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:  March 31, 2015
 
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 and posted on its corporate Web site, if any, every Interactive Data File required to be submitted and posted pursuant to Rule 405 of Regulation S-T (§232.405 of this chapter) during the preceding 12 months (or for such shorter period that the registrant was required to submit and post such files).  Yes  þ No  o .
 
Indicate by check mark whether the Registrant is a large accelerated filer, an accelerated filer, a non-accelerated filer, or a smaller reporting company. See definitions of “large accelerated filer,” “accelerated filer,” and “smaller reporting company” in Rule 12b-2 of the Exchange Act.  (Check one):

Large accelerated filer
o
Accelerated filer
þ
       
Non-accelerated filer 
o
Smaller reporting company
o
(Do not check if a smaller reporting company)
   

Indicate by check mark whether the Registrant is a shell company (as defined in Rule 12b-2 of the Exchange Act).  Yes   ¨  No   þ
 
On April 24, 2015, there were 43,540,098 shares outstanding of the Registrant’s common stock, par value $0.01 per share.  
 
 
 

 
 
 
 
 
PERNIX THERAPEUTICS HOLDINGS, INC.
 
Quarterly Report on Form 10-Q
For the Three Months Ended March 31, 2015

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 Cash Flows  
   
5
 
 
Notes to Condensed Consolidated Financial Statements
   
6
 
Item 2. 
Management’s Discussion and Analysis of Financial Condition and Results of Operations 
   
20
 
Item 3.
Quantitative and Qualitative Disclosures About Market Risk 
   
29
 
Item 4.
Controls and Procedures
   
29
 
           
PART II. 
OTHER INFORMATION
       
           
Item 1. 
Legal Proceedings 
   
30
 
Item 1A. 
Risk Factors
   
30
 
Item 2. 
Unregistered Sales of Equity Securities and Use of Proceeds 
   
62
 
Item 3.
Defaults upon Senior Securities
   
62
 
Item 4.
Mine Safety Disclosures
   
63
 
Item 5.
Other Information
   
63
 
Item 6.  
Exhibits
   
63
 
 
Signatures
   
64
 
 
 
1

 
 
Cautionary Statement Regarding Forward-Looking Statements

The Private Securities Litigation Reform Act of 1995 provides a “safe harbor” for forward-looking statements to encourage companies to provide prospective information, so long as those statements are identified as forward-looking and are accompanied by meaningful cautionary statements identifying important factors that could cause actual results to differ materially from those discussed in the statement.  We desire to take advantage of these “safe harbor” provisions with regard to the forward-looking statements in this Form 10-Q and in the documents that are incorporated herein by reference.  These forward-looking statements reflect our current views with respect to future events and financial performance.  Specifically, forward-looking statements may include:
 
 
projections of revenues, expenses, income, income per share and other performance measures;

 
statements regarding expansion of operations, including entrance into new markets and development of products; and

 
statements preceded by, followed by or that include the words “estimate,” “plan,” “project,” “forecast,” “intend,” “expect,” “anticipate,” “believe,” “seek,” “target” or similar expressions.

These forward-looking statements express our best judgment based on currently available information and we believe that the expectations reflected in our forward-looking statements are reasonable.

By their nature, however, forward-looking statements often involve assumptions about the future.  Such assumptions are subject to risks and uncertainties that could cause actual results to differ materially from those described in the forward-looking statements.  As such, we cannot guarantee you that the expectations reflected in our forward-looking statements will actually be achieved.  Actual results may differ materially from those in the forward-looking statements due to, among other things, the following factors:
 
 
changes in general business, economic and market conditions;

 
volatility in the securities markets generally or in the market price of our stock specifically; and

 
the risks outlined in the section entitled “Risk Factors” contained in our Annual Report on Form 10-K for the fiscal year ended December 31, 2014 and this Quarterly Report on Form 10-Q for the three months ended March 31, 2015.

We caution you not to place undue reliance on any forward-looking statements, which speak only as of the date of this Form 10-Q. Except as required by law, we do not undertake any obligation to publicly update or release any revisions to these forward-looking statements to reflect any events or circumstances after the date hereof or to reflect the occurrence of unanticipated events.
 
 
2

 

PART I.   FINANCIAL INFORMATION
 
ITEM 1. FINANCIAL STATEMENTS
PERNIX THERAPEUTICS HOLDINGS, INC.
CONDENSED CONSOLIDATED BALANCE SHEETS
(in thousands, except per share data)
 
   
March 31,
 
December 31,
 
   
2015
 
2014
 
   
(unaudited)
     
ASSETS
         
Current assets:
         
   Cash and cash equivalents
  $ 18,929   $ 34,855  
   Accounts receivable, net
    44,841     44,127  
   Inventory, net
    12,741     11,362  
   Prepaid expenses and other current assets
    9,802     10,346  
   Note receivable, net of unamortized discount of $80 and $127, respectively
    4,770     4,723  
   Prepaid income taxes
    9,175     7,911  
   Deferred income tax assets – current
    16,792     15,933  
Total current assets
    117,050     129,257  
Property and equipment, net
    1,668     1,514  
Other assets:
             
   Goodwill
    44,900     44,900  
   Intangible assets, net
    282,125     300,489  
   Other long-term assets
    10,359     11,253  
Total assets
  $ 456,102   $ 487,413  
LIABILITIES
             
Current liabilities:
             
   Accounts payable and accrued expenses
  $ 25,748   $ 27,569  
   Accrued allowances
    51,737     52,604  
   Interest payable
    4,812     10,159  
   Debt – current
    10,659     7,345  
   Senior secured notes – Treximet – current
    3,884  
 
Total current liabilities
    96,840     97,677  
Long-term liabilities:
             
   Other liabilities
    9,307     11,755  
   Senior convertible notes – long-term
    65,000     65,000  
   Senior secured notes – Treximet – long-term
    216,116     220,000  
   Deferred income taxes
    7,017     9,389  
Total liabilities
    394,280     403,821  
               
Commitments and contingencies  (Notes 11, 12, 13)
             
               
STOCKHOLDERS’ EQUITY
             
   Common stock, $.01 par value, 90,000 shares authorized, 41,439 and  40,805 issued and 38,872 and 38,341 outstanding at March 31,  2015 and December 31, 2014, respectively
    389     383  
   Treasury stock, at cost, 2,566 and 2,464 shares held at March 31, 2015  and December 31, 2014, respectively
    (5,540 )   (5,431 )
   Additional paid-in capital
    131,135     129,128  
   Retained deficit
    (64,162   (40,488
Total stockholders’ equity
    61,822     83,592  
Total liabilities and stockholders’ equity
  $ 456,102   $ 487,413  
 
See accompanying notes to condensed consolidated financial statements.
 
 
3

 

PERNIX THERAPEUTICS HOLDINGS, INC.
CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS
(in thousands, except per share data, unaudited)
 
   
Three Months Ended
March 31,
 
   
2015
   
2014
 
             
Net revenues
  $ 33,889     $ 19,052  
Costs and operating expenses:
               
   Cost of product sales
    11,076       9,956  
   Selling, general and administrative expense
    20,986       13,623  
   Research and development expense
    994       969  
   Loss on sale of PML (including impairment charge)
 
      6,457  
   Depreciation and amortization expense
    18,433       2,191  
   Restructuring costs
    1,305    
 
                 
      Total costs and operating expenses
    52,794       33,196  
                 
Loss from operations
    (18,905 )     (14,144 )
                 
Other income (expense):
               
   Interest income
    56       92  
   Interest expense
    (9,398 )     (1,356 )
      Total other income (expense), net
    (9,342 )     (1,264 )
                 
Loss before income taxes
    (28,247 )     (15,408 )
   Income tax benefit
    (4,573 )     (5,866 )
Net loss
  $ (23,674 )   $ (9,542 )
                 
                 
Net loss per share, basic
  $ (0.62 )   $ (0.26 )
                 
Net loss per share, diluted
  $ (0.62 )   $ (0.26 )
                 
Weighted-average common shares, basic
    38,453       37,271  
                 
Weighted-average common shares, diluted
    38,453       37,271  
 
   See accompanying notes to condensed consolidated financial statements.
 
 
4

 
 
PERNIX THERAPEUTICS HOLDINGS, INC.
CONDENSED CONSOLIDATED STATEMENTS OF CASH FLOWS
(in thousands, unaudited)
 
  
 
Three months ended
 
   
March 31,
 
   
2015
 
2014
 
Cash flows used in operating activities:
         
Net loss
 
$
(23,674)
 
$
(9,542
)
Adjustments to reconcile net loss to net cash used in operating activities:
             
    Depreciation
   
69
   
150
 
    Amortization of intangibles
   
18,364
   
2,041
 
    Amortization of deferred financing costs
   
793
   
313
 
    Interest accretion of notes receivable
   
(48)
   
(86
)
    Deferred income tax benefit
   
(3,231)
   
(6,421
)
    Stock compensation expense
   
1,871
 
1,779
 
    Expense for stock options issued in exchange for services
   
 
119
 
    Loss on sale of PML (including impairment)
   
 
6,457
 
    Changes in operating assets and liabilities (net of effect of acquisitions and dispositions):
             
        Accounts receivable
   
(714)
   
(6,203
)
        Income taxes
   
(1,264)
   
189
 
        Inventory
   
(1,379)
   
1,836
 
        Prepaid expenses and other assets
   
645
   
417
 
        Accounts payable and accrued expenses
   
(3,647)
   
1,774
 
        Accrued allowances
   
(867)
   
4,718
 
        Interest payable
   
(5,347)
   
478
 
        Other liabilities
   
(615)
   
(4,137)
 
    Net cash used in operating activities
   
(19,044)
   
(6,118
)
               
Cash flows used in investing activities:
             
        Purchase of equipment
   
(223)
   
(115
)
     Net cash used in investing activities
   
(223)
   
(115
               
Cash flows provided by financing activities:
             
        Proceeds from issuance of the February 2014 Convertible Notes
 
   
65,000
 
        Net drawdowns (payments) on revolving credit facility
   
3,313
 
(11,812
)
        Payments on financing costs
   
 
(6,201
)
        Payments on mortgages and capital leases
   
(7)
 
(34
)
        Proceeds from issuance of common stock, net of tax
   
152
 
294
 
        Stock issuance costs
   
(8)
   
 
        Tax benefit on stock-based awards
   
   
(131
)
        Payment of employee income tax liability with surrender of employee restricted
         stock
   
(109)
   
(679
)
    Net cash provided by financing activities
   
3,341
   
46,437
 
               
Net increase (decrease) in cash and cash equivalents
   
(15,926)
   
40,204
 
Cash and cash equivalents, beginning of period
   
34,855
   
15,647
 
Cash and cash equivalents, end of period
 
$
18,929
 
$
55,851
 
               
Supplemental disclosure:
             
        Cash paid for income taxes
 
$
67
 
$
497
 
        Interest paid during the period
 
$
13,896
 
$
448
 
Non-cash transactions:
             
        Acquisition of license – contract payable
 
$
 
$
2,500
 
 
See accompanying notes to condensed consolidated financial statements.
 
 
5

 
PERNIX THERAPEUTICS HOLDINGS, INC.
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 targets underserved therapeutic areas, such as the central nervous system (“CNS”), including neurology and psychiatry, and has an interest in expanding into additional specialty segments.  The Company promotes its branded products to physicians through its Pernix sales force, uses contracted sales organizations to market its non-core cough and cold products, 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 Treximet, a medication indicated for the acute treatment of migraine pain and inflammation, Silenor, a non-controlled substance and approved medication for the treatment of insomnia characterized by difficulty with sleep, Cedax, an antibiotic for middle ear infections, and a family of prescription products for cough and cold (Zutripro, Rezira, and Vituz).  The Company also has an exclusive license agreement with Osmotica Pharmaceutical Corp. to promote Khedezla, a prescription medication for major depressive disorder.

             The accompanying unaudited condensed consolidated financial statements have been prepared in accordance with generally accepted accounting principles in the United States (“GAAP”) and following the requirements of the Securities and Exchange Commission (“SEC”) for interim reporting.  As permitted under those rules, certain footnotes and other financial information that are normally required by GAAP can be condensed or omitted.  The information included in this Quarterly Report on Form 10-Q should be read in conjunction with the Company’s consolidated financial statements and notes thereto included in its Annual Report on Form 10-K for the year ended December 31, 2014.
 
In the opinion of management, the accompanying unaudited condensed consolidated financial statements have been prepared on the same basis as the annual consolidated financial statements and include all adjustments, consisting only of normal recurring adjustments, considered necessary for the fair presentation of the Company’s financial position and operating results.  The results for the three months ended March 31, 2015 are not necessarily indicative of the results to be expected for the year ending December 31, 2015, for any other interim period or for any future period.

Acquisition of Treximet

                On August 20, 2014, the Company, through a wholly owned subsidiary Pernix Ireland Limited (“PIL”), completed the acquisition of the U.S. intellectual property rights to the pharmaceutical product, Treximet from GlaxoSmithKline plc and certain of its related affiliates (together “GSK”).

The total purchase price consisted of an upfront cash payment of $250.0 million paid to GSK upon closing of the transaction, and $17.0 million payable to GSK upon receipt of an updated Written Request for pediatric exclusivity from the U.S. Food & Drug Administration (“FDA”), subject to certain deductions based on delays in supplying the commercial product to the Company.  Subsequently, the deductions resulting from delays in supplying the commercial product reduced the $17.0 million payable amount to approximately $1.95 million, which was paid during the fourth quarter of 2014.  The Company funded this acquisition with $220.0 million in debt, plus approximately $32.0 million from available cash.

The results of operations of the acquired Treximet asset, along with the estimated fair values of the assets acquired in the transaction have been included in the Company’s condensed consolidated financial statements since we acquired Treximet on August 20, 2014.
 
 
6

 

Principles of Consolidation
 
The condensed consolidated financial statements include the accounts of Pernix’s wholly-owned subsidiaries Pernix Therapeutics, LLC, GTA GP, Inc., GTA LP, Inc., Gaine, Inc., Macoven, Pernix Manufacturing, LLC, (“PML”) (closed on sale on April 21, 2014), Respicopea, Inc., Cypress, Cypress’ subsidiary, Hawthorn Pharmaceuticals, Inc., Pernix Sleep, Inc., also known as Somaxon Pharmaceuticals, Inc., or Somaxon and Pernix Ireland Limited.  Transactions between and among the Company and its consolidated subsidiaries are eliminated.

Fair Value of Financial Instruments
 
A financial instrument is defined as cash equivalent, evidence of an ownership interest in an entity, or a contract that creates a contractual obligation or right to deliver or receive cash or another financial instrument from another party.  The Company’s financial instruments consist primarily of cash equivalents (including our Regions Trust Account which invests in short-term securities consisting of sweep accounts, money market accounts and money market mutual funds), notes receivable, our credit facility and senior convertible notes.  The carrying values of these assets and liabilities approximate their fair value.

Management’s Estimates and Assumptions

The preparation of consolidated financial statements in conformity with GAAP requires management to make estimates and assumptions that affect the reported amounts of assets and liabilities and disclosure of contingent assets and liabilities at the date of the consolidated financial statements and the reported amounts of revenues and expenses during the period.  Actual results could differ from those estimates.  The Company reviews all significant estimates affecting the consolidated financial statements on a recurring basis and records the effect of any necessary adjustments prior to their issuance.  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.

Significant Customers
 
The Company’s customers consist of drug wholesalers, 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 months ended March 31, 2015 and 2014, or 10% of total accounts receivable as of March 31, 2015 and December 31, 2014.
 
Gross Product Sales:
 
   
Three Months Ended
March 31,
 
   
2015
   
2014
 
McKesson Corporation
   
46
%
   
36
%
AmerisourceBergen Drug Corporation
   
17
%
   
35
%
Cardinal Health, Inc.
   
29
%
   
17
%
Total
   
 92
%
   
88
%
 
Accounts Receivable:
 
   
March 31,
   
December 31,
 
   
2015
   
2014
 
McKesson Corporation
   
46
%
   
29
%
AmerisourceBergen Drug Corporation
   
20
%
   
42
%
Cardinal Health, Inc.
   
27
%
   
18
%
Total
   
 93
%
   
89
%
 
 
7

 

Cost of Product Sales

Cost of product sales is comprised of (i) costs to manufacture or acquire products sold to customers; (ii) royalty, co-promotion and other revenue sharing payments under license and other agreements granting the Company rights to sell related products; (iii) direct and indirect distribution costs incurred in the sale of products; and (iv) the value of any write-offs or donations of obsolete or damaged inventory that cannot be sold.  The Company acquired the rights to sell certain of its commercial products through license and assignment agreements with the original developers or other parties with interests in these products.  These agreements obligate the Company to make payments under varying payment structures based on its net revenue from related products.

In connection with the acquisitions of Cypress and Somaxon, the Company adjusted the predecessor cost basis, increasing inventory to fair value as required by Accounting Standards Codification (“ASC”) 820, Fair Value Measurements and Disclosures .  As a result, the Company recorded adjustments to increase the inventory to fair value in the amount of $8.6 million and $695,000 at the time of acquisition for Cypress and Somaxon, respectively.  For the three months ended March 31, 2015 and 2014, $97,000 and $1.6 million of the increase in the basis of the inventory was amortized and included in cost of product sales, as the inventory was subsequently sold.  The balance remaining of the increase in the basis of the inventory acquired was $0 as of March 31, 2015.

Note 2.  Earnings per Share
 
Earnings per common share is presented under two formats: basic earnings per common share and diluted earnings per common share.  Basic earnings per common share is computed by dividing net income attributable to common shareholders by the weighted average number of common shares outstanding during the period.  Diluted earnings per common share is computed by dividing net income by the weighted average number of common shares outstanding during the period, plus the potentially dilutive impact of common stock equivalents (i.e. restricted stock, stock options, warrants and convertible notes).  Dilutive common share equivalents consist of the incremental common shares issuable upon exercise of stock options. 
 
The following table sets forth the computation of basic and diluted net loss per share (in thousands except per share data):

   
Three Months Ended
March 31,
 
   
2015
   
2014
 
Numerator:
           
Net loss
 
$
(23,674
)
 
$
(9,542
)
Denominator:
               
Weighted-average common shares, basic
   
38,453
     
37,271
 
Dilutive effect of stock options
 
   
 
                 
Weighted-average common shares, diluted
   
38,453
     
37,271
 
                 
Net loss per share, basic and diluted
 
$
(0.62
)
 
$
(0.26
)

During the three months ended March 31, 2015 and 2014, stock options and awards to purchase 4.8 million and 4.1 million shares, respectively, were excluded from the diluted earnings per share calculation because they were anti-dilutive.  See Note 9, Stockholder’s Equity , for additional information.

During the three months ended March 31, 2015 and 2014, warrants to purchase 1.0 million and 469,000 shares, respectively, were excluded from the diluted earnings per share calculation because they were anti-dilutive.  See Note 9, Stockholder’s Equity , for additional information.
 
 
8

 

During the three months ended March 31, 2015 and 2014, the conversion of 18.1 million and 18.1 million shares, respectively, were excluded from the diluted earnings per share calculation because they were anti-dilutive.  See Note 8, Debt and Lines of Credit , for additional information.

As discussed in Note 8, Debt and Lines of Credit , in February 2014, the Company issued $65 million aggregate principal amount of 8.00% Convertible Senior Notes due 2019 (the “February 2014 Convertible Notes”) pursuant to Regulation D and Section 4(2) under the Securities Act.  Upon conversion, the February 2014 Convertible Notes may be settled in shares of the Company’s common stock.  For purposes of calculating the maximum dilutive impact, it is presumed that the February 2014 Convertible Notes will be settled in common stock with the resulting potential common shares included in diluted earnings per share if the effect is more dilutive.  The effect of the conversion of the February 2014 Convertible Notes is excluded from the calculation of diluted loss per share because the net loss for the three months ended March 31, 2015 and 2014 causes such securities to be anti-dilutive.  The potential dilutive effect of these securities is shown in the chart below (in thousands):
 
    Three Months Ended March 31,  
   
2015
   
2014
 
Conversion of the February 2014 Convertible Notes
    18,056       18,056  
Frontline warrants
    241    
 
Pozen warrants
    226    
 
Somaxon warrants
    55    
 
Total potential dilutive effect of warrants
    18,578       18,056  

Note 3.
Fair Value Measurement

Fair value is defined as the exchange price that would be received for an asset or paid to transfer a liability (an exit price) in the principal or most advantageous market for the asset or liability in an orderly transaction between market participants on the measurement date.  The fair value hierarchy is based on three levels of inputs, of which the first two are considered observable and the last unobservable, that may be used to measure fair value as follows:
 
Level 1 
Quoted prices in active markets for identical assets or liabilities as of the reporting date.
   
Level 2
Inputs other than level 1 that are observable, either directly or indirectly, such as quoted prices for similar assets or liabilities; quoted prices in markets that are not active; or other inputs that are observable or can be corroborated by observable market data for substantially the full term of the assets or liabilities as of the reporting date.
   
Level 3
Unobservable inputs that are supported by little or no market activity and that are significant to the fair value of the assets or liabilities.
 
            The following tables summarize the Company’s fair value hierarchy for its financial assets and liabilities measured at fair value on a recurring basis as of March 31, 2015 and December 31, 2014 (in thousands):
 
    March 31, 2015  
Assets
  Level 1     Level 2     Level 3     Total  
   Money market fund and trust cash sweep investments (1)
  $ $17,203     $     $     $ 17,203  
Total Assets
  $ $17,203     $     $     $ 17,203  
 
    December 31, 2014  
Assets
  Level 1     Level 2     Level 3    
Total
 
   Money market fund and trust cash sweep investments (1)
  $ 26,297     $     $     $ 26,297  
Total Assets
  $ 26,297     $     $     $ 26,297  

(1)
The Company’s money market and trust cash sweep investments are included in cash and cash equivalents within the Condensed Consolidated Balance Sheet.
   
 
 
9

 
 
             The Company believes the carrying amount of its debt, notes payable and contracts payable, are a reasonable estimate of their fair value due to the short remaining maturity of these items and/or their fluctuating interest rates.  There were no transfers between levels of the fair value hierarchy in 2015 or 2014.
 
Note 4.
Inventory

Inventories consist of the following (in thousands):
 
   
March 31,
2015
   
December 31,
2014
 
Raw materials
 
$
3,065
   
$
417
 
Packaging materials
   
61
     
82
 
Samples
   
2,262
     
883
 
Finished goods
   
9,648
     
12,200
 
Inventory, gross
   
15,036
     
13,582
 
Reserve for obsolescence
   
(2,295)
     
(2,220
)
    I   Inventory, net
 
$
12,741
   
$
11,362
 

An increase in the basis of inventory related to the acquisitions of Cypress and Somaxon are included in the balances above as of March 31, 2015 and December 31, 2014.  The increase included in raw materials was $0 and $97,000 as of March 31, 2015 and December 31, 2014, respectively.
 
Note 5.
Disposal of PML

On March 31, 2014, the Company entered into a definitive agreement to divest its manufacturing operations, PML, to Woodfield Pharmaceutical LLC.  Accordingly, during the three months ended March 31, 2014, the Company adjusted PML’s net assets to fair value and, as a result, recorded the assets as held for sale, net of an impairment charge of approximately $6.5 million.  The Company closed on the sale of PML on April 21, 2014.  The Company received approximately $1.2 million in proceeds, net of the assumed mortgage and working capital liabilities at closing.  The entire PML operation and the mortgage was assumed by the acquirer.  The Company recorded an additional loss on the sale of approximately $202,000 at closing.  The Company does not believe the disposal of PML qualifies as discontinued operations as the manufacturing facility was not a major line of business and was not a significant component of the Company’s financial results during our period of ownership.


Note 6.
Intangible Assets and Goodwill
 
Intangible assets consist of the following (in thousands, except years):
     
As of March 31, 2015
 
 
Weighted
Average Life
 
Gross Carrying Amount
   
Accumulated Amortization
   
Net Carrying
Amount
 
Unamortized intangible assets:
                   
    Trademark rights
Indefinite
  $ 400     $
    $ 400  
    In-process research and development
Indefinite
    48,300    
      48,300  
Total unamortized intangible assets
      48,700    
      48,700  
                         
Amortized intangible assets:
                       
    Patents 
11.0 years
    500       (366 )     134  
    Brand
8.0 years
    3,887       (2,429 )     1,458  
    Product licenses
11.0 years
    17,581       (4,483 )     13,098  
    Non-compete and supplier contracts
5.3 years
    5,194       (4,490 )     704  
    Acquired developed technologies
4.4 years
    269,826       (51,795 )     218,031  
Total amortized intangible assets
      296,988       (63,563 )     233,425  
                           
Total intangible assets
    $ 345,688     $ (63,563 )   $ 282,125  
 
 
10

 
 
     
As of December 31, 2014
 
 
Weighted
Average Life
 
Gross Carrying Amount
   
Accumulated Amortization
   
Net Carrying
Amount
 
Unamortized intangible assets:
                   
    Trademark rights
Indefinite
  $ 400     $
    $ 400  
    In-process research and development
Indefinite
    48,300    
      48,300  
Total unamortized intangible assets
      48,700    
      48,700  
                         
Amortized intangible assets:
                       
    Patents 
11.0 years
    500       (355 )     145  
    Brand
8.0 years
    3,887       (2,308 )     1,579  
    Product licenses
11.0 years
    17,581       (4,058 )     13,523  
    Non-compete and supplier contracts
5.3 years
    5,194       (4,342 )     852  
    Acquired developed technologies
4.4 years
    269,826       (34,136 )     235,690  
Total amortized intangible assets
      296,988       (45,199 )     251,789  
                           
Total intangible assets
    $ 345,688     $ (45,199 )   $ 300,489  
 
As of March 31, 2015, the weighted average life for our definite-lived intangible assets in total was approximately 4.86 years.

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
 
         
2015 (April – December)
 
$
55,353
 
2016
   
72,864
 
2017
   
71,198
 
2018
   
12,887
 
2019
   
4,347
 
Thereafter
   
16,776
 
Total
 
$
233,425
 
 
Amortization expense was $18.4 million and $2.0 million for the three months ended March 31, 2015 and 2014, respectively.
 
Note 7.
Accrued Allowances
 
Accrued allowances consist of the following (in thousands):
 
   
March 31,
   
December 31,
 
   
2015
   
2014
 
Accrued returns allowance
 
$
11,315
   
$
9,691
 
Accrued price adjustments
   
35,438
     
32,945
 
Accrued government program rebates
   
4,984
     
9,968
 
Total
 
$
51,737
   
$
52,604
 
 
 
11

 


Note 8.
Debt and Lines of Credit
 
Debt consists of the following (in thousands):
 
   
March 31, 2015
   
December 31,
2014
 
Amounts outstanding under the Midcap Credit Facility
 
$
10,659
   
$
7,345
 
Senior secured notes (the “Treximet Notes”)
   
220,000
     
220,000
 
February 2014 Convertible Notes
   
65,000
     
65,000
 
        Total debt
 
$
295,659
   
$
292,345
 
                 
        Debt – current
 
$
14,543
   
$
7,345
 
        Debt – long term
 
$
281,116
   
$
285,000
 

Credit Facility – MidCap Funding V, LLC

On February 21, 2014, in connection with the February 2014 Convertible Notes offering discussed below, the Company entered into Amendment No. 1 to the Amended and Restated Credit Agreement (the “Amendment” and together with the Amended and Restated Credit Agreement, as amended by the Amendment, the “Amended Credit Agreement”) with MidCap Funding IV, LLC, as Agent and as a lender (“MidCap”), and the other lenders from time to time parties thereto.  In addition to allowing for the note issuance, the Amendment provides for the addition of a $20.0 million uncommitted accordion feature to the lenders’ existing $20.0 million revolving loan commitment.  Pursuant to the Amendment, MidCap and the other lenders released their liens on certain Company assets.  The obligations under the Amended Credit Agreement are secured by a first priority security interest in the Company’s accounts, inventory, deposit accounts, securities accounts, securities entitlements, permits and cash.  On April 23, 2014, the Company entered into Amendment No. 2 to the Amended and Restated Credit Agreement with MidCap to increase the letter of credit sublimit from $0 to $750,000.  On August 19, 2014 the Company, MidCap, and certain subsidiaries of the Company entered into Amendment No. 3 to the Amended and Restated Credit Agreement dated as of May 8, 2013 to permit the Company to consummate the purchase of the Treximet assets from GSK.

  The covenants contained in the Amended Credit Agreement required the Company to maintain a minimum amount of earnings before interest, tax, depreciation and amortization (“EBITDA”) and net invoiced revenues unless the Company demonstrated minimum liquidity of at least $30.0 million through June 30, 2014.  This was revised and not required with Amendment No. 3.  Beginning with the calendar month ending March 31, 2015, the Company is required to meet a minimum fixed charge coverage ratio (“FCCR”).  The FCCR test of 1.0x beginning on the calendar month ending March 31, 2015 is based on the trailing three months ending March 31, 2015.  The Defined Period for the FCCR test of 1.0x will then build monthly until it reaches a trailing twelve month Defined Period beginning on December 31, 2015 through maturity.  The Amended Credit Agreement also continues to include customary covenants for a secured credit facility, which include, among other things, (a) restrictions on (i) the incurrence of indebtedness, (ii) the creation of or existence of liens, (iii) the incurrence or existence of contingent obligations, (iv) making certain dividends or other distributions, (v) certain consolidations, mergers or sales of assets and (vi) purchases of assets, investments and acquisitions; and (b) requirements to deliver financial statements, reports and notices to the agent and the other lenders, provided that, the restrictions described in (a)(i)-(vi) above are subject to certain exceptions and permissions limited in scope and dollar value. The Amended Credit Agreement also contains customary representations and warranties and event of default provisions for a secured credit facility.

The loans under this facility bear interest at a rate equal to the sum of the LIBOR (with a floor of 1.5%) plus an applicable margin of 7.50% per annum (9% at March 31, 2015).  The expiration date of the agreement has been extended to February 21, 2017.  Amounts outstanding under this agreement are recorded on the balance sheet as current debt as of March 31, 2015 and December 31, 2014.
 
 
12

 
 
 February 2014 Convertible Note Offering

On February 21, 2014, the Company issued $65.0 million aggregate principal amount 8% Convertible Senior Notes.  The February 2014 Convertible Notes mature on February 15, 2019, unless earlier converted.  The Company received net proceeds from the sale of the February 2014 Convertible Notes of $58.8 million, after deducting underwriting discounts and commissions and offering expenses payable by the Company.  Interest on the February 2014 Convertible Notes is payable on March 15, June 15, September 15 and December 15 of each year, beginning June 15, 2014.  The note balance of $65.0 million is recorded as long-term debt on the balance sheet as of March 31, 2015.

The February 2014 Convertible Notes are governed by the terms of an indenture (the “February 2014 Indenture”), between the Company and Wilmington Trust, National Association (the “February 2014 Trustee”), each of which were entered into on February 21, 2014.

The February 2014 Convertible Notes are senior unsecured obligations and are: senior in right of payment to the Company’s future indebtedness that is expressly subordinated in right of payment to the February 2014 Convertible Notes; equal in right of payment to the Company’s existing and future unsecured indebtedness that is not so subordinated; effectively junior to any of the Company’s secured indebtedness to the extent of the value of the assets securing such indebtedness; and structurally junior to all existing and future indebtedness (including trade payables) incurred by the Company’s subsidiaries.

The Company may not redeem the February 2014 Convertible Notes prior to the maturity date (February 15, 2019).  However, the holders may convert their February 2014 Convertible Notes at any time prior to the close of business on the business day immediately preceding February 15, 2019.  Upon conversion, the Company will deliver a number of shares of the Company’s common stock equal to the conversion rate in effect on the conversion date.  The initial conversion rate will be 277.7778 shares of the Company’s common stock for each $1,000 principal amount of the February 2014 Convertible Notes, which represents an initial conversion price of approximately $3.60 per share.  Following certain corporate transactions that can occur on or prior to the stated maturity date, the Company will increase the conversion rate for a holder that elects to convert its February 2014 Convertible Notes in connection with such a corporate transaction.

As the Company was not required to separate the conversion option in the February 2014 Convertible Notes under ASC 815, Derivatives and Hedging , it considered whether the cash conversion guidance contained in ASC 470-20, Debt with Conversion and Other Options , is applicable to the February 2014 Convertible Notes.  However, as the conversion option may not be settled in cash upon the Company’s election, the Company concluded that the cash conversion guidance is not applicable to the February 2014 Convertible Notes, and the Company therefore recorded the entire proceeds of the February 2014 Convertible Notes as a liability, without allocating any portion to equity.

Because the conversion option is not bifurcated as a derivative pursuant to ASC 815 and is not separately accounted for under the cash conversion guidance, the Company further evaluated the conversion option to determine whether it is considered a beneficial conversion option at inception.  The Company determined the effective conversion price at issuance to be $3.60 per share.  Because the fair value of the common stock at the close of trading on the date of issuance was $3.08, no beneficial conversion feature existed at the issuance date.

For the three months ended March 31, 2015, total interest expense related to the outstanding principal balance of the February 2014 Convertible Notes was $1.3 million and $0 for 2014 at the stated interest rate of 8.0% per annum.  As of March 31, 2015, the Company had outstanding borrowings of $65.0 million related to the February 2014 Convertible Notes.  The Company has $5.4 million in deferred financing costs related to the February 2014 Convertible Notes as of March 31, 2015.  This is recorded on the balance sheet in Prepaid and Other Current Assets ($1.4 million) and Other Long-Term Assets ($4.0 million).
 
 
13

 

Treximet Note Offering

On August 19, 2014, the Company issued $220.0 million aggregate principal amount of its 12% Senior Secured Notes due 2020 (the “Treximet Notes”) pursuant to an Indenture (the “August 2014 Indenture”) dated as of August 19, 2014 among the Company, certain of its subsidiaries (the “Guarantors”) and U.S. Bank National Association (the “August 2014 Trustee”), as trustee and collateral agent.

The Treximet 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 will pay an installment of principal of the Treximet 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 Notes on such Payment Date).

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

The Company may redeem the Treximet Notes at its option, in whole at any time or in part from time to time, on any business day, on not less than 30 days’ nor more than 60 days prior notice provided to each holder’s registered address.  If such redemption is prior to August 1, 2015, the redemption price is equal to the greater of (i) the principal amount of the Treximet Notes being redeemed and (ii) the present value, discounted at the applicable treasury rate of the principal amount of the Treximet Notes being redeemed plus 1.00%, of such principal payment amounts and interest at the rate per annum shown above on the outstanding principal balance of the Treximet Notes being redeemed assuming the principal balances are amortized at the times and in the assumed amounts set forth on Schedule A to the August 2014 Indenture. If such redemption occurs (i) on or after August 1, 2015 and prior to August 1, 2016, the redemption price will equal 106% of the outstanding principal amount of August Notes being redeemed plus accrued and unpaid interest thereon, (ii) on or after August 1, 2016 and prior to August 1, 2017, the redemption price will equal 103% of the outstanding principal amount of the August Notes being redeemed plus accrued and unpaid interest thereon and (iii) on or after August 1, 2017, the redemption price will equal 100% of the outstanding principal amount of the Treximet Notes being redeemed plus accrued and unpaid interest thereon.

The August 2014 Indenture contains covenants that limit the ability of the Company and the Guarantors to, among other things: incur certain additional indebtedness; pay dividends on, redeem or repurchase stock or make other distributions in respect of its capital stock; repurchase, prepay or redeem certain indebtedness; make certain investments; create restrictions on the ability of the Guarantors to pay dividends to the Company or make other intercompany transfers; create liens; transfer or sell assets; consolidate, merge or sell or otherwise dispose of all or substantially all of its assets and enter into certain transactions with affiliates. Upon the occurrence of certain events constituting a change of control, the Company is required to make an offer to repurchase all of the Treximet Notes (unless otherwise redeemed) at a purchase price equal to 101% of their principal amount, plus accrued and unpaid interest, if any to the repurchase date.

The August 2014 Indenture provides that an Event of Default (as defined in the August 2014 Indenture) will occur if, among other things, (a) the Company defaults in any payment of interest on any note when due and payable, and such default continues for a period of 30 days; (b) the Company defaults in the payment of principal of or premium, if any, on any note when due and payable on the maturity date, upon declaration of acceleration or otherwise, or to pay the change of control repurchase price, when due and payable, and such default continues for a period of five days; (c) failure to make a repurchase offer in the event of a change in control when required under the August 2014 Indenture, which continues for three business days; (d) the Company or any Guarantor fails to comply with certain covenants after receiving written notice from the August 2014 Trustee or the holders of more than 25% of the principal amount of the outstanding Treximet Notes; (e) the Company or any Guarantor defaults with respect to other indebtedness for borrowed money in excess of $8.0 million and such default is not cured within 30 days after written notice from the August 2014 Trustee or the holders of more than 25% of the principal amount of the outstanding Treximet Notes; (f) the Company or any Guarantor has rendered against it a final judgment for the payment of $8.0 million (or its foreign currency equivalent) or more (excluding any amounts covered by insurance) under certain circumstances; (g) certain bankruptcy, insolvency, liquidation, reorganization or similar events occur with respect to the Company or any Guarantor; (h) a guarantee of the Treximet Notes (with certain exceptions) is held to be unenforceable or invalid in a judicial proceeding or ceases to be in full force and effect or a Guarantor disaffirms its obligations under its guarantee of the Treximet Notes; and (i) certain changes in control of a Guarantor.
 
 
14

 

On August 19, 2014, the Company entered into the First Supplemental Indenture to the February 2014 Indenture for the Company’s February 2014 Convertible Notes due 2019 (the “First Supplemental Indenture”) to permit the Company to consummate the purchase of the Treximet assets from GSK and to issue the Treximet Notes.  On August 19, 2014, the Company also entered into the Second Supplemental Indenture to the February 2014 Indenture for the Company’s February 2014 Convertible Notes due 2019 (the “Second Supplemental Indenture”) to add PIL, a wholly owned subsidiary of the Company, as a guarantor.

For the three months ended March 31, 2015 and 2014, total interest expense related to the outstanding principal balance of the Treximet Notes was $6.6 million and $0, respectively, at the stated interest rate of 8.0% per annum, respectively.  As of March 31, 2015, the Company had outstanding borrowings of $220.0 million related to the Treximet Notes, of which $3.9 million is classified as short term and $216.1 million is classified as long term.  The Company has $7.0 million in deferred financing costs related to the Treximet notes as of March 31, 2015.  This is recorded on the balance sheet in Prepaid and Other Current Assets ($1.3 million) and Other Long-Term Assets ($5.7 million).

The following table represents the future maturity schedule of the outstanding debt and line of credit:

As of March 31, 2015 (amounts in thousands)
     
2015 (line of credit and current portion of Treximet Notes)
  $ 14,543  
2016
 
 
2017
 
 
2018
 
 
2019  
65,000
 
Thereafter
   
  216,116
 
Total maturities
  $ 295,659  
 
Note 9.
Stockholders’ Equity
 
Warrants

In March 2015, Pozen exercised all 500,000 of their warrants in a cashless exercise for which 315,835 shares were issued.  In February 2015, Frontline exercised 222,631 of their 500,000 warrants in a cashless exercise for which 133,257 shares were issued.  There are 277,369 warrants remaining for Frontline.  As of March 31, 2015, the Company assumed approximately 464,564 outstanding warrants in connection with the acquisition of Somaxon in March 2013.
 
  Stock Option Plans

The Company’s 2009 Stock Incentive Plan (the “2009 Plan”) was approved concurrent with its merger with Golf Trust of America (“GTA”), Inc. on March 9, 2010 and subsequently amended.  The maximum number of shares that can be offered under this plan, as amended, is 7.75 million.  Incentives may be granted under the 2009 Plan to eligible participants in the form of (a) incentive stock options, (b) non-qualified stock options, (c) restricted stock, (d) restricted stock units, (e) stock appreciation rights and (f) other stock-based awards.  Incentive grants under the 2009 Plan generally vest based on four years of continuous service and have 10-year contractual terms.

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.
 
 
15

 
 
The Company currently uses the Black-Scholes option pricing model to determine the fair value of its stock options.  The determination of the fair value of stock-based payment awards on the date of grant using an option pricing model is affected by the Company’s stock price, as well as assumptions regarding a number of complex and subjective variables.  These variables include the Company’s expected stock price volatility over the term of the awards, actual employee exercise behaviors, risk-free interest rate and expected dividends.
 
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 March 31,
 
   
2015
   
2014
 
Weighted average expected stock price volatility
    73.7 %     74.0 %
Estimated dividend yield
    0.0 %     0.0 %
Risk-free interest rate
    1.6 %     1.8 %
Expected life of option (in years)
    6.3       6.1  
Weighted average grant date fair value per option
  $ 6.76     $ 2.60  

The expected stock price volatility for the stock options is based on historical volatility of the Company’s stock.  The Company has not paid and does not anticipate paying cash dividends; therefore, the expected dividend rate is assumed to be 0%.  The risk-free rate was based on the U.S. Treasury yield curve in effect at the time of grant commensurate with the expected life assumption.  The expected life of the stock options granted was estimated based on the historical exercise patterns over the option lives.  
 
Stock-based compensation expense was $1.9 million and $1.8 million for the three months ended March 31, 2015 and 2014, respectively.  Stock-based compensation expense for the periods presented are included within the selling, general and administrative expenses line of the unaudited condensed consolidated statements of operations.

Stock Options
 
As of March 31, 2015, approximately 4.7 million options are outstanding that have been issued to current officers and employees under the Company’s 2007 Stock Option Plan and the 2009 Plan.  As of March 31, 2015, there was approximately $10.9 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 3.3 years.

 
The following table shows the option activity, described above, during the three months ended March 31, 2015 (share and intrinsic values in thousands):
 
   
 
 
 
Shares
 
Average Exercise Price
 
Weighted Average Remaining Contractual Life Years
 
 
Aggregate Intrinsic Value
 
Options outstanding at December 31, 2014
  4,551   $ 5.35          
  Granted
  297     10.23          
  Exercised
  (39 )   3.92       $ 211  
  Cancelled
  (91 )   7.43            
  Expired
 
 
           
Options outstanding at March 31, 2015
  4,718   $ 5.63   9.0   $ 23,960  
Options vested and expected to vest as of March 31, 2015
  3,936   $ 5.57   8.9   $ 20,204  
Options vested and exercisable as of March 31, 2015
  680   $ 4.45   7.8   $ 4,248  
 
 
16

 

The total intrinsic value of options exercised during the three months ended March 31, 2015 and 2014 were $211,000 and $142,000, respectively. 
 
     Restricted Stock

The following table shows the Company's non-vested restricted stock activity during the three months ended March 31, 2015 (share and intrinsic values in thousands):

   
Shares
 
Weighted Average Grant Date Fair Value
 
Aggregate Intrinsic Value
 
Non-vested restricted stock outstanding at December 31, 2014
    140   $ 4.52      
  Granted
 
 
     
  Vested
    (56 )   6.09   $ 539  
  Forfeited
    (19 )   3.09        
Non-vested restricted stock outstanding at March 31, 2015
    65   $ 3.58        
 
As of March 31, 2015, there was approximately $10,000 of 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 0.7 years.

Note 10.
Income Taxes
 
The Company’s income tax benefit was $4.6 million and $5.9 million for the three months ended March 31, 2015 and 2014, respectively.  The Company’s effective tax rate was 16.2% for the three months ended March 31, 2015, compared to an effective tax rate of 38.1% for the three months ended March 31, 2014.  The change in the tax rate for the quarter ended March 31, 2015 was primarily due to a new mix of jurisdictional earnings resulting from recent merger and acquisition activity.

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.

Our deferred tax assets are comprised primarily of U.S. federal net operating losses and accruals.  A substantial portion of the deferred tax liability at March 31, 2015 relates to the difference between the financial statement and tax basis of the intangibles acquired in the Cypress acquisition.  The deferred tax liability related to these Cypress intangibles is reduced on an annual basis by the financial statement amortization of such intangibles.
     
Note 11.
Commitments and Contingencies
 
Legal Proceedings

The Company is subject to various claims and litigation arising in the ordinary course of business.  In the opinion of management, the outcome of such matters will not have a material effect on the Company’s financial position or results of operations.

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 March 31, 2015, remaining payment obligations owed to Somaxon under these settlement agreements are $2.3 million, payable in equal annual installments of $250,000 through 2019, and equal installments of $500,000 through 2017.

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.
 
 
17

 

In connection with the acquisition of Treximet, the Company is responsible for the payment of royalties to Pozen of 18% of net sales with quarterly minimum royalty amounts of $4.0 million for the calendar quarters commencing on January 1, 2015 and ending on March 31, 2018.

GSK has claimed that the Company owes GSK damages relating to an alleged breach by the Company of a covenant contained in the Asset Purchase and Sale Agreement dated as of May 13, 2014 by and among GSK and its affiliates and the Company pertaining to a pre-existing customer agreement.  The Company and GSK are currently negotiating the terms of an interim settlement agreement pursuant to which the parties will submit the disputed matters to arbitration and the Company will make certain payments to GSK and escrow additional funds in advance of resolution of the disputed matters in such arbitration.  The Company made a payment of approximately $3.0 million to GSK and intends to deposit an additional approximately $1.8 million into an escrow account on account of the settlement of disputed amounts relating to calendar year 2014 and made a payment of approximately $573,000 and intends to escrow an additional approximately $344,000 related to January and February 2015.  The amounts paid by the Company to GSK and escrowed represent approximately 57% of the amounts GSK claims are owed to them as a result of the Company’s alleged breach.  As it relates to these amounts, the Company had accrued $3.5 million at December 31, 2014 in connection with this dispute and recorded an additional $1.3 million during the three months ended March 31, 2015 related to GSK’s 2014 claims.  The amounts paid and to be escrowed by the Company for 2015 GSK claims are consistent the amounts accrued by the Company for managed care rebates and fees during the three months ended March 31, 2015.  While the Company intends to vigorously contest GSK's allegations that its damages are a result of the Company’s breach and that they are compensable under the Asset Purchase and Sale Agreement or otherwise, any material liability resulting from this claim could negatively impact the Company’s financial results.

Note 12.                         Restructuring

On March 16, 2015, the Company decided to institute an initiative to restructure operations and shut down the Charleston, South Carolina site.  This step is being done in order to consolidate operations within the Company’s headquarters located in Morristown, New Jersey.

The charge related to this restructuring during the three months ended March 31, 2015 was $1.3 million.  The charge during the three months ended March 31, 2015 was comprised of $649,000 in severance related cash expenses, and $656,000 for the modification and accelerated vesting of options and awards under existing employee agreements.  Associated severance payments are anticipated to be paid by December 31, 2015.

A summary of accrued restructuring costs, included as a component of accounts payable and accrued expenses on the condensed consolidated balance sheet, is as follows (in thousands):
 
December 31, 2014
 
Charges
 
Cash
 
Non-cash
   
March 31, 2015
 
$ -   $ 1,305   $ -   $ -     $ 1,305  

Note 13.
Subsequent Events

Resignation of Executive Officer.   On April 6, 2015, the Company’s Vice President of Accounting/ Principal Accounting Officer/Secretary resigned on good terms with the Company with an effective date of May 31, 2015 in connection with the closure of the Charleston, South Carolina site.  The Company has agreed to pay severance in connection with this resignation equivalent to one year of normal salary, less applicable deductions and withholdings on normal Company pay days and shall also pay one year of the monthly car allowance and will continue to pay the Company’s current premium contribution for this individual and her dependents if COBRA is elected, in exchange for reasonable assistance with the transition of the duties of this position during the severance period.  Additionally, fully vested stock options of this individual on her termination date will not be cancelled and will retain their original expiration date.  With respect to the unvested balance of 75,000 restricted stock units that this individual received on February 11, 2014, restrictions on 18,750 units shall lapse on February 11, 2016 and restrictions on 37,500 units shall lapse on the Severance End Date of May 31, 2016 and the balance of 18,750 units were cancelled.  With respect to the unvested balance of 6,667 restricted stock units that this individual received on December 7, 2012, restrictions on these units shall lapse on December 7, 2015.  The financial impact of these transactions have been accrued as of March 31, 2015.
 
 
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An individual has been hired as of April 6, 2015 to assume the positions of Vice President, Corporate Controller and Principal Accounting Officer effective as of May 31, 2015.

Inducement Agreement .  On April 16, 2015, the Company entered into an agreement (the “Inducement Agreement”) with all of the holders of its February 2014 Convertible Notes representing $65 million aggregate principal amount of the February 2014 Convertible Notes, pursuant to which such holders agreed to the removal of substantially all of the material restrictive covenants in the indenture governing the February 2014 Convertible Notes and to convert their notes in accordance with the provisions of such indenture in exchange for an aggregate of 2,338,129 shares of the Company’s common stock (the “Inducement Shares”), such Inducement Shares being in addition to the 18,055,556 shares of common stock underlying the February 2014 Convertible Notes which the Company shall issue upon conversion.  The issuance of the Inducement Shares will be made pursuant to an exemption from the registration requirements of the Securities Act contained in Section 4(a)(2).  Each of the holders entering into the Inducement Agreement agreed not to sell the shares of our common stock to be issued to it upon conversion of the February 2014 Convertible Notes for 145 days (the "lock-up period") subject to exceptions, including in connection with settling existing short positions with respect to the February 2014 Convertible Notes and underwritten public offerings pursuant to existing registration rights with respect to such shares of our common stock.  In addition, such holders are permitted to dispose of up to 80 percent of such shares of our common stock remaining after settling existing short positions prior to the end of the lock-up period in specified intervals.

$130 million 4.25% Convertible Senior Notes Due 2021.   On April 17, 2015, the Company announced the pricing of the private offering of $130 million of 4.25% Convertible Senior Notes due 2021.  The notes will pay interest semi-annually at a rate of 4.25% per annum and will mature on April 1, 2021, unless redeemed, repurchased or converted in accordance with their terms prior to such date.  The notes will have an initial conversion rate, subject to adjustment, of 87.2030 shares of the Company’s common stock per $1,000 principal amount of the notes, representing a conversion price of approximately $11.47 per share of the Company’s common stock, based on the last reported sale price of $8.34 per share of the Company’s common stock on April 16, 2015.  The gross proceeds from the offering will be $130 million.  The Company used approximately $80.9 million of the gross proceeds from the offering to finance the cash consideration portion of the consideration necessary to consummate its previously announced acquisition of the Zohydro® ER franchise, and expects to use approximately $8.3 million to pay fees and expenses related to such acquisition and the offering, up to $2.2 million to pay the consent fee related to the Company’s previously announced consent solicitation of its 12.00% senior secured notes due 2020 and the remainder for working capital and other general corporate purposes, including to fund possible acquisitions of, or investments in, complementary businesses, products, services and technologies.

Zohydro ER Acquisition.  On April 24, 2015, the Company, through its wholly-owned subsidiary, Ferrimill, Limited (“Ferrimill”), an Irish corporation, completed its previously announced acquisition of the Zohydro® ER (hydrocodone bitartrate) franchise from Zogenix Inc., comprising three extended release hydrocodone products, including an abuse-deterrent pipeline and all related intellectual property.  Under the terms of the Asset purchase Agreement, as amended (the “Asset Purchase Agreement”), Ferrimill (a) paid Zogenix $70 million in cash; (b) transferred 1,682,086 shares of Company common stock (with an approximate value of $20 million based on the $11.89 per share closing price of the Company’s common stock on March 9, 2015, the trading day immediately preceding the execution date of the Asset Purchase Agreement) to Zogenix (the “Stock Consideration”); and (c) deposited an additional $10 million in escrow to fund potential indemnification claims for a period of 12 months following the Closing Date.

In addition to the consideration paid at Closing, Zogenix is eligible to receive additional cash payments of up to $283.5 million based on the achievement of pre-determined milestones, including a $12.5 million payment upon approval by the U.S. Food and Drug Administration of a third generation product currently in development in collaboration with Altus Formulation Inc. and up to $271 million in potential sales milestones.  Under the terms of the Asset Purchase Agreement, over 80% of the value of the sales milestones is tied to the achievement of net sales targets ranging from $500 million to $1 billion, and Ferrimill has agreed to use Commercially Reasonable Efforts (as defined in the Asset Purchase Agreement) to meet such milestones.  Following the Closing Date, Ferrimill will assume responsibility for Zogenix’s obligations under the purchased contracts and regulatory approvals, as well as other liabilities associated with the Zohydro ER business arising after the Closing Date, and Zogenix will retain all liabilities associated with the Zohydro ER business arising prior to the Closing Date.
 
 
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In connection with the acquisition of the Zohydro ER franchise, the Company will seek to hire certain employees of Zogenix, including the field sales force of approximately 100 sales professionals and additional personnel related to the Zohydro ER business.

