10-Q 1 v113009_10q.htm
 
UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
Washington, DC 20549

________________

FORM 10-Q
QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d)
OF THE SECURITIES EXCHANGE ACT OF 1934

For the quarterly period ended: March 29, 2008
Commission file number: 1-10827

PAR PHARMACEUTICAL COMPANIES, INC.
(Exact name of registrant as specified in its charter)

Delaware
 
22-3122182
(State or other jurisdiction of
 
(I.R.S. Employer
incorporation or organization)
 
Identification No.)

300 Tice Boulevard, Woodcliff Lake, New Jersey 07677
(Address of principal executive offices)
Registrant’s telephone number, including area code: (201) 802-4000

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

Indicate by check mark whether the registrant is a large accelerated filer, an accelerated filer, or a non-accelerated filer. See definition of “accelerated filer and large accelerated filer” in Rule 12b-2 of the Exchange Act:

Large accelerated filer x
Accelerated filer o
Non-accelerated filer o
 
Indicate by check mark whether the Registrant is a shell company (as defined in Rule 12b-2 of the Exchange Act).
Yes o No x

Number of shares of the Registrant’s common stock outstanding as of May 1, 2008: 34,532,466



TABLE OF CONTENTS
PAR PHARMACEUTICAL COMPANIES, INC.
FORM 10-Q
FOR THE FISCAL QUARTER ENDED MARCH 29, 2008

 
 
     
PART I
FINANCIAL INFORMATION
 
     
Item 1.
Condensed Consolidated Financial Statements (unaudited)
 
     
 
Condensed Consolidated Balance Sheets as of March 29, 2008 and December 31, 2007
 3
     
 
Condensed Consolidated Statements of Operations for the three months ended March 29, 2008 and March 31, 2007
 4
     
 
Condensed Consolidated Statements of Cash Flows for the three months ended March 29, 2008 and March 31, 2007
 5
     
 
Notes to Condensed Consolidated Financial Statements
 7
     
Item 2.
Management’s Discussion and Analysis of Financial Condition and Results of Operations
29
     
Item 3.
Quantitative and Qualitative Disclosures about Market Risk
37
     
Item 4.
Controls and Procedures
38
     
PART II
OTHER INFORMATION
 
     
Item 1.
Legal Proceedings
39
     
Item 1A.
Risk Factors
45
     
Item 2.
Unregistered Sales of Equity Securities and Use of Proceeds
46
     
Item 6.
Exhibits
46
 
   
 
47

2


PART I - FINANCIAL INFORMATION
ITEM 1. FINANCIAL STATEMENTS
 
PAR PHARMACEUTICAL COMPANIES, INC.
CONDENSED CONSOLIDATED BALANCE SHEETS
(In Thousands, Except Share Data)
(Unaudited)
 
   
March 29,
 
December 31,
 
 
 
2008
 
2007
 
ASSETS
             
Current assets:
             
Cash and cash equivalents
 
$
231,193
 
$
200,132
 
Available for sale debt and marketable equity securities
   
67,893
   
85,375
 
Accounts receivable, net
   
84,035
   
64,182
 
Inventories
   
65,183
   
84,887
 
Prepaid expenses and other current assets
   
14,023
   
14,294
 
Deferred income tax assets
   
56,921
   
56,921
 
Income taxes receivable
   
13,475
   
17,516
 
Total current assets
   
532,723
   
523,307
 
               
Property, plant and equipment, at cost less accumulated depreciation and amortization
   
83,316
   
82,650
 
Available for sale debt and marketable equity securities
   
5,959
   
6,690
 
Investment in joint venture
   
6,433
   
6,314
 
Other investments
   
2,500
   
2,500
 
Intangible assets, net
   
33,643
   
36,059
 
Goodwill
   
63,729
   
63,729
 
Deferred financing costs and other assets
   
2,314
   
2,544
 
Non-current deferred income tax assets, net
   
57,935
   
57,730
 
Total assets
 
$
788,552
 
$
781,523
 
               
 LIABILITIES AND STOCKHOLDERS’ EQUITY
             
Current liabilities:
             
