies, distributions received from equity method investees, beneficial interests in securitization transactions and separately identifiable cash flows and application of the predominance principle. ASU 2016-15 is effective for interim and annual periods beginning after December 15, 2017. The Company adopted the provisions of ASU 2016-15 as of January 1, 2018. There was no material impact on the Company's results of operations resulting from the adoption of this guidance.

In January 2016, the FASB issued ASU 2016-01, Financial Instruments-Overall (Subtopic 825-10): Recognition and Measurement of Financial Assets and Financial Liabilities. The accounting standard primarily affects the accounting for equity investments, financial liabilities under the fair value option, and the presentation and disclosure requirements for financial instruments. In addition, it includes a clarification related to the valuation allowance assessment when recognizing deferred tax assets resulting from unrealized losses on available-for-sale debt securities. The accounting guidance is effective for annual reporting periods (including interim periods within those periods) beginning after December 15, 2017. The Company adopted ASU 2016-01 as of January 1, 2018, and there was no material impact on the Company's condensed consolidated financial statements resulting from the adoption of this guidance.

Recently Issued Accounting Standards, Not Adopted as of September 30, 2018

In August 2018, the FASB issued ASU No. 2018-13, Fair Value Measurement (Topic 820) - Disclosure Framework - Changes to the Disclosure Requirements for Fair Value Measurement, which is designed to improve the effectiveness of disclosures by removing, modifying and adding disclosures related to fair value measurements. ASU No. 2018-13 is effective for fiscal years beginning after December 15, 2019, including interim periods within those fiscal years; the ASU allows for early adoption in any interim period after issuance of the update. The Company is currently assessing the impact this ASU will have on its consolidated financial statements.

In March 2018, the FASB issued ASU No. 2018-05, Income Taxes (Topic 740): Amendments to SEC Paragraphs Pursuant to SEC Staff Accounting Bulletin No. 118 which allowed SEC registrants to record provisional amounts in earnings for the year ended December 31, 2017 due to the complexities involved in accounting for the enactment of the U.S. Tax Cuts and Jobs Act (TCJA) on December 22, 2017. The Company continues to analyze the TCJA, see Note 12, Income taxes for more information.

In February 2016, the FASB issued ASU no. 2016-02, Leases, which requires lessees to recognize assets and liabilities on the balance sheet for the rights and obligations created by all leases with terms of more than 12 months. The leasing standard will be effective for calendar year-end public companies beginning after December 15, 2018, and interim periods within those fiscal years. In July 2018, the FASB issued additional authoritative guidance providing companies with an optional prospective transition method to apply the provisions of this guidance. The Company will adopt the standard in the first quarter of 2019 and elect this transition method to apply the standard prospectively. While the Company is currently evaluating the impact of adoption of this ASU, the adoption is expected to result in a material increase in the assets and liabilities recorded on the condensed consolidated balance sheets.

Management does not believe that any other recently issued, but not yet effective, accounting standards if currently adopted would have a material effect on the Company's consolidated financial statements.

Significant Customers

The Company's customers consist of drug wholesalers, specialty pharmacies, retail drug stores, mass merchandisers and grocery store pharmacies in the United States. The Company primarily sells its products directly to large national drug wholesalers, which in turn resell the products to smaller or regional wholesalers, retail pharmacies, chain drug stores, and other third parties. The following tables list the Company's customers that individually comprised greater than 10% of total gross product sales for the three and nine months ended September 30, 2018 and 2017, or 10% of total accounts receivable as of September 30, 2018 and December 31, 2017.

      Three Months Ended     Nine Months Ended
      September 30,     September 30,
      2018     2017     2018     2017
                         
McKesson Corporation     39%     35%     35%     34%
AmerisourceBergen Drug Corporation     26%     29%     26%     30%
Cardinal Health, Inc.     25%     23%     24%     24%
     Total     90%     87%     85%     88%

 

Accounts Receivable, net:            
      September 30,     December 31,
      2018     2017
             
McKesson Corporation     37%     29%
Cardinal Health, Inc.     29%     31%
AmerisourceBergen Drug Corporation     27%     27%
     Total     93%     87%

 

 

 

XML 27 R10.htm IDEA: XBRL DOCUMENT v3.10.0.1
3. Business Combinations/Divestitures
9 Months Ended
Sep. 30, 2018
Business Combinations [Abstract]  
3. Business Combinations/Divestitures

Note 3. Business Combinations/Divestitures

Closing of Transactions Regarding Worldwide Rights to Contrave® (naltrexone HCl / bupropion HCl)

On April 17, 2018, PIP DAC entered into a commitment letter (the Commitment Letter) pursuant to which PIP DAC committed to provide Nalpropion with $7.5 million in debt and/or equity capital to fund Nalpropion's purchase of certain assets of Orexigen® Therapeutics, Inc. (Orexigen) on the terms and conditions contained in the Commitment Letter. Nalpropion is a special purpose vehicle jointly owned by PIP DAC and certain other co-investors. Nalpropion submitted a "stalking horse" bid to purchase certain assets of Orexigen, which filed a voluntary petition for relief under Chapter 11 of Title 11 of the United States Code, 11 U.S.C. §§ 101, et seq. in the United States Bankruptcy Court for the District of Delaware. On June 22, 2018, the Company announced that no other bids for Orexigen's assets were received by the court-approved bid deadline and, on July 27, 2018, Nalpropion acquired substantially all of the assets of Orexigen, including worldwide rights to Contrave® (Contrave), a prescription-only weight loss medication (the Orexigen Acquisition). The purchase price for the Orexigen Acquisition was $73.5 million with $5 million held back to cover potential indemnification claims. The Company, through PIP DAC, received two purchase options that will enable it to acquire up to 49.9% and 100% of Nalpropion at specified time periods and purchase prices.

Nalpropion financed the Orexigen acquisition utilizing capital sourced from PIP DAC and certain other co-investors, including the full amount of borrowing available, from its 2018 Term Loan facility as defined and as discussed in Note 10. PIP DAC provided capital of $7.35 million, and an incremental $1.82 million for working capital requirements via its existing delayed draw term loan facility, which is structured as a 50% loan and 50% equity contribution to Nalpropion. The co-investors contributed $66.15 million and an incremental $16.35 million for working capital requirements, which was structured as a 50% loan and 50% equity contribution to Nalpropion. PIP DAC and certain affiliates of the co-investors are lenders to Nalpropion under its 2018 Term Loan (see Note 10, Debt and Lines of Credit).

As Nalpropion qualifies as a VIE based on its governance structure and contractual relationship with the Company, the Company will therefore consolidate Nalpropion in its condensed consolidated financial statements since the Company has the power to direct activities that most significantly impact Nalpropion's economic performance (see Note 4, Variable Interest Entity). The Orexigen Acquisition has been accounted for as a business combination using the acquisition method of accounting under the provisions of Accounting Standards Codification ("ASC") 805, Business Combinations by Nalpropion.

Fair Value of Consideration Transferred

The following table indicates the consideration transferred to effect the Orexigen Acquisition:

      Preliminary
      Purchase
      Price
      Allocation
Cash consideration   $ 68,500 
Holdback     5,000 
Total consideration transferred   $ 73,500 

 

Assets Acquired and Liabilities Assumed

The following table summarizes the estimated fair values of the assets acquired and liabilities assumed as of the acquisition date. The following recognized amounts are provisional and subject to change:

  • amounts for intangible assets, property and equipment, certain liabilities, and other working capital balances pending finalization of the valuation; and
  • amount of goodwill pending the completion of the valuation of the assets acquired and liabilities assumed.
      Amounts
      Recognized
      as of the
      Acquisition
      Date
Cash and cash equivalents   $ 730 
Accounts receivable     27,700 
Inventory (a)     18,219 
Prepaids and other current assets      344 
Property and equipment     426 
Intangible assets (b)     50,500 
Goodwill (c)     5,472 
Accounts payable     (1,097)
Accrued allowances     (13,574)
Accrued personnel expense     (841)
Other liabilities - current     (1,877)
Deferred revenue     (12,502)
    $ 73,500 

_________________________

(a) Includes an estimated fair value step-up adjustment to inventory of $5.6 million.
(b) The following table summarizes the preliminary amounts and useful lives assigned to identifiable intangible assets:

 

      Preliminary      
      Intangible     Estimated
      Asset     Useful
      Valuation     Life
Acquired developed technologies   $ 44,800      10 years
Tradenames     4,800      12 years
Other     900      5 years
    $ 50,500       

 

(c) Goodwill is calculated as the difference between the acquisition date fair value of the consideration transferred and the values assigned to the assets acquired and liabilities assumed. None of the goodwill is expected to be deductible for tax purposes. The goodwill recorded represents the following:
  • cost savings and operating synergies expected to result from utilizing the Company's shared services;
  • intangible assets that do not qualify for separate recognition (for instance, assembled workforce) and the residual amount paid not allocated to other net assets acquired.

Nalpropion will finalize these amounts as it obtains the information necessary to complete the measurement process. Any changes resulting from facts and circumstances that existed as of the acquisition date may result in retrospective adjustments to the provisional amounts recognized at the acquisition date. These changes could be significant. Nalpropion will finalize these amounts no later than one year from the acquisition date. To date, Nalpropion has incurred $3.9 million in transaction costs directly related to the Orexigen Acquisition, which includes expenditures for advisory, legal, valuation, accounting and other similar services. These costs have been expensed as acquisition-related costs and is included in selling, general and administrative expenses.

Pro Forma Information

The following table represents the consolidated financial information for the Company on a pro forma basis, assuming that the Orexigen Acquisition occurred as of January 1, 2017. The historical financial information has been adjusted to give effect to pro forma items that are directly attributable to the Orexigen Acquisition and are expected to have a continuing impact on the consolidated results. These items include, among others, adjustments to record the amortization of definite-lived intangible assets and interest expense. Additionally, the following table sets forth unaudited financial information and has been compiled from historical financial statements and other information, but is not necessarily indicative of the results that actually would have been achieved had the transactions occurred on the dates indicated or that may be achieved in the future.

 

      Three Months Ended     Nine Months Ended
      September 30,     September 30,
      2018     2017     2018     2017
Net revenues   $ 40,868    $ 59,372    $ 132,572    $ 165,931 
Net income (loss) attributable to Pernix     (22,371)     4,372      (59,890)     (55,574)
                         
Net income (loss) per share attributable to Pernix:                        
Basic   $ (1.68)   $ 0.39    $ (4.84)   $ (5.35)
Diluted   $ (1.68)   $ 0.30    $ (4.84)   $ (5.35)

 

Sale of Non-Core Assets

On May 29, 2018, the Company received proceeds of $446,000 from the sale of certain obsolete equipment and was recorded as a Gain on sale of assets line in the unaudited condensed consolidated statements of operations for the nine months ended September 30, 2018.

On November 6, 2017, the Company announced the sale of a non-core product, Cedax (ceftibuten capsules and ceftibuten for oral suspension), a third-generation cephalosporin antibiotic for the treatment of acute bacterial exacerbations of chronic bronchitis and middle ear infection, to SI Pharmaceuticals, LLC, for $2.0 million in gross cash proceeds. Cedax was discontinued by Pernix in 2016 and the Company did not generate any sales from this product in 2017.

 

 

 

XML 28 R11.htm IDEA: XBRL DOCUMENT v3.10.0.1
4. Variable Interest Entity
9 Months Ended
Sep. 30, 2018
Organization, Consolidation and Presentation of Financial Statements [Abstract]  
Note 4. Variable Interest Entity

Note 4. Variable Interest Entity

The Company evaluates its investment in Nalpropion in accordance with the variable interest model to determine whether it has a controlling financial interest in an investment. This evaluation is made as of the date on which the Company makes its initial investment, and subsequent evaluations are made if the structure of the investment changes. If the Company determines that Nalpropion is a VIE, then the Company evaluates whether Nalpropion is required to be consolidated. When the Company holds rights that give it the power to direct the activities of an entity that most significantly impact the entity's economic performance, combined with the obligation to absorb an entity's losses or the right to receive benefits, the Company consolidates a VIE. This determination may involve complex and subjective analyses.

As of September 30, 2018, the Company holds a variable interest in Nalpropion, for which the primary beneficiary of the VIE needs to be determined. The Company has concluded, based on its qualitative consideration of the relationship with Nalpropion and by virtue of the management agreement whereby the Company will assume responsibility for product distribution in the United States and managing Nalpropion, that the Company is the primary beneficiary of Nalpropion.

When the Company consolidates a VIE, it discloses the noncontrolling interest of investors other than the Company in its consolidated financial statements.

The following items of Nalpropion are included in the Company's condensed consolidated statement of operations for the three and nine months ended September 30, 2018:

    Three Months Ended September 30, 2018
    Pernix     Nalpropion     Eliminations (1)     Total Company
Net revenues incl. related party $ 20,544    $ 17,923    $ (1,311)   $ 37,156 
                       
Costs and operating expenses:                      
     Cost of product sales   6,470      6,664      (1,311)     11,823 
     Selling, general and administrative expense   14,857      17,015      -       31,872 
     Research and development expense       1,522      -       1,524 
     Depreciation and amortization expense   1,434      957      -       2,391 
     Other operating expenses   73      -       -       73 
          Total costs and operating expenses   22,836      26,158      (1,311)     47,683 
                -       -  
Income (loss) from operations   (2,292)     (8,235)     -       (10,527)
                       
Other income (expense):                      
     Interest expense, net   (9,409)     (664)           (10,073)
     Other, net   (83)     (1,661)     1,056      (688)
          Total other income (expense), net   (9,492)     (2,325)     1,056      (10,761)
                       
Income (loss) before income tax expense $ (11,784)   $ (10,560)   $ 1,056    $ (21,288)
                       
(1) Included in Eliminations are transactions Pernix and Nalpropion enter into with one another. Such transactions include the sale of 
     Contrave inventory from Nalpropion to Pernix and elimination of equity in earnings of Nalpropion. 

 

    Nine Months Ended September 30, 2018
    Pernix     Nalpropion     Eliminations (1)     Total Company
Net revenues incl. related party $ 69,771    $ 17,923    $ (1,311)   $ 86,383 
                       
Costs and operating expenses:                      
     Cost of product sales   21,000      6,664      (1,311)     26,353 
     Selling, general and administrative expense   50,397      17,015      -       67,412 
     Research and development expense   12      1,522      -       1,534 
     Depreciation and amortization expense   12,729      957      -       13,686 
     Other operating expenses   1,430      -       -       1,430 
          Total costs and operating expenses   85,568      26,158      (1,311)     110,415 
                       
Income (loss) from operations   (15,797)     (8,235)     -       (24,032)
                       
Other income (expense):                      
     Interest expense, net   (28,399)     (664)     -       (29,063)
     Other, net   363      (1,661)     1,056      (242)
          Total other income (expense), net   (28,036)     (2,325)     1,056      (29,305)
                       
Income (loss) before income tax expense $ (43,833)   $ (10,560)   $ 1,056    $ (53,337)
                       
(1) Included in Eliminations are transactions Pernix and Nalpropion enter into with one another. Such transactions include the sale of 
     Contrave inventory from Nalpropion to Pernix and elimination of equity in earnings of Nalpropion. 

 

The following assets and liabilities of Nalpropion are included in the Company's condensed consolidated balance sheet as of September 30, 2018.

    As of September 30, 2018
    Pernix     Nalpropion     Eliminations (1)     Total Company
Cash and cash equivalents (2) $ 18,202    $ 6,309    $ -     $ 24,511 
Accounts receivable, net (3)   58,907      7,536      -       66,443 
Inventory, net   4,174      13,614      -       17,788 
Related party receivable   5,841      38,305      (44,146)     -  
Other current assets   4,844      7,136      -       11,980 
Property and equipment, net   634      366      -       1,000 
Goodwill   12,100      5,472      -       17,572 
Intangible assets   84,047      49,602      -       133,649 
Investment in VIE   3,528      -       (3,528)     -  
Related party loan   4,584      -       (4,584)     -  
Other assets   1,827      -       -       1,827 
                -       -  
Total assets $ 198,688    $ 128,340    $ (52,258)   $ 274,770 
                       
Accounts payable and other accrued expenses $ 15,775    $ 10,856    $ -     $ 26,631 
Accrued allowances   54,543      17,155      -       71,698 
Interest payable   5,784      597      -       6,381 
Related party payable   38,305      5,841      (44,146)     -  
Other liabilities - current   5,806      1,095      -       6,901 
Long term debt excluding 2018 Term Loan   281,207      -       -       281,207 
2018 Term Loan   -       45,834      (4,584)     41,250 
Deferred revenue   -       10,840      -       10,840 
Other liabilities - long-term   2,144      -       -       2,144 
                       
Total liabilities   403,564    $ 92,218    $ (48,730)   $ 447,052 
                       
Total equity   (204,876)   $ 36,122    $ (36,038)   $ (204,792)
Noncontrolling interest   -       -       32,510      32,510 
                       
Total liabilities and equity $ 198,688    $ 128,340    $ (52,258)   $ 274,770 
                       
                       
(1) Included in Eliminations are transactions Pernix and Nalpropion enter into with one another. Such transactions may include the following:
     •   Operating transactions in accordance with a services agreement between Nalpropion and Pernix.
     •   Elimination of investments in Nalpropion.
     •   Elimination of investments in Nalpropion’s earnings.
(2) Approximately $12.2 million of cash and cash equivalents related to Nalpropion is held by Pernix at September 30, 2018.
(3) Approximately $23.5 million of Pernix's accounts receivable, net includes accounts receivables related to sales of Contrave.

 

 

 

 

XML 29 R12.htm IDEA: XBRL DOCUMENT v3.10.0.1
5. Earnings per Share
9 Months Ended
Sep. 30, 2018
Earnings Per Share [Abstract]  
5. Earnings per Share

Note 5. Earnings per Share

Basic net income (loss) per common share is the amount of net income (loss) for the period divided by the weighted average shares of Common Stock outstanding during the reporting period. Diluted income (loss) per common share is the amount of income (loss) for the period plus interest expense on convertible debt divided by the sum of weighted average shares of Common Stock outstanding during the reporting period and weighted average shares that would have been outstanding assuming the issuance of common shares for all dilutive potential common shares.

The following table sets forth the computation of basic and diluted net income (loss) per share (in thousands except per share data):

      Three Months Ended     Nine Months Ended
      September 30,     September 30,
      2018     2017     2018     2017
Numerator:                         
     Net income (loss)   $ (11,845)   $ 6,360    $ (43,942)   $ (44,718)
                         
Denominator - Basic:                        
     Weighted-average common shares     13,301      11,117      12,377      10,387 
                         
Numerator - Diluted:                        
     Net income (loss)   $ (11,845)   $ 6,360    $ (43,942)   $ (44,718)
     Adjustment for interest, net of income tax effect     -       599      -       -  
     Net income (loss), adjusted   $ (11,845)   $ 6,959    $ (43,942)   $ (44,718)
                         
Denominator - Diluted:                        
     Weighted-average common shares     13,301      11,117      12,377      10,387 
     Effect of dilutive securities:                        
          Stock options, Awards and Warrants     -       246      -       -  
          Exchangeable notes     -       5,157      -       -  
     Dilutive potential common shares     -       5,403      -       -  
Weighted-average common shares, diluted     13,301      16,520      12,377      10,387 
                         
Basic income (loss) per share   $ (0.89)   $ 0.57    $ (3.55)   $ (4.31)
Diluted income (loss) per share   $ (0.89)   $ 0.42    $ (3.55)   $ (4.31)

 

The following table sets forth the potential common shares that could potentially dilute basic income per share in the future that were not included in the computation of diluted income (loss) per share because to do so would have been anti-dilutive for the periods presented (in thousands):

      Three Months Ended     Nine Months Ended
      September 30,     September 30,
      2018     2017     2018     2017
Treximet Secured Notes     27,238      -       27,238      -  
Exchangeable Notes     6,572      -       6,572      1,738 
Converible Preferred Stock     3,389      -       3,389      -  
Stock options and restricted stock units     1,511      370      1,511      562 
4.25% Convertible Notes     682      780      682      1,014 
Warrants         -           33 
Total potential dilutive effect     39,396      1,150      39,396      3,347 

 

 

 

 

XML 30 R13.htm IDEA: XBRL DOCUMENT v3.10.0.1
6. Fair Value Measurement
9 Months Ended
Sep. 30, 2018
Fair Value Disclosures [Abstract]  
6. Fair Value Measurement

Note 6. Fair Value Measurement

The Company's financial assets and liabilities are measured using inputs from the three levels of the fair value hierarchy. The three levels are as follows:

Level 1- Inputs are unadjusted quoted prices in active markets for identical assets or liabilities that the Company has the ability to access at the measurement date.

Level 2- Inputs are other than quoted prices included within Level 1 that are observable for the asset or liability, either directly or indirectly. Level 2 inputs include quoted prices for similar assets and liabilities in active markets, quoted prices for identical or similar assets or liabilities in markets that are not active, inputs other than quoted prices that are observable for the asset or liability (i.e., interest rates, yield curves, etc.), and inputs that are derived principally from or corroborated by observable market data by correlation or other means (market corroborated inputs).

Level 3- Inputs are unobservable and reflect the Company's assumptions that market participants would use in pricing the asset or liability. The Company develops these inputs based on the best information available.

Summary of Assets Recorded at Fair Value

The Company's cash equivalents are classified within Level 1 of the fair value hierarchy because they are valued using quoted market prices or broker or dealer quotations for similar assets.

The Company had no financial assets that are required to be measured at fair value as of September 30, 2018 and December 31, 2017.

There were no transfers of assets or liabilities between Level 1 and Level 2 during the three and nine months ended September 30, 2018 and 2017.

The carrying amounts reflected in the unaudited condensed consolidated balance sheets for certain short-term financial instruments including accounts receivable, accounts payable, accrued expenses, and other liabilities approximate fair value due to their short-term nature.

Summary of Liabilities Recorded at Carrying Value and Fair Value

The 4.25% Convertible Notes, Exchangeable Notes, 2018 Term Loan, Delayed Draw Term Loan and the Treximet Secured Notes (each, as defined below in Note 10) are recorded at carrying value. The derivative liability and contingent consideration are recorded at fair value. The fair and carrying value of our debt instruments are detailed as follows (in thousands):

      As of September 30, 2018     As of December 31, 2017
      Fair     Carrying     Fair     Carrying
      Value     Value     Value     Value
4.25% Convertible Notes   $ 33,714    $ 67,823    $ 36,208    $ 65,194 
Exchangeable Notes     13,631      10,030      21,375      7,975 
2018 Term loan     41,250      41,250      -       -  
Delayed draw term loan     36,940      37,805      30,300      27,248 
Derivative liability     54      54      93      93 
Contingent consideration     1,501      1,501      1,358      1,358 
Treximet Secured Notes     132,335      151,364      139,201      167,551 
     Total   $ 259,425    $ 309,827    $ 228,535    $ 269,419 

 

4.25% Convertible Notes, Exchangeable Notes, 2018 Term Loan and Delayed Draw Term Loan

The fair values of the 4.25% Convertible Notes and the Exchangeable Notes were estimated using the (i) terms of the Convertible Notes and Exchangeable Notes; (ii) rights, preferences, privileges, and restrictions of the underlying security; (iii) time until any restriction(s) are released; (iv) fundamental financial and other characteristics of the Company; (v) trading characteristics of the underlying security (exchange, volume, price, dividend yield and volatility); (vi) prevailing interest rates; and (vii) precedent sale transactions. The fair value was determined using a convertible note model that incorporated these inputs, as the convertible notes are not listed on any securities exchange or quoted on an inter-dealer automated quotation system.