Note 14.
Recent Accounting Pronouncements
 
In May 2014, the FASB issued ASU 2014-09, Revenue from Contracts with Customers.   ASU 2014-09 will eliminate transaction- and industry-specific revenue recognition guidance under current GAAP and replace it with a principle-based approach for determining revenue recognition.  ASU 2014-09 will require that companies recognize revenue based on the value of transferred goods or services as they occur in the contract.  The ASU also will require additional disclosure about the nature, amount, timing and uncertainty of revenue and cash flows arising from customer contracts, including significant judgments and   changes in judgments and assets recognized from costs incurred to obtain or fulfill a contract.  ASU 2014-09 is effective for annual reporting periods beginning after December 15, 2016.  Early application is not permitted.  Entities can transition to the standard either retrospectively or as a cumulative-effect adjustment as of the date of adoption.  The Company is currently evaluating the effect of the new revenue recognition guidance.

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, 2014.  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, 2014 and “Part II—Item1A.  Risk Factors” of this Quarterly Report on Form 10-Q for the three months ended March 31, 2015.

The discussion below contains forward-looking statements within the meaning of Section 21E of the Securities Exchange Act of 1934, as amended, or the Exchange Act.  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,” ”anticipate,” “expect” 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: 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 continue to successfully recruit and retain sales and marketing personnel in the U.S.; our ability to obtain additional financing; our ability to maintain regulatory approvals for our products; 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; the success and timing of our clinical development efforts; the loss of key scientific or management personnel; regulatory developments in the U.S. and foreign countries; our ability to either acquire or develop and commercialize other product candidates in addition to our current products 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, 2014 and “Part II—Item1A.  Risk Factors” of this Quarterly Report on Form 10-Q for the three months ended March 31, 2015.
 
 
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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.  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;
Acquiring additional marketed specialty products or products close to regulatory approval to leverage our existing expertise and infrastructure; and
Pursuing targeted development of a pipeline of post-discovery specialty product candidates.
 
We target underserved segments, such as central nervous system (CNS) indications, including neurology and psychiatry, as well as other specialty therapeutic areas.  We promote our core branded products to physicians through our sales force.  We promote our non-core branded products, such as our cough and cold products, through contracted sales organizations, and we market our generic products through our wholly owned subsidiaries, Macoven and Cypress.

Our branded products include Treximet, a medication indicated for the acute treatment of migraine attacks, with or without aura, in adults, Silenor, a non-controlled substance and approved medication indicated for the treatment of insomnia characterized by difficulty with sleep maintenance, Cedax, an antibiotic for middle ear infections, and a family of prescription treatments for cough and cold (Zutripro, Rezira, and Vituz).  During the third quarter of 2014, we engaged a contract sales team to promote Cedax and entered into an agreement with a third party to promote Zutripro, Rezira, and Vituz.  The term of these agreements cover the cough and cold season and terminated on March 31, 2015.  We also promote Khedezla, for major depressive disorder through an exclusive license agreement with Osmotica Pharmaceutical Corp.  See Part I, Item 1 – Business included in our Annual Report on Form 10-K for additional information regarding our products and product candidates.

Quarterly Update

During March 2015, through our wholly-owned subsidiary Ferrimill, we entered into an asset purchase agreement, with Zogenix, Inc. (“Zogenix”) pursuant to which we will acquire certain assets related to the product Zohydro ER from Zogenix, including, among other things, the registered patents and trademarks, certain contracts, the new drug application and other regulatory approvals, documentation, and authorizations, the books and records, marketing materials and product data relating to Zohydro ER (collectively, the “Purchased Assets”). Upon closing of this transaction on April 24, 2015, we paid Zogenix $70.0 million in cash, deposited $10.0 million in escrow to fund potential indemnification claims for a period of 12 months following the closing and issued approximately 1.7 million shares of our common stock, with an approximate value of $20.0 million, based on the closing price of $11.89 on March 9, 2015, the trading day immediately preceding the execution date of the Asset Purchase Agreement.  See Note 13, Subsequent Events, for additional information.
 
 
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On March 16, 2015, the Company decided to institute an initiative to restructure operations and shut down the Charleston, South Carolina site.  This step is being done in order to consolidate operations within the Company’s headquarters located in Morristown, New Jersey.
 
On April 22, 2015 we sold a private offering of $130.0 million aggregate principal amount of our 4.25% Convertible Senior Notes due 2021.  The notes are general unsecured obligations.  The interest will be paid on the notes semi-annually at a rate of 4.25% per annum and will mature on April 1, 2021, unless redeemed, repurchased or converted in accordance with their terms prior to such date.  The notes will have an initial conversion rate, subject to adjustment, of 87.2030 shares of our common stock per $1,000 principal amount of the notes, representing a conversion price of approximately $11.47 per share of our common stock, based on the last reported sale price of $8.34 per share of our common stock on April 16, 2015.  The gross proceeds from the offering will be $130.0 million.  We used approximately $80.9 million of the gross proceeds from the offering to finance the cash consideration portion of the consideration necessary to consummate its previously announced acquisition of the Zohydro ER franchise, and expect to use approximately $8.3 million to pay fees and expenses related to such acquisition and the offering, up to $2.2 million to pay the consent fee related to our consent solicitation of our 12.00% senior secured notes due 2020 and the remainder for working capital and other general corporate purposes, including to fund possible acquisitions of, or investments in, complementary businesses, products, services and technologies.

Results of Operations

The following table summarizes our results of operations for the three months ended March 31, 2015 and 2014 (in thousands):

   
Three Months Ended March 31,
       
   
2015
   
2014
   
Increase / (Decrease)
 
Net revenues
  $ 33,889     $ 19,052       78 %
Cost of product sales
    11,076       9,956       11 %
Selling, general and administrative expense
    20,986       13,623       54 %
Research and development expense
    994       969       3 %
Depreciation and amortization expense
    18,433       2,191       742 %
Loss on sale of PML (including impairment charge)
 
      6,457       N/A (1)
Restructuring costs
    1,305    
      N/A (1)
Interest expense, net
    9,342       1,264       639 %
Income tax benefit
    (4,573 )     (5,866 )     (22 )%
 
(1) Comparison to prior period is not meaningful.
 
Comparison of Three Months Ended March 31, 2015 and 2014
 
Net Revenues

Net revenues consist of net product sales and revenue from co-promotion and other revenue sharing arrangements, as well as revenue from PML until the manufacturing operations were sold on April 21, 2014.  We recognized 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 primary 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 revenue on 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 March 31, 2015 and 2014 (in thousands):

   
Three Months Ended
March 31,
 
   
2015
   
2014
 
             
Net product sales – Treximet
  $ 20,986     $
 
Net product sales – Silenor
    5,002       1,844  
Net product sales – Other
    7,594       15,687  
   Net product sales
    33,582       17,531  
Manufacturing revenue
 
      871  
Co-promotion and other revenue
    307       650  
Total net revenues
  $ 33,889     $ 19,052  
 
            Net revenues increased $14.8 million or 78% during the three months ended March 31, 2015 compared to the three months ended March 31, 2014.  Treximet was acquired in August 2014 with the first sale occurring on September 2, 2014.  Our net product sales for the three months ended March 31, 2015 was approximately $21.0 million.  Per unaudited financial information provided by GSK for pro forma purposes, their net product sales for the three months ended March 31, 2014 was $15.1 million.  Net product sales - Silenor increased by $3.2 million, or 171%, during the three months ended March 31, 2015 compared to the three months ended March 31, 2014.  The price increase contributed 46% and a volume increase due to a new focused marketing and selling strategy contributed 54% offset by revenue deductions that increased due to the increase in sales revenue.  Net product sales – other decreased by $8.1 million, or 52%, during the three months ended March 31, 2015 compared to the three months ended March 31, 2014.  Declining net product sales - other was due to (i) the discontinuation of certain less profitable products, primarily generics, and certain OTC monograph seasonal cough and cold products, (ii) the termination of certain contracts pursuant to which we marketed and distributed products for others and invoiced those sales and (iii) the increase of certain deductions such as higher returns due to decrease in prescriptions of our cough and cold products during the cough and cold season (October 2014 – March 2015).  The decrease in net product sales – other was offset by price increases on certain products.  Manufacturing revenue decreased by $871,000 during the three months ended March 31, 2015 compared to the three months ended March 31, 2014, as we sold our manufacturing subsidiary, PML, in April 2014.  Co-promotion and other revenue decreased by $343,000 during the three months ended March 31, 2015 compared to the three months ended March 31, 2014.  The decrease in co-promotion and other revenue was primarily attributable to the termination of the co-promotion agreement on Natroba.

Cost of Product Sales

Cost of product sales increased by $1.1 million, or 11%, during the three months ended March 31, 2015, compared to the three months ended March 31, 2014.  The increase was primarily due to an increase in royalty and collaboration expense of $3.8 million, of which $4.0 million was attributable to the royalty due to the patent holder of Treximet, equal to 18% of the product’s net sales, and the cost of Treximet of $778,000.  The increase was partially offset by a decrease in the acquisition cost basis of the inventory sold of $1.5 million, as all of the Cypress and Somaxon acquired inventory has been sold and a decrease in the allowance for obsolete, slow moving inventory, included in cost of sales, of $1.4 million and a decrease in the cost of our products, excluding Treximet, of $172,000.  Gross profit margin as a percentage of net revenues (excluding costs of sales attributed to sales of the acquired inventory which has a higher basis than the inventory purchased post-closing) was 67.6% during the three months ended March 31, 2015, compared to 56.3% for the three months ended March 31, 2014.  The increase in our gross profit margin percentage during the three months ended March 31, 2015 was primarily due to a change in product mix, in particular, the addition of the Treximet product line.  We expect cost of product sales to continue to increase in 2015 over 2014, primarily due to expected growth in the sales of Treximet and Silenor, which will result in an increase in royalty expense as well as the costs of the Treximet and Silenor products.
 
 
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Selling, General and Administrative Expenses

Selling, general and administrative (“SG&A”) expenses increased by $7.4 million, or 54%, during the three months ended March 31, 2015 compared to the three months ended March 31, 2014.  The increase was driven by an increase in marketing costs of $3.1 million related to our Silenor and Treximet products, increased compensation of $2.8 million, due to the expansion of our management team and support staff to position the company for continued growth, increases in (i) legal settlements of $1.4 million, (ii) training costs of $1.2 million and (iii) deal costs of $740,000.  We also realized increases in legal fees, cost of samples, professional services, public relations and third party logistics costs.  These increases were partially offset by a decrease in costs related to the employees transferred to the buyer in the sale of our manufacturing facility, PML, of $1.2 million as well as the related non-personnel SG&A costs of $460,000.  We also realized decreases in bad debt expense, consulting and insurance.

Research and Development Expense

Research and Development (“R&D”) expenses increased by $25,000, or 3%, during the three months ended March 31, 2015 compared to the three months ended March 31, 2014.  Treximet related R&D expense increased $481,000, while R&D expenses, excluding Treximet, decreased $456,000.

Depreciation and Amortization Expense

Depreciation and amortization expense increased by $16.2 million, or 742%, during the three months ended March 31, 2015 compared to the three months ended March 31, 2014.  The increase was primarily as a result of $16.4 million of amortization related to the Treximet developed technologies acquired.  The increase was partially offset by a decrease in depreciation expense of $81,000, primarily due to the sale of PML and its related fixed assets in April 2014.

Restructuring Costs

Restructuring increased by $1.3 million during the three months ended March 31, 2015 compared to the three months ended March 31, 2014.  The increase is due to the accrued costs related to the initiative to restructure operations and shut down the Charleston, South Carolina site.  For further discussion, see Note 12, Restructuring , to our condensed consolidated financial statements included in this Quarterly Report on Form 10-Q.

Interest Expense, net

Interest expense, net, increased by $8.1 million, or 639%, during the three months ended March 31, 2015 compared to the three months ended March 31, 2014.  The increase was primarily driven by an increase in interest expense of $8.0 million, which was primarily due to the recognition of interest expense related to our $220.0 million Treximet Notes, issued in August 2014 and $65.0 million February 2014 Convertible Notes, issued in February 2014, of $6.6 million and $1.3 million, respectively.  For further discussion, see Note 8, Debt and Lines of Credit , to our condensed consolidated financial statements included in this Quarterly Report on Form 10-Q.

Income Tax Provision

During the three months ended March 31, 2015, we recognized an income tax benefit of $4.6 million.  Our effective rate during the three months ended March 31, 2015 from continuing operations rate was 16.2%.  During the three months ended March 31, 2014, we recognized an income tax benefit of $5.9 million.  Our effective rate during the three months ended March 31, 2014 was 38.1%.  The change in the tax rate for the three months ended March 31, 2015 was primarily due to a new mix of jurisdictional earnings resulting from recent merger and acquisition activity.
 
 
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Non-GAAP Financial Measures

To supplement our financial results determined by U.S. generally accepted accounting principles (“GAAP”), we have also disclosed in the tables below the following non-GAAP information: (a) adjusted earnings before interest, taxes, depreciation and amortization (“EBITDA”) and (b) adjusted EBITDA per basic and diluted common share.  This financial measure excludes the impact of certain items and, therefore, has not been calculated in accordance with GAAP.  These non-GAAP financial measures exclude depreciation and amortization, net interest, taxes, net revenue adjustments, deal expenses, share-based compensation expense, amortization of inventory step-up included in cost of product sales, loss on sale of PML (including impairment charge),severance expenses and restructuring costs (comprehensively “Adjustment Items”).  In addition, from time to time in the future there may be other items that we may exclude for the purposes of our non-GAAP financial measures; likewise, we may in the future cease to exclude items that we have historically excluded for the purpose of our non-GAAP financial measures.  We believe that these non-GAAP financial measures provide meaningful supplemental information regarding our operating results because they exclude 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 these non-GAAP financial measures provides consistency and comparability with past reports of financial results and provides consistency in calculations by outside analysts reviewing our results.  Accordingly, we believe these non-GAAP financial measures are useful to investors in allowing for greater transparency of supplemental information used by management.

We believe that non-GAAP financial measures are helpful in understanding our past financial performance and potential future results, 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 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 supplements to GAAP financial measures and by reconciling the non-GAAP financial measures to their most comparable GAAP financial measure.  Investors are encouraged to review the reconciliations of the non-GAAP financial measures to their most comparable GAAP financial measures that are included elsewhere in this Quarterly Report on Form 10-Q.

Reconciliation of GAAP reported net loss to adjusted EBITDA and the related per share amounts are as follows (in thousands, except per share amounts):
 
 
   
Three Months Ended March 31,
 
   
2015
   
2014
 
GAAP net loss
  $ (23,674 )   $ (9,542 )
Adjustments:
               
    Interest expense, net
    9,342       1,264  
    Depreciation and amortization
    18,433       2,191  
    Income tax benefit
    (4,573 )     (5,866 )
EBITDA
    (472 )     (11,953
    Net revenue adjustments
    303 (1)  
(1)
    Cost of product sales adjustments
    97 (2)     1,622 (2)
    Selling, general and administrative adjustments
    3,358 (3)     1,922 (3)
    Loss on sale of PML (including impairment charge)
 
      6,457  
Restructuring costs
    1,305 (4)  
(4)
Adjusted EBITDA
  $ 4,591     $ (1,953 )
                 
Basic adjusted EBITDA per common share
  $ 0.12     $ (0.05 )
Diluted adjusted EBITDA per common share
  $ 0.08     $ (0.05 )
                 
Weighted average number common shares outstanding
    38,453       37,271  
Weighted average number common shares outstanding
               
    assuming dilution
    59,129 (5)     37,271  
 
 
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(1)   To exclude impact on returns from FDA reclass of Hydrocodone products from C3 to C2 classification of $303 and $0 for the three months ended March 31, 2015 and 2014, respectively.
 
(2)   To exclude amortization of inventory step-up of $97 and $1,622, for the three months ended March 31, 2015 and 2014, respectively.
 
(3)   To exclude deal costs of $742 and $2; stock compensation expense of $1,215 and $1,779; ParaPro stock compensation expense of $0 and $119; severance expense of $0 and $22 and litigation settlement expenses of $1,401 and $0, for the three months ended March 31, 2015 and 2014, respectively.
 
(4)   To exclude the accrued cost related to the initiative to restructure operations and shut down the Charleston, South Carolina site.  Stock compensation related to the modification and acceleration of vesting of equity and awards of $656 and $0, and severance expense of $649 and $0 for the three months ended March 31, 2015 and 2014, respectively.
 
(5)   Includes the dilutive effect of the February 2014 Convertible Notes, warrant and stock awards of 18,056 shares, 522 shares and 2,098 shares, respectively.
 
Liquidity and Capital Resources
 
As of March 31, 2015, we had cash and cash equivalents of $18.9 million, borrowing availability of $29.3 million under our $20.0 million revolving loan and a related $20.0 million uncommitted accordion feature and long-term debt of $281.1 million.

We have an effective shelf registration statement on Form S-3, which covers the offering, issuance and sale of up to $300.0 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 $100.0 million of 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.  This program will provide us with financial flexibility and the ability to opportunistically access the capital markets.
               
We currently have no immediate plans to issue securities pursuant to this registration statement.
 
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; 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.
 
 
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On each Payment Date, commencing August 1, 2015, the Company will pay an installment of principal on the Treximet 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 Notes on such Payment Date of $6.6 million per quarter).  Pursuant to the August 2014 Indenture the first principal payment is due on August 1, 2015 and will be calculated on net sales for the first and second quarters of 2015, less interest paid during those same two quarters.  At each month-end beginning during 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 Notes.  If the Treximet net sales less the interest due at each month-end of each six-month period does not result in any excess over the interest due, no principal payment will be paid at that time.  The balance outstanding on the Treximet Notes, or the full amount of the $220.0 million principal of the notes if the calculation as described does not result in any principal payments during the term of the Treximet Notes, will be due on the maturity date of the Treximet Notes which is August 1, 2020.  Based on the calculation of the principal payments as described, the Company has recorded $216.1 million of Treximet Notes as long-term debt and $3.9 million as short-term debt as of March 31, 2015.

A significant portion of our planned expenditures for the remainder of 2015 are associated with our acquisition of certain assets related to Zohydro ER.  We funded our acquisition of Zohydro ER with cash of approximately $80.9 million and issued approximately 1.7 million shares of our common stock, with an approximate value of $20.0 million, based on the closing price of $11.89 on March 9, 2015, the trading day immediately preceding the execution date of the Asset Purchase Agreement.  As of May 1, 2015, we believe that our existing cash balance, cash from operations, net proceeds from our the offering of our $130.0 million Convertible Senior Notes due 2021 and funds remaining available under our Midcap $20.0 million revolving loan and related $20.0 million uncommitted accordion feature will be sufficient to fund our existing level of operating expenses, current development activities and general capital expenditure requirements through 2015.

To continue to grow our business over the longer term, we may need to commit substantial resources to one or more of the following: product acquisition, product development and clinical trials of product candidates, business acquisition, technology acquisition and expansion of other operations.  In this regard, we have evaluated and expect to continue to evaluate a wide array of strategic transactions as part of our strategy to acquire or in-license and develop additional products and product candidates.  Acquisition opportunities that we pursue could materially affect our liquidity and capital resources and may require us to incur additional indebtedness, seek equity capital or both.  In addition, we may pursue new operations or the expansion of our existing operations.

Cash Flows

The following table provides information regarding our cash flows for the three months ended March 31, 2015, and 2014 (in thousands).
 
   
Three Months Ended March 31,
 
Cash (used in) provided by
 
2015
   
2014
 
Operating activities
 
$
(19,044
 
$
(6,118
)
Investing activities
   
(223
   
(115
Financing activities
   
3,341
     
46,437
 
Net increase (decrease) in cash and cash equivalents
 
$
(15,926
 
$
40,204
 

Comparison of the Three Months Ended March 31, 2015 and 2014

Net cash used in operating activities

Net cash used in operating activities during the three months ended March 31, 2015 was $19.0 million, an increase of $12.9 million from cash used in operating activities during the three months ended March 31, 2014 of $6.1 million.  The $19.0 million used in operating activities during the three months ended March 31, 2015 was driven by: net loss of $23.7 million, adjusted by non-cash expenses totaling $21.0 million, offset by a non-cash deferred income tax benefit of $3.2 million and $13.2 million in net changes in accounts receivable, inventories, accounts payable, accrued expenses and other operating assets and liabilities.  The $6.1 million used in operating activities during the three months ended March 31, 2014 was primarily driven by: net loss of $9.5 million, adjusted by non-cash expenses totaling $10.8 million, offset by a non-cash deferred income tax benefit of $6.4 million and $927,000 in net changes in accounts receivable, inventories, accounts payable, accrued expenses and other operating assets and liabilities.
 
 
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Net cash used in investing activities

Net cash used in investing activities during the three months ended March 31, 2015 was $223,000, which represents an increase of $108,000 from the cash used in investing activities during the three months ended March 31, 2014 of $115,000.  The increase in cash used in investing activities was due to an increase in equipment purchases of $108,000.

Net cash provided by financing activities

Net cash provided by financing activities during the three months ended March 31, 2015 was $3.3 million, which represents a decrease of $43.1 million from cash provided by financing activities during the three months ended March 31, 2014 of $46.4 million.  The $3.3 million provided by financing activities during the three months ended March 31, 2015 was primarily attributable to net proceeds from our revolving credit facility of $3.3 million.  The $46.4 million provided by financing activities during the months ended March 31, 2014 was primarily attributable to net proceeds from the issuance of our February 2014 Convertible Notes of $65.0 million, partially offset by financing costs related to the issuance of these notes of $6.2 million and net payments on our revolving credit facility of $11.8 million.

Contractual Obligations
 
Contractual obligations represent future cash commitments and liabilities under agreements with third parties and exclude contingent contractual liabilities for which we cannot reasonably predict future payment, including contingencies related to potential future development, financing, royalty payments and/or scientific, regulatory, or commercial milestone payments under development agreements.  Further, obligations under employment agreements contingent upon continued employment are not included in the table below.  The following table summarizes our contractual obligations as of March 31, 2015 (in thousands):
 
   
Payments Due by Period
 
   
Total
   
Less than
1 Year
   
2-3 Years
   
4-5 Years
   
More than
5 Years
 
                               
Operating leases  (1)
 
$
4,153
   
$
525
   
$
1,236
   
$
1,200
   
$
1,192
 
Professional services agreements  (2)
   
6,890
     
6,215
     
675
     
     
 
Supply agreements and purchase
   obligations (3)
   
8,323
     
2,081
     
1,998
     
1,998
     
2,246
 
License and development agreements  (4)
   
51,000
     
19,000
     
32,000
     
     
 
Short-term borrowings (5)
   
15,893
     
15,893
     
     
     
 
Long-term debt obligations  (6)
   
422,086
     
31,367
     
62,268
     
328,451
     
 
Restructuring costs (7)
   
649
     
649
     
     
     
 
Settlement obligations 
   
12,800
     
4,550
     
5,500
     
2,500
     
250
 
Total contractual obligations
 
$
521,794
   
$
80,280
   
$
103,677
   
$
334,149
   
$
3,688
 
 
(1)
Operating leases include minimum payments under leases for our facilities and certain equipment.
  
(2)
Professional service agreements include agreements with a specific term for consulting, information technology, telecom and software support, data and sales reporting tools and services.
   
(3)
Supply agreements and purchase obligations include fixed or minimum payments under manufacturing and supply agreements with third-party manufacturers and other providers of goods and services.  The contractual obligations table set forth above does not reflect certain minimum sales requirements related to our co-promotion agreements nor does it include supply agreements for which the failure to meet the purchase or sale requirements under such agreements generally allows the counterparty to terminate the agreement and/or results in a loss of our exclusivity rights.
   
(4)
Future scheduled or specific payments pursuant to license or development agreements.  Future payments for which the date of payments or amount cannot be determined are excluded.
   
(5)
Short-term borrowings represent the current portion of the Treximet Notes, and Mid-Cap Credit Facility as of March 31, 2015 plus the minimum interest payments that must be paid on 75% of the total amount available, $20.0 million before consideration of the accordion feature, under the revolver regardless of the balance outstanding.  As of March 31, 2015, we had borrowings of approximately $10.7 million outstanding under our revolving credit facility.
   
(6)
 
The long-term debt obligations represent the principle repayments on the February 2014 Convertible Notes and the Treximet Notes and the associated contractual interest payments assuming that principle payments are made only on each issuances’ respective maturity date based on the terms of these notes.  See Note 8, Debt and Lines of Credit , for further information on the classification of this long-term debt.
   
(7)
Severance related obligation to the initiative to restructure operations and shut down the Charleston, South Carolina site.  The non-cash modification and accelerated vesting of options and awards under existing employee agreements is not included.
 
 
See Note 8, Debt and Lines of Credit, to our consolidated financial statements included in this Quarterly Report on Form 10-Q for additional information.

In addition to the material contractual cash obligations included the chart above, we have committed to make potential future milestone payments to third parties as part of licensing, distribution, acquisition and development agreements.  Payments under these agreements generally become due and payable only upon achievement of certain development, regulatory and/or commercial milestones.  As the achievement of milestones is neither probable nor reasonably estimable, such contingent payments have not been recorded on our consolidated balance sheets and have not been included in the table above.      
 
 
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 ITEM 3.
QUANTITATIVE AND QUALITATIVE DISCLOSURES ABOUT MARKET RISK
 
We are exposed to market risk related to changes in interest rates on our revolving credit facility.  We do not utilize derivative financial instruments or other market risk-sensitive instruments to manage exposure to interest rate changes.  The main objective of our cash investment activities is to preserve principal while maximizing interest income through our trust account.

The interest rate related to borrowings under our revolving credit facility is a variable rate of LIBOR (with a floor of 1.5%) plus an Applicable Margin (7.5%), as defined in the debt agreement (9.0% at March 31, 2015).  As of March 31, 2015 we had outstanding borrowings of approximately $10.7 million under our revolving credit facility.  We are required to pay minimum interest on 75% of the available revolver balance of $20.0 million.  If interest rates increased by 1.0%, our annual interest expense on our borrowings would increase by approximately $150,000.

See Note 8,  Debt and Lines of Credit , to our unaudited condensed consolidated financial statements included within this report for further discussion.
 
 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, or 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 Chief 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.
 
Evaluation of Disclosure Controls and Procedures.  As of March 31, 2015, 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 Chief Financial Officer.  Immediately following the Signatures section of the Quarterly report on Form 10-Q are certifications of our Chief Executive Officer and Chief 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 Chief Financial Officer concluded that as of the date of their evaluation, our disclosure controls and procedures were effective to accomplish their intended purpose. 

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.
 
 
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PART II. OTHER INFORMATION
 
 ITEM 1.
LEGAL PROCEEDINGS
 
See  Legal Proceedings under Note 11, Commitments and Contingencies , to our unaudited condensed consolidated financial statements for the three months ended March 31, 2015 and 2014 contained in Part I, Item 1 of this Quarterly Report on Form 10-Q.
 
 ITEM 1A.
RISK FACTORS
 
If any of the following risks actually occur, our business, financial condition, results of operations and cash flows could be materially adversely affected and the value of our securities could be negatively impacted.  Although we believe that we have identified and discussed below the key risk factors affecting our business, there may be additional risks and uncertainties that are not presently known that may materially adversely affect our business.
 
Risks Related to our Acquisition Strategy and Managing Growth
 
We may not be able to continue to grow through acquisitions of businesses and assets.
 
We have sought growth largely through acquisitions, including the acquisitions of Pernix Sleep in 2013, the rights to Treximet intellectual property in 2014, and the asset acquisition of the Zohydro ER business in April 2015.  As part of our ongoing expansion strategy, we plan to make additional strategic acquisitions of assets and businesses.  However, our credit agreement with MidCap and the indentures governing  our outstanding notes include 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.  In addition to these restrictive covenants, our credit agreement with MidCap contains certain financial covenants.  For additional information see Note 8, Debt and Lines of Credit to our unaudited condensed consolidated financial statements for the three months ended March 31, 2015 and 2014 contained in Part I, Item 1 of this Quarterly Report on Form 10-Q.  In the future, we may pursue growth opportunities through acquisitions that are not directly similar to those currently operated by us.  We cannot assure you that acquisitions will be available on terms attractive to us.  Moreover, we cannot assure you that such acquisitions will be permissible under our existing credit agreement with MidCap or the indentures governing our outstanding notes 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.
 
            Management has in the past devoted, and will in the future devote, significant attention and resources to integrating newly acquired businesses and assets.  Potential difficulties we have or may in the future encounter in the integration process 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 customers of Pernix or the newly acquired business or asset deciding not to do business with us following such acquisition;
the additional complexities of integrating newly acquired businesses and assets with different core products and markets;
performance shortfalls as a result of the diversion of management’s attention caused by integrating the operations of a newly acquired business with those of Pernix or a newly acquired asset into the existing product portfolio
 
 
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            For all these reasons, you should be aware that it is possible that integrating a newly acquired business or asset 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.
 
Our future results will suffer if we do not effectively manage our expanded operations.
 
            Our acquisitions of Somaxon, the rights to Treximet intellectual property, and the asset acquisition of Zohydro significantly changed the composition of our operations, markets and product mix.  Our future success depends, in part, on our ability to address these changes, and, where necessary, to attract and retain new personnel that possess the requisite skills called for by these changes.
 
            We may continue to expand our operations through additional acquisitions, license arrangements, other strategic transactions and new product offerings.  Our future success depends, in part, upon our ability to manage our expansion opportunities.  Integrating new operations into our existing business in an efficient and timely manner, successfully monitoring our operations, costs, regulatory compliance and customer relationships, and maintaining other necessary internal controls pose substantial challenges for us.  As a result, we cannot assure you that our expansion or acquisition opportunities will be successful, or that we will realize our expected operating efficiencies, cost savings, revenue enhancements, synergies or other benefits.
 
Our business operations and financial position could be adversely affected as a result of our substantial indebtedness.
 
            As of March 31, 2015, after giving effect to our issuance of an aggregate of $65.0 million of February 2014 Convertible Notes and an aggregate of $220.0 million of Treximet Notes in August 2014, we had approximately $295.7 million of debt outstanding and the ability to borrow approximately $29.3 million under our credit agreement with MidCap, utilizing the revolver accordion feature and subject to borrowing base capacity.  Subsequent to March 31, 2015, we issued an additional $130.0 million of convertible notes in connection with our acquisition of Zohydro ER and for working capital and general corporate purposes.  This significant indebtedness could have important consequences.  For example, it may:
 
make it difficult for us to satisfy our obligations under our outstanding notes, the credit agreement with MidCap and our other indebtedness and contractual and commercial commitments;
 
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.
 
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:
 
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.
 
 
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Additional equity or debt financing, or corporate collaboration and licensing arrangements, may not be permissible under the indentures governing our outstanding notes or the credit agreement with MidCap 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.  Any exploration of strategic alternatives may not result in an agreement or transaction and, if completed, any agreement or transaction may not be successful or on attractive terms.  The inability to enter into a strategic transaction, or a strategic transaction that is not successful or on attractive terms, could accelerate our need for cash and make securing funding on reasonable terms more difficult.  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.
 
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 agreement with MidCap and the indentures governing our outstanding notes limit our ability and the ability of our subsidiaries to incur additional indebtedness, these restrictions are subject to a number of qualifications and exceptions and, under certain circumstances, debt incurred in compliance with these restrictions could be substantial.  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 higher 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.  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. These alternative strategies may not be effected 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.
 
            In addition, the borrowings under our credit agreement with MidCap 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.
 
 
32

 
 
The indentures governing our outstanding notes and the credit agreement with MidCap 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 our outstanding notes and the credit agreement with MidCap 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, their 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 in exceeding a specified amount; and
 
merge, consolidate or transfer all or substantially all of their assets.
 
In addition, the terms of these agreements require us to maintain a minimum liquidity of $8.0 million at all times.
 
            Upon the occurrence of a change of control, as described in the indenture governing the February 2014 Convertible Notes, holders of the February 2014 Convertible Notes may require us to repurchase for cash all or part of their February 2014 Convertible Notes at a repurchase price equal to 100% plus a specified percentage (that is initially 40% and declines over the life of the February 2014 Convertible Notes) of the principal amount of the February 2014 Convertible Notes to be repurchased, plus accrued and unpaid interest.  If, upon the occurrence of a change of control, as described in the indenture, a holder elects to convert its February 2014 Convertible Notes in connection with such change of control, such holder may be entitled to an increase in the conversion rate as described in the indenture.  To the extent such increase in the conversion rate would result in the conversion price of the February 2014 Convertible Notes to be less than $2.3278 per share (subject to adjustment) and equal to or greater than $2.09 per share (subject to adjustment), 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 February 2014 Convertible Notes surrendered therefor or payments of cash on February 2014 Convertible Notes converted in connection with certain change of control transactions.  In addition, our ability to repurchase the February 2014 Convertible Notes or to pay cash upon conversions of the February 2014 Convertible Notes may be limited by law, by regulatory authority or by agreements governing our indebtedness.  Our failure to repurchase the February 2014 Convertible Notes at a time when the repurchase is required by the indenture or to pay any cash payable on future conversions of the February 2014 Convertible Notes in connection with certain change of control transaction as required by the indenture would constitute a default under the indenture.  A default under the indenture or the change of control itself could also lead to a default under agreements governing our 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 February 2014 Convertible Notes or make cash payments upon conversions in connection with certain change of control transactions.  These and other provisions could prevent or deter a third party from acquiring us, even where the acquisition could be beneficial to you.
 
              In addition, the credit agreement with MidCap requires that we maintain a minimum amount of EBITDA and net invoiced revenues unless we demonstrate minimum liquidity of at least $30 million.
 
 
33

 
 
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 will 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 or to engage in other business activities that would be in our interest.
 
            Our ability to borrow under the credit agreement with MidCap 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 could reduce our borrowing capacity under the credit agreement with MidCap.
 
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, particularly Douglas Drysdale, our Chairman, President and Chief Executive Officer.  The loss of the services of Mr. Drysdale or any one or more other 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, impose 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 will require us to incur 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 August 2014 acquisition of the rights to Treximet intellectual property and our April 2015 asset acquisition of Zohydro ER; 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 acquired the rights to Treximet intellectual property in August 2014 and closed our acquisition of certain assets relating to Zohydro ER in April 2015.  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.
 
 
34

 
 
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 and 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; and
 
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.
 
             If we are unable to successfully identify and acquire rights to products, product candidates and 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.
 
            If we fail to successfully manage any acquisitions, our ability to develop our product candidates and expand our product pipeline may be harmed.
 
            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;
 
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.
 
 
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If we are unable to successfully manage our acquisitions, 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 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 of pharmaceutical products.  The members of our sales force may have no prior experience promoting the pharmaceutical products that we may acquire in the future.  As a result, we may have to 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 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.  We have also experienced, and may continue to experience, turnover of the sales representatives that we hired or will hire, requiring us to train new sales representatives.  If we are unable to effectively train our sales force and equip them with effective materials relating to the pharmaceutical products that we may acquire in the future, 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.

Although we have closed the acquisition of the Zohydro ER business, the economic benefit to us may not meet our expectations.

Pursuant to the Asset Purchase Agreement, in addition to the consideration we paid to Zogenix at closing, Zogenix is eligible to receive additional cash payments of up to $283.5 million based on the achievement of pre-determined milestones.  Under the terms of the Asset Purchase Agreement, over 80% of the value of the sales milestones is tied to the achievement of net sales targets ranging from $500 million to $1 billion, and we have agreed to use Commercially Reasonable Efforts (as defined in the Asset Purchase Agreement) to meet such milestones.  Even if we use such Commercially Reasonable Efforts, we may not be able to successfully maintain and increase market demand for Zohydro ER or achieve those milestones.  Furthermore, we have assumed responsibility for Zogenix’s obligations under the purchased contracts and regulatory approvals, as well as other liabilities associated with the Zohydro ER business arising after the acquisition’s closing date.  These liabilities may be greater than we expect.

 
Risks Related to Commercialization
 
The commercial success of our currently marketed products 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 development and commercialization of drugs is highly competitive.  We face competition with respect to our currently marketed products and any products that we may seek to develop or commercialize in the future.  Our competitors include major pharmaceutical companies, specialty pharmaceutical companies and biotechnology companies worldwide.  Potential competitors also include academic institutions, government agencies and other private and public research organizations that seek patent protection and establish collaborative arrangements for development, manufacturing and commercialization.  We face significant competition for our currently marketed products.  Some of our currently marketed branded products, including Zutripro, Rezira and Vituz, do not have patent protection and in most cases face generic competition.  All of our products face significant price competition from a range of branded and generic products for the same therapeutic indications.
 
Some or all of our product candidates, if approved, 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.  For example, our product candidates may not demonstrate sufficient additional clinical benefits to physicians to justify a higher price compared to other lower cost products within the same therapeutic class.  Notwithstanding the fact that we may devote substantial amounts of our resources to bringing product candidates to market, our commercial opportunity 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 any products that we may develop and/or commercialize.
 
              Our patent rights may not protect our patent protected products and product candidates if competitors devise ways of making products that compete with us without legally infringing our patent rights.  For example, our patent rights in Silenor are limited in ways that affect our ability to exclude third parties from competing against us.  In particular, we do not hold composition of matter patents covering the active pharmaceutical ingredient (“API”), of Silenor.  Composition of matter patents on APIs are a particularly effective form of intellectual property protection for pharmaceutical products, as they apply without regard to any method of use or other type of limitation.  As a result, competitors who obtain the requisite regulatory approval can offer products with the same API as Silenor so long as the competitors do not infringe any method of use or formulations patents that we may hold.
 
            The Federal Food, Drug, and Cosmetic Act (“FDCA”) and FDA regulations and policies provide certain exclusivity incentives to manufacturers to create modified, non-infringing versions of a drug in order to facilitate the approval of abbreviated new drug applications (“ANDAs”) for generic substitutes.  These same types of exclusivity incentives encourage manufacturers to submit new drug applications (“NDAs”) that rely, in part, on literature and clinical data not prepared for or by such manufacturers.  Manufacturers might only be required to conduct a relatively inexpensive study to show that their product has the same API, dosage form, strength, route of administration and conditions of use or labeling as our product and that the generic product is absorbed in the body at the same rate and to the same extent as our product, a comparison known as bioequivalence.  Such products would be significantly less costly than certain of our products to bring to market and could lead to the existence of multiple lower-priced competitive products, which would substantially limit our ability to obtain a return on the investments we have made in those products.  Our competitors also may obtain FDA or other regulatory approval for their product candidates more rapidly than we may obtain approval for our product candidates.
 
            Products in our portfolio that do not have patent protection are potentially at risk for generic competition.  We utilize our generic business to attempt to retain market share from other generic competitors for our branded products.  For example, we have attempted to maintain market share in the prescription cough and cold market by offering an authorized generic of Cedax and Zutripro.  Additionally, products we sell through our collaborative or co-promotion arrangements may also face competition in the marketplace.
 
 
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            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 will 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 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.
   
If our competitors introduce their own generic equivalents of our products, our net revenues from such products are expected to decline.
 
            Product sales of generic pharmaceutical products often follow a particular pattern over time based on regulatory and competitive factors.  The first company to introduce a generic equivalent of a branded product is often able to capture a substantial share of the market.  However, as other companies introduce competing generic products, the first entrant’s market share, and the price of its generic product, will typically decline.  The extent of the decline generally depends on several factors, including the number of competitors, the price of the branded product and the pricing strategy of the new competitors.
 
            For example, in the generic drug industry, when a company is the first to introduce a generic drug, the pricing of the generic drug is typically set based on a discount from the published price of the equivalent branded product.  Other generic manufacturers may enter the market and, as a result, the price of the drug may decline significantly.  In such event, we may in our discretion provide our customers a credit with respect to the customers’ remaining inventory for the difference between our new price and the price at which we originally sold the product to our customers.  There are circumstances under which we may, as a matter of business strategy, not provide price adjustments to certain customers and, consequently, we may lose future sales to competitors.
 
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.
 
                As of March 31, 2015, our sales force consisted of approximately 98 sales territories.  In October 2013 we entered into a co-promotion agreement with Cumberland, under which Cumberland will promote Omeclamox-Pak to gastroenterologists across the United States through its field sales force.  In September 2014, we entered into an agreement with Sallus Laboratories LLC under which Sallus will promote Zutripro, Rezira and Vituz through its field sales force until March 31, 2015.  In August 2014, the Company entered into an agreement with PDI, Inc. for services related to the promotion of Cedax and its authorized generic.
 
 
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            We, Cumberland 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 revenues we receive from sales of products that are the subject to commercial partnerships will largely depend upon the efforts our partners, including Cumberland.  The efforts of our partners in many instances are likely to be outside our control.  If we are unable to maintain our commercial partnerships or to effectively establish alternative arrangements for our products, our business could be adversely affected.  In addition, despite our arrangements with Cumberland and our 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.
 
            The efforts of our sales force and partners are complemented by on-line and other non-personal promotional initiatives that target both physicians and patients.  We are also focused on ensuring broad patient access to our products by negotiating agreements with leading commercial managed care organizations 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.
 
           Some of our products, including Zutripro, its generic equivalent, Rezira, Vituz and certain other generic products contain controlled substances, which are regulated by the DEA under the Controlled Substances Act.  DEA quota requirements 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 our products as a result of DEA regulations and because of the limited number of suppliers of pseudoephedrine, an active ingredient in several of our products. 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 products, our reputation and our brands could be harmed and physicians may be less likely to prescribe our products in the future, each of which could have a material adverse effect on our business, financial condition, results of operations and cash flows.
 
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 or biologic product, the FDA requires that the facilities at which the product will be manufactured be in compliance with current Good Manufacturing Practices, which we refer to herein as cGMP, which include requirements relating to quality control and quality assurance, as well as the maintenance of records and documentation and utilization of qualified raw materials.  To be successful, our products must be manufactured for development and, following approval, in commercial quantities, in compliance with regulatory requirements and at acceptable costs.
 
We and our contract manufacturers must comply with these cGMP requirements.  While we believe that we and our contract manufacturers currently meet these requirements, we cannot assure that our manufacturing facilities or those of our contract manufacturers 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.
 
 
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            We and our 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 contract manufacturers are required to register our manufacturing facilities with the FDA and other regulatory authorities and to subject them to inspections confirming compliance with cGMP or other regulations.  If we or our contract manufacturers fail to maintain regulatory compliance, the FDA can impose regulatory sanctions including, among other things, refusal to permit us or our 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 our third party manufacturers fail to comply with regulatory requirements for our controlled substance products, the DEA may take regulatory actions detrimental to our business, resulting in temporary or permanent interruption of distribution, withdrawal of products from the market or other penalties.
 
We, our third party manufacturers and certain of our products including Zutripro, its generic equivalent, Rezira, Vituz and certain other generic products are subject to the Controlled Substances Act and DEA regulations thereunder.  Accordingly, we must adhere to a number of requirements with respect to our controlled substance products including registration, recordkeeping 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.

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 or commercialize.  If we cannot successfully defend ourselves against claims that our products or product candidates caused injuries, we will incur substantial liabilities.  Regardless of merit or eventual outcome, liability claims may result in:
 
decreased demand for our products or any products that we may develop
 
injury to reputation
 
withdrawal of client 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;
 
the inability to commercialize any products that we may develop.
 
The amount of insurance that we currently hold may not be adequate to cover all liabilities that we may incur.  Insurance coverage is increasingly expensive.  We may not be able to maintain insurance coverage at a reasonable cost and we may not be able to obtain insurance coverage that will be adequate to satisfy any liability that may arise.
 
 
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Seasonality may cause fluctuations in our financial results.
 
            We generally experience some effects of seasonality due to increases in demand for cough and cold products during the winter season.  Accordingly, sales of cough and cold products and associated revenue have generally increased at a higher rate immediately prior and during the winter season.  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.  

Our business, financial condition and results of operations will be materially affected if Zohydro ER is not commercially successful.

Our ability to become profitable will depend in part on the commercial success of Zohydro ER.  The commercial success of Zohydro ER depends on several factors, including our ability to:
successfully launch and educate prescribers on Zohydro ER’s efficacy and safety, as well as our safe use initiatives, through our own marketing and sales activities;
create market demand for Zohydro ER through our own marketing and sales activities, and any other arrangements that we may later establish to promote this product;
commercialize Zohydro ER with BeadTek™ and successfully develop and commercialize ZX-007;
establish and maintain adequate levels of coverage and reimbursement for Zohydro ER from commercial health plans and government health programs, which we refer to collectively as third-party payors, particularly in light of the availability of alternative branded and generic competitive products;
maintain compliance with regulatory requirements;
establish and maintain agreements with wholesalers and distributors on commercially reasonable terms;
maintain commercial manufacturing arrangements with third-party manufacturers as necessary to meet commercial demand for Zohydro ER and manufacture commercial quantities at acceptable cost levels; and
successfully maintain intellectual property protection for Zohydro ER.
If we are unable to successfully commercialize Zohydro ER, our business, financial condition and results of operations will be materially adversely affected.

Negative publicity and political action regarding Zohydro ER could delay or impair our ability to market this product, present significant distractions to our management and result in the incurrence of significant costs.

Products used to treat and manage pain, especially in the case of opioids like Zohydro ER, are from time to time subject to negative publicity, including publicity regarding political action, illegal use, overdoses, abuse, diversion, serious injury and death.  In November 2013, eight members of Congress submitted a letter to Department of Health and Human Services Secretary, Kathleen Sebelius, urging reconsideration of the FDA’s approval of Zohydro ER, and in December 2013, a bipartisan coalition of attorneys general from 29 states and territories submitted a letter to FDA Commissioner Margaret Hamburg with the same request.  In April 2014, Purdue Pharma, L.P. (“Purdue”), announced that it submitted a New Drug Application (“NDA”) for its extended-release hydrocodone product (Hysingla) that is formulated to incorporate abuse deterrent properties, which was approved by the FDA in November 2014.  On October 29, 2014, Zogenix entered into a mutual exclusivity waiver agreement with Purdue, pursuant to which Zogenix granted a waiver to Purdue of the three-year Hatch-Waxman regulatory exclusivity period with respect to NDA 202880 for Zohydro ER in support of certain Purdue Products (as defined in the waiver agreement), including Hysingla ER.  In addition, Teva Pharmaceutical Industries Limited announced that the FDA has accepted their NDA submission for an abuse deterrent extended-release hydrocodone product as of February 2015.  Approval of additional abuse-deterrent formulation of hydrocodone may drive further negative publicity and political action, or even result in the FDA revoking its approval of our NDA for Zohydro ER.  While we do not believe that the FDA will revoke its Zohydro ER approval, and, in any event, the FDA would have to provide us with notice and opportunity for a hearing first, the related negative publicity, political influences and actions by our competitors could negatively affect our ability to market Zohydro ER and any opioid analgesic product candidates for which we may seek approval in the future.  If the FDA were to revoke its approval of Zohydro ER, our business, results of operations, financial condition and prospects would be materially and adversely affected.
 
 
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In addition, in March 2014, the Governor of the Commonwealth of Massachusetts issued an executive order to ban Zohydro ER in Massachusetts.  In response, in April 2014 Zogenix filed a lawsuit in the U.S. District Court in Massachusetts requesting that the court preliminarily enjoin implementation of Governor Patrick’s executive order prohibiting the prescribing and dispensing of Zohydro ER.  The lawsuit asserted that the executive order was in direct conflict with the authority of the FDA to determine on behalf of the public whether a drug is safe and effective and to impose the measures necessary to ensure that such drug will be used safely and appropriately.  After the U.S. District Court in Massachusetts entered the requested preliminary injunction preventing the implementation of the Governor’s order on constitutional grounds, the Commonwealth adopted emergency regulations which restricted distribution of Zohydro ER in Massachusetts.  Zogenix challenged these emergency regulations as preempted by the FDA approval for Zohydro ER, and on July 8, 2014 the U.S. District Court in Massachusetts agreed that implementation of the emergency regulations also should be preliminarily enjoined.  Meanwhile, Massachusetts has issued final regulations also imposing certain restrictions on distribution of Zohydro ER, and Zogenix has challenged these final regulations in U.S. District Court in Massachusetts.  While we believe the FDA has the authority to determine on behalf of the public whether a drug is safe and effective and to impose the measures necessary to ensure that such drug will be used safely and appropriately, and the U.S. District Court in Massachusetts has ruled in Zogenix’s favor, state officials in Massachusetts or elsewhere may nevertheless seek to place additional restrictions on the prescription and use of Zohydro ER, which could negatively affect our ability to market Zohydro ER.

This negative publicity and political action could also cause a diversion of our management’s time and attention, cause us to incur additional significant costs with respect to litigation, marketing or otherwise, and could also result in an increased number of product liability claims, whether or not these claims have a valid basis.
 
Risks Related to Our Dependence on Third Parties
 
If the manufacturers upon whom we rely fail to produce our products in the volumes that we require on a timely basis, or to comply with stringent regulations applicable to pharmaceutical drug manufacturers, we may face delays in the development and commercialization of, or be unable to meet demand for, our products and may lose potential revenues.
 
We do not manufacture our marketed products, and we do not currently plan to develop any capacity to do so.  We rely on third party manufacturers for 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.  Our manufacturers may not perform as agreed or may terminate their agreements with us.  Additionally, our manufacturers may experience manufacturing difficulties due to resource constraints or as a result of labor disputes or unstable political environments.  If our manufacturers were to encounter any of these difficulties, or otherwise fail to comply with their contractual obligations, our ability to sell our marketed 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 marketed products will result in the loss of potential revenues.
 
In connection with our acquisition of the rights to Treximet intellectual property in August 2014, we discovered short-term supply constraints for the product.  Our failure to obtain sufficient supply of Treximet to meet anticipated demand in the future may result in the loss of potential revenues.
 
All manufacturers of pharmaceutical products must comply with current good manufacturing practice, or cGMP, requirements enforced by the FDA through its facilities inspection program.  The FDA is also likely to conduct inspections of our manufacturers’ facilities as part of their review of any marketing applications we submit.  These cGMP requirements include 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.  A 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 of any quantities supplied is compromised due to our 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 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 marketed products.  We do not have alternate manufacturing plans in place at this time.  If we need to change to other manufacturers, the FDA and comparable foreign regulators must approve these manufacturers’ facilities and processes prior to our use, which would require new testing and compliance inspections, and the new manufacturers would have to be educated in or independently develop the processes necessary for production.
 
Any of these factors could adversely affect the commercial activities for our marketed 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 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.
 
We rely entirely on GSK as the sole supplier of Treximet.  GSK's inability to continue manufacturing adequate supplies of Treximet, or its refusal to supply us with commercial quantities of Treximet, may materially harm our business and financial condition and adversely impact our commercialization and sales efforts with respect to the product.
 
                We have entered into a supply agreement with GSK pursuant to which GSK will manufacture and supply to us commercial quantities of Treximet.  GSK is currently our sole source for Treximet   We may from time to time experience disruptions by GSK in the manufacture or supply of Treximet, or may experience disruptions in our business relationship with GSK.  For example, in connection with our acquisition of the rights to Treximet intellectual property in August 2014, we discovered short-term supply constraints for the product.  The failure by GSK for any reason to provide us with sufficient commercial quantities of Treximet may materially harm our business and financial condition and adversely impact our commercialization and sales efforts with respect to the product.
 
If GSK fails to provide us with commercial quantities of Treximet, the process of changing or adding a new contract manufacturer or supplier may require additional testing and prior FDA approval and may be expensive and time-consuming.  If we were unable to manage such changes effectively, we could face supply disruptions that could result in significant costs and delays, damage to our reputation or commercial prospects and cause us to lose potential revenues relating to the product.

We will rely entirely on Daravita Limited (“Daravita”) as the sole manufacturer and supplier of Zohydro ER.  Daravita’s inability to continue manufacturing adequate supplies of Zohydro ER, or its refusal to supply us with commercial quantities of Zohydro ER, may materially harm our business and financial condition and adversely impact our commercialization and sales efforts with respect to the product.

In March 2015, Zogenix entered into a commercial manufacturing and supply agreement with Daravita, which agreement as amended we assumed upon closing of the acquisition, for the manufacture and supply of Zohydro ER finished commercial product.  Under the agreement, Daravita is the exclusive manufacturer and supplier to us, subject to certain exceptions, of Zohydro ER.  We must purchase all of our requirements of Zohydro ER, subject to certain exceptions, from Daravita.  We may from time to time experience disruptions by Daravita in the manufacture or supply of Zohydro ER, or may experience disruptions in our business relationship with Daravita.  The failure by Daravita for any reason to provide us with sufficient commercial quantities of Zohydro ER may materially harm our business and financial condition and adversely impact our commercialization and sales efforts with respect to the product.
 