Current portion of long-term debt
 
$
200,000
 
$
200,000
 
Accounts payable
   
30,513
   
32,200
 
Payables due to distribution agreement partners
   
45,253
   
36,479
 
Accrued salaries and employee benefits
   
6,713
   
16,596
 
Accrued expenses and other current liabilities
   
32,211
   
27,518
 
Total current liabilities
   
314,690
   
312,793
 
               
Long-term debt, less current portion
   
-
   
-
 
Other long-term liabilities
   
31,448
   
30,975
 
Commitments and contingencies
   
-
   
-
 
               
Stockholders’ equity:
             
Preferred Stock, par value $0.0001 per share, authorized 6,000,000 shares; none issued and outstanding
   
-
   
-
 
Common Stock, par value $0.01 per share, authorized 90,000,000 shares, issued 37,203,975 and 36,460,461 shares
   
372
   
364
 
Additional paid-in-capital
   
278,411
   
274,963
 
Retained earnings
   
232,781
   
230,195
 
Accumulated other comprehensive loss
   
(1,680
)
 
(1,362
)
Treasury stock, at cost, 2,658,335 and 2,604,977 shares
   
(67,470
)
 
(66,405
)
Total stockholders’ equity
   
442,414
   
437,755
 
Total liabilities and stockholders’ equity
 
$
788,552
 
$
781,523
 

The accompanying notes are an integral part of these condensed consolidated financial statements.

3


PAR PHARMACEUTICAL COMPANIES, INC.
CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS
(In Thousands, Except Per Share Data)
(Unaudited)
 
   
Three Months Ended
 
   
March 29,
2008
 
March 31,
2007
 
Revenues:
             
Net product sales
 
$
151,237
 
$
222,589
 
Other product related revenues
   
3,691
   
11,621
 
Total revenues
   
154,928
   
234,210
 
Cost of goods sold
   
105,407
   
146,521
 
Gross margin
   
49,521
   
87,689
 
Operating expenses:
             
Research and development
   
17,158
   
14,039
 
Selling, general and administrative
   
31,346
   
32,557
 
Settlements, net
   
-
   
(578
)
Total operating expenses
   
48,504
   
46,018
 
Gain on sale of product rights and other
   
(1,625
)
 
(20,000
)
Operating income
   
2,642
   
61,671
 
Other expense, net
   
-
   
(19
)
Equity in loss of joint venture
   
(20
)
 
(148
)
Realized gain on sale of marketable securities
   
-
   
1,397
 
Interest income
   
3,014
   
2,684
 
Interest expense
   
(1,667
)
 
(1,718
)
Income from continuing operations before provision for income taxes
   
3,969
   
63,867
 
Provision for income taxes
   
1,443
   
22,353
 
Income from continuing operations
   
2,526
   
41,514
 
Discontinued operations:
             
Gain from discontinued operations
   
505
   
-
 
Provision for income taxes
   
445
   
-
 
Gain from discontinued operations
   
60
   
-
 
Net income
 
$
2,586
 
$
41,514
 
               
Basic earnings per share of common stock:
             
Income from continuing operations
 
$
0.08
 
$
1.20
 
Gain from discontinued operations
   
0.00
   
-
 
               
Net income
 
$
0.08
 
$
1.20
 
               
Diluted earnings per share of common stock:
             
Income from continuing operations
 
$
0.08
 
$
1.19
 
Gain from discontinued operations
   
0.00
   
-
 
Net income
 
$
0.08
 
$
1.19
 
               
Weighted average number of common shares outstanding:
             
Basic
   
33,220
   
34,618
 
Diluted
   
33,587
   
34,997
 

The accompanying notes are an integral part of these condensed consolidated financial statements.