The Delayed Draw Term Loan and the 2018 Term Loan are classified within Level 3 of the fair value measurements hierarchy. The fair value of these instruments has been estimated using a discounted cash flow analysis based on incremental borrowing rate for similar borrowing arrangements. The carrying amount of the Nalpropion's 2018 Term Loan approximates fair value as the interest rate on the debt approximates the estimated borrowing rate currently available to Nalpropion.

Given the nature and the variable interest rates under the ABL Facility (as defined below), the fair value of borrowings under this facility approximated their carrying value as of September 30, 2018.

Derivative Liability

The derivative liability is classified within Level 3 of the fair value measurements hierarchy and the fair value is determined using a "with and without" conversion scenario. Under this methodology, valuations are performed on the 4.25% Convertible Notes inclusive of all terms as well as for a convertible note that has identical terms and features but excluding the conversion option. The difference between the two valuations is equal to the fair value of the conversion option. Significant increases or decreases in these inputs would result in a significant change in the fair value of the derivative liability.

Contingent Consideration

The contingent consideration is classified within Level 3 of the fair value measurements hierarchy and the fair value is based on two components - a regulatory milestone and commercial milestone.

For the regulatory milestone, the expected regulatory earn out payment was discounted taking into account (a) the Company's cost of debt, (b) the expected timing of the payment and (c) subordinate nature of the earn out obligation.

The fair value of the commercial milestone was determined using a Monte Carlo simulation. This simulation assumed a risk-neutral framework, whereby future net revenue was simulated over the earn out period using the Geometric Brownian Motion. For each simulation path, the earn out payments were calculated based on the achievement of the revenue milestone and then were discounted to the valuation date. Significant increases or decreases in these unobservable inputs and/or the probability of achievement of these milestones would result in a significant change in the fair value of the contingent consideration.

Treximet Secured Notes

The Company's Treximet Secured Notes is classified within Level 3 of the fair value measurements hierarchy and the fair value was estimated using a discounted cash flow model.

Fair Value Measurements Using Significant Unobservable Inputs (Level 3)

For the Company's assets and liabilities measured at fair value on a recurring basis using significant unobservable inputs (Level 3), the following table provides a reconciliation of the beginning and ending balances for each category therein, and gains or losses recognized during the periods (in thousands).

      As of and for the     As of and for the
      Nine Months Ended     Nine Months Ended
      September 30, 2018     September 30, 2017
Derivative liability:            
Balance at beginning of year   93    230 
     Impairment due to partial conversion     -       (90)
     Remeasurement adjustments - loss (gains) included in earnings     (39)     38 
Ending Balance    54    178 
             
Contingent consideration:            
Balance at beginning of year   1,358    2,403 
     Remeasurement adjustments - loss (gains) included in earnings     143      344 
Ending Balance    1,501    2,747 

 

 

 

XML 31 R14.htm IDEA: XBRL DOCUMENT v3.10.0.1
7. Inventory
9 Months Ended
Sep. 30, 2018
Inventory Disclosure [Abstract]  
7. Inventory

Note 7. Inventory

Inventories are stated at the lower of cost or market. Inventories consist of the following (in thousands):

      September 30,     December 31,
      2018     2017
Raw materials   $ 4,297    $ 727 
Work-in-process     2,957      238 
Finished goods     11,524      5,889 
Inventory, gross     18,778      6,854 
Reserve for obsolescence     (990)     (1,458)
     Inventory, net   $ 17,788    $ 5,396 

 

As of September 30, 2018, $13.6 million of inventory related to the Company's consolidation of Nalpropion as a VIE is included in the Company's unaudited condensed consolidated balance sheets.

 

 

 

 

 

 

 

 

 

 

XML 32 R15.htm IDEA: XBRL DOCUMENT v3.10.0.1
8. Goodwill and Intangible Assets
9 Months Ended
Sep. 30, 2018
Goodwill and Intangible Assets Disclosure [Abstract]  
8. Goodwill and Intangible Assets

Note 8. Goodwill and Intangible Assets

Goodwill consists of the following (in thousands):

      Amount
Balance at December 31, 2016   $ 30,600 
     Impairment     (18,500)
Balance at December 31, 2017     12,100 
     Additions     5,472 
     Impairment     -  
Balance at September 30, 2018   $ 17,572 

 

The Company performs an impairment test of goodwill annually in the fourth quarter of each fiscal year unless there are triggering events that would require such analysis during an interim period. There were no triggering events during the nine months ended September 30, 2018. For the year ended December 31, 2017, the carrying value of the reporting unit exceeded its fair value by $18.5 million and accordingly an impairment charge of $18.5 million was recorded in 2017. The decline in the estimated fair value of the reporting unit resulted from management's review of its then-current forecast. As a result of this review, management lowered its forecast for Zohydro ER. The lower projected operating results reflected changes in assumptions related to revenue, market trends, cost structure, and other expectations about the anticipated short-term and long-term operating results of the business.

As of September 30, 2018, $5.5 million of goodwill related to the Company's consolidation of Nalpropion as a VIE is included in the Company's unaudited condensed consolidated balance sheets.

Intangible assets consist of the following (dollars in thousands):

          As of September 30, 2018
      Weighted Average     Gross Carrying           Accumulated     Net Carrying
      Life Remaining     Amount     Impairment     Amortization     Amount
Unamortized intangible assets:                              
     In-process research and development     Indefinite   $ 11,000    $ -     $ -     $ 11,000 
Total unamortized intangible assets           11,000      -       -       11,000 
                               
Amortized intangible assets:                              
     Product licenses     4.8 years     2,846      -       (1,823)     1,023 
     Supplier contracts     2.6 years     583      -       (282)     301 
     Customer Lists     4.8 years     900      -       (32)     868 
     Tradename      11.8 years     4,800      -       (71)     4,729 
     Acquired developed technologies     12.7 years     409,486      -       (293,758)     115,728 
Total amortized intangible assets           418,615      -       (295,966)     122,649 
                               
Total intangible assets         $ 429,615    $ -     $ (295,966)   $ 133,649 

 

          As of December 31, 2017
      Weighted Average     Gross Carrying           Accumulated     Net Carrying
      Life Remaining     Amount     Impairment     Amortization     Amount
Unamortized intangible assets:                              
     In-process research and development     Indefinite   $ 11,000    $ -     $ -     $ 11,000 
Total unamortized intangible assets           11,000      -       -       11,000 
                               
Amortized intangible assets:                              
     Product licenses     5.4 years     2,846      -       (1,623)     1,223 
     Supplier contracts     3.3 years     583      -       (194)     389 
     Acquired developed technologies     13.7 years     364,686      -       (280,692)     83,994 
Total amortized intangible assets           368,115      -       (282,509)     85,606 
                               
Total intangible assets         $ 379,115    $ -     $ (282,509)   $ 96,606 

 

As of September 30, 2018, the weighted average remaining life for our definite-lived intangible assets in total was approximately 12.5 years.

In process research and development (IPR&D) will be amortized on a straight-line basis over its useful life once the receipt of regulatory approval is obtained.

Estimated amortization expense related to intangible assets with definite lives for each of the five succeeding years and thereafter is as follows (in thousands):

      Amount
2018 (October - December)   $ 2,642 
2019     10,567 
2020     10,480 
2021     10,385 
2022     10,346 
Thereafter     78,229 
Total   $ 122,649 

 

Amortization expense was $2.3 million and $13.5 million for the three months and nine months ended September 30, 2018, respectively, of which, $29,000 and $88,000 are included in cost of product sales in the unaudited condensed consolidated statements of operations for the three and nine months ended September 30, 2018, respectively.

Amortization expense was $18.2 million and $54.8 million for the three and nine months ended September 30, 2017, respectively, of which, $30,000 and $88,000 are included in cost of product sales in the unaudited condensed consolidated statements of operations for the three and nine months ended September 30, 2017, respectively

As of September 30, 2018, $49.6 million of intangible assets related to the Company's consolidation of Nalpropion as a VIE is included in the Company's unaudited condensed consolidated balance sheets.

 

 

 

 

XML 33 R16.htm IDEA: XBRL DOCUMENT v3.10.0.1
9. Accrued Allowances
9 Months Ended
Sep. 30, 2018
Accrued Liabilities [Abstract]  
9. Accrued Allowances

Note 9. Accrued Allowances

Accrued allowances consist of the following (in thousands):

      September 30,     December 31,
      2018     2017
Accrued returns allowance   $ 25,370    $ 21,681 
Accrued price adjustments     22,823      10,766 
Accrued managed care rebates     17,230      17,221 
Accrued government program rebates     6,275      6,641 
     Total   $ 71,698    $ 56,309 

 

As of September 30, 2018, $17.2 million of accrued allowances related to the Company's consolidation of Nalpropion as a VIE is included in the Company's unaudited condensed consolidated balance sheets.

 

 

 

 

XML 34 R17.htm IDEA: XBRL DOCUMENT v3.10.0.1
10. Debt and Lines of Credit
9 Months Ended
Sep. 30, 2018
Debt Disclosure [Abstract]  
10. Debt and Lines of Credit

Note 10. Debt and Lines of Credit

Debt, net of discounts and deferred financing costs, consists of the following (in thousands):

      As of September 30, 2018     As of December 31, 2017
      Principal     Note
Discount
    Deferred
Financing
Costs
    Net of Discount
and Deferred
Financing Costs
    Principal     Note
Discount
    Deferred
Financing
Costs
    Net of Discount
and Deferred
Financing Costs
4.25% Convertible Notes   $ 78,225    $ (8,828)   $ (1,574)   $ 67,823    $ 78,225    $ (11,060)   $ (1,971)   $ 65,194 
Exchangeable Notes     36,145      (22,913)     (3,202)     10,030      35,743      (24,363)     (3,405)     7,975 
Delayed Draw Term Loan     40,074      -       (2,269)     37,805      30,000      -       (2,752)     27,248 
Treximet Secured Notes - Long Term     154,515      -       (3,151)     151,364      166,697      -       (2,810)     163,887 
Treximet Secured Notes - Short Term     -       -       -       -       5,373      -       (1,709)     3,664 
2018 Term Loan     41,250      -       -       41,250      -       -       -       -  
ABL Facility     14,185      -       -       14,185      14,185      -       -       14,185 
     Total outstanding debt   $ 364,394    $ (31,741)   $ (10,196)   $ 322,457    $ 330,223    $ (35,423)   $ (12,647)   $ 282,153 
                                                 
     Less: Current portion of long-term debt                       -                         3,664 
     Long-term debt outstanding, net                     $ 322,457                      $ 278,489 

 

Convertible Notes:

4.25% Convertible Notes

On April 22, 2015, the Company issued $130.0 million aggregate principal amount 4.25% Convertible Notes. The 4.25% Convertible Notes mature on April 1, 2021, unless earlier converted, redeemed or repurchased. Interest on the 4.25% Convertible Notes is payable on April 1 and October 1 of each year, beginning October 1, 2015.

The 4.25% Convertible Notes are governed by the terms of an indenture, between the Company and Wilmington Trust, National Association, each of which were entered into on April 22, 2015. The Company may not redeem the 4.25% Convertible Notes prior to April 6, 2019. However, the holders may convert their 4.25% Convertible Notes at any time prior to the close of business on the business day immediately preceding January 1, 2021 only under certain circumstances. The effective interest rate on the 4.25% Convertible Notes, including debt issuance costs and bifurcated conversion option derivative (discussed below), is 10.4%.

The Company is required to separate the conversion option in the 4.25% Convertible Notes under Accounting Standards Codification (ASC) 815, Derivatives and Hedging. During April 2015, the Company recorded the bifurcated conversion option valued at $28.5 million as a derivative liability, which created a discount on the debt. The derivative liability is marked to market through the other income (expense) section on the unaudited condensed consolidated statements of operations for each reporting period, while the discount created on the 4.25% Convertible Notes is accreted as interest expense over the life of the debt. The derivative liability is valued at $54,000 and $93,000 as of September 30, 2018 and December 31, 2017, respectively.

Interest expense was $1.7 million and $5.1 million for the three and nine months ended September 30, 2018, respectively, and $1.9 million and $6.9 million for the three and nine months ended September 30, 2017, respectively, related to the 4.25% Convertible Notes. Interest expense includes amortization of deferred financing costs and accretion of debt discount.

Change in fair value of derivative liability was a benefit of $18,000 and $39,000 for the three and nine months ended September 30, 2018, respectively, and a benefit of $46,000 and an expense of $38,000 for the three and nine months ended September 30, 2017, respectively. Accrued interest on the 4.25% Convertible Notes was approximately $1.7 million and $0.8 million as of September 30, 2018 and December 31, 2017, respectively.

As a result of the Exchangeable Notes transaction during the third quarter of 2017, the Company recorded $14.7 million as gain from exchange of debt for the three months ended September 30, 2017.

Exchangeable Notes

On July 20, 2017, the Company entered into an exchange agreement (the 2017 Exchange Agreement) with certain holders of its 4.25% Convertible Notes (Holders) pursuant to which $51.8 million of aggregate principal amount of its 4.25% Convertible Notes held by the Holders were exchanged for (i) $36.2 million aggregate principal amount of 4.25%/5.25% Exchangeable Senior Notes due 2022 (the Exchangeable Notes), issued by PIP DAC pursuant to an Indenture, dated July 21, 2017 (the Exchangeable Notes Indenture), among PIPL, the guarantors party thereto (the Guarantors), and Wilmington Trust, National Association, as Trustee and (ii) 1,100,498 shares of Common Stock.

The Exchangeable Notes issued under the Exchangeable Notes Indenture are guaranteed by the Company and each other subsidiary thereof. The Exchangeable Notes are senior, unsecured obligations of PIP DAC. Interest on the Exchangeable Notes will be paid in cash or a combination of cash and in-kind interest at PIP DAC's election. Interest paid in cash (the All Cash Method) will accrue at a rate of 4.25% per annum, while interest paid in a combination of cash and in-kind will accrue at a rate of 5.25% per annum, with 2.25% per annum (plus additional interest, if any) capitalized to the principal amount of the Exchangeable Notes, and the balance paid in cash. The maturity date of the Exchangeable Notes Indenture is July 15, 2022. The Exchangeable Notes initially are exchangeable into shares of Common Stock at an exchange price per share of $5.50 (the Exchange Price).

The 2017 Exchange Agreement allowed the Company to reduce the principal amount of its outstanding indebtedness through the exchange of the Holders' 4.25% Convertible Notes for a smaller principal amount of the Exchangeable Notes. The principal amount of the Exchangeable Notes may be reduced if the Holders thereof exchange their Exchangeable Notes for shares of Common Stock. The Exchangeable Notes Indenture will provide capacity to refinance up to an additional $25.0 million principal amount of the 4.25% Convertible Notes, which refinancing could also provide an opportunity to further reduce the principal amount of the Company's outstanding indebtedness.

The outstanding borrowings of the Exchangeable Notes were paid down by $500,000 in November 2017 with a portion of the proceeds from the sale of certain non-core assets. Interest expense was $1.0 million and $3.0 million for the three and nine months ended September 30, 2018, respectively, and $0.6 million for the three and nine months ended September 30, 2017, related to the Exchangeable Notes and included amortization of deferred financing costs and accretion of debt discount. During the first quarter of 2018, PIP DAC elected the PIK option in lieu of making scheduled interest payments. The election increased the principal due on the Exchangeable Notes by $402,000 as of September 30, 2018. Accrued interest on the Exchangeable Notes was approximately $396,000 and $675,000 as of September 30, 2018 and December 31, 2017, respectively.

Term Facility:

On July 21, 2017 PIP DAC entered into a term loan credit agreement (the Delayed Draw Term Loan, the Term Facility or DDTL) with Cantor Fitzgerald Securities, as agent and the lenders party thereto to obtain the DDTL. $30.0 million under the DDTL was drawn on July 21, 2017 in connection with the closing of several refinancing transactions and the remaining $15.0 million will be available for subsequent draws for certain specified purposes, including to finance certain acquisitions, subject to conditions set forth in the DDTL credit agreement. The DDTL includes an incremental feature that allows PIP DAC, with the consent of the requisite lenders under the Term Facility, to obtain up to an additional $20.0 million in term loan commitments. Interest on the loans will accrue either in cash or a combination of cash and in kind interest, at PIP DAC's election. Cash interest will accrue at a rate of 7.50% per annum, while the combination of cash and in-kind interest will accrue at a rate of 8.50% per annum, with up to 4.00% per annum added to the principal amount of loans and the balance paid in cash. The DDTL will mature on July 21, 2022. During the first quarter of 2018, PIP DAC elected the PIK option in lieu of making scheduled interest payments. The election increased the principal due on the DDTL by $906,000 as of September 30, 2018.

On July 27, 2018, PIP DAC drew $9.2 million under the DDTL. The proceeds were used to fund the Company's investment in Nalpropion for Nalpropion's purchase of certain assets of Orexigen and for working capital requirements.

PIP DAC also entered into a mortgage debenture with Cantor Fitzgerald Securities as agent, pursuant to which PIP DAC's obligations under the DDTL will be secured by substantially all of the assets of PIP DAC and its future-acquired subsidiaries.

On August 1, 2018 the Company entered into an amendment of its Term Facility. These amendments were made to permit the exchange of the 12% Senior Secured Notes due 2020 (Treximet Secured Notes) for newly issued shares of Common Stock in the exchange transactions and equitization transaction (as defined below), and to amend certain terms of the Term Facility and the ABL Facility (collectively, the Credit Facilities), including (i) changes to permit the use of subsequent draws under the Term Facility for working capital or other general corporate purposes, and (ii) changes to the interest payment provisions under the Term Facility increasing the minimum percentage of interest that must be paid in cash to 6.00% per annum from 4.50% per annum.

Interest expense was approximately $1.0 million and $2.6 million for the three and nine months ended September 30, 2018 related to the DDTL and includes amortization of deferred financing costs. Accrued interest on the DDTL was approximately $624,000 and $484,000 as of September 30, 2018 and December 31, 2017, respectively.

Secured Notes:

Treximet Note Offering

On August 19, 2014, the Company issued $220.0 million aggregate principal amount of its Treximet Secured Notes pursuant to an Indenture (the August 2014 Indenture) dated as of August 19, 2014 among the Company, certain of its subsidiaries (the Treximet Guarantors) and U.S. Bank National Association (the August 2014 Trustee), as trustee and collateral agent.

On April 13, 2015, the Company amended the August 2014 Indenture to allow the Company to, among other things, incur up to $42.2 million of additional debt. On December 29, 2017, the Company and the August 2014 Trustee entered into a third supplemental indenture to amend the August 2014 Indenture to clarify the definition of "Net Sales", as such term is defined in the August 2014 Indenture and resulted in the deferral of $3.2 million of principal payments until maturity of the notes.

The Treximet Secured Notes mature on August 1, 2020 and bear interest at a rate of 12% per annum, payable in arrears on February 1 and August 1 of each year (each, a Payment Date), beginning on February 1, 2015. On each Payment Date, commencing August 1, 2015, the Company began paying installments of principal of the Treximet Secured Notes in an amount equal to 50% of net sales of Treximet for the two consecutive fiscal quarters immediately preceding such Payment Date (less the amount of interest paid on the Treximet Secured Notes on such Payment Date). At each month-end beginning with January 2015, the net sales of Treximet will be calculated, the monthly interest accrual amount will then be deducted from the net sales and this resulting amount will be recorded as the current portion of the Treximet Secured Notes. If the Treximet net sales less the interest due at the end of each six-month period does not result in any excess over the interest due, no principal payment must be paid at that time. The remaining balance outstanding on the Treximet Secured Notes will be due on the maturity date, which is August 1, 2020. As of September 30, 2018, the principal amount outstanding of the Treximet Secured Notes is $154.5 million and is classified as a non-current liability. As of December 31, 2017, the Company classified $5.4 million, of the Treximet Secured Notes as a current liability and $166.7 million as a non-current liability at December 31, 2017.

The Treximet Secured Notes are secured by a continuing first-priority security interest in substantially all of the assets of the Company and the Treximet Guarantors related to Treximet other than inventory and certain inventory related assets, including accounts arising from the sale of the inventory.

On August 1, 2018, the Company entered into an exchange agreement (2018 Exchange Agreement) with certain holders (Exchange Holders) of the Treximet Secured Notes for newly issued shares of Common Stock and shares of a newly created class of convertible preferred stock of the Company designated as Convertible Preferred Stock (Exchange Transactions).

The Exchange Transactions closed on August 1, 2018 and were as follows:

  • exchange of approximately $2.7 million aggregate principal amount of the Treximet Secured Notes for 1,204,586 shares of Common Stock which includes $0.2 million of accrued and unpaid interest on the Treximet Secured Notes;
  • exchange of $8.0 million principal amount of the Treximet Secured Notes plus $0.1 million of accrued and unpaid interest for 81,000 shares of Convertible Preferred Stock.

The 2018 Exchange Agreement affords certain Exchange Holders the right to exchange up to an additional $65.1 million aggregate principal amount of the Treximet Secured Notes plus accrued and unpaid interest, into additional Convertible Preferred Stock until February 1, 2020. The Company evaluated the transaction under ASC 470-50, Debtors Accounting for a Modification or Exchange of Debt Instruments and determined the inclusion of the conversion right was not substantive and therefore does not constitute a debt extinguishment.

On August 1, 2018, the Company entered into separate Equitization Exchange Agreements by and among Pernix and certain Equitization Holders of Treximet Secured Notes. Pursuant to the Equitization Exchange Agreements, the Company issued 650,190 shares of its Common Stock in exchange for approximately $1.5 million aggregate principal amount of Treximet Secured Notes held by such Equitization Holders plus $0.1 million of accrued and unpaid interest thereon (Equitization Transaction). This transaction closed on August 1, 2018.

As a result of the Exchange Transactions and Equitization Transaction, the Company recorded a net gain on early extinguishment of debt of $0.1 million.

Interest expense related to the Treximet Secured Notes was $5.2 million and $16.1 million for the three and nine months ended September 30, 2018, respectively, and was $5.6 million and $17.2 million for the three and nine months ended September 30, 2017, respectively. Interest expense includes amortization of deferred financing costs. Accrued interest on the Treximet Secured Notes was approximately $3.1 million and $8.6 million as of September 30, 2018 and December 31, 2017, respectively.