 
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We believe that Daravita has installed production capacity to support launch and initial forecast demand for Zohydro ER and has received final packaging qualification.  In order to meet future anticipated growth in demand for Zohydro ER, Daravita has initiated activities to qualify additional production lines and expand the manufacturing capacity for Zohydro ER.  However, if Daravita is unable to deliver the required commercial quantities of Zohydro ER and we are unable to find one or more replacement manufacturers or suppliers capable of production at a substantially equivalent cost, in substantially equivalent volumes and quality and on a timely basis, we would likely be unable to meet demand for Zohydro ER and we would lose potential revenue.

If Daravita fails to provide us with commercial quantities of Zohydro ER, the process of changing or adding a new contract manufacturer or supplier may require additional testing and prior FDA approval and may be expensive and time-consuming.  If we were unable to manage such changes effectively, we could face supply disruptions that could result in significant costs and delays, damage to our reputation or commercial prospects and cause us to lose potential revenues relating to the product.

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 three months ended March 31, 2015, McKesson Corporation accounted for 46% of our total gross sales, AmerisourceBergen Drug Corporation accounted for 17% of our total gross sales and Cardinal Health accounted for 29% of our total gross sales.  For the three months ended March 31, 2014, McKesson Corporation accounted for 36% of our total gross sales, AmerisourceBergen Drug Corporation accounted for 35% of our total gross sales and Cardinal Health accounted for 17% 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.  Of our current product portfolio, we market Omeclamox-Pak, Khedezla, Cedax, Zutripro, Rezira, Vituz and certain of our generic products pursuant to collaboration arrangements.  The success of our collaboration arrangements will 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 a collaboration arrangement regarding clinical development and commercialization matters can lead to delays in the development process or commercialization of the applicable product candidate 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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We intend to rely on third parties to conduct our clinical trials, and those third parties may not perform satisfactorily, including failing to meet established deadlines for the completion of such trials.
 
            We do not intend to independently conduct clinical trials for our product candidates.  We will rely on third parties, such as contract research organizations, clinical data management organizations, medical institutions and clinical investigators, to perform this function.  Our reliance on these third parties for clinical development activities reduces our control over these activities.  We are responsible for ensuring that each of our clinical trials is conducted in accordance with the general investigational plan and protocols for the trial.  Moreover, the FDA requires us to comply with standards, commonly referred to as 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, integrity and confidentiality of trial participants are protected.  Our reliance on third parties that we do not control does not relieve us of these responsibilities and requirements.  Furthermore, these third parties may 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 will not be able to obtain, or may be delayed in obtaining, regulatory approvals for our product candidates and will not be able to, or may be delayed in our efforts to, successfully commercialize our 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.  In particular, GSK has claimed significant damages stemming from an alleged breach of a covenant contained in the Asset Purchase Agreement pursuant to which we purchased the Treximet assets pertaining to a pre-existing customer agreement.  Our dispute with GSK and other legal proceedings and disputes 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.  We may also be required to pay substantial amounts or grant 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.  For more information regarding legal proceedings and contingencies, see Note 11, Commitments and Contingencies , to our unaudited consolidated financial statements included in this Quarterly Report on Form 10-Q.

Risks Related to Intellectual Property
 
If we are unable to obtain and maintain protection for the intellectual property relating to our technology and products, the value of our technology and products will be adversely affected.
 
Our success will depend in part on our ability to obtain and maintain protection for the intellectual property covering or incorporated into our technology and products.  The patent situation in the field of pharmaceuticals is highly uncertain and involves complex legal and scientific questions.  We rely upon patents, trade secret laws and confidentiality agreements to protect our technology and products.  We may not be able to obtain additional patent rights relating to our technology or products and pending patent applications to which we have rights may not issue as patents or if issued, may not issue in a form that will be advantageous to us.  Even if issued, any patents issued to us or licensed to us may be challenged, narrowed, invalidated, held to be unenforceable or circumvented, which could limit our ability to stop competitors from marketing similar products or limit the length of term of patent protection we may have for our products.  For example, the principal patent protection that covers Silenor consists of method of use patents.  This type of patent protects the product only when used or sold for the specified method.  However, this type of patent does not limit a competitor from making and marketing a product that is identical or similar to Silenor for an indication that is outside of the patented method.  Moreover, physicians may prescribe such a competitive or similar product for off-label indications that are covered by the applicable patents.  Some physicians are prescribing generic 10mg doxepin capsules and generic oral solution doxepin for insomnia on such an off-label basis in lieu of prescribing Silenor.  In addition, some managed healthcare plans are requiring the substitution of these generic doxepin products for Silenor, and some pharmacies are suggesting such substitution.  Although such off-label prescriptions may induce or contribute to the infringement of method of use patents, the practice is common and such infringement is difficult to prevent or prosecute.
 
 
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Our patent rights also may not afford us protection against competitors with similar technology.  Because patent applications in the United States and many other jurisdictions are typically not published until 18 months after filing, or in some cases not at all, and because publications of discoveries in the scientific literature often lag behind actual discoveries, neither we nor our licensors can be certain that we or they were the first to make the inventions claimed in our or their issued patents or pending patent applications, or that we or they were the first to file for protection of the inventions set forth in these patent applications. If a third party has also filed a U.S. patent application covering our product candidates or a similar invention, we may have to participate in an adversarial proceeding, known as an interference, declared by the U.S. Patent and Trademark Office to determine priority of invention in the United States.  The costs of these proceedings could be substantial and it is possible that our efforts could be unsuccessful, resulting in a loss of our U.S. patent position.  In addition, patents generally expire, regardless of the date of issue, 20 years from the earliest non-provisional effective U.S. filing date.
 
            Our collaborators and licensors may not adequately protect our intellectual property rights.  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.  
 
                In September 2011, the Leahy-Smith America Invents Act, or the Leahy-Smith Act, was signed into law and includes a number of significant changes to U.S. patent law.  These include changes in the way patent applications will be prosecuted and may also affect patent litigation.  The U.S. Patent and Trademark Office is currently developing regulations and procedures to administer the Leahy-Smith Act, and many of the substantive changes to patent law associated with the Leahy-Smith Act did not become effective until 18 months after its enactment.  Accordingly, it is not clear what, if any, impact the Leahy-Smith Act will have on the cost of prosecuting our patent applications, our ability to obtain patents based on our patent applications and our ability to enforce or defend our issued patents.  An inability to obtain, enforce and defend patents covering our proprietary technologies would materially and adversely affect our business prospects and financial condition.  Further, the laws of some foreign countries do not protect proprietary rights to the same extent as the laws of the United States.  As a result, we may encounter significant problems in protecting and defending our intellectual property both in the United States and abroad.  If we are unable to prevent material disclosure of the intellectual property related to our technologies to third parties, we will not be able to establish or, if established, maintain a competitive advantage in our market, which could materially adversely affect our business, operating results and financial condition.
 
Trademark protection of our products may not provide us with a meaningful competitive advantage.
 
                We use trademarks on most of our currently marketed branded products and believe that having distinctive marks is an important factor in marketing those products.  Trademarks are also an important factor in marketing products of other parties under license or co-promotion agreements.  Distinctive marks may also be important for any additional products that we successfully develop and commercially market.  However, we generally do not expect our marks to provide a meaningful competitive advantage over other branded or generic products.  We believe that efficacy, safety, convenience, price, the level of generic competition and the availability of reimbursement from government and other third party payors are and are likely to continue to be more important factors in the commercial success of our products.  For example, physicians and patients may not readily associate our trademark with the applicable product or active pharmaceutical ingredient.  In addition, prescriptions written for a branded product are typically filled with the generic version at the pharmacy, resulting in a significant loss in sales of the branded product, including for indications for which the generic version has not been approved for marketing by the FDA.  Competitors also may use marks or names that are similar to our trademarks.  If we initiate legal proceedings to seek to protect our trademarks, the costs of these proceedings could be substantial and it is possible that our efforts could be unsuccessful.
 
 
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If we fail to comply with our obligations 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 obligations on us.
 
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 licensed patents.  Even if we contest any such termination or claim and are ultimately successful, our results of operations and stock price could suffer.  In addition, upon any termination of a license agreement, we may be required to license to the licensor any related intellectual property that we developed.  
             
            For example, we in-licensed rights to Silenor through an exclusive licensing arrangement, and may enter into similar licenses in the future.  Under our license agreement for Silenor, we are required to use commercially reasonable efforts to commercialize Silenor.  In addition, our licensor has the contractual right to terminate the license agreement upon the breach by us or a specified insolvency event.  In the event that our licensor for Silenor terminates the license agreement, even though we would maintain ownership of our clinical data and the other intellectual property we developed relating to Silenor, we would be unable to continue our commercialization activities relating to Silenor and our business and financial condition may be materially harmed.
 
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 patented technology, we rely upon unpatented proprietary technology, processes and know-how.  We seek to protect our unpatented proprietary information in part by confidentiality agreements with our employees, consultants and third parties.  We may not be able to prevent the unauthorized disclosure or use of our technical knowledge or other trade secrets by consultants, third parties, vendors or former or current employees, despite the existence generally of confidentiality agreements and other contractual restrictions.  Monitoring unauthorized use and disclosure of our intellectual property is difficult, and we do not know whether the steps we have taken to protect our intellectual property will be adequate.
 
            In addition, the laws of many foreign countries may not protect our intellectual property rights to the same extent as the laws of the United States.  To the extent that our intellectual property protection is inadequate, we are exposed to a greater risk of direct competition.  If our intellectual property is not adequately protected against competitors’ products, our competitive position could be adversely affected, as could our business.  We also rely upon trade secrets, technical know-how and continuing technological innovation to develop and maintain our competitive position.  We require our consultants and third parties, when appropriate, to execute confidentiality and assignment-of-inventions agreements with us.  These agreements typically provide that all materials and confidential information developed or made known to the individual during the course of the individual’s relationship with us be kept confidential and not disclosed to third parties except in specific circumstances and that all inventions arising out of the individual’s relationship with us shall be our exclusive property.  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 may fall within the scope of one or more claims in a published patent application that may be subsequently issued and to which we do not hold a license or other rights.  Third parties may own or control these patents or patent applications in the United States and/or abroad.  Such third parties 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.
 
 
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              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 practicing the subject matter claimed in such patents, or would be required to obtain licenses from the patent owners of each such patent, or to redesign our products, and could be liable for monetary 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, if, as a result of actual or threatened patent infringement claims, we or our collaborators are unable to enter into licenses on acceptable terms.  This could harm our business significantly.  Accordingly, an adverse determination in a judicial or administrative proceeding or failure to obtain necessary licenses could prevent us or our future collaborators from manufacturing and selling our products, which would have a material adverse effect on our business, financial condition and results of operations.
            
          There has been substantial litigation and other proceedings regarding patent 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.
 
Although a granted three-year Hatch-Waxman exclusivity has been granted for Zohydro ER, Zogenix executed a waiver agreement with Purdue of the three-year Hatch-Waxman regulatory exclusivity period with respect to NDA 202880 for Zohydro ER in support of the Purdue Products and we can offer no assurance that such exclusivity will effectively prevent or otherwise limit further competition from other hydrocodone products, either generic or otherwise.
 
In addition to patent protection, we will rely in part, on Hatch-Waxman marketing exclusivity for the commercialization of Zohydro ER in the United States.  Under the Drug Price Competition and Patent Term Restoration Act of 1984, known as the Hatch-Waxman Amendments, newly approved drugs may benefit from certain statutory periods of non-patent marketing exclusivity in the United States.  Exclusivity provides the holder of an approved application limited protection from new competition in the marketplace for the innovation represented by its approved drug product.
 
A three-year period of exclusivity is available for a drug product that contains an active ingredient that has been previously approved and the application contains reports of new clinical investigations (other than bioavailability studies) conducted or sponsored by the applicant that were essential to approval of the application.  Changes to an approved drug product that may qualify for this exclusivity include changes that affect the product’s active ingredient(s), strength, dosage form, route of administration, or conditions of use, so long as clinical investigations were essential to approval of the application containing those changes.  The exclusivity prevents FDA from approving other applications for the same change for three years from the date of the new product’s approval.
 
While Zohydro ER has been granted three-year Hatch-Waxman exclusivity as the first single-entity hydrocodone product approved for the treatment of chronic pain on the basis of a comprehensive Phase 3 safety and efficacy program, there can be no assurance that such exclusivity will effectively prevent or otherwise limit competition from other hydrocodone products, either generic or otherwise.  On October 29, 2014, Zogenix entered into a waiver agreement with Purdue, pursuant to which Zogenix granted a waiver to Purdue of the three-year Hatch-Waxman regulatory exclusivity period with respect to NDA 202880 for Zohydro ER in support of the Purdue Products.  On November 20, 2014, Purdue announced that the FDA had approved its product Hysingla ER®.  Such competition by the Purdue Products and other hydrocodone products, including other 505(b)(2) applications for different conditions of use or other changes to the hydrocodone products that would not be restricted by the three-year exclusivity, could have a significantly negative impact on our future revenues from Zohydro ER.
 
 
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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 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 successfully integrate the operations of newly acquired businesses and assets into our product portfolio;
 
the level of product sales from 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 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 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 and 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.  Any exploration of strategic alternatives may not result in an agreement or transaction and, if completed, any agreement or transaction may not be successful or on attractive terms.  The inability to enter into a strategic transaction, or a strategic transaction that is not successful or on attractive terms, could accelerate our need for cash and make securing funding on reasonable terms more difficult.  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.
 
                    If our efforts in raising additional funds when needed 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 choose or 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 may 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 accounting principles generally accepted in the United States.  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 on 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.
 
The accounting method for convertible debt securities that may be settled in cash, such as the notes we recently issued in connection with the Zohydro ER acquisition, could have a material effect on our reported financial results.

In May 2008, the Financial Accounting Standards Board, which we refer to as FASB, issued FASB Staff Position No.  APB 14-1, Accounting for Convertible Debt Instruments That May Be Settled in Cash Upon Conversion (Including Partial Cash Settlement), which has subsequently been codified as Accounting Standards Codification 470-20, Debt with Conversion and Other Options, which we refer to as ASC 470-20.  Under ASC 470-20, an entity must separately account for the liability and equity components of convertible debt instruments that may be settled entirely or partially in cash upon conversion in a manner that reflects the issuer’s economic interest cost.  The effect of ASC 470-20 on the accounting for the notes we recently issued in connection with the Zohydro ER acquisition would be that the equity component would be required to be included in the additional paid-in capital section of stockholders’ equity on our consolidated balance sheet, and the value of the equity component would be treated as original issue discount for purposes of accounting for the debt component of the notes.  As a result, we would be required to record a greater amount of non-cash interest expense in current periods presented as a result of the amortization of the discounted carrying value of the notes to their face amount over the term of the notes.  We would report lower net income in our financial results because ASC 470-20 would require interest to include both the current period’s amortization of the debt discount and the instrument’s coupon interest, which could adversely affect our reported or future financial results, the trading price of our common stock and the trading price of the notes.

Furthermore, under certain circumstances, convertible debt instruments that may be settled entirely or partly in cash are currently accounted for utilizing the treasury stock method, the effect of which is that the shares issuable upon conversion of such convertible debt instruments are not included in the calculation of diluted earnings per share except to the extent that the conversion value of such convertible debt instruments exceeds their principal amount.  Under the treasury stock method, for diluted earnings per share purposes, the transaction is accounted for as if the number of shares of common stock that would be necessary to settle such excess, if we elected to settle such excess in shares, are issued.  We cannot be sure that the accounting standards in the future will continue to permit the use of the treasury stock method.  If we are unable to use the treasury stock method in accounting for the shares issuable upon conversion of the notes (including during the period prior to our receipt of shareholder approval to remove the conversion cap on the notes), then our diluted earnings per share would be adversely affected.
In addition, so long as the conversion share cap applies, the conversion option that is part of the notes may be accounted for as a derivative pursuant to accounting standards relating to derivative instruments and hedging activities.  This could adversely affect our reported or future financial results, the market price of our common stock and the trading price of the notes.
 
 
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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 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.
 
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, 2014, and 2013.  We are currently investing in our promoted product lines and product candidates 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 our credit agreement with MidCap and the indentures governing our outstanding notes 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.    
 
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.
 
 
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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 due to our shifting strategic focus or otherwise, 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.  
          
                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.

The historical and pro forma financial statements we have filed with the SEC relating to Treximet may not be an indication of our ability to commercialize Treximet

              In August 2014, we completed the acquisition of the intellectual property rights to Treximet in the United States from GSK.  In October 2014, we filed historical financial statements and pro forma financial information relating to the Treximet product line, and the SEC stated that it would not object to our conclusion that the filing of the historical financial statements relating to the Treximet product line represents substantial compliance with the requirements of Rule 3-05 of Regulation S-X, or Rule 3-05.  However, we were advised by GSK that the Treximet product line had not been a separate legal entity of GSK and was never operated as a stand-alone business, division or subsidiary.  GSK also advised us that it had never prepared full stand-alone or full carve-out financial statements for the Treximet business, and that GSK has never maintained the distinct and separate accounts necessary to prepare financial statements that fully comply with the requirements of Rule 3-05.  As a result, these historical statements may not be an indication of the performance of Treximet under GSK for the periods indicated.  In addition, the assumptions used in preparing the pro forma financial information may not prove to be accurate or relevant to the Treximet product line, in particular on a go-forward basis, and therefore should not be relied upon as a measure of our ability to commercialize Treximet.
 
 
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Risks Related to Product Development
 
  We may invest a significant portion of our efforts and financial resources in the development of our product candidates and there is no guarantee we will obtain requisite regulatory approvals or otherwise timely bring these product candidates to market.
 
            Our ability to bring any of our product candidates to market depends on a number of factors including:
 
successful completion of pre-clinical laboratory and animal testing;
 
an FDA approved investigational new drug application or IND application, becoming effective, which must occur before human clinical trials may commence;
 
successful completion of clinical trials;
 
submission of an NDA;
 
receipt of marketing approvals from the FDA;
 
establishing commercial manufacturing arrangements with third-party manufacturers;
 
launching commercial sales of the product;
 
acceptance of the product by patients, the medical community and third party payors;
 
competition from other therapies;
 
achieving and maintaining compliance with all regulatory requirements applicable to the product; and
 
a continued acceptable safety profile of the product following approval.
 
There are no guarantees that we will be successful in completing these tasks.  If we are not successful in commercializing any of our product candidates, or are significantly delayed in doing so, our business will be harmed, possibly materially.
 
If our clinical trials do not demonstrate safety and efficacy in humans, we may experience delays, incur additional costs and ultimately be unable to commercialize our product candidates.
 
            Before obtaining regulatory approval for the sale of some of our product candidates, we must conduct, at our own expense, extensive clinical trials to demonstrate the safety and efficacy of our product candidates in humans.  In the United States, we must demonstrate with substantial evidence gathered in well-controlled studies, and to the satisfaction of the FDA, that each product candidate is safe and effective for use in the target indication.  Clinical testing is expensive, difficult to design and implement, can take many years to complete and is uncertain as to outcome.  The outcome of early clinical trials may not be predictive of the success of later clinical trials, and interim results of a clinical trial do not necessarily predict final results.  Even if early phase clinical trials are successful, it is necessary to conduct additional clinical trials in larger numbers of patients taking the drug for longer periods before seeking approval from the FDA to market and sell a drug in the United States.  Clinical data is often susceptible to varying interpretations, and companies that have believed their products performed satisfactorily in clinical trials have nonetheless failed to obtain FDA approval for their products.  Similarly, even if clinical trials of a product candidate are successful in one indication, clinical trials of that product candidate for other indications may be unsuccessful.  A failure of one or more of our clinical trials can occur at any stage of testing.
 
 
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Failures or delays in the commencement or completion of our clinical trials could result in increased costs to us and delay or limit our ability to generate revenues.
 
            We may experience numerous unforeseen events during, or as a result of, the clinical trial process that could delay or prevent our ability to receive regulatory approval or commercialize our product candidates.  Commencement or completion of clinical trials can be delayed or prevented for a number of reasons, including:
 
FDA or institutional review boards may not authorize us to commence a clinical trial or conduct a clinical trial at a prospective trial site;
 
difficulty complying with conditions imposed by a regulatory authority regarding the scope or term of a clinical trial;
 
delays in reaching or failure to reach agreement on acceptable terms with prospective clinical research organizations, or CROs, and trial sites, the terms of which can be subject to extensive negotiation and may vary significantly among different CROs and trial sites;
 
our clinical trials may produce negative or inconclusive results, and we may decide, or the FDA or analogous foreign governmental entities may require us, to conduct additional clinical trials or we may abandon projects that we expect to be promising;
 
the number of patients required for our clinical trials may be larger than we anticipate, enrollment in our clinical trials may be slower or more difficult than we anticipate, or participants may drop out of our clinical trials at a higher rate than we anticipate;
 
our third-party contractors may fail to comply with regulatory requirements or meet their contractual obligations to us in a timely manner;
 
we might have to suspend or terminate our clinical trials if the participants are being exposed to unacceptable health risks;
 
regulators or institutional review boards may require that we hold, suspend or terminate clinical research for various reasons, including noncompliance with regulatory requirements;
 
the cost of our clinical trials may be greater than we anticipate;
 
the supply or quality of our product candidates or other materials necessary to conduct our clinical trials may be insufficient or inadequate; and
 
the effects of our product candidates may not be the desired effects or may include undesirable side effects or the product candidates may have other unexpected characteristics.
 
If we are required to conduct additional clinical trials or other testing of our product candidates in addition to those that we currently contemplate, if we are unable to successfully complete our clinical trials or other testing, if the results of these trials or tests are not positive or are only modestly positive or if there are safety concerns, we may:
 
be delayed in obtaining marketing approval for one or more of our product candidates;
 
not be able to obtain marketing approval; or
 
obtain approval for indications that are not as broad as intended.
 
     Our product development costs also will increase if we experience delays in testing or approvals.  Significant clinical trial delays also could shorten the patent protection period during which we may have the exclusive right to commercialize our product candidates or allow our competitors to bring products to market before we do and impair our ability to commercialize our products or product candidates.  In addition, failure to conduct the clinical trial in accordance with regulatory requirements or the trial protocols may also result in the ineligibility to use the data to support market approval.
 
Risks Related to Regulatory Matters
 
Some of our specialty pharmaceutical products are now being marketed without FDA approvals.
 
Even though the FDCA requires pre-marketing approval of all new drugs, as a matter of history and regulatory policy, the FDA has historically refrained from taking enforcement action against some marketed, unapproved new drugs.  Specifically, some marketed prescription and nonprescription drugs are not the subject of an approved marketing application because they are thought to be identical, related, or similar to historically-marketed products, which were thought not to require pre-market review and approval, or which were approved only on the basis of safety, at the time they entered the marketplace.  When enacted in 1938, the FDCA required proof of safety but not efficacy for new drugs.  Between 1938 and 1962, if a drug obtained approval, FDA considered drugs that were identical, related, or similar to the approved drug to be covered by that approval, and allowed those drugs to be marketed without independent approval.  In 1962, Congress amended the FDCA to require that a new drug be proven effective, as well as safe, to obtain FDA approval.  The FDA established the Drug Efficacy Study Implementation, or DESI, program, which was established to determine the effectiveness of drug products approved before 1962.  Drugs that were not subject to applications approved between 1938 and 1962 were not subject to DESI review.  For a period of time, the FDA permitted these drugs to remain on the market without approval. In 1984, the FDA created a program, known as the Prescription Drug Wrap-Up, also known as DESI II, to address the remaining unapproved drugs.  Most of these drugs contain active pharmaceutical ingredients that were first marketed prior to 1938.  The FDA asserts that all drugs subject to the Prescription Drug Wrap-Up are on the market illegally and are subject to FDA enforcement discretion because all prescription drugs must be the subject of an approved drug application.
 
 
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There are a few narrow exceptions.  Under the 1938 grandfather clause, a drug product that was on the market prior to the passage of the FDCA in 1938 and which contains in its labeling the same representations concerning the conditions of use as it did prior to passage of the FDCA was not considered a “new drug” and therefore was exempt from the requirement of having an approved NDA.  The 1962 grandfather clause exempts a drug from the effectiveness requirements if its composition and labeling has not changed since 1962 and if, on the day before the 1962 Amendments became effective, it was (a) used or sold commercially in the United States, (b) not a new drug as defined by the FDCA at that time, and (c) not covered by an effective application.  The FDA and the courts have interpreted these two grandfather clauses very narrowly.  The FDA believes that there are very few drugs on the market that are actually entitled to grandfather status because the drugs currently on the market likely differ from the previous versions in some respect, such as formulation, dosage or strength, dosage form, route of administration, indications, or intended patient population.  It is a company’s burden to prove that its product is grandfathered.
 
                The FDA has adopted a risk-based enforcement policy concerning these unapproved drugs.  While all such drugs are considered to require FDA approval, FDA enforcement against such products as unapproved new drugs prioritizes products that pose potential safety risks, lack evidence of effectiveness, prevent patients from seeking effective therapies or are marketed fraudulently.  In addition, the FDA has indicated that approval of an NDA for one drug within a class of drugs marketed without FDA approval may also trigger agency enforcement of the new drug requirements against all other drugs within that class that have not been so approved.  
            
               Some of our specialty pharmaceutical products are marketed in the United States without an FDA-approved marketing application because they have been considered by us to be identical, related or similar to products that have existed in the market without an NDA or ANDA.  These products are marketed subject to the FDA’s regulatory discretion and enforcement policies, and it is possible that the FDA could disagree with our determination that one or more of these products is identical, related or similar to products that have existed in the marketplace without an NDA or ANDA.  On March 3, 2011, the FDA announced its intent to remove certain unapproved prescription cough, cold, and allergy products from the U.S. market and named products from two cough and cold product families that Pernix sold, as well as certain Cypress products.  The FDA provided three dates for the cessation of manufacturing, shipping or other introduction or delivery into commerce – March 3, 2011 for drugs not listed with the FDA under Section 510 of the FDCA, June 1, 2011 for cessation of manufacturing of listed drugs and August 31, 2011 for cessation of shipping of listed drugs covered by the notice.  Manufacturing or shipping of the drug products covered by the notice beyond the date specified can result in enforcement action, including seizure, injunction, or other judicial or administrative proceedings.  The time periods will not be extended for those who have submitted but not yet received approval of an NDA or ANDA application for a drug product covered by the notice.  The Company completed the conversion of the ALDEX and BROVEX product families, two of our legacy cough and cold product families, to OTC monograph from DESI drugs in 2011. The Company believes it has appropriately marketed these lines as OTC monograph products.  If the FDA were to disagree with our determination, it could require the removal of our unapproved products from the market.  We voluntarily discontinued these products in 2013.
 
                The Company’s authorized generic products that are OTC monograph products have not been affected by the FDA announcement.  Certain Macoven generic products that were not marketed as OTC monograph were converted, and we did not experience any suspension, delay or interruption in our sales of these products.  Our remaining generic DESI cough and cold products that were not being converted to OTC monograph were phased out by 2011 and did not have a material impact on the results of operations or financial condition of the Company.  If the FDA were to disagree with our determination, it could ask or require the removal of our unapproved products from the market; however, this would no longer have a material impact on our gross sales.
 
 
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                In addition, if the FDA issues an approved NDA for one of the drug products within the class of drugs that includes one or more of our unapproved products or completes the efficacy review for that drug product, it may require us to also file an NDA or ANDA application for its unapproved products in that class of drugs in order to continue marketing them in the United States.  While the FDA generally provides sponsors with a one-year grace period during which time they are permitted to continue selling the unapproved drug, it is not statutorily required to do so and could ask or require that the unapproved products be removed from the market immediately.  In addition, the time it takes us to complete the necessary clinical trials and submit an NDA or ANDA to the FDA may exceed any applicable grace period, which would result in an interruption of sales of such unapproved products.  If the FDA asks or requires that the unapproved products be removed from the market, our financial condition and results of operations would be materially and adversely affected.
 
If the FDA disagrees with our determination that several of our products meet the over-the-counter requirements, those products may be removed from the market.
 
                Drugs must meet all of the general conditions for OTC drugs and all of the conditions contained in an applicable final monograph to be considered generally recognized as safe and effective (GRAS/GRAE) and to be marketed without FDA approval of a marketing application.  The general conditions include, among other things, compliance with cGMP, establishment registration and labeling requirements.  Any product which fails to comply with the general conditions and a monograph is liable to regulatory action.  We believe our promoted branded products comply with FDA OTC monograph requirements.  However, if the FDA determines that our products do not comply with the monograph or if we fail to meet the general conditions, the products may be removed from the market and we may face actions including, but not limited to, restrictions on the marketing or distribution of such products, warning letters, fines, product seizure, or injunctions or the imposition of civil or criminal penalties.  Any of these actions would reduce our gross sales.
 
The implementation of a Risk Evaluation and Mitigation Strategy (“REMS”) for Zohydro ER has resulted in additional regulatory requirements, including the requirement for a medication guide and educational requirements for prescribers and patients, which could significantly impact our ability to commercialize Zohydro ER and dramatically reduce its market potential.
 
The Federal Food, Drug and Cosmetic Act (“FFDCA”) permits the FDA to require a REMS for a drug product to ensure the safe use of the drug.  A REMS is a strategic safety program that the FDA requires to ensure that the benefits of a drug outweigh its risks.  In determining whether a REMS is necessary, the FDA will consider the size of the population likely to use the drug, the seriousness of the disease or condition to be treated, the expected benefit of the drug, the duration of treatment, the seriousness of known or potential adverse events, and whether the drug is a new molecular entity.  If the FDA determines a REMS is necessary, the drug sponsor must agree to the REMS plan at the time of approval.  A REMS may be required to include various elements, such as a medication guide or patient package insert, a communication plan to educate health care providers of the drug’s risks, limitations on who may prescribe or dispense the drug, requirements that patients enroll in a registry or undergo certain health evaluations, or other measures that the FDA deems necessary to assure the safe use of the drug.  In addition, the REMS must include a timetable to assess the strategy minimally at 18 months, three years and seven years after the strategy's approval.
 
In February 2009, the FDA informed opioid analgesic drug manufacturers that it would require a class-wide REMS for all long-acting and sustained-release opioid drug products, and as an extended-release formulation of hydrocodone, Zohydro ER became subject to the ER/LA opioid REMS upon approval.  Pursuant to the FFDCA, the manufacturers subject to this class-wide REMS must work together to implement the REMS as part of a single shared system to reduce the burden of the REMS on the healthcare system.  The central component of the ER/LA opioid REMS program is an education program for prescribers and patients.  Specifically, the REMS for these products includes a medication guide available for distribution to patients who are dispensed the drug, as well as a number of elements to assure safe use.  These elements include training for healthcare professionals who prescribe the drug; information provided to prescribers that they can use to educate patients in the safe use, storage, and disposal of opioids; and information provided to prescribers of the existence of the REMS and the need to successfully complete the necessary training.  The prescriber training required as part of the REMS is conducted by accredited, independent continuing education providers, without cost to the healthcare professionals, under unrestricted grants funded by the opioid analgesic manufacturers.  Moreover, REMS assessments must be submitted to the FDA on an annual basis to assess the extent to which the elements to assure safe use are meeting the goals of the REMS and whether the goals or elements should be modified.
 
 
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In addition to the REMS, on September 10, 2013 the FDA announced post-marketing requirements for all ER/LA opioid analgesic NDA holders, which we are required to comply with.  These post-marketing requirements are currently being addressed by the NDA holders.  These requirements and the REMS could significantly impact our ability to commercialize Zohydro ER and dramatically reduce its market potential.
 
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.
 
                Our 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.  Failure to obtain regulatory approval for a product candidate will prevent us from commercializing the product candidate.  Securing FDA approval requires the submission of extensive preclinical and clinical data and supporting information to the FDA 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.  Our future products may not be effective, may be only moderately effective or may prove to 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 regulatory review for each submitted product application, may cause delays in the approval 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.  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 we ultimately obtain may be limited or subject to restrictions or post-approval commitments that render the approved product not commercially viable.

If we are unable to achieve and maintain adequate levels of coverage and reimbursement for Zohydro ER, its commercial success may be severely hindered.

Our sales of Zohydro ER will be dependent, in part, on the availability of coverage and adequate reimbursement from third-party payors, including government health care programs such as Medicare and Medicaid, and private insurance plans.  Favorable coverage decisions and adequate reimbursement from governmental healthcare programs, such as Medicare and Medicaid, and commercial payors are critical to new product acceptance.  Coverage decisions may depend upon clinical and economic standards that disfavor new drug products when more established or lower cost therapeutic alternatives are already available or subsequently become available.  Assuming coverage is approved, the resulting reimbursement payment rates might not be adequate or may require co-payments that patients find unacceptably high.  Patients are unlikely to use Zohydro ER unless coverage is provided and reimbursement is adequate to cover a significant portion of its cost.

Third-party payors, whether foreign or domestic, or governmental or commercial, are developing increasingly sophisticated methods of controlling healthcare costs.  In addition, in the United States, no uniform policy of coverage and reimbursement for drug products exists among third-party payors.  Therefore, coverage and reimbursement for drug products can differ significantly from payor to payor.

In addition, the market for Zohydro ER will depend significantly on access to third-party payors’ drug formularies, or lists of medications for which third-party payors provide coverage and reimbursement.  The industry competition to be included in such formularies often leads to downward pricing pressures on pharmaceutical companies.  Also, third-party payors may refuse to include a particular branded drug in their formularies or otherwise restrict patient access to a branded drug when a less costly generic equivalent or other alternative is available.  For example, in August 2014, Express Scripts added Zohydro ER to its list of excluded drugs for its National Preferred Drug formulary for 2015.  Express Scripts is the largest U.S. pharmacy benefit manager, and the inclusion of Zohydro ER on its list of excluded drugs for their National Preferred Drug formulary has had a negative impact on prescriptions and sales of Zohydro ER.
 
 
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In addition, regional healthcare authorities and individual hospitals are increasingly using competitive bidding procedures to determine what pharmaceutical products and which suppliers will be included in their prescription drug and other healthcare programs.  This may reduce demand for Zohydro ER or put pressure on our pricing of Zohydro ER, which could negatively affect our business, results of operations, financial condition and prospects.

Any product for which we obtain 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, when and if any of them are approved.
 
Any product for which we obtain marketing approval, along with the manufacturing processes, post-approval clinical data, recordkeeping, labeling, advertising and promotional activities for such product, will be subject to continual requirements of and review by the FDA and comparable regulatory authorities.  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 if regulatory approval of a product is granted, the approval may be subject to limitations on the indicated uses for which the product may be marketed or to the conditions of approval, or contain 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 actions such as:
 
withdrawal of the products from the market;
 
restrictions on the marketing or distribution of such products;
 
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; or
 
injunctions or the imposition of civil or criminal penalties.
 
            In addition, the FDA strictly regulates labeling, advertising, promotion and other types of information on products that are placed on the market.  Drugs may be promoted only for the approved indications and in accordance with the provisions of the approved label, or for the indications specified in an applicable OTC monograph and in accordance with the monograph’s labeling requirements.  An organization that is found to have improperly promoted off-label uses may be subject to significant liability by the FDA and other agencies that actively enforce laws and regulations prohibiting the promotion of off-label uses.  The Federal Trade Commission regulates advertising for OTC drug products and advertising for these products must be truthful, not misleading and adequately substantiated.  If we are found to have promoted off-label uses, our OTC products may be deemed out of compliance with the applicable OTC monograph, we may be enjoined from such off-label promotion and become subject to significant liability, which would have an adverse effect on our reputation, business and revenues, if any.
 
 
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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 are, and any future sales of our product candidates will be, dependent, in part, on the availability of coverage and reimbursement from third-party payors, including government health care programs such as Medicare and Medicaid, and private insurance plans.  All of our products are generally 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.  For example, Cedax is covered by private insurance plans similar to other marketed, branded cephalosporins.  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 and submit all of our products for inclusion in this program.  Coverage of our products under individual state Medicaid plans varies from state to state.  Additionally, some of our products are purchased under the 340B Drug Pricing Program, which is codified as Section 340B of the Public Health Service Act.  Section 340B limits the cost of covered outpatient drugs to certain federal grantees, federally qualified health center lookalikes and qualified disproportionate share hospitals.
 
              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 the MMA, created a new Medicare benefit for prescription drugs.  More recently, the Deficit Reduction Act of 2005 significantly reduced reimbursement for drugs under the Medicaid program.  Legislative or administrative acts that reduce reimbursement for our products could adversely impact our business.
 
                In March 2010, the President signed the PPACA, which makes extensive changes to the delivery of healthcare in the U.S.  This act includes numerous provisions that affect pharmaceutical companies, some of which were effective immediately and others of which will be taking effect over the next several years.  For example, the act seeks to expand healthcare coverage to the uninsured through private health insurance reforms and an expansion of Medicaid.  The act also imposes substantial costs on pharmaceutical manufacturers, such as an increase in liability for rebates paid to Medicaid, new drug discounts that must be offered to certain enrollees in the Medicare prescription drug benefit, an annual fee imposed on all manufacturers of brand prescription drugs in the U.S., increased disclosure obligations and an expansion of an existing program requiring pharmaceutical discounts to certain types of hospitals and federally subsidized clinics.  The act also contains cost-containment measures that could reduce reimbursement levels for healthcare items and services generally, including pharmaceuticals.  It also will require reporting and public disclosure of payments and other transfers of value provided by pharmaceutical companies to physicians and teaching hospitals.  These measures could result in decreased net revenues from our pharmaceutical products and decreased potential returns from our development efforts.  Although the PPACA was recently upheld by the U.S. Supreme Court, it is possible that the PPACA may be modified or repealed in the future.  
            
            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 may change at any time.
 
 
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              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 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 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.
 
            If we succeed in bringing 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.
 
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, reputation harm, and diminished profits and future earnings.
 
            Healthcare providers, physicians and others play a primary role in the recommendation and prescription of our products.  Our arrangements with third-party payors and customers may expose 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, persons from knowingly and willfully soliciting, offering, receiving or providing remuneration, directly or indirectly, in cash or in kind, to induce or reward either the referral of an individual for, or the purchase, order or recommendation of, any good or service, for which payment may be made under federal healthcare programs such as Medicare and Medicaid;
 
the Ethics in Patient Referrals Act, commonly referred to as the Stark Law, and its corresponding regulations, prohibit physicians from referring patients for designated health services reimbursed under the Medicare and Medicaid programs to entities with which the physicians or their immediate family members have a financial relationship or an ownership interest, subject to narrow regulatory exceptions;
 
the federal False Claims Act imposes criminal and civil penalties, including civil whistleblower or qui tam actions, against individuals or entities for knowingly presenting, or causing to be presented, to the federal government, claims for payment that are false or fraudulent or making a false statement to avoid, decrease, or conceal an obligation to pay money 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 federal 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 and also imposes obligations, including mandatory contractual terms, with respect to safeguarding the privacy, security and transmission of individually identifiable health information;
 
the federal false statements statute prohibits knowingly and willfully falsifying, concealing or covering up a material fact or making any materially false statement in connection with the delivery of or payment for healthcare benefits, items or services; and
 
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, and some state laws require pharmaceutical companies to comply with the pharmaceutical industry’s voluntary compliance guidelines and the relevant compliance guidance promulgated by the federal government.
 
 
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In addition, there have been a number of other legislative and regulatory proposals aimed at changing the pharmaceutical industry.  These include proposals to permit reimportation of pharmaceutical products from other countries and proposals concerning safety matters.  For example, in an attempt to protect against counterfeiting and diversion of drugs, a bill was introduced in a previous Congress that would establish an electronic drug pedigree and track-and-trace system capable of electronically recording and authenticating every sale of a drug unit throughout the distribution chain.  This bill or a similar bill may be introduced in Congress in the future.  California has already effected legislation that requires development of an electronic pedigree to track and trace each prescription drug at the saleable unit level through the distribution system. Compliance with California and any future federal or state electronic pedigree requirements will likely require an increase in our operational expenses and will likely be administratively burdensome.  As a result of these and other new proposals, we may determine to change our current manner of operation, provide additional benefits or change our contract arrangements, any of which could have a material adverse effect on our business, financial condition and results of operations.
 
We, as well as many other pharmaceutical companies, sponsor prescription drug coupons and other cost-savings programs to help reduce the burden of co-payments and co-insurance.  During 2012, lawsuits have been filed against several pharmaceutical companies alleging, among other things, that the drug-makers violated anti-trust laws and the Racketeer Influenced and Corrupt Organizations Act, or RICO, when they provided coupon programs to privately-insured consumers that subsidize all or part of the cost-sharing obligation (co-pay or co-insurance) for a branded prescription drug or drugs.  We cannot be certain as to whether we will be named in any future similar lawsuit or concerning the potential outcome of the ongoing litigation.  
        
              Efforts to ensure that our business arrangements with third parties comply with applicable healthcare laws and regulations could be costly.  It is possible that governmental authorities will conclude that our business practices may 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, are 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, fines, exclusion from third-party payor 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, which increases the risk of potential violations.  In addition, these laws and their interpretations are subject to change.  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.
 
The Food and Drug Administration Amendments Act of 2007 may make it more difficult and costly for us to obtain regulatory approval of our product candidates and to produce, market and distribute our existing products.
 
                The Food and Drug Administration Amendments Act of 2007, or the FDAAA, grants a variety of new powers to the FDA, many of which are aimed at improving drug safety and assuring the safety of drug products after approval.  The amendments, among other things, require some new drug applicants to submit risk evaluation and minimization strategies to monitor and address potential safety issues for products upon approval, grant the FDA the authority to impose risk management measures for marketed products and to mandate labeling changes in certain circumstances, and establish new requirements for disclosing the results of clinical trials.  Companies that violate the law are subject to substantial civil monetary penalties.  Additional measures have also been enacted to address the perceived shortcomings in the FDA’s handling of drug safety issues, and to limit pharmaceutical company sales and promotional practices.  While the FDAAA has had, and is expected to have, a substantial effect on the pharmaceutical industry, the full extent of that effect is not yet known.  As the FDA issues further regulations, guidance and interpretations relating to this legislation, the impact on the industry as well as our business will become clearer.  The requirements and other changes that the FDAAA imposes may make it more difficult, and likely more costly, to obtain approval of new pharmaceutical products and to produce, market and distribute existing products.  Our and our partners’ ability to commercialize approved products successfully may be hindered, and our business may be harmed as a result.
 
 
61

 
 
We may be subject to investigations or other inquiries concerning our compliance with reporting obligations under federal healthcare program pharmaceutical pricing requirements.
 
              Under federal healthcare programs, some state governments and private payors investigate and have filed civil actions against numerous pharmaceutical companies alleging that the reporting of prices for pharmaceutical products has resulted in false and overstated average wholesale price, which in turn may be alleged to have improperly inflated the reimbursements paid by Medicare, private insurers, state Medicaid programs, medical plans and others to healthcare providers who prescribed and administered those products or pharmacies that dispensed those products. These same payors may allege that companies do not properly report their “best prices” to the state under the Medicaid program.  Suppliers of outpatient pharmaceuticals to the Medicaid program are also subject to price rebate agreements.  Failure to comply with these price rebate agreements may lead to federal or state investigations, criminal or civil liability, exclusion from federal healthcare programs, contractual damages, and otherwise harm our reputation, business and prospects.
 
Annual Drug Enforcement Administration (“DEA”) quotas on the amount of hydrocodone allowed to be produced in the United States, and the DEA’s specific allocation of hydrocodone production to us could significantly limit the production or sale of Zohydro ER.
 
The DEA limits the production and availability of all Schedule II substances through a quota system which includes a national aggregate production quota and individual procurement quotas.  Because hydrocodone is subject to the DEA’s production and procurement quota scheme, the DEA establishes annually an aggregate production quota for how much hydrocodone may be produced in total in the United States based on the DEA’s estimate of the quantity needed to meet legitimate scientific and medicinal needs.  This limited aggregate amount of hydrocodone that the DEA allows to be produced in the United States each year is allocated among individual companies, which must submit applications annually to the DEA for individual production and procurement quotas.  The DEA may adjust individual procurement quotas from time to time during the year, although the DEA has substantial discretion in whether or not to make such adjustments.  The DEA requires substantial evidence and documentation of expected legitimate medical and scientific needs before assigning procurement quotas to manufacturers and research organizations.  Daravita, which has licensed us the right to sell Zohydro ER in the United States, has been granted sufficient procurement quota of hydrocodone by the DEA to support our expected current demand of Zohydro ER and expected growth through the end of 2015.
 
We do not know what amounts of hydrocodone other companies manufacturing or developing product candidates containing hydrocodone may request for future years.  The DEA, in assessing factors such as medical need, abuse and diversion potential and other policy considerations, may choose to set the aggregate hydrocodone production quota lower than the total amount requested for procurement by the companies.  Daravita is permitted to petition the DEA to increase the annual procurement quota after it is initially established, but there is no guarantee that the DEA would act favorably upon such a petition.  Daravita’s procurement quota of hydrocodone may not be sufficient to meet any future clinical development needs or commercial demand for Zohydro ER.  Any delay or refusal by the DEA in establishing the procurement quota or a reduction in Daravita’s procurement quota for hydrocodone, or the DEA’s failure to increase it over time, could delay or stop commercial sale of Zohydro ER or cause us not to achieve our expected operating results, which could have a material adverse effect on our business, results of operations, financial condition and prospects.
 

 
 ITEM 2.
UNREGISTERED SALES OF EQUITY SECURITIES AND USE OF PROCEEDS
 
None.
 
 ITEM 3.
DEFAULTS UPON SENIOR SECURITIES
 
None.
 
 
62

 
 
 ITEM 4.
MINE SAFETY DISCLOSURES
 
 
Not applicable.
 
 ITEM 5.
OTHER INFORMATION
 
None.

ITEM 6.
EXHIBITS
 
EXHIBIT INDEX
 
Exhibit No.
 
Description
     
2.1   Asset Purchase Agreement, dated as of March 10, 2015, between Zogenix Inc., Pernix Ireland Limited, and soley with respect to Sections 5.9.2, 10.2 and 10.14, Pernix Theraputics Holding Inc.
2.2   Amendment to Asset Purchase Agreement, dated as of April 23, 2015, between Zogenix Inc., Pernix Ireland Limited and Pernix Theraputics Holding Inc.
4.1
 
Third Supplemental Indenture, dated as of April 21, 2015, between Pernix Therapeutics Holdings, Inc. and Wilmington Trust, National Association, as Trustee (incorporated by reference to Exhibit 4.1 to the Company’s  Current Report on Form 8-K filed with the Commission on April 24, 2015).
4.2
 
First Supplemental Indenture, dated as of April 21, 2015, between Pernix Therapeutics Holdings, Inc. and U.S. Bank National Association, as Trustee (incorporated by reference to Exhibit 4.2 to the Company’s  Current Report on Form 8-K filed with the Commission on April 24, 2015).
4.3
 
Indenture, dated April 22, 2015, between Pernix Therapeutics Holdings, Inc. and Wilmington Trust, National Association, as Trustee (incorporated by reference to Exhibit 4.3 to the Company’s  Current Report on Form 8-K filed with the Commission on April 24, 2015).
4.4
 
Forms of 4.25% Convertible Senior Notes due 2021 (included in Exhibit 4.3) (incorporated by reference to Exhibit 4.4 to the Company’s  Current Report on Form 8-K filed with the Commission on April 24, 2015).
     
10.1
 
Consent Solicitation Support Agreement, dated as of April 13, 2015, between the Company and each of the Noteholders party thereto (incorporated by reference to Exhibit 10.1 to the Company’s  Current Report on Form 8-K filed with the Commission on April 16, 2015).
10.2
 
Inducement Agreement, dated as of April 16, 2015, by and among Pernix Therapeutics Holdings, Inc. and the investors listed on Schedule 1 thereto (incorporated by reference to Exhibit 10.1 to the Company’s Current Report on Form 8-K filed with the Commission on April 17, 2015).
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 March 31, 2015 and December 31, 2014;
   
(ii) Condensed Consolidated Statements of Operations for the Three Months Ended March 31, 2015 and 2014;
   
(iii) Condensed Consolidated Statements of Cash Flows for the Three Months Ended March 31, 2015 and 2014 and
   
(iv) Notes to Condensed Consolidated Financial Statements.
_______________________

*   Filed herewith.
 
 
63

 
 
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: May 1, 2015
By:
/s/ DOUGLAS L. DRYSDALE
 
   
Douglas L. Drysdale
 
   
Chairman and Chief Executive Officer and President and Director
(Principal Executive Officer)
 
       
Date: May 1, 2015
By:
/s/ SANJAY S. PATEL
 
   
Sanjay S. Patel
Chief Financial Officer
 
   
(Principal Financial Officer)
 
 
 

 
64


 
Exhibit 2.1
CERTAIN MATERIAL (INDICATED BY AN ASTERISK) HAS BEEN OMITTED FROM THIS DOCUMENT PURSUANT TO A REQUEST FOR CONFIDENTIAL TREATMENT. THE OMITTED MATERIAL HAS BEEN FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION.

 
ASSET PURCHASE AGREEMENT
 
By and between
 
PERNIX IRELAND LIMITED
 
and
 
ZOGENIX, INC.
 