4


PAR PHARMACEUTICAL COMPANIES, INC.
CONDENSED CONSOLIDATED STATEMENTS OF CASH FLOWS
(In Thousands)
(Unaudited)

   
Three Months Ended
 
   
March 29,
 
March 31,
 
   
2008
 
2007
 
Cash flows from operating activities:
             
Net income
 
$
2,586
 
$
41,514
 
Deduct: Gain from discontinued operations, net of tax
   
60
   
-
 
Income from continuing operations
 
$
2,526
 
$
41,514
 
               
Adjustments to reconcile net income to net cash provided by operating activities:
             
Depreciation and amortization
   
6,274
   
7,347
 
Gain on marketable securities, net
   
-
   
(1,397
)
Equity in loss of joint venture
   
20
   
148
 
Allowances against accounts receivable
   
(18,924
)
 
7,978
 
Share-based compensation expense
   
3,463
   
3,702
 
Loss on disposal of fixed assets
   
21
   
-
 
Excess tax benefits on exercise of nonqualified stock options
   
(194
)
 
(138
)
Other
   
(50
)
 
102
 
Changes in assets and liabilities:
             
Increase in accounts receivable
   
(929
)
 
(55,965
)
Decrease in inventories
   
19,704
   
18,648
 
Decrease in prepaid expenses and other assets
   
1,006
   
1,858
 
Decrease in accounts payable, accrued expenses and other liabilities
   
(6,947
)
 
(7,458
)
Increase in payables due to distribution agreement partners
   
8,774
   
50
 
Decrease in net income taxes receivable
   
3,735
   
20,298
 
Net cash provided by operating activities
   
18,479
   
36,687
 
Net cash related to operating activities from discontinued operations
   
-
   
-
 
               
Cash flows from investing activities:
             
Capital expenditures
   
(4,023
)
 
(1,719
)
Purchases of intangibles
   
-
   
(600
)
Purchases of available for sale debt securities
   
(17,305
)
 
(36,415
)
Proceeds from maturity and sale of available for sale debt and marketable equity securities
   
34,995
   
31,085
 
Acquisition of subsidiary, contingent payment
   
-
   
(5,000
)
Capital contributions to joint venture
   
(591
)
 
(1,244
)
Net cash provided by (used in) investing activities
   
13,076
   
(13,893
)
Net cash related to investing activities from discontinued operations
   
-
   
-
 
               
Cash flows from financing activities:
             
Proceeds from issuances of common stock upon exercise of stock options
   
301
   
124
 
Proceeds from the issuance of common stock under the Employee Stock Purchase Program
   
75
   
-
 
Excess tax benefits on exercise of nonqualified stock options
   
194
   
138
 
Purchase of treasury stock
   
(1,064
)
 
(745
)
Payments of short-term debt related to financed insurance premiums
   
-
   
(1,805
)
Principal payments under long-term and other borrowings
   
-
   
(20
)
Net cash used in financing activities
   
(494
)
 
(2,308
)
Net cash related to financing activities from discontinued operations
   
-
   
-
 
               
Net increase in cash and cash equivalents
   
31,061
   
20,486
 
Cash and cash equivalents at beginning of period
   
200,132
   
120,991
 
Cash and cash equivalents at end of period
 
$
231,193
 
$
141,477
 
               
Supplemental disclosure of cash flow information:
             
Cash (received) paid during the period for:
             
Income taxes, net
 
$
(2,291
)
$
2,056
 

5


   
Three Months Ended
 
   
March 29,
 
March 31,
 
   
2008
 
2007
 
Interest
 
$
2,875
 
$
2,926
 
               
Non-cash transactions:
             
(Decrease) increase in fair value of available for sale debt and marketable equity securities
 
$
(523
)
$
6,022
 
Capital expenditures incurred but not yet paid
 
$
1,916
 
$
112
 
Capital contribution to joint venture not yet paid
 
$
138
 
$
148
 

The accompanying notes are an integral part of these condensed consolidated financial statements.