2018 Term Loan

On July 27, 2018, Nalpropion entered into a credit agreement (2018 Credit Agreement) with Wilmington Savings Fund Society, FSB, as administrative and collateral agent, and certain lenders including PIP DAC and certain affiliates of Highbridge Capital Management, LLC (Highbridge) and Whitebox Advisors LLC (Whitebox, and collectively, the Lenders) from time to time party thereto providing for $45.8 million principal amount of a three-year term loan (the 2018 Term Loan). Loans under the 2018 Term Loan bear interest at 8.0% per year and mature on July 27, 2021. PIP DAC provided $4.6 million of the total commitment under the credit facility established under the 2018 Credit Agreement (2018 Credit Facility). Nalpropion borrowed the full $45.8 million available under the 2018 Term Loan to partially fund the Orexigen Acquisition and for working capital requirements. As PIP DAC is one of the lenders under the 2018 Credit Facility and provided $4.6 million of the total commitment under the 2018 Credit Facility, the $4.6 million is eliminated in consolidation as the transaction is between affiliates. As of September 30, 2018, $41.3 million of borrowings under the 2018 Term Loan related to the Company's consolidation of Nalpropion as a VIE is included in the Company's unaudited condensed consolidated balance sheets.

The borrowings under the 2018 Credit Agreement are secured, subject to customary permitted liens and other agreed upon exceptions, by a perfected security interest in the intangible assets of Nalpropion. Nalpropion is permitted to make voluntary prepayments at any time without payment of a premium or penalty. Nalpropion is required to make mandatory prepayments of outstanding indebtedness under the 2018 Credit Agreement (without payment of a premium) with (a) net cash proceeds from certain non-ordinary course asset sales (subject to reinvestment rights and other exceptions), (b) casualty proceeds and condemnation awards (subject to reinvestment rights and other exceptions), and (c) 75% of the excess cash flow generated during a semi-annual period (commencing with the period subsequent to June 30, 2019), depending on certain factors as defined in the 2018 Credit Agreement.

The 2018 Credit Agreement contains certain negative covenants (subject to exceptions, materiality thresholds and other allowances) including, without limitation, negative covenants that limit Nalpropion's ability to incur additional debt, guarantee other obligations, grant liens on assets, make loans, acquisitions or other investments, dispose of certain assets, make optional payments in connection with or modify certain debt instruments, pay dividends or make other payments on capital stock, engage in mergers or consolidations, enter into arrangements that restrict Nalpropion's ability to pay dividends or grant liens, engage in transactions with affiliates, or change its fiscal year.

In addition, the 2018 Credit Agreement also contains customary events of default (with customary grace periods and materiality thresholds). Upon the occurrence of certain events of default, the obligations under the 2018 Credit Agreement may be accelerated and any remaining commitments thereunder may be terminated.

Interest expense related to the 2018 Term Loan was $0.7 million for the three months ended September 30, 2018 of which $0.1 million is due to the Company and is eliminated in consolidation. As of September 30, 2018, $0.6 million of accrued interest on the 2018 Term Loan related to the Company's consolidation of Nalpropion as a VIE is included in the Company's unaudited condensed consolidated balance sheets.

Credit Facility:

Cantor Fitzgerald

On July 21, 2017, Pernix and certain subsidiaries of Pernix as borrowers and guarantors (the ABL Borrowers) and PIP DAC, Pernix Ireland Limited, Pernix Holdco 1, LLC, Pernix Holdco 2, LLC and Pernix Holdco 3, LLC as additional guarantors (the ABL Guarantors), entered into an asset-based revolving credit agreement (the ABL Credit Agreement) with Cantor Fitzgerald Securities, as agent (the ABL Agent) and the lenders party thereto to obtain a five-year $40 million asset-based revolving credit facility (the ABL Facility). On April 23, 2018, the Company entered into an amendment, effective as of April 12, 2018, to modify the borrowing base formula which determines the Company's capacity to draw on the ABL Facility, which could increase such capacity. The amendment also removed concentration limits for accounts receivable due from individual customers or other account debtors that may be included in the borrowing base.

The ABL Borrowers' obligations under the ABL Credit Agreement are guaranteed by the ABL Borrowers and the ABL Guarantors are secured by, among other things, the ABL Borrowers' cash, inventory and accounts receivable, in each case pursuant to a guaranty and security agreement between the ABL Borrowers, ABL Guarantors and Cantor Fitzgerald Securities as agent. Borrowings under the ABL Credit Agreement bear interest at the rate of LIBOR plus 7.50%, payable monthly, in addition to a commitment fee on any undrawn commitments at a rate per annum of 0.25%, payable monthly. The ABL Credit Agreement contains representations and warranties, affirmative and negative covenants, and events of default applicable to the Company, the other ABL Borrowers, the ABL Guarantors and their respective subsidiaries that are customary for credit facilities of this type. The ABL Credit Agreement will mature on July 21, 2022.

On August 1, 2018 the Company entered into an amendment of the ABL Facility. The amendment provides for certain changes to the borrowing base calculation under the ABL Facility that are intended to improve the Company's borrowing capacity under the ABL Facility and that will also permit the Company, among other things, to include Contrave inventory owned by the Company in the calculation of the borrowing base, and a reduction in the commitments under the ABL Facility from $40.0 million to $32.5 million.

Interest expense was $0.5 million and $1.5 million for the three and nine months ended September 30, 2018, respectively, and was $0.4 million for the three and nine months ended September 30, 2017, related to the ABL Credit Agreement and includes amortization of deferred financing costs. As of September 30, 2018, unamortized debt issuance costs of $0.6 million and $1.6 million are recorded on the unaudited consolidated balance sheets in Prepaid expenses and other currents assets and Other assets, respectively, and are being amortized to interest expense over the life of the agreement. As of December 31, 2017, $0.6 million and $2.1 million of unamortized debt issuance costs are recorded on the unaudited consolidated balance sheets in Prepaid expenses and other currents assets and Other assets, respectively.

Wells Fargo

On August 21, 2015, the Company entered into a credit agreement with Wells Fargo, as Administrative Agent and the lenders party thereto for a $50.0 million, three-year senior secured revolving credit facility (the Wells Fargo Credit Facility).

The ABL Facility entered into on July 21, 2017 replaced the Wells Fargo Credit Facility and the Company used the proceeds from the ABL Facility to repay the outstanding obligation of the Wells Fargo Credit Facility.

Interest expense including amortization of deferred financing costs related to the Wells Fargo Credit Facility amounted to $142,000 and $748,000, for the three and nine months ending September 30, 2017, respectively.

The following table represents the future maturity schedule of the outstanding debt and line of credit at September 30, 2018 (in thousands):

      Amount
2018 (October - December)   $ -  
2019     -  
2020     154,515 
2021     119,475 
2022     90,404 
Thereafter     -  
     Total maturities     364,394 
Less:      
     Note discount     (31,741)
     Deferred financing costs     (10,196)
Total outstanding debt, net   $ 322,457 

 

 

 

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11. Stockholders' Equity
9 Months Ended
Sep. 30, 2018
Stockholders Equity  
11. Stockholders' Equity

Note 11. Stockholders' Equity 

Convertible Preferred Stock

On August 1, 2018, in connection with the 2018 Exchange Agreement, the Company reclassified and designated 1,500,000 shares of the authorized but unissued preferred stock of the Company to the Convertible Preferred Stock. In connection with the Exchange Transactions, $8.0 million principal amount of the Treximet Secured Notes plus $100,000 of accrued and unpaid interest was exchanged for 81,000 shares of Convertible Preferred Stock. The Convertible Preferred Stock was recorded at fair value in the amount of $7.2 million, net of issuance costs of $0.5 million and is recorded to additional paid-in capital.

Holders of Convertible Preferred Stock have the right to convert their shares of Convertible Preferred Stock, in whole or in part, into shares of Common Stock at any time on or after August 1, 2018 (the Initial Issue Date). The Company has the right, at its option, to automatically convert all shares of Convertible Preferred Stock into shares of Common Stock, subject to the satisfaction of certain specified conditions. Upon any conversion of an Exchange Holder's Convertible Preferred Stock, the Company will deliver shares of Common Stock, calculated by multiplying the number of shares of Convertible Preferred Stock by 41.841 shares of Common Stock per share of Convertible Preferred Stock (the Conversion Rate). The Conversion Rate is initially equal to the number of shares of Common Stock convertible into Common Stock at a price $0.01 above the consolidated closing bid price on the date immediately preceding Initial Issue Date, or $2.39 per share.

Subsequent to the Initial Issue Date, an Exchange Holder is not able to convert Convertible Preferred Stock into Common Stock to the extent that the Common Stock held by such Exchange Holder and its affiliates would exceed 4.985% of the Common Stock outstanding immediately after giving effect to the issuance of shares of Common Stock.

Moreover, at any time on or after the Initial Issue Date, the Company has the right to redeem the Convertible Preferred Stock, in whole or in part, at a redemption price equal to 100% of the liquidation preference of the shares to be redeemed, plus any accrued and unpaid dividends. Except as required by law or the Articles Supplementary, the Exchange Holders of Convertible Preferred Stock have no voting rights (other than with respect to certain matters regarding the Convertible Preferred Stock).

In accordance with the Articles Supplementary, the Company will not authorize, declare or pay regular or special dividends or other distributions (whether in the form of cash, shares, indebtedness or any other property or asset, but excluding any purchase, redemption or other acquisition of shares) on the shares of the Common Stock, unless simultaneously with the authorization, declaration or payment, it authorizes, declares or pays, as applicable, dividends or other distributions on the Convertible Preferred Stock.

On October 3, 2018, holders of 13,100 shares of the Company' 0% Series C Perpetual Convertible Preferred Stock elected to convert such Convertible Preferred Stock into 548,115 shares of the Company's Common Stock.

Controlled Equity Offering

On November 7, 2014, the Company entered into a controlled equity offering sales agreement (the Sales Agreement) with Cantor Fitzgerald & Co. (Cantor) pursuant to which the Company could issue and sell shares of its Common Stock having an aggregate offering price of up to one hundred million dollars, pursuant to an effective registration statement on Form S-3 (No. 333-200005), from time to time through Cantor, acting as agent. On November 22, 2017, the Company filed a registration statement on Form S-3 (No. 333-221717) to replace the previously-filed registration statement, which was subsequently declared effective by the SEC on December 18, 2017. The Company will pay Cantor a commission rate of 3.0% of the gross sales price per share of the Common Stock sold through Cantor as agent under the Sales Agreement.

During the nine months ended September 30, 2018, the Company sold 191,170 shares of Common Stock under the Sales Agreement at an average price of approximately $2.51 per share for gross proceeds of $480,000 and net proceeds of $453,000, after deducting commission and fees. During the nine months ended September 30, 2017, the Company sold 372,176 shares of Common Stock under the Sales Agreement at an average price of approximately $3.21 per share for gross proceeds of $1.2 million and net proceeds of $1.1 million, after deducting commission and fees. As of September 30, 2018, approximately $77.0 million of Common Stock remained available to be sold under this facility, subject to certain limitation to the extent the Company continues to have a public float of less than $75.0 million.

Noncontrolling Interest

Ownership interests in subsidiaries held by parties other than the Company are presented as non-controlling interest within stockholders' equity, separately from the equity held by the Company on the consolidated statements of stockholders' equity. Revenues, expenses, net income and other comprehensive income are reported in the condensed consolidated financial statements at the consolidated amounts, which includes amounts attributable to both the Company's interest and the non-controlling interests in Nalpropion. Net loss and other comprehensive loss is then attributed to the Company's interest and the non-controlling interests. Net loss to non-controlling interests is added to net loss in the consolidated statements of loss to determine net loss attributable to the Company's common shareholders (see unaudited condensed consolidated statements of stockholders' equity (deficit) for activity related to the noncontrolling interest).

Warrants

As of September 30, 2018, the Company has approximately 4,380 outstanding Common Stock warrants assumed in connection with the acquisition of Somaxon Pharmaceuticals, Inc. (Somaxon) in March 2013, with exercise prices ranging from $83.73 to $258.51 and expiration dates ranging from August 2021 through December 2021.

Share-Based Compensation Plans

In November 2017, the Company's shareholders approved the 2017 Omnibus Incentive Plan (the 2017 Plan) for future equity awards granted by the Company. Subject to the adjustments described below, the maximum number of shares of  Common Stock that will be available for issuance under the 2017 Omnibus Incentive Plan will be equal to the sum of (i) one million (1,000,000) shares of Common Stock plus (ii) the number of shares of our Common Stock available for future awards under the 2015 Omnibus Incentive Plan and the 2009 Stock Incentive Plan as of November 15, 2017, plus (iii) the number of shares of Common Stock related to awards outstanding under such plans as of November 15, 2017 that terminate after such date by expiration or forfeiture, cancellation, or otherwise without the issuance of such shares of Common Stock. On May 22, 2018, the Company's stockholders approved an amendment to the 2017 Plan to increase the number of shares reserved under the 2017 Plan from 642,294 shares of Common Stock to 1,242,294 shares of Common Stock.

Stock-Based Compensation

Stock-based compensation expense is recognized, net of an estimated forfeiture rate, on a straight-line basis over the requisite service period, which is the vesting period.

The Company uses the Black-Scholes option pricing model to determine the fair value of its stock options. The weighted average fair value of stock options granted during the periods and the assumptions used to estimate those values using the Black-Scholes option pricing mode were as follows:

      Three Months Ended     Nine Months Ended
      September 30,     September 30,
      2018     2017     2018     2017
Weighted average expected stock price volatility     86.4%     88.0%     86.4%     87.6%
Estimated dividend yield     -     -     -     -
Risk-free interest rate     2.9%     2.0%     2.8%     2.0%
Expected life of option (in years)     6.3     6.2     6.3     6.2
Weighted average grant date fair value per option   $ 0.69   $ 2.15   $ 1.61   $ 2.15

 

The Company measures the grant date fair value of restricted stock units (RSUs) using the Company's closing Common Stock price on the grant date.

The accounting policy with respect to stock options and RSUs is described in the audited consolidated financial statements contained in the Company's Annual Report on Form 10-K for the year ended December 31, 2017.

Stock-based compensation expense was $0.4 million and $1.3 million for the three and nine months ended September 30, 2018, respectively and was $0.5 million and $1.9 million for the three and nine months ended September 30, 2017. Stock-based compensation expense for the periods presented is included within the selling, general and administrative expense in the unaudited condensed consolidated statements of operations.

Stock Options

The following table shows the option activity, described above, during the nine months ended September 30, 2018 (shares and intrinsic value in thousands):

                  Weighted Average      
            Average     Remaining     Aggregate
            Exercise     Contractual Life     Intrinsic
      Shares     Price     (years)     Value
Options Outstanding at December 31, 2017     1,042    $ 13.80      8.8       
     Granted     556      2.17             
     Exercised     -       -              
     Cancelled     (228)     12.29             
     Expired     -       -              
Options outstanding at September 30, 2018     1,370    $ 9.34      8.7    $
Options vested and expected to vest as of September 30, 2018     895    $ 12.86      8.3    $
Options vested and exercisable as of September 30, 2018     339    $ 24.88      7.3    $

 

As of September 30, 2018, there was approximately $1.4 million of total unrecognized compensation cost related to non-vested stock options issued to employees and directors of the Company, which is expected to be recognized ratably over a weighted-average period of 2.0 years.

The total intrinsic value of options exercised during each of the three and nine months ended September 30, 2018 and 2017 was $0.

Options issued subsequent to January 2014 have a graded vesting schedule over either three or four years. The Company's stock option grants expire ten years from the date of grant.

Restricted Stock

The following table shows the Company's non-vested restricted stock activity during the nine months ended September 30, 2018 (shares in thousands):

            Weighted Average
            Grant Date Fair
      Shares     Value
Non-vested restricted stock outstanding at December 31, 2017     135    $ 3.17 
     Granted     62      2.46 
     Vested     (54)     3.25 
     Forfeited     (2)     2.60 
Non-vested restricted stock outstanding at September 30, 2018     141    $ 2.83 

 

The total fair value of RSUs vested in the nine months ended 2018 and 2017, were $177,000 and $220,000, respectively. As of September 30, 2018, there was $0.8 million total unrecognized compensation cost related to non-vested restricted stock issued to employees and directors of the Company which is expected to be recognized ratably over a weighted-average period of 1.97 years.

 

 

 

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12. Income Taxes
9 Months Ended
Sep. 30, 2018
Income Tax Disclosure [Abstract]  
12. Income Taxes

Note 12. Income Taxes

On December 22, 2017, the U.S. Tax Cuts and Jobs Act ("TCJA") was enacted reducing the corporate Federal tax rate from 35% to 21% effective for tax years beginning on or after January 1, 2018. ASC 740, Income Taxes, requires the effects of changes in tax laws to be recognized in the period in which the legislation is enacted. However, due to the complexity and significance of the TCJA's provisions and anticipated guidance from the U.S. Treasury and the Internal Revenue Service regarding the TCJA, the SEC staff issued Staff Accounting Bulletin 118, which allows companies to record the tax effects of the TCJA on a provisional basis based on a reasonable estimate, and then, if necessary, subsequently adjust such amounts during a limited measurement period as more information becomes available. The measurement period ends when a company has obtained, prepared, and analyzed the information necessary to finalize its accounting, but cannot extend beyond one year from enactment of the TCJA.

Under the TCJA, the Corporate Alternative Minimum Tax ("AMT") was repealed. The Company's previously recorded AMT credits of approximately $0.2 million are now refundable subject to budgetary sequestration over a four-year period beginning in 2018, and the previously recorded valuation allowance for these AMT credits was reversed during the year ended December 31, 2017. The Company's Irish subsidiaries have accumulated deficits in earnings and profits and thus the Company will not be subject to the one-time transition tax.

The TCJA creates a new requirement that certain income (i.e., Global intangible low taxed income "GILTI") earned by foreign subsidiaries must be included currently in the gross income of the U.S. shareholder. Due to the complexity of the new GILTI tax rules, the Company is continuing to evaluate this provision of the Tax Act and the application of ASC 740. Under U.S. GAAP, the Company is permitted to make an accounting policy election to either treat taxes due on future inclusions in U.S. taxable income related to GILTI as a current-period expense when incurred or to factor such amounts into the Company's measurement of its deferred taxes. The Company has not yet completed its analysis of the GILTI tax rules and is not yet able to reasonably estimate the effect of this provision of the Tax Act or make an accounting policy election for the ASC 740 treatment of the GILTI tax. Therefore, the Company has not recorded any amounts related to potential GILTI tax in its consolidated financial statements and has not yet made a policy decision regarding whether to record deferred taxes on GILTI.

The Company reported an income tax expense of approximately $61,000 and $109,000 for the three and nine months ended September 30, 2018, respectively and an income tax expense of approximately $27,000 and $122,000 for the three and nine months ended September 30, 2017, respectively. The Company's effective tax rate was (0.2%) for the nine months ended September 30, 2018, compared to an estimated annual effective rate of (0.3%) for the nine months ended September 30, 2017.

Deferred income taxes reflect the net tax effects of temporary differences between the carrying amount of the assets and liabilities for financial reporting purposes and the amounts used for income tax purposes. All deferred tax assets were subject to a full valuation allowance as of December 31, 2017.

The Company evaluates the realizability of its U.S. net deferred tax assets based on all available evidence, both positive and negative, on a quarterly basis. The realization of net deferred tax assets is dependent on the Company's ability to generate sufficient future taxable income during periods prior to the expiration of tax attributes to fully utilize these assets. The Company weighed both positive and negative evidence and determined that due to recent losses there is a continued need for a full valuation allowance against all of the Company's deferred tax assets as of September 30, 2018 and December 31, 2017.

As of September 30, 2018, the Company's gross deferred tax assets are comprised primarily of U.S. Federal net operating losses and accruals, and its gross deferred tax liabilities are comprised primarily of differences in the financial statement and tax bases of intangible assets.

The Company files income tax returns with both federal and state-level taxing authorities in the U.S., and with the taxing authorities of various foreign jurisdictions. The associated tax filings remain subject to examination by applicable tax authorities for a certain length of time following the tax year to which those filings relate. The IRS audit of the Company's 2014 and 2015 Federal tax returns concluded during the quarter ended September 30, 2018, and there were no material impacts to the Company's income tax provision as a result.  The Company's 2016 and 2017 tax returns are subject to potential examination.

 

 

 

 

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13. Commitments and Contingencies
9 Months Ended
Sep. 30, 2018
Commitments and Contingencies Disclosure [Abstract]  
13. Commitments and Contingencies

Note 13. Commitments and Contingencies

Legal Proceedings

Pernix Ireland Pain Limited (n/k/a Pernix Ireland Pain Designated Activity Company) and Pernix Therapeutics, LLC v. Actavis Laboratories FL, Inc. (Actavis), District of Delaware Case No. 16-138; Pernix Ireland Pain Limited and Pernix Therapeutics, LLC v. Alvogen Malta Operations, Ltd. (Alvogen), District of Delaware Case No. 16-139.

PIP DAC is the owner of: (a) U.S. Patent No. 9,265,760 (the '760 Patent), issued on February 23, 2016, (b) U.S. Patent No. 9,326,982 (the '982 Patent), issued on May 3, 2016, (c) U.S. Patent No. 9,333,201 (the '201 Patent), issued on May 10, 2016, and (d) U.S. Patent No. 9,339,499 (the '499 Patent), issued on May 17, 2016 (collectively, the Pernix Zohydro ER Patents).  The Pernix Zohydro ER Patents are listed in the United States Food and Drug Administration's (FDA) Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations (the Orange Book) as covering Zohydro ER.  Pernix Therapeutics, LLC (Pernix LLC) is the sole distributor of Zohydro ER in the United States. Pernix LLC and PIP DAC (collectively for the purpose of this paragraph, Pernix) brought suit against Actavis and Alvogen in the District of Delaware on March 4, 2016, seeking declaratory judgment of infringement of the '760 Patent. The Complaints relating to the '760 Patent were served on March 7, 2016. Pernix filed and served First and Second Amended Complaints on May 13, 2016 and May 31, 2016 against Alvogen and Actavis, respectively, adding allegations of infringement with respect to the '982, '201, and '499 Patents.  Actavis Motion to Dismiss was completed on July 11, 2016.  United States Patent Nos. 9,421,200 (the '200 Patent) and 9,433,619 (the '619 Patent) issued on August 23, 2016 and September 5, 2016, respectively.  Pernix filed and served Second and Third Amended Complaints, against Alvogen and Actavis respectively, on October 12, 2016, adding allegations of infringement with respect to the '200 and '619 Patents.  Actavis and Alvogen filed their respective Answers on November 30, 2016, denying Pernix's infringement allegations and raising Counterclaims of non-infringement and invalidity as to each of the asserted patents.  Pernix and Actavis entered into a settlement agreement on January 29, 2018.  Under the terms of the agreement, Pernix will grant Actavis a license to begin selling a generic version of Zohydro ER on March 1, 2029, or earlier under certain circumstances.  Other details of the settlement are confidential.  The launch of Actavis's generic product is contingent upon Actavis receiving final approval from the FDA of its ANDA for a generic version of Zohydro ER. For the Alvogen case, trial testimony was heard from June 11-13, 2018, post-trial briefing was completed on July 12, 2018, and the trial concluded with the parties' closing arguments on July 25, 2018. The district court's trial decision was rendered on August 24, 2018, finding the asserted claims of the Zohydro ER Patents to be infringed by Alvogen's proposed generic Zohydro ER product and not to be invalid for anticipation under 35 U.S.C. § 102. The district court also found the asserted claims to be invalid for obviousness under 35 U.S.C. § 103 and as lacking adequate written description under 35 U.S.C. § 112. Pernix filed a Notice of Appeal on September 7, 2018, appealing the district court's decision that the asserted claims are invalid for obviousness and lacking adequate written description to the United States Court of Appeals for the Federal Circuit. Pernix's opening appellate brief is due no later than November 13, 2018, Alvogen's answering brief is due no later December 24, 2018 and Pernix's reply brief is due no later than January 7, 2019. Oral argument on the appeal is expected in the second quarter of 2019, with a written decision to follow thereafter.