 
Dated as of March 10, 2015
 
 
 

 
 
TABLE OF CONTENTS
 
ARTICLE 1     DEFINITIONS  
1
 
1.1
Certain Defined Terms
 
1
 
1.2
Construction
 
22
     
ARTICLE 2     SALE AND PURCHASE OF ASSETS; LIABILITIES  
23
 
2.1
Sale of Purchased Assets
 
23
 
2.2
Liabilities
 
24
 
2.3
Consideration
 
25
 
2.4
Escrow
 
30
 
2.5
Closing
 
31
     
ARTICLE 3     REPRESENTATIONS AND WARRANTIES OF SELLER  
33
 
3.1
Entity Status
 
33
 
3.2
Authority
 
33
 
3.3
Non-Contravention
 
34
 
3.4
No Broker
 
34
 
3.5
No Litigation; Consents
 
34
 
3.6
Title to the Purchased Assets
 
35
 
3.7
Contracts
 
36
 
3.8
Compliance with Law
 
36
 
3.9
Regulatory Matters
 
38
 
3.1
Taxes
 
40
 
3.11
Debarred Personnel
 
40
 
3.12
Intellectual Property
 
41
 
3.13
Inventory
 
44
 
3.14
Product Financial Information
 
44
 
3.15
Sufficiency of Purchased Assets
 
44
 
3.16
Products
 
45
 
3.17
Labor Matters
 
45
 
3.18
Suppliers and Customers
 
46
 
3.19
Solvency
 
46
 
3.2
Affiliate Transactions; Intercompany Arrangements
 
46
 
3.21
Accredited Investor
 
46
 
3.22
Exclusivity of Representations
 
47
     
ARTICLE 4     REPRESENTATIONS AND WARRANTIES OF PURCHASER  
47
 
4.1
Corporate Status
 
47
 
4.2
Authority
 
47
 
4.3
Non-Contravention
 
47
 
4.4
No Broker
 
48
 
4.5
Litigation; Consents
 
48
 
4.6
Financial Capacity
 
48
 
4.7
Exclusivity of Representations
 
48
 
 
i

 
 
     
ARTICLE 5      PRE-CLOSING COVENANTS  
49
 
5.1
No Solicitation
 
49
 
5.2
Access and Information
 
49
 
5.3
Ordinary Course of Business
 
50
 
5.4
Obligation to Consummate the Transaction
 
52
 
5.5
Competition Filings
 
52
 
5.6
Notices
 
53
 
5.7
Paragraph IV Notices
 
54
 
5.8
Product Inventory
 
54
 
5.9
Stock Consideration
 
55
     
ARTICLE 6     ADDITIONAL COVENANTS  
56
 
6.1
Cooperation in Litigation and Investigations
 
56
 
6.2
Further Assurances
 
56
 
6.3
Publicity
 
57
 
6.4
Confidentiality
 
58
 
6.5
FDA Letters
 
60
 
6.6
Regulatory Responsibilities
 
60
 
6.7
Pharmacovigilance Obligations
 
61
 
6.8
Medical and Other Inquiries
 
61
 
6.9
Commercialization
 
61
 
6.1
Returned Products, Chargebacks, Rebates, Health Care Reform Fees and Coupons
 
61
 
6.11
Certain Tax Matters
 
61
 
6.12
Accounts Receivable and Payable
 
63
 
6.13
Net Sales Reports; Audit Rights
 
63
 
6.14
Exclusivity
 
64
 
6.15
Exchange Act Filings
 
65
 
6.16
Release of Encumbrances
 
65
 
6.17
Diligent Efforts
 
65
 
6.18
Financing Cooperation
 
66
     
ARTICLE 7     CONDITIONS PRECEDENT  
66
 
7.1
Conditions to Obligations of Purchaser and Seller
 
67
 
7.2
Conditions to Obligations of Purchaser
 
67
 
7.3
Conditions to Obligations of Seller
 
68
 
7.4
Frustration of Closing Conditions
 
69
     
ARTICLE 8     INDEMNIFICATION  
69
 
8.1
Survival
 
69
 
8.2
Effect of Investigation, Knowledge or Waiver
 
70
 
8.3
Indemnification
 
70
 
8.4
Claim Procedure
 
72
 
8.5
Limitations on Indemnification
 
74
 
8.6
Designated Action
 
76
 
8.7
Tax Treatment of Indemnification Payments
 
77
 
8.8
Exclusive Remedy
 
77
 
8.9
Setoff Rights
 
77
     
ARTICLE 9     TERMINATION  
77
 
9.1
Termination
 
78
 
9.2
Procedure and Effect of Termination
 
79
 
 
ii

 
 
     
ARTICLE 10      MISCELLANEOUS  
79
 
10.1
Governing Law, Jurisdiction, Venue and Service
 
80
 
10.2
Notices
 
81
 
10.3
No Benefit to Third Parties
 
82
 
10.4
Waiver and Non-Exclusion of Remedies
 
82
 
10.5
Expenses
 
82
 
10.6
Assignment
 
83
 
10.7
Amendment
 
83
 
10.8
Severability
 
83
 
10.9
Equitable Relief
 
83
 
10.1
Use of Affiliates
 
83
 
10.11
Bulk Sales Statutes
 
84
 
10.12
Counterparts
 
84
 
10.13
Fair Market Value
 
84
 
10.14
Guarantee
 
84
 
10.15
Entire Agreement
 
85

EXHIBITS
 
Exhibit A
Bill of Sale, Assignment and Assumption Agreement
Exhibit B
Copyright Assignment Agreement
Exhibit C
Domain Name Assignment Agreement
Exhibit D
Patent Assignment Agreement
Exhibit E
Promissory Note
Exhibit F
Registration Rights Agreement
Exhibit G
Security Agreement
Exhibit H
Seller FDA Letters
Exhibit I
Trademark Assignment Agreement
Exhibit J
Transition Services Agreement
Exhibit K
Press Release
 
 
iii

 
 
SCHEDULES
 
Section 1.1.117
Permitted Encumbrances
Section 1.1.125
Product Business Employees
Section 1.1.170
Copyrights
Section 1.1.172
Seller Domain Names
Section 1.1.188
Seller Trademarks
Section 1.1.189
Seller’s Knowledge
Section 2.1.1
Assets
Section 2.3.1
Notional NSP
Section 2.3.2(d)
Development Plan
Section 2.3.3
Product Inventory
Section 3.3
Third Party Consents
Section 3.5.1
Pending Litigation
Section 3.5.2
Outstanding Judgments
Section 3.5.5
Paragraph IV Notices (ANDA or NDA)
Section 3.7.1
Material Contracts
Section 3.7.2
Restrictive Contracts
Section 3.8.2
Seller Authorizations
Section 3.9.1
Regulatory Matters
Section 3.9.2
Adverse Product Facts
Section 3.9.4
Adverse Drug Experiences/Safety Concerns
Section 3.12.1
Intellectual Property Agreements
Section 3.12.2
Registered Product IP
Section 3.12.3
Licensed Product IP
Section 3.12.5
Patent-Involved Litigation/Investigation
Section 3.12.7
IP Infringement on Third Party
Section 3.12.8
Third Party Infringement on IP
Section 3.13.1
Product Inventory
Section 3.14
Product Financial Information
Section 3.15
Sufficiency of Product upon Sale
Section 3.16
Products
Section 3.18
Suppliers and Customers
Section 5.3
Deviation from Ordinary Course of Business
Section 5.3.4
Binding Purchase Orders Entered Into During the Pre-Closing Period
Section 5.8
Product Inventory
Section 8.3.1(e)
Designated Action

 
iv

 

ASSET PURCHASE AGREEMENT
 
This Asset Purchase Agreement (this “ Agreement ”) is made and executed as of March 10, 2015 (the “ Execution Date ”), by and among Zogenix, Inc., a Delaware corporation (“ Seller ”), Pernix Ireland Limited, an Irish corporation (“ Purchaser ”), and, solely with respect to Sections 5.9.2, 10.2 and 10.14, Pernix Therapeutics Holdings, Inc., a Maryland corporation (“ Guarantor ”). Seller and Purchaser are sometimes referred to herein individually as a “ Party ” and collectively as the “ Parties .”
 
RECITALS
 
A.             WHEREAS , Seller and certain of its Affiliates are engaged in business operations and activities involving or related to the sourcing, research, development, registration, transportation, use, promotion, marketing, distribution, sale and other commercialization of Seller Products (collectively, the “ Product Business ”); and
 
B.             WHEREAS , Seller wishes to sell to Purchaser, and Purchaser desires to purchase from Seller, certain assets and rights comprising or associated with the Product Business, upon the terms and conditions hereinafter set forth;
 
C.             WHEREAS , Seller’s board of directors (“ Seller’s Board ”) has (a) determined that it is in the best interests of Seller and its stockholders to enter into this Agreement; and (b) unanimously approved the execution, delivery and performance by Seller of this Agreement and the consummation of the Transactions contemplated hereby; and
 
D.             WHEREAS , at the Closing, Seller and Purchaser shall enter into the Ancillary Agreements.
 
NOW, THEREFORE , in consideration of the mutual benefits to be derived from this Agreement and of the representations, warranties, conditions, agreements and promises contained herein and other good and valuable consideration, the receipt and sufficiency of which are hereby acknowledged, the Parties, intending to be legally bound, hereby agree as follows:
 
ARTICLE 1
DEFINITIONS
 
1.1   Certain Defined Terms. As used herein, the following terms shall have the following meanings:
 
1.1.1   Accountants ” means an accounting firm of national reputation (excluding each of Seller’s and Purchaser’s respective regular outside accounting firms) as may be mutually acceptable to Seller and Purchaser; provided , however , if Seller and Purchaser are unable to agree on such accounting firm within ten (10) days or any such mutually selected accounting firm is unwilling or unable to serve, then Seller shall deliver to Purchaser a list of three other accounting firms of national reputation that have not performed services for Seller or Purchaser in the preceding three-year period, and Purchaser shall select one of such three accounting firms.
 
 
1

 
1.1.2   Accounts Receivable ” means all accounts receivable, notes receivable and other indebtedness due and owed by any Third Party to Seller or any of its Affiliates arising from sales of the Product by or on behalf of Seller or its Affiliates prior to the Closing Date.
 
1.1.3   Act ” means the United States Federal Food, Drug, and Cosmetic Act.
 
1.1.4   Adverse Event ” means, with respect to a Seller Product, any undesirable, untoward or noxious event or experience associated with the use, or occurring during or following the administration, of such product in humans, occurring at any dose, whether expected and whether considered related to or caused by such Seller Product, including such an event or experience as occurs in the course of the use of such Seller Product in professional practice, in a clinical trial, from overdose, whether accidental or intentional, from abuse, from withdrawal or from a failure of expected pharmacological or biological therapeutic action of such Seller Product, and including those events or experiences that are required to be reported to the FDA under 21 C.F.R. sections 312.32, 314.80 or 600.80, as applicable, or to foreign Governmental Authorities under corresponding applicable Law outside the United States.
 
1.1.5   Affiliate ” means, with respect to a Person, any other Person that, directly or indirectly, through one or more intermediaries, controls, is controlled by or is under common control with such first Person. For purposes of this definition, “control” and, with correlative meanings, the terms “controlled by” and “under common control with” means (a) the possession, directly or indirectly, of the power to direct the management or policies of a business entity, whether through the ownership of voting securities, by contract relating to voting rights or corporate governance, or otherwise; or (b) the ownership, directly or indirectly, of more than fifty percent (50%) of the voting securities or other ownership interest of a business entity (or, with respect to a limited partnership or other similar entity, its general partner or controlling entity).
 
1.1.6   Aggregate Outstanding Claims ” has the meaning set forth in Section 2.4.4.
 
1.1.7   Agreed Amount” has the meaning set forth in Section 8.4.1.
 
1.1.8   Agreement ” has the meaning set forth in the preamble hereto.
 
1.1.9   Allocation ” has the meaning set forth in Section 2.3.5.
 
1.1.10   Alternative Transaction Proposal ” shall mean any bona fide proposal or offer from any Person or group (as defined under Section 13(d) of the Exchange Act) (other than Purchaser and its Affiliates) relating to, in a single transaction or series of related transactions, any (a) acquisition of or the granting of rights with respect to (for example, rights resulting from Seller’s or its Affiliates’ entry into a license, collaboration or similar agreement) twenty percent (20%) or more of the Purchased Assets or Purchased Assets to which twenty percent (20%) or more of Seller’s revenues or earnings associated with the Product Business are attributable; (b) acquisition of twenty percent (20%) or more of any class of Common Stock or other equity securities of Seller; (c) tender offer or exchange offer that, if consummated, would result in any Person or group beneficially owning twenty percent (20%) or more of any class of Common Stock or other equity securities of Seller; or (d) merger, consolidation, share exchange, business combination, recapitalization, liquidation, dissolution or similar transaction involving Seller.
 
 
2

 
1.1.11   Ancillary Agreements ” means the Bill of Sale, the Transition Services Agreement, the Domain Name Assignment Agreement, the Patent Assignment Agreement, the Trademark Assignment Agreement, the Copyright Assignment Agreement, the Escrow Agreement, the Registration Rights Agreement, the Promissory Note, the Security Agreement, the Final Agreement (as defined in the MidCap Signing Date Agreement and in form and substance reasonably satisfactory to Seller); the Senior Loan Amendment (as defined in the MidCap Signing Date Agreement and in form and substance reasonably satisfactory to Seller).
 
1.1.12   ANDA ” means an Abbreviated New Drug Application filed pursuant to Section 505(j) of the Act.
 
1.1.13   Apportioned Obligations   has the meaning set forth in Section 6.11.1(b).
 
1.1.14   Assumed Liabilities ” means (a) all Liabilities of Seller and its Affiliates pursuant to the Purchased Regulatory Approvals; (b) all Liabilities of Seller or, if applicable, the applicable Affiliate of Seller, arising pursuant to the Purchased Contracts but, in the case of each of clauses (a) and (b), only to the extent attributable to circumstances arising after the Closing Date and excluding any Liabilities arising out of any breach by Seller or its applicable Affiliate under such Purchased Regulatory Approvals or Purchased Contracts; (c) all Liabilities for or relating to Taxes with respect to the Product Business or the Purchased Assets for any Post-Closing Tax Period; (d) any binding purchase orders for Product; and (e) any and all other Liabilities that arise out of or are related to the Product Business or the Purchased Assets attributable to circumstances arising after the Closing Date.
 
1.1.15   Audited Financial Statements ” has the meaning set forth in Section 6.15.
 
1.1.16   Auditors ” has the meaning set forth in Section 6.15.
 
1.1.17   Authorization ” means any consent, approval, order, license, permit and other similar authorization of or from any Governmental Authority, together with any renewals, extensions, or modifications thereof and additions thereto.
 
1.1.18   Beneficially Owned Shares ” has the meaning set forth in Section 5.9.3.
 
1.1.19   Bill of Sale ” means one or more Bill of Sale and Assignment and Assumption Agreements in the form of Exhibit A attached hereto.
 
 
3

 
1.1.20   Business Day ” means any day other than Saturday, Sunday or a day on which banking institutions in New York, New York are permitted or obligated by Law to remain closed.
 
1.1.21   Calendar Quarter ” means each respective period of three consecutive calendar months ending on March 31, June 30, September 30 or December 31, except that the first Calendar Quarter of the this Agreement shall commence on the Closing Date and end on the first quarter in which the Closing Date occurs.
 
1.1.22   Calendar Year ” means each successive period of 12 calendar months commencing on January 1 and ending on December 31, except that the first Calendar Year of the this Agreement shall commence on the Closing Date and end on December 31 of the year in which the Closing Date occurs.
 
1.1.23   cGCP ” means the ethical, scientific, and quality standards required by FDA for designing, conducting, recording, and reporting human clinical trials, as set forth in FDA regulations in 21 C.F.R. Parts 50, 54, 56, and 312 and by the International Conference on Harmonization E6: Good Clinical Practices Consolidated Guideline, or as otherwise required by applicable Law.
 
1.1.24   cGMP ” means standards and methods required   to be used in, and the facilities or controls to be used for, the Manufacture of a drug, as set forth in FDA regulations in 21 C.F.R. Parts 210 and 211.
 
1.1.25   Cap ” has the meaning set forth in Section 8.5.2(a).
 
1.1.26   Claim Notice ” has the meaning set forth in Section 8.4.2.
 
1.1.27   Closing ” has the meaning set forth in Section 2.5.1.
 
1.1.28   Closing Date ” means the date on which the Closing occurs.
 
1.1.29   Closing Payment ” has the meaning set forth in Section 2.3.1(a).
 
1.1.30   Code ” means the Internal Revenue Code of 1986.
 
1.1.31   Commercially Reasonable Efforts ” means [ ***] 1 .  “Commercially Reasonable” as used herein shall be interpreted in a corresponding manner.
 
1.1.32   Common Stock ” means the common stock of Seller, par value $0.001 per share.
 
1.1.33   Competitive Activity ” has the meaning set forth in Section 6.14.
 
1.1.34   Confidential Information ” has the meaning set forth in Section 6.4.1.
 

***Certain information on this page has been omitted and filed separately with the Commission. Confidential treatment has been requested with respect to the omitted portions.
 
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1.1.35   Confidentiality Agreement ” means that certain Confidentiality Agreement, dated December 24, 2014, by and between Seller and Guarantor.
 
1.1.36   Contract ” means any written or oral, contract, agreement, lease, sublease, license, sublicense instrument, note, guaranty, deed, assignment, purchase order, or other legally binding commitment or arrangement.
 
1.1.37   Control ” means, with respect to any Intellectual Property Rights, Regulatory Approval, Regulatory Documentation or Seller Products Technical Information, possession of the right, whether directly or indirectly, and whether by ownership, license or otherwise, to assign or grant a license, sublicense or other right to or under such Intellectual Property Rights, Regulatory Approval, Regulatory Documentation or Seller Products Technical Information as provided for herein or in any of the Ancillary Agreements without violating the terms of any Contract with any Third Party.
 
1.1.38   Controlling Party ” has the meaning set forth in Section 8.4.3.
 
1.1.39   Copyright ” means copyrights and rights in copyrightable works, copyright registrations, or any application therefor and all extensions, restorations, reversions and renewals of any of the foregoing.
 
1.1.40   Copyright Assignment Agreement ” means the copyright assignment agreement under which the Copyrights listed in Section 1.1.173 of the Seller Disclosure Schedule are sold and transferred to Purchaser in the form of Exhibit B attached hereto.
 
1.1.41   Daravita License Agreement ” means that certain license agreement dated as of November 27, 2007 by and between Seller and Daravita Limited (as successor in interest to Elan Pharma International Limited), as amended.
 
1.1.42   Data Protection Laws ” means all applicable Laws in connection with privacy and the processing, collection, use and protection of personal data in any jurisdiction.
 
1.1.43   Designated Action ” has the meaning set forth in Section 8.3.1(e).
 
1.1.44   Development Plan ” has the meaning set forth in Section 2.3.2(d).
 
1.1.45   “Disclosing Party ” has the meaning set forth in Section 6.4.1.
 
1.1.46   Disputed Item ” has the meaning set forth in Section 2.3.3(c).
 
1.1.47   Domain Name Assignment Agreement ” means the domain name assignment agreement under which the Domain Names listed in Section 1.1.175 of the Seller Disclosure Schedule are sold and transferred to Purchaser in the form of Exhibit C attached hereto.
 
1.1.48   Domain Names ” means any and all internet or global computing network addresses or locations, including all generic top-level domains (“ gTLDs ”) and country code top-level domains (“ ccTLDs ”).
 
 
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1.1.49   Early Termination ” has the meaning set forth in Section 2.5.1.
 
1.1.50   Encumbrance ” means any mortgage, lien, hypothecation, charge, license, pledge, security interest, encumbrance, trust, equitable interest, claim, preference, imperfection of title, or right of possession.
 
1.1.51   End Date ” has the meaning set forth in Section 9.1.2.
 
1.1.52   Enforcement Proceeds ” means any and all damages, awards, license fees, royalties, proceeds, in-kind consideration or other compensation (including any amounts received in settlement) resulting from Purchaser, its Affiliates or sublicensees enforcing or threatening to enforce any of the Seller Intellectual Property against a Third Party, less any court costs, attorneys' fees and disbursements and other documented out-of-pocket unreimbursed litigation expenses.
 
1.1.53   Environmental Laws ” means all Laws related to the protection of the environment or human health and safety or the release, presence of, exposure to, or the management, manufacture, use, containment, storage, recycling, reclamation, monitoring, reuse, treatment, generation, discharge, transportation, processing, production, disposal, leaching, migration, emission or remediation of Hazardous Substances, including the Comprehensive Environmental Response, Compensation and Liability Act, 42 U.S.C. § 9901 et seq., the Resource Conservation and Recovery Act of 1976, 42 U.S.C. § 6901 et seq., the Emergency Planning and Community Right-to-Know Act, 42 U.S.C. § 11001 et seq., the Clean Air Act, 42 U.S.C. § 7401 et seq., the Federal Water Pollution Control Act, 33 U.S.C. § 1251 et seq., the Toxic Substance Control Act, 15 U.S.C. § 2601 et seq., the Safe Drinking Water Act, U.S.C. § 300f et seq., the Occupational Safety and Health Act, 42 U.S.C. § 1801 et seq., the Federal Insecticide, Fungicide and Rodenticide Act, 7 U.S.C. § 136 et seq., the Hazardous Materials Transportation Act, 49 U.S.C. § 1801 et seq.
 
1.1.54   Escrow Agent ” means a nationally recognized bank mutually agreeable to Purchasers and Seller.
 
1.1.55   Escrow Agreement ” has the meaning set forth in Section 2.4.1.
 
1.1.56   Escrow Amount ” has the meaning set forth in Section 2.4.1.
 
1.1.57   Escrow Earnings ” has the meaning set forth in Section 2.4.5.
 
1.1.58   Escrow Fund ” means the fund into which and from which, as applicable, the Escrow Amount is to be deposited and distributed, pursuant to this Agreement and the Escrow Agreement.
 
1.1.59   Escrow Payment ” means the aggregate amount released from the Escrow Fund to Seller in accordance with Section 2.4.4 and the Escrow Agreement.
 
 
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1.1.60   Escrow Period ” has the meaning set forth in Section 2.4.1.
 
1.1.61   Exchange Act ” means the Securities Exchange Act of 1934, as amended.
 
1.1.62   Excluded Assets ” means all assets, property, rights and interests of Seller and its Affiliates other than the Purchased Assets, including (a) all tangible personal property of Seller or any of its Affiliates (other than the Purchased Product Inventory and other tangible Purchased Assets); (b) all Accounts Receivable; (c) all rights to payments under the Waiver Agreement, dated October 29, 2014, between Purdue Pharma L.P. and Seller; (d) any prepaid Tax, Tax receivable, Tax refund or Tax credit of Seller or its Affiliates with respect to any Pre-Closing Tax Period; and (e) any other rights, claims or causes of action (including warranty claims) of or involving Seller or any of its Affiliates (i) arising prior to the Closing and relating to any Purchased Contract, or (ii) related to products supplied or services provided by or to Seller or its Affiliates prior to or after the Closing that are not included in the Purchased Assets.
 
1.1.63   Excluded Liabilities ” has the meaning set forth in Section  2.2.2.
 
1.1.64   Execution Date ” has the meaning set forth in the preamble hereto.
 
1.1.65   Expiration Date ” has the meaning set forth in Section 8.1.3.
 
1.1.66   Exploit ” or “ Exploitation ” means to make, have made, import, export, use, have used, sell, offer for sale, have sold, research, develop (including seeking, obtaining and maintaining Regulatory Approval), commercialize, hold or keep (whether for disposal or otherwise), transport, distribute, promote, market, or otherwise dispose of.
 
1.1.67   FCA ” has the meaning ascribed to such term under Incoterms, 2010 edition, published by the International Chamber of Commerce, ICC Publication 720.
 
1.1.68   FDA ” means the United States Food and Drug Administration and any successor agency thereto.
 
1.1.69   Financing ” means, collectively, Purchaser’s financing of the Closing Payment and the obligations under the Promissory Note.
 
1.1.70   Final Product Inventory Value ” has the meaning set forth in Section 2.3.3(d).
 
1.1.71   Financial Information ” has the meaning set forth in Section 3.14.
 
1.1.72   Financing Cooperation Indemnity ” has the meaning set forth in Section 6.18.
 
1.1.73   Financing Indemnitees ” has the meaning set forth in Section 6.18.
 
1.1.74   Fraud ” means, with respect to a Party, an actual and intentional fraud with respect to the making of the representations and warranties pursuant to ARTICLE 3 or ARTICLE 4 (as applicable) or any certificate delivered pursuant to Section 2.5, provided, that such actual and intentional fraud of such Party shall only be deemed to exist if Seller or Purchaser (as applicable) had actual knowledge (as opposed to imputed or constructive knowledge) that the representations and warranties made by such Party pursuant to, in the case of Seller, ARTICLE 3 (as qualified by the Seller Disclosure Schedule) and any certificate delivered pursuant to Section 2.5 or, in the case of Purchaser, ARTICLE 4 and any certificate delivered pursuant to Section 2.5, were actually breached when made, with the express intention that the other Party rely thereon to its detriment.
 
 
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1.1.75   Fundamental Representations Cap ” has the meaning set forth in Section 8.5.2(b).
 
1.1.76   GAAP ” means generally accepted accounting principles in the United States.
 
1.1.77   Guarantor ” has the meaning set forth in the preamble hereto.
 
1.1.78   Guarantor Common Stock ” means the common stock of Guarantor, par value $0.01 per share.
 
1.1.79   Guaranty ” means the guaranty agreement to be delivered by Purchaser to Seller at the Closing, in form and substance reasonably acceptable to Seller, providing an absolute, unconditional and irrevocable guarantee to Seller, as the primary obligor and not merely as surety, the due and punctual observance, payment, performance and discharge of the obligations under this Agreement, the Promissory Note and the Security Agreement.
 
1.1.80   Governmental Authority ” means any supranational, international, nation, commonwealth, province, territory, county, municipality, district, federal, state or local court (or any arbitrator or other tribunal having competent jurisdiction), administrative agency or commission or other governmental authority, instrumentality, domestic or foreign, including the FDA and any corresponding foreign agency, or any self-regulated organization or quasi-governmental authority.
 
1.1.81   Hazardous Substance ” means any: contaminant or pollutant; toxic, radioactive or hazardous waste, chemical, substance, material or constituent; asbestos; polychlorinated byphenyls (PCBs); paint containing lead or mercury; fixtures containing mercury or urea formaldehyde; natural or liquefied gas; flammable, explosive, corrosive, radioactive, medical and infectious waste; and oil or other petroleum product, all as defined in applicable Environmental Laws.
 
1.1.82   Health Care Reform Fees ” means the fees described in Section 9008 of the Patient Protection and Affordable Care Act, Pub. L. No. 111-148, as amended by Section 1404 of the Health Care and Education Reconciliation Act of 2010, Pub. L. No. 111-152.
 
1.1.83   HSR Act ” means the Hart-Scott-Rodino Antitrust Improvements Act of 1976.
 
 
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1.1.84   IND ” means an Investigational New Drug Application as defined in the Act.
 
1.1.85   Indemnification Certificate ” has the meaning set forth in Section 8.4.1.
 
1.1.86   Indemnified Party ” has the meaning set forth in Section 8.4.1.
 
1.1.87   Indemnifying Party ” has the meaning set forth in Section 8.4.1.
 
1.1.88   Independent Auditor ” has the meaning set forth in Section 6.13.
 
1.1.89   Initial Escrow Amount ” has the meaning set forth in Section 2.3.1(a).
 
1.1.90   Intellectual Property Rights ” means any and all of the following: Copyrights, Domain Names, Patent Rights, Trademarks and Trade Secrets.
 
1.1.91   Key Suppliers, Customers and Distributors ” has the meaning set forth in Section 3.18.
 
1.1.92   Law ” means any domestic or foreign, federal, state or local statute, law, treaty, judgment, ordinance, rule, administrative interpretation, regulation, order or other requirement of any Governmental Authority.
 
1.1.93   Liabilities ” means any debts, liabilities, obligations, commitments, claims or complaints, whether accrued or fixed, known or unknown, fixed or contingent, determined or determinable (including all adverse reactions, recalls, product and packaging complaints and other liabilities) and whether or not the same would be required to be reflected in financial statements or disclosed in the notes thereto.
 
1.1.94   Litigation ” means any claim, action, arbitration, mediation, hearing, investigation, proceeding, litigation, suit, warning letter, inquiry, audit, examination, finding of deficiency or non-compliance, notice of violation or request for recall (whether civil, criminal, administrative, investigative, appellate or informal).
 
1.1.95   Lock-up Period ” has the meaning set forth in Section 5.9.3.
 
1.1.96   Loss ” or “ Losses ” means any Liabilities, losses, damages, judgments, fines, penalties, awards, Taxes, amounts paid in settlement, reasonable fees (including costs and expenses in connection with investigations, suits and proceedings, expert fees, accounting fees, advisory fees and legal fees), charges and costs.
 
1.1.97   Manufacture   and   Manufacturing   means all activities related to the production, manufacture, processing, filling, finishing, packaging, labeling, and shipping and holding (prior to distribution) of any Seller Product or any intermediate thereof, including process development, process qualification and validation, scale-up, pre-clinical, clinical and commercial manufacture and analytic development, product characterization, stability testing, quality assurance and quality control.
 
 
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1.1.98   Market Value   means the consolidated closing bid price per share of Guarantor Common Stock immediately preceding the execution of this Agreement by the Parties.  For the avoidance of doubt, if this Agreement is executed by the Parties (a)(i) on a day that is not a Trading Day, or (ii) on a Trading Day during market hours and before the close of the regular trading session of the NASDAQ Global Market, “ Market Value ” shall equal the consolidated closing bid price per share of Guarantor Common Stock on the Trading Day immediately preceding the Execution Date; and (b) on a Trading Day but after the close of the regular trading session of the NASDAQ Global Market, “ Market Value ” shall equal the consolidated closing bid price per share of Guarantor Common Stock on that Trading Day.
 
1.1.99   Material Adverse Effect ” means an event, fact, condition, occurrence, circumstance, change or effect (“ Effect ”) that, considered together with all other Effects is, or would reasonably be expected to (a) be materially adverse to the business, results of operations or condition (financial or otherwise) of the Product Business, the Purchased Assets, and the Assumed Liabilities, taken as a whole, or (b) prevent or materially impede or delay the consummation by Seller of any of the Transactions; provided , however , that, except as provided in the last sentence of this definition, none of the following, and no Effects resulting from the following, shall be deemed (individually or in combination) to constitute, or shall be taken into account in determining whether there has been, a “Material Adverse Effect”: (i) political or economic conditions or conditions affecting the capital or financial markets generally; (ii) any change in accounting requirements or applicable Law; (iii) any hostility, act of war, sabotage, terrorism or military actions, or any escalation of any of the foregoing; (iv) any hurricane, flood, tornado, earthquake or other natural disaster or force majeure event; (v) the public announcement, execution or delivery of the Agreement or the pendency or consummation of the Transactions contemplated hereby; (vi) conditions affecting the prescription opioid market generally; and (vii) the failure of the Product Business to achieve any financial projections, predictions or forecasts in and of itself ( provided, that the underlying causes of such failure shall not be excluded); except, in each of clauses (i), (ii) and (vi), for those conditions that have a disproportionate effect on the Product Business, the Purchased Assets, and Assumed Liabilities, taken as a whole, relative to other Persons operating businesses in the pharmaceutical industry.
 
1.1.100    “ MidCap Signing Date Agreement ” means that certain agreement regarding entry into final agreement dated as of the date hereof between Seller, Purchaser, Guarantor and MidCap Financial LLC.
 
1.1.101    “ Milestone Event ” has the meaning set forth in Section 2.3.2(a).
 
1.1.102    “ Milestone Information ” has the meaning set forth in Section 2.3.2(d).
 
 
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1.1.103    “ Milestone Payment ” has the meaning set forth in Section 2.3.2(a).
 
1.1.104    “ NDA ” means a New Drug Application as defined in the Act.
 
1.1.105    “ NDC ” means “National Drug Code,” which is the eleven digit code registered by a company with the FDA with respect to a pharmaceutical product.
 
1.1.106    “ Net Sales ” means the aggregate gross amounts invoiced on sale or other commercial distribution of any Seller Product during the applicable period in the Territory by or on behalf of Purchaser or any of its Affiliates or sublicensees to a Third Party (but not including sales between Purchaser and its Affiliates or sublicensees where a Seller Product is intended for resale) and Enforcement Proceeds less the following deductions as relating to such sales (in accordance with GAAP, consistently applied, and solely to the extent such deductions are actually incurred, allowed, accrued or specifically allocated in their normal and customary amounts and as reported in the financial statements included in Purchaser’s filings with the SEC):
 
(a)   [ ***] 2 ,
 
(i)   [***];
 
(ii)   [***];
 
(iii)   [***]; and
 
(iv)   [***];
 
(b)   [***];
 
(c)   [***]; and
 
(d)   [***].
 
(e)   Notwithstanding anything in this Agreement to the contrary, in the event an Affiliate or sublicensee is the end-user of the product, the transfer of such product to such Affiliate or sublicensee shall be included in the calculation of Net Sales at the average selling price charged in an arm’s length sale to a Third Party who is not an Affiliate or Sublicensee in the relevant period.
 
(f)   The following principles shall apply in the calculation of Net Sales:
 
(i)   In the case of any sale or other commercial disposition of Seller Product which is not invoiced or is delivered before invoice, the sale of a Seller Product shall be deemed to have occurred at the time of shipment or when the same is paid for, if paid for before shipment or invoice;
 

***Certain information on this page has been omitted and filed separately with the Commission. Confidential treatment has been requested with respect to the omitted portions.
 
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(ii)   In the case Seller or its Affiliates or sublicensees receive any in-kind or non-cash consideration from any sale or other commercial disposition of Seller Product or Enforcement Proceeds, the fair market value for such in-kind or non-cash consideration shall be determined in accordance with Section 10.13.
 
1.1.107    “ Net Sales Reports ” has the meaning set forth in Section 6.13.
 
1.1.108    “ Non-Controlling Party ” has the meaning set forth in Section 8.4.3.
 
1.1.109    “ Notice ” has the meaning set forth in Section 10.2.1.
 
1.1.110    “ Notice of Disagreement has the meaning set forth in Section 2.3.3(c).
 
1.1.111    “ Objection Notice ” has the meaning set forth in Section 8.4.1.
 
1.1.112    “ Obligations ” has the meaning set forth in Section 10.14.
 
1.1.113    “ Orange Book ” means the FDA’s “Approved Drug Products with Therapeutic Equivalence Evaluations” publication.
 
1.1.114    “ Ordinary Course of Business Exceptions ” has the meaning set forth in Section 5.3.
 
1.1.115    “ Paragraph IV Claim ” has the meaning set forth in Section 5.7.1.
 
1.1.116    “ Partner ” has the meaning set forth in Section 3.8.1.
 
1.1.117    “ Party(ies) ” has the meaning set forth in the preamble hereto.
 
1.1.118    “ Patent Assignment Agreement ” means the patent assignment agreement under which the Patents listed in Section 3.12.2 of the Seller Disclosure Schedule are sold and transferred to Purchaser in the form of Exhibit D attached hereto.
 
1.1.119    “ Patent Rights ” means all patents and filed patent applications, including provisional and non-provisional patent applications, design registrations, design registration applications, industrial designs, industrial design applications and industrial design registrations, and including any and all divisions, continuations, continuations in part, extensions, substitutions, renewals, registrations, revalidations, reversions, reexaminations, reissues or additions, of or to any of the foregoing items, and all rights and priorities afforded under any applicable Law with respect thereto.
 
1.1.120    “ Permitted Encumbrance ” means any (a) Encumbrance for Taxes not yet due or delinquent; (b) Encumbrance caused by   Law for amounts not material or overdue that do not or would not be reasonably expected to detract from the current value of, or interfere with, the present use and enjoyment of any Purchased Asset subject thereto or affected thereby in the ordinary course of business of the Product Business; (c) right, title or interest of a licensor or licensee under a license disclosed in Section 3.12.1 of the Seller Disclosure Schedule; and (d) any Encumbrance disclosed on Section 1.1.120 of the Seller Disclosure Schedule.
 
 
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1.1.121    “ Person ” means any individual, partnership, limited partnership, limited liability company, joint venture, syndicate, sole proprietorship, corporation, unincorporated association, trust, trustee, executor, administrator or other legal personal representative, or any other legal entity, including a Governmental Authority.
 
1.1.122    “ Post-Closing Tax Period ” means any Tax period beginning after the Closing Date and that portion of a Straddle Period beginning after the Closing Date.
 
1.1.123    “ Pre-Closing Period ” has the meaning set forth in Section 5.2.1.
 
1.1.124    “ Pre-Closing Tax Period ” means any Tax period ending on or before the Closing Date and that portion of any Straddle Period ending on the Closing Date.
 
1.1.125    “ Product ” means the strengths and package sizes and types of the pharmaceutical product containing a controlled release formulation of hydrocodone bitartrate (or its pharmaceutically active salts) as a single active ingredient as described in NDA #202880, which has been commercialized prior to the Closing by Seller or its Affiliates under the brand name Zohydro® ER. For the avoidance of doubt, the Product shall include the second generation formulation of Zohydro® ER with BeadTek™, which is sometimes referred to as the “ Second Generation Product .”
 
1.1.126    “ Product ANDA Litigation ” has the meaning set forth in Section 5.7.2.
 
1.1.127    “ Product Business ” has the meaning set forth in the Recital A hereto.
 
1.1.128    “ Product Business Employee ” means the employees of Seller or any of its Affiliates identified by Seller or its Affiliates in Section 1.1.128 of the Seller Disclosure Schedule, as actively engaged in promotion or sales activities with respect to, or the management of, the Product Business in the ordinary course of such employee’s duties.
 
1.1.129    “ Product Cost-of-Goods ” means the actual expenses incurred by Seller in procuring supply of the Product, as reflected in the Product Inventory Value.
 
1.1.130    “ Product Criteria ” has the meaning set forth in Section 2.3.3(c).
 
1.1.131    “ Product Inventory ” means all inventory owned as of the Closing by Seller or any Affiliate thereof of finished Product that is in conformance with the Specifications and has an expiration date of October 1, 2016 or later, regardless of whether such inventory is held at a location or facility of Seller or any Affiliate (or of any other Person on behalf of Seller or any Affiliate, including in any of Seller’s warehouses, manufacturers, suppliers, distributors or consignees) or in transit to or from Seller or any Affiliate (or any such other Person).
 
 
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1.1.132    “ Product Inventory Delivery Date ” has the meaning set forth in Section 2.3.3(b).
 
1.1.133    “ Product Inventory Schedule ” has the meaning set forth in Section 2.3.3(a).
 
1.1.134    “ Product Inventory Value ” has the meaning set forth in Section 2.3.3(a).
 
1.1.135    “ Product Promotional Materials ” means all market research, existing customer lists, marketing plans, media plans, advertising, sales training materials, promotional, managed care and marketing books and records Controlled by Seller or any of its Affiliates and used or necessary in connection with the marketing and promotion of the Product, and any and all Intellectual Property Rights therein; provided, however , Product Promotional Materials shall not include any such items to the extent that (i) any applicable Law prohibits its transfer or (ii) any transfer thereof by Seller or any of its Affiliates would constitute a material contractual violation.
 
1.1.136    “ Product Records ” means all books and records Controlled by Seller or any of its Affiliates relating to, and reasonably necessary to Exploit, any Seller Product or to perform research and development activities with respect to any Seller Product, or to conduct the Product Business, as Exploited, performed or conducted (as applicable) as of the Closing Date and other than the Regulatory Documentation, but excluding, in all cases, (a) all books, documents, records and files prepared in connection with or relating to the Transactions contemplated under this Agreement, including bids received from Third Parties and strategic, financial or Tax analyses relating to the divestiture of the Purchased Assets, the Assumed Liabilities, the Product, the Third Generation Product or the Product Business; (b) all books, documents, records and files to the extent related to the Manufacture of the Product or the Third Generation Product; (c) trade secrets of Third Parties; (d) any attorney work product, attorney-client communications and other items protected by established legal privilege, unless the books and records can be transferred without losing such privilege; (e) human resources and any other employee books and records, other than any such books and records relating solely to any Product Business Employee who accepts an offer of employment with Purchaser; (f) any financial, Tax and accounting records to the extent not related to the Product, the Third Generation Product, or any other Purchased Asset; and (g) any items to the extent applicable Law prohibits their transfer or where transfer thereof would subject Seller or any of its Affiliates to any Liability. It is hereby clarified that a particular book or record may include information that does not constitute Product Records as well as information that constitutes Product Records and Seller may redact the portion of such book or record that does not constitute Product Records before delivering to Purchaser the portion of such book or record that constitutes Product Records.
 
1.1.137    “ Promissory Note ” means the promissory note, in the original principal amount of $50,000,000, to be delivered by Purchaser to Seller at the Closing in the form of Exhibit E attached hereto.
 
1.1.138    “ Promissory Note Escrow Amount ” has the meaning set forth in Section 2.4.1.
 
 
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1.1.139    “ Purchase Price ” means (a) the Closing Payment; plus , (b) to the extent actually paid by Purchaser in accordance with Section 2.3.2, the Milestone Payment or Milestone Payments; and plus , (c) to the extent actually paid, the Escrow Payment.
 
1.1.140    “ Purchased Assets ” has the meaning set forth in Section 2.1.1.
 
1.1.141    “ Purchased Contracts ” has the meaning set forth in Section 2.1.1(a).
 
1.1.142    “ Purchased Regulatory Approvals ” has the meaning set forth in Section 2.1.1(b).
 
1.1.143    “ Purchaser ” has the meaning set forth in the preamble hereto.
 
1.1.144    “ Purchaser Confidential Information ” has the meaning set forth in Section 6.4.2.
 
1.1.145    “ Purchaser FDA Letters ” shall mean a letter or letters, in a standard and customary form and reasonably acceptable to Seller, to the FDA from Purchaser accepting the transfer of rights to the Purchased Regulatory Approvals from Seller.
 
1.1.146    “ Purchaser Fundamental Representations ” has the meaning set forth in Section 7.3.1.
 
1.1.147    “ Purchaser Indemnitees ” has the meaning set forth in Section 8.3.1.
 
1.1.148    “ Purchaser Material Adverse Effect ” means any event, fact, condition, occurrence, change or effect that prevents or materially impedes or materially delays the consummation by Purchaser of the Transactions.
 
1.1.149    “ Purchaser Permitted Purpose ” has the meaning set forth in Section 6.4.3.
 
1.1.150    “ Purchased Product Inventory ” means the quantities of finished Product set forth on Section 5.8 of the Seller Disclosure Schedule.
 
1.1.151    “ Purchased Product Inventory Value ” has the meaning set forth in Section 2.3.3(a).
 
1.1.152    “ Rebates ” means rebates, price reductions and administrative fees and related adjustments charged by or payments to state Medicaid and other federal, state and local governmental programs and their participants, and by health plans, insurance companies, Medicare Part D prescription drug plans, pharmacy benefits managers, mail service pharmacies, long term care providers, specialty pharmacies and other health care providers based upon the utilization and sales of the Product, and service, administrative and inventory management fees due to wholesalers, distributors and group purchasing organizations based on sales of the Product (in each case, other than chargeback claims).
 
 
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1.1.153    “ Receiving Party ” has the meaning set forth in Section 6.4.1.
 
1.1.154    “ Registration Rights Agreement ” means the registration rights agreement to be delivered by Parent to Seller at the Closing in the form of Exhibit F attached hereto.
 
1.1.155    “ Regulatory Approval   means, with respect to the Seller Products, any and all approvals (including NDAs and supplements and amendments thereto and active INDs), licenses, registrations (except manufacturing establishment registrations) or authorizations of any Governmental Authority necessary to conduct clinical trials, commercially distribute, sell or market such product, including, where applicable, (a) pre- and post-approval marketing authorizations; and (b) labeling approvals.
 
1.1.156    “ Regulatory Authority ” means any Governmental Authority that is concerned with the safety, efficacy, reliability, Manufacture, investigation, sale or marketing of pharmaceutical products, medical products, biologics or biopharmaceuticals, including the FDA and the Public Health Service.
 
1.1.157    “ Regulatory Documentation   means all (a) documentation Controlled by Seller or any of its Affiliates comprising the Regulatory Approvals for the Product and the Third Generation Product; (b) correspondence and reports Controlled by Seller or any of its Affiliates necessary to, or otherwise describing the ability to, commercially distribute, sell or market the Seller Products submitted to or received from Governmental Authorities (including minutes and official contact reports relating to any communications with any Governmental Authority) and relevant supporting documents submitted to or received from Governmental Authorities with respect thereto, including all regulatory drug lists, final versions of advertising and promotion documents, Adverse Event files and complaint files; and (c) data Controlled by Seller or any of its Affiliates (including clinical and pre-clinical data) contained in any of the foregoing.
 
1.1.158    “ Reporting Period ” means the period commencing on the Closing Date and ending on the first date on which Seller has received Milestone Payments with respect to each Sales Milestone Event.
 
1.1.159    “ Representatives ” means, with respect to each Party, such Party’s Affiliates and its and its Affiliates respective directors, officers, employees, agents, attorneys, clinical and other consultants, advisors and other representatives.
 
1.1.160    “ Response Period ” has the meaning set forth in Section 8.4.1.
 
1.1.161    “ Retained Escrow Funds ” has the meaning set forth in Section 2.4.4.
 
1.1.162    “ Right of Setoff ” has the meaning set forth in Section 8.9.
 
1.1.163    “ SEC ” means the U.S. Securities and Exchange Commission.
 
 
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1.1.164    “ Second Generation Supply Agreement ” mean the Second Generation (ZX004) Commercial Manufacturing and Supply Agreement by and between Daravita Limited and Seller dated March 5, 2015.
 
1.1.165    “ Section 505(b)(2) NDA   means an NDA filed pursuant to Section 505(b)(2) of the Act.
 
1.1.166    “ Securities Act ” means the Securities Act of 1933, as amended.
 
1.1.167    “ Security Agreement ” means the security agreement to be delivered by Purchaser to Seller at the Closing in the form of Exhibit G attached hereto.
 
1.1.168    “ Seller ” has the meaning set forth in the preamble hereto.
 
1.1.169     “ Seller Authorizations ” has the meaning set forth in Section 3.8.2.
 
1.1.170    “ Seller Benefit Plan ” means all “employee pension benefit plans” (as defined in Section 3(2) of the Employee Retirement Income Security Act of 1974, as amended (“ ERISA ”)), maintained or contributed to by Seller or any of its Affiliates for the benefit of any Product Business Employee and all “employee welfare benefit plans” (as defined in Section 3(1) of ERISA), bonus, stock option, stock purchase, deferred compensation plans or arrangements and other employee fringe benefit plans maintained, or contributed to, by Seller or any of its Affiliates for the benefit of any Product Business Employee.
 
1.1.171    “ Seller’s Board ” has the meaning set forth in Recital C hereto.
 
1.1.172    “ Seller Confidential Information ” has the meaning set forth in Section 6.4.3.
 
1.1.173    “ Seller Copyrights ” means all Copyrights that are Controlled by Seller and that are exclusively used by Seller or any of Seller’s Affiliates in connection with the Product Business, including those Copyrights listed on Section 1.1.173 of the Seller Disclosure Schedule.
 
1.1.174    “ Seller Disclosure Schedule ” means the disclosure schedules of Seller supplied by Seller to Purchaser dated as of the date hereof.
 
1.1.175    “ Seller Domain Names ” means the Domain Names listed on Section 1.1.175 of the Seller Disclosure Schedule.
 
1.1.176   Seller FDA Letters ” means letters to the FDA substantially in the form of Exhibit H, transferring the rights to the Purchased Regulatory Approvals to Purchaser.
 
1.1.177   Seller Fundamental Representations ” has the meaning set forth in Section 7.2.1.
 
1.1.178   Seller Governmental Consent ” means all consents, waivers, approvals, orders and authorizations of, and declarations or filings with, any Governmental or Regulatory Authority that are required by, or with respect to, Seller or any of its Affiliates in connection with the execution and delivery of this Agreement and the Ancillary Agreements to be executed pursuant hereto by Seller, the consummation by Seller or any of its Affiliates of the Transactions contemplated hereby and thereby and the performance of its obligations hereunder and thereunder.
 
 
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1.1.179    “ Seller Indemnitees ” has the meaning set forth in Section 8.3.2.
 
1.1.180    “ Seller Intellectual Property ” means Seller Copyrights, Seller Domain Names, Seller Patents, Seller Trademarks and Seller Know-How.
 
1.1.181    “ Seller Know-How ” means all data, know-how and other information that is not generally known, is Controlled by Seller or its Affiliates, and is reasonably necessary to Exploit any Seller Product or for the Manufacture of any Seller Product for sale.
 
1.1.182    “ Seller License Agreements ” has the meaning set forth in Section 3.12.1.
 
1.1.183    “ Seller Licensed Registered Product IP ” has the meaning set forth in Section 3.12.3.
 
1.1.184    “ Seller Owned Registered Product IP ” has the meaning set forth in Section 3.12.2.
 
1.1.185    “ Seller Patents ” has the meaning set forth in Section 3.12.5.
 
1.1.186    “ Seller Permitted Purpose ” has the meaning set forth in Section 6.4.2.
 
1.1.187    “ Seller Products Technical Information ” shall mean, to the extent Controlled by Seller as of the Closing and to the extent exclusively relating to any of Seller Products (including, but not limited to, any development, pre-clinical trial, clinical trial and/or manufacturing activities for any of Seller Products), any and all (a) specifications, test methods, manufacturing process information and other manufacturing-related information and documentation; (b) chemical, pharmacological, toxicological, pharmaceutical, physical and analytical, safety, quality assurance, quality control and clinical data; and (c) any other information, data, know-how, inventions, discoveries and trade secrets, in each case including, but not limited to, any such information or documentation included in the Regulatory Approvals.
 
1.1.188    “ Seller Products ” means, collectively, the Product and the Third Generation Product and “ Seller Product ” means any of the Product or the Third Generation Product.
 
1.1.189    “ Seller Regulatory Documentation ” means any and all Regulatory Documentation related to the Seller Products, in each case, Controlled by Seller or any of its Affiliates as of and prior to the Closing.
 
1.1.190    “ Seller Third Party Consent ” means all consents, waivers, approvals or authorizations of, or notices to, any Person (other than a Governmental or Regulatory Authority) that are required by, or with respect to, Seller or any of its Affiliates in connection with the execution and delivery of this Agreement and the Ancillary Agreements to be executed pursuant hereto by Seller, the consummation by Seller or any of its Affiliates of the Transactions contemplated hereby and thereby and the performance of its obligations hereunder and thereunder and set forth on Section 3.3 of the Seller Disclosure Schedule.
 
 
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1.1.191    “ Seller Trademarks ” means all Trademarks Controlled by Seller or any of its Affiliates, which are exclusively used in connection with the Seller Products and as listed in Section 1.1.191 of the Seller Disclosure Schedule.
 
1.1.192    “ Seller’s Knowledge ” means the collective actual knowledge, after due inquiry in the course of performing their respective duties, of the individuals listed on Section 1.1.192 of the Seller Disclosure Schedule.  As used in this definition, the term “due inquiry” means that each of such individuals has (i) read the applicable provisions of this Agreement; and (ii) has made inquiry of those other individuals within Seller or its Affiliates whom such inquiring individual reasonably believes would have direct knowledge of the relevant matters; but (iii) does not require such individuals to contact any Third Party except to the extent such conduct would be in the ordinary course of business, taking into account the applicable circumstances and the scope of such individual’s normal duties.
 
1.1.193    “ SKU ” means stock keeping unit.
 
1.1.194    “ Solvent ” means, when used with respect to any Person, that, as of any date of determination (a) the sum of such Person’s debts is not greater than the Person’s property, at a fair valuation; (b) the present fair salable value of the Person’s assets will not be less than the amount required to pay its probable Liabilities on its existing debts (including contingent Liabilities) as such debts become absolute and matured; (c) such Person will not have unreasonably small capital with which to conduct any business or transaction in which it is engaged or is proposed to be engaged; and (d) such Person does not intend to, and does not believe it will, incur debts beyond its ability to pay as such debts mature.  For purposes of this definition, “not have an unreasonably small amount of capital for the operation of the businesses in which it is engaged or proposed to be engaged” and “pay its probable liabilities on its existing debts (including contingent liabilities) as such debts become absolute and matured” means that such Person will be able to generate enough cash from operations, asset dispositions or financing, or a combination thereof, to meet its probable obligations as they become due.
 
1.1.195    “ Specifications ” means, with respect to each Seller Product, the manufacturing formula, manufacturing instructions, analytical methods, raw material specifications, packaging material specifications, bulk specifications and finished product specifications, in each case as set forth in the applicable Regulatory Approval for such Seller Product.
 
1.1.196    “ Stock Consideration ” means the number of shares of Guarantor Common Stock equal to the quotient (rounded to the nearest integer) of (i) $20,000,000 divided by (ii) the Market Value.
 
 
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1.1.197    “ Straddle Period ” means any Tax period beginning before or on and ending after the Closing Date.
 
1.1.198    “ Tax Return ” means any return, declaration, report, claim for refund, information return or statement relating to Taxes, including any schedule or attachment thereto, and including any amendment thereof.
 
1.1.199    “ Taxes means all taxes of any kind including all U.S. federal, state, local or non-U.S. net income, capital gains, gross income, gross receipt, license, property, franchise, sales, use, excise, withholding, payroll, employment, social security, worker’s compensation, disability, severance, unemployment, health-care, stamp, occupation, capital stock, transfer, registration, value added, alternative, estimated, gains, windfall profits, net worth, asset, transaction and other taxes, whether computed on a separate or consolidated, unitary or combined basis or in any other manner, and any interest, penalties or additions to tax with respect thereto, imposed upon any Person by any taxing authority or other Governmental Authority under applicable Law, whether disputed or not.
 
1.1.200    “ Territory ” means the United States and its territories and possessions.
 
1.1.201    “ Testing Laboratory ” has the meaning set forth in Section 2.3.3(d).
 
1.1.202    “ Third Generation Product ” means any Product as such term is defined under that certain Development and Option Agreement, dated November 1, 2013, as amended, by and between Seller and Altus Formulation, Inc. and any license agreement therefrom.
 
1.1.203    “ Third Party ” means any Person other than Seller, Purchaser and their respective Affiliates and permitted successors and assigns.
 
1.1.204    “ Trade Secrets ” means information that derives independent economic value from not being generally known to, and not being readily ascertainable by proper means by other persons who can obtain economic value from its disclosure or use.
 
1.1.205    “ Trademark Assignment Agreement ” means the trademark assignment agreement under which the Trademarks listed in Section 1.1.191 of the Seller Disclosure Schedule are sold and transferred to Purchaser in the form of Exhibit I attached hereto.
 
1.1.206    “ Trademark ” means any word, name, symbol, color, product shape, designation or device or any combination thereof that functions as a source identifier, including any trademark, trade dress, brand mark, service mark, trade name, brand name, trade dress rights, slogans, product configuration, logo or business symbol, whether or not registered, and any registrations or applications for registration to use any of the foregoing.
 
1.1.207    “ Trading Day ” means a day on which the NASDAQ Global Market is open for trading.
 
1.1.208    “ Transactions ” means all of the Transactions contemplated by this Agreement and each of the Ancillary Agreements.
 
 
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1.1.209    “ Transfer Taxes ” has the meaning set forth in Section 6.11.1(a).
 
1.1.210    “ Transition Services Agreement ” means that certain Transition Services Agreement, in substantially the form attached as Exhibit J.
 
1.1.211    “ Transitional Trademarks ” means the trademark or trade name “Zogenix®” or any other trademark or trade name that includes “Zogenix” including but not limited to U.S. Registration Nos. 3949157, 3886568, 3886567, 4045619, 3886566, and 4042283, in each case to the extent controlled by Seller or its Affiliates at the Closing and used by Seller or its Affiliates in connection with the Product Inventory.
 
1.1.212    “ Unit ” means a single dose of Product.
 
1.1.213    “ Units Produced ” means individual Units produced.
 
1.1.214    “ Units Sold ” means individual Units sold to any Third Party.
 
1.2   Construction.
 
1.2.1   Except where the context otherwise requires, wherever used, the singular includes the plural, the plural the singular, the use of any gender shall be applicable to all genders and the word “or” is used in the inclusive sense (and/or).
 