6


PAR PHARMACEUTICAL COMPANIES, INC.
NOTES TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS
March 29, 2008
(In thousands, except per share amounts or as otherwise noted)
(Unaudited)

Par Pharmaceutical Companies, Inc. operates primarily through its wholly owned subsidiary, Par Pharmaceutical, Inc. (collectively referred to herein as the “Company”), in two business segments, for the development, manufacture and distribution of generic pharmaceuticals and branded pharmaceuticals in the United States. In 2007, the Company began operating the brand pharmaceutical segment under the name Strativa Pharmaceuticals. The Company also wholly owns Kali Laboratories, Inc. (“Kali”), a generic pharmaceutical research and development company located in Somerset, New Jersey. Marketed products are principally in the solid oral dosage form (tablet, caplet and two-piece hard-shell capsule). The Company also distributes several oral suspension products and certain products in the semi-solid form of a cream.

Note 1 - Basis of Presentation:

The accompanying condensed consolidated financial statements at March 29, 2008 and for the three-month periods ended March 29, 2008 and March 31, 2007 are unaudited; in the opinion of the Company’s management, however, such statements include all adjustments necessary to present fairly the information presented therein. The condensed consolidated balance sheet at December 31, 2007 was derived from the Company’s audited consolidated financial statements included in the Company’s 2007 Annual Report on Form 10-K.

Pursuant to accounting requirements of the Securities and Exchange Commission (the “SEC”) applicable to quarterly reports on Form 10-Q, the accompanying condensed consolidated financial statements and these Notes do not include all disclosures required by accounting principles generally accepted in the United States (“GAAP”) for audited financial statements. Accordingly, these statements should be read in conjunction with the Company’s 2007 Annual Report on Form 10-K. Results of operations for interim periods are not necessarily indicative of those that may be achieved for full fiscal years.

Note 2 – Recent Accounting Pronouncements:

In December 2007, the Financial Accounting Standards Board (“FASB”) ratified Emerging Issue Task Force Issue No. 07-1 (“EITF 07-1”), Accounting for Collaborative Arrangements. The key elements of EITF 07-1 relate to: (a) the scope of the issue; (b) the income statement presentation of transactions with third parties; (c) the income statement presentation of payments between parties to the collaborative arrangement; (d) the disclosures about collaborative arrangements that should be required in the financial statements of the parties to the collaborative arrangements; and (e) the transition method. A contractual arrangement falls within the scope of EITF 07-1 if the arrangement requires the parties to be active participants and the arrangement exposes the parties to significant risks and rewards that are tied to the commercial success of the endeavor. Costs incurred and revenue generated on sales to third parties should be reported in the statement of operations based on the guidance in EITF Issue No. 99-19, Reporting Revenue Gross as a Principal versus Net as an Agent. The equity method of accounting should not be applied to a collaborative arrangement within the scope of this issue without the creation of a separate legal entity for the arrangement. Payments between parties to the collaborative arrangement should be presented in the statement of operations based on the nature of the arrangement and each entity's business operations, the contractual terms of the arrangement as well as if existing GAAP is applicable. EITF 07-1 requires companies to disclose the nature and purpose of the arrangement, its rights and obligations under the arrangement, the accounting policy applied to the arrangement, and the amounts attributable to transactions between other participants to the collaborative arrangement and where in the statement of operations these amounts have been classified. EITF 07-1 requires that companies comply in its first fiscal year beginning after December 15, 2008 and transition to the guidance in this issue by retrospectively applying the guidance to all periods presented for all arrangements existing at the effective date, unless it is impracticable to do so. The impracticability assessment should be made on an arrangement-by-arrangement basis and certain disclosures would be required if a company utilizes the impracticability exception. The Company is currently evaluating the potential impact of adopting EITF 07-1 on its condensed consolidated financial statements, but does not expect a material impact upon adoption.