Medicine to Go Pharmacies, Inc. v. Macoven Pharmaceuticals, LLC and Pernix Therapeutics Holdings, Inc., District Court of New Jersey Case No. 2:16-cv-07717.

On October 23, 2016, Medicine to Go Pharmacies, Inc. (Plaintiff) filed an action against Pernix and its subsidiary, Macoven and unidentified individuals seeking redress for sending allegedly unlawful advertisements to facsimile machines in violation of the Telephone Consumer Protection Act, 47 U.S.C. 227. On December 2, 2016, the Company filed its answers in defense of the allegations. The December 2013 fax campaign that is the subject of this litigation was administered by a third party, Odyssey Services, Inc. (Odyssey), which was not initially named as a defendant in this litigation. On June 22, 2017, the Company filed a third-party complaint against Odyssey, seeking indemnity and contribution for any amounts that the Company may be liable to pay to the Plaintiff. Odyssey answered the third-party complaint and, in addition, filed a counterclaim for indemnification against the Company, alleging that the Company, not Odyssey, was responsible for the content of the facsimiles transmitted, and thus is liable to Odyssey for any costs or judgments associated with this action. Odyssey also filed a motion for summary judgment, seeking to dismiss the third-party claims against it; the Company has moved for summary judgment to hold Odyssey liable to indemnify the Company.

A settlement conference was conducted by the Court on July 12, 2018 during which counsel for Plaintiff and the Company agreed in principle that for purposes of settlement the defendants will create a settlement fund and the Company will contribute a total of $1.2 million to said fund, which amount shall be final and includes any and all costs of the settlement, including payment of claims submitted by class members, class notice, settlement administration, Plaintiff's attorneys' fees and costs, and any incentive award to Plaintiff. Further, the Company will not oppose Plaintiff's request that a Rule 23(b)(3) settlement class consisting of all persons and entities with fax numbers who received a copy of the December 2013 "Dear Pharmacist" fax be certified by the Court and the Company will agree that any unclaimed amounts of the settlement fund shall be distributed to one or more cy pres organizations to be selected by the Parties and subject to the approval of the Court. Odyssey subsequently agreed to participate in the settlement and to contribute to the proposed settlement fund. Plaintiff filed its unopposed motion for preliminary approval of the settlement on October 12, 2018, and the Court approved the motion on October 29, 2018.  As a result, notice of the settlement will be sent to all potential class members, who may submit a claim. Class members will have until January 5, 2019 to submit a claim, object to the settlement, or exclude themselves from the settlement. On February 21, 2019, the Court will conduct a final hearing to determine whether to grant final approval of the settlement, which will release all claims against Pernix and Odyssey. If the Court grants final approval, the settlement monies will be distributed thereafter.

Opioids Litigation

Beginning in 2014 and continuing to the present, a number of pharmaceutical companies have been named in numerous lawsuits brought by certain state and local governments related to the marketing of opioid pain medications. The claims are generally based on alleged misrepresentations and/or omissions in connection with the sale and marketing of prescription opioid pain medications and/or an alleged failure to take adequate steps to prevent abuse and diversion. The suits generally seek penalties and/or injunctive and monetary relief. These cases are in early stages of litigation. In May 2018, the Company was notified that the State of Arkansas has named approximately 65 companies and individuals, including the Company, in an ongoing lawsuit relative to the marketing and sale of opioid pain medications. In September of 2018, the Company filed a motion to dismiss the Arkansas lawsuit. That motion is currently pending.

During the second quarter of 2018, the Company was also served with two additional lawsuits in which it was included as a defendant, both of which were filed in Philadelphia County, PA (UFCW Local 23 Health Fund v. Endo Pharmaceuticals, Inc., et al. and Iron Workers Dist. Council of Philadelphia & Vicinity, Benefit Fund v. Abbott Laboratories, Inc., et al.). These cases have since been transferred to Delaware County, PA, although the decision to transfer the cases is currently on appeal. At this time, the Company is unaware of whether it will be named in any of the other opioid pain medication lawsuits. 

The Company intends to vigorously defend against the claims asserted against it in these litigations but is unable to predict probable outcomes at this time.

Navigators Insurance Company v. Pernix Therapeutics Holdings, Inc. (U.S. District Court, Eastern District of PA)

On October 26, 2018, Navigators Insurance Company ("Navigators") initiated an insurance coverage declaratory judgment action against Pernix in the United States District Court for the Eastern District of Pennsylvania.  The action pertains to a dispute between the parties as to whether Navigators owes coverage under certain insurance policies for the defense and potential indemnity of Pernix in three lawsuits pending against Pernix: (1) UFCW, Local 23 and Employers Health Fund v. Endo Pharmaceuticals, Inc. et al., Case No. 180403485, filed in the Pennsylvania Court of Common Pleas, Philadelphia County ("UFCW Action"); (2) Iron Workers District Council of Philadelphia and Vicinity, Benefit Fund v. Abbott Laboratories, Inc. et al., Case No. 180502442, filed in the Pennsylvania Court of Common Pleas, Philadelphia County ("Iron Workers Action"); and (3) State of Arkansas, ex. rel. Scott Ellington et al. v. Purdue Pharma, L.P. et al., Case No. CV-2018-268, filed in the Circuit Court of Crittenden County, Arkansas ("Arkansas Action") (collectively, the "Underlying Actions"). 

The complaint alleges that Pernix requested that Navigators defend and indemnify it in the Underlying Actions under three policies Navigators issued to Pernix, all of which are effective from November 30, 2017 to November 30, 2018: a Products-Completed Operations Liability policy (the "Products Liability Policy"), a Commercial General Liability policy (the "CGL Policy"), and (3) a Commercial Umbrella Liability policy (the "Umbrella Policy") (collectively, the "Policies").  The complaint further alleges that, by letter dated October 23, 2018, Navigators: (1) disclaimed any duty to defend or indemnify Pernix in the UFCW Action and Iron Workers Action under the Policies; (2) disclaimed any duty to defend or indemnify Pernix in the Arkansas Lawsuit under the CGL and Umbrella Policies; (3) disclaimed any duty to defend or indemnify Pernix on Counts Three to Nine of the Arkansas Action under the Products Liability Policy; and (4) reserved the right to disclaim any duty to defend or indemnify Pernix on Counts One and Two of the Arkansas Action under the Products Liability Policy.  Navigators alleges that Pernix disputes the propriety of Navigator's disclaimers. 

Navigators has asserted seven counts against Pernix.  Counts I through VI seek declarations that Navigators has no duty to defend or indemnify Pernix in the Underlying Actions under any of the Policies.  These counts contain allegations of the various provisions of the Policies on which Navigators relies.  Count VII is pled in the alternative and seeks a declaration that Navigators is entitled to allocation between covered and uncovered defense and indemnification costs to the extent that any counts of the Underlying Actions are covered by one or more of the Policies.

Pernix intends to vigorously contest these claims, and file a counterclaim that Navigators owes Pernix a duty to defend all of the Underlying Actions in full, and that any determination of the duty to indemnify at this point is premature.

Other Commitments and Contingencies

In July 2012 and January 2013, Somaxon settled two patent litigation claims with parties seeking to market generic equivalents of Silenor.  As of September 30, 2018, remaining payment obligations of the Company owed under these settlement agreements are $250,000. The balance is payable in the third quarter 2019 and is recorded in "other liabilities - current" on the Company's unaudited condensed consolidated balance sheets as of September 30, 2018.

During the first quarter of 2014, the Company settled all claims arising from certain actions by Cypress under the Texas Medicaid Fraud Prevention Act prior to its acquisition by the Company. As part of the settlement, the Company agreed to pay $12.0 million, payable in annual amounts of $2.0 million until the settlement is paid in full. As of September 30, 2018, the net present value of remaining payment obligations owed under this settlement agreement is $2.0 million and is recorded within other liabilities - current on the Company's unaudited condensed consolidated balance sheets as of September 30, 2018.

GlaxoSmithKline (GSK) Arbitration

Pursuant to Amendment No. 2, the Company agreed that if on or before September 30, 2019, the Company (x) redeems or repurchases its 4.25% Convertible Notes for greater than 31 cents for every one dollar of principal amount outstanding or (y) exchange such notes for new notes or similar instruments that have a face value providing such exchanging holders a recovery that is greater than 31 cents for every one dollar of 4.25% Convertible Notes exchanged by such holders, the Company shall, no later than five business days thereafter, distribute to GSK additional cash or notes, as applicable, equal to such excess recovery, but in no event to exceed $2.0 million.  GSK has agreed that for so long as the Company complies with the payment terms set forth in the Amendment No. 2, enforcement of the award will be stayed and GSK shall not seek to enforce or exercise any other remedies in respect of the award, and that the outstanding balance of the Award shall be unconditionally and irrevocably forgiven upon satisfaction of such terms.  As of September 30, 2018 and December 31, 2017, the Company has recorded $2.0 million as contingent consideration for the potential payment due by September 30, 2019 and is recorded in "other liabilities - current" and "Arbitration Award" on the Company's consolidated balance sheets, respectively. Also, the Company recorded $10.5 million as a gain from legal settlement for the year ended December 31, 2017 pursuant to Amendment No. 2 in the consolidated statements of operations and comprehensive loss.

Nalpropion Related Litigation

In April 2015, Orexigen and Takeda Pharmaceutical Company Limited (Takeda) received notification of a Paragraph IV certification for certain patents for Contrave which are listed in the Orange Book. The certification resulted from the filing by Actavis Laboratories FL, Inc. (Actavis) of an ANDA challenging such patents for Contrave. In June 2015, Orexigen and Takeda filed a lawsuit in the U.S. District Court for the District of Delaware against Actavis on the basis that Actavis' proposed generic products infringe certain patents for Contrave. Takeda held the NDA for Contrave and was a licensee of Orexigen's patents until August 2016, at which point the ownership of the NDA was transferred to Orexigen and Takeda's rights to the Orexigen patents were terminated. A bench trial took place in June 2017 and on October 13, 2017, the court issued an opinion finding that the claims of the three patents at issue (U.S. Patent Nos. 7,462,626, 7,375,111 and 8,916,195, which expire in 2024, 2025 and 2030, respectively) were valid and infringed. Actavis filed an appeal, which is pending in the U.S. Court of Appeals for the Federal Circuit (Federal Circuit Appeal), and filed its opening appeal brief on February 21, 2018. The Federal Circuit ordered that the appeal be stayed during Orexigen's pending bankruptcy proceedings. On July 27, 2018, Nalpropion acquired worldwide rights to Contrave, including the rights to the patents at issue. Nalpropion filed motions to substitute itself as a party in the appeal and to lift the stay. Those motions were granted on September 19, 2018, allowing the appeal to proceed. Nalpropion's answering was filed on September 28, 2018, and Acatvis's reply appeal brief is due on November 13, 2018. Oral argument is expected sometime in the first half of 2019. If Actavis is successful in the Federal Circuit Appeal, a generic version of Contrave could be launched prior to the expiration of one or more of the patents at issue, which would materially impact Nalpropion's and our financial condition and results of operations. Further, if Contrave infringes or is alleged to infringe intellectual property rights of third parties, we may be adversely affected.

 

 

 

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14. Restructuring
9 Months Ended
Sep. 30, 2018
Restructuring and Related Activities [Abstract]  
14. Restructuring

Note 14. Restructuring

On January 4, 2018, the Company committed to and commenced a realignment plan to reduce operating costs and better align our workforce with the needs of our business in anticipation of the expiration of certain patents related to Treximet® (2018 Restructuring). The Company completed the realignment plan on January 5, 2018, resulting in a reduction of our workforce by 41 employees, the majority of which were associated with our sales force and commercial infrastructure. As of September 30, 2018, the Company has incurred $0.8 million in costs related to the 2018 Restructuring, consisting of $0.7 million related to employee termination benefits and $0.1 million related to contract termination costs.

On July 7, 2016, the Company announced a restructuring of its sales force and operations (2016 Restructuring). The 2016 Reorganization included a reduction of 54 sales positions, primarily from the Company's Neurology sales team and reduced its administrative staff by 6 employees. To date, the Company has incurred $2.8 million in costs related to the 2016 Restructuring, consisting of $1.4 million related to employee termination benefits and $1.4 million related to contract termination costs. All associated contract termination cost payments are expected to be made by 2020.

A summary of accrued restructuring costs, included as a component of accounts payable and accrued expenses on the unaudited condensed consolidated balance sheets, is as follows (in thousands):

      December 31,
2017
    Charges     Cash     Non-cash     September 30,
2018
2018 Restructuring    $ -     $ 774    $ (774)   $ -     $ -  
                               
      December 31,
2017
    Charges     Cash     Non-cash     September 30,
2018
2016 Restructuring     $ 265    $ 438    $ (277)   $ -     $ 426 

 

 

 

 

 

 

 

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15. Supplemental Cash Flow Information
9 Months Ended
Sep. 30, 2018
Supplemental Cash Flow Elements [Abstract]  
15. Supplemental Cash Flow Information

Note 15. Supplemental Cash Flow Information

Supplemental cash flow information is as follows (in thousands):

      Nine Months Ended
      September 30,
      2018     2017
             
     Cash (received) paid for income taxes, net   $ 29    $ (873)
     Cash paid for interest     24,984      25,920 
Supplemental disclosures of Non-cash Investing and Financing activities:            
     Conversion of Treximet Secured Notes and interest to Common Stock    $ 4,433    $
     Conversion of Treximet Secured Notes and interest to Convertible Preferred Stock      8,100     
     Amount added to principal of Delayed Draw Term Loan and Exchangeable notes for Payment-in-kind (PIK) interest     1,308     
     Conversion of 4.25% Convertible Notes     -       (51,775)
     Issuance of 1,100,498 shares in exchange transaction     -       3,775 
     Issuance of Exchangeable Notes     -       36,243 

 

 

 

 

 

 

 

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2. Basis of Presentation and Summary of Significant Accounting Policies (Policies)
9 Months Ended
Sep. 30, 2018
Accounting Policies [Abstract]  
Basis of Presentation

Basis of Presentation

The accompanying unaudited condensed consolidated financial statements included herein have been prepared by the Company in accordance with generally accepted accounting principles in the United States (GAAP) and under the rules and regulations of the United States Securities and Exchange Commission (SEC) for interim reporting. In management's opinion, the interim financial data presented includes all adjustments (consisting solely of normal recurring items) necessary for fair presentation. All intercompany accounts and transactions have been eliminated. Certain information required by GAAP has been condensed or omitted in accordance with rules and regulations of the SEC. Operating results for the three and nine months ended September 30, 2018 are not necessarily indicative of the results that may be expected for any future period or for the year ending December 31, 2018.

These unaudited condensed consolidated financial statements should be read in conjunction with the Company's audited consolidated financial statements and the notes thereto for the year ended December 31, 2017, included in Pernix's 2017 Annual Report on Form 10-K filed with the SEC.

The preparation of the unaudited condensed consolidated financial statements requires management to make estimates and assumptions relating to reporting of the assets and liabilities and the disclosure of contingent assets and liabilities to prepare these unaudited condensed consolidated financial statements and the reported amounts of revenues and expenses during the reporting period in conformity with GAAP. Significant estimates of the Company include: revenue recognition, sales allowances such as returns on product sales, government program rebates, customer coupon redemptions, wholesaler/pharmacy discounts, product service fees, rebates and chargebacks, sales commissions, amortization, stock-based compensation, the determination of fair values of assets and liabilities in connection with business combinations, and deferred income taxes. Actual results could differ from these estimates.

 

 

Interim Financial Statements

The accompanying unaudited condensed consolidated financial statements included herein have been prepared by the Company in accordance with generally accepted accounting principles in the United States (GAAP) and under the rules and regulations of the United States Securities and Exchange Commission (SEC) for interim reporting. In management's opinion, the interim financial data presented includes all adjustments (consisting solely of normal recurring items) necessary for fair presentation. All intercompany accounts and transactions have been eliminated. Certain information required by GAAP has been condensed or omitted in accordance with rules and regulations of the SEC. Operating results for the three and nine months ended September 30, 2018 are not necessarily indicative of the results that may be expected for any future period or for the year ending December 31, 2018.

These unaudited condensed consolidated financial statements should be read in conjunction with the Company's audited consolidated financial statements and the notes thereto for the year ended December 31, 2017, included in Pernix's 2017 Annual Report on Form 10-K filed with the SEC.

 

 

 

 

Management's Estimates and Assumptions

The preparation of the unaudited condensed consolidated financial statements requires management to make estimates and assumptions relating to reporting of the assets and liabilities and the disclosure of contingent assets and liabilities to prepare these unaudited condensed consolidated financial statements and the reported amounts of revenues and expenses during the reporting period in conformity with GAAP. Significant estimates of the Company include: revenue recognition, sales allowances such as returns on product sales, government program rebates, customer coupon redemptions, wholesaler/pharmacy discounts, product service fees, rebates and chargebacks, sales commissions, amortization, stock-based compensation, the determination of fair values of assets and liabilities in connection with business combinations, and deferred income taxes. Actual results could differ from these estimates.

Nasdaq Deficiency Notices

On October 17, 2018, the Company received notice (the Minimum Market Value of Publicly Held Shares Notice) from the Nasdaq Stock Market LLC (Nasdaq) that the Company is not currently in compliance with the $15 million minimum market value of publicly held shares requirement of Nasdaq Listing Rule 5450(b)(3)(C). The Minimum Market Value of Publicly Held Shares Notice indicated that, consistent with Nasdaq Listing Rule 5810(c)(3)(D), the Company has until April 15, 2019 to regain compliance with the minimum market value of publicly held shares requirement by having the closing market value of publicly held shares, calculated by multiplying the closing bid price of the Company's common stock (Common Stock) by the Company's total shares outstanding (less any shares held by officers, directors or beneficial owners of 10% or more of the total shares outstanding ), meet or exceed $15 million for at least ten consecutive business days.

On October 19, 2018, the Company received notice (the Minimum Bid Price Notice) from Nasdaq that the Company is not currently in compliance with the $1.00 minimum closing bid price requirement of Nasdaq Listing Rule 5450(a)(1). The Minimum Bid Price Notice indicated that, consistent with Nasdaq Listing Rule 5810(c)(3)(A), the Company has until April 17, 2019 to regain compliance with the minimum bid price requirement by having the closing bid price of the Common Stock meet or exceed $1.00 per share for at least ten consecutive business days. If the Company does not regain compliance with the minimum bid price requirement by April 17, 2019, the Company may be eligible to transfer the listing of the Common Stock from the Nasdaq Global Market to the Nasdaq Capital Market if, at the time of such transfer, the Company meets the initial listing requirement for market value of publicly held shares ($1 million) and all other initial listing standards for the Nasdaq Capital Market (except for the minimum bid price requirement) and provides Nasdaq with written notice of its intention to cure the minimum bid price requirement deficiency. In response, Nasdaq may provide the Company with an additional 180 day period to satisfy the minimum bid price requirement. However, if it appears to the Nasdaq staff that the Company will not be able to cure the deficiency, or if the Company is otherwise not eligible, Nasdaq will provide notice to the Company that the Common Stock will be subject to delisting pursuant to Nasdaq's delisting procedures.

The notices do not result in the immediate delisting of the Common Stock from the Nasdaq Global Market. If the Common Stock is delisted from the Nasdaq Global Market, the holders of the Convertible Notes (as defined in Note 10 below) and the Exchangeable Notes (as defined in Note 10 below) would have the right to require the Company (in the case of the Convertible Notes) or Pernix Ireland Pain Designated Activity Company (PIP DAC) (in the case of the Exchangeable Notes) to repurchase all of the Convertible Notes and Exchangeable Notes owned by such holders at a price equal to 100% of the principal amount thereof, plus any accrued and unpaid interest thereon, within 35 business days following the Company or PIP DAC giving notice to such holders of the delisting. The Company's or PIP DAC's failure to pay such amounts when due would result in a default under the indentures governing the Convertible Notes or the Exchangeable Notes, as the case may be, which would ripen into an event of default immediately under the indenture governing the Convertible Notes, and within five days of becoming due under the indenture governing the Exchangeable Notes. Further, an event of default under either of these indentures would result in a cross-default under the Delayed Draw Term Loan (as defined in Note 10 below) as well as the ABL Facility (as defined in Note 10 below), which could result in indebtedness outstanding under those instruments to become immediately due and payable. In addition, any acceleration of the debt under the Convertible Notes, the Exchangeable Notes, the Delayed Draw Term Loan or the ABL Facility would trigger an event of default under the indenture governing the Treximet Secured Notes (as defined in Note 10 below), which could result in such indebtedness becoming immediately due and payable.

Going Concern

As of October 17, 2018, the Company was not in compliance with certain Nasdaq Global Market listing requirements. The Company's outstanding 4.25% Convertible Notes (as defined in Note 10 below) in the principal amount of $78.2 million that contain redemption features in the event the Company was not able to maintain its Nasdaq Global Market listing. In addition, the Company's outstanding Exchangeable Notes (as defined in Note 10 below) in the principal amount of $36.1 million contain redemption features in the event the Company is not able to maintain any Nasdaq listing. These factors raise substantial doubt about the ability of the Company to continue as a going concern within one year after the date that these financial statements are issued. The Company continues to seek other sources of capital and alternatives. However, if the Company is unable to raise sufficient capital or maintain its Nasdaq listing to prevent the redemption of its outstanding indebtness, the Company will not have sufficient liquidity to fund its business operations for at least the next year following the date that the financial statements are issued. The financial statements do not include any adjustments relating to the recoverability and classification of recorded asset amounts or the amounts and classification of liabilities that might be necessary should the Company be unable to continue as a going concern.

 

 

 

 

 

Reclassifications

Certain prior period amounts have been reclassified to conform to the current period presentation including reclassifying capitalized debt issuance costs of approximately $1.5 million from "Prepaid expenses and other current assets" to the Company's long-term debt instruments within "Total liabilities" except for those related to revolving credit facilities. This reclassification had no effect on previously reported results of operations, financial position or cash flows.