1.2.2   The captions of this Agreement are for convenience of reference only and in no way define, describe, extend or limit the scope or intent of this Agreement or the intent of any provision contained in this Agreement.
 
1.2.3   The term “including” and “include” and variations thereof shall not be deemed to be terms of limitation, but rather shall be deemed to be followed by the words “without limitation.”
 
1.2.4   The term “day” shall mean a calendar day, commencing at 12:00 a.m. (prevailing Eastern time). The term “month” shall mean a calendar month; provided, that when a period measured in months commences on a date other than the first (1st) day of a month, the period shall run from the date on which it commences to the corresponding date in the next month and, as appropriate, to succeeding months thereafter. Whenever an event is to be performed or a payment is to be made by a particular date and the date in question falls on a day which is not a Business Day, the event shall be performed, or the payment shall be made, on the next succeeding Business Day; provided, however , that all calculations shall be made regardless of whether any given day is a Business Day and whether or not any given period ends on a Business Day.
 
1.2.5   The language of this Agreement shall be deemed to be the language mutually chosen by the Parties and no rule of strict construction shall be applied against any Party.
 
 
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1.2.6   Unless otherwise specified or where the context otherwise requires, (a) references in this Agreement to any Article, Section, Schedule or Exhibit are references to such Article, Section, Schedule or Exhibit of this Agreement; (b) references in any Section to any clause are references to such clause of such Section; (c) ”hereof,” “hereto,” “hereby,” “herein” and “hereunder” and words of similar import when used in this Agreement refer to this Agreement as a whole and not to any particular provision of this Agreement; (d) references to a Person are also to its permitted successors and assigns; (e) references to a Law include any amendment or modification to such Law and any rules or regulations issued thereunder, in each case, as in effect at the relevant time of reference thereto; (f) references to any agreement, instrument or other document in this Agreement refer to such agreement, instrument or other document as originally executed or, if subsequently amended, replaced or supplemented from time to time, as so amended, replaced or supplemented and in effect at the relevant time of reference thereto; and (g) references to monetary amounts are denominated in United States Dollars.
 
ARTICLE 2
SALE AND PURCHASE OF ASSETS; LIABILITIES
 
2.1   Sale of Purchased Assets.
 
2.1.1   Purchase and Sale of Purchased Assets. Upon the terms and subject to the conditions of this Agreement, at and effective as of the Closing, Seller shall (or shall cause its applicable Affiliates to) sell, transfer, convey, assign and deliver to Purchaser free and clear of all Encumbrances other than Permitted Encumbrances, all right, title and interest of Seller and its Affiliates in and to all of the following properties, rights, interests and tangible and intangible assets, as existing as of the Execution Date or acquired during the Pre-Closing Period (collectively, the “ Purchased Assets ”) and Purchaser shall purchase and accept from Seller (or such Affiliates) the Purchased Assets:
 
(a)   all rights of Seller or its Affiliates under the Contracts set forth on Section 2.1.1(a) of the Seller Disclosure Schedule, as such Schedule may be updated by Seller not less than two (2) Business Days prior to the Closing Date to include rights and interests under any Contracts relating to the Product Business entered into by Seller or its Affiliates during the Pre-Closing Period and added, with Purchaser’s prior written consent, as a Purchased Contract in accordance with Section 5.3.4 (such Contracts set forth on Section 2.1.1(a) of the Seller Disclosure Schedule, as amended or supplemented, the “ Purchased Contracts ”) excluding, in each case, all rights to (i) any Accounts Receivable; and (ii) any other rights, claims or causes of action (including warranty claims) of or involving Seller or any of its Affiliates (A) arising prior to the Closing and relating to any Purchased Contract, or (B) related to products supplied or services provided by or to Seller or its Affiliates prior to the Closing that are not included in the Purchased Assets;
 
(b)   all rights and interests of Seller and its Affiliates to or in all Regulatory Approvals listed on Section 2.1.1(b) of the Seller Disclosure Schedule (the “ Purchased Regulatory Approvals ”);
 
(c)   all Seller Regulatory Documentation relating to Seller Products to the extent in the possession of Seller or any of its Affiliates, agents or attorneys;
 
 
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(d)   all Authorizations relating specifically to the Product Business including, but not limited to, the Seller Authorizations;
 
(e)   all Seller Intellectual Property;
 
(f)   all Product Records;
 
(g)   all Product Promotional Material;
 
(h)   all Seller Products Technical Information;
 
(i)   all Purchased Product Inventory; and
 
(j)   all goodwill and the going concern value of the Product Business.
 
2.1.2   Excluded Assets. Purchaser shall not acquire pursuant to this Agreement or any Ancillary Agreement, and Seller shall retain following the Closing Date, the Excluded Assets.
 
2.1.3   Retention of Rights. Except as expressly granted herein or in any Ancillary Agreement, Seller grants no other right or license to any assets or rights, including Intellectual Property Rights, of Seller and its Affiliates.
 
2.2   Liabilities.
 
2.2.1   Assumed Liabilities. Upon the terms and subject to the conditions of this Agreement, at the Closing, Seller shall assign and Purchaser shall assume and agree to pay and discharge when due the Assumed Liabilities.
 
2.2.2   Excluded Liabilities.
 
(a)   Notwithstanding anything to the contrary herein, neither Purchaser nor any of its Affiliates shall assume any Liabilities of Seller or any of its Affiliates (whether or not related to the Product Business) other than the Assumed Liabilities (such Liabilities of Seller or any of its Affiliates other than the Assumed Liabilities, the “ Excluded Liabilities ”), and the Excluded Liabilities shall remain the sole obligation and responsibility of Seller and its Affiliates.
 
(b)   For the purposes of clarity (and notwithstanding Section 2.2.1), neither Purchaser nor any Affiliate of Purchaser shall assume (and the Excluded Liabilities shall include, but not be limited to) the following Liabilities of Seller or any of its Affiliates:
 
(i)   Liabilities for:
 
(1)   Taxes of the Seller or any of its Affiliates, whether arising prior to or after the Closing Date;
 
 
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(2)   or relating to Taxes with respect to the Product Business or the Purchased Assets for any Pre-Closing Tax Period; and
 
(3)   [ ***] 3 of any Transfer Taxes.
 
provided, that , in each case of Sections 2.2.2(b)(i)(1) and 2.2.2(b)(i)(2), responsibility for Apportioned Obligations shall be determined in accordance with Section 6.11.1; and provided , further , for the avoidance of doubt, that Section 2.2.2(b)(i)(1) shall not include any Liability for or relating to Taxes with respect to the Product Business or the Purchased Assets for any Post-Closing Tax Period;
 
(ii)   any Liabilities of Seller or any of its Affiliates relating to accounts payable, indebtedness, legal services, accounting services, financial advisory services, investment banking services or other professional services performed in connection with the sale of the Purchased Assets;
 
(iii)   any Liabilities of Seller or any of its Affiliates that relate to, or that arise out of, the employment or the termination of the employment with Seller or any of its Affiliates of any employee or former employee of Seller or any of its Affiliates (including as a result of the Transactions contemplated by this Agreement);
 
(iv)   any Liabilities (x) under or relating to Environmental Laws; or (y) relating to any actual or alleged violation by Seller or any of its Affiliates of any other Law, in each case regardless of whether arising prior to or after the Closing Date;
 
(v)   any Liabilities (i) for claims arising under product liability or product warranty for any Seller Product manufactured or sold by or for Seller, Seller’s Affiliates or their respective predecessors, licensees, distributors or other collaborators prior to the Closing Date, or (ii) to the extent relating to the manufacture, use, sale, marketing, promotion or distribution of any Seller Product or the ownership or use of the Purchased Assets, in each case prior to the Closing Date;
 
(vi)   any Liabilities to the extent arising from the Excluded Assets;
 
(vii)   subject only to the provisions of the Transition Services Agreement, any Liabilities arising out of or relating to any return of Product, including all Liabilities for any credits or Rebates with respect to Product, in all cases only to the extent that they relate to Product sold on or prior to the Closing Date by or on behalf of Seller or its Affiliates; or
 
(viii)   any Liabilities of Seller or any of its Affiliates (x) arising out of any actual or alleged breach by Seller, or nonperformance by Seller or any of its Affiliates under, any Purchased Contract prior to the Closing; or (y) accruing under any Purchased Contract with respect to any period prior to the Closing.
 

***Certain information on this page has been omitted and filed separately with the Commission. Confidential treatment has been requested with respect to the omitted portions.
 
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2.3   Consideration.
 
2.3.1   Purchase Price.
 
(a)   In consideration of the conveyances contemplated under Section 2.1, Purchaser shall (a) pay to Seller (i) on the Closing Date an amount equal to the sum of (A) $27,000,000; (B) the Stock Consideration; (C) the Promissory Note; and (D) the Purchased Product Inventory Value (collectively, the “ Closing Payment ”), by wire transfer of immediately available funds to the account designated by Seller by notice to Purchaser at least three (3) Business Days prior to the Closing Date; (ii) the Milestone Payment(s), as and to the extent provided in Section 2.3.2; and (iii) the Difference as set forth in Section 2.3.1(b) below and (b) deliver to the Escrow Agent, at the Closing, $3,000,000 in cash (the “ Initial Escrow Amount ”), by wire transfer of immediately available funds. The Escrow Fund shall be held, administered and distributed in accordance with Section 2.4 and the terms of the Escrow Agreement.
 
(b)   In addition to the Purchased Product Inventory Value and subject to the last sentence of this Section 2.3.1(b), Purchaser shall pay Seller the difference (the “ Difference ”) between the Purchased Product Inventory Value and the Final Product Inventory Value determined in accordance with Section 2.3.3 in installments (the “ Installments ”) within five (5) Business Days of each payment by Purchaser to Daravita Limited for quantities of Second Generation Replacement Product (as defined in the Second Generation Supply Agreement). Each Installment shall be equal to the difference between [ ***] 4 of Notional NSP (as set forth on Section 2.3.1 of the Seller Disclosure Schedule) for such Second Generation Replacement Product and the corresponding amounts due and payable to Daravita Limited under the Second Generation Supply Agreement with respect to such Second Generation Replacement Product until either (i) the Difference, if any, has been paid in full to Seller; or (ii) Daravita Limited’s obligation to supply Second Generation Replacement Product at the Discounted Supply Price (as defined in the Second Generation Supply Agreement) pursuant to Section 16.2.1 of the Second Generation Supply Agreement terminates.
 
2.3.2   Milestone Payments.
 
(a)   In addition to the Closing Payment, subject to this Section 2.3.2, Purchaser shall pay or cause to be paid to Seller the following additional amounts (each, a “ Milestone Payment ”) upon the achievement by or on behalf of Purchaser or its Affiliates, licensees, sublicensees or transferees, if any, of the following events with respect to the Product and the Third Generation Product (each, a “ Milestone Event ”):
 
(i)   $12,500,000 upon the FDA’s granting of Regulatory Approval of an NDA for a Third Generation Product that practices a patent listable in the Orange Book that has an expiration date which is January 1, 2025 or later;
 
(ii)   [***];
 
 
 

***Certain information on this page has been omitted and filed separately with the Commission. Confidential treatment has been requested with respect to the omitted portions.
 
 
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(iii) [ ***] 5 ;
 
(iv)   [***];
 
(v)   [***];
 
(vi)   [***]; and
 
(vii)   [***].
 
(b)   For the avoidance of doubt, (i) notwithstanding anything to the contrary herein, each Milestone Payment shall be due and payable only once; and, (ii) with respect to the Milestone Events set forth in Sections 2.3.2(a)(ii) through 2.3.2(a)(vii) above, in the event that more than one Milestone Event is achieved in [***], Purchaser shall pay Seller Milestone Payments for each Milestone Event that is achieved unless, with respect to any such Milestone Event, Seller has previously been paid for achieving such Milestone Event.  By way of example only, (A) if aggregate Net Sales reach [***], Purchaser shall pay Seller the Milestone Payments associated with Sections 2.3.2(a)(ii) ([***]) and 2.3.2(a)(iii) ([***]); and (ii) if aggregate Net Sales reach [***] during the following [***], Purchaser shall pay Seller the Milestone Payment associated with Section 2.3.2(a)(iv) ([***]), but would not pay Seller the Milestone Payments associated with Sections 2.3.2(a)(ii) or 2.3.2(a)(iii) since Seller had previously received Milestone Payments with respect to those Milestone Events.
 
(c)   The Milestone Payment due and payable under Section 2.3.2(a)(i) shall be paid by Purchaser to Seller promptly (but no more than thirty (30) days) following the occurrence of the Milestone Event and all Milestone Payments due and payable under Sections 2.3.2(a)(ii) through 2.3.2(a)(vii) shall be paid by Purchaser to Seller promptly (but no more than seventy-five (75) days) following the end of the Calendar Year in which the applicable Milestone Event occurred (but subject to the limitation in Section 2.3.2(b) that each Milestone shall be due and payable only once), in each case, by wire transfer of immediately available funds to the account designated by Seller by notice to Purchaser.
 
(d)   Purchaser shall, and shall cause its Affiliates, licensees and sublicensees engaged in the Exploitation of any Seller Product to keep copies of the case study reports related to the in vitro and in vivo abuse liability studies in the development plan set forth in Section 2.3.2(d) of the Seller Disclosure Schedule (the “ Development Plan ”) and keep reasonable, correct and complete books and records substantiating the Net Sales amounts recognized in each Calendar Year, in each case, as related to achieving the Milestone Events (the “ Milestone Information ”) and shall maintain such Milestone Information until the third (3 rd ) year following the end of the Calendar Year to which such Milestone Information relates. Until the first Calendar Year following the Calendar Year in which the Reporting Period terminates, Purchaser shall provide Seller, (i) on a quarterly basis, not later than forty-five (45) days after the end of each Calendar Quarter other than the Calendar Quarter ended December 31, the quarterly Net Sales Reports; and (ii) on an annual basis, not later than  sixty (60) days after the end of each Calendar Year, the annual Net Sales Reports, in each case as provided in Section 6.13. Seller’s inspection and audit rights with respect to the Milestone Information and Net Sales Reports are set forth in Section 6.13.
 

***Certain information on this page has been omitted and filed separately with the Commission. Confidential treatment has been requested with respect to the omitted portions.
 
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(e)   Prior to the expiration of the Reporting Period, if Purchaser and its Affiliates transfer, sell, license, convey or otherwise dispose of all or substantially all of Seller’s and its Affiliates’ rights in the Product Business or, with respect to Section 2.3.2(a)(i), the rights to the Third Generation Product, Purchaser shall (i) remain responsible for all of its obligations with respect to the Milestone Payments set forth in this Section 2.3.2; and (ii) cause the transferee, licensee or assignee of such transferred material rights to comply with this Section 2.3.2.
 
2.3.3   Product Inventory Value.
 
(a)   Not more than five (5) Business Days before the Closing Date, Seller shall provide to Purchaser a schedule (the “ Product Inventory Schedule ”) listing the total inventory of finished Product, that constitutes the Product Inventory in accordance with the principles and worked example set forth on Section 2.3.3 of the Seller Disclosure Schedule (the aggregate value of the Product Inventory calculated in this manner, the “ Product Inventory Value ”) and listing the Purchased Product Inventory in accordance with the principles and worked example set forth on Section 2.3.3 of the Seller Disclosure Schedule (the “ Purchased Product Inventory Value ”).
 
(b)   Seller shall deliver to and Purchaser shall accept all Purchased Product Inventory tendered to Purchaser’s common carrier (FCA from the facility at which such Product Inventory is located as of the Closing Date) within no more than five (5) Business Days following the Closing (the “ Product Inventory Delivery Date ”).
 
(c)   Purchaser shall have fifteen (15) days from the Product Inventory Delivery Date to review the Product Inventory Schedule and perform a physical inspection of the Purchased Product Inventory to confirm that the Purchased Product Inventory meets the applicable Specifications and shelf life requirements (the “ Product Criteria ”) and validate the information set forth on the Product Inventory Schedule. Seller shall cooperate with Purchaser and its Representatives to provide them with all access and information needed to perform such review and inspection. The Product Inventory Schedule shall become final and binding on the fifteenth (15 th ) day following the Product Inventory Delivery Date, unless prior to the end of such period, Purchaser delivers to Seller a written notice of its disagreement (“ Notice of Disagreement ”) specifying the number of Units which it believes do not satisfy the Product Criteria (each, a “ Disputed Item ”) and the basis for that belief. Purchaser shall be deemed to have agreed with all items and amounts in the Product Inventory Schedule not specifically identified as a Disputed Item in the Notice of Disagreement, and such undisputed items shall be deemed final and binding and shall not be subject to review in accordance with Section 2.3.3(d).
 
(d)   During the ten (10) Business Day period following delivery of a Notice of Disagreement by Purchaser to Seller, Purchaser and Seller in good faith shall seek to resolve in writing any differences that they may have with respect to the Disputed Items specified therein. During such ten (10) Business Day period, Purchaser shall cooperate with Seller and its Representatives to provide them with any information used in preparing the Notice of Disagreement reasonably requested by Seller or its Representatives. Any Disputed Items resolved in writing between Purchaser and Seller within such ten (10) Business Day period shall be final and binding with respect to such items, and if Seller and Purchaser agree in writing on the resolution of each Disputed Item, the resulting Product Inventory Value, as adjusted to reflect the resolution of the Disputed Items, shall be deemed to be the “ Final Product Inventory Value ”. If Seller and Purchaser have not resolved all such differences by the end of such ten (10) Business Day period, Seller and Purchaser shall jointly appoint an independent testing laboratory (the “ Testing Laboratory ”) to review records and test data and to perform comparative tests and/or analyses on the Disputed Items. The Parties shall act in good faith and co-operate with the Testing Laboratory in its investigation. The Testing Laboratory’s determination as to whether any Disputed Item satisfies the Product Criteria shall be final and binding, and the resulting Product Inventory Value, as adjusted to reflect the Testing Laboratory’s resolution of the Disputed Items, shall be deemed to be the “ Final Product Inventory Value ”. The Final Product Inventory Value, whether agreed to by the Parties or determined by the Testing Laboratory, shall be final and binding on the Parties. The costs of any dispute resolution pursuant to this Section 2.3.3(d), including the fees and expenses of the Testing Lab and of any enforcement of the determination thereof, shall be borne by the Parties in inverse proportion as they may prevail on the matters resolved by the Testing Lab, which proportionate allocation shall be calculated on an aggregate basis based on the relative values of the amounts in dispute and shall be determined by the Testing Lab at the time the determination of such firm is rendered on the merits of the matters submitted.
 
 
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(e)   If Purchaser timely submits a Notice of Disagreement and the Product Inventory Value exceeds the Final Product Inventory Value, as determined in accordance with Section 2.3.3(d), Seller shall pay Purchaser the amount by which the Product Inventory Value exceeds the Final Product Inventory Value within ten (10) days after the Final Product Inventory Value is determined in accordance with Section 2.3.3(d). Any such payment hereunder shall be made by wire transfer of immediately available funds to an account designated in writing by Purchaser and shall be treated as an adjustment to the Closing Payment.
 
2.3.4   Transitional License. In connection with the purchase of the Purchased Product Inventory, Seller hereby grants Purchaser a non-exclusive, fully paid up, transferable, royalty-free license, with the right to sublicense, (a) the Transitional Trademarks; and (b) product identification numbers (including NDC numbers) or consumer information telephone numbers, in each case, solely to the extent necessary to sell the Purchased Product Inventory after the Closing. Such license shall become effective on the Closing Date and expire six (6) months after the last expiration date on Seller labeled Purchased Product Inventory.
 
2.3.5   Allocation of Consideration. Purchaser shall allocate the Purchase Price (including the Assumed Liabilities, to the extent properly taken into account under Section 1060 of the Code) among the Purchased Assets, the transitional license provided in Section 2.3.4 and the covenant provided in Section 6.14 in accordance with Section 1060 of the Code (and any similar provision of state, local or foreign law, as appropriate) (the “ Allocation ”) prior to or within ninety (90) days following the Closing and shall deliver to Seller a copy of such Allocation (IRS Form 8594) promptly after such determination. Seller shall have the right to review and raise any objections in writing to the Allocation during the ten (10)-day period after its receipt thereof. If Seller disagrees with respect to any item in the Allocation, the Parties shall negotiate in good faith to resolve the dispute. If the Parties are unable to agree on the Allocation within thirty (30) days after the commencement of such good faith negotiations (or such longer period as Seller and Purchaser may mutually agree in writing), then the Accountants shall be engaged at that time to review the Allocation, and shall make a determination as to the resolution of such Allocation. The determination of the Accountants regarding the Allocation shall be delivered as soon as practicable following engagement of the Accountants, but in no event more than sixty (60) days thereafter, and shall be final, conclusive and binding upon Seller and Purchaser, and Purchaser shall revise the Allocation accordingly. Seller, on the one hand, and Purchaser on the other hand, shall each pay one-half of the cost of the Accountants. The Parties agree to file all Tax Returns (including IRS Form 8594 and, if required, supplemental Forms 8594, in accordance with the instructions to Form 8594) and any other forms, reports or information statements required to be filed pursuant to Section 1060 of the Code and the applicable regulations thereunder, and any similar or corresponding provision of U.S. state, local or non-U.S. Tax Law, in a manner that is consistent with the finalized Allocation and to refrain from taking any position inconsistent therewith unless required by applicable Law or a final determination of a taxing authority.
 
 
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2.4   Escrow.
 
2.4.1   Escrow Amount. During the Escrow Period, upon the payment of the Promissory Note, Purchaser shall promptly deliver to the Escrow Agent $7,000,000 in cash from such payment (the “ Promissory Note Escrow Amount ” and, together with the Initial Escrow Amount, the “ Escrow Amount ”), by wire transfer of immediately available funds.
 
2.4.2   Escrow Agreement.  Subject to the terms and conditions of a mutually acceptable escrow agreement to be entered into at the Closing by each of Seller and Purchaser (the “ Escrow Agreement ”) and this Section 2.4, the Escrow Agent shall hold the Escrow Amount and all other amounts deposited into the Escrow Fund for a period commencing on the Closing Date and ending on the date that is twelve (12) months after the Closing Date (the “ Escrow Period ”) as security to pay, or be applied against, any Losses incurred by any Purchaser Indemnitee that are subject to the indemnification obligations of Seller pursuant to ARTICLE 8.  Purchaser shall be treated for Tax purposes as the owner of all amounts held in the Escrow Fund unless and until such amounts are released therefrom, at which time the Party to whom such amounts are released shall be treated for Tax purposes as the owner of such released amounts.
 
2.4.3   Payment of Claims.  Subject to the terms and conditions of the Escrow Agreement, the Escrow Agent shall disburse to Purchaser Indemnitees such portion of the Escrow Fund as may be necessary to satisfy claims for which Purchaser Indemnitees are entitled to indemnification pursuant to ARTICLE 8 hereof.
 
 
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2.4.4   Release of Escrow Amounts.  Following the expiration of the Escrow Period, the Escrow Agent shall pay to Seller the balance of the funds in the Escrow Fund at such time, if any, minus an amount equal to the aggregate dollar amount of claims for Losses made by all Purchaser Indemnitees pursuant to ARTICLE 8 hereof (the “ Aggregate Outstanding Claims ”) which are then outstanding and unresolved (such amount retained in the Escrow Fund, as it may be further reduced after expiration of the Escrow Period by distributions to Seller as set forth below and recoveries by Purchaser Indemnitees pursuant to ARTICLE 8 hereof, the “ Retained Escrow Funds ”); provided, however , that  in the event that the amount of the Aggregate Outstanding Claims exceeds the balance remaining in the Escrow Fund, all amounts remaining in the Escrow Fund shall be retained in the Escrow Fund as the Retained Escrow Funds.  In the event and to the extent that after the expiration of the Escrow Period any outstanding claim made by any Purchaser Indemnitee pursuant to ARTICLE 8 hereof is resolved against such Purchaser Indemnitee, the Escrow Agent shall distribute to Seller an aggregate amount of the Retained Escrow Funds equal to the amount of the outstanding claim resolved against such Purchaser Indemnitee; provided, however , that such distribution shall only be made to the extent that the Retained Escrow Funds remaining after such distribution would be sufficient to cover the amount of the Aggregate Outstanding Claims that are still unresolved at such time.  In the event and to the extent that after expiration of the Escrow Period any outstanding claim made by any Purchaser Indemnitee pursuant to ARTICLE 8 hereof is resolved in favor of such Purchaser Indemnitee, such Purchaser Indemnitee shall be entitled to recover pursuant to ARTICLE 8 hereof an amount equal to the amount of the outstanding claim resolved in favor of such Purchaser Indemnitee.
 
2.4.5   Escrow Agent Fees and Expenses.  Seller, on the one hand, and Purchaser, on the other hand, shall pay to the Escrow Agent fifty percent (50%) of any fees and expenses of the Escrow Agent by wire transfer of immediately available funds.  During the period in which the Escrow Funds (including any Retained Escrow Funds) are retained in the Escrow Account, all interest or other income earned from the investment of the Escrow Funds (the “ Escrow Earnings ”) shall be retained as additional amounts in the Escrow Account.
 
2.5   Closing.
 
2.5.1   Closing. Pursuant to the terms and subject to the conditions of this Agreement, the closing of the Transactions contemplated hereby (the “ Closing ”) shall take place at the offices of Lowenstein Sandler LLP, 1251 Avenue of the Americas, New York, New York 10020, at 10:00 a.m., local time, on a Business Day on a date not later than three (3) Business Days following satisfaction of all conditions (other than those that by their terms are to be satisfied or taken at the Closing (but subject to the satisfaction or waiver of such conditions) and those that are waived by the Party entitled to do so under applicable Law and the terms of this Agreement) set forth in ARTICLE 7, or such other time and place as Purchaser and Seller may agree to in writing; provided, however , that if the waiting period under the HSR Act is terminated before the thirty (30) day statutory period expires (an “ Early Termination ”), Purchaser may, but shall not be obligated to, defer the Closing until a date no later than ten (10) days after the Early Termination by providing Seller written notice of such deferral within two (2) Business Days of the Parties’ receipt of notice of Early Termination.  The Closing shall be deemed to have occurred at 12:00 a.m., eastern time, on the Closing Date, such that Purchaser shall be deemed the owner of the Purchased Assets on and after the Closing Date.
 
 
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2.5.2   Closing Deliveries.
 
(a)   Except as otherwise indicated below, at the Closing, Seller shall deliver the following to Purchaser:
 
(i)   each of the Ancillary Agreements to which Seller is a party, validly executed by a duly authorized officer of Seller.
 
(ii)   a certificate, executed by an officer of Seller and dated the Closing Date, confirming on behalf of Seller that the conditions set forth in Sections 7.2.1, 7.2.2 and 7.2.3 have been satisfied;
 
(iii)   copies of all Seller Third Party Consents;
 
(iv)   copies of all Seller FDA Letters;
 
(v)   the Purchased Contracts;
 
(vi)   all other Purchased Assets; provided, that (A) with respect to tangible Purchased Assets, delivery shall, unless the Parties otherwise mutually agree, be in accordance with the Transition Services Agreement and to a place within the continental United States specified by Purchaser by notice to Seller at a time prior to or after the Closing as the Parties mutually agree; and (B) Seller may retain one copy of the Product Records included within the Purchased Assets and the Purchased Contracts (and, for clarity, prior to delivering or making available any files, documents, instruments, papers, books and records containing Product Records to Purchaser, Seller shall be entitled to redact from such files, documents, instruments, papers, books and records any information to the extent that it does not relate to the Product Business); and
 
(vii)   a non-foreign affidavit of Seller dated as of the Closing Date, sworn under penalty of perjury and in the form and substance required under Treasury Regulations issued pursuant to Section 1445 of the Code certifying that Seller is not a “foreign person” as defined in Section 1445 of the Code.
 
(b)   At the Closing, Purchaser shall deliver the following to Seller:
 
(i)   each of the Ancillary Agreements to which Purchaser is a party, validly executed by a duly authorized officer of Purchaser;
 
(ii)   the Stock Consideration;
 
(iii)   a certificate, executed by an officer of Purchaser and dated the Closing Date, confirming on behalf of Purchaser that the conditions set forth in Sections 7.3.1 and 7.3.2 have been satisfied;
 
 
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(iv)   an agent for services of process letter from Purchaser, in form and substance reasonably requested by Seller covering this Agreement, the Promissory Note, the Security Agreement, the Guaranty and the Ancillary Agreements; and
 
(v)   copies of all Purchaser FDA Letters.
 
2.5.3   Withholding. If applicable Laws require withholding of Taxes imposed upon any payments made by Purchaser to Seller pursuant to this Agreement, Purchaser shall make such withholding payments as may be required and shall subtract such withholding payments from such payments. To the extent such amounts are so deducted or withheld, such amounts will be treated for all purposes under this Agreement as having been paid to Seller; provided, however , that Purchaser may deduct such amounts only if Purchaser shall (i) give Seller reasonable advance notice of the intention to make such deduction or withholding; (ii) upon Seller’s reasonable request, explain the basis for such deduction or withholding; (iii) cooperate with Seller to the extent reasonably requested to obtain any applicable reduction of or relief from such deduction or withholding; and (iv) timely file all Tax Returns related to such withholding and provide to Seller such information statements and other documents required to be provided to Seller.
 
ARTICLE 3
REPRESENTATIONS AND WARRANTIES OF SELLER
 
Seller represents and warrants to Purchaser that, except as set forth in the Seller Disclosure Schedule (but subject to the immediately following sentence), the statements contained in this ARTICLE 3 are true and correct (a) as of the date hereof; and (b) as of the Closing (unless in each case the particular statement speaks expressly as of a particular date, in which case it is true and correct only as of such date). Notwithstanding the foregoing, it is expressly understood and acknowledged that any information disclosed in the Disclosure Schedule under any numbered or lettered section or subsection shall be deemed to relate to and qualify such section or subsection, as well as any other sections or subsections of the Seller Disclosure Schedule, but only where the relevance of such disclosure to such other section or subsection is reasonably apparent from the text of such disclosure; provided, that the mere listing of an agreement shall not provide reasonably apparent disclosure, except to the extent that only a listing is required by the representation and warranty.
 
3.1   Entity Status.   Seller is a corporation duly organized, validly existing and in good standing under the Laws of the State of Delaware. Seller has all requisite corporate power and authority to own, use and operate the Purchased Assets and to carry on the Product Business as now being conducted. Seller is duly qualified or licensed to do business and is in good standing in each jurisdiction in which such qualification or licensing is necessary under applicable Law, except where the failure to be so qualified or licensed and to be in good standing would not have a Material Adverse Effect.
 
3.2   Authority.
 
3.2.1   Seller has the requisite corporate power and authority to enter into and deliver this Agreement and the Ancillary Agreements and to perform its obligations hereunder and thereunder and to consummate the Transactions contemplated hereby and thereby. The execution and delivery of this Agreement and the Ancillary Agreements and the consummation of the Transactions contemplated hereby and thereby have been duly authorized and approved by Seller’s Board, and no other corporate action on the part of Seller is necessary to authorize and approve the execution, delivery and performance by Seller of this Agreement and the Ancillary Agreements and the consummation by it of the Transactions contemplated hereby and thereby. This Agreement constitutes, and each Ancillary Agreement, when executed and delivered by Seller, will constitute, the valid and legally binding obligation of Seller, enforceable against Seller in accordance with its terms, subject to bankruptcy, insolvency, fraudulent transfer, reorganization, moratorium or similar Laws of general application affecting or relating to the enforcement of creditors’ rights generally, and subject to equitable principles of general applicability, whether considered in a proceeding at law or in equity.
 
 
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3.3   Non-Contravention.   The execution, delivery, consummation and performance by Seller of this Agreement and each Ancillary Agreement to which it is a party do not and will not (a) contravene, conflict with or violate the certificate of incorporation or bylaws or comparable organizational documents; or contravene or conflict with any resolution adopted by the stockholders or members, board of directors and any committee of the board of directors (or other equivalent bodies) of Seller or such Affiliate of Seller; (b) subject to compliance with the HSR Act, contravene, conflict with or violate any Law applicable to Seller or such Affiliates of Seller, the Product Business, or the Purchased Assets; (c) subject to obtaining Seller Third Party Consents, contravene, conflict with, violate, breach or constitute a default (with or without due notice or lapse of time or both) under, result in the loss of rights under, or result in the termination of, or give rise to a right of termination, cancellation or acceleration of any right or obligation under, any Contract used in the conduct of the Product Business to which Seller or such Affiliate is a party, including any Purchased Contract, or any Contract to which the Purchased Assets is subject; or (d) result in the imposition of creation of any Encumbrance other than a Permitted Encumbrance upon or with respect to any Purchased Asset, except, in the case of (b) and (c), for such violations, breaches, defaults, accelerations, cancellations or terminations that would not reasonably be expected to materially affect the Product Business or the Purchased Assets.
 
3.4   No Broker.   Seller shall be solely responsible for the fees and expenses of any broker, finder, investment banker or financial advisor entitled to any brokerage, finder’s or other fee or commission in connection with the Transactions contemplated by this Agreement based upon arrangements made by or on behalf of Seller.
 
3.5   No Litigation; Consents.
 
3.5.1   Except as set forth on Section 3.5.1 of the Seller Disclosure Schedule, there is no Litigation (other than any investigation, inquiry, audit, examination or finding of deficiency or noncompliance) pending or, to Seller’s Knowledge, threatened against Seller or any of its Affiliates before any Governmental Authority or private dispute resolution body, that (i) involves or otherwise relates to the Product Business, the Purchased Assets, or the Assumed Liabilities; or (ii) challenges or, if resolved against Seller, would prevent, delay or make illegal any of the Transactions; or (iii) would reasonably be expected to impose any material limitation on the ability of Purchaser or any of its Affiliates to operate the Product Business as of the Closing.
 
 
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3.5.2   Except as set forth on Section 3.5.2 of the Seller Disclosure Schedule, there is no order or judgment of a Governmental Authority to which Seller or any of its Affiliates is subject that involves or otherwise relates to the Product Business, the Purchased Assets or the Assumed Liabilities that would reasonably be expected to impose any Liability on Purchaser or the Product Business, or imposes any limitation on the ability of Seller to sell the Purchased Product Inventory or operate the Product Business or the Purchased Assets as currently conducted or planned to be conducted as of the date hereof by Seller and, to Seller’s Knowledge, there are no facts which would form a basis for such order or judgment.
 
3.5.3   Since May 1, 2012, Seller has not received any written notice, claim or complaint from any other Person alleging (a) a violation of, or failure to comply with, or any Liability under, any Laws relating to the Product Business, the Purchased Assets or the Assumed Liabilities as a result of Seller’s and its Affiliates’ operation of the Product Business, except for any such notice relating to a failure to comply that has since been cured; or (b) any material defects in the Product or alleging any failure of the Product to meet Specifications.
 
3.5.4   Except for (i) if required, the filings under the HSR Act and the expiration or termination of the waiting periods thereunder; (ii) consents, permits or authorizations that if not received, or declarations, filings or registrations that if not made, would not reasonably be expected to materially affect the Product Business, the Purchased Assets or the Assumed Liabilities; (iii) consents, permits, authorizations, declarations, filings or registrations that have become applicable solely as a result of the specific regulatory status of Purchaser or its Affiliates; and (iv) Seller Third Party Consents, no notice to, filing with or Authorization of, any Governmental Authority or other Person is required for Seller or any of its Affiliates to consummate the Transactions.
 
3.5.5   Except as set forth on Section 3.5.5 of the Seller Disclosure Schedule, as of the Execution Date, neither Seller nor any Affiliate of Seller has received or been notified in writing of any paragraph IV certification filed pursuant to Section 505(j)(2)(A)(vii)(IV) or 505(b)(2)(A)(iv) of the Act advising Seller or any of its Affiliates of the filing of an ANDA or Section 505(b)(2) NDA that relies on the FDA’s prior finding of safety and effectiveness for the Product.
 
3.5.6   Since May 1, 2012, no product liability claims by any Third Party or any notice of investigation from a Governmental or Regulatory Authority have been received by Seller or any of its Affiliates and, to Seller’s Knowledge, no such product liability claims or investigations have been threatened against Seller or any of its Affiliates relating to marketing and sale of the Product, and to Seller’s Knowledge, there are no facts or circumstances that would reasonably give rise to any Litigation for product liability.  There is no order outstanding against Seller relating to Product liability claims or Governmental or Regulatory Authority investigations relating to the marketing and sale of the Product.
 
 
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3.6   Title to the Purchased Assets.   Seller, or its Affiliates, owns and has good and valid title to, or valid contract rights in, as applicable, the Purchased Assets, free and clear of all Encumbrances other than Permitted Encumbrances.
 
3.7   Contracts.
 
3.7.1   Section 3.7.1 of the Seller Disclosure Schedule sets forth a complete and correct list of each Contract to which Seller or any of its Affiliates is a party that relates to the Product Business or is necessary for the Exploitation or Manufacture of the Product with a value in excess of One Hundred Thousand Dollars ($100,000) and any other Contract if a default thereunder would reasonably be expected to materially adversely affect the Product Business or Purchased Assets.
 
3.7.2   Except as set forth on Section 3.7.2 of the Seller Disclosure Schedule, Seller is not a party to or bound by any Contract relating to the Product Business which Contract (a) limits the freedom of the Product Business to compete in any line of business or any geographic area; (b) grants any rights of exclusivity to any Third Party; or (c) grants any “most favored customer”, “most favored supplier” or similar rights to any Third Party.
 
3.7.3   Each of the Purchased Contracts is in full force and effect and constitutes a legal, valid and binding agreement of Seller or an Affiliate of Seller, enforceable in accordance with its terms, subject to bankruptcy, insolvency, fraudulent transfer, reorganization, moratorium or similar Laws of general application affecting or relating to the enforcement of creditors’ rights generally, and subject to equitable principles of general applicability, whether considered in a proceeding at law or in equity. Neither Seller nor any of its Affiliates, nor, to Seller’s Knowledge, any other party thereto is (with or without notice or lapse of time, or both) in breach or default in the performance, observance or fulfillment of any material obligation or material covenant contained in any Purchased Contract, nor does there exist any condition which upon the passage of time or the giving of notice or both, would reasonably be expected to cause such material violation of or material default under or permit the termination or modification of any Purchased Contract. Neither Seller nor any of its Affiliates has given or received written notice to or from any Person relating to any such actual or alleged, breach or default. Neither Seller nor any of its Affiliates has received any written notice from a Third Party stating that such Third Party intends to terminate any Purchased Contract and Seller has not waived any right under the Purchased Contracts. True and complete copies of all Purchased Contracts have been made available to Purchaser, except to the extent such Contracts have been redacted to (a) enable compliance with Laws relating to antitrust or the safeguarding of data privacy; (b) comply with confidentiality obligations owed to Third Parties; or (c) exclude information not related to the Product Business.
 
3.8   Compliance with Law.
 
3.8.1   Seller and its Affiliates, with respect to the operation of the Product Business or the ownership of and use of the Purchased Assets and, to Seller’s Knowledge, any Person that Manufactures, tests, distributes or conducts research on behalf of Seller with respect to a Seller Product pursuant to a development, commercialization, manufacturing, supply, testing, contract research or other collaboration arrangement with Seller or any of its Affiliates (a “ Partner ”), are and have been since May 1, 2012, in compliance with all applicable Laws and in each country in which any Seller Product is Manufactured, except for such noncompliance that would not reasonably be expected to materially adversely affect the Product Business or Purchased Assets, including (i) any applicable Laws governing the research, development, approval, Manufacture, sale, advertising, marketing, promotion, pricing, pharmacovigilance, recordkeeping or distribution of drugs and the purchase or prescription of or reimbursement for drugs by any Governmental Authority, private health plan or entity, or individual; and (ii) all applicable Laws regulating the pharmaceutical industry, including the federal Anti-Kickback Statute (42 U.S.C. §1320a-7b(b)), the criminal False Claims Act (42 U.S.C. §1320a-7b(a)), the civil False Claims Act (31 U.S.C. §§3729 et seq.), the Civil Monetary Penalties Law (42 U.S.C. §1320a-7a), the federal Physician Payment Sunshine Act (42 U.S.C.§1320a-7h), the federal health care program exclusion laws (42 U.S.C. §1320a-7), the Act, the Controlled Substances Act, as amended (21 U.S.C. 801 et seq.), the Health Insurance Portability and Accountability Act of 1996 (42 U.S.C. §1320d et. seq.) as amended by the Health Information Technology for Economic and Clinical Health Act (42 U.S.C. §§17921 et seq.), the Foreign Corrupt Practices Act (15 U.S.C. §§78dd-1 et seq.), and the Patient Protection and Affordable Care Act of 2010, as amended by the Health Care and Education Reconciliation Act of 2010, and any comparable state or local Laws.
 
 
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3.8.2   Each of Seller and its Affiliates possesses, and is in compliance in all material respects with, all material Authorizations (other than Regulatory Approvals, which are the subject of Section 3.9.1) necessary for the conduct of the Product Business as it is currently conducted and the ownership of or use of the Purchased Assets (collectively, the “ Seller Authorizations ”). All such material Seller Authorizations are set forth in Section 3.8.2 of the Seller Disclosure Schedule, and all of such Seller Authorizations are in full force and effect, except as would not reasonably be expected to materially and adversely affect the Product Business.  Neither Seller nor any of its Affiliates have received any communication with respect to the Product Business from any Governmental Authority regarding, and, to Seller’s Knowledge, there are no facts or circumstances that are likely to give rise to, (i) any material adverse change in any Seller Authorization, or any failure to materially comply with any applicable Law or any term or requirement of any Seller Authorization; or (ii) any revocation, withdrawal, suspension, cancellation or termination of any Seller Authorization.
 
3.8.3   Since May 1, 2012, Seller has complied with all applicable Data Protection Laws, as well as with its own rules, policies, and procedures relating to privacy, data protection, and the collection and use of personal information collected, used, or held for use by Seller, except for such noncompliance that would not reasonably be expected to materially adversely affect the Product Business or Purchased Assets. No claims have been asserted or threatened against Seller alleging a violation of any Person’s privacy or personal information or data rights and, to Seller’s Knowledge, nothing has been done or omitted to be done and no circumstances exist which could give rise to any proceeding, action or claim in connection with the applicable Data Protection Laws. To Seller’s Knowledge, the consummation of the Transactions contemplated by this Agreement will not breach or otherwise cause any violation of any Data Protection Law or rule, policy or procedure relating to privacy, data protection, and the collection and use of personal information collected, used, or held for use by Seller in the conduct of the Product Business.
 
 
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3.8.4   Seller, or an Affiliate of Seller, has established and maintains a corporate compliance program that addresses the material Laws of the Territory with respect to the Product Business and each country in which the Product is Manufactured.
 
3.8.5   To Seller’s Knowledge, neither Seller nor any of its Affiliates engaged in the Product Business have made any voluntary or involuntary self-disclosure to any Governmental Authority or representative thereof regarding any material non-compliance with any Law applicable to the Product Business, which non-compliance remains uncured.
 
3.9   Regulatory Matters.
 
3.9.1   Seller, or an Affiliate of Seller, possesses, and since May 1, 2012 has possessed, or has a right of reference to all material Regulatory Approvals necessary to conduct the Product Business as currently or then conducted or develop the Third Generation Product as currently being developed.  All such material Regulatory Approvals are in full force and effect, and no Governmental Authority has imposed any material obligation or other Encumbrance upon any such Regulatory Approval that remains unsatisfied or undischarged, except as set forth in Section 3.9.1 of the Seller Disclosure Schedule. Since May 1, 2012, neither Seller nor its Affiliates, and to Seller’s Knowledge, no Partners have received any written communication from any Governmental Authority threatening to revoke, withdraw, suspend, cancel or terminate any such Regulatory Approvals, and there is no proceeding pending or, to Seller’s Knowledge, threatened regarding the suspension or revocation of any such Regulatory Approval. Since May 1, 2012, Seller has not received, and to Seller’s Knowledge, no Partners have received (i) any written notice that the FDA or any other Governmental Authority has commenced, or threatened to initiate, any action to request a recall of the Product, or commenced, or threatened to initiate, any action to enjoin production at any facility at which the Product is Manufactured; or (ii) any FDA Form 483, notice, warning letter, untitled letters, or any other similar correspondence or notice related to the Seller Products stating that Seller and/or the applicable Partner was or is in material violation of any Law, clearance, approval, or exemption. Seller has not voluntarily or involuntarily surrendered, terminated or permitted to lapse or expire any Regulatory Approval used or maintained by Seller in the conduct of the Product Business or the development of the Third Generation Product except where the surrender, termination, or lapse would not reasonably be expected to materially adversely affect the Product Business or Purchased Assets.  Since May 1, 2012, Seller or its Affiliates and, to Seller’s Knowledge, any Partner that Manufactures or distributes any Seller Product, have timely filed with the applicable Governmental Authority all required filings, declarations, listings, registrations, reports or submissions that are material to conduct of the Product Business or the development of the Third Generation Product, including Adverse Event reports. All such filings, declarations, listings, registrations, reports or submissions (A) were in compliance in all material respects with all applicable Laws when filed; (B) were true, accurate and complete in all material respects as of the date made, and, to the extent required to be updated, as so updated remained true, accurate and complete in all material respects, or were corrected or supplemented by a subsequent filing; (C) do not materially misstate any of the statements or information included therein or omit to state a material fact necessary to make the statements therein not misleading; and (D) no material deficiencies have been asserted by any applicable Governmental Authority with respect to any such filings, declarations, listings, registrations, reports or submissions. Neither Seller nor its Affiliates is in material violation of the terms of any Regulatory Approval related to the Product or Third Generation Product.
 
 
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3.9.2   Since May 1, 2012, there has not been any product recall, dear doctor letter or market withdrawal conducted by or on behalf of Seller concerning the Product or any product recall, dear doctor letter, market withdrawal or replacement conducted by or on behalf of any Third Party as a result of any alleged defect in the Product. Seller has made available to Purchaser true and correct summary reports regarding material complaints and notices of alleged defect or adverse reaction with respect to the Product that have been received in writing by Seller and its Affiliates since May 1, 2012.  To Seller’s Knowledge, except as set forth on Section 3.9.2 of the Seller Disclosure Schedule, there are no facts which are reasonably likely to cause (i) the recall, market withdrawal or replacement of any Product sold or intended to be sold by Seller; (ii) a material change in the labeling of the Product; or (iii) a termination or suspension of the marketing of the Product.
 
3.9.3   Since May 1, 2012, the Product has been Manufactured in compliance with applicable Law, including cGMP, and applicable Regulatory Approvals, except where any noncompliance would not reasonably be expected to materially adversely affect the Product Business or Purchased Assets.
 
3.9.4   Except as set forth on Section 3.9.4 of the Seller Disclosure Schedule, since May 1, 2012 and with respect to Seller Products, there have been no (i) serious adverse drug experiences as defined in 21 C.F.R. § 314.80; or (ii) material events concerning or affecting safety.
 
3.9.5   The clinical trials conducted by or on behalf of Seller or its Affiliates with respect to the Product and the Third Generation Product were conducted or are being conducted, as applicable, in all material respects in accordance with cGCP and all applicable Laws. Seller and its Affiliates have made all necessary material filings and received all necessary material approvals and consents for the conduct of clinical trials from the necessary Governmental Authorities and, to Seller’s Knowledge, there is no Litigation pending or threatened by such Governmental Authorities to suspend or terminate any ongoing clinical trials for any Seller Product. Seller has not received any written notice, charge, subpoena or other request for information, which has not been complied with or withdrawn, by a Governmental Authority asserting any material breach of the conditions for approval of any ongoing clinical trials for the Product   or Third Generation Product. Seller and its Affiliates have conducted all clinical trials for the Seller Products pursuant to valid protocols.
 
 
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3.9.6   Seller has calculated and reported all prices reported to or used to calculate pricing or discounts under the Medicaid Program (42 U.S.C. § 1396r-8), the 340B Drug Discount Program (42 U.S.C. § 256b), and Section 603 of the Veterans Healthcare Act of 1993 (Pub. L. 102-585) for the Product in compliance in all material respects with applicable Law.
 
3.10   Taxes.
 
3.10.1   Neither Seller nor any of its Affiliates has any material Liability for Taxes for a Pre-Closing Tax Period for which Purchaser would reasonably be expected to become liable or that would reasonably be expected to materially adversely affect (a) the interests to be acquired by Purchaser hereunder and under the Ancillary Agreements; or (b) Purchaser’s right to use or enjoy (free and clear of any Encumbrances, including liens for Taxes, other than Permitted Encumbrances) any Purchased Asset.
 
3.10.2   All Tax Returns required to be filed by or on behalf of Seller or any of its Affiliates, to the extent related to the Purchased Assets, have been duly and timely filed with the appropriate taxing authority in all jurisdictions in which such Tax Returns are required to be filed (after giving effect to any valid extensions of time in which to make such filings), and all such Tax Returns are true, complete and correct in all material respects.  Each of Seller and its Affiliates has timely paid all Taxes shown as due and payable on such Tax Returns.  Neither Seller nor any of its Affiliates is currently the beneficiary of any extension of time within which to file any of the aforementioned Tax Returns and neither has waived any statute of limitations in respect of the aforementioned Taxes or agreed to any extension of time with respect to a Tax assessment or deficiency regarding the aforementioned Taxes.
 
3.10.3   There is no action, suit, proceeding, audit, claim or assessment pending or threatened in writing concerning any Tax Return of the Seller or its Affiliates that relates to the Purchased Assets.
 
3.10.4   Neither Seller nor any of its Affiliates has any obligation to indemnify or otherwise assume or succeed to the Tax liability of another Person (excluding for purposes of this Section 3.10.4 liability pursuant to customary provisions in Contracts entered into in the ordinary course of business and not primarily related to Taxes).
 
3.10.5   Neither Seller nor any of its Affiliates has treated any of the Purchased Assets as an interest (other than indebtedness within the meaning of Section 163 of the Code) in an entity taxable as a corporation, partnership, trust or  real  estate  mortgage  investment  conduit  for  federal  income  tax  purposes.
 
3.10.6   Neither Seller nor any of its Affiliates has executed or entered into any agreement with, or obtained any consents or clearances from, any taxing authority, or has been subject to any ruling guidance specific to the Seller or any of its Affiliates, that would be binding on Purchaser for any Post-Closing Tax Period.
 
3.11   Debarred Personnel.   Neither Seller nor any of its Representatives who has undertaken activities in connection with the Product Business is or has been (a) debarred or convicted, or is subject to a pending debarment or conviction, pursuant to section 306 of the Act; (b)(A) listed by any government or regulatory agencies as ineligible to participate in a “Federal Health Care Program” (as that term is defined in 42 U.S.C. 1320a-7b(f)), or in any other government payment program, or (B) excluded, debarred, suspended or otherwise made ineligible to participate in any such program; (c) listed on the General Services Administration’s List of parties Excluded from Federal Procurement and Nonprocurement Programs; or (d) to Seller’s Knowledge, convicted of a criminal offense related to the provision of healthcare items or services, or that could lead to debarment, exclusion, suspension, or the loss of eligibility to participate in a Federal Health Care Program or in Federal Procurement and Nonprocurement Programs.
 
 
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3.12   Intellectual Property.
 
3.12.1   Seller or one of its Affiliates owns, or otherwise has the right to use, the Seller Intellectual Property (provided the foregoing is not to be interpreted a representation of non-infringement). Section 3.12.1 of the Seller Disclosure Schedule sets forth a true and complete list of all Contracts to which Seller or any of its Affiliates is a party and under which Seller or any of its Affiliates is a licensor or licensee of any Seller Intellectual Property that is material to the Product Business (collectively, the “ Seller License Agreements ”). Seller has made available to Purchaser a complete and accurate copy of each such Seller License Agreement. Each of the Seller License Agreements is in full force and effect. Seller and its Affiliates are not in breach of any material obligation under any Seller License Agreement and have not received any written notice of termination of any such Seller License Agreement. To Seller’s Knowledge, no other party to any Seller License Agreement is in breach of any material obligation under such Seller License Agreement.
 
3.12.2   Section 3.12.2 of the Seller Disclosure Schedule sets forth a true and complete list of all applications and registrations for the Seller Intellectual Property filed or registered with or issued by any Governmental Authority which are owned by Seller and that have not lapsed, expired or been abandoned (“ Seller Owned Registered Product IP ”).  All registrations and applications for Seller Owned Registered Product IP have been duly filed or registered (as applicable) with the applicable Governmental Authority and maintained in accordance with applicable Law, including the timely submission prior to the expiration of the applicable grace period of all necessary filings and payment of fees for the purposes of maintaining such Seller Owned Registered Product IP.
 