In December 2007, the FASB issued FASB Statement No. 141 (Revised 2007) (“SFAS 141R”), Business Combinations. SFAS 141R will significantly change the accounting for business combinations. Under SFAS 141R, an acquiring entity will be required to recognize all the assets acquired and liabilities assumed in a transaction at the acquisition date fair value with limited exceptions. SFAS 141R will change the accounting treatment for certain specific items, including; acquisition costs will be generally expensed as incurred, minority interests will be valued at fair value at the acquisition date, acquired contingent liabilities will be recorded at fair value at the acquisition date and subsequently measured at either the higher of such amount or the amount determined under existing guidance for non-acquired contingencies, in-process research and development will be recorded at fair value as an indefinite-lived intangible asset at the acquisition date, restructuring costs associated with a business combination will be generally expensed subsequent to the acquisition date, and changes in deferred tax asset valuation allowances and income tax uncertainties after the acquisition date generally will affect income tax expense. SFAS 141R also includes a substantial number of new disclosure requirements. SFAS 141R applies prospectively to business combinations for which the acquisition date is on or after the beginning of the first annual reporting period beginning on or after December 15, 2008. Earlier adoption is prohibited. The Company will be required to record and disclose business combinations following existing GAAP until January 1, 2009.

7


In December 2007, SFAS No. 160, Noncontrolling Interests in Consolidated Financial Statements - an amendment of ARB No. 51 (“SFAS 160”), was issued. SFAS 160 requires entities to report noncontrolling (minority) interests as a component of stockholders’ equity on the balance sheet; include all earnings of a consolidated subsidiary in consolidated results of operations; and treat all transactions between an entity and noncontrolling interest as equity transactions between the parties. SFAS 160 is effective for the Company’s fiscal year beginning 2009 and adoption is prospective only; however, presentation and disclosure requirements described above must be applied retrospectively. The Company is currently evaluating the potential impact of adopting SFAS 160 on its condensed consolidated financial statements, but does not expect a material impact upon adoption.

In June 2007, the FASB ratified Emerging Issue Task Force Issue No. 07-3 (“EITF 07-3”), Accounting for Non-Refundable Advance Payments for Goods or Services to Be Used in Future Research and Development Activities, which requires nonrefundable advance payments for goods and services that will be used or rendered for future research and development activities to be deferred and capitalized. These amounts will be recognized as an expense in the period that the related goods are delivered or the related services are performed or when an entity does not expect the goods to be delivered or services to be rendered. EITF 07-3 is effective for the fiscal years beginning after December 31, 2007, including interim periods within those fiscal years. The Company’s adoption of the provisions of EITF 07-3, beginning January 1, 2008 did not have a material impact on its condensed consolidated financial statements.

In February 2007, the FASB issued SFAS No. 159 The Fair Value Option for Financial Assets and Financial Liabilities — Including an Amendment of FASB Statement No. 115 (“SFAS 159”), which becomes effective for fiscal periods beginning after November 15, 2007.  Under SFAS 159, companies may elect to measure specified financial assets and liabilities at fair value that are not otherwise measured at fair value, with changes in fair value recognized in earnings each subsequent reporting period.  This election, called the “fair value option,” will enable some companies to reduce volatility in reported earnings caused by measuring related assets and liabilities differently.  SFAS 159 also establishes presentation and disclosure requirements designed to draw a comparison between the different measurement attributes a company elects for similar types of assets and liabilities. The Company did not elect the “fair value option” for any of its eligible financial assets or liabilities and therefore the Company’s adoption of SFAS 159 did not have a material impact on its condensed consolidated financial statements.
 