 

 

 

 

Principles of Consolidation

The unaudited condensed consolidated financial statements include the accounts of the Company, its wholly owned subsidiaries, and variable interest entities (VIEs) for which the Company is the primary beneficiary. All significant intercompany balances and transactions have been eliminated in consolidation.

The Company evaluates its ownership, contractual, and other interests in entities that are not wholly owned to determine if these entities are VIEs, and, if so, whether the Company is the primary beneficiary of the VIE. In determining whether the Company is the primary beneficiary of a VIE and therefore required to consolidate the VIE, a qualitative approach is applied that determines whether the Company has both (1) the power to direct the activities of the VIE that most significantly impact the VIE's economic performance and (2) the obligation to absorb losses of, or the rights to receive benefits from, the VIE that could potentially be significant to that VIE. The Company will continuously assess whether it is the primary beneficiary of a VIE as changes to existing relationships or future transactions may result in the consolidation or deconsolidation of such VIE. During the three and nine months ended September 30, 2018, the Company's consolidated VIE includes Nalpropion™ Pharmaceuticals Inc. (Nalpropion), and the Company remains the primary beneficiary of Nalpropion (see note 4, Variable Interest Entity). The equity of Nalpropion held by investors other than the Company are treated as a noncontrolling interest in the condensed consolidated financial statements.

 

 

Recently Adopted Accounting Pronouncements

Recently Adopted Accounting Pronouncements

In May 2014, the Financial Accounting Standards Board (FASB) issued Accounting Standards Update (ASU) No. 2014-09, Revenue from Contracts with Customers (Topic 606) which supersedes nearly all existing revenue recognition guidance. Effective January 1, 2018, the Company adopted ASU No. 2014-09, Revenue from Contracts with Customers (ASC 606) and all the related amendments (new revenue standard) to all contracts using the modified retrospective method. No material differences were identified as compared to the Company's historical revenue recognition accounting and accordingly, the Company did not recognize a cumulative effect of applying the new revenue standard as an adjustment to the opening balance of retained earnings. The comparative information has not been restated and continues to be reported under the accounting standards in effect for those periods. The Company does not expect the adoption of the new revenue standard to have a material impact to the Company's net income on an ongoing basis.

The Company's new revenue recognition policy is as follows:

Revenue is recognized upon transfer of control of promised products or services to customers in an amount that reflects the consideration the Company expects to receive in exchange for those products or services. The Company generally enters into contracts to sell approved branded and generic pharmaceutical drugs.

  • Product Sales

Product sales revenue is recognized at the estimated consideration to be received when control has transferred to the customer, which is typically on delivery to the customer or, in the case of products that are subject to consignment agreements, when the customer removes product from the Company's consigned inventory location for shipment directly to a patient. Payment terms vary by customer and the products or services offered and is generally required in a term ranging from 30 to 90 days from date of shipment or satisfaction of the performance obligation.

  • Significant Judgments

Product sales contracts provide the customer with the right to return the product and also provide for a variety of discounts and allowances including, specialty distributor fees, wholesaler fees, prompt payment discounts, government rebates, government chargebacks, coupon programs and rebates under managed care plans which are accounted for as variable consideration. Returns are estimated through comparison of historical return data to their related sales on a production lot basis. Historical rates of return are determined for each product and are adjusted for known or expected changes in the marketplace specific to each product, when appropriate.

Judgment is required to estimate the appropriate adjustments for variable consideration which is based on sales or invoice data, contractual terms, historical utilization rates, new information regarding changes in these programs regulations and guidelines that would impact the amount of the actual rebates, the Company's expectations regarding future utilization rates for these programs and channel inventory data.

  • Contract Balances

The timing of customer invoicing generally does not differ from the timing of revenue recognition. The Company records provisions for returns, specialty distributor fees, wholesaler fees, government rebates, coupon programs and rebates under managed care plans are included within current liabilities in the Company's consolidated balance sheets. Provision for prompt payment discounts are generally shown as a reduction in accounts receivable.

In May 2017, the FASB issued ASU 2017-09, Compensation-Stock Compensation (Topic 718): Scope of Modification Accounting, (ASU 2017-09). ASU 2017- 09 provides clarity and reduces both (1) diversity in practice and (2) cost and complexity when applying the guidance in Topic 718, to a change to the terms or conditions of a share-based payment award. ASU 2017-09 is effective for the interim and annual periods beginning after December 15, 2017. The Company adopted the provisions of ASU 2017-09 as of January 1, 2018. There was no material impact on the Company's condensed consolidated financial statements resulting from the adoption of this guidance.

In January 2017, the FASB issued ASU 2017-01, Business Combinations (Topic 805): Clarifying the Definition of a Business, which changes the definition of a business to assist entities with evaluating when a set of transferred assets and activities is deemed to be a business. Determining whether a transferred set constitutes a business is important because the accounting for a business combination differs from that of an asset acquisition. The definition of a business also affects the accounting for dispositions. Under the new standard, when substantially all of the fair value of assets acquired are concentrated in a single asset, or a group of similar assets, the assets acquired would not represent a business and business combination accounting would not be required. The new standard may result in more transactions being accounted for as asset acquisitions rather than business combinations. The standard is effective for interim and annual periods beginning after December 15, 2017 and shall be applied prospectively. The Company adopted ASU 2017-01 as of January 1, 2018, and there was no material impact on the Company's condensed consolidated financial statements resulting from the adoption of this guidance.

In August 2016, the FASB issued ASU 2016-15 Statement of Cash Flows - Classification of Certain Cash Receipts and Cash Payments, which provides updated guidance on eight classification issues related to the statement of cash flows: debt prepayments and extinguishment costs, settlement of zero-coupon bonds, contingent consideration payments made after a business combination, proceeds from the settlement of insurance claims, proceeds from the settlement of corporate-owned life insurance policies, distributions received from equity method investees, beneficial interests in securitization transactions and separately identifiable cash flows and application of the predominance principle. ASU 2016-15 is effective for interim and annual periods beginning after December 15, 2017. The Company adopted the provisions of ASU 2016-15 as of January 1, 2018. There was no material impact on the Company's results of operations resulting from the adoption of this guidance.

In January 2016, the FASB issued ASU 2016-01, Financial Instruments-Overall (Subtopic 825-10): Recognition and Measurement of Financial Assets and Financial Liabilities. The accounting standard primarily affects the accounting for equity investments, financial liabilities under the fair value option, and the presentation and disclosure requirements for financial instruments. In addition, it includes a clarification related to the valuation allowance assessment when recognizing deferred tax assets resulting from unrealized losses on available-for-sale debt securities. The accounting guidance is effective for annual reporting periods (including interim periods within those periods) beginning after December 15, 2017. The Company adopted ASU 2016-01 as of January 1, 2018, and there was no material impact on the Company's condensed consolidated financial statements resulting from the adoption of this guidance.

 

 

Recent Issued Accounting Pronouncements

Recently Issued Accounting Standards, Not Adopted as of September 30, 2018

In August 2018, the FASB issued ASU No. 2018-13, Fair Value Measurement (Topic 820) - Disclosure Framework - Changes to the Disclosure Requirements for Fair Value Measurement, which is designed to improve the effectiveness of disclosures by removing, modifying and adding disclosures related to fair value measurements. ASU No. 2018-13 is effective for fiscal years beginning after December 15, 2019, including interim periods within those fiscal years; the ASU allows for early adoption in any interim period after issuance of the update. The Company is currently assessing the impact this ASU will have on its consolidated financial statements.

In March 2018, the FASB issued ASU No. 2018-05, Income Taxes (Topic 740): Amendments to SEC Paragraphs Pursuant to SEC Staff Accounting Bulletin No. 118 which allowed SEC registrants to record provisional amounts in earnings for the year ended December 31, 2017 due to the complexities involved in accounting for the enactment of the U.S. Tax Cuts and Jobs Act (TCJA) on December 22, 2017. The Company continues to analyze the TCJA, see Note 12, Income taxes for more information.

In February 2016, the FASB issued ASU no. 2016-02, Leases, which requires lessees to recognize assets and liabilities on the balance sheet for the rights and obligations created by all leases with terms of more than 12 months. The leasing standard will be effective for calendar year-end public companies beginning after December 15, 2018, and interim periods within those fiscal years. In July 2018, the FASB issued additional authoritative guidance providing companies with an optional prospective transition method to apply the provisions of this guidance. The Company will adopt the standard in the first quarter of 2019 and elect this transition method to apply the standard prospectively. While the Company is currently evaluating the impact of adoption of this ASU, the adoption is expected to result in a material increase in the assets and liabilities recorded on the condensed consolidated balance sheets.

Management does not believe that any other recently issued, but not yet effective, accounting standards if currently adopted would have a material effect on the Company's consolidated financial statements.

 

 

Revenue Recognition

The Company's new revenue recognition policy is as follows:

Revenue is recognized upon transfer of control of promised products or services to customers in an amount that reflects the consideration the Company expects to receive in exchange for those products or services. The Company generally enters into contracts to sell approved branded and generic pharmaceutical drugs.

  • Product Sales

Product sales revenue is recognized at the estimated consideration to be received when control has transferred to the customer, which is typically on delivery to the customer or, in the case of products that are subject to consignment agreements, when the customer removes product from the Company's consigned inventory location for shipment directly to a patient. Payment terms vary by customer and the products or services offered and is generally required in a term ranging from 30 to 90 days from date of shipment or satisfaction of the performance obligation.

  • Significant Judgments

Product sales contracts provide the customer with the right to return the product and also provide for a variety of discounts and allowances including, specialty distributor fees, wholesaler fees, prompt payment discounts, government rebates, government chargebacks, coupon programs and rebates under managed care plans which are accounted for as variable consideration. Returns are estimated through comparison of historical return data to their related sales on a production lot basis. Historical rates of return are determined for each product and are adjusted for known or expected changes in the marketplace specific to each product, when appropriate.

Judgment is required to estimate the appropriate adjustments for variable consideration which is based on sales or invoice data, contractual terms, historical utilization rates, new information regarding changes in these programs regulations and guidelines that would impact the amount of the actual rebates, the Company's expectations regarding future utilization rates for these programs and channel inventory data.

  • Contract Balances

The timing of customer invoicing generally does not differ from the timing of revenue recognition. The Company records provisions for returns, specialty distributor fees, wholesaler fees, government rebates, coupon programs and rebates under managed care plans are included within current liabilities in the Company's consolidated balance sheets. Provision for prompt payment discounts are generally shown as a reduction in accounts receivable.

 

Significant Customers

Significant Customers

The Company's customers consist of drug wholesalers, specialty pharmacies, retail drug stores, mass merchandisers and grocery store pharmacies in the United States. The Company primarily sells its products directly to large national drug wholesalers, which in turn resell the products to smaller or regional wholesalers, retail pharmacies, chain drug stores, and other third parties.  

 

 

 

Earnings per Share

Basic net income (loss) per common share is the amount of net income (loss) for the period divided by the weighted average shares of Common Stock outstanding during the reporting period. Diluted income (loss) per common share is the amount of income (loss) for the period plus interest expense on convertible debt divided by the sum of weighted average shares of Common Stock outstanding during the reporting period and weighted average shares that would have been outstanding assuming the issuance of common shares for all dilutive potential common shares.

 

 

XML 41 R24.htm IDEA: XBRL DOCUMENT v3.10.0.1
2. Significant Customers (Tables)
9 Months Ended
Sep. 30, 2018
Accounting Policies [Abstract]  
Significant Customers

The following tables list the Company's customers that individually comprised greater than 10% of total gross product sales for the three and nine months ended September 30, 2018 and 2017, or 10% of total accounts receivable as of September 30, 2018 and December 31, 2017.

      Three Months Ended     Nine Months Ended
      September 30,     September 30,
      2018     2017     2018     2017
                         
McKesson Corporation     39%     35%     35%     34%
AmerisourceBergen Drug Corporation     26%     29%     26%     30%
Cardinal Health, Inc.     25%     23%     24%     24%
     Total     90%     87%     85%     88%

 

Accounts Receivable, net:            
      September 30,     December 31,
      2018     2017
             
McKesson Corporation     37%     29%
Cardinal Health, Inc.     29%     31%
AmerisourceBergen Drug Corporation     27%     27%
     Total     93%     87%

 

 

 

 

 

 

 

 

XML 42 R25.htm IDEA: XBRL DOCUMENT v3.10.0.1
3. Business Combinations (Tables)
9 Months Ended
Sep. 30, 2018
Business Combinations  
Schedule of Purchase Price Allocation

The following table indicates the consideration transferred to effect the Orexigen Acquisition:

      Preliminary
      Purchase
      Price
      Allocation
Cash consideration   $ 68,500 
Holdback     5,000 
Total consideration transferred   $ 73,500 

 

Purchase price components of business combination

Assets Acquired and Liabilities Assumed

The following table summarizes the estimated fair values of the assets acquired and liabilities assumed as of the acquisition date. The following recognized amounts are provisional and subject to change:

  • amounts for intangible assets, property and equipment, certain liabilities, and other working capital balances pending finalization of the valuation; and
  • amount of goodwill pending the completion of the valuation of the assets acquired and liabilities assumed.
      Amounts
      Recognized
      as of the
      Acquisition
      Date
Cash and cash equivalents   $ 730 
Accounts receivable     27,700 
Inventory (a)     18,219 
Prepaids and other current assets      344 
Property and equipment     426 
Intangible assets (b)     50,500 
Goodwill (c)     5,472 
Accounts payable     (1,097)
Accrued allowances     (13,574)
Accrued personnel expense     (841)
Other liabilities - current     (1,877)
Deferred revenue     (12,502)
    $ 73,500 
Schedule of Acquired Finite-Lived Intangible Assets by Major Class [Table Text Block]

 

      Preliminary      
      Intangible     Estimated
      Asset     Useful
      Valuation     Life
Acquired developed technologies   $ 44,800      10 years
Tradenames     4,800      12 years
Other     900      5 years
    $ 50,500       

 

Business Acquisition, Pro Forma Information

Pro Forma Information

The following table represents the consolidated financial information for the Company on a pro forma basis, assuming that the Orexigen Acquisition occurred as of January 1, 2017. The historical financial information has been adjusted to give effect to pro forma items that are directly attributable to the Orexigen Acquisition and are expected to have a continuing impact on the consolidated results. These items include, among others, adjustments to record the amortization of definite-lived intangible assets and interest expense. Additionally, the following table sets forth unaudited financial information and has been compiled from historical financial statements and other information, but is not necessarily indicative of the results that actually would have been achieved had the transactions occurred on the dates indicated or that may be achieved in the future.

 

      Three Months Ended     Nine Months Ended
      September 30,     September 30,
      2018     2017     2018     2017
Net revenues   $ 40,868    $ 59,372    $ 132,572    $ 165,931 
Net income (loss) attributable to Pernix     (22,371)     4,372      (59,890)     (55,574)
                         
Net income (loss) per share attributable to Pernix:                        
Basic   $ (1.68)   $ 0.39    $ (4.84)   $ (5.35)
Diluted   $ (1.68)   $ 0.30    $ (4.84)   $ (5.35)

 

 

 

 

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4. Variable Interest Entity (Tables)
9 Months Ended
Sep. 30, 2018
Variable Interest Entity  
Schedule of Variable Interest Entities [Table Text Block]

The following items of Nalpropion are included in the Company's condensed consolidated statement of operations for the three and nine months ended September 30, 2018:

    Three Months Ended September 30, 2018
    Pernix     Nalpropion     Eliminations (1)     Total Company
Net revenues incl. related party $ 20,544    $ 17,923    $ (1,311)   $ 37,156 
                       
Costs and operating expenses:                      
     Cost of product sales   6,470      6,664      (1,311)     11,823 
     Selling, general and administrative expense   14,857      17,015      -       31,872 
     Research and development expense       1,522      -       1,524 
     Depreciation and amortization expense   1,434      957      -       2,391 
     Other operating expenses   73      -       -       73 
          Total costs and operating expenses   22,836      26,158      (1,311)     47,683 
                -       -  
Income (loss) from operations   (2,292)     (8,235)     -       (10,527)
                       
Other income (expense):                      
     Interest expense, net   (9,409)     (664)           (10,073)
     Other, net   (83)     (1,661)     1,056      (688)
          Total other income (expense), net   (9,492)     (2,325)     1,056      (10,761)
                       
Income (loss) before income tax expense $ (11,784)   $ (10,560)   $ 1,056    $ (21,288)
                       
(1) Included in Eliminations are transactions Pernix and Nalpropion enter into with one another. Such transactions include the sale of  Contrave inventory from Nalpropion to Pernix and elimination of equity in earnings of Nalpropion. 
    

 

    Nine Months Ended September 30, 2018
    Pernix     Nalpropion     Eliminations (1)     Total Company
Net revenues incl. related party $ 69,771    $ 17,923    $ (1,311)   $ 86,383 
                       
Costs and operating expenses:                      
     Cost of product sales   21,000      6,664      (1,311)     26,353 
     Selling, general and administrative expense   50,397      17,015      -       67,412 
     Research and development expense   12      1,522      -       1,534 
     Depreciation and amortization expense   12,729      957      -       13,686 
     Other operating expenses   1,430      -       -       1,430 
          Total costs and operating expenses   85,568      26,158      (1,311)     110,415 
                       
Income (loss) from operations   (15,797)     (8,235)     -       (24,032)
                       
Other income (expense):                      
     Interest expense, net   (28,399)     (664)     -       (29,063)
     Other, net   363      (1,661)     1,056      (242)
          Total other income (expense), net   (28,036)     (2,325)     1,056      (29,305)
                       
Income (loss) before income tax expense $ (43,833)   $ (10,560)   $ 1,056    $ (53,337)
                       
(1) Included in Eliminations are transactions Pernix and Nalpropion enter into with one another. Such transactions include the sale of 
     Contrave inventory from Nalpropion to Pernix and elimination of equity in earnings of Nalpropion. 

 

The following assets and liabilities of Nalpropion are included in the Company's condensed consolidated balance sheet as of September 30, 2018.

    As of September 30, 2018
    Pernix     Nalpropion     Eliminations (1)     Total Company
Cash and cash equivalents (2) $ 18,202    $ 6,309    $ -     $ 24,511 
Accounts receivable, net (3)   58,907      7,536      -       66,443 
Inventory, net   4,174      13,614      -       17,788 
Related party receivable   5,841      38,305      (44,146)     -  
Other current assets   4,844      7,136      -       11,980 
Property and equipment, net   634      366      -       1,000 
Goodwill   12,100      5,472      -       17,572 
Intangible assets   84,047      49,602      -       133,649 
Investment in VIE   3,528      -       (3,528)     -  
Related party loan   4,584      -       (4,584)     -  
Other assets   1,827      -       -       1,827 
                -       -  
Total assets $ 198,688    $ 128,340    $ (52,258)   $ 274,770 
                       
Accounts payable and other accrued expenses $ 15,775    $ 10,856    $ -     $ 26,631 
Accrued allowances   54,543      17,155      -       71,698 
Interest payable   5,784      597      -       6,381 
Related party payable   38,305      5,841      (44,146)     -  
Other liabilities - current   5,806      1,095      -       6,901 
Long term debt excluding 2018 Term Loan   281,207      -       -       281,207 
2018 Term Loan   -       45,834      (4,584)     41,250 
Deferred revenue   -       10,840      -       10,840 
Other liabilities - long-term   2,144      -       -       2,144 
                       
Total liabilities   403,564    $ 92,218    $ (48,730)   $ 447,052 
                       
Total equity   (204,876)   $ 36,122    $ (36,038)   $ (204,792)
Noncontrolling interest   -       -       32,510      32,510 
                       
Total liabilities and equity $ 198,688    $ 128,340    $ (52,258)   $ 274,770 
                       
                       
(1) Included in Eliminations are transactions Pernix and Nalpropion enter into with one another. Such transactions may include the following:
     •   Operating transactions in accordance with a services agreement between Nalpropion and Pernix.
     •   Elimination of investments in Nalpropion.
     •   Elimination of investments in Nalpropion’s earnings.
(2) Approximately $12.2 million of cash and cash equivalents related to Nalpropion is held by Pernix at September 30, 2018.
(3) Approximately $23.5 million of Pernix's accounts receivable, net includes accounts receivables related to sales of Contrave.

 

 

 

 

 

 

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5. Earnings per Share (Tables)
9 Months Ended
Sep. 30, 2018
Earnings Per Share [Abstract]  
Earnings per Share

The following table sets forth the computation of basic and diluted net income (loss) per share (in thousands except per share data):

      Three Months Ended     Nine Months Ended
      September 30,     September 30,
      2018     2017     2018     2017
Numerator:                         
     Net income (loss)   $ (11,845)   $ 6,360    $ (43,942)   $ (44,718)
                         
Denominator - Basic:                        
     Weighted-average common shares     13,301      11,117      12,377      10,387 
                         
Numerator - Diluted:                        
     Net income (loss)   $ (11,845)   $ 6,360    $ (43,942)   $ (44,718)
     Adjustment for interest, net of income tax effect     -       599      -       -  
     Net income (loss), adjusted   $ (11,845)   $ 6,959    $ (43,942)   $ (44,718)
                         
Denominator - Diluted:                        
     Weighted-average common shares     13,301      11,117      12,377      10,387 
     Effect of dilutive securities:                        
          Stock options, Awards and Warrants     -       246      -       -  
          Exchangeable notes     -       5,157      -       -  
     Dilutive potential common shares     -       5,403      -       -  
Weighted-average common shares, diluted     13,301      16,520      12,377      10,387 
                         
Basic income (loss) per share   $ (0.89)   $ 0.57    $ (3.55)   $ (4.31)
Diluted income (loss) per share   $ (0.89)   $ 0.42    $ (3.55)   $ (4.31)

 

 

 

 

 

 

 

Antidilutive securitites

The following table sets forth the potential common shares that could potentially dilute basic income per share in the future that were not included in the computation of diluted income (loss) per share because to do so would have been anti-dilutive for the periods presented (in thousands):

      Three Months Ended     Nine Months Ended
      September 30,     September 30,
      2018     2017     2018     2017
Treximet Secured Notes     27,238      -       27,238      -  
Exchangeable Notes     6,572      -       6,572      1,738 
Converible Preferred Stock     3,389      -       3,389      -  
Stock options and restricted stock units     1,511      370      1,511      562 
4.25% Convertible Notes     682      780      682      1,014 
Warrants         -           33 
Total potential dilutive effect     39,396      1,150      39,396      3,347 

 

 

 

 

 

 

 

 

 

 

 

 

XML 45 R28.htm IDEA: XBRL DOCUMENT v3.10.0.1
6. Fair Value Measurement (Tables)
9 Months Ended
Sep. 30, 2018
Fair Value Disclosures [Abstract]  
Company's fair value hierarchy for its financial assets and liabilities measured at fair value on a recurring and nonrecurring basis

The fair and carrying value of our debt instruments are detailed as follows (in thousands):

      As of September 30, 2018     As of December 31, 2017
      Fair     Carrying     Fair     Carrying
      Value     Value     Value     Value
4.25% Convertible Notes   $ 33,714    $ 67,823    $ 36,208    $ 65,194 
Exchangeable Notes     13,631      10,030      21,375      7,975 
2018 Term loan     41,250      41,250      -       -  
Delayed draw term loan     36,940      37,805      30,300      27,248 
Derivative liability     54      54      93      93 
Contingent consideration     1,501      1,501      1,358      1,358 
Treximet Secured Notes     132,335      151,364      139,201      167,551 
     Total   $ 259,425    $ 309,827    $ 228,535    $ 269,419 

 

 

 

 

 

 

 

Fair Value Measurements Using Significant Unobservable Input (Tables)

For the Company's assets and liabilities measured at fair value on a recurring basis using significant unobservable inputs (Level 3), the following table provides a reconciliation of the beginning and ending balances for each category therein, and gains or losses recognized during the periods (in thousands).