3.12.3   Section 3.12.3 of the Seller Disclosure Schedule sets forth a true and complete list of all applications and registrations for the Seller Intellectual Property filed or registered with or issued by any Governmental Authority which are licensed to Seller pursuant to a Seller License Agreement (“ Seller Licensed Registered Product IP ”). To Seller’s Knowledge, all registrations and applications for Seller Licensed Registered Product IP have been duly filed or registered (as applicable) with the applicable Governmental Authority and maintained in accordance with applicable Law, including the timely submission prior to the expiration of the applicable grace period of all necessary filings and payment of fees for the purposes of maintaining such Seller Licensed Registered Product IP.
 
 
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3.12.4   Seller or one of its Affiliates owns or otherwise has the right to use all Intellectual Property Rights necessary to conduct the Product Business as presently conducted (provided the same is not to be interpreted as a representation as to non-infringement). To Seller’s Knowledge, other than Seller Intellectual Property, Seller and its Affiliates do not own or have license rights to any Intellectual Property Rights that would be infringed, violated or misappropriated by use, offer for sale or sale (by an unauthorized Third Party) of any Seller Product.
 
3.12.5   None of the Patent Rights owned by Seller set forth on Section 3.12.2 of the Seller Disclosure Schedule, is involved in any Litigation (other than any investigation, inquiry, audit, examination or finding of deficiency or noncompliance), reissue, interference, reexamination or opposition proceeding, or, to Seller’s Knowledge, any investigation, inquiry, audit, examination or finding of deficiency or noncompliance, and, to Seller’s Knowledge, no such Litigation, reissue, interference, reexamination or opposition proceeding is threatened in a writing received by Seller. To Seller’s Knowledge, except as set forth in Section 3.12.5 of the Seller Disclosure Schedule, none of the Patent Rights licensed to Seller set forth on Section 3.12.3 of the Seller Disclosure Schedule (together with the Patent Rights owned by Seller set forth on Section 3.12.2 of the Seller Disclosure Schedule, the “ Seller Patents ”) is involved in any Litigation, reissue, interference, reexamination or opposition proceeding nor is any such Litigation, reissue, interference, reexamination or opposition proceeding threatened.
 
3.12.6   None of Seller Trademarks or Seller Copyrights owned by Seller, or any registrations or applications to use or register such items, is involved in any Litigation (other than any investigation, inquiry, audit, examination or finding of deficiency or noncompliance), cancellation, nullification, interference, concurrent use or opposition proceeding, or, to Seller’s Knowledge, any investigation, inquiry, audit, examination or finding of deficiency or noncompliance, and, to Seller’s Knowledge, no such Litigation, cancellation, nullification, interference, concurrent use or opposition proceeding is threatened. To Seller’s Knowledge, none of Seller Trademarks or Seller Copyrights licensed to Seller, or any registrations or applications to use or register such items, is involved in any Litigation, cancellation, nullification, interference, concurrent use or opposition proceeding nor is any such Litigation, cancellation, nullification, interference, concurrent use or opposition proceeding threatened in a writing received by Seller.
 
3.12.7   To Seller’s Knowledge, except as set forth in Section 3.12.7 of the Seller Disclosure Schedule, the conduct of the Product Business as conducted, and as contemplated to be Exploited by Purchaser with respect to the Product and the Third Generation Product as of the Closing Date, does not infringe or misappropriate any Third Party’s Intellectual Property Rights or constitute unfair competition or an unfair trade practice under applicable Law. To Seller’s Knowledge, the Manufacturing of the Product as Manufactured on the Execution Date does not infringe or misappropriate any Third Party’s Intellectual Property Rights or in the location(s) where Product is Manufactured or constitute unfair competition or an unfair trade practice under applicable Law.  As of the Execution Date, no letter or other written or electronic communication or correspondence has been received by Seller or any of its Affiliates or any of their Representatives at any time within the six (6) years prior to the Execution Date, regarding any actual, alleged, or suspected infringement or misappropriation of any Third Party’s Intellectual Property Rights or unfair competition or unfair trade practice under any applicable Law in connection with the conduct of the Product Business. To Seller’s Knowledge, except as set forth in Section 3.12.7 of the Seller Disclosure Schedule, no Litigation (A) is pending or threatened against Seller (i) based upon, challenging or seeking to deny or restrict the use of any of Seller Intellectual Property; (ii) alleging that Seller’s conduct of the Product Business infringes or misappropriates the Intellectual Property Rights of any Third Party; or (iii) alleging that Seller’s conduct of the Product Business constitutes unfair competition or an unfair trade practice under any applicable Law; or (B) is pending or threatened against Seller as of the Execution Date asserting a paragraph IV certification filed pursuant to Section 505(j)(2)(A)(vii)(IV) or 505(b)(2)(A)(iv) of the Act advising Seller or any of its Affiliates of the filing of an ANDA or Section 505(b)(2) NDA relative to any Patent Rights listed in any Regulatory Approval held by Seller.
 
 
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3.12.8   To Seller’s Knowledge, no Person is currently infringing or misappropriating in any material respect any Seller Patents or Seller Trademarks in a manner that would reasonably be expected to materially adversely affect the Product Business or Purchased Assets. Section 3.12.8 of the Seller Disclosure Schedule accurately identifies (and Seller has provided to Purchaser a complete and accurate copy of) each letter or other written or electronic communication or correspondence that has been sent by Seller or any of its Affiliates or any of their Representatives regarding any actual, alleged, or suspected infringement or misappropriation of any Seller Intellectual Property or unfair competition or unfair trade practice under any applicable Law in connection with the conduct of the Product Business.
 
3.12.9   Seller and, as applicable, Seller’s Affiliates, have taken reasonable measures to maintain in confidence all Trade Secrets and other material confidential information included in Seller Know-How except to the extent such failure would not reasonably be expected to materially adversely affect the Product Business or Purchased Assets. To Seller’s Knowledge, none of such Trade Secrets or material confidential information have been disclosed to any Person by Seller or its Affiliates except pursuant to reasonable non-disclosure or license agreements. To Seller’s Knowledge, no current or former employee, consultant or independent contractor of Seller or any of its Affiliates has any claim of ownership in or to any Seller Intellectual Property owned by Seller or any of its Affiliates.
 
3.12.10    To Seller’s Knowledge (i) all registrations of Seller Intellectual Property included in Seller Licensed Registered Product IP or Seller Owned Registered Product IP which are material to the Product Business, are presumed valid, subsisting, and have not been held unenforceable; and (ii) all applications for registration of licensed Intellectual Property Rights included in Seller Licensed Registered Product IP or in Seller Owned Registered Product IP which are material to the Product Business are subsisting. To Seller’s Knowledge, Seller and its Affiliates have complied in all material respects with applicable Law regarding the duty to disclose and duties of candor in the filing, maintaining and prosecution of the patents and patent applications included in Seller Intellectual Property.
 
 
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3.12.11    All material fees, annuities and royalties that are due and properly payable to a licensor of Seller Licensed Registered Product IP by Seller have been paid or will be paid prior to such payment being deemed late under the applicable Seller License Agreement.
 
3.12.12   For the avoidance of doubt, the representations and warranties in Section 3.12 shall be true and correct only as of the Execution Date with respect to any paragraph IV certification filed pursuant to Section 505(j)(2)(A)(vii)(IV) or 505(b)(2)(A)(iv) of the Act advising Seller or any of its Affiliates of the filing of an ANDA or Section 505(b)(2) NDA relative to any Patent Rights listed in any Regulatory Approval held by Seller
 
3.13   Inventory.
 
3.13.1   Section 3.13.1 of the Seller Disclosure Schedule sets forth a true and accurate description of all Product Inventory as of the date of this Agreement and lists (i) the lot numbers associated with the Product Inventory; and (ii) the manufacturing, warehousing, distribution and consignee locations where the Product Inventory is located.
 
3.13.2   The Product Inventory will represent all Product finished goods owned and on hand or in the control of Seller at any of its warehouses, manufacturers, suppliers or other Third Parties on Seller’s behalf on the Closing Date.
 
3.13.3   In the 12 months prior to the Execution Date, other than in the ordinary course of business or in the transition to the formulation of the Second Generation Project, Seller has not (a) materially altered its activities and practices with respect to inventory levels of the Product maintained at the wholesale, chain, institutional or retail levels; or (b) engaged in any activity or practice that would reasonably be expected to result, directly or indirectly, in a trade buy-in that is significantly in excess of normal customer purchasing patterns consistent with past practice of the Product Business.
 
3.14   Product Financial Information.   Section 3.14 of the Seller Disclosure Schedule sets forth the net sales as recognized by Seller upon the earlier to occur of prescription units dispensed or expiration of the right of return (the gross amount invoiced by Seller for sale or other commercial disposition of the Product (in final, finished presentation for use by an end-user) to an unrelated Third Party in an arms-length transaction, minus the deductions (other than for Product returns), if any, described in the definition of “Net Sales”), deferred revenue, Product Cost-of-Goods, Units Produced and Units Sold for the Product for the twelve-months ended December 31, 2014 and the Units of inventory of finished Product owned by Seller or any Affiliate at December 31, 2014 (the “ Financial Information ”), together with reasonably detailed supporting documentation. The Financial Information has been prepared in accordance with GAAP as applied by Seller from the books and records of Seller and fairly presents in all material respects such net sales, Product Cost-of-Goods, inventory of finished Product, Units Produced, and Units Sold for the Product for the periods indicated.
 
3.15   Sufficiency of Purchased Assets.   Except as set forth on Section 3.15 of the Seller Disclosure Schedule, the Purchased Assets comprise all of the assets and rights necessary for Seller and its Affiliates in the conduct of the Product Business, and are sufficient for the continued conduct of the Product Business after the Closing Date in substantially the same manner as conducted prior to the Closing Date (provided the foregoing is not to be interpreted as a representation of non-infringement).  None of the Excluded Assets are material to the Product Business.  No Trademarks other than the Seller Trademarks and the Transitional Trademarks will be required to Exploit the Purchased Product Inventory on or following the Closing Date.
 
 
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3.16   Products.   Except as set forth on Section 3.16 of the Seller Disclosure Schedule, each Product sold by or on behalf of Seller or its Affiliates prior to the Closing Date was Manufactured in accordance with applicable Specifications and applicable Law, except where any noncompliance would not reasonably be expected to materially adversely affect the Product Business or Purchased Assets.
 
3.17   Labor Matters.
 
3.17.1   There are no pending or, to Seller’s Knowledge, threatened strikes, lockouts, work stoppages or slowdowns involving Product Business Employees, except for any such strikes, lockouts, work stoppages or slowdowns that would not reasonably be expected to have, individually or in the aggregate, a Material Adverse Effect.
 
3.17.2   There is no unfair labor practice proceeding involving any Product Business Employee before the National Labor Relations Board pending or, to Seller’s Knowledge, threatened against Seller.
 
3.17.3   Neither Seller nor any Subsidiary is a party to any labor or collective bargaining agreement which represents Product Business Employees and there are no labor or collective bargaining agreements which pertain to Product Business Employees.  No Product Business Employees are represented by any labor organization with respect to their employment with Seller or any Subsidiary; no labor organization or group of Product Business Employees has made a pending demand for recognition or certification to Seller and there are no representation or certification proceedings or petitions seeking a representation proceeding presently pending or, to Seller’s Knowledge, threatened to be brought or filed with the National Labor Relations Board or any other labor relations tribunal or authority relating to Seller with respect to Product Business Employees.  There are no organizing activities involving Seller with respect to the Product Business pending with any labor organization or group of Product Business Employees.
 
3.17.4   There are no material complaints, charges, or claims against Seller pending, or to Seller’s Knowledge, threatened in writing to be brought or filed, by or with any Governmental Authority or arbitrator based on, arising out of, in connection with, or otherwise relating to the employment or termination of employment of any individual by Seller with respect to the Product Business.
 
3.17.5   The Product Business is not under investigation or audit with respect to its treatment of independent contractors as independent contractors rather than employees.
 
3.17.6   With respect to the Product Business and Product Business Employees, Seller is in compliance in all material respects with all laws governing the employment of labor, including, but not limited to, all such laws relating to wages, hours, collective bargaining, discrimination, civil rights, safety and health, workers’ compensation.
 
 
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3.18   Suppliers and Customers.   Section 3.18 of the Seller Disclosure Schedule sets forth: (a) active pharmaceutical ingredient suppliers of the Product Business; (b) the most significant supplier of the Product Business taken as a whole, based on amounts invoiced during the 12-month period ended December 31, 2014; and (c) the ten most significant customers and distributors of Seller and its Affiliates pertaining to the Product Business, taken as a whole, based on dollar sales volumes during the 12-month period ended December 31, 2014; (the suppliers customers and distributors set forth on Section 3.18 of the Seller Disclosure Schedule, the “ Key Suppliers, Customers and Distributors ”). Except as set forth in Section 3.18 of the Seller Disclosure Schedule, no such supplier, customer or distributor has canceled, otherwise terminated or, to Seller’s Knowledge, threatened in writing to cancel, otherwise terminate or otherwise materially and adversely modify its relationship with the Product Business. Seller has made available to Purchasers complete and correct copies of all Contracts with the Third Parties listed on Section 3.18 of the Seller Disclosure Schedule, except where such disclosure would violate any term or confidentiality obligations owed to Third Parties listed on Section 3.18 of the Seller Disclosure Schedule.
 
3.19   Solvency.    Assuming satisfaction of the conditions to this Agreement, and after giving effect to the Transactions contemplated hereby, the assumption or retention (as applicable) of the Excluded Liabilities by Seller and its Affiliates, payment of all amounts required to be paid in connection with the consummation of the Transactions contemplated hereby, and payment of all related fees and expenses, Seller and its Affiliates (on a consolidated basis) will be Solvent as of the Closing Date and immediately after the consummation of the Transactions contemplated hereby. Seller has no current plans to file and prosecute a petition for relief under Chapter 11 or 7 of the United States Bankruptcy Code.
 
3.20   Affiliate Transactions; Intercompany Arrangements.   There are no agreements or arrangements, written or unwritten, of any kind (other than any Ancillary Agreements), between Seller or any of its Affiliates, on the one hand, and the Product Business, on the other hand.
 
3.21   Accredited Investor.    Seller understands that the securities comprising the Stock Consideration and the Promissory Note will be “restricted securities” under the Securities Act and have not been registered under the Securities Act, nor qualified under any state securities laws, and that they are being offered and sold pursuant to an exemption from such registration and qualification based in part upon the representations of Seller contained herein.  Seller is familiar with the business and operations of Guarantor, is an “accredited investor” as such term is defined in Rule 501(a) of the Securities Act, and is able to bear the economic risk of its investment in Guarantor indefinitely.  Seller is acquiring the Stock Consideration and Promissory Note solely for its own account for investment and not with a view toward the resale, transfer, or distribution thereof, nor with any present intention of distributing the Stock Consideration or Promissory Note. No other Person has any right with respect to or interest in the Stock Consideration or Promissory Note to be purchased by Seller, nor has Seller agreed to give any Person any such interest or right in the future. Seller is not purchasing the Stock Consideration or Promissory Note as a result of any (a) registration statement filed by Purchaser with the Securities and Exchange Commission with respect to any of its securities; or (b) advertisement, article, notice or other communication regarding the Stock Consideration or Promissory Note published in any newspaper, magazine or similar media or broadcast over television or radio or presented at any seminar or any other general advertisement that would be deemed a “general solicitation” under the provisions of Regulation D of the Securities Act.
 
 
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3.22   Exclusivity of Representations.   SELLER ACKNOWLEDGES AND AGREES THAT, EXCEPT FOR THE EXPRESS REPRESENTATIONS AND WARRANTIES CONTAINED IN ARTICLE 4, THE ANCILLARY AGREEMENTS TO BE ENTERED INTO AT THE CLOSING AND THE CERTIFICATE DELIVERED BY PURCHASER PURSUANT TO SECTION 2.5.2(b)(iii) PURCHASER HAS MADE NO REPRESENTATION OR WARRANTY WHATSOEVER RELATED TO THE TRANSACTIONS CONTEMPLATED HEREBY AND SELLER HAS NOT RELIED ON ANY REPRESENTATION OR WARRANTY, EXPRESS OR IMPLIED.
 
ARTICLE 4
REPRESENTATIONS AND WARRANTIES OF PURCHASER
 
Purchaser hereby represents and warrants to Seller that the statements contained in this ARTICLE 4 are true and correct as of the date hereof and as of the Closing (unless the particular statement speaks expressly as of a particular date, in which case it is true and correct only as of such date):
 
4.1   Corporate Status.   Purchaser is a corporation duly organized, validly existing and in good standing under the Laws of Ireland.
 
4.2   Authority.   Purchaser has the requisite corporate power and authority to enter into this Agreement and the Ancillary Agreements to which it is a party, to perform its obligations hereunder and thereunder and to consummate the Transactions contemplated hereby and thereby. The execution and delivery of this Agreement and Ancillary Agreements to which Purchaser is a party and the consummation of the Transactions contemplated hereby and thereby have been duly authorized by the necessary corporate actions of Purchaser. This Agreement constitutes and each Ancillary Agreement to which Purchaser is a party, when executed and delivered by Purchaser will constitute, the valid and legally binding obligation of Purchaser, enforceable against Purchaser in accordance with its terms, subject to bankruptcy, insolvency, fraudulent transfer, reorganization, moratorium or similar Laws of general application affecting or relating to the enforcement of creditors’ rights generally, and subject to equitable principles of general applicability, whether considered in a proceeding at law or in equity.
 
4.3   Non-Contravention.   Subject to the receipt of the Senior Loan Amendment (as defined in the MidCap Signing Date Agreement), the execution, delivery, consummation and performance by Purchaser of this Agreement and of each Ancillary Agreement to which it is a party do not and will not (a) violate the certificate of incorporation or bylaws, or comparable organization documents, of Purchaser; (b) subject to compliance with the HSR Act, contravene, conflict with or violate any Law or other restriction of any Governmental Authority applicable to Purchaser; or (c) contravene, conflict with, violate, breach or constitute a default under or result in the termination of any material Contract to which Purchaser is a party, except with respect to clause “(c)” for violations or breaches that that would not reasonably be expected to result in a Purchaser Material Adverse Effect.
 
 
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4.4   No Broker.   Purchaser shall be solely responsible for the fees and expenses of any broker, finder, investment banker or financial advisor entitled to any brokerage, finder’s or other fee or commission in connection with the Transactions contemplated by this Agreement based upon arrangements made by or on behalf of Purchaser.
 
4.5   Litigation; Consents.
 
4.5.1   There is no (i) Litigation (other than any investigation, inquiry, audit or examination) pending or, to the knowledge of Purchaser, threatened against Purchaser or any of its Affiliates by or before any Governmental Authority and to Purchaser’s knowledge, there are no investigations, inquiries, audits or examinations pending or threatened against Purchaser or any of its Affiliates by or before any Governmental Authority; or (ii) order or judgment of a Governmental Authority to which Purchaser or any of its Affiliates is subject, in each case, except for such Litigation, orders or judgments that would not reasonably be expected to result in a Purchaser Material Adverse Effect.
 
4.5.2   Except for (i) if required, the filings under the HSR Act and the expiration or termination of the waiting periods thereunder; and (ii) consents, permits or authorizations that if not received, or declarations, filings or registrations that if not made, would not be reasonably expected to result in a Purchaser Material Adverse Effect, no notice to, filing with, permit of, authorization of, exemption by, or consent of, Governmental Authority or other Person is required for Purchaser to consummate the Transactions.
 
4.6   Financial Capacity.   On the Closing Date, Purchaser’s immediately available cash, together with the Stock Consideration and the Promissory Note, will be sufficient to enable Purchaser to pay the Closing Payment at the Closing.
 
4.7   Exclusivity of Representations.   PURCHASER ACKNOWLEDGES AND AGREES THAT, EXCEPT FOR THE EXPRESS REPRESENTATIONS AND WARRANTIES CONTAINED IN ARTICLE 3, THE ANCILLARY AGREEMENTS TO BE ENTERED INTO AT THE CLOSING AND THE CERTIFICATE DELIVERED BY SELLER PURSUANT TO SECTION 2.5.2(a)(ii), SELLER HAS MADE NO REPRESENTATION OR WARRANTY WHATSOEVER RELATED TO THE TRANSACTIONS CONTEMPLATED HEREBY AND PURCHASER HAS NOT RELIED ON ANY REPRESENTATION OR WARRANTY, EXPRESS OR IMPLIED.
 
ARTICLE 5
PRE-CLOSING COVENANTS
 
5.1   No Solicitation . Seller and its Subsidiaries shall, and shall direct their respective Representatives to, cease and cause to be terminated any discussions or negotiations with any Person conducted heretofore with respect to an Alternative Transaction Proposal.  Seller and its Affiliates shall not, and shall use their reasonable best efforts to cause their Representatives not to, directly or indirectly (a) initiate, solicit or encourage (including by way of furnishing non-public information), or take any other action to facilitate, any inquiries regarding, or the making of any proposal or offer (including any proposal or offer to Seller’s stockholders) that constitutes, or could reasonably be expected to result in, an Alternative Transaction Proposal; (b) engage in, continue or otherwise participate in any discussions or negotiations regarding an Alternative Transaction Proposal; (c) agree to, approve, endorse, recommend or consummate an Alternative Transaction Proposal; or (d) resolve, propose or agree, or authorize or permit any Representative, to do any of the foregoing.  Notwithstanding anything to the contrary contained in this Section 5.1 or elsewhere in this Agreement, the provisions of this Section 5.1 shall not apply to any transaction that is conditioned on the consummation of the Transactions contemplated by this Agreement, including, without limitation, any investment in or tender offer for Common Stock or other equity securities of Seller or any merger, consolidation, recapitalization or other business combination involving Seller or any of its Affiliates or any sale of all or substantially all of the assets of Seller and its Affiliates.
 
 
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5.2   Access and Information.
 
5.2.1   During the period commencing on the Execution Date and ending on the earlier to occur of (a) the Closing and (b) the termination of this Agreement in accordance with ARTICLE 9 (the “ Pre-Closing Period ”), upon reasonable notice, Seller shall, at Purchaser’s sole cost and expense: (i) afford Purchaser, its Representatives and potential financing sources reasonable access to the properties and the Product Records Controlled by Seller to the extent related to the Product Business, the Purchased Assets, the Assumed Liabilities or the Product Inventory; and (ii) furnish to Purchaser, its Representatives and potential financing sources such additional financial and operating data and other information regarding the Product Business (or copies thereof) Controlled by Seller as Purchaser, its Representatives and potential financing sources may from time to time reasonably request, in each case (A) to facilitate the Financing; or (B) as may be agreed by Purchaser and Seller as useful and allowable for post-Closing integration planning; provided, however, that such access shall not unreasonably disrupt Seller’s ordinary course operations; provided, further , that Seller shall not be required to furnish any information to Purchaser’s financing sources to facilitate the Financing that is not publicly available unless and until such financing sources are bound by a confidentiality agreement, in a form reasonably acceptable to Seller, to keep all such information acquired from Seller confidential. Notwithstanding anything to the contrary contained in this Agreement, Seller shall not be required to disclose any information or provide any such access if such disclosure or access would reasonably be expected, in the reasonable judgment of Seller’s outside counsel, to (i) violate applicable Law, including applicable antitrust Laws; (ii) jeopardize any attorney/client privilege or other established legal privilege; (iii) violate any term or confidentiality obligations owed to Third Parties; or (iv) disclose any Trade Secrets not included in Seller Intellectual Property; provided, however , that to the extent any such information is withheld pursuant to any the reasons set forth in clauses (i) through (iii) of this sentence, Seller shall provide to Purchaser, to the extent permissible based on the advice of Seller’s outside counsel, written summaries of such withheld information.
 
 
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5.2.2   As soon as reasonably practicable after the Execution Date, Seller shall request the written consent of the Product Business Employees to the disclosure of their respective official personnel files to Purchaser and, as soon as practicable after the Execution Date and during the Pre-Closing Period, Seller shall afford Purchaser and its Representatives access to the personnel files of those Product Business Employees who provide such written consent. To the extent reasonably requested by Purchaser, Seller shall arrange to permit Purchaser to conduct interviews of any of the Product Business Employees as soon as reasonably practicable after the Execution Date and during the Pre-Closing Period; provided , however , that such access to Product Business Employees shall not unreasonably disrupt Seller’s ordinary course operations and such access will be at the Purchaser’s cost and expense.
 
5.3   Ordinary Course of Business. Except (a) as set forth in Section 5.3 of the Seller Disclosure Schedule or as otherwise contemplated by this Agreement or any Ancillary Agreement; (b) as required by applicable Law; (c) for any actions as expressly contemplated by this Agreement; or (d) as Purchaser shall otherwise consent in writing, which consent shall not be unreasonably withheld, conditioned or delayed, from and after the Execution Date and during the Pre-Closing Period (clauses (a) – (d), the “ Ordinary Course of Business Exceptions ”), Seller shall (i) conduct the Product Business in substantially the same manner as heretofore conducted and in the ordinary course of business consistent with past practice; and (ii) use all commercially reasonable efforts to: (A) preserve the Product Business and its goodwill and maintain its relations and goodwill with (1) the Key Suppliers, Customers and Distributors; (2) material licensors and licensees; and (3) and other Persons having business relationships with the Product Business; and (B) prosecute in good faith and maintain all the Seller Owned Registered Product IP and, to the extent Seller has prosecution rights pursuant to the Seller License Agreements, the Seller Licensed Registered Product IP in the Purchased Assets.  Prior to the Closing, Seller shall not, and shall cause each of its Affiliates to not, take any action that would, or that could reasonably be expected to, result in any of the conditions set forth in ARTICLE 7 not being satisfied.  In addition (and without limiting the generality of the foregoing), except to the extent constituting an Ordinary Course of Business Exception, Seller shall not, and shall cause its Affiliates to not:
 
5.3.1   acquire any properties or assets that constitute Purchased Assets or Product Inventory, either tangible or intangible, other than in the ordinary course of business consistent with past practice or with respect to binding orders entered into prior to the date of this Agreement;
 
5.3.2   (i) settle or commence any Litigation or material claim; or (ii) waive any material claims or rights of material value, in either case in a manner that would constitute an Assumed Liability or otherwise be materially adverse to the Product Business or Purchased Assets from and after the Closing;
 
5.3.3   sell, transfer, lease, license or otherwise dispose of or encumber (other than with a Permitted Encumbrance) any of the Purchased Assets, other than in connection with the use of Product Promotional Materials in the ordinary course of business consistent with past practice;
 
 
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5.3.4   (a) terminate, amend or modify in any material way, grant a license to, waive any right under, or take any action or fail to take any action that would result in a breach or constitute a default (with or without due notice or lapse of time or both) under any of the Purchased Contracts (except in the ordinary course of business consistent with past practice for Purchased Contracts requiring payment of less than One Hundred Thousand Dollars ($100,000) on an annual basis); (b) grant a license under or assign any of the Purchased Contracts or any Contract granting rights in, to, or under Seller Intellectual Property; or (c) enter into any material Contract relating to the Product Business, other than  in the ordinary course of business consistent with past practice; provided, that notwithstanding anything herein to the contrary, no Contract subject to this Section 5.3.4 entered into by Seller during the Pre-Closing Period (other than the binding purchase orders for Product entered into in the ordinary course of business consistent with past practice and set forth on Section 5.3.4 of the Seller Disclosure Schedule, which such schedule shall be delivered to Purchaser at least five (5) Business Days prior to Closing) shall be added to Section 2.1.1(a) of the Seller Disclosure Schedule as a “Purchased Contract” without the prior written consent of Purchaser;
 
5.3.5   other than in the ordinary course of business consistent with past practice or in the transition to the formulation of the Second Generation Product, materially alter its activities and practices with respect to inventory levels of the Product maintained at the wholesale, chain, institutional or retail levels;
 
5.3.6   terminate, cancel, permit to lapse, amend, waive or materially modify any Seller Authorizations;
 
5.3.7   (a) take any action which is intended, or known to, or reasonably likely to have a Material Adverse Effect; or (b) take or omit to take any action which is intended, or known to, or reasonably likely to render any of Seller’s representations or warranties untrue or misleading, or which would be likely to result in a material breach of any of Seller’s covenants;
 
5.3.8   grant to any Product Business Employee any increase in compensation or benefits, except in the ordinary course of business and consistent with past practice or as may be required under existing Contracts;
 
5.3.9   (a) adopt or amend in any material respect any Seller Benefit Plan (or any plan that would be a Seller Benefit Plan if adopted) to the extent such adoption or amendment would result in any of the actions described in Section 5.3.8; or (b) enter into or adopt any collective bargaining agreement or other Contract with any labor organization, union or association relating to or affecting the Product Business Employees; or
 
5.3.10   agree, commit or offer (in writing or otherwise) to take any of the actions described in Sections 5.3.1 through 5.3.9.
 
5.4   Obligation to Consummate the Transaction. Each of the Parties agrees that, subject to this Section 5.4 and Section 5.5, it shall use its reasonable best efforts to take, or cause to be taken, all action, and to do, or cause to be done, all things necessary, proper or advisable to the extent permissible under applicable Law, to consummate and make effective the Transactions contemplated by this Agreement and to ensure that the conditions set forth in ARTICLE 7 are satisfied, insofar as such matters are within the control of either of them. Without limiting the generality of the foregoing, as soon as reasonably practicable after the Execution Date, Seller shall use its reasonable best efforts to obtain Seller Third Party Consents.
 
 
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5.5   Competition Filings.
 
5.5.1   If required pursuant to applicable Law, each of Purchaser and Seller shall file or cause to be filed as soon as practicable, and in any event no later than five (5) Business Days following the Execution Date, any notifications required under the HSR Act and any comparable filing required by applicable foreign Law. Thereafter, each of Purchaser and Seller shall use commercially reasonable efforts to respond as promptly as practicable to any inquiries or requests received from any Governmental Authority for additional information or documentation and to cause the waiting periods or approvals under the HSR Act and any applicable foreign Law to terminate or expire or to be approved at the earliest possible date after the date of filing ; provided , however , that Purchaser shall have the right to withdraw and re-file its HSR notification if Purchaser reasonably determines that doing so is likely to cause the waiting period under the HSR Act to terminate or expire sooner.
 
5.5.2   Purchaser and Seller shall cooperate with each other and shall (a) promptly prepare and file all necessary documentation; and (b) effect all necessary applications, notices, petitions and filings and execute all agreements and documents. In connection with the foregoing, (i) Purchaser shall have the right to review and approve in advance all characterizations of the information relating to Purchaser; (ii) Seller shall have the right to review and approve in advance all characterizations of the information relating to Seller and its Affiliates; and (iii) each of Purchaser and Seller shall have the right to review and approve in advance all characterizations of the information relating to the Transactions contemplated hereby, in each case, that appear in any material filing made in connection with this Section 5.5.
 
5.5.3   Notwithstanding anything to the contrary in this Section 5.5, except as otherwise may be mutually agreed to by the Parties, nothing in this Agreement shall require or obligate Purchaser or any of its Affiliates to, and Seller shall not and shall not permit its Representatives to, without the prior written consent of Purchaser, agree or otherwise be required to sell, divest, dispose of, license, hold separate, or take or commit to take any action that limits in any respect its freedom of action after the Closing with respect to, or its ability to retain after the Closing, any businesses, products, rights, services, licenses, or assets of Purchaser, Seller or any of their respective Affiliates, as applicable.
 
5.5.4   Each Party shall promptly notify the other Party of any communication it or any of its Affiliates receives from any Governmental Authority relating to the matters that are the subject of this Agreement and permit the other Party to review in advance any proposed communication by such Party to any Governmental Authority relating to the matters that are the subject of this Agreement.  Neither Party shall agree to participate in any meeting with any Governmental Authority in respect of any filings, investigation or other inquiry related to the Transactions contemplated by this Agreement (including any proceedings under or relating to the HSR Act or other competition law) unless it consults with the other Party in advance and, to the extent permitted by such Governmental Authority, gives the other Party the opportunity to attend and participate at such meeting.  Subject to the Confidentiality Agreement, the Parties shall coordinate and cooperate fully with each other in exchanging such information and providing such assistance as the other Party may reasonably request in connection with the foregoing; provided, that , notwithstanding anything herein to the contrary, no Party to this Agreement shall be under an obligation to disclose confidential information with respect to its Affiliates to (a) any other Party or (b) any Governmental Authority except where such confidential information is afforded confidential treatment.  Subject to the Confidentiality Agreement, the Parties shall provide each other with copies of all correspondence, filings or communications between them or any of their Representatives, on the one hand, and any Governmental Authority or members of its staff, on the other hand, with respect to this Agreement and the Transactions contemplated by this Agreement.
 
 
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5.5.5   All filing fees under the HSR Act and any applicable foreign Law, and all expenses (other than legal fees and expenses, which shall be borne by the Party incurring such expenses) in complying with any request for additional information or documentary material from any applicable Governmental Authority, shall be borne equally by the Parties.
 
5.6   Notices.
 
5.6.1   Subject to Section 7.4, during the Pre-Closing Period, each Party shall give prompt written notice to the other Party of any Litigation, examination or audit in which such Party is involved as a party that concerns and would reasonably be expected to materially and adversely affect the Product Business, Purchased Assets or Assumed Liabilities or the other Party’s rights in the same or that would otherwise reasonably be expected to have a Material Adverse Effect or Purchaser Material Adverse Effect, as applicable. During the Pre-Closing Period, Seller shall promptly (and in any event within five (5) Business Days) notify Purchaser following receipt of written notice of any paragraph IV certification filed pursuant to Section 505(j)(2)(A)(vii)(IV) or 505(b)(2)(A)(iv) of the Act advising Seller or any of its Affiliates of the filing of an ANDA or Section 505(b)(2) NDA that relies on the FDA’s prior finding of safety and effectiveness for the Product and provide Purchaser a copy of each such certification notice.
 
5.6.2   During the Pre-Closing Period, (a) Seller shall promptly notify Purchaser in writing of any event, condition, fact or circumstance that reasonably would be expected to make the satisfaction of any of the conditions set forth in Section 7.1 or Section 7.2 impossible or unlikely; and (b) Purchaser shall promptly notify Seller in writing of any event, condition, fact or circumstance that reasonably would be expected to (i) make the satisfaction of any of the conditions set forth in Section 7.1 or Section 7.3 impossible or unlikely or (ii) cause Purchaser’s representations and warranties in Section 4.6 to be untrue in any respect prior to or as of the End Date.
 
5.6.3   No notification or update by Seller under Section 5.6.1 or Section 5.6.2 or by Purchaser under Section 5.6.1 or Section 5.6.2 shall be taken into account (or, with respect to Seller, deemed to supplement or amend Seller Disclosure Schedule) for the purpose of: (a) determining the accuracy of any representation or warranty made by Seller or Purchaser, as applicable (for purposes of ARTICLE 8 or otherwise); or (y) determining whether any of the conditions set forth in Section 7.1, Section 7.2 or Section 7.3, as applicable, has been satisfied.
 
 
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5.7   Paragraph IV Notices.
 
5.7.1   Subject to any rights that Daravita Limited may have under the Daravita License Agreement, during the Pre-Closing Period, if Seller or any of its Affiliates receives or is notified in writing of any paragraph IV certification filed pursuant to Section 505(j)(2)(A)(vii)(IV) or 505(b)(2)(A)(iv) of the Act advising Seller or any of its Affiliates of the filing of an ANDA or Section 505(b)(2) NDA that relies on the FDA’s prior finding of safety and effectiveness for the Product (a “ Paragraph IV Claim ”), then Seller shall provide a copy of such Paragraph IV Claim to Purchaser within five (5) Business Days after its receipt thereof.
 
5.7.2   Subject to Seller’s obligations to Daravita Limited under the Daravita License Agreement, Seller will, to the extent practicable, consult with Purchaser in exercising any rights it may have under the Daravita License Agreement with respect to any patent infringement litigation for a Paragraph IV Claim (“ Product ANDA Litigation ”) and consider in good faith Purchaser’s comments with respect to strategic decisions and their implementation with respect to such action.
 
5.7.3   Subject to any rights that Daravita Limited may have under the Daravita License Agreement, if Daravita Limited does not exercise its right to control any Product ANDA Litigation, Seller shall exercise its step-in rights under the Daravita License Agreement to control such Product ANDA Litigation and shall (a) keep Purchaser reasonably informed regarding Seller’s actions with respect to such action; and (b) to the extent practicable, consult with Purchaser prior to exercising any rights it may have with respect to such Product ANDA Litigation and consider in good faith Purchaser’s comments with respect to strategic decisions and their implementation with respect to such action.
 
5.8   Product Inventory . Prior to Closing, Seller shall ensure that the quantities of finished Product set forth on Section 5.8 of the Seller Disclosure Schedule are available at Closing.
 
5.9   Stock Consideration .
 
5.9.1   Restrictive Legend. Certificates evidencing the shares of Guarantor Common Stock issued as the Stock Consideration shall bear any legend as required by the “blue sky” laws of any state and a restrictive legend in substantially the following form, until such time as they are not required under Section 5.9.2 or applicable Law:
 
“THE SECURITIES REPRESENTED HEREBY HAVE NOT BEEN REGISTERED WITH THE SECURITIES AND EXCHANGE COMMISSION OR THE SECURITIES COMMISSION OF ANY STATE IN RELIANCE UPON AN EXEMPTION FROM REGISTRATION UNDER THE SECURITIES ACT OF 1933, AS AMENDED (THE “SECURITIES ACT”), AND, ACCORDINGLY, MAY NOT BE TRANSFERRED UNLESS (I) SUCH SECURITIES HAVE BEEN REGISTERED FOR SALE PURSUANT TO THE SECURITIES ACT AND SUCH REGISTRATION STATEMENT REMAINS EFFECTIVE, (II) SUCH SECURITIES MAY BE SOLD PURSUANT TO RULE 144, OR (III) THE COMPANY HAS RECEIVED AN OPINION OF COUNSEL TO THE COMPANY, STATING THAT SUCH TRANSFER MAY LAWFULLY BE MADE WITHOUT REGISTRATION UNDER THE SECURITIES ACT.”
 
 
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5.9.2   Removal of Legends. The restrictive legend set forth in Section 5.9.1 above shall be removed and Guarantor shall issue a certificate or instrument representing such shares of Guarantor Common Stock without such restrictive legend or any other restrictive legend to Seller if (a) such securities are registered for resale under the Securities Act; or (b) such securities are sold or transferred pursuant to Rule 144 (if Seller is not and has not been an Affiliate of Guarantor during the ninety (90)-day period immediately preceding the sale or transfer).
 
5.9.3   Lock-up.  Seller hereby agrees that for a period of six (6) months following the Closing Date (the “ Lock-Up Period ”), Seller will not, directly or indirectly, (a) offer, sell, assign, transfer, pledge, contract to sell, or otherwise dispose of, any shares of Guarantor Common Stock comprising the Stock Consideration or securities convertible into or exercisable or exchangeable for Guarantor Common Stock (including, without limitation, shares of Guarantor Common Stock or any such securities which may be deemed to be beneficially owned by Seller in accordance with the rules and regulations promulgated under the Exchange Act (such shares or securities, the “ Beneficially Owned Shares ”)); (b) enter into any swap, hedge or other agreement or arrangement that transfers in whole or in part, the economic risk of ownership of any Beneficially Owned Shares, Guarantor Common Stock or securities convertible into or exercisable or exchangeable for Guarantor Common Stock; or (c) engage in any short selling of any Beneficially Owned Shares, Guarantor Common Stock or securities convertible into or exercisable or exchangeable for Guarantor Common Stock.  The foregoing sentence shall not apply (i) in connection with the sale or other bona fide transfer in a single transaction of all or substantially all of Seller’s capital stock; or (ii) to transfers pursuant to a sale or an offer to purchase one hundred percent (100%) of the outstanding Guarantor Common Stock, whether pursuant to a merger, tender offer or otherwise, to a Third Party or group of Third Parties.
 
ARTICLE 6
ADDITIONAL COVENANTS
 
6.1   Cooperation in Litigation and Investigations. Subject to Section 6.4 and except as set forth in any Ancillary Agreement, from and after the Closing Date, Purchaser and Seller shall fully cooperate with each other in the defense or prosecution of any Litigation, examination or audit instituted prior to the Closing or which may be instituted thereafter against or by either Party relating to or arising out of the conduct of the Product Business or the Exploitation or Manufacture of the Product prior to the Closing (other than Litigation between Purchaser and Seller or their respective Affiliates arising out of the Transactions contemplated hereby or by the Ancillary Agreements). In connection therewith, and except as set forth in any Ancillary Agreement, from and after the Closing Date, each of Seller and Purchaser shall make available to the other during normal business hours and upon reasonable prior written notice, but without unreasonably disrupting its business, all records relating   exclusively to the Purchased Assets, the Assumed Liabilities and the Excluded Liabilities to the extent maintained by or under the Control of the requested Party and reasonably necessary to permit the defense or investigation of any such Litigation, examination or audit (other than Litigation between Purchaser and Seller or their respective Affiliates arising out of the Transactions contemplated hereby or by the Ancillary Agreements, with respect to which applicable rules of discovery shall apply), and shall preserve and retain all such records for eighteen (18) months; provided, however , that either Party may restrict the foregoing access to the extent that such access (i) violates applicable Law, including applicable antitrust Laws; (ii) jeopardizes any attorney/client privilege or other established legal privilege; or (iii) violates any confidentiality obligations owed to Third Parties. The Party requesting such cooperation shall pay the reasonable out-of-pocket costs and expenses of providing such cooperation (including legal fees and disbursements) incurred by the Party providing such cooperation and by its Representatives, and any applicable Taxes in connection therewith.
 
 
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6.2   Further Assurances
 
6.2.1   Each of Seller and Purchaser shall, at any time or from time to time after the Closing, at the request and expense of the other, execute and deliver to the other all such instruments and documents or further assurances as the other may reasonably request in order to (a) vest in Purchaser all of the rights, title and interests of Seller and its Affiliates in and to the Purchased Assets as contemplated hereby; (b) effectuate Purchaser’s assumption of the Assumed Liabilities; and (c) grant to each Party all rights contemplated herein to be granted to such Party under the Ancillary Agreements. Without limitation of the foregoing, except as expressly set forth in the Ancillary Agreements, neither Seller nor Purchaser shall have any obligation to assist or otherwise participate in the amendment or supplementation of the Purchased Regulatory Approvals or otherwise to participate in any filings or other activities relating to the Purchased Regulatory Approvals other than as necessary to effect the assignment thereof to Purchaser in connection with the Closing pursuant to this Agreement.
 
6.2.2   To the extent that Seller’s rights under any Purchased Asset may not be assigned without the approval, consent or waiver of another Person and such approval, consent or waiver has not been obtained prior to the Closing, the Closing shall proceed without the assignment of such Purchased Asset and this Agreement shall not constitute an agreement for the sale, assignment, transfer, conveyance or delivery of such Purchased Asset; provided, however , that nothing in this Section 6.2.2 shall be deemed to waive Purchaser’s rights not to consummate the Transactions contemplated by this Agreement if the conditions to its obligations set forth in ARTICLE 7 have not been satisfied. In the event that the Closing proceeds without the sale, assignment, transfer, conveyance or delivery of any Purchased Asset (regardless of whether such Closing occurs as a result of Purchaser waiving its obligations set forth in ARTICLE 7 or otherwise), then following the Closing, Seller shall use its commercially reasonable efforts to obtain all necessary approvals, consents and waivers to the assignment and transfer thereof, and Purchaser shall use its commercially reasonable efforts to assist and cooperate with Seller in connection therewith; provided, that until any such approval, consent or waiver is obtained and the related Purchased Asset is transferred and assigned to Purchaser or Purchaser’s designee, Seller shall use its commercially reasonable efforts to provide to Purchaser substantially comparable benefits thereof and enforce, at the request of and for the account of Purchaser, any rights of Seller arising under any such Purchased Asset against any Person; and provided further , to the extent that Purchaser is provided with benefits of any such Purchased Asset, Purchaser shall perform the obligations of Seller thereunder. It is understood and agreed that, in the event of Seller’s or an Affiliate’s inability to assign or transfer a Purchased Contract identified on Section 2.1.1(a) of the Seller Disclosure Schedule, Seller or the applicable Affiliate shall remain responsible for completion of the applicable Purchased Contract as Purchaser’s agent, and at Purchaser’s sole expense as described in the Transition Services Agreement.  Once authorization, approval, consent or waiver for the sale, assignment, transfer, conveyance or delivery of any such Purchased Asset not sold, assigned, transferred, conveyed or delivered at the Closing is obtained, Seller shall assign, transfer, convey and deliver such Purchased Asset to Purchaser at no additional cost to Purchaser.
 
 
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6.3   Publicity No public announcement related to this Agreement or the Transactions contemplated herein will be issued without the joint approval of Seller and Purchaser, which approval shall not be unreasonably withheld, conditioned or delayed, except in any public disclosure which either Seller or Purchaser, in its good faith judgment, believes is required by applicable Law or by any stock exchange on which its securities or those of its Affiliates are listed. If either Party, in its good faith judgment, believes such disclosure is required, such Party will use its commercially reasonable efforts to consult with the other Party and its Representatives, and to consider in good faith any revisions proposed by the other Party or its Representatives, as applicable, prior to making (or prior to any of its Affiliates making) such disclosure, and shall limit such disclosure to only that information which is legally required to be disclosed. Notwithstanding the foregoing, the Parties shall be permitted to issue a press release announcing the execution of this Agreement and the Transactions contemplated hereby, substantially in the form of Exhibit K attached hereto, following the execution of this Agreement and, to the extent required pursuant to U.S. securities laws and the rules and regulations promulgated thereunder, shall be permitted to include descriptions and copies of this Agreement in their respective filings with the SEC.  Nothing herein shall prohibit a Party to issue a press release that includes information that was previously made public without such Party’s violation of this Section 6.3.
 
6.4   Confidentiality.
 
6.4.1   Prior to the Closing, all Confidential Information provided by one Party (or its Representatives) (collectively, the “ Disclosing Party ” with respect to such information) to the other Party (or its Representatives) (collectively, the “ Receiving Party ” with respect to such information) shall be subject to and treated in accordance with the terms of the Confidentiality Agreement. As used in this Section 6.4, “ Confidential Information ” means, as to a Party (a) all information disclosed by such Party (or its Representatives) to the Receiving Party in connection with this Agreement or any Ancillary Agreement, including all information with respect to the Disclosing Party’s licensors, licensees or Affiliates; (b) all information disclosed to the Receiving Party by the Disclosing Party under the Confidentiality Agreement; and (c) all memoranda, notes, analyses, compilations, studies and other materials prepared by or for the Receiving Party to the extent containing or reflecting the information in the preceding clause (a) or (b). Notwithstanding the foregoing, Confidential Information shall not include information that, in each case as demonstrated by competent written documentation:
 
 
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(a)   was already known to the Receiving Party or its Affiliates, other than under an obligation of confidentiality, at the time of disclosure by the Disclosing Party;
 
(b)   was generally available to the public or otherwise part of the public domain at the time of its disclosure to the Receiving Party;
 
(c)   became generally available to the public or otherwise part of the public domain after its disclosure to the Receiving Party other than through any act or omission of the Receiving Party in breach of this Agreement or the Confidentiality Agreement or through any act or omission of a Third Party under an obligation to the Disclosing Party; or
 
(d)   is subsequently disclosed to the Receiving Party by a Third Party without obligations of confidentiality with respect thereto.
 
6.4.2   From and after the Closing, (a) all Confidential Information obtained by Seller (or its Representatives) from Purchaser (or its Representatives); and (b) all Confidential Information to the extent relating primarily to the Product Business, the Purchased Assets or the Assumed Liabilities ((a) and (b), collectively, the “ Purchaser Confidential Information ”) shall be deemed to be Confidential Information disclosed by Purchaser to Seller for purposes of this Section 6.4 and shall be used by Seller solely as required to (i) perform its obligations or exercise or enforce its rights under this Agreement or any Ancillary Agreement; or (ii) comply with applicable Law (each of (i) and (ii), a “ Seller Permitted Purpose ”), and for no other purpose. For a period of ten (10) years after the Closing Date, Seller shall not disclose, or permit the disclosure of, any of Purchaser Confidential Information to any Person except those Persons to whom such disclosure is necessary in connection with any Seller Permitted Purpose and Seller shall not use Purchaser Confidential Information except in connection with Seller Permitted Purpose. Seller shall treat, and will cause its Affiliates and the Representatives of Seller or any of its Affiliates to treat, Purchaser Confidential Information as confidential, using the same degree of care as Seller normally employs to safeguard its own confidential information from unauthorized use or disclosure, but in no event less than a reasonable degree of care.
 
6.4.3   All Confidential Information obtained by Purchaser (or its Representatives) from Seller (or its Representatives) other than Purchaser Confidential Information (the “ Seller Confidential Information ”) shall be used by Purchaser solely as required to (a) perform its obligations or exercise or enforce its rights under this Agreement or any Ancillary Agreement; or (b) comply with applicable Law (each of (a) and (b), a “ Purchaser Permitted Purpose ”), and for no other purpose. For a period of ten (10) years after the Closing Date, Purchaser shall not disclose, or permit the disclosure of, any of Seller Confidential Information to any Person except to its employees and consultants under a duty of confidentiality or to Persons to whom such disclosure is necessary in connection with a Purchaser Permitted Purpose and Purchaser shall not use, or permit the use of, Seller Confidential Information, except in connection with a Purchaser Permitted Purpose or other internal business purpose. Purchaser shall treat, and will cause its Affiliates and the Representatives of Purchaser or any of its Affiliates to treat, Seller Confidential Information as confidential, using the same degree of care as Purchaser normally employs to safeguard its own confidential information from unauthorized use or disclosure, but in no event less than a reasonable degree of care.
 
 
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6.4.4   In the event either Party is requested pursuant to, or required by, applicable Law to disclose any of the other Party’s Confidential Information ( i.e ., Seller Confidential Information or Purchaser Confidential Information, as applicable), it will notify the other Party in a timely manner so that such Party may seek a protective order or other appropriate remedy or, in such Party’s sole discretion, waive compliance with the confidentiality provisions of this Agreement. Each Party will cooperate in all reasonable respects in connection with any reasonable actions to be taken for the foregoing purpose. In any event, the Party requested or required to disclose such Confidential Information may furnish it as requested or required pursuant to applicable Law (subject to any such protective order or other appropriate remedy) without liability hereunder, provided, that such Party furnishes only that portion of the Confidential Information which such Party is advised by an opinion of its counsel is legally required, and if confidential treatment is available such Party exercises reasonable efforts to obtain reliable assurances that confidential treatment will be accorded such Confidential Information.
 
6.4.5   Nothing in this Section 6.4 shall be construed as preventing or in any way inhibiting either Party from complying with applicable Law governing activities and obligations undertaken pursuant to this Agreement or any Ancillary Agreement in any manner which it reasonably deems appropriate. Either Party may disclose information relating to this Agreement to the SEC or any securities exchange or any Governmental Authority if required by applicable Law, provided, that the Disclosing Party shall: (a) unless prohibited by applicable Law, provide the other Party with reasonable advance notice of and an opportunity to comment on any such required disclosure; (b) if requested by such other Party, seek, or cooperate with such Party’s efforts to obtain, confidential treatment or a protective order with respect to any such disclosure to the extent available at the Disclosing Party’s expense; and (c) take into consideration the comments of such other Party in any such disclosure or request for confidential treatment or protective order; provided, however , that a Party shall not be required to provide any notice to the other Party with respect to any disclosure in any securities filings (including 10-K filings and 10-Q filings) that discloses information that has been previously disclosed in an earlier filing or press release or that reports aggregate financial results related to this Agreement.
 
6.5   FDA Letters. As soon as practicable after the Closing, but in any event no later than three (3) Business Days following the Closing Date, Purchaser and Seller shall file Purchaser FDA Letters and Seller FDA Letters, respectively, with the FDA (in accordance with 21 C.F.R. § 314.72) providing notification of the transfer to Purchaser effective as of the Closing Date of the Purchased Regulatory Approvals; provided, that Purchaser’s obligation shall be conditioned on it receiving from Seller not less than three (3) Business Days prior to the Closing Date the complete regulatory file Controlled by Seller for all the relevant INDs and NDAs.
 
 
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6.6   Regulatory Responsibilities.
 
6.6.1   From and after the Closing, subject to the terms of the Transition Services Agreement and except as required by a Party to comply with applicable Law or to exercise its rights and obligations hereunder or under any other Ancillary Agreement, Purchaser shall have the sole right and responsibility for preparing, obtaining and maintaining all Regulatory Approvals necessary for the Product Business, and for conducting communications with Governmental Authorities of competent jurisdiction, for Seller Products. Without limitation of the foregoing, promptly following the Closing, Purchaser shall obtain such FDA approvals as are necessary for Purchaser’s own Product labeling and shall comply with such FDA approvals upon receipt thereof.
 