In September 2006, the FASB issued SFAS No. 157 Fair Value Measurements (“SFAS 157”).  SFAS 157 establishes a common definition for fair value to be applied to GAAP guidance requiring use of fair value, establishes a framework for measuring fair value, and expands disclosure about such fair value measurements.  SFAS 157 applies to fair value measurements that are already required or permitted by other accounting standards, except for measurements of share-based payments and measurements that are similar to, but not intended to be, fair value. The FASB has previously concluded in those accounting pronouncements that fair value is the relevant measurement attribute. Accordingly, this Statement does not require any new fair value measurements. SFAS 157 is effective for fiscal years beginning after November 15, 2007.  In November 2007, FASB granted a one year deferral for the implementation of SFAS 157 for non-financial assets and liabilities. The Company’s adoption of SFAS 157 with respect to financial assets and liabilities as of January 1, 2008 did not have a material impact on its condensed consolidated financial statements. Refer to Note 20, “Fair Value Measurements.”

Note 3 - Share-Based Compensation:

The Company adopted Statement of Financial Accounting Standards No. 123 (Revised 2004), “Share-Based Payment” (“SFAS 123R”), effective January 1, 2006. SFAS 123R requires companies to recognize compensation expense in the amount equal to the fair value of all share-based payments granted to employees. The Company elected the modified prospective transition method and, therefore, adjustments to prior periods were not required as a result of adopting SFAS 123R. Under this method, the provisions of SFAS 123R apply to all awards granted after the date of adoption and to any unrecognized expense of non-vested awards at the date of adoption based on the grant date fair value. Under SFAS 123R, the Company will recognize share-based compensation ratably over the service period applicable to the award. SFAS 123R also amends SFAS No. 95, “Statement of Cash Flows,” to require that excess tax benefits that have been reflected as operating cash flows be reflected as financing cash flows. In accordance with SFAS 123R, $194 and $138 of excess tax benefits for the three months ended March 29, 2008 and March 31, 2007, respectively, have been classified as both an operating cash outflow and financing cash inflow.

8


The Company grants share-based awards under its various plans, which provide for the granting of non-qualified stock options, restricted stock (including restricted stock with market conditions) and restricted stock units to the employees of the Company and others. Stock options, restricted stock and restricted stock units generally vest ratably over four years, and stock options have a maximum term of ten years.

As of March 29, 2008, there were approximately 5.5 million shares of common stock available for future stock option grants. The Company issues new shares of common stock when stock option awards are exercised. Stock option awards outstanding under the Company’s current plans have been granted at exercise prices that were equal to the market value of the Company’s common stock on the date of grant.

Stock Options

The Company uses the Black-Scholes stock option pricing model to estimate the fair value of stock option awards with the following weighted average assumptions:
 
   
For the three
 
For the three
 
   
months ended
 
months ended
 
   
March 29,
 
March 31,
 
   
2008
 
2007
 
Risk-free interest rate
   
3.0
%
 
4.6
%
Expected life (in years)
   
6.3
   
6.2
 
Expected Volatility
   
48.5
%
 
53.8
%
Dividend
   
0
%
 
0
%
 
The Black-Scholes option pricing model was developed for use in estimating the fair value of traded options, which have no vesting restrictions and are fully transferable. The Company compiled historical data on an employee-by-employee basis from the grant date through the settlement date. The results of analyzing the historical data showed that there were three distinct populations of optionees, the Executive Officers Group, the Outside Directors Group, and the All Others Group. The expected life of options represents the period of time that the options are expected to be outstanding and is based generally on historical trends. However, because none of the Company’s existing options have reached their full 10-year term, and also because the majority of such options granted are out-of-the-money and the expected life of out-of-the-money options is uncertain, the Company opted to use the “simplified” method for “plain vanilla” options described in SAB 107. The “simplified method” calculation is the average of the vesting term plus the original contractual term divided by 2. The Company anticipates that most grants in the future will be four-year graded vesting; however, Outside Directors will continue to have one-year vesting. The Company will revisit this assumption at least annually or sooner if circumstances warrant. The risk-free rate is based on the yield on the Federal Reserve treasury rate with a maturity date corresponding to the expected term of the option granted. The expected volatility assumption is based on the historical volatility of the Company’s common stock over a term equal to the expected term of the option granted. SFAS 123R also requires forfeitures to be estimated at the time of grant and revised, if necessary, in subsequent periods if actual forfeitures differ from those estimates. It is assumed that no dividends will be paid during the entire term of the options. All option valuation models require input of highly subjective assumptions. Because the Company's employee stock options have characteristics significantly different from those of traded options, and because changes in subjective input assumptions can materially affect the fair value estimate, the actual value realized at the time the options are exercised may differ from the estimated values computed above. The weighted average per share fair values of options granted in the three month periods ended March 29, 2008 and March 31, 2007 were $9.92 and $13.86, respectively.
 