      As of and for the     As of and for the
      Nine Months Ended     Nine Months Ended
      September 30, 2018     September 30, 2017
Derivative liability:            
Balance at beginning of year   93    230 
     Impairment due to partial conversion     -       (90)
     Remeasurement adjustments - loss (gains) included in earnings     (39)     38 
Ending Balance    54    178 
             
Contingent consideration:            
Balance at beginning of year   1,358    2,403 
     Remeasurement adjustments - loss (gains) included in earnings     143      344 
Ending Balance    1,501    2,747 

 

 

 

 

 

 

 

 

 

 

 

 

XML 46 R29.htm IDEA: XBRL DOCUMENT v3.10.0.1
7. Inventory (Tables)
9 Months Ended
Sep. 30, 2018
Inventory Disclosure [Abstract]  
Schedule of Inventory

Inventories are stated at the lower of cost or market. Inventories consist of the following (in thousands):

      September 30,     December 31,
      2018     2017
Raw materials   $ 4,297    $ 727 
Work-in-process     2,957      238 
Finished goods     11,524      5,889 
Inventory, gross     18,778      6,854 
Reserve for obsolescence     (990)     (1,458)
     Inventory, net   $ 17,788    $ 5,396 

 

 

 

 

 

 

 

 

 

 

 

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8. Goodwill and Intangible Assets (Tables)
9 Months Ended
Sep. 30, 2018
Goodwill and Intangible Assets Disclosure [Abstract]  
Changes in the carrying amount of goodwill

Goodwill consists of the following (in thousands):

      Amount
Balance at December 31, 2016   $ 30,600 
     Impairment     (18,500)
Balance at December 31, 2017     12,100 
     Additions     5,472 
     Impairment     -  
Balance at September 30, 2018   $ 17,572 

 

 

 

 

 

 

 

Intangible assets

Intangible assets consist of the following (dollars in thousands):

          As of September 30, 2018
      Weighted Average     Gross Carrying           Accumulated     Net Carrying
      Life Remaining     Amount     Impairment     Amortization     Amount
Unamortized intangible assets:                              
     In-process research and development     Indefinite   $ 11,000    $ -     $ -     $ 11,000 
Total unamortized intangible assets           11,000      -       -       11,000 
                               
Amortized intangible assets:                              
     Product licenses     4.8 years     2,846      -       (1,823)     1,023 
     Supplier contracts     2.6 years     583      -       (282)     301 
     Customer Lists     4.8 years     900      -       (32)     868 
     Tradename      11.8 years     4,800      -       (71)     4,729 
     Acquired developed technologies     12.7 years     409,486      -       (293,758)     115,728 
Total amortized intangible assets           418,615      -       (295,966)     122,649 
                               
Total intangible assets         $ 429,615    $ -     $ (295,966)   $ 133,649 

 

          As of December 31, 2017
      Weighted Average     Gross Carrying           Accumulated     Net Carrying
      Life Remaining     Amount     Impairment     Amortization     Amount
Unamortized intangible assets:                              
     In-process research and development     Indefinite   $ 11,000    $ -     $ -     $ 11,000 
Total unamortized intangible assets           11,000      -       -       11,000 
                               
Amortized intangible assets:                              
     Product licenses     5.4 years     2,846      -       (1,623)     1,223 
     Supplier contracts     3.3 years     583      -       (194)     389 
     Acquired developed technologies     13.7 years     364,686      -       (280,692)     83,994 
Total amortized intangible assets           368,115      -       (282,509)     85,606 
                               
Total intangible assets         $ 379,115    $ -     $ (282,509)   $ 96,606 

 

 

 

 

 

 

 

Intangible Assets Estimated Amortization Expenses

Estimated amortization expense related to intangible assets with definite lives for each of the five succeeding years and thereafter is as follows (in thousands):

      Amount
2018 (October - December)   $ 2,642 
2019     10,567 
2020     10,480 
2021     10,385 
2022     10,346 
Thereafter     78,229 
Total   $ 122,649 

 

 

 

 

 

XML 48 R31.htm IDEA: XBRL DOCUMENT v3.10.0.1
9. Accrued Allowances (Tables)
9 Months Ended
Sep. 30, 2018
Accrued Liabilities [Abstract]  
Accrued allowances

Accrued allowances consist of the following (in thousands):

      September 30,     December 31,
      2018     2017
Accrued returns allowance   $ 25,370    $ 21,681 
Accrued price adjustments     22,823      10,766 
Accrued managed care rebates     17,230      17,221 
Accrued government program rebates     6,275      6,641 
     Total   $ 71,698    $ 56,309 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

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10. Debt and Lines of Credit (Tables)
9 Months Ended
Sep. 30, 2018
Debt Disclosure [Abstract]  
Debt consists

Debt, net of discounts and deferred financing costs, consists of the following (in thousands):

      As of September 30, 2018     As of December 31, 2017
      Principal     Note
Discount
    Deferred
Financing
Costs
    Net of Discount
and Deferred
Financing Costs
    Principal     Note
Discount
    Deferred
Financing
Costs
    Net of Discount
and Deferred
Financing Costs
4.25% Convertible Notes   $ 78,225    $ (8,828)   $ (1,574)   $ 67,823    $ 78,225    $ (11,060)   $ (1,971)   $ 65,194 
Exchangeable Notes     36,145      (22,913)     (3,202)     10,030      35,743      (24,363)     (3,405)     7,975 
Delayed Draw Term Loan     40,074      -       (2,269)     37,805      30,000      -       (2,752)     27,248 
Treximet Secured Notes - Long Term     154,515      -       (3,151)     151,364      166,697      -       (2,810)     163,887 
Treximet Secured Notes - Short Term     -       -       -       -       5,373      -       (1,709)     3,664 
2018 Term Loan     41,250      -       -       41,250      -       -       -       -  
ABL Facility     14,185      -       -       14,185      14,185      -       -       14,185 
     Total outstanding debt   $ 364,394    $ (31,741)   $ (10,196)   $ 322,457    $ 330,223    $ (35,423)   $ (12,647)   $ 282,153 
                                                 
     Less: Current portion of long-term debt                       -                         3,664 
     Long-term debt outstanding, net                     $ 322,457                      $ 278,489 

 

 

 

Future maturity schedule of the outstanding debt and line of credit

The following table represents the future maturity schedule of the outstanding debt and line of credit at September 30, 2018 (in thousands):

      Amount
2018 (October - December)   $ -  
2019     -  
2020     154,515 
2021     119,475 
2022     90,404 
Thereafter     -  
     Total maturities     364,394 
Less:      
     Note discount     (31,741)
     Deferred financing costs     (10,196)
Total outstanding debt, net   $ 322,457 

 

 

 

 

 

 

 

 

 

 

 

XML 50 R33.htm IDEA: XBRL DOCUMENT v3.10.0.1
11. Stockholders' Equity (Tables)
9 Months Ended
Sep. 30, 2018
Stockholders Equity Tables  
Stock option assumptions

The weighted average fair value of stock options granted during the periods and the assumptions used to estimate those values using the Black-Scholes option pricing mode were as follows:

      Three Months Ended     Nine Months Ended
      September 30,     September 30,
      2018     2017     2018     2017
Weighted average expected stock price volatility     86.4%     88.0%     86.4%     87.6%
Estimated dividend yield     -     -     -     -
Risk-free interest rate     2.9%     2.0%     2.8%     2.0%
Expected life of option (in years)     6.3     6.2     6.3     6.2
Weighted average grant date fair value per option   $ 0.69   $ 2.15   $ 1.61   $ 2.15

 

 

 

 

 

 

Stock option activity

The following table shows the option activity, described above, during the nine months ended September 30, 2018 (shares and intrinsic value in thousands):

                  Weighted Average      
            Average     Remaining     Aggregate
            Exercise     Contractual Life     Intrinsic
      Shares     Price     (years)     Value
Options Outstanding at December 31, 2017     1,042    $ 13.80      8.8       
     Granted     556      2.17             
     Exercised     -       -              
     Cancelled     (228)     12.29             
     Expired     -       -              
Options outstanding at September 30, 2018     1,370    $ 9.34      8.7    $
Options vested and expected to vest as of September 30, 2018     895    $ 12.86      8.3    $
Options vested and exercisable as of September 30, 2018     339    $ 24.88      7.3    $

 

 

 

 

 

 

 

 

Restricted stock activity

The following table shows the Company's non-vested restricted stock activity during the nine months ended September 30, 2018 (shares in thousands):

            Weighted Average
            Grant Date Fair
      Shares     Value
Non-vested restricted stock outstanding at December 31, 2017     135    $ 3.17 
     Granted     62      2.46 
     Vested     (54)     3.25 
     Forfeited     (2)     2.60 
Non-vested restricted stock outstanding at September 30, 2018     141    $ 2.83 

 

 

 

 

 

 

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14. Restructuring (Tables)
9 Months Ended
Sep. 30, 2018
Restructuring and Related Activities [Abstract]  
Accrued restructuring costs

A summary of accrued restructuring costs, included as a component of accounts payable and accrued expenses on the unaudited condensed consolidated balance sheets, is as follows (in thousands):

      December 31,
2017
    Charges     Cash     Non-cash     September 30,
2018
2018 Restructuring    $ -     $ 774    $ (774)   $ -     $ -  
                               
      December 31,
2017
    Charges     Cash     Non-cash     September 30,
2018
2016 Restructuring     $ 265    $ 438    $ (277)   $ -     $ 426 

 

 

 

 

 

 

 

 

 

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15. Schedule of Cash Flow, Supplemental Disclosures (Tables)
9 Months Ended
Sep. 30, 2018
Schedule Of Cash Flow Supplemental Disclosures  
Schedule of cash flow, supplemental disclosures

Supplemental cash flow information is as follows (in thousands):

      Nine Months Ended
      September 30,
      2018     2017
             
     Cash (received) paid for income taxes, net   $ 29    $ (873)
     Cash paid for interest     24,984      25,920 
Supplemental disclosures of Non-cash Investing and Financing activities:            
     Conversion of Treximet Secured Notes and interest to Common Stock    $ 4,433    $
     Conversion of Treximet Secured Notes and interest to Convertible Preferred Stock      8,100     
     Amount added to principal of Delayed Draw Term Loan and Exchangeable notes for Payment-in-kind (PIK) interest     1,308     
     Conversion of 4.25% Convertible Notes     -       (51,775)
     Issuance of 1,100,498 shares in exchange transaction     -       3,775 
     Issuance of Exchangeable Notes     -       36,243 

 

 

 