6.6.2   Subject to the terms of the Transition Services Agreement from and after the Closing, Seller shall support Purchaser, as may be reasonably necessary and practicable, at Purchaser’s cost and expense, in preparing, obtaining and maintaining all Regulatory Approvals for the Seller Products, including providing necessary documents or other materials required by applicable Law for Purchaser to obtain or maintain such Regulatory Approvals, in each case, in accordance with the terms and conditions of this Agreement.
 
6.6.3   Except to the extent otherwise provided in the Transition Services Agreement, from and after the Closing, Seller shall provide Purchaser with (i) copies of all written or electronic correspondence relating to any Seller Product received by Seller, its Affiliates, licensees, sublicensees or distributors from, or submitted by Seller, its Affiliates, licensees, sublicensees or distributors to, Regulatory Authorities;   and (ii) copies of all meeting minutes and other similar summaries of all meetings, conferences and discussions held by Seller with Regulatory Authorities to the extent relating to any Seller Product, including copies of all contact reports produced by Seller and its Affiliates, licensees, sublicensees and distributors, in each case ((i) and (ii)), within ten (10) Business Days after Seller’s receipt, submission or production of the foregoing, as applicable. To the extent applicable, Seller shall provide Purchaser a draft of any written response thereto reasonably in advance (in light of the prevailing circumstances) of submitting such response to the applicable Regulatory Authorities.
 
6.7   Pharmacovigilance Obligations.   After the Closing, Seller shall promptly provide Purchaser an electronic copy of the CIOMS I form for all legacy data of Adverse Events with respect to any Seller Product that is within Seller’s (or its Affiliate’s, as appropriate) possession, for inclusion in Purchaser’s safety database for the Product. After the Closing, Purchaser shall have all responsibility for required reporting of Adverse Events with respect to Seller Products.
 
 
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6.8   Medical and Other Inquiries. Except to the extent otherwise provided in the Transition Services Agreement, from and after the Closing Date, Purchaser or its designee (a) shall be responsible for, and shall handle and respond to, all customer complaints and inquiries (including medical and non-medical inquiries) related to any Seller Product used, marketed, distributed or sold; and (b) shall be responsible for, and shall conduct, all correspondence and communication with physicians and other health care professionals relating to Seller Products. Purchaser shall keep such records and make such reports as shall be reasonably necessary to document such communications in compliance with applicable Law.
 
6.9   Commercialization. From and after the Closing Date, (a) Purchaser, at its own cost and expense, shall be responsible for and have sole discretion over the commercialization, marketing strategy, promotion, distribution and sale of Seller Products and shall independently determine and set prices for Seller Products, including the selling price, volume discounts, Rebates, chargeback claims, and similar matters; (b) Purchaser shall be responsible, at its own cost and expense, for all marketing, advertising and promotional materials related to Seller Products; and (c) Purchaser or its Affiliates shall be responsible for receiving and processing all orders, undertaking all invoicing, collection and receivables, and providing all customer service related to the sale of Seller Products.
 
6.10   Returned Products, Chargebacks, Rebates, Health Care Reform Fees and Coupons.   The Parties shall comply with all applicable terms and conditions of the Transition Services Agreement, which shall, at a minimum, address respective rights, obligations and payment issues pertaining to the transition of NDC numbers, returned products, Rebate payments, chargeback claims, Health Care Reform Fees, coupons and vouchers, and government program price reporting issues.
 
6.11   Certain Tax Matters.
 
6.11.1   Transfer Taxes and Apportioned Obligations.
 
(a)   All sales, use, goods and services, value added, excise, and other Taxes (but excluding any Taxes based on or attributable to income for capital gains), duties or charges of a similar nature imposed by any Governmental Authority, or other taxing authority in connection with the transfer of the Purchased Assets or Product Business to Purchaser (collectively, “ Transfer Taxes ”) shall be borne [ ***] 6 . The Party responsible for filing any Tax Return relating to any Transfer Tax shall prepare and file such Tax Return at its expense, provided , that such Party shall deliver a copy of such Tax Return to the other Party at least [***] prior to the due date for such Tax Return and such other Party shall deliver to the Party that prepared such Tax Return such other Party’s [***] share of the Transfer Tax due in connection with filing such Tax Return at least [***] prior to such due date. Each of Seller and Purchaser shall take any action reasonably requested by the other Party in connection with preparing and filing any Tax Return relating to any Transfer Tax, and shall use commercially reasonable efforts to minimize obligations relating to Transfer Taxes as a result of the Transactions contemplated by this Agreement.
 

***Certain information on this page has been omitted and filed separately with the Commission. Confidential treatment has been requested with respect to the omitted portions.
 
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(b)   All personal property and similar ad valorem obligations levied with respect to the Purchased Assets for a Straddle Period (collectively, the “ Apportioned Obligations ”) shall be apportioned between Seller and Purchaser based on the number of days of such Straddle Period included in the Pre-Closing Tax Period and the number of days of such Straddle Period included in the Post-Closing Tax Period. Seller shall be liable for the proportionate amount of such Apportioned Obligations that is attributable to the Pre-Closing Tax Period, and Purchaser shall be liable for the proportionate amount of such Apportioned Obligations that is attributable to the Post-Closing Tax Period.
 
(c)   Apportioned Obligations and Transfer Taxes shall be timely paid, and all applicable filings, reports and returns shall be filed, as provided by applicable Law. With respect to the Apportioned Obligations, the paying Party shall be entitled to reimbursement from the non-paying Party in accordance with Section 6.11.1(b). Upon payment of any such Apportioned Obligation, the paying Party shall present a statement to the non-paying Party setting forth the amount of reimbursement to which the paying Party is entitled under Section 6.11.1(b) together with such supporting evidence as is reasonably necessary to calculate the amount to be reimbursed. The non-paying Party shall make such reimbursement promptly but in no event later than [ ***] 7 after the presentation of such statement.
 
6.11.2   Cooperation and Exchange of Information. Each of Seller and Purchaser shall (a) provide the other with such assistance as may reasonably be requested by the other in connection with the preparation of any Tax Return, audit or other examination by any taxing authority or judicial or administrative proceeding relating to Liability for Taxes in connection with the Product Business or the Purchased Assets; (b) retain and provide the other with any records or other information that may be relevant to such Tax Return, audit or examination, proceeding or determination; and (c) inform the other of any final determination of any such audit or examination, proceeding or determination that affects any amount required to be shown on any Tax Return of the other for any period.
 
6.11.3   Survival of Covenants. The covenants contained in this Section 6.11 shall survive until the expiration of the applicable statute of limitations (including extensions thereof).
 
6.12   Accounts Receivable and Payable.
 
6.12.1   Accounts Receivable. The Parties acknowledge and agree that all Accounts Receivable outstanding on the Closing Date shall remain the property of Seller or its Affiliates and shall be collected by Seller or its Affiliates subsequent to the Closing. In the event that, subsequent to the Closing, Purchaser or an Affiliate of Purchaser receives any payments from any obligor with respect to an Account Receivable, then Purchaser shall, within thirty (30) days of receipt of such payment, remit the full amount of such payment to Seller. In the case of the receipt by Purchaser of any payment from any obligor of both Seller and Purchaser then, unless otherwise specified by such obligor, such payment shall be applied first to amounts owed to Purchaser with the excess, if any, remitted to Seller. In the event that, subsequent to the Closing, Seller or any of its Affiliates receives any payments from any obligor with respect to an account receivable of Purchaser for any period after the Closing Date, then Seller shall, within thirty (30) days of receipt of such payment, remit the full amount of such payment to Purchaser. In the case of the receipt by Seller of any payment from any obligor of both Seller and Purchaser then, unless otherwise specified by such obligor, such payment shall be applied first to amounts owed to Seller with the excess, if any, remitted to Purchaser.
 

***Certain information on this page has been omitted and filed separately with the Commission. Confidential treatment has been requested with respect to the omitted portions.
 
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6.12.2   Accounts Payable. In the event that, subsequent to the Closing, Purchaser or an Affiliate of Purchaser receives any invoices from any Third Party with respect to any account payable or other Liability of the Product Business that constitutes an Excluded Liability, then Purchaser shall, within thirty (30) days of receipt of such invoice, provide such invoice to Seller. In the event that, subsequent to the Closing, Seller or any of its Affiliates receives any invoices from any Third Party with respect to any account payable of Purchaser or any of its Affiliates for any period after the Closing that constitutes an Assumed Liability, then Seller shall, within thirty (30) days of receipt of such invoice, provide such invoice to Purchaser.
 
6.12.3   In the event of a conflict or ambiguity between this Section 6.12 and any applicable section of the Transition Services Agreement, the Transition Services Agreement shall control.
 
6.13   Net Sales Reports; Audit Rights.   Until Purchaser has satisfied its reporting obligations set forth in this Section 6.13 with respect to the Reporting Period, Purchaser shall provide Seller with reasonably detailed quarterly and annual reports, not later than [ ***] 8 after the end of each Calendar Quarter and not later than [***] after the end of each Calendar Year, of the aggregate gross sales of Seller Products and Net Sales for such Calendar Quarter or Calendar Year, as applicable (collectively, the “ Net Sales Reports ”). All Net Sales Reports shall include separate line items for gross sales and Net Sales of each SKU of the Product or Third Generation Product, in each case, as applicable. Purchaser shall, and shall cause its Affiliates, licensees and sublicensees engaged in the Exploitation of any Seller Product to keep and maintain Milestone Information until the third (3 rd ) year following the end of the Calendar Year to which such Milestone Information relates. Purchaser shall, at the request of Seller, permit a nationally recognized registered independent auditor in the United States selected by Seller and reasonably acceptable to Purchaser (the “ Independent Auditor ”) to review during ordinary business hours and upon no less than [***] prior written notice, but on no more than [***] per calendar year, such books and records as may be necessary to determine the accuracy of any Net Sales Report.  The Independent Auditor shall be bound by a confidentiality agreement, in a form reasonably acceptable to Purchaser, to keep all information acquired from Purchaser confidential, and shall be permitted to disclose to Seller only whether any Net Sales Report was accurate and the amount, if any, owed to or by Seller under Section 2.3.2.  The Independent Auditor shall send a copy of its written reports to Purchaser at the same time such reports are sent to Seller, and the findings of the Independent Auditor in such report shall be binding on the Parties for all purposes.  Seller shall be responsible for the fees and expenses of the Independent Auditor; provided, however , that Purchaser shall reimburse Seller in full for all such costs and expenses of the Independent Auditor if the Independent Auditor determines that a Milestone Payment was not paid pursuant to Section 2.3.2. Purchase shall promptly make any payments necessary to Seller to correct any failure to make a Milestone Payment when due and payable, which payments shall include interest on any unpaid amounts calculated at a rate per annum equal to the lesser of the prime rate of interest plus five percent (5%), as reported by New York edition of The Wall Street Journal on the last Business Day of the applicable Calendar Quarter, or the highest rate permitted by applicable Law, calculated on the number of days such payments are paid after the date such payments are due.
 

***Certain information on this page has been omitted and filed separately with the Commission. Confidential treatment has been requested with respect to the omitted portions.
 
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6.14   Exclusivity. During the sixty (60) months following the Closing Date, Seller covenants and agrees that it shall not, and it shall cause its Affiliates not to develop, market or sell single entity, extended release hydrocodone (a “ Competitive Activity ”); provided, however , that it shall not be deemed to be a violation of this Section 6.14 for Seller to, directly or indirectly: (a) invest in or own any non-voting or non-convertible debt securities or other debt obligations of any Person; (b) make any equity investments in publicly-traded companies that may compete with the Product Business, (provided, that such investments are passive in nature and do not exceed five percent (5%) of the outstanding voting power of such public companies); (c) own any interests in any Person through any means “employee benefit plan” (within the meaning of Section 3(3) of ERISA), including multiemployer plans within the meaning of Section 3(37) of ERISA; or (d) acquire (by purchase of stock or assets, merger or otherwise) any Person; provided, however , that Seller or its Affiliates, as applicable, promptly divest that portion of such Person that engages in the Competitive Activity within twelve (12) months after the acquisition of such Person or Seller or its Affiliates, as applicable, cease to engage in the Competitive Activity within twelve (12) months. In addition, if Seller or any of its Affiliates are acquired by or merged with a Third Party that engages in the Competitive Activity at the time of such acquisition or merger, such Third Party and its other Affiliates will not have any obligations under this Section 6.14. The Parties recognize that the Laws and public policies of the various states of the United States and other jurisdictions may differ as to the validity and enforceability of covenants similar to those set forth in this Section 6.14.  It is the intention of the Parties that a determination by a jurisdiction that one or more provisions of this Section 6.14 is invalid or unenforceable shall not render unenforceable, or impair, the remainder of the provisions of this Section 6.14.  Accordingly, if any provision of this Section 6.14 shall be determined to be invalid or unenforceable, such invalidity or unenforceability shall be deemed to apply only with respect to the operation of such provision in the particular jurisdiction in which such determination is made and not with respect to any other provision or jurisdiction, and Section 10.8 shall apply to substitute a valid and enforceable provision thereof.
 
6.15   Exchange Act Filings. Seller shall, at its sole cost and expense, deliver to Purchaser, as soon as practicable after the Closing but no later than forty-five (45) days thereafter, such financial information requested by Purchaser to enable it to satisfy its SEC disclosure obligations under Regulation S-X and the Exchange Act including, but not limited to, “abbreviated carve-out financial statements” (as provided for in Staff Accounting Bulletin Topic 1.B and Sections 7200, 7400 and 2065.4-6 of the SEC Financial and Reporting Manual) relating to the Product for each of the three (3) years ended December 31, 2014, 2013 and 2012 and for any additional interim period as required, with a report thereon (with no exception or qualification) of Ernst & Young LLP or other reputable independent certified accountants selected by Seller (the “ Auditors ”), including in each case the notes thereto (the “ Audited Financial Statements ”). Seller also hereby agrees to consent to the inclusion of such financial statements or information obtained by Purchaser pursuant to this Section 6.15, by or at the request of Purchaser, in any filings by Purchaser with the SEC or any other securities regulatory authority or exchange. Seller further agrees that it will use, as applicable, commercially reasonable efforts to cause the Auditors to provide to Purchaser (or Purchaser’s successor) (a) the Auditors’ consent to the inclusion of any such financial statements or the information contained therein in any filings by or on behalf of Purchaser (or Purchaser’s successor); and (b) comfort letters, consents for use of their reports and any other pertinent financial or other information or documents as reasonably requested by Purchaser, in each case in connection with Purchaser’s SEC filings and at the sole expense of Purchaser.
 
 
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6.16   Release of Encumbrances.   On or prior to the Closing, Seller shall (a) take all actions necessary to extinguish or cause to be extinguished, as the case may be, all Encumbrances on the Purchased Assets and the Purchased Product Inventory, excluding Permitted Encumbrances, but including all Encumbrances on the Purchased Assets and the Purchased Product Inventory arising in connection with any debt financing, in each case on terms reasonably satisfactory to Purchaser; and (b) file in the appropriate jurisdictions termination statements of Uniform Commercial Code financing statements (or equivalent filings in jurisdictions outside the United States) that have been filed by the holders of such Encumbrances with respect to Seller or any of the Purchased Assets or the Purchased Product Inventory, to Purchaser’s reasonable satisfaction. In the event that, after the Closing, any such lienholder asserts any Encumbrance or security interest in the Purchased Assets or the Purchased Product Inventory, Seller shall, upon written request from Purchasers, take all actions necessary to obtain a release from such lienholder of all such Encumbrances or security interests.
 
6.17   Diligent Efforts .
 
6.17.1   Purchaser agrees and covenants, for itself and its Affiliates, that Purchaser shall use, and shall cause its Affiliates to use, Commercially Reasonable Efforts to (i) conduct the Development Plan; (ii) file an NDA for the Third Generation Product; and (iii) Exploit the Seller Products.  Without limiting the foregoing, Purchaser shall have the right to amend the Development Plan from time to time based on the results of studies conducted with the Third Generation Product and commercial, scientific and regulatory considerations.
 
6.17.2   Seller acknowledges and agrees that except to the extent set forth in Section 6.17.1 (i) Purchaser and its Affiliates shall have the right to operate their respective businesses, including the Product Business and the sale of the Seller Products, in their sole discretion; (ii) the achievement of the Milestone Payments contemplated herein is speculative and is subject to numerous factors outside the control of Purchaser and its Affiliates; (iii) as a result, there is no assurance that Seller will receive any Milestone Payment and neither Purchaser nor its Affiliates has promised or projected payment of any Milestone Payment; (iv) neither Purchaser nor its Affiliates owe a fiduciary duty or express or implied duty to Seller other than to pay Milestone Payments in accordance with the express terms of this Agreement; and (v) the contingent right of Seller to receive any Milestone Payment is not an investment in Purchaser or its Affiliates.  Notwithstanding the foregoing, neither Purchaser nor any Affiliate thereof will take or omit to take any action if the primary purpose of such action or omission is to reduce or eliminate any payment obligation of Purchaser pursuant to Section 2.3.2.
 
 
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6.18   Financing Cooperation.   Prior to the Closing, Seller shall use commercially reasonable efforts, and shall cause its Affiliates and its and their Representatives to use commercially reasonable efforts, to provide Purchaser with all cooperation reasonably requested by Purchaser in connection obtaining the Financing, including but not limited to (a) participation by Seller’s officers in a reasonable number of meetings (including one-on-one), due diligence sessions and similar activities, in each case at such times as coordinated reasonably in advance thereof; and (b) obtaining reasonable access to Seller’s accountants; provided, however , that nothing herein shall require (i) such cooperation to the extent that it would interfere materially and unreasonably with the business and operations of Seller; or (ii) the taking of any action that would conflict with or violate the certificate of incorporation or bylaws of Seller or any applicable Law. Nothing in this Section 6.18 shall require Seller to (a) bear any out-of-pocket cost or expense that is not reimbursed pursuant to this Section 6.18 or pay any fee in connection with Financing; (b) incur any liability (or cause their respective directors, officers or employees to incur any liability) under the Financing; or (c) enter into any definitive agreement or commitment. Furthermore, Purchaser shall, promptly upon request by Seller, reimburse Seller for all reasonable and documented out-of-pocket costs and expenses incurred by Seller and its representatives in connection with their respective obligations pursuant to this Section 6.18. Purchaser shall indemnify and hold harmless Seller, its Affiliates and its representatives (collectively, the “ Financing Indemnitees ”) from and against any and all losses, damages, claims, costs or expenses suffered or incurred by any of them in connection with the Financing and any information utilized in connection therewith (other than any information provided in writing specifically for use by or on behalf of Seller), in each case other than to the extent any of the foregoing arises from the bad faith, gross negligence or willful misconduct of, or breach of this Agreement by a Financing Indemnitee (the obligations in this sentence, the “ Financing Cooperation Indemnity ”). The obligations of Purchaser in the foregoing sentence shall survive the Closing and any termination of this Agreement.
 
ARTICLE 7
CONDITIONS PRECEDENT
 
7.1   Conditions to Obligations of Purchaser and Seller. The obligations of Purchaser and Seller to complete the Transactions contemplated by this Agreement are subject to the satisfaction at or prior to the Closing of the following conditions:
 
7.1.1   No Adverse Law; No Injunction. No Law shall have been enacted, entered, promulgated or enforced by any Governmental Authority that prohibits the consummation of all or any part of the Transactions contemplated by this Agreement or the Ancillary Agreements, and no order by any Governmental Authority restraining, enjoining or otherwise preventing the consummation of the Transactions contemplated hereby shall be in effect.
 
 
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7.1.2   Governmental Approvals. All required consents of, notifications to and filings with any Governmental Authority shall have been made and any waiting periods or required approvals applicable to the Transactions contemplated hereby pursuant to any applicable Law shall have expired or been terminated or been granted, including any applicable waiting period or approvals under the HSR Act.
 
7.1.3   Litigation.
 
(a)   There shall not be pending or threatened Litigation by a Governmental Authority, and neither Purchaser nor Seller shall have received any written communication from any Governmental in which such Governmental Authority indicates that it intends to commence any Litigation or take any other action (a) challenging or seeking to restrain or prohibit any of the Transactions; (b) that will have, or would be reasonably likely to have, the effect of preventing, delaying or making illegal any of the Transactions; (c) seeking to prohibit or limit the ownership or operation by Purchaser or any of its Subsidiaries of any material portion of the business or assets of Purchaser (including the Product Business), or any of its Subsidiaries, or to compel Purchaser, or any of its Subsidiaries to dispose of or hold separate any material portion of the business or assets of Purchaser (including the Product Business), Seller or any of their respective Subsidiaries, in each case as a result of the Transactions; (d) seeking to impose limitations on the ability of Purchaser to acquire or hold, or exercise full rights of ownership of, the Purchased Assets; or (e) seeking to prohibit Purchaser or any of its Subsidiaries from effectively controlling in any material respect the Product Business.
 
(b)   No Governmental Authority shall have enacted, issued, promulgated, enforced or entered any Law or order (whether temporary, preliminary or permanent) that has the effect of making the Transactions contemplated by this Agreement illegal or otherwise prohibiting the consummation of such Transactions contemplated by this Agreement.
 
7.2   Conditions to Obligations of Purchaser. The obligation of Purchaser to complete the Transactions contemplated by this Agreement is subject to the satisfaction or waiver by Purchaser at or prior to the Closing of the following additional conditions:
 
7.2.1   Representations and Warranties. Each of (a) the representations and warranties of Seller set forth in this Agreement in Section 3.1 (Entity Status), Section 3.2 (Authority), Section 3.4 (No Broker), Section 3.6 (Title to Purchased Assets) and Section 3.15 (Sufficiency of Assets) (collectively, the “ Seller Fundamental Representations ”), disregarding all qualifications and exceptions contained therein relating to materiality, Material Adverse Effect or other materiality qualifications, shall each be true and correct in all material respects on and as of the date of this Agreement and as of the Closing Date with the same force and effect as though made on and as of the Closing Date (except to the extent that any representation or warranty is limited by its terms to a specific date or range of dates (in which case such representation and warranty need only be true and correct on the date or during the range of dates so specified)); and (b) and all other representations and warranties of Seller, disregarding all qualifications and exceptions contained therein relating to materiality, Material Adverse Effect or other materiality qualifications, shall each be true and correct in all material respects on and as of the date of this Agreement and as of the Closing Date with the same force and effect as though made on and as of the Closing Date, except to the extent that any representation or warranty is limited by its terms to a specific date or range of dates (in which case such representation and warranty need only be true and correct on the date or during the range of dates so specified), except where the failure of any representation and warranty in this clause (b) to be so true and correct, individually or in the aggregate, has not had or would not reasonably be expected to have a Material Adverse Effect.
 
 
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7.2.2   Covenants. Seller shall have performed and complied in all material respects with all covenants, agreements and obligations required to be performed or complied with on or prior to the Closing Date;
 
7.2.3   No Material Adverse Effect. Since the Execution Date, no Material Adverse Effect shall have occurred; and
 
7.2.4   Closing Deliveries. Seller shall have delivered to Purchaser each of the items listed in Section 2.5.2(a).
 
7.3   Conditions to Obligations of Seller. The obligation of Seller to complete the Transactions contemplated by this Agreement is subject to the satisfaction or waiver by Seller at or prior to the Closing of the following additional conditions:
 
7.3.1   Representations and Warranties. Each of (a) the representations and warranties of Purchaser set forth in this Agreement in Section 4.1 (Corporate Status), Section 4.2 (Authority), and Section 4.4 (No Broker), (collectively, the “ Purchaser Fundamental Representations ”), disregarding all qualifications and exceptions contained therein relating to materiality, Material Adverse Effect or other materiality qualifications, shall each be true and correct in all material respects on and as of the date of this Agreement and as of the Closing Date with the same force and effect as though made on and as of the Closing Date (except to the extent that any representation or warranty is limited by its terms to a specific date or range of dates (in which case such representation and warranty need only be true and correct on the date or during the range of dates so specified)); and (b) and all other representations and warranties of Purchaser, disregarding all qualifications and exceptions contained therein relating to materiality or other materiality qualifications, shall each be true and correct in all material respects on and as of the date of this Agreement and as of the Closing Date with the same force and effect as though made on and as of the Closing Date, except to the extent that any representation or warranty is limited by its terms to a specific date or range of dates (in which case such representation and warranty need only be true and correct on the date or during the range of dates so specified), except where the failure of any representation and warranty in this clause (b) to be so true and correct, individually or in the aggregate, has not had or would not reasonably be expected to result in a Purchaser Material Adverse Effect.
 
7.3.2   Covenants. Purchaser shall have performed and complied in all material respects with all covenants, agreements and obligations required to be performed or complied with on or prior to the Closing Date; and
 
 
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7.3.3   Closing Deliveries. Purchaser shall have delivered to Seller each of the items listed in Section 2.5.2(b).
 
7.4   Frustration of Closing Conditions . With respect to the condition to Purchaser’s and Seller’s respective obligations to consummate the Transactions contemplated by this Agreement as provided hereunder and each Party’s right to terminate this Agreement as provided in Section 9.1, neither Purchaser nor Seller may rely on the failure of any condition set forth in this ARTICLE 7 to be satisfied if such failure was caused by such Party’s failure to act in good faith or to use its reasonable best efforts to cause the condition to be satisfied to the extent required by Section 5.4.
 
ARTICLE 8
INDEMNIFICATION
 
8.1   Survival.
 
8.1.1   Survival of Representations and Warranties.                                                                             The representations and warranties of Purchaser and Seller contained herein and any other certificate or document delivered pursuant to this Agreement or any Transaction Document shall survive the Closing Date and shall expire on the applicable Expiration Date as set forth in Section 8.1.3.
 
8.1.2   Survival of Covenants. The covenants and agreements of the Parties hereto contained in this Agreement shall survive the Closing Date and remain in full force for the applicable periods described therein or, if no such period is specified, until fully performed.
 
8.1.3   Claims Period. Any claim for indemnification by a Party under this ARTICLE 8 shall be made by giving an Indemnification Certificate or Claim Notice, as applicable, of a good faith claim to the other Party in accordance with Section 8.4 on or before the applicable Expiration Date, or the claim under this ARTICLE 8 shall be invalid. For purposes of this Agreement, “ Expiration Date ” means:
 
(a)   the twelve (12) month anniversary of the Closing Date for claims for indemnification based on a breach of a representation or warranty; provided, however , for claims for indemnification based on a breach of Seller Fundamental Representations or Purchaser Fundamental Representations, “ Expiration Date ” shall mean the date that the applicable statute of limitations (including any extensions thereof) expires with respect to such claim;
 
(b)   for claims for indemnification based on a breach of a covenant which by its terms contemplates performance after the Closing Date but expires on a date certain, such date certain;
 
(c)   for claims for indemnification based on a breach of a covenant which by its terms contemplates performance after the Closing Date but does not expire on a date certain, the date that the applicable statute of limitations (including any extensions thereof) expires with respect to such claim; and
 
 
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(d)   for claims to indemnify an Indemnified Party pursuant to Sections 8.3.1(c), 8.3.1(d), 8.3.1(e), 8.3.1(f), 8.3.2(c), 8.3.2(d), or 8.3.2(e), the date that the applicable statute of limitations (including any extensions thereof) expires with respect to such claim.
 
8.2   Effect of Investigation, Knowledge or Waiver.   The right to indemnification or other remedy based on the representations, warranties, covenants and agreements herein will not be affected by any investigation conducted with respect to, or any knowledge acquired (or capable of being acquired by the Party seeking indemnification), at any time (including as a result of any notices delivered pursuant to Section 10.2), whether before or after the execution and delivery of this Agreement, with respect to the accuracy or inaccuracy of or compliance with, any such representation, warranty, covenant or agreement.  The waiver of any condition based on the accuracy of any representation or warranty, or on the performance of or compliance with any covenant or obligation, will not affect the right to indemnification, reimbursement, or other remedy based on such representations, warranties, covenants and obligations.  The Parties acknowledge and agree that with respect to the right to indemnification, reimbursement, or other remedy based on a breach of a representation or warranty, the Party seeking indemnification shall not have any obligation to prove reliance upon such representation or warranty.
 
8.3   Indemnification.
 
8.3.1   Indemnification by Seller. Following the Closing, but subject to the provisions of this ARTICLE 8, Seller shall indemnify, defend and hold harmless Purchaser and its Representatives (collectively, “ Purchaser Indemnitees ”) from and against, and shall compensate and reimburse each of Purchaser Indemnitees for, any and all Losses suffered or incurred by any Purchaser Indemnitee or to which any Purchaser Indemnitee may otherwise become subject arising out of or related to:
 
(a)   any inaccuracy in or breach by Seller of any of the representations or warranties made by Seller: (i) in this Agreement; or (ii) in any certificate delivered on behalf of Seller pursuant to Section 2.5.2(a)(ii) (in each case of the foregoing clauses (i) and (ii), without giving effect to any “material”, “in all material respects”, and “Material Adverse Effect” qualification limiting the scope of such representation or warranty, but solely for purposes of determining the amount of Losses and not for purposes of determining whether a breach has occurred);
 
(b)   any failure of Seller to perform or any breach by Seller of any of its covenants, agreements or obligations contained in this Agreement;
 
(c)   any Excluded Liability;
 
(d)   any failure of Seller to comply with any applicable bulk sales statute in connection with the Transactions contemplated hereby;
 
(e)   any of the matters described on Section 8.3.1(e) of the Seller Disclosure Schedule (a “ Designated Action ”); or
 
(f)   any failure of Seller to pay Transfer Taxes or Apportioned Obligations allocated to Seller under Section 6.11.1;
 
 
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provided, however , that Seller shall not be required to indemnify any Purchaser Indemnitee to the extent that such Losses arise out of or result from (i) the gross negligence, recklessness or willful misconduct of any Purchaser Indemnitee; or (ii) any claim for Losses that is indemnifiable by Purchaser under Section 8.3.2.
 
8.3.2   Indemnification by Purchaser. Following the Closing, but subject to the provisions of this ARTICLE 8, Purchaser shall indemnify and hold harmless Seller and its Representatives (collectively, “ Seller Indemnitees ”) from and against and shall compensate and reimburse each of Seller Indemnitees for, any and all Losses suffered or incurred by any Seller Indemnitee or to which any Seller Indemnitee may otherwise become subject arising out of or related to:
 
(a)   any inaccuracy in or breach by Purchaser of any of the representations or warranties made by Purchaser: (i) in this Agreement or (ii) in any certificate delivered on behalf of Purchaser pursuant to Section 2.5.2(b)(iii) (in each case of the foregoing clauses (i) and (ii), without giving effect to any “material”, “in all material respects”, and “Purchaser Material Adverse Effect” qualification limiting the scope of such representation or warranty, but solely for purposes of determining the amount of Losses and not for purposes of determining whether a breach or inaccuracy has occurred);
 
(b)   any failure of Purchaser to perform or any breach by Purchaser of any of its covenants, agreements or obligations contained in this Agreement;
 
(c)   any Assumed Liability;
 
(d)   any Product sold by or on behalf of Purchaser or any of its Affiliates on or after the Closing Date; or
 
(e)   any failure of Purchaser to pay Transfer Taxes or Apportioned Obligations allocated to Purchaser under Section 6.11.1;
 
provided, however , that Purchaser shall not be required to indemnify any Seller Indemnitee to the extent that such Losses arise out of or result from (i) the gross negligence, recklessness or willful misconduct of any Seller Indemnitee; or (ii) any claim for Losses that is indemnifiable by Seller under Section 8.3.1.
 
8.4   Claim Procedure.
 
8.4.1   Indemnification Claim Procedure. Except as provided in Section 8.4.2 with respect to Third Party claims, in the event of a claim made by a Purchaser Indemnitee or a Seller Indemnitee (the “ Indemnified Party ”), the Indemnified Party shall give reasonably prompt written notice to the other Party (the “ Indemnifying Party ”), which notice (an “ Indemnification Certificate ”) shall: (a) state that the Indemnified Party has paid or properly accrued or in good faith anticipates that it will have to pay or accrue Losses that are subject to indemnification by the Indemnifying Party pursuant to Section 8.3.1 or Section 8.3.2, as applicable; and (b) specify in reasonable detail the facts and circumstances supporting the Indemnified Party’s claim for indemnification (to the extent known) and contain a non-binding preliminary, good faith estimate of the amount to which the Indemnified Party claims to be entitled (to the extent known); provided, however , that the failure to give reasonably prompt notice shall not relieve the applicable Indemnifying Party of its indemnification obligations under this Agreement except to the extent that the Indemnifying Party is materially prejudiced by any delay in receiving such notice. In the event that the Indemnifying Party agrees to or is determined to have an obligation to indemnify or reimburse the Indemnified Party for Losses as provided in this ARTICLE 8, the Indemnifying Party shall, subject to the provisions of this Section 8.4.1, promptly (but in any event, within thirty (30) days of receipt of the Indemnification Certificate) pay such amount to the Indemnified Party by wire transfer of immediately available funds to the account specified in writing by the Indemnified Party. If the Indemnifying Party objects to all or a portion of the Indemnified Party’s claim made in the Indemnification Certificate, the Indemnifying Party will notify the Indemnified Party of such objection by delivering a written statement (the “ Objection Notice ”) to the Indemnifying Party within sixty (60) days following receipt of the Indemnification Certificate (the “ Response Period ”). The Objection Notice shall indicate whether the Indemnifying Party objects to all or only a portion of the claim specified in the Indemnification Certificate and shall specify in reasonable detail the facts and circumstances supporting the Indemnifying Party’s basis and reasons for such objection. An Indemnifying Party’s failure to deliver an Objection Notice in accordance with the provisions of this Section 8.4.1 within the Response Period to any claim set forth in an Indemnification Certificate shall be deemed to be the Indemnifying Party’s acceptance of, and waiver of any objections to, such claim and the Indemnifying Party shall be deemed to have agreed that an amount equal to the full claimed amount specified in the Indemnification Certificate is owed to the Indemnified Party. If the Indemnifying Party in its Objection Notice objects only to a portion of the claim set forth in the Indemnification Certificate (the amount of Losses claimed in the Indemnification Certificate to which the Indemnifying Party does not object shall be referred to herein as the “ Agreed Amount ”), then such Indemnifying Party shall, within ten (10) Business Days following the delivery of such Objection Notice pay the Agreed Amount to the Indemnified Party. If an Indemnifying Party shall provide Objection Notice in accordance with the provisions of this Section 8.4.1, the Indemnifying Party and the Indemnified Party shall attempt in good faith for a period of twenty (20) days following the Indemnified Party’s receipt of the Objection Notice to agree upon the rights of the respective parties with respect to each of such claims. If no such agreement can be reached after such twenty (20)-day period of good faith negotiation, either the Indemnifying Party or the Indemnified Party may initiate Litigation for purposes of having the matter settled in accordance with the terms of this Agreement.
 
 
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8.4.2   Third Party Claim Procedure. In the event an Indemnified Party becomes aware of a claim made by a Third Party (including any action or proceeding commenced or threatened to be commenced by any Third Party) that such Indemnified Party in good faith believes may result in an indemnification claim pursuant to Section 8.3, such Indemnified Party shall promptly (and in any event within ten (10) Business Days after receiving written notice of such claim) notify the Indemnifying Party in writing of such claim (such notice, the “ Claim Notice ”). The Claim Notice shall be accompanied by reasonable supporting documentation submitted by the Third Party making such claim and shall describe in reasonable detail (to the extent known by the Indemnified Party) the facts constituting the basis for such claim and the amount of the claimed damages; provided , however , that no delay or failure on the part the Indemnified Party in delivering a Claim Notice shall relieve the applicable Indemnifying Party of its indemnification obligations under this Agreement except to the extent that the Indemnifying Party is materially prejudiced by any delay in receiving such notice. Within thirty (30) days after receipt of any Claim Notice, the Indemnifying Party may, upon written notice thereof to the Indemnified Party, assume control of the defense of the claim referred to therein at the Indemnifying Party’s sole cost and expense (which shall be subject to Section 8.5) with counsel reasonably satisfactory to the Indemnified Party; provided, however , that (A) the Indemnifying Party shall not be entitled to assume control of such defense if (i) such claim is subject to the Cap and could, when aggregated with all other potential claims subject to the Cap, reasonably be expected to give rise to Losses which exceed the Cap; (ii) the claim for indemnification relates to or arises in connection with any criminal proceeding, action, indictment, allegation or investigation; exists of a conflict of interest between Seller, on the one hand, and Purchaser, on the other; (iii) the claim seeks an injunction or equitable relief against the Indemnified Party; or (iv) the claim does not seek only monetary damages and the Indemnified Party’s counsel reasonably believes an adverse determination with respect to the Litigation giving rise to such claim for indemnification would be detrimental to or materially injure the reputation or future business prospects of Indemnified Party; and (B) Seller shall not be entitled to assume control of such defense of claims related to a Designated Action. The assumption of the defense of a Third Party claim by the Indemnifying Party shall not be construed as an acknowledgment that the Indemnifying Party is liable to indemnify any Indemnified Party in respect of the Third Party claim, nor shall it constitute a waiver by the Indemnifying Party of any defenses it may assert against any Indemnified Party’s claim for indemnification. In the event that it is ultimately determined that the Indemnifying Party is not obligated to indemnify, defend or hold harmless an Indemnified Party from and against the Third Party claim, the Indemnified Party shall reimburse the Indemnifying Party for any and all Losses incurred by the Indemnifying Party in its defense of the Third Party claim with respect to such Indemnified Party. For the avoidance of doubt, reasonable fees (including costs and expenses in connection with investigations, suits and proceedings, expert fees, accounting fees, advisory fees and legal fees) incurred by an Indemnified Party in defending a Third Party claim shall constitute Losses for purposes of this this ARTICLE 8; provided, however , in the event the Indemnifying Party actually assumes the conduct and control of such claim, only the reasonable fees incurred prior to the Indemnifying Party’s assumption of such defense shall constitute Losses unless otherwise provided for herein.
 
 
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8.4.3   If the Indemnifying Party does not so assume control of the defense of such claim, the Indemnified Party shall control the defense of such claim. The Party not controlling the defense of such claim (the “ Non-Controlling Party ”) may participate therein at its own expense; provided , however , that if the Indemnifying Party assumes control of the defense of such claim and the Indemnifying Party and the Indemnified Party have materially conflicting interests or different defenses available with respect to such claim that cause the Indemnified Party to hire its own separate counsel with respect to such proceeding, the reasonable fees and expenses of a single counsel to the Indemnified Party shall be considered “Losses” for purposes of this Agreement. The Party controlling the defense of such claim (the “ Controlling Party ”) shall keep the Non-Controlling Party advised of the status of such claim and the defense thereof and shall consider in good faith recommendations made by the Non-Controlling Party with respect thereto. The Non-Controlling Party shall furnish the Controlling Party with such information as it may have with respect to such claim (including copies of any summons, complaint or other pleading that may have been served on such Party and any written claim, demand, invoice, billing or other document evidencing or asserting the same) and shall otherwise cooperate with and assist the Controlling Party in the defense of such claim. Neither the Indemnified Party nor the Indemnifying Party shall agree to any settlement of, or the entry of any judgment arising from, any such claim without the prior written consent of the other Party, which consent shall not be unreasonably withheld, conditioned or delayed; provided, however , that the consent of the Indemnified Party shall not be required with respect to any such settlement or judgment if the Indemnifying Party agrees in writing to pay or cause to be paid any amounts payable pursuant to such settlement or judgment and such settlement or judgment includes no admission of liability by or other obligation on the part of the Indemnified Party and includes a complete release of the Indemnified Party from further Liability.
 
 
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8.5   Limitations on Indemnification .
 
8.5.1   Threshold and Deductible. The provisions for indemnity under Section 8.3.1(a) or Section 8.3.2(a) shall be effective only (a) for any individual claim where the Loss exceeds [ ***] 9 ; and (b) when the aggregate amount of all Losses for claims in excess of [***] for which indemnification is sought from any Indemnifying Party exceeds [***], in which case the Indemnified Party shall be entitled to indemnification of all the Indemnified Party’s Losses in excess of [***]; provided, however , that the foregoing limitation shall not be applicable for breaches of any of Seller Fundamental Representations or Purchaser Fundamental Representations or in the case of claims based on Fraud, intentional misrepresentation or willful misconduct.
 
8.5.2   Liability Caps.
 
(a)   Subject to the limitations set forth in Section 8.5, from and after the Closing, neither Party shall have any indemnification obligations for Losses under Section 8.3.1(a) or 8.3.2(a), as applicable, that exceed, in the aggregate, [***] (the “ Cap ”); provided, however , the Cap shall not apply to claims for indemnification in respect of either the Seller Fundamental Representations or Purchaser Fundamental Representations; and provided, further , that Losses in respect of breaches of the Seller Fundamental Representations or Purchaser Fundamental Representations shall not be considered for purposes of determining when the Cap has been met.  For the avoidance of doubt, the Cap shall not apply to claims to indemnify an Indemnified Party pursuant to Sections 8.1.3(b), 8.3.1(c), 8.3.1(d), 8.3.1(e), 8.3.1(f), 8.3.2(b), 8.3.2(c), 8.3.2(d), or 8.3.2(e).
 

***Certain information on this page has been omitted and filed separately with the Commission. Confidential treatment has been requested with respect to the omitted portions.
 
 
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(b)   The Parties’ respective aggregate liability for Losses in respect of breaches of Seller Fundamental Representations or Purchaser Fundamental Representations, shall not, in the aggregate, exceed [ ***] 10 (the “ Fundamental Representations Cap ”); provided, however , that the Fundamental Representations Cap shall be increased by the amount of any Milestone Payments that are paid by Purchaser to Seller pursuant to Section 2.3.2 (or that have been deemed to have been paid to Seller pursuant to Section 8.9); and provided, further , a Party’s obligation to pay the other Party in respect of such breaches of Seller Fundamental Representations or Purchaser Fundamental Representations any amount in excess of [***] shall be deferred until such time as the Promissory Note has been paid in full (or deemed to have been paid in full, after giving effect to the provisions of Section 8.9).
 
8.5.3   Off-Sets. The amount of Losses recovered by an Indemnified Party under Section 8.3.1 or Section 8.3.2, as applicable, shall be reduced by (a) any amounts actually recovered by the Indemnified Party from a Third Party in connection with such claim; and (b) the amount of any insurance proceeds paid to the Indemnified Party relating to such claim, in each case of clauses “(a)” and “(b)” net of any amounts spent in obtaining such amounts (including the cost of the insurance policy) and any increase in future premiums reasonably attributable to such claim; provided, however , that for the avoidance of doubt, no Indemnified Party shall have any obligation to seek recovery from any Third Party or insurer with respect to such Losses. If any amounts referenced in the preceding clauses (a) and (b) are received after payment by the Indemnifying Party of the full amount otherwise required to be paid to an Indemnified Party pursuant to this ARTICLE 8, the Indemnified Party shall repay to the Indemnifying Party, promptly after such receipt, any amount that the Indemnifying Party would not have had to pay pursuant to this ARTICLE 8 had such amounts been received prior to such payment.
 
8.5.4   TO THE FULLEST EXTENT PERMITTED BY APPLICABLE LAW AND EXCEPT AS A RESULT OF THIRD PARTY INDEMNIFICATION CLAIMS OR FRAUD, INTENTIONAL MISREPRESENTATION OR WILLFUL MISCONDUCT, NEITHER PURCHASER NOR SELLER SHALL BE LIABLE TO THE OTHER, OR THEIR AFFILIATES, FOR ANY CLAIMS, DEMANDS OR SUITS FOR CONSEQUENTIAL, INCIDENTAL, SPECIAL, EXEMPLARY, PUNITIVE, INDIRECT OR MULTIPLE DAMAGES, INCLUDING LOSS OF PROFITS, REVENUE OR INCOME, DIMINUTION IN VALUE OR LOSS OF BUSINESS OPPORTUNITY (WHETHER OR NOT FORESEEABLE AT THE EXECUTION DATE) CONNECTED WITH OR RESULTING FROM ANY BREACH, OR ANY ACTIONS UNDERTAKEN IN CONNECTION WITH, OR RELATED HERETO, INCLUDING ANY SUCH DAMAGES THAT ARE BASED UPON BREACH OF CONTRACT, TORT (INCLUDING NEGLIGENCE AND MISREPRESENTATION), BREACH OF WARRANTY, STRICT LIABILITY, STATUTE, OPERATION OF LAW OR ANY OTHER THEORY OF RECOVERY.
 

***Certain information on this page has been omitted and filed separately with the Commission. Confidential treatment has been requested with respect to the omitted portions.
 
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8.6   Designated Action . Notwithstanding anything in ARTICLE 8 of the Agreement to the contrary, the provision for indemnity for the Designated Action pursuant to Section 8.3.1(e) shall be subject to the following terms and conditions:
 
8.6.1   Deductible.  The provisions for indemnity under Section 8.3.1(e) shall be effective only when claims exceed [ ***] 11 , in which case the Purchaser Indemnitees shall be entitled to indemnification of the Purchaser Indemnitees’ Losses in excess of [***].
 
8.6.2   Cost-Sharing and Cap.  The Seller shall indemnify the Purchaser Indemnitees for [***] of any Losses under Section 8.3.1(e) up to an aggregate of $5,000,000, subject to reduction pursuant to Section 8.6.4 below. For the avoidance of doubt, the Purchaser Indemnitees shall only be entitled to recover for any Losses arising out of the Designated Action under Section 8.3.1(e).
 
8.6.3   Recourse.  The Parties agree that for any claims for which the Purchaser Indemnitees are entitled to indemnification under Section 8.3.1(e), payment for such Losses shall be paid solely from the Escrow Fund, in accordance with Section 2.4 and the Escrow Agreement; provided, that , following the final distribution of any amounts in the Escrow Fund pursuant to Section 2.4, the Escrow Fund shall cease to be the sole recourse for claims under Section 8.3.1(e) and such indemnifiable Losses may then be withheld solely from the Milestone Payments.  For the avoidance of doubt, such withholding from the Milestone Payments shall be on a dollar-for-dollar basis up to the limitation set forth in Section 8.6.2 above.
 
8.6.4   Reduction of Losses.  The Purchaser Indemnitees’ Losses otherwise recoverable under Section 8.3.1(e) shall be reduced by (i) any amounts paid to or otherwise actually recovered by (including in the form of royalty reductions or payment offsets) any Purchaser Indemnitee in connection with the Designated Action pursuant to the Daravita License Agreement or from Altus Formulations pursuant to the Development and Option Agreement between Altus Formulations Inc. and Seller, dated November 1, 2013, as amended and any license agreement therefrom; (ii) any amounts actually recovered by any Purchaser Indemnitee from a Third Party in connection with the Designated Action; and (iii) the amount of any insurance proceeds paid to any Purchaser Indemnitee relating to the Designated Action, in each case of clauses “(ii)” and “(iii)” net of any amounts spent in obtaining such amounts (including the cost of the insurance policy) and any increase in future premiums reasonably attributable to such claim.  If any amounts referenced in the preceding clauses (i), (ii) and (iii) are received or recovered after payment by Seller of the full amount otherwise required to be paid to a Purchaser Indemnitee pursuant to Section 8.3.1(e) and this Section 8.6, the Purchaser Indemnitee shall repay to Seller, promptly after such receipt, any amount that Seller would not have had to pay pursuant to Section 8.3.1(e) and this Section 8.6 had such amounts been received prior to such payment.
 

***Certain information on this page has been omitted and filed separately with the Commission. Confidential treatment has been requested with respect to the omitted portions.
 
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8.6.5   Definition of Losses. For purposes of the indemnity under Section 8.3.1(e) and this Section 8.6, the term “ Loss ” or “ Losses ” shall mean any Liabilities, losses, damages, judgments, fines, penalties, awards, Taxes, amounts paid in settlement, reasonable fees (including costs and expenses in connection with investigations, suits and proceedings, expert fees, accounting fees, advisory fees and legal fees), charges and costs incurred in connection with or arising out of the Designated Action, including any ancillary Litigation such as actions in the nature of counterclaims and declaratory judgment actions where Purchaser Indemnitees or their licensors are the plaintiffs.
 
8.7   Tax Treatment of Indemnification Payments. All payments made pursuant to this ARTICLE 8 shall be treated as adjustments to the Purchase Price for all Tax purposes, unless otherwise required by applicable Law or a final determination of a taxing authority.
 
8.8   Exclusive Remedy .   Except as expressly provided otherwise in this Agreement or any Ancillary Agreement and subject to Section 10.9, each Party acknowledges and agrees that, following the Closing, the remedies provided for in this ARTICLE 8 shall be the sole and exclusive remedies for claims and damages available to the Parties and their respective Affiliates arising out of or relating to this Agreement and the transactions contemplated hereby.  Nothing herein shall limit the Liability of either Party for Fraud.
 
8.9   Setoff Rights. Neither Party shall have any right of setoff of any amounts due and payable, or any Liabilities arising, under against any amounts due and payable under this Agreement against any other amounts due and payable under this Agreement or any amounts due and payable, or any Liabilities arising, under any Ancillary Agreement; provided , however , that Purchaser may set-off against and deduct from any amounts due and payable to Seller pursuant to (a) Section 2.3.2; or (b) the Promissory Note any amounts due and payable by Seller pursuant to Section 8.3.1(a) for breaches of Seller Fundamental Representations (“ Right of Setoff ”); and provided further , any amounts that are set-off pursuant to Purchaser’s Right of Setoff shall be deemed to have been paid to Seller for purposes of Section 8.5. Except as expressly set forth in this Section 8.9, the payment obligations under each of this Agreement and the Ancillary Agreements remain independent obligations of each Party, irrespective of any amounts owed to any other Party under this Agreement or the respective Ancillary Agreements.
 
ARTICLE 9
TERMINATION
 
9.1   Termination. Prior to the Closing, this Agreement shall terminate on the earliest to occur of any of the following events:
 
9.1.1   the mutual written agreement of Purchaser and Seller;
 
9.1.2   by written notice delivered by either Purchaser or Seller to the other, if the Closing shall not have occurred on or prior to May 9, 2015 (the “ End Date ”); provided, however , that if, as of May 9, 2015, either (a) all of the conditions set forth in ARTICLE 7 shall have been satisfied (other than (x) the conditions set forth in Section 7.1.2 of this Agreement; and (y) those conditions that by their nature cannot be satisfied other than at the Closing); or (b) any court of competent jurisdiction or other Governmental Authority shall have issued an order, decree or ruling or taken any other action restraining, enjoining or otherwise prohibiting the Transactions contemplated by this Agreement and such order, decree, ruling or other action has not become final and nonappealable, the End Date shall be July 8, 2015; provided further , however, that the right to terminate this Agreement under this Section 9.1.2 shall not be available to any Party whose failure to fulfill any obligation under this Agreement shall have been the proximate cause of, or shall have resulted in, the failure of the Closing to occur on or prior to such date;
 
 
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9.1.3   by either Seller or Purchaser in the event (a) there shall be any Law that makes consummation of the Transactions contemplated by this Agreement illegal or otherwise prohibited; or (b) any Governmental Authority shall have issued an order restraining or enjoining the Transactions contemplated by this Agreement, and such order shall have become final and non-appealable; provided, however , that the right to terminate this Agreement under this Section 9.1.3 shall not be available to any Party whose failure to fulfill any obligation under this Agreement shall have been the proximate cause of, or shall have resulted in, the failure of the Closing to occur on or prior to such date;
 
9.1.4   by either Seller or Purchaser, by giving written notice of such termination to the other Party, if such other Party shall have breached any of its material obligations or agreements under this Agreement and such breach shall be incapable of cure or has not been cured within thirty (30) days following the giving of written notice by the non-breaching Party to the other Party of such breach (or, if the End Date is fewer than thirty (30) days from provision of such notice, cured by the End Date);
 
9.1.5   by Seller, by giving written notice of such termination to Purchaser, if there has been a breach of the representations and warranties of Purchaser contained in this Agreement which (i) would result in the failure of the condition set forth in Section 7.3.1; and (ii) cannot be or is not cured prior to the End Date; provided, that Seller may not terminate this Agreement pursuant to this Section 9.1.5 if Seller is in material breach of its agreements or covenants contained in this Agreement;
 
9.1.6   by Purchaser, by giving written notice of such termination to Seller, if there has been a breach of the representations and warranties of Seller contained in this Agreement which (i) would result in the failure of the condition set forth in Section 7.2.1; and (ii) cannot be or is not cured prior to the End Date; provided, that Purchaser may not terminate this Agreement pursuant to this Section 9.1.6 if Purchaser is in material breach of its agreements or covenants contained in this Agreement;
 
9.1.7   by Seller, if all of the conditions set forth in Sections 7.1 and 7.2 have been satisfied (other than those conditions that by their nature cannot be satisfied other than at the Closing) and Purchaser fails to consummate the Transactions contemplated by this Agreement upon the earlier of (a) five (5) Business Days after the date the Closing should have occurred pursuant to Section 2.5; and (b) the later of the date the Closing should have occurred pursuant to Section 2.5 and one (1) Business Day before the End Date, and Seller has irrevocably notified Purchaser in writing that Seller is ready, willing and able to consummate the Transactions contemplated by this Agreement during such period.
 