Set forth below is the impact on the Company’s results of operations of recording share-based compensation from its stock options for the three-month periods ended March 29, 2008 and March 31, 2007:

   
For the three months ended
 
   
March 29,
 
March 31,
 
   
2008
 
2007
 
           
Cost of sales
 
$
62
 
$
168
 
Research and development
   
156
   
422
 
Selling, general and administrative
   
560
   
1,518
 
Total, pre-tax
 
$
778
 
$
2,108
 
Tax benefit of share-based compensation
   
(296
)
 
(822
)
Total, net of tax
 
$
482
 
$
1,286
 
 
The incremental stock-based compensation expense decreased both basic and diluted earnings per share by $0.01 per share for the three-month period ended March 29, 2008 and by $0.04 per share for the three-month period ended March 31, 2007.

9


The following is a summary of the Company’s stock option activity:
 
       
Weighted
 
Weighted
 
Aggregate
 
       
Average
 
Average
 
Intrinsic
 
   
Shares
 
Exercise Price
 
Remaining Life
 
Value
 
                   
Balance at December 31, 2007
   
4,526
 
$
34.76
             
Granted
   
2
   
19.56
             
Exercised
   
(42
)
 
7.11
             
Forfeited
   
(85
)
 
30.86
             
Balance at March 29, 2008
   
4,401
 
$
35.09
   
5.6
 
$
1,596
 
Exercisable at March 29, 2008
   
3,584
 
$
37.70
   
4.9
 
$
1,434
 
Vested and expected to vest at March 29, 2008
   
4,282
 
$
35.43
   
5.3
 
$
1,566
 
 
The total fair value of shares vested during the three-month periods ended March 29, 2008 and March 31, 2007 was $5,253 and $6,501, respectively. As of March 29, 2008, the total compensation cost related to all non-vested stock options granted to employees but not yet recognized was approximately $8,972. This cost will be amortized on a straight-line basis over the remaining weighted average vesting period of 2.3 years.

Restricted Stock/Restricted Stock Units

Outstanding restricted stock and restricted stock units generally vest ratably over four years. The related share-based compensation expense is recorded over the requisite service period, which is the vesting period. The fair value of restricted stock is based on the market value of the Company’s common stock on the date of grant.

In the quarter ended March 31, 2007, the Company accelerated the vesting of 7 outstanding non-vested restricted shares in connection with the termination of an executive. The effect of this acceleration resulted in additional compensation expense of $154 in the quarter ended March 31, 2007.

The impact on the Company’s results of operations of recording share-based compensation from restricted stock for the three-month periods ended March 29, 2008 and March 31, 2007 was as follows:
 
   
For the three months ended
 
   
March 29,
 
March 31,
 
   
2008
 
2007
 
           
Cost of sales
 
$
164
 
$
115
 
Research and development
   
410
   
288
 
Selling, general and administrative
   
1,475
   
1,191
 
Total, pre-tax
 
$
2,049
 
$
1,594
 
Tax benefit of stock-based compensation
   
(779
)
 
(622
)
Total, net of tax
 
$
1,270
 
$
972
 
 
The following is a summary of the Company’s restricted stock activity (shares in thousands):
 