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2. Significant Customers (Details)
3 Months Ended 9 Months Ended
Sep. 30, 2018
Sep. 30, 2017
Sep. 30, 2018
Sep. 30, 2017
Company's customers that individually comprised greater than 10% of total gross product sales        
Percentage of gross product sales 90.00% 87.00% 85.00% 88.00%
McKesson Corporation        
Company's customers that individually comprised greater than 10% of total gross product sales        
Percentage of gross product sales 39.00% 35.00% 35.00% 34.00%
Amerisource Bergen Drug Corporation        
Company's customers that individually comprised greater than 10% of total gross product sales        
Percentage of gross product sales 26.00% 29.00% 26.00% 30.00%
Cardinal Health Inc        
Company's customers that individually comprised greater than 10% of total gross product sales        
Percentage of gross product sales 25.00% 23.00% 24.00% 24.00%
XML 54 R37.htm IDEA: XBRL DOCUMENT v3.10.0.1
2. Significant Customers (Details 1)
9 Months Ended 12 Months Ended
Sep. 30, 2018
Dec. 31, 2017
Accounts Receivable    
McKesson Corporation 37.00% 29.00%
Cardinal Health, Inc. 29.00% 31.00%
AmerisourceBergen Drug Corporation 27.00% 27.00%
Total 93.00% 87.00%
XML 55 R38.htm IDEA: XBRL DOCUMENT v3.10.0.1
3. Business Combinations (Consideration Transferred) (Details)
$ in Thousands
3 Months Ended
Jul. 27, 2018
USD ($)
Business Combinations Consideration Transferred  
Cash consideration $ 68,500
Holdback 5,000
Total consideration transferred $ 73,500
XML 56 R39.htm IDEA: XBRL DOCUMENT v3.10.0.1
3. Business Combinations (Purchase Price Components) (Details)
$ in Thousands
Sep. 30, 2018
USD ($)
Business Combinations Purchase Price Components  
Cash and cash equivalents $ 730
Accounts receivable 27,700
Inventory 18,219
Prepaids and other current assets 344
Property and equipment 426
Intangible assets 50,500
Goodwill 5,472
Accounts payable (1,097)
Accrued allowances (13,574)
Accrued personnel expense (841)
Other liabilities - current (1,877)
Deferred revenue (12,502)
Net $ 73,500
XML 57 R40.htm IDEA: XBRL DOCUMENT v3.10.0.1
3. Business Combinations (Acquired Intangibles (Value and Useful Lives) (Details) - Orexigen
$ in Thousands
3 Months Ended
Jul. 27, 2018
USD ($)
Preliminary Intangible Asset Valuation $ 50,500
Acquired developed technologies  
Preliminary Intangible Asset Valuation $ 44,800
Estimated Useful Life 10 years
Tradenames  
Preliminary Intangible Asset Valuation $ 4,800
Estimated Useful Life 12 years
Other  
Preliminary Intangible Asset Valuation $ 900
Estimated Useful Life 5 years
XML 58 R41.htm IDEA: XBRL DOCUMENT v3.10.0.1
3. Business Combinations (Pro Forma Financial Information with Narrative) (Details) - USD ($)
$ / shares in Units, $ in Thousands
3 Months Ended 9 Months Ended
Sep. 30, 2018
Sep. 30, 2017
Sep. 30, 2018
Sep. 30, 2017
Business Combinations Pro Forma Financial Information With Narrative        
Net revenues $ 40,868 $ 59,372 $ 132,572 $ 165,931
Net income (loss) attributable to Pernix $ (22,371) $ 4,372 $ (59,830) $ (55,574)
Net income (loss) per share attributable to Pernix        
Business Acquisition, Pro Forma Earnings Per Share, Basic $ (1.68) $ 0.39 $ (4.84) $ (5.35)
Business Acquisition, Pro Forma Earnings Per Share, Diluted $ (1.68) $ 0.30 $ (4.84) $ (5.35)
XML 59 R42.htm IDEA: XBRL DOCUMENT v3.10.0.1
4. VIE Condensed Consolidating Statements of Operations (Details) - USD ($)
$ in Thousands
3 Months Ended 9 Months Ended
Sep. 30, 2018
Sep. 30, 2017
Sep. 30, 2018
Sep. 30, 2017
Net revenues $ 37,156 $ 40,469 $ 86,383 $ 104,527
Costs and operating expenses:        
Cost of product sales 11,823 10,580 26,353 31,113
Selling, general and administrative expense 31,872 20,226 67,412 59,519
Research and development expense 1,524 99 1,534 709
Depreciation and amortization expense 2,391 18,214 13,686 54,976
Other operating expenses 73   1,430  
Total costs and operating expenses 47,683 39,455 110,415 136,244
Income (loss) from operations (10,527) 1,014 (24,032) (31,717)
Other income (expense):        
Interest expense, net (10,073) (9,323) (29,063) (27,491)
Other, net (688)   (242)  
Total other income (expense), net (10,761) 5,373 (29,305) (12,879)
Income (loss) before income tax expense (21,288) $ 6,387 (53,337) $ (44,596)
Pernix        
Net revenues 20,544   69,771  
Costs and operating expenses:        
Cost of product sales 6,470   21,000  
Selling, general and administrative expense 14,857   50,397  
Research and development expense 2   12  
Depreciation and amortization expense 1,434   12,729  
Other operating expenses 73   1,430  
Income (loss) from operations (2,292)   (15,797)  
Other income (expense):        
Interest expense, net (9,409)   (28,399)  
Other, net (83)   363  
Total other income (expense), net (9,492)   (28,036)  
Income (loss) before income tax expense (11,784)   (43,833)  
Nalpropion        
Net revenues 17,923   17,923  
Costs and operating expenses:        
Cost of product sales 6,664   6,664  
Selling, general and administrative expense 17,015   17,015  
Research and development expense 1,522   1,522  
Depreciation and amortization expense 957   957  
Other operating expenses 0   0  
Income (loss) from operations (8,235)   (8,235)  
Other income (expense):        
Interest expense, net (664)   (664)  
Other, net (1,661)   (1,661)  
Total other income (expense), net (2,325)   (2,325)  
Income (loss) before income tax expense (10,560)   (10,560)  
Consolidation, Eliminations [Member]        
Net revenues (1,311)   (1,311)  
Costs and operating expenses:        
Cost of product sales (1,311)   (1,311)  
Selling, general and administrative expense 0   0  
Research and development expense 0   0  
Depreciation and amortization expense 0   0  
Other operating expenses 0   0  
Income (loss) from operations 0   0  
Other income (expense):        
Interest expense, net 0   0  
Other, net 1,056   1,056  
Total other income (expense), net 1,056   1,056  
Income (loss) before income tax expense $ 1,056   $ 1,056  
XML 60 R43.htm IDEA: XBRL DOCUMENT v3.10.0.1
4. VIE Condensed Consolidating Balance Sheet (Details) - USD ($)
$ in Thousands
Sep. 30, 2018
Dec. 31, 2017
Sep. 30, 2017
Dec. 31, 2016
Cash and cash equivalents $ 24,511 $ 32,820 $ 27,241 $ 36,375
Accounts receivable, net 66,443 45,317    
Inventory, net 17,788 5,396    
Related party receivable 0      
Other currents assets 11,980      
Property and equipment, net 1,000 752    
Goodwill 17,572 12,100   $ 30,600
Intangible assets 133,649 96,606    
Investment in VIE 0      
Relared party loan 0      
Other 1,827 2,263    
Total assets 274,770 204,005    
Accounts payable and other accrued expenses 26,631      
Accrued allowances 71,698 56,309    
Interest payable 6,381 10,612    
Related party payable 0      
Other liabilities - current 6,901 2,648    
Long term debt excluding 2018 Term Loan 281,207      
2018 Term loan 41,250 0    
Deferred revenue 10,840 0    
Other liabilities - long-term 2,144      
Total liabilities 447,052 378,262    
Total equity (204,792) (174,257)    
Noncontrolling interest 32,510 0    
Total liabilities and equity 274,770 $ 204,005    
Pernix        
Cash and cash equivalents 18,202      
Accounts receivable, net 58,907      
Inventory, net 4,174      
Related party receivable 5,841      
Other currents assets 4,844      
Property and equipment, net 634      
Goodwill 12,100      
Intangible assets 84,047      
Investment in VIE 3,528      
Relared party loan 4,584      
Other 1,827      
Total assets 198,688      
Accounts payable and other accrued expenses 15,775      
Accrued allowances 54,543      
Interest payable 5,784      
Related party payable 38,305      
Other liabilities - current 5,806      
Long term debt excluding 2018 Term Loan 281,207      
2018 Term loan 0      
Deferred revenue 0      
Other liabilities - long-term 2,144      
Total liabilities 403,564      
Total equity (204,876)      
Noncontrolling interest 0      
Total liabilities and equity 198,688      
Nalpropion        
Cash and cash equivalents 6,309      
Accounts receivable, net 7,536      
Inventory, net 13,614      
Related party receivable 38,305      
Other currents assets 7,136      
Property and equipment, net 366      
Goodwill 5,472      
Intangible assets 49,602      
Investment in VIE 0      
Relared party loan 0      
Other 0      
Total assets 128,340      
Accounts payable and other accrued expenses 10,856      
Accrued allowances 17,155      
Interest payable 597      
Related party payable 5,841      
Other liabilities - current 1,095      
Long term debt excluding 2018 Term Loan 0      
2018 Term loan 45,834      
Deferred revenue 10,840      
Other liabilities - long-term 0      
Total liabilities 92,218      
Total equity 36,122      
Noncontrolling interest 0      
Total liabilities and equity 128,340      
Eliminations        
Cash and cash equivalents 0      
Accounts receivable, net 0      
Inventory, net 0      
Related party receivable (44,146)      
Other currents assets 0      
Property and equipment, net 0      
Investment in VIE (3,528)      
Relared party loan 4,584      
Other 0      
Total assets (52,258)      
Accounts payable and other accrued expenses 0      
Accrued allowances 0      
Interest payable 0      
Related party payable (44,146)      
Other liabilities - current 0      
Long term debt excluding 2018 Term Loan 0      
2018 Term loan (4,584)      
Deferred revenue 0      
Other liabilities - long-term 0      
Total liabilities (48,730)      
Total equity (36,038)      
Noncontrolling interest 32,510      
Total liabilities and equity $ (52,258)      
XML 61 R44.htm IDEA: XBRL DOCUMENT v3.10.0.1
5. Earnings per Share (Details) - USD ($)
$ / shares in Units, shares in Thousands, $ in Thousands
3 Months Ended 9 Months Ended 12 Months Ended
Sep. 30, 2018
Sep. 30, 2017
Sep. 30, 2018
Sep. 30, 2017
Dec. 31, 2017
Numerator:          
Net income (loss) $ (11,845) $ 6,360 $ (43,942) $ (44,718) $ (77,141)
Weighted-average common shares 13,301 11,117 12,377 10,387  
Numerator - Diluted:          
Net income (loss) $ (11,845) $ 6,360 $ (43,942) $ (44,718) $ (77,141)
Adjustment for interest, net of income tax effect 0 599 0 0  
Net income, (loss) adjusted $ (11,845) $ 6,959 $ (43,942) $ (44,718)  
Denominator - Basic:          
Weighted-average common shares 13,301 11,117 12,377 10,387  
Effect of dilutive securities:          
Stock options, Awards and Warrants 0 246 0 0  
Exchangeable notes 0 5,157 0 0  
Dilutive potential common shares 0 5,403 0 0  
Weighted-average common shares, diluted 13,301 16,520 12,377 10,387  
Basic income (loss) per share $ (0.89) $ 0.57 $ (3.55) $ (4.31)  
Diluted income (loss) per share $ (0.89) $ 0.42 $ (3.55) $ (4.31)  
XML 62 R45.htm IDEA: XBRL DOCUMENT v3.10.0.1
5. Earnings Per Share Potentially Diluted Shares Excluded (Details) - shares
shares in Thousands
3 Months Ended 9 Months Ended
Sep. 30, 2018
Sep. 30, 2017
Sep. 30, 2018
Sep. 30, 2017
Anti-dilutive shares 39,396 1,150 39,396 3,347
Treximet        
Anti-dilutive shares 27,238 0 27,238 0
Exchangeable Notes        
Anti-dilutive shares 6,572 0 6,572 1,738
Convertible Preferred Stock        
Anti-dilutive shares 3,389 0 3,389 0
Stock Options and Restricted Stock        
Anti-dilutive shares 1,511 370 1,511 562
4.25% Convertible Notes        
Anti-dilutive shares 682 780 682 1,014
Warrants        
Anti-dilutive shares 4 0 4 33
XML 63 R46.htm IDEA: XBRL DOCUMENT v3.10.0.1
6. Fair Value Measurement (Debt Instruments) (Details) - USD ($)
$ in Thousands
Sep. 30, 2018
Dec. 31, 2017
Debt instruments, fair value $ 259,425 $ 228,535
Debt instruments, carrying value 309,827 269,419
4.25% Convertible Notes    
Debt instruments, fair value 33,714 36,208
Debt instruments, carrying value 67,823 65,194
Exchangeable Notes    
Debt instruments, fair value 13,631 21,375
Debt instruments, carrying value 10,030 7,975
2018 Term Loan    
Debt instruments, fair value 41,250 0
Debt instruments, carrying value 41,250 0
Delayed Draw Term Loan    
Debt instruments, fair value 36,940 30,300
Debt instruments, carrying value 37,805 27,248
Derivative Liability    
Debt instruments, fair value 54 93
Debt instruments, carrying value 54 93
Contingent Consideration    
Debt instruments, fair value 1,501 1,358
Debt instruments, carrying value 1,501 1,358
Treximet Secured Notes    
Debt instruments, fair value 132,335 139,201
Debt instruments, carrying value $ 151,364 $ 167,551
XML 64 R47.htm IDEA: XBRL DOCUMENT v3.10.0.1
6. Fair Value Measurements Using Significant Unobservable Inputs (Level 3) (Details) - USD ($)
$ in Thousands
9 Months Ended
Sep. 30, 2018
Sep. 30, 2017
Derivative Liability    
Beginning balance $ 93 $ 230
Impairment due tp partial conversion 0 (90)
Remeasurement adjustments - loss (gains) included in earnings (39) 38
Ending balance 54 178
Contingent Consideration    
Beginning balance 1,358 2,403
Remeasurement adjustments - loss (gains) included in earnings 143 344
Ending balance $ 1,501 $ 2,747
XML 65 R48.htm IDEA: XBRL DOCUMENT v3.10.0.1
7. Inventory (Details) - USD ($)
$ in Thousands
Sep. 30, 2018
Dec. 31, 2017
Inventory Disclosure [Abstract]    
Raw materials $ 4,297 $ 727
Work-in-process 2,957 238
Finished goods 11,524 5,889
Inventory gross 18,778 6,854
Reserve for obsolescence (990) (1,458)
Inventory, net $ 17,788 $ 5,396
XML 66 R49.htm IDEA: XBRL DOCUMENT v3.10.0.1
8. Goodwill and Intangible Assets - Goodwill (Details) - USD ($)
$ in Thousands
9 Months Ended 12 Months Ended
Sep. 30, 2018
Dec. 31, 2016
Dec. 31, 2017
Goodwill And Intangible Assets - Goodwill      
Goodwill $ 17,572 $ 30,600 $ 12,100
Additions 5,472    
Impairment $ 0 $ (18,500)  
XML 67 R50.htm IDEA: XBRL DOCUMENT v3.10.0.1
8. Goodwill and Intangible Assets (Details) - USD ($)
$ in Thousands
9 Months Ended
Sep. 30, 2018
Dec. 31, 2017
Dec. 31, 2016
Goodwill $ 17,572 $ 12,100 $ 30,600
Increase in goodwill related to acquisitions $ 5,472    
XML 68 R51.htm IDEA: XBRL DOCUMENT v3.10.0.1
8. Goodwill and Intangible Assets (Details 1) - USD ($)
$ in Thousands
9 Months Ended 12 Months Ended
Sep. 30, 2018
Dec. 31, 2017
Intangible assets consist of the following    
Gross Carrying Amount $ 429,615 $ 379,115
Impairment 0 0
Accumulated Amortization (295,966) (282,509)
Net Carrying Amount 133,649 96,606
In Process Research And Development Member    
Intangible assets consist of the following    
Gross Carrying Amount 11,000 11,000
Impairment 0 0
Accumulated Amortization 0 0
Net Carrying Amount 11,000 11,000
Total Indefinite Lived    
Intangible assets consist of the following    
Gross Carrying Amount 11,000 11,000
Impairment 0 0
Accumulated Amortization 0 0
Net Carrying Amount $ 11,000 $ 11,000
Product Licenses Member    
Intangible assets consist of the following    
Weighted Average Life Remaining 4 years 288 days 5 years 144 days
Gross Carrying Amount $ 2,846 $ 2,846
Impairment 0 0
Accumulated Amortization (1,823) (1,623)
Net Carrying Amount $ 1,023 $ 1,223
Supplier Contracts Member    
Intangible assets consist of the following    
Weighted Average Life Remaining 2 years 216 days 3 years 108 days
Gross Carrying Amount $ 583 $ 583
Impairment 0 0
Accumulated Amortization (282) (194)
Net Carrying Amount $ 301 $ 389
Customer lists    
Intangible assets consist of the following    
Weighted Average Life Remaining 4 years 288 days  
Gross Carrying Amount $ 900  
Impairment 0  
Accumulated Amortization (32)  
Net Carrying Amount $ 868  
Tradenames    
Intangible assets consist of the following    
Weighted Average Life Remaining 11 years 288 days  
Gross Carrying Amount $ 4,800  
Impairment 0  
Accumulated Amortization (71)  
Net Carrying Amount $ (293,758)  
Acquired Developed Technology Member    
Intangible assets consist of the following    
Weighted Average Life Remaining 12 years 252 days 13 years 216 days
Gross Carrying Amount $ 409,486 $ 364,686
Impairment 0 0
Accumulated Amortization (293,758) (280,692)
Net Carrying Amount 115,728 83,994
Total Definite Lived    
Intangible assets consist of the following    
Gross Carrying Amount 418,615 368,115
Impairment 0 0
Accumulated Amortization (295,966) (282,509)
Net Carrying Amount $ 122,649 $ 85,606
XML 69 R52.htm IDEA: XBRL DOCUMENT v3.10.0.1
8. Goodwill and Intangible Assets (Details 2)
$ in Thousands
Sep. 30, 2018
USD ($)
Estimated amortization expense related to intangible assets  
2018 (October - December) $ 2,642
2019 10,567
2020 10,480
2021 10,385
2022 10,346
Thereafter 78,229
Total $ 122,649
XML 70 R53.htm IDEA: XBRL DOCUMENT v3.10.0.1
8. Goodwill and Intangible Assets (Details Narrative) - USD ($)
$ in Thousands
3 Months Ended 9 Months Ended
Sep. 30, 2018
Sep. 30, 2017
Sep. 30, 2018
Sep. 30, 2017
Goodwill and Intangible Assets Disclosure [Abstract]        
Amortization expense $ 2,300 $ 18,200 $ 13,500 $ 54,800
XML 71 R54.htm IDEA: XBRL DOCUMENT v3.10.0.1
9. Accrued Allowances (Details) - USD ($)
$ in Thousands
Sep. 30, 2018
Dec. 31, 2017
Accrued allowances consist of the following    
Accrued returns allowance $ 25,370 $ 21,681
Accrued price adjustments 22,823 10,766
Accrued managed care rebates 17,230 17,221
Accrued government program rebates 6,275 6,641
Total $ 71,698 $ 56,309
XML 72 R55.htm IDEA: XBRL DOCUMENT v3.10.0.1
10. Debt and Lines of Credit (Details) - USD ($)
$ in Thousands
9 Months Ended
Sep. 30, 2018
Dec. 31, 2017
Total gross long-term debt $ 364,394 $ 330,223
Less unamortized discount (31,741) (35,423)
Less unamortized deferred financing costs (10,196) (12,647)
Total net long-term debt 322,457 282,153
Less current portion of long-term debt 0 3,664
Long-term debt outstanding, net 322,457 278,489
4.25% Convertible Notes    
Total gross long-term debt 78,225 78,225
Less unamortized discount (8,828) (11,060)
Less unamortized deferred financing costs (1,574) (1,971)
Total net long-term debt $ 67,823 65,194
Debt, Description <p style="font: 10pt Times New Roman, Times, Serif; margin-right: 0; margin-left: 0"><i>4.25% Convertible Notes </i></p> <p style="font: 10pt Times New Roman, Times, Serif; margin-right: 0; margin-left: 0">On April 22, 2015, the Company issued $130.0 million aggregate principal amount 4.25% Convertible Notes. The 4.25% Convertible Notes mature on April 1, 2021, unless earlier converted, redeemed or repurchased. Interest on the 4.25% Convertible Notes is payable on April 1 and October 1 of each year, beginning October 1, 2015.</p> <p style="font: 10pt Times New Roman, Times, Serif; margin-right: 0; margin-left: 0">The 4.25% Convertible Notes are governed by the terms of an indenture, between the Company and Wilmington Trust, National Association, each of which were entered into on April 22, 2015. The Company may not redeem the 4.25% Convertible Notes prior to April 6, 2019. However, the holders may convert their 4.25% Convertible Notes at any time prior to the close of business on the business day immediately preceding January 1, 2021 only under certain circumstances. The effective interest rate on the 4.25% Convertible Notes, including debt issuance costs and bifurcated conversion option derivative (discussed below), is 10.4%.</p> <p style="font: 10pt Times New Roman, Times, Serif; margin-right: 0; margin-left: 0">The Company is required to separate the conversion option in the 4.25% Convertible Notes under Accounting Standards Codification (ASC) 815, <i>Derivatives and Hedging</i>. During April 2015, the Company recorded the bifurcated conversion option valued at $28.5 million as a derivative liability, which created a discount on the debt. The derivative liability is marked to market through the other income (expense) section on the unaudited condensed consolidated statements of operations for each reporting period, while the discount created on the 4.25% Convertible Notes is accreted as interest expense over the life of the debt. The derivative liability is valued at $54,000 and $93,000 as of September 30, 2018 and December 31, 2017, respectively.</p> <p style="font: 10pt Times New Roman, Times, Serif; margin-right: 0; margin-left: 0">Interest expense was $1.7 million and $5.1 million for the three and nine months ended September 30, 2018, respectively, and $1.9 million and $6.9 million for the three and nine months ended September 30, 2017, respectively, related to the 4.25% Convertible Notes. Interest expense includes amortization of deferred financing costs and accretion of debt discount.</p> <p style="font: 10pt Times New Roman, Times, Serif; margin-right: 0; margin-left: 0">Change in fair value of derivative liability was a benefit of $18,000 and $39,000 for the three and nine months ended September 30, 2018, respectively, and a benefit of $46,000 and an expense of $38,000 for the three and nine months ended September 30, 2017, respectively. Accrued interest on the 4.25% Convertible Notes was approximately $1.7 million and $0.8 million as of September 30, 2018 and December 31, 2017, respectively.</p> <p style="font: 10pt Times New Roman, Times, Serif; margin-right: 0; margin-left: 0">As a result of the Exchangeable Notes transaction during the third quarter of 2017, the Company recorded $14.7 million as gain from exchange of debt for the three months ended September 30, 2017.</p> <p style="font: 10pt Times New Roman, Times, Serif; margin-right: 0; margin-left: 0"> </p> <p style="font: 10pt Times New Roman, Times, Serif; margin-right: 0; margin-left: 0"></p> <p style="font: 10pt Times New Roman, Times, Serif; margin-right: 0; margin-left: 0"> </p>  
Exchangeable Notes    
Total gross long-term debt $ 36,145 35,743
Less unamortized discount (22,913) (24,363)
Less unamortized deferred financing costs (3,202) (3,405)
Total net long-term debt $ 10,030 7,975
Debt, Description <p style="font: 10pt Times New Roman, Times, Serif; margin-right: 0; margin-left: 0"><i>Exchangeable Notes</i></p> <p style="font: 10pt Times New Roman, Times, Serif; margin-right: 0; margin-left: 0">On July 20, 2017, the Company entered into an exchange agreement (the 2017 Exchange Agreement) with certain holders of its 4.25% Convertible Notes (Holders) pursuant to which $51.8 million of aggregate principal amount of its 4.25% Convertible Notes held by the Holders were exchanged for (i) $36.2 million aggregate principal amount of 4.25%/5.25% Exchangeable Senior Notes due 2022 (the Exchangeable Notes), issued by PIP DAC pursuant to an Indenture, dated July 21, 2017 (the Exchangeable Notes Indenture), among PIPL, the guarantors party thereto (the Guarantors), and Wilmington Trust, National Association, as Trustee and (ii) 1,100,498 shares of Common Stock.</p> <p style="font: 10pt Times New Roman, Times, Serif; margin-right: 0; margin-left: 0">The Exchangeable Notes issued under the Exchangeable Notes Indenture are guaranteed by the Company and each other subsidiary thereof. The Exchangeable Notes are senior, unsecured obligations of PIP DAC. Interest on the Exchangeable Notes will be paid in cash or a combination of cash and in-kind interest at PIP DAC's election. Interest paid in cash (the All Cash Method) will accrue at a rate of 4.25% per annum, while interest paid in a combination of cash and in-kind will accrue at a rate of 5.25% per annum, with 2.25% per annum (plus additional interest, if any) capitalized to the principal amount of the Exchangeable Notes, and the balance paid in cash. The maturity date of the Exchangeable Notes Indenture is July 15, 2022. The Exchangeable Notes initially are exchangeable into shares of Common Stock at an exchange price per share of $5.50 (the Exchange Price).</p> <p style="font: 10pt Times New Roman, Times, Serif; margin-right: 0; margin-left: 0">The 2017 Exchange Agreement allowed the Company to reduce the principal amount of its outstanding indebtedness through the exchange of the Holders' 4.25% Convertible Notes for a smaller principal amount of the Exchangeable Notes. The principal amount of the Exchangeable Notes may be reduced if the Holders thereof exchange their Exchangeable Notes for shares of Common Stock. The Exchangeable Notes Indenture will provide capacity to refinance up to an additional $25.0 million principal amount of the 4.25% Convertible Notes, which refinancing could also provide an opportunity to further reduce the principal amount of the Company's outstanding indebtedness.</p> <p style="font: 10pt Times New Roman, Times, Serif; margin-right: 0; margin-left: 0">The outstanding borrowings of the Exchangeable Notes were paid down by $500,000 in November 2017 with a portion of the proceeds from the sale of certain non-core assets. Interest expense was $1.0 million and $3.0 million for the three and nine months ended September 30, 2018, respectively, and $0.6 million for the three and nine months ended September 30, 2017, related to the Exchangeable Notes and included amortization of deferred financing costs and accretion of debt discount. During the first quarter of 2018, PIP DAC elected the PIK option in lieu of making scheduled interest payments. The election increased the principal due on the Exchangeable Notes by $402,000 as of September 30, 2018. Accrued interest on the Exchangeable Notes was approximately $396,000 and $675,000 as of September 30, 2018 and December 31, 2017, respectively.</p> <p style="font: 10pt Times New Roman, Times, Serif; margin-right: 0; margin-left: 0"> </p> <p style="font: 10pt Times New Roman, Times, Serif; margin-right: 0; margin-left: 0"></p> <p style="font: 10pt Times New Roman, Times, Serif; margin-right: 0; margin-left: 0"></p> <p style="font: 10pt Times New Roman, Times, Serif; margin-right: 0; margin-left: 0"> </p> <p style="font: 10pt Times New Roman, Times, Serif; margin-right: 0; margin-left: 0"> </p> <p style="font: 10pt Times New Roman, Times, Serif; margin-right: 0; margin-left: 0"></p>  
Delayed Draw Term Loan    
Total gross long-term debt $ 40,074 30,000
Less unamortized discount 0 0
Less unamortized deferred financing costs (2,269) (2,752)
Total net long-term debt $ 37,805 27,248
Debt, Description <p style="font: 10pt Times New Roman, Times, Serif; margin-right: 0; margin-left: 0"><b><i>Term Facility:</i></b></p> <p style="font: 10pt Times New Roman, Times, Serif; margin-right: 0; margin-left: 0">On July 21, 2017 PIP DAC entered into a term loan credit agreement (the Delayed Draw Term Loan, the Term Facility or DDTL) with Cantor Fitzgerald Securities, as agent and the lenders party thereto to obtain the DDTL. $30.0 million under the DDTL was drawn on July 21, 2017 in connection with the closing of several refinancing transactions and the remaining $15.0 million will be available for subsequent draws for certain specified purposes, including to finance certain acquisitions, subject to conditions set forth in the DDTL credit agreement. The DDTL includes an incremental feature that allows PIP DAC, with the consent of the requisite lenders under the Term Facility, to obtain up to an additional $20.0 million in term loan commitments. Interest on the loans will accrue either in cash or a combination of cash and in kind interest, at PIP DAC's election. Cash interest will accrue at a rate of 7.50% per annum, while the combination of cash and in-kind interest will accrue at a rate of 8.50% per annum, with up to 4.00% per annum added to the principal amount of loans and the balance paid in cash. The DDTL will mature on July 21, 2022. During the first quarter of 2018, PIP DAC elected the PIK option in lieu of making scheduled interest payments. The election increased the principal due on the DDTL by $906,000 as of September 30, 2018.</p> <p style="font: 10pt Times New Roman, Times, Serif; margin-right: 0; margin-left: 0">On July 27, 2018, PIP DAC drew $9.2 million under the DDTL. The proceeds were used to fund the Company's investment in Nalpropion for Nalpropion's purchase of certain assets of Orexigen and for working capital requirements.</p> <p style="font: 10pt Times New Roman, Times, Serif; margin-right: 0; margin-left: 0">PIP DAC also entered into a mortgage debenture with Cantor Fitzgerald Securities as agent, pursuant to which PIP DAC's obligations under the DDTL will be secured by substantially all of the assets of PIP DAC and its future-acquired subsidiaries.</p> <p style="font: 10pt Times New Roman, Times, Serif; margin-right: 0; margin-left: 0">On August 1, 2018 the Company entered into an amendment of its Term Facility. These amendments were made to permit the exchange of the 12% Senior Secured Notes due 2020 (Treximet Secured Notes) for newly issued shares of Common Stock in the exchange transactions and equitization transaction (as defined below), and to amend certain terms of the Term Facility and the ABL Facility (collectively, the Credit Facilities), including (i) changes to permit the use of subsequent draws under the Term Facility for working capital or other general corporate purposes, and (ii) changes to the interest payment provisions under the Term Facility increasing the minimum percentage of interest that must be paid in cash to 6.00% per annum from 4.50% per annum.</p> <p style="font: 10pt Times New Roman, Times, Serif; margin-right: 0; margin-left: 0">Interest expense was approximately $1.0 million and $2.6 million for the three and nine months ended September 30, 2018 related to the DDTL and includes amortization of deferred financing costs. Accrued interest on the DDTL was approximately $624,000 and $484,000 as of September 30, 2018 and December 31, 2017, respectively.</p> <p style="font: 10pt Times New Roman, Times, Serif; margin-right: 0; margin-left: 0"> </p> <p style="font: 10pt Times New Roman, Times, Serif; margin-right: 0; margin-left: 0"> </p> <p style="font: 10pt Times New Roman, Times, Serif; margin-right: 0; margin-left: 0"></p>  