 
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9.2   Procedure and Effect of Termination.
 
9.2.1   Notice of Termination. Termination of this Agreement by either Purchaser or Seller shall be by delivery of a written notice to the other. Such notice shall state the termination provision in this Agreement that such terminating Party is claiming provides a basis for termination of this Agreement. Termination of this Agreement pursuant to the provisions of Section 9.1 shall be effective upon and as of the date of delivery of such written notice as determined pursuant to Section 10.2.
 
9.2.2   Effect of Termination. In the event of the termination of this Agreement pursuant to Section 9.1 by Purchaser or Seller, this Agreement shall be terminated and have no further effect, and there shall be no liability hereunder on the part of Seller, Purchaser or any of their respective Representatives, except that Sections 6.3 (Publicity), 6.4 (Confidentiality), 9.2.2 (Effect of Termination), 9.2.3 (Withdrawal of Certain Filings), and ARTICLE 10 (Miscellaneous) shall survive any termination of this Agreement. For clarity, in the event of termination of this Agreement pursuant to Section 9.1, the Parties shall not enter into any of the Ancillary Agreements or have any obligations thereunder. Nothing in this Section 9.2.2 shall relieve any Party to this Agreement of liability for Fraud or willful misconduct, or intentional misrepresentation prior to the termination hereof.
 
9.2.3   Withdrawal of Certain Filings. As soon as practicable following a termination of this Agreement for any reason, but in no event less than thirty (30) days after such termination, Purchaser or Seller shall, to the extent practicable, withdraw all filings, applications and other submissions relating to the Transactions contemplated by this Agreement filed or submitted by or on behalf of such Party, any Governmental Authority or other Person.  Each Party, if requested, will redeliver all documents, work papers and other material to the other Party and its Affiliates relating to the Transactions contemplated hereby, whether so obtained before or after the execution date hereof, to the Party furnishing the same.
 
ARTICLE 10
MISCELLANEOUS
 
10.1   Governing Law, Jurisdiction, Venue and Service.
 
10.1.1   GOVERNING LAW. THIS AGREEMENT SHALL BE GOVERNED BY AND CONSTRUED AND INTERPRETED IN ACCORDANCE WITH THE LAWS OF THE STATE OF DELAWARE, IRRESPECTIVE OF THE CHOICE OF LAWS PRINCIPLES OF THE STATE OF DELAWARE, AS TO ALL MATTERS, INCLUDING MATTERS OF VALIDITY, CONSTRUCTION, EFFECT, ENFORCEABILITY, PERFORMANCE, REMEDIES AND STATUTE OF LIMITATIONS.
 
10.1.2   Jurisdiction.
 
(a)   Subject to Section 10.9, the Parties hereby irrevocably and unconditionally consent to the exclusive jurisdiction of the courts of the State of Delaware (or, if a state court located within the State of Delaware declines to accept jurisdiction over a particular matter, any court of the United States located in the State of Delaware) for any action, suit or proceeding arising out of or relating to this Agreement or the Transactions contemplated hereby. Each Party hereto hereby agrees not to commence any legal proceedings relating to or arising out of this Agreement or the Transactions contemplated hereby in any jurisdiction or courts other than as provided herein.
 
 
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(b)   EACH PARTY ACKNOWLEDGES AND AGREES THAT ANY CONTROVERSY THAT MAY ARISE UNDER THIS AGREEMENT IS LIKELY TO INVOLVE COMPLICATED AND DIFFICULT ISSUES, AND THEREFORE EACH SUCH PARTY HEREBY IRREVOCABLY AND UNCONDITIONALLY WAIVES ANY RIGHT SUCH PARTY MAY HAVE TO A TRIAL BY JURY IN RESPECT OF ANY LITIGATION DIRECTLY OR INDIRECTLY ARISING OUT OF OR RELATING TO THIS AGREEMENT.  EACH PARTY CERTIFIES AND ACKNOWLEDGES THAT (i) NO REPRESENTATIVE, AGENT OR ATTORNEY OF ANY OTHER PARTY HAS REPRESENTED, EXPRESSLY OR OTHERWISE, THAT SUCH OTHER PARTY WOULD NOT, IN THE EVENT OF LITIGATION, SEEK TO ENFORCE THE FOREGOING WAIVER, (ii) EACH PARTY UNDERSTANDS AND HAS CONSIDERED THE IMPLICATIONS OF THIS WAIVER, (iii) EACH PARTY MAKES THIS WAIVER VOLUNTARILY AND (iv) EACH PARTY HAS BEEN INDUCED TO ENTER INTO THIS AGREEMENT BY, AMONG OTHER THINGS, THE MUTUAL WAIVERS AND CERTIFICATIONS IN THIS SECTION 10.1.2(b).
 
10.1.3   Venue. The Parties further hereby irrevocably and unconditionally waive any objection to the laying of venue of any action, suit or proceeding arising out of or relating to this Agreement in the courts of the State of Delaware (or, if a state court located within the State of Delaware declines to accept jurisdiction over a particular matter, any court of the United States located in the State of Delaware), and hereby further irrevocably and unconditionally waive and agree not to plead or claim in any such court that any such action, suit or proceeding brought in any such court has been brought in an inconvenient forum.
 
10.1.4   Service. Each Party further agrees that service of any process, summons, notice or document by registered mail to its address set forth in Section 10.2.2 shall be effective service of process for any action, suit or proceeding brought against it under this Agreement in any such court.
 
10.2   Notices.
 
10.2.1   Notice Requirements. Any notice, request, demand, waiver, consent, approval or other communication permitted or required under this Agreement (each, a “ Notice ”) shall be in writing, shall refer specifically to this Agreement and shall be deemed given only if delivered by hand or sent by facsimile transmission (with transmission confirmed) or by overnight registered mail, courier or express delivery service that maintains records of delivery, addressed to the Parties at their respective addresses specified in Section 10.2.2 or to such other address as the Party to whom notice is to be given may have provided to the other Party at least ten (10) days’ prior to such address taking effect in accordance with this Section 10.2. Such Notice shall be deemed to have been received: (a) as of the date delivered by hand or by overnight registered mail, courier or express delivery service; or (b) on the day sent by facsimile provided, that the sender had received confirmation of transmission (by facsimile receipt confirmation or confirmation by telephone or email) prior to 6:00 p.m. Eastern Time on such day (and if is received confirmation is received after 6:00 p.m. Eastern Time, such Notice shall be deemed to have been delivered on the following Business Day). Any Notice delivered by facsimile shall be confirmed by a hard copy delivered promptly thereafter.
 
 
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10.2.2   Address for Notice.
 
If to Seller, to:
 
Zogenix, Inc.
12400 High Bluff Drive, Suite 650
San Diego, CA 92130
Attention: Chief Executive Officer
Facsimile: (858)-259-1166
 
with a copy (which shall not constitute notice) to:
 
Latham & Watkins LLP
12670 High Bluff Drive
San Diego, CA 92130
Attention: Cheston Larson, Esq.
Facsimile: (858) 523-5450
 
If to Purchaser, to:
 
Pernix Ireland Limited
c/o Pernix Therapeutics Holdings, Inc.
10 North Park Place, Suite 201
Morristown, NJ 07960
Attention: Barry J. Siegel
Facsimile: 800-793-2145
[ ***] 12
 
with a copy (which shall not constitute notice) to:
 
Lowenstein Sandler LLP
1251 Avenue of the Americas
New York, New York 10020
Attention: Michael J. Lerner
Facsimile: 973-597-6395
 

***Certain information on this page has been omitted and filed separately with the Commission. Confidential treatment has been requested with respect to the omitted portions.
 
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If to Guarantor, to:
 
Pernix Therapeutics Holdings, Inc.
10 North Park Place, Suite 201
Morristown, NJ 07960
Attention: Barry J. Siegel
Facsimile: 800-793-2145
[ ***] 13
 
with a copy (which shall not constitute notice) to:
 
Lowenstein Sandler LLP
1251 Avenue of the Americas
New York, New York 10020
Attention: Michael J. Lerner
Facsimile: 973-597-6395
 
10.3   No Benefit to Third Parties. The covenants and agreements set forth in this Agreement are for the sole benefit of the Parties and their successors and permitted assigns, and, except for the rights of (a) the Financing Indemnitees under Section 6.18; and (b) Purchaser Indemnitees and Seller Indemnitees under ARTICLE 8, they shall not be construed as conferring any rights on any other Persons.
 
10.4   Waiver and Non-Exclusion of Remedies. Any term or condition of this Agreement may be waived at any time by the Party that is entitled to the benefit thereof, but no such waiver shall be effective unless set forth in a written instrument duly executed by or on behalf of the Party waiving such term or condition. The waiver by any Party of any right hereunder or of the failure to perform or of a breach by the other Party shall not be deemed a waiver of any other right hereunder or of any other breach or failure by said other Party whether of a similar nature or otherwise. The rights and remedies provided herein are cumulative and do not exclude any other right or remedy provided by applicable Law or otherwise available except as expressly set forth herein.
 
10.5   Expenses. Except as otherwise specified herein, and whether or not the Closing takes place, each Party shall bear any costs and expenses incurred by it with respect to the Transactions contemplated herein.
 
10.6   Assignment. Neither this Agreement nor either Party’s rights or obligations hereunder may be assigned or delegated by such Party without the prior written consent of the other Party, and any attempted assignment or delegation of this Agreement or any of such rights or obligations by either Party without the prior written consent of the other Party shall be void and of no effect; provided , however , that either Party may assign or delegate any or all of its rights or obligations hereunder to an Affiliate without the prior written consent of the other Party but only if such assignment or delegation would not adversely affect such other Party under this Agreement or any of the Ancillary Agreements (including, but not limited to, resulting in a new or increased obligation to withhold or deduct Taxes from any payment thereunder). Subject to the preceding sentence, this Agreement will be binding upon, inure to the benefit of, and be enforceable by, the Parties and their respective successors and permitted assigns.
 

***Certain information on this page has been omitted and filed separately with the Commission. Confidential treatment has been requested with respect to the omitted portions.
 
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10.7   Amendment. This Agreement may not be modified, amended, altered or supplemented except upon the execution and delivery of a written agreement executed by both Parties.
 
10.8   Severability. If any provision of this Agreement is held to be illegal, invalid or unenforceable under any present or future Law, and if the rights or obligations of either Party under this Agreement will not be materially and adversely affected thereby, (a) such provision shall be fully severable; (b) this Agreement shall be construed and enforced as if such illegal, invalid or unenforceable provision had never comprised a part hereof; (c) the remaining provisions of this Agreement shall remain in full force and effect and shall not be affected by the illegal, invalid or unenforceable provision or by its severance herefrom; and (d) in lieu of such illegal, invalid or unenforceable provision, there shall be added automatically as a part of this Agreement a legal, valid and enforceable provision as similar in terms to such illegal, invalid or unenforceable provision as may be possible and reasonably acceptable to the Parties.
 
10.9   Equitable Relief. The Parties hereto agree that irreparable damage would occur if any provision of this Agreement were not performed in accordance with the specific terms hereof or were otherwise breached. It is accordingly agreed that the Parties shall be entitled, without posting a bond or similar indemnity, to an injunction or injunctions to prevent breaches of this Agreement or to enforce specifically the performance of the terms and provisions hereof in any court of the United States or any state having jurisdiction, this being in addition to any other remedy to which they are entitled at law or in equity.  Each Party agrees that it will not oppose the granting of an injunction, specific performance and other equitable relief when expressly available pursuant to the terms of this Agreement on the basis that such Party has an adequate remedy at law or an award of specific performance is not an appropriate remedy for any reason at law or equity.
 
10.10   Use of Affiliates. Seller shall have the right to exercise its rights and perform its obligations under this Agreement either itself or through any of its Affiliates. In addition, in each case where an Affiliate of Seller has an obligation pursuant to this Agreement or performs an obligation pursuant to this Agreement, Seller shall cause and compel such Affiliate to perform such obligation and comply with the terms of this Agreement.
 
10.11   Bulk Sales Statutes. Purchaser hereby waives compliance by Seller with any applicable bulk sales statutes in any jurisdiction in connection with the Transactions under this Agreement.
 
10.12   Counterparts. This Agreement may be executed in any number of counterparts, and each such counterpart hereof shall be deemed to be an original instrument, but all such counterparts together shall constitute but one agreement. Delivery of an executed counterpart of a signature page of this Agreement by facsimile or other electronic transmission shall be effective as delivery of a manually executed original counterpart of this Agreement.
 
 
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10.13   Fair Market Value. In the event that, according to this Agreement, a “fair market value” has to be determined, the Party obliged to suggest such fair market value shall provide the other Party in due time with a good faith determination of the fair market value, together with any information necessary or useful to support such determination. Each Party shall have the right to dispute any determination of fair market value by providing written notice of the Party’s good faith estimate of the fair market value to the other Party within fifteen (15) calendar days of its receipt of such Party’s notice of its determination.  In such event, the Parties shall negotiate in good faith the determination of fair market value for a period of not less than thirty (30) days.  If the Parties do not agree in writing upon the fair market value within such thirty (30)-day period, then the fair market value shall be determined by an independent appraiser mutually selected by the Parties within fifteen (15) business days of the written notice.  If the Parties are unable to agree on a single appraiser, each Party shall each select an appraiser and the two appraisers so selected shall thereupon determine fair market value.  If one Party fails to select an appraiser within fifteen (15) business days of the aforesaid notice, the sole appraiser selected shall determine the fair market value.  If the two appraisers cannot agree on fair market value within thirty (30) calendar days after their selection, they shall, within ten (10) business days, mutually select a third appraiser.  The mutually selected appraiser (or, if applicable, the third appraiser) shall determine the fair market value within thirty (30) calendar days of selection, and such determination shall be conclusive and binding upon the Parties.  Each selected appraiser shall be experienced in valuing assets similar in nature to the assets that are the subject of the dispute.  The fees and expenses of the appraisers shall be borne by the disputing Party unless the deciding appraiser determines that the fair market value was less than [ ***] 14 of the final fair market value determined by the deciding appraiser, in which event the Party providing the original determination of fair market value shall bear the fees and expenses of the appraisers.
 
10.14   Guarantee.
 
10.14.1   Guarantor absolutely, unconditionally and irrevocably (a) guarantees to Seller, as the primary obligor and not merely as surety, the due and punctual observance, payment, performance and discharge of the obligations of Purchaser pursuant to this Agreement including, but not limited to, the payment of the Promissory Note (the “ Obligations ”); and (b) agrees to pay any and all reasonable expenses (including reasonable legal expenses and reasonable attorneys’ fees) incurred by Seller in successfully enforcing any rights under this Section 10.14.  If Purchaser fails to pay or perform the Obligations when due, then all of Guarantors’ liabilities to Seller hereunder in respect of such Obligations shall, at Seller’s option, become immediately due and payable and Seller may at any time and from time to time take any and all actions available hereunder or under applicable Law to enforce and collect the Obligations from Guarantor.  In furtherance of the foregoing, Guarantor acknowledges that Seller may, in its sole discretion, bring and prosecute a separate action or actions against Guarantor for the full amount of the Obligations, regardless of whether any action is brought against Purchaser.  To the fullest extent permitted by Law, Guarantor hereby expressly and unconditionally waives (i) any and all rights or defenses arising by reason of any Law, promptness, diligence, notice of the acceptance of this guarantee and of the Obligations, presentment, demand for payment, notice of non-performance, default, dishonor and protest, marshalling of assets, notice of the Obligations incurred and all other notices of any kind; and (ii) all suretyship defenses including all defenses based upon any statute or rule of law that provides that the obligation of a surety must be neither larger in amount nor in other respects more burdensome than that of the principal (other than payment in full of the Obligations).  The Guarantor acknowledges that it will receive substantial direct and indirect benefits from the transactions contemplated by this Agreement and that the waivers set forth in this Guarantee are knowingly made in contemplation of such benefits.  This Section 10.14 contains the entire agreement between Seller and Guarantor with respect to Guarantor’s obligations to Seller in connection with this Agreement, and supersedes all prior agreements, understandings, promises and representations, whether written or oral, between Seller and Guarantor with respect to the subject matter hereof.
 

***Certain information on this page has been omitted and filed separately with the Commission. Confidential treatment has been requested with respect to the omitted portions.
 
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10.14.2    Guarantor represents and warrants to Seller that:
 
(a)   Guarantor is a corporation duly incorporated, validly existing and in good standing under the laws of Maryland; and
 
(b)   Guarantor has the requisite corporate power and authority to enter into this Agreement and to perform its obligations contemplated by Section 10.14.1. The execution and delivery of this Agreement and performance of the transactions contemplated by Section 10.14.1 have been duly authorized by the necessary corporate actions of Guarantor. This Agreement constitutes the valid and legally binding obligation of Guarantor, enforceable against Guarantor in accordance with its terms, subject to bankruptcy, insolvency, fraudulent transfer, reorganization, moratorium or similar Laws of general application affecting or relating to the enforcement of creditors’ rights generally, and subject to equitable principles of general applicability, whether considered in a proceeding at law or in equity.
 
10.14.3    If at any time any payment of any of the Obligations is rescinded or is otherwise required by applicable Law to be returned by Seller upon the insolvency, bankruptcy, reorganization, dissolution, liquidation, arrangement, assignment for the benefit of creditors or other similar proceeding of Purchaser or Guarantor, or otherwise, then Guarantor’s obligations under Section 10.14.1 with respect to such payment shall be reinstated as though such payment had been due but not been made.
 
10.15   Entire Agreement. This Agreement, together with the Schedules and Exhibits expressly contemplated hereby and attached hereto, Seller Disclosure Schedule, the Ancillary Agreements, the Confidentiality Agreement and the other agreements, certificates and documents delivered in connection herewith or therewith or otherwise in connection with the Transactions contemplated hereby and thereby, contain the entire agreement between the Parties with respect to the Transactions contemplated hereby or thereby and supersede all prior agreements, understandings, promises and representations, whether written or oral, between the Parties with respect to the subject matter hereof and thereof. In the event of any inconsistency between any such Schedules and Exhibits and this Agreement, the terms of this Agreement shall govern.
 
Signature page follows
 
 
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IN WITNESS WHEREOF , the Parties have executed this Agreement as of the date first set forth above.
 
  ZOGENIX, INC.  
       
 
By:
/s/ Roger Hawley  
    Name: Roger Hawley  
    Title: CEO  
       
  PERNIX IRELAND LIMITED  
       
 
By:
/s/ Douglas Drysdale  
    Name: Douglas Drysdale  
    Title: Director  
       
  PERNIX THERAPEUTICS HOLDINGS, INC  
  (solely with respect to Sections 5.9.2, 10.2 and 10.14)  
       
 
By:
/s/ Douglas Drysdale  
    Name: Douglas Drysdale  
    Title: CEO  
       
       
 
[Signature Page to Asset Purchase Agreement]

85

Exhibit 2.2
AMENDMENT TO ASSET PURCHASE AGREEMENT
 
THIS AMENDMENT TO ASSET PURCHASE AGREEMENT (this “ Amendment ”) is made as of April 23, 2015, by and among Zogenix, Inc., a Delaware corporation (“ Seller ”), Pernix Ireland Limited, an Irish corporation (“ Purchaser ”), and Pernix Therapeutics Holdings, Inc., a Maryland corporation (“ Guarantor ”). Capitalized terms used herein and not otherwise defined herein shall have the meanings ascribed to such terms in the Purchase Agreement (as defined below).
 
WHEREAS , Seller, Purchaser and, for purposes of Sections 5.9.2, 10.2 , and 10.14 thereof only, Guarantor, entered into an Asset Purchase Agreement, dated as of March 10, 2015 (the “ Purchase Agreement ”), pursuant to which Seller agreed to sell, transfer, convey, assign and deliver to Purchaser all right, title and interest of Seller and its Affiliates in and to all Purchased Assets, and Purchaser agreed to purchase and accept from Seller (or such Affiliates) the Purchased Assets, in each case upon the terms and conditions set forth therein;
 
WHEREAS , Section 10.7 of the Purchase Agreement provides that the Purchase Agreement may be modified, amended, altered or supplemented only upon the execution and delivery of a written agreement executed by both Parties; and
 
WHEREAS , the Parties now wish to enter into this Amendment to, among other things, alter the composition of the Closing Payment, and provide Purchaser with the right to designate a substitute to serve as Purchaser for all purposes of the Purchase Agreement and the Ancillary Agreements to which Purchaser would be a party in the absence of the appointment of such Substitute Purchaser.
 
NOW, THEREFORE , in consideration of the foregoing, the mutual promises contained herein, and other good and valuable consideration, the receipt and sufficiency of which are hereby acknowledged, the Parties hereto, intending legally to be bound, hereby agree as follows:
 
1.   Amendments to the Purchase Agreement .
 
(a)   Table of Contents
 
(i)   The portion of the Table of Contents on page I pertaining to ARTICLE 2 is hereby amended and restated to read in its entirety as follows:
 
  “ARTICLE 2SALE AND PURCHASE OF ASSETS; LIABILITIES; SUBSTITUTE PURCHASER    23
    2.1 Sale of Purchased Assets    23
    2.2 Liabilities    24
    2.3 Consideration    25
    2.4 Escrow    30
    2.5 Closing    31
    2.6 Substitute Purchaser    31
 
(b)   Exhibit List
 
 
1

 
(i)   The Exhibit List on page v of the Purchase Agreement is hereby amended and restated to read in its entirety as follows:
 
EXHIBITS
 
 
Exhibit A
Bill of Sale, Assignment and Assumption Agreement
 
Exhibit B
Copyright Assignment Agreement
 
Exhibit C
Domain Name Assignment Agreement
 
Exhibit D
Patent Assignment Agreement
 
Exhibit E
[RESERVED]
 
Exhibit F
Registration Rights Agreement
 
Exhibit G
[RESERVED]
 
Exhibit H
Seller FDA Letters
 
Exhibit I
Trademark Assignment Agreement
 
Exhibit J
Transition Services Agreement
 
Exhibit K
Press Release”
 
(c)   Preamble . The Preamble of the Purchase Agreement is hereby amended and restated to read in its entirety as follows:
 
“This Asset Purchase Agreement (this “ Agreement ”) is made and executed as of March 10, 2015 (the “ Execution Date ”), by and among Zogenix, Inc., a Delaware corporation (“ Seller ”), Pernix Ireland Limited, an Irish corporation, and, solely with respect to Sections 5.9.2 , 10.2 and 10.14 , Pernix Therapeutics Holdings, Inc., a Maryland corporation (“ Guarantor ”). Seller and Purchaser are sometimes referred to herein individually as a “ Party ” and collectively as the “ Parties .””
 
(d)   Restated Definitions .
 
(i)   Section 1.1.11 of the Purchase Agreement is hereby amended and restated to read in its entirety as follows:
 
“1.1.11                 “ Ancillary Agreements ” means Bill of Sale, the Transition Services Agreement, the Domain Name Assignment Agreement, the Patent Assignment Agreement, the Trademark Assignment Agreement, the Copyright Assignment Agreement, the Escrow Agreement, the Registration Rights Agreement, and the Senior Loan Amendment (as defined in the MidCap Signing Date Agreement and in form and substance reasonably satisfactory to Seller).”
 
(ii)   Section 1.1.56 of the Purchase Agreement is hereby amended and restated to read in its entirety as follows:
 
1.1.56                 “ Escrow Amount ” has the meaning set forth in Section 2.3.1 .”
 
(iii)   Section 1.1.69 of the Purchase Agreement is hereby amended and restated to read in its entirety as follows:
 
“1.1.69                 “ Financing ” means, collectively, Purchaser’s financing of the Closing Payment.”
 
 
2

 
(iv)   Section 1.1.79 of the Purchase Agreement is hereby amended and restated to read in its entirety as follows:
 
“1.1.79 [RESERVED]”
 
(v)   Section 1.1.89 of the Purchase Agreement is hereby amended and restated to read in its entirety as follows:
 
“1.1.89                 [RESERVED]”
 
(vi)   Section 1.1.137 of the Purchase Agreement is hereby amended and restated to read in its entirety as follows:
 
“1.1.137                 [RESERVED]”
 
(vii)   Section 1.1.138 of the Purchase Agreement is hereby amended and restated to read in its entirety as follows:
 
“1.1.138                 [RESERVED]”
 
(viii)   Section 1.1.143 of the Purchase Agreement is hereby amended and restated to read in its entirety as follows:
 
“1.1.143                 “ Purchaser ” means Pernix Ireland Limited unless Pernix Ireland Limited delivers an Appointment Notice pursuant to Section 2.6.1 , in which case “ Purchaser ” shall mean the Substitute Purchaser identified in the Appointment Notice.”
 
(ix)   1.1.167 of the Purchase Agreement is hereby amended and restated to read in its entirety as follows:
 
“1.1.167                 [RESERVED]”
 
(x)   The following new Sections 1.1.215 , 1.1.216 , 1.1.217 and 1.1.218 shall be inserted into the Purchase Agreement immediately following Section 1.1.214 :
 
“1.1.215                 “ Appointment Date ” has the meaning set forth in Section 2.6.2(a) .
 
1.1.216                 “ Appointment Notice ” has the meaning set forth in Section 2.6.1 .
 
1.1.217                 “ Deferral Notice ” has the meaning set forth in Section 2.5.1 .
 
1.1.218                 “ Substitute Purchaser ” has the meaning set forth in Section 2.6.1 .”
 
 
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(e)   Section 2.3.1(a) of the Purchase Agreement is hereby amended and restated to read in its entirety as follows:
 
“(a)           In consideration of the conveyances contemplated under Section 2.1 , Purchaser shall (a) pay to Seller (i) on the Closing Date an amount equal to the sum of (A) $70,000,000; (B) the Stock Consideration; and (C) the Purchased Product Inventory Value (collectively, the “ Closing Payment ”), by wire transfer of immediately available funds to the account designated by Seller by notice to Purchaser at least two (2) Business Days prior to the Closing Date; (ii) the Milestone Payment(s), as and to the extent provided in Section 2.3.2 ; and (iii) the Difference as set forth in Section 2.3.1(b) below and (b) deliver to the Escrow Agent, at the Closing, $10,000,000 in cash (the “ Escrow Amount ”), by wire transfer of immediately available funds. The Escrow Fund shall be held, administered and distributed in accordance with Section 2.4 and the terms of the Escrow Agreement.”
 
(f)   Section 2.4.1 of the Purchase Agreement is hereby amended and restated to read in its entirety as follows:
 
“2.4.1           [RESERVED]”
 
(g)   Section 2.5.1 of the Purchase Agreement is hereby amended and restated to read in its entirety as follows:
 
2.5.1            Closing . Pursuant to the terms and subject to the conditions of this Agreement, the closing of the Transactions contemplated hereby (the “ Closing ”) shall take place at the offices of Lowenstein Sandler LLP, 1251 Avenue of the Americas, New York, New York 10020, at 10:00 a.m., local time, on a Business Day on a date not later than three (3) Business Days following satisfaction of all conditions (other than those that by their terms are to be satisfied or taken at the Closing (but subject to the satisfaction or waiver of such conditions) and those that are waived by the Party entitled to do so under applicable Law and the terms of this Agreement) set forth in ARTICLE 7 , or such other time and place as Purchaser and Seller may agree to in writing; provided, however , that if the waiting period under the HSR Act is terminated before the thirty (30) day statutory period expires (an “ Early Termination ”), Purchaser may, but shall not be obligated to, defer the Closing until a date no later than ten (10) days after the Early Termination by providing Seller written notice of such deferral within two (2) Business Days of the Parties’ receipt of notice of Early Termination (a “ Deferral Notice ”). Notwithstanding whether an Early Termination has occurred and/or Purchaser has previously submitted a Deferral Notice, if Purchaser deems it reasonably necessary to defer (or further defer in the event a Deferral Notice has been previously sent) the Closing Date to consummate the Financing, Purchaser may defer the Closing to a date no later than April 24, 2015 by providing Seller written notice of such deferral period prior to the Closing Date, and such Closing Date set forth in such notice shall be the Closing Date (and shall supersede the Closing Date set forth in the Deferral Notice in the event a Deferral Notice has previously been sent) for all purposes of this Agreement. The Closing shall be deemed to have occurred at 12:00 a.m., eastern time, on the Closing Date, such that Purchaser shall be deemed the owner of the Purchased Assets on and after the Closing Date.
 
 
4

 
(h)   Section 2.5.2(b)(iv) of the Purchase Agreement is hereby amended and restated to read in its entirety as follows:
 
“(iv)           [RESERVED]; and”
 
(i)   The following new Section 2.6 shall be inserted into the Purchase Agreement immediately following Section 2.5 :
 
“2.6            Substitute Purchaser .
 
2.6.1            Designation of Substitute Purchaser . Purchaser may, but shall not be obligated to, appoint another wholly-owned subsidiary of Guarantor (the “ Substitute Purchaser ”) to serve as Purchaser for all purposes of the Purchase Agreement and the Ancillary Agreements to which Purchaser would be a party in the absence of the appointment of such Substitute Purchaser pursuant to the terms of this Section 2.6.1 by providing written notice of such appointment (the “ Appointment Notice ”) to Seller on or prior to the expected Closing Date; provided, however , any such (a) Substitute Purchaser shall (i) have been formed or organized as a foreign subsidiary; and (ii) not have any assets, Liabilities or properties other than assets contributed to such Substitute Purchaser by or indebtedness owed to Guarantor or its Affiliates, in each case in connection with consummating the Financing of the Transactions; (b) Appointment Notice shall be substantially in the form of Annex A attached hereto, and shall include, as an exhibit to such Appointment Notice, an executed joinder agreement between Purchaser and Substitute Purchaser substantially in the form set forth in Annex A pursuant to which such Substitute Purchaser will acknowledge and agree (1) to pay and discharge when due all obligations of Purchaser under this Agreement and the Ancillary Agreements to which Purchaser would be a party in the absence of the appointment of such Substitute Purchaser pursuant to the terms of this Section 2.6.1 ; and (2) that it will become bound by and a party to this Agreement as though an original party hereto, in each case upon the execution of such joinder agreement; and (c) the appointment of such Substitute Purchaser would not adversely affect Seller under this Agreement or any of the Ancillary Agreements (including, but not limited to, resulting in a new or increased obligation to withhold or deduct Taxes from any payment thereunder).
 
2.6.2            Effect of Designating a Substitute Purchaser .
 
(a)           From and after the date the Appointment Notice is deemed to be received by Seller in accordance with Section 10.2 (such date, the “ Appointment Date ”), the parties hereto acknowledge and agree that (i) Purchaser shall have no further rights or obligations under this Agreement (but shall, for the avoidance of doubt, remain entitled to enforce the provisions of the Confidentiality Agreement prior to and after the Appointment Date); (ii) except with respect to the cover page of the Agreement, the preamble, the Recitals, the definition of “Purchaser” and the signature page to the Agreement, references to “Purchaser” shall be deemed to be references to “Substitute Purchaser”; (iii) the notice information for Purchaser in Section 10.2.2 shall be changed in accordance with the terms of the Appointment Notice; and (iv) conforming changes shall be made to the Ancillary Agreements, as appropriate, to reflect the appointment of Substitute Purchaser.
 
 
5

 
(b)           For purposes of ARTICLE IV , the representations and warranties set forth therein shall be deemed to have been made (i) by Purchaser on the Execution Date (unless the particular representation and warranty speaks expressly as of a particular date, in which case such representation and warranty shall be deemed to have been made only as of such date)(and any Liability arising from breaches thereof shall be assumed and discharged by Substitute Purchaser in accordance with the terms and conditions of the Purchase Agreement); and (ii) by Substitute Purchaser on the Appointment Date and as of the Closing (unless, in each case, the particular representation and warranty speaks expressly as of a particular date, in which case such representation and warranty shall be deemed to have been made only as of such date).
 
(j)   Section 3.21 of the Purchase Agreement is hereby amended and restated to read in its entirety as follows:
 
“3.21            Accredited Investor . Seller understands that the securities comprising the Stock Consideration will be “restricted securities” under the Securities Act and have not been registered under the Securities Act, nor qualified under any state securities laws, and that they are being offered and sold pursuant to an exemption from such registration and qualification based in part upon the representations of Seller contained herein.  Seller is familiar with the business and operations of Guarantor, is an “accredited investor” as such term is defined in Rule 501(a) of the Securities Act, and is able to bear the economic risk of its investment in Guarantor indefinitely.  Seller is acquiring the Stock Consideration solely for its own account for investment and not with a view toward the resale, transfer, or distribution thereof, nor with any present intention of distributing the Stock Consideration. No other Person has any right with respect to or interest in the Stock Consideration to be purchased by Seller, nor has Seller agreed to give any Person any such interest or right in the future. Seller is not purchasing the Stock Consideration as a result of any (a) registration statement filed by Purchaser with the Securities and Exchange Commission with respect to any of its securities; or (b) advertisement, article, notice or other communication regarding the Stock Consideration published in any newspaper, magazine or similar media or broadcast over television or radio or presented at any seminar or any other general advertisement that would be deemed a “general solicitation” under the provisions of Regulation D of the Securities Act.”
 
 
6

 
(k)   Section 4.6 of the Purchase Agreement is hereby amended and restated to read in its entirety as follows:
 
“4.6            Financial Capacity .  On the Closing Date, Purchaser’s immediately available cash, together with the Stock Consideration, will be sufficient to enable Purchaser to pay the Closing Payment at the Closing.”
 
(l)   Section 6.2.2 of the Purchase Agreement is hereby amended and restated to read in its entirety as follows:
 
“6.2.2 To the extent that Seller’s rights under any Purchased Asset may not be assigned without the approval, consent or waiver of another Person and such approval, consent or waiver has not been obtained prior to the Closing, the Closing shall proceed without the assignment of such Purchased Asset and this Agreement shall not constitute an agreement for the sale, assignment, transfer, conveyance or delivery of such Purchased Asset; provided, however , that nothing in this Section 6.2.2 shall be deemed to waive Purchaser’s rights not to consummate the Transactions contemplated by this Agreement if the conditions to its obligations set forth in ARTICLE 7 have not been satisfied. In the event that the Closing proceeds without the sale, assignment, transfer, conveyance or delivery of any Purchased Asset (regardless of whether such Closing occurs as a result of Purchaser waiving its obligations set forth in ARTICLE 7 or otherwise), then following the Closing, Purchaser shall use its commercially reasonable efforts to obtain all necessary approvals, consents and waivers to the assignment and transfer thereof, and Seller shall use its commercially reasonable efforts to assist and cooperate with Purchaser in connection therewith; provided, that until any such approval, consent or waiver is obtained and the related Purchased Asset is transferred and assigned to Purchaser or Purchaser’s designee, Seller shall use its commercially reasonable efforts to provide to Purchaser substantially comparable benefits thereof and enforce, at the request of and for the account of Purchaser, any rights of Seller arising under any such Purchased Asset against any Person; and provided further , to the extent that Purchaser is provided with benefits of any such Purchased Asset, Purchaser shall perform the obligations of Seller thereunder. It is understood and agreed that, in the event of Seller’s or an Affiliate’s inability to assign or transfer a Purchased Contract identified on Section 2.1.1(a) of the Seller Disclosure Schedule before the Closing, or Purchaser’s inability to do the same following the Closing, Seller or the applicable Affiliate shall remain responsible for completion of the applicable Purchased Contract as Purchaser’s agent, and at Purchaser’s sole expense as described in the Transition Services Agreement. Once authorization, approval, consent or waiver for the sale, assignment, transfer, conveyance or delivery of any such Purchased Asset not sold, assigned, transferred, conveyed or delivered at the Closing is obtained, Seller shall assign, transfer, convey and deliver such Purchased Asset to Purchaser at no additional cost to Purchaser.”
 
 
7

 
(m)   Section 8.5.2(b) of the Purchase Agreement is hereby amended and restated to read in its entirety as follows:
 
“(b)           The Parties’ respective aggregate liability for Losses in respect of breaches of Seller Fundamental Representations or Purchaser Fundamental Representations, shall not, in the aggregate, exceed $100,000,000 (the “ Fundamental Representations Cap ”); provided, however , that the Fundamental Representations Cap shall be increased by the amount of any Milestone Payments that are paid by Purchaser to Seller pursuant to Section 2.3.2 (or that have been deemed to have been paid to Seller pursuant to Section 8.9 ).
 
(n)   Section 8.9 of the Purchase Agreement is hereby amended and restated to read in its entirety as follows:
 
“8.9            Setoff Rights .   Neither Party shall have any right of setoff of any amounts due and payable, or any Liabilities arising, under against any amounts due and payable under this Agreement against any other amounts due and payable under this Agreement or any amounts due and payable, or any Liabilities arising, under any Ancillary Agreement; provided , however , that Purchaser may set-off against and deduct from any amounts due and payable to Seller pursuant to Section 2.3.2 any amounts due and payable by Seller pursuant to Section 8.3.1(a) for breaches of Seller Fundamental Representations (“ Right of Setoff ”); and provided further , any amounts that are set-off pursuant to Purchaser’s Right of Setoff shall be deemed to have been paid to Seller for purposes of Section 8.5 . Except as expressly set forth in this Section 8.9 , the payment obligations under each of this Agreement and the Ancillary Agreements remain independent obligations of each Party, irrespective of any amounts owed to any other Party under this Agreement or the respective Ancillary Agreements.”
 
(o)   Section 10.14.1 of the Purchase Agreement is hereby amended and restated to read in its entirety as follows:
 
“10.14.1                      Guarantor absolutely, unconditionally and irrevocably (a) guarantees to Seller, as the primary obligor and not merely as surety, the due and punctual observance, payment, performance and discharge of the obligations of Purchaser pursuant to this Agreement (the “ Obligations ”); and (b) agrees to pay any and all reasonable expenses (including reasonable legal expenses and reasonable attorneys’ fees) incurred by Seller in successfully enforcing any rights under this Section 10.14 .  If Purchaser fails to pay or perform the Obligations when due, then all of Guarantors’ liabilities to Seller hereunder in respect of such Obligations shall, at Seller’s option, become immediately due and payable and Seller may at any time and from time to time take any and all actions available hereunder or under applicable Law to enforce and collect the Obligations from Guarantor.  In furtherance of the foregoing, Guarantor acknowledges that Seller may, in its sole discretion, bring and prosecute a separate action or actions against Guarantor for the full amount of the Obligations, regardless of whether any action is brought against Purchaser.  To the fullest extent permitted by Law, Guarantor hereby expressly and unconditionally waives (i) any and all rights or defenses arising by reason of any Law, promptness, diligence, notice of the acceptance of this guarantee and of the Obligations, presentment, demand for payment, notice of non-performance, default, dishonor and protest, marshalling of assets, notice of the Obligations incurred and all other notices of any kind; and (ii) all suretyship defenses including all defenses based upon any statute or rule of law that provides that the obligation of a surety must be neither larger in amount nor in other respects more burdensome than that of the principal (other than payment in full of the Obligations).  The Guarantor acknowledges that it will receive substantial direct and indirect benefits from the transactions contemplated by this Agreement and that the waivers set forth in this Guarantee are knowingly made in contemplation of such benefits.  This Section 10.14 contains the entire agreement between Seller and Guarantor with respect to Guarantor’s obligations to Seller in connection with this Agreement, and supersedes all prior agreements, understandings, promises and representations, whether written or oral, between Seller and Guarantor with respect to the subject matter hereof.”
 
 
8

 
(p)   Notwithstanding the Contracts listed on Schedule 2.1.1(a) of the Seller Disclosure Schedule, the Contract identified thereto with the number 32 shall be deleted from Schedule 2.1.1(a) of the Seller Disclosure Schedule.
 
2.   No Other Amendment or Waiver .  Except as expressly set forth in this Amendment, all the representations, warranties, terms, covenants and conditions of the Purchase Agreement and any other agreement or document contemplated in connection therewith (including, but not limited to, the Ancillary Agreements), shall remain unamended and shall continue to be and shall remain in full force and effect in accordance with their respective terms.  The terms set forth in this Amendment shall be limited precisely as provided herein to the provisions expressly referred to herein and shall not be deemed an amendment or modification of or consent or waiver to any other term or provision of the Purchase Agreement or any other agreement or document contemplated in connection therewith (including, but not limited to, the Ancillary Agreements).
 
3.   Captions .  The paragraph captions used herein are for reference purposes only, and shall not in any way affect the meaning or interpretation of this Amendment.
 
4.   Incorporation of Purchase Agreement Provisions .  The provisions contained in Sections 10.1 (Governing Law, Jurisdiction, Venue and Service) and 10.2 (Notices) of the Purchase Agreement are incorporated herein by reference to the same extent as if reproduced herein in their entirety.
 
5.   Severability .  If any provision of this Amendment is held to be illegal, invalid or unenforceable under any present or future Law, and if the rights or obligations of either Party under this Amendment will not be materially and adversely affected thereby, (a) such provision shall be fully severable; (b) this Amendment shall be construed and enforced as if such illegal, invalid or unenforceable provision had never comprised a part hereof; (c) the remaining provisions of this Amendment shall remain in full force and effect and shall not be affected by the illegal, invalid or unenforceable provision or by its severance herefrom; and (d) in lieu of such illegal, invalid or unenforceable provision, there shall be added automatically as a part of this Amendment a legal, valid and enforceable provision as similar in terms to such illegal, invalid or unenforceable provision as may be possible and reasonably acceptable to the Parties.
 
 
9

 
6.   Entire Agreement .  The Purchase Agreement, as amended by this Amendment, together with the Schedules and Exhibits expressly contemplated thereby and attached thereto, the Seller Disclosure Schedule, as amended by this Amendment, the Ancillary Agreements, the Confidentiality Agreement and the other agreements, certificates and documents delivered in connection therewith or otherwise in connection with the Transactions contemplated thereby, contain the entire agreement between the Parties with respect to the Transactions contemplated thereby and supersede all prior agreements, understandings, promises and representations, whether written or oral, between the Parties with respect to the subject matter hereof and thereof.  All references in the Purchase Agreement to “this Agreement”, “hereof”, “hereby” and words of similar import shall refer to the Purchase Agreement as amended by this Amendment.
 
7.   Counterparts . This Amendment may be executed in any number of counterparts, and each such counterpart hereof shall be deemed to be an original instrument, but all such counterparts together shall constitute but one agreement. Delivery of an executed counterpart of a signature page of this Amendment by facsimile or other electronic transmission shall be effective as delivery of a manually executed original counterpart of this Amendment.
 
[ Signature Page Follows ]

 
10

 
 
IN WITNESS WHEREOF , the parties hereto have caused this Amendment to be executed as of the day and year first above written.
 
SELLER:
 
ZOGENIX, INC.


By:                                                                                      
Name:
Title:


PURCHASER:
 
PERNIX IRELAND LIMITED


By:                                                                                      
Name:
Title:



PERNIX THERAPEUTICS HOLDINGS, INC.


By:                                                                                      
Name:
Title:
 
 
11

 
ANNEX A
PERNIX IRELAND LIMITED
 
April ___, 2015
SENT VIA FACSIMILE AND COURIER
Zogenix, Inc.
12400 High Bluff Drive, Suite 650
San Diego, CA 92130
Attention: Chief Executive Officer
Facsimile: (858)-259-1166
 
Latham & Watkins LLP
12670 High Bluff Drive
San Diego, CA 92130
Attention: Cheston Larson, Esq.
Facsimile: (858) 523-5450
 
Re:            Section 2.6 Appointment Notice
 
Ladies and Gentlemen:
 
Reference is made to that certain Asset Purchase Agreement executed as of March 10, 2015, as amended April ____, 2015 (as amended, modified, supplemented or restated from time to time, the “ APA ”) by and among Zogenix, Inc., a Delaware corporation (“ Seller ”), Pernix Ireland Limited, an Irish corporation (“ Pernix Ireland ”), and, solely with respect to Sections 5.9.2 , 10.2 and 10.14 , Pernix Therapeutics Holdings, Inc., a Maryland corporation (“ Guarantor ”). Unless otherwise expressly provided herein, all capitalized terms not otherwise used herein shall have the respective meanings set forth in the APA.
 
Pursuant to Section 2.5.1 of the APA, Pernix Ireland hereby notifies Seller that (a) Pernix Ireland is exercising its right to extend the Closing to April ____, 2015.  In addition, pursuant to Section 2.6 of the APA, Pernix Ireland also hereby notifies Seller that (a) Pernix Ireland is exercising its right to appoint [XXXX] , another wholly-owned subsidiary of Guarantor, as Substitute Purchaser to serve as Purchaser for all purposes of the APA and the Ancillary Agreements to which Pernix Ireland would be a party in the absence of the appointment of such Substitute Purchaser; and (b) in connection with such appointment, Purchaser’s contact information for notice purposes set forth in Section 10.2.2 should be revised as follows:
 
If to Purchaser, to:
 
[XXXX]
c/o Pernix Therapeutics Holdings, Inc.
10 North Park Place, Suite 201
Morristown, NJ 07960
Attention: Barry J. Siegel
Facsimile: 862-260-8752
[***]
 
 
A-1

 
with a copy (which shall not constitute notice) to:
 
Lowenstein Sandler LLP
1251 Avenue of the Americas
New York, New York 10020
Attention: Michael J. Lerner
Facsimile: 973-597-6395
 
In accordance with Section 2.6 , an executed copy of the required joinder agreement is attached hereto as Appendix A .  Please indicate your acknowledgement and acceptance of [XXXX] as Substitute Purchaser by countersigning the joinder agreement where indicated.
 
[ Remainder of This Page is Intentionally Left Blank ]
 
 
A-2

 
Very truly yours,
 
PERNIX IRELAND LIMITED
 
By:                                                                 
Name:
Title:
 
 
A-3

 
Appendix A
 
JOINDER AGREEMENT
 
This JOINDER (“ Joinder ”) to the Asset Purchase Agreement by and among Zogenix, Inc., a Delaware corporation (“ Seller ”), Pernix Ireland Limited, an Irish corporation (“ Pernix Ireland ”) and, for purposes of Sections 5.9.2 , 10.2 , and 10.14 of the Asset Purchase Agreement only, Pernix Therapeutics Holdings, Inc., a Maryland corporation (“ Guarantor ”), dated as of March 10, 2015 (such agreement as amended, modified, supplemented or restated from time to time, the “ APA ”) is (a) made and entered into as of April ___, 2015 by and between Pernix Ireland and [XXXX] , an Irish corporation (“ [XXXX] ”); and (b) acknowledged and agreed to by Seller.  Pernix Ireland and [XXXX]   are sometimes referred to herein individually as a “ Party ” and collectively as the “ Parties .”
 
W I T N E S S E T H
 
WHEREAS , Section 2.6 of the APA (a) provides that Pernix Ireland may, but shall not be obligated to, appoint a Substitute Purchaser to serve as Purchaser for all purposes of the Purchase Agreement and the Ancillary Agreements to which Pernix Ireland would be a party in the absence of the appointment of such Substitute Purchaser pursuant to the terms of Section 2.6.1 of the APA by providing an Appointment Notice to Seller on or prior to the expected Closing Date; and (b) conditions such right on such Substitute Purchaser’s execution of a joinder agreement pursuant to which such Substitute Purchaser will acknowledge and agree to pay and discharge when due all obligations of Pernix Ireland under APA and the Ancillary Agreements to which Pernix Ireland would be a party in the absence of the appointment of such Substitute Purchaser pursuant to the terms of Section 2.6.1 of the APA;
 
WHEREAS , Pernix Ireland has agreed to appoint [XXXX]   as Substitute Purchaser and [XXXX]   has agreed to accept such appointment subject to the terms and conditions of the APA and this Joinder; and
 
WHEREAS , Seller has acknowledged and agreed to the appointment of [XXXX]   as Substitute Purchaser subject to the terms and conditions of the APA and this Joinder.
 
NOW, THEREFORE , in consideration of the foregoing, the mutual promises contained herein, and other good and valuable consideration, the receipt and sufficiency of which are hereby acknowledged, the Parties to this Joinder, intending legally to be bound, hereby agree as follows:
 
1.   Definitions . Capitalized terms used herein and not otherwise defined herein shall have the meanings ascribed to such terms in the APA
 
2.   Appointment of Substitute Purchaser . Pursuant to Section 2.6 of the APA, Pernix Ireland hereby appoints [XXXX]   as Substitute Purchaser and [XXXX]   agrees to (a) accept such appointment as Substitute Purchaser; and (b) pay and discharge when due all obligations of Pernix Ireland under the APA and the Ancillary Agreements to which Pernix Ireland would be a party in the absence of [XXXX] ’s appointment as Substitute Purchaser pursuant to this Joinder.
 
 
A-4

 
3.   Agreement to be Bound . [XXXX]   agrees and acknowledges that upon the execution of this Joinder, [XXXX]   shall become bound by and a party to the APA, and shall be fully bound by and subject to, all of the applicable benefits, rights, restrictions and obligations of the APA as though an original party thereto.
 
4.   Effectiveness . This Joinder shall take effect and shall become part of the APA immediately upon the execution hereof.
 
5.   Incorporation of Purchase Agreement Provisions .  The provisions contained in Sections 10.1 (Governing Law, Jurisdiction, Venue and Service) of the APA are incorporated herein by reference to the same extent as if reproduced herein in their entirety, and shall govern any dispute arising under or in connection with this Joinder.
 
6.   Entire Agreement; Third Party Beneficiaries .  This Joinder contains the entire agreement between the Parties with respect to the transactions contemplated hereby and supersedes all prior agreements, understandings, promises and representations, whether written or oral, between the Parties with respect to the subject matter hereof and thereof.  The covenants and agreements set forth in this Joinder are for the sole benefit of the Parties and their successors and permitted assigns, and, except with respect to Parties’ respective rights and obligations under this Joinder for which the Parties acknowledge and agree that Seller is an intended third party beneficiary and is therefore entitled to enforce the provisions of this Joinder, they shall not be construed as conferring any rights on any other Persons.
 
7.   Headings . The headings in this Joinder are for the purpose of reference only and shall not limit or otherwise affect the meaning hereof.
 
8.   Counterparts . This Joinder may be executed in any number of counterparts, and each such counterpart hereof shall be deemed to be an original instrument, but all such counterparts together shall constitute but one agreement. Delivery of an executed counterpart of a signature page of this Joinder by facsimile or other electronic transmission shall be effective as delivery of a manually executed original counterpart of this Joinder.
 
[ Signature Page Follows ]
 
 
A-5

 

 
IN WITNESS WHEREOF , the parties hereto have caused this Joinder to be executed as of the day and year first above written.
 

PERNIX IRELAND LIMITED


By:                                                                                      
Name:
Title:

[XXXX]


By:                                                                                      
Name:
Title:

 
ACKNOWLEDGED AND AGREED TO:


ZOGENIX, INC.



By: ____________________________________
Name:
Title:

A-6

EXHIBIT 31.1

CERTIFICATION

I, Douglas L. Drysdale, certify that:
 
1. I have reviewed this Quarterly Report on Form 10-Q of Pernix Therapeutics Holdings, Inc.;

2. Based on my knowledge, this quarterly 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 quarterly 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 quarterly 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, including any corrective actions with regard to significant deficiencies and material weaknesses; 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.

       
May 1, 2015
 
/s/ DOUGLAS L. DRYSDALE
 
   
Douglas L. Drysdale
 
   
Chairman and Chief Executive Officer and President and Director
(Principal Executive Officer)
 
 

EXHIBIT 31.2

CERTIFICATION

I, Sanjay Patel, certify that:

1. I have reviewed this Quarterly Report on Form 10-Q of Pernix Therapeutics Holdings, Inc.;

2. Based on my knowledge, this quarterly 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 quarterly report;

3. Based on my knowledge, the financial statements, and other financial information included in this quarterly 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 quarterly 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, including any corrective actions with regard to significant deficiencies and material weaknesses; 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.

May 1, 2015
 
/s/ SANJAY S. PATEL
 
   
Sanjay S. Patel
 
   
Chief Financial Officer
(Principal Financial Officer)
 
 



 
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: May 1, 2015
 
/s/ DOUGLAS L. DRYSDALE
 
   
Douglas L. Drysdale
 
   
Chairman and Chief Executive Officer and President and Director
(Principal Executive Officer)
 
       
Date: May 1, 2015
 
/s/ SANJAY S. PATEL
 
   
Sanjay S. Patel
Chief Financial Officer
 
   
(Principal Financial Officer)