Treximet Secured Notes    
Total gross long-term debt $ 154,515 166,697
Less unamortized discount 0 0
Less unamortized deferred financing costs (3,151) (2,810)
Total net long-term debt $ 151,364 163,887
Debt, Description <p style="font: 10pt Times New Roman, Times, Serif; margin-right: 0; margin-left: 0"><i>Treximet Note Offering</i></p> <p style="font: 10pt Times New Roman, Times, Serif; margin-right: 0; margin-left: 0"></p> <p style="font: 10pt Times New Roman, Times, Serif; margin-right: 0; margin-left: 0">On August 19, 2014, the Company issued $220.0 million aggregate principal amount of its Treximet Secured Notes pursuant to an Indenture (the August 2014 Indenture) dated as of August 19, 2014 among the Company, certain of its subsidiaries (the Treximet Guarantors) and U.S. Bank National Association (the August 2014 Trustee), as trustee and collateral agent.</p> <p style="font: 10pt Times New Roman, Times, Serif; margin-right: 0; margin-left: 0">On April 13, 2015, the Company amended the August 2014 Indenture to allow the Company to, among other things, incur up to $42.2 million of additional debt. On December 29, 2017, the Company and the August 2014 Trustee entered into a third supplemental indenture to amend the August 2014 Indenture to clarify the definition of "Net Sales", as such term is defined in the August 2014 Indenture and resulted in the deferral of $3.2 million of principal payments until maturity of the notes.</p> <p style="font: 10pt Times New Roman, Times, Serif; margin-right: 0; margin-left: 0">The Treximet Secured Notes mature on August 1, 2020 and bear interest at a rate of 12% per annum, payable in arrears on February 1 and August 1 of each year (each, a Payment Date), beginning on February 1, 2015. On each Payment Date, commencing August 1, 2015, the Company began paying installments of principal of the Treximet Secured Notes in an amount equal to 50% of net sales of Treximet for the two consecutive fiscal quarters immediately preceding such Payment Date (less the amount of interest paid on the Treximet Secured Notes on such Payment Date). At each month-end beginning with January 2015, the net sales of Treximet will be calculated, the monthly interest accrual amount will then be deducted from the net sales and this resulting amount will be recorded as the current portion of the Treximet Secured Notes. If the Treximet net sales less the interest due at the end of each six-month period does not result in any excess over the interest due, no principal payment must be paid at that time. The remaining balance outstanding on the Treximet Secured Notes will be due on the maturity date, which is August 1, 2020. As of September 30, 2018, the principal amount outstanding of the Treximet Secured Notes is $154.5 million and is classified as a non-current liability. As of December 31, 2017, the Company classified $5.4 million, of the Treximet Secured Notes as a current liability and $166.7 million as a non-current liability at December 31, 2017.</p> <p style="font: 10pt Times New Roman, Times, Serif; margin-right: 0; margin-left: 0">The Treximet Secured Notes are secured by a continuing first-priority security interest in substantially all of the assets of the Company and the Treximet Guarantors related to Treximet other than inventory and certain inventory related assets, including accounts arising from the sale of the inventory.</p> <p style="font: 10pt Times New Roman, Times, Serif; margin-right: 0; margin-left: 0">On August 1, 2018, the Company entered into an exchange agreement (2018 Exchange Agreement) with certain holders (Exchange Holders) of the Treximet Secured Notes for newly issued shares of Common Stock and shares of a newly created class of convertible preferred stock of the Company designated as Convertible Preferred Stock (Exchange Transactions).</p> <p style="font: 10pt Times New Roman, Times, Serif; margin-right: 0; margin-left: 0">The Exchange Transactions closed on August 1, 2018 and were as follows:</p> <ul> <li style="margin: 0pt 0 12pt; font-size: 10pt"><font style="font-family: Times New Roman, Times, Serif">exchange of approximately $2.7 million aggregate principal amount of the Treximet Secured Notes for 1,204,586 shares of Common Stock which includes $0.2 million of accrued and unpaid interest on the Treximet Secured Notes;</font></li> <li style="margin: 0pt 0 12pt; font-size: 10pt"><font style="font-family: Times New Roman, Times, Serif">exchange of $8.0 million principal amount of the Treximet Secured Notes plus $0.1 million of accrued and unpaid interest for 81,000 shares of Convertible Preferred Stock.</font></li> </ul> <p style="font: 10pt Times New Roman, Times, Serif; margin-right: 0; margin-left: 0">The 2018 Exchange Agreement affords certain Exchange Holders the right to exchange up to an additional $65.1 million aggregate principal amount of the Treximet Secured Notes plus accrued and unpaid interest, into additional Convertible Preferred Stock until February 1, 2020. The Company evaluated the transaction under ASC 470-50, <i>Debtors Accounting for a Modification or Exchange of Debt Instruments</i> and determined the inclusion of the conversion right was not substantive and therefore does not constitute a debt extinguishment.</p> <p style="font: 10pt Times New Roman, Times, Serif; margin-right: 0; margin-left: 0">On August 1, 2018, the Company entered into separate Equitization Exchange Agreements by and among Pernix and certain Equitization Holders of Treximet Secured Notes. Pursuant to the Equitization Exchange Agreements, the Company issued 650,190 shares of its Common Stock in exchange for approximately $1.5 million aggregate principal amount of Treximet Secured Notes held by such Equitization Holders plus $0.1 million of accrued and unpaid interest thereon (Equitization Transaction). This transaction closed on August 1, 2018.</p> <p style="font: 10pt Times New Roman, Times, Serif; margin-right: 0; margin-left: 0">As a result of the Exchange Transactions and Equitization Transaction, the Company recorded a net gain on early extinguishment of debt of $0.1 million.</p> <p style="font: 10pt Times New Roman, Times, Serif; margin-right: 0; margin-left: 0">Interest expense related to the Treximet Secured Notes was $5.2 million and $16.1 million for the three and nine months ended September 30, 2018, respectively, and was $5.6 million and $17.2 million for the three and nine months ended September 30, 2017, respectively. Interest expense includes amortization of deferred financing costs. Accrued interest on the Treximet Secured Notes was approximately $3.1 million and $8.6 million as of September 30, 2018 and December 31, 2017, respectively.</p> <p style="font: 10pt Times New Roman, Times, Serif; margin-right: 0; margin-left: 0"> </p> <p style="font: 10pt Times New Roman, Times, Serif; margin-right: 0; margin-left: 0"></p>  
Treximet Secured - Short Term    
Total gross long-term debt $ 0 5,373
Less unamortized discount 0 0
Less unamortized deferred financing costs 0 (1,709)
Total net long-term debt 0 3,664
2018 Term Loan    
Total gross long-term debt 41,250 0
Less unamortized discount 0 0
Less unamortized deferred financing costs 0 0
Total net long-term debt $ 41,250 0
Line of Credit Facility, Description <p style="font: 10pt Times New Roman, Times, Serif; margin-right: 0; margin-left: 0"><b><i>2018 Term Loan</i></b></p> <p style="font: 10pt Times New Roman, Times, Serif; margin-right: 0; margin-left: 0">On July 27, 2018, Nalpropion entered into a credit agreement (2018 Credit Agreement) with Wilmington Savings Fund Society, FSB, as administrative and collateral agent, and certain lenders including PIP DAC and certain affiliates of Highbridge Capital Management, LLC (Highbridge) and Whitebox Advisors LLC (Whitebox, and collectively, the Lenders) from time to time party thereto providing for $45.8 million principal amount of a three-year term loan (the 2018 Term Loan). Loans under the 2018 Term Loan bear interest at 8.0% per year and mature on July 27, 2021. PIP DAC provided $4.6 million of the total commitment under the credit facility established under the 2018 Credit Agreement (2018 Credit Facility). Nalpropion borrowed the full $45.8 million available under the 2018 Term Loan to partially fund the Orexigen Acquisition and for working capital requirements. As PIP DAC is one of the lenders under the 2018 Credit Facility and provided $4.6 million of the total commitment under the 2018 Credit Facility, the $4.6 million is eliminated in consolidation as the transaction is between affiliates. As of September 30, 2018, $41.3 million of borrowings under the 2018 Term Loan related to the Company's consolidation of Nalpropion as a VIE is included in the Company's unaudited condensed consolidated balance sheets.</p> <p style="font: 10pt Times New Roman, Times, Serif; margin-right: 0; margin-left: 0">The borrowings under the 2018 Credit Agreement are secured, subject to customary permitted liens and other agreed upon exceptions, by a perfected security interest in the intangible assets of Nalpropion. Nalpropion is permitted to make voluntary prepayments at any time without payment of a premium or penalty. Nalpropion is required to make mandatory prepayments of outstanding indebtedness under the 2018 Credit Agreement (without payment of a premium) with (a) net cash proceeds from certain non-ordinary course asset sales (subject to reinvestment rights and other exceptions), (b) casualty proceeds and condemnation awards (subject to reinvestment rights and other exceptions), and (c) 75% of the excess cash flow generated during a semi-annual period (commencing with the period subsequent to June 30, 2019), depending on certain factors as defined in the 2018 Credit Agreement.</p> <p style="font: 10pt Times New Roman, Times, Serif; margin-right: 0; margin-left: 0">The 2018 Credit Agreement contains certain negative covenants (subject to exceptions, materiality thresholds and other allowances) including, without limitation, negative covenants that limit Nalpropion's ability to incur additional debt, guarantee other obligations, grant liens on assets, make loans, acquisitions or other investments, dispose of certain assets, make optional payments in connection with or modify certain debt instruments, pay dividends or make other payments on capital stock, engage in mergers or consolidations, enter into arrangements that restrict Nalpropion's ability to pay dividends or grant liens, engage in transactions with affiliates, or change its fiscal year.</p> <p style="font: 10pt Times New Roman, Times, Serif; margin-right: 0; margin-left: 0">In addition, the 2018 Credit Agreement also contains customary events of default (with customary grace periods and materiality thresholds). Upon the occurrence of certain events of default, the obligations under the 2018 Credit Agreement may be accelerated and any remaining commitments thereunder may be terminated.</p> <p style="font: 10pt Times New Roman, Times, Serif; margin-right: 0; margin-left: 0">Interest expense related to the 2018 Term Loan was $0.7 million for the three months ended September 30, 2018 of which $0.1 million is due to the Company and is eliminated in consolidation. As of September 30, 2018, $0.6 million of accrued interest on the 2018 Term Loan related to the Company's consolidation of Nalpropion as a VIE is included in the Company's unaudited condensed consolidated balance sheets.</p> <p style="font: 10pt Times New Roman, Times, Serif; margin-right: 0; margin-left: 0"> </p>  
ABL Credit Agreement    
Total gross long-term debt $ 14,185 14,185
Less unamortized discount 0 0
Less unamortized deferred financing costs 0 0
Total net long-term debt $ 14,185 $ 14,185
Line of Credit Facility, Description <p style="font: 10pt Times New Roman, Times, Serif; margin-right: 0; margin-left: 0"><i>Cantor Fitzgerald</i></p> <p style="font: 10pt Times New Roman, Times, Serif; margin-right: 0; margin-left: 0"></p> <p style="font: 10pt Times New Roman, Times, Serif; margin-right: 0; margin-left: 0">On July 21, 2017, Pernix and certain subsidiaries of Pernix as borrowers and guarantors (the ABL Borrowers) and PIP DAC, Pernix Ireland Limited, Pernix Holdco 1, LLC, Pernix Holdco 2, LLC and Pernix Holdco 3, LLC as additional guarantors (the ABL Guarantors), entered into an asset-based revolving credit agreement (the ABL Credit Agreement) with Cantor Fitzgerald Securities, as agent (the ABL Agent) and the lenders party thereto to obtain a five-year $40 million asset-based revolving credit facility (the ABL Facility). On April 23, 2018, the Company entered into an amendment, effective as of April 12, 2018, to modify the borrowing base formula which determines the Company's capacity to draw on the ABL Facility, which could increase such capacity. The amendment also removed concentration limits for accounts receivable due from individual customers or other account debtors that may be included in the borrowing base.</p> <p style="font: 10pt Times New Roman, Times, Serif; margin-right: 0; margin-left: 0">The ABL Borrowers' obligations under the ABL Credit Agreement are guaranteed by the ABL Borrowers and the ABL Guarantors are secured by, among other things, the ABL Borrowers' cash, inventory and accounts receivable, in each case pursuant to a guaranty and security agreement between the ABL Borrowers, ABL Guarantors and Cantor Fitzgerald Securities as agent. Borrowings under the ABL Credit Agreement bear interest at the rate of LIBOR plus 7.50%, payable monthly, in addition to a commitment fee on any undrawn commitments at a rate per annum of 0.25%, payable monthly. The ABL Credit Agreement contains representations and warranties, affirmative and negative covenants, and events of default applicable to the Company, the other ABL Borrowers, the ABL Guarantors and their respective subsidiaries that are customary for credit facilities of this type. The ABL Credit Agreement will mature on July 21, 2022.</p> <p style="font: 10pt Times New Roman, Times, Serif; margin-right: 0; margin-left: 0">On August 1, 2018 the Company entered into an amendment of the ABL Facility. The amendment provides for certain changes to the borrowing base calculation under the ABL Facility that are intended to improve the Company's borrowing capacity under the ABL Facility and that will also permit the Company, among other things, to include Contrave inventory owned by the Company in the calculation of the borrowing base, and a reduction in the commitments under the ABL Facility from $40.0 million to $32.5 million.</p> <p style="font: 10pt Times New Roman, Times, Serif; margin-right: 0; margin-left: 0">Interest expense was $0.5 million and $1.5 million for the three and nine months ended September 30, 2018, respectively, and was $0.4 million for the three and nine months ended September 30, 2017, related to the ABL Credit Agreement and includes amortization of deferred financing costs. As of September 30, 2018, unamortized debt issuance costs of $0.6 million and $1.6 million are recorded on the unaudited consolidated balance sheets in Prepaid expenses and other currents assets and Other assets, respectively, and are being amortized to interest expense over the life of the agreement. As of December 31, 2017, $0.6 million and $2.1 million of unamortized debt issuance costs are recorded on the unaudited consolidated balance sheets in Prepaid expenses and other currents assets and Other assets, respectively.</p> <p style="font: 10pt Times New Roman, Times, Serif; margin-right: 0; margin-left: 0"> </p> <p style="font: 10pt Times New Roman, Times, Serif; margin-right: 0; margin-left: 0"> </p> <p style="font: 10pt Times New Roman, Times, Serif; margin-right: 0; margin-left: 0"> </p>  
Wells Fargo Credit Facility    
Line of Credit Facility, Description <p style="font: 10pt Times New Roman, Times, Serif; margin-right: 0; margin-left: 0"><i>Wells Fargo</i></p> <p style="font: 10pt Times New Roman, Times, Serif; margin-right: 0; margin-left: 0">On August 21, 2015, the Company entered into a credit agreement with Wells Fargo, as Administrative Agent and the lenders party thereto for a $50.0 million, three-year senior secured revolving credit facility (the Wells Fargo Credit Facility).</p> <p style="font: 10pt Times New Roman, Times, Serif; margin-right: 0; margin-left: 0">The ABL Facility entered into on July 21, 2017 replaced the Wells Fargo Credit Facility and the Company used the proceeds from the ABL Facility to repay the outstanding obligation of the Wells Fargo Credit Facility.</p> <p style="font: 10pt Times New Roman, Times, Serif; margin-right: 0; margin-left: 0">Interest expense including amortization of deferred financing costs related to the Wells Fargo Credit Facility amounted to $142,000 and $748,000, for the three and nine months ending September 30, 2017, respectively.</p> <p style="font: 10pt Times New Roman, Times, Serif; margin-right: 0; margin-left: 0"> </p> <p style="font: 10pt Times New Roman, Times, Serif; margin-right: 0; margin-left: 0"></p> <p style="font: 10pt Times New Roman, Times, Serif; margin-right: 0; margin-left: 0"></p> <p style="font: 10pt Times New Roman, Times, Serif; margin-right: 0; margin-left: 0"> </p> <p style="font: 10pt Times New Roman, Times, Serif; margin-right: 0; margin-left: 0"></p> <p style="font: 10pt Times New Roman, Times, Serif; margin-right: 0; margin-left: 0"> </p>  
XML 73 R56.htm IDEA: XBRL DOCUMENT v3.10.0.1
10. Debt (Details 1) - USD ($)
$ in Thousands
Sep. 30, 2018
Dec. 31, 2017
Debt And Lines Of Credit Details 1    
2018 (October - December) $ 0  
2019 0  
2020 154,515  
2021 119,475  
2022 90,404  
Thereafter 0  
Total maturities 364,394 $ 330,223
Less: note discount (31,741) (35,423)
Less: deferred financing costs (10,196) $ (12,647)
Total outstanding debt $ 322,457  
XML 74 R57.htm IDEA: XBRL DOCUMENT v3.10.0.1
11. Stockholders' Equity (Details) - USD ($)
3 Months Ended 9 Months Ended
Sep. 30, 2018
Sep. 30, 2017
Sep. 30, 2018
Sep. 30, 2017
Weighted average of the assumptions used to value stock options on the date of grant        
Weighted average expected stock price volatility 86.40% 88.00% 86.40% 87.60%
Estimated dividend yield 0.00% 0.00% 0.00% 0.00%
Risk-free interest rate 2.90% 2.00% 2.80% 2.00%
Expected life of option (in years) 6 years 108 days 6 years 72 days 6 years 108 days 6 years 72 days
Weighted average grant date fair value per option $ 0.69 $ 2.15 $ 1.61 $ 2.15
XML 75 R58.htm IDEA: XBRL DOCUMENT v3.10.0.1
11. Stockholders' Equity (Details 1)
$ / shares in Units, shares in Thousands, $ in Thousands
9 Months Ended
Sep. 30, 2018
USD ($)
$ / shares
shares
Option Shares  
Outstanding at December 31, 2017 | shares 1,042
Granted | shares 556
Exercised | shares 0
Cancelled | shares (228)
Expired | shares 0
Outstanding at September 30, 2018 | shares 1,370
Options vested and expected to vest, as of September 30, 2018 | shares 895
Options vested and exercisable, as of September 30, 2018 | shares 339
Option Average Exercise Price  
Outstanding at December 31, 2017 | $ / shares $ 13.80
Granted | $ / shares 2.17
Exercised | $ / shares 0
Cancelled | $ / shares 12.29
Expired | $ / shares 0
Outstanding at September 30, 2018 | $ / shares 9.34
Options vested and expected to vest, as of September 30, 2018 | $ / shares 12.86
Options vested and exercisable, as of September 30, 2018 | $ / shares $ 24.88
Option Weighted Average Remaining Contractual Life Years  
Options outstanding at September 30, 2018 8 years 252 days
Options vested and expected to vest, as of September 30, 2018 8 years 108 days
Options vested and exercisable, as of September 30, 2018 7 years 108 days
Option Aggregate Intrinsic Value  
Options outstanding at September 30, 2018 | $ $ 5
Options vested and expected to vest as of September 30, 2018 | $ 2
Options vested and exercisable as of September 30, 2018 | $ $ 0
XML 76 R59.htm IDEA: XBRL DOCUMENT v3.10.0.1
11. Stockholders' Equity (Details 2) - Restricted shares
$ / shares in Units, shares in Thousands, $ in Thousands
9 Months Ended
Sep. 30, 2018
USD ($)
$ / shares
shares
Non-vested restricted stock outstanding at December 31, 2017 | shares 135
Granted | shares 62
Vested | shares (54)
Forfeited | shares (2)
Non-vested restricted stock outstanding at September 30, 2018 | shares 141
Weighted Average Grant Date Fair Value | $ / shares $ 3.17
Granted | $ / shares 2.46
Vested | $ / shares 3.25
Forfeited | $ / shares 2.60
Weighted Average Grant Date Fair Value | $ / shares $ 2.83
Unrecognized compensation cost related to non-vested retricted stock | $ $ 800
Employee Service Share-based Compensation, Nonvested Awards, Compensation Cost Not yet Recognized, Period for Recognition 1 year 349 days
XML 77 R60.htm IDEA: XBRL DOCUMENT v3.10.0.1
13. Commitments and Contingencies (Details Narrative)
9 Months Ended
Sep. 30, 2018
Texas Medicaid Fraud Prevention Act  
Settlement description <p style="font: 10pt Times New Roman, Times, Serif; margin-right: 0; margin-left: 0">During the first quarter of 2014, the Company settled all claims arising from certain actions by Cypress under the Texas Medicaid Fraud Prevention Act prior to its acquisition by the Company. As part of the settlement, the Company agreed to pay $12.0 million, payable in annual amounts of $2.0 million until the settlement is paid in full. As of September 30, 2018, the net present value of remaining payment obligations owed under this settlement agreement is $2.0 million and is recorded within other liabilities - current on the Company's unaudited condensed consolidated balance sheets as of September 30, 2018.</p> <p style="font: 10pt Times New Roman, Times, Serif; margin-right: 0; margin-left: 0"> </p> <p style="font: 10pt Times New Roman, Times, Serif; margin-right: 0; margin-left: 0"></p> <p style="font: 10pt Times New Roman, Times, Serif; margin-right: 0; margin-left: 0"> </p> <p style="font: 10pt Times New Roman, Times, Serif; margin-right: 0; margin-left: 0"> </p> <p style="font: 10pt Times New Roman, Times, Serif; margin-right: 0; margin-left: 0"> </p> <p style="font: 10pt Times New Roman, Times, Serif; margin-right: 0; margin-left: 0"> </p> <p style="font: 10pt Times New Roman, Times, Serif; margin-right: 0; margin-left: 0"> </p>
GSK  
Settlement description <p style="font: 10pt Times New Roman, Times, Serif; margin-right: 0; margin-left: 0">GlaxoSmithKline (GSK) Arbitration</p> <p style="font: 10pt Times New Roman, Times, Serif; margin-right: 0; margin-left: 0">Pursuant to Amendment No. 2, the Company agreed that if on or before September 30, 2019, the Company (x) redeems or repurchases its 4.25% Convertible Notes for greater than 31 cents for every one dollar of principal amount outstanding or (y) exchange such notes for new notes or similar instruments that have a face value providing such exchanging holders a recovery that is greater than 31 cents for every one dollar of 4.25% Convertible Notes exchanged by such holders, the Company shall, no later than five business days thereafter, distribute to GSK additional cash or notes, as applicable, equal to such excess recovery, but in no event to exceed $2.0 million.  GSK has agreed that for so long as the Company complies with the payment terms set forth in the Amendment No. 2, enforcement of the award will be stayed and GSK shall not seek to enforce or exercise any other remedies in respect of the award, and that the outstanding balance of the Award shall be unconditionally and irrevocably forgiven upon satisfaction of such terms.  As of September 30, 2018 and December 31, 2017, the Company has recorded $2.0 million as contingent consideration for the potential payment due by September 30, 2019 and is recorded in "other liabilities - current" and "Arbitration Award" on the Company's consolidated balance sheets, respectively. Also, the Company recorded $10.5 million as a gain from legal settlement for the year ended December 31, 2017 pursuant to Amendment No. 2 in the consolidated statements of operations and comprehensive loss.</p> <p style="font: 10pt Times New Roman, Times, Serif; margin-right: 0; margin-left: 0"></p>
Somaxon [Member]  
Settlement description <p style="font: 10pt Times New Roman, Times, Serif; margin-right: 0; margin-left: 0">In July 2012 and January 2013, Somaxon settled two patent litigation claims with parties seeking to market generic equivalents of Silenor.  As of September 30, 2018, remaining payment obligations of the Company owed under these settlement agreements are $250,000. The balance is payable in the third quarter 2019 and is recorded in "other liabilities - current" on the Company's unaudited condensed consolidated balance sheets as of September 30, 2018.</p> <p style="font: 10pt Times New Roman, Times, Serif; margin-right: 0; margin-left: 0"> </p> <p style="font: 10pt Times New Roman, Times, Serif; margin-right: 0; margin-left: 0"> </p> <p style="font: 10pt Times New Roman, Times, Serif; margin-right: 0; margin-left: 0"> </p> <p style="font: 10pt Times New Roman, Times, Serif; margin-right: 0; margin-left: 0"></p> <p style="font: 10pt Times New Roman, Times, Serif; margin-right: 0; margin-left: 0"> </p> <p style="font: 10pt Times New Roman, Times, Serif; margin-right: 0; margin-left: 0"></p> <p style="font: 10pt Times New Roman, Times, Serif; margin-right: 0; margin-left: 0"></p> <p style="font: 10pt Times New Roman, Times, Serif; margin-right: 0; margin-left: 0"> </p>
XML 78 R61.htm IDEA: XBRL DOCUMENT v3.10.0.1
14. Restructuring (Details) - USD ($)
$ in Thousands
3 Months Ended 9 Months Ended
Sep. 30, 2018
Sep. 30, 2017
Sep. 30, 2018
Sep. 30, 2017
Dec. 31, 2017
Restructuring charges $ (2) $ (97) $ 1,212 $ 34  
2018 Restructuring          
Accrued restructuring costs 0   0   $ 0
Restructuring charges     774    
Restructuring cash     (774)    
Restructuring noncash     0    
2016 Restructuring          
Accrued restructuring costs $ 426   426   $ 265
Restructuring charges     438    
Restructuring cash     $ (277)    
XML 79 R62.htm IDEA: XBRL DOCUMENT v3.10.0.1
15. Supplemental Cash Flow Information (Details) - USD ($)
$ in Thousands
9 Months Ended
Sep. 30, 2018
Sep. 30, 2017
Supplemental disclosures of Cash Flow Information:    
Cash (received) paid for income taxes, net $ 29 $ (873)
Cash paid for interest 24,984 25,920
Supplemental disclosures of Non-cash Investing and Financing Activities:    
Conversion of Treximet Secured Notes and interest to Common Stock 4,433 0
Conversion of Treximet Secured Notes and interest to Convertible Preferred Stock 8,100 0
Amount added to principal of Delayed Draw Term Loan and Exchangeable notes for Payment-in-kind (PIK) interest 1,308 0
Conversion of 4.25% Convertible notes 0 (51,775)
Issuance of 1,100,498 shares in exchange transaction 0 3,775
Issuance of Exchangeable Notes $ 0 $ 36,243
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