       
Weighted
 
Aggregate
 
       
Average
 
Intrinsic
 
   
Shares
 
Grant Price
 
Value
 
Non-vested balance at December 31, 2007
   
698
 
$
26.35
       
Granted
   
318
   
21.52
       
Vested
   
(141
)
 
29.04
       
Forfeited
   
(22
)
 
26.82
       
Non-vested balance at March 29, 2008
   
853
 
$
24.09
 
$
14,763
 

The following is a summary of the Company’s restricted stock unit activity (shares in thousands):
 
       
Weighted
 
Aggregate
 
       
Average
 
Intrinsic
 
   
Shares
 
Grant Price
 
Value
 
Non-vested balance at December 31, 2007
   
173
 
$
23.53
       
Granted
   
29
   
22.79
       
Vested
   
(13
)
 
31.59
       
Forfeited
   
(9
)
 
21.68
       
Non-vested balance at March 29, 2008
   
180
 
$
22.95
 
$
3,110
 

10

 
As of March 29, 2008, the total compensation cost related to all non-vested restricted stock and restricted stock units (excluding restricted stock grants with market conditions described below) granted to employees but not yet recognized was approximately $22.5 million; this cost will be amortized on a straight-line basis over the remaining weighted average vesting period of approximately 2.8 years. At March 29, 2008, approximately 0.9 million shares remain available for restricted stock (including restricted stock with market conditions described below) and restricted stock unit grants.

Restricted Stock Grants With Market Conditions
 
In the first quarter of 2008, the Company issued restricted stock grants with market conditions for the first time. Restricted stock grants issued to certain employees of the Company have a three-year cliff vesting schedule and are contingent upon multiple market conditions that are factored into the fair value of the restricted stock at grant date. Vesting will occur if the applicable continued employment condition is satisfied and the Total Stockholder Return ("TSR") on the Company’s common stock exceeds a minimum TSR relative to the Company’s stock price at the beginning of the three-year vesting period, the TSR meets or exceeds the median of a defined peer group of approximately 15 companies, and/or the TSR exceeds the Standard and Poor’s 400 Mid Cap Index ("S&P 400") over the three-year measurement period beginning on January 1 in the year of grant and ending after three years on December 31. A maximum number of 720 shares of common stock could be issued after the three-year vesting period depending on the achievement of the TSR goals. No shares of common stock will be issued if the Company’s TSR is below 6% annualized return over the three-year vesting period. Any shares earned will be distributed after the end of the three-year period. In all circumstances, restricted stock granted does not entitle the holder the right, or obligate the Company, to settle the restricted stock in cash.

        The effect of the market conditions on the restricted stock issued to certain employees of the Company is reflected in the fair value on the grant date for the quarter ended March 29, 2008. The restricted stock grants with market conditions were valued using a Monte Carlo simulation. The Monte Carlo simulation estimates the fair value based on the expected term of the award, risk-free interest rate, expected dividends, and the expected volatility for the Company, its peer group, and the S&P 400. The expected term was estimated based on the vesting period of the awards (3 years), the risk-free interest was based on the yield on the Federal Reserve treasury rate with a maturity matching the vesting period (2.6%). The expected dividends were assumed to be zero for the Company. Volatility was based on historical volatility over the expected term (40%). Restricted stock that included multiple market conditions granted during the quarter ended March 29, 2008 had a grant date fair value per restricted share of $24.78.

        The following table summarizes the components of the Company's stock-based compensation related to its restricted stock grants with market conditions recognized in the Company's financial statements for the three-month periods ended March 29, 2008 and March 31, 2007:
   
For the three months ended
 
   
March 29,
 
March 31,
 
   
2008
 
2007
 
           
Cost of sales
 
$
51
 
$
-
 
Research and development
   
127
   
-
 
Selling, general and administrative
   
458
   
-
 
Total, pre-tax
 
$
636
 
$
-
 
Tax benefit of stock-based compensation
   
(242
)
 
-
 
Total, net of tax
 
$
394
 
$
-
 
 
        As of March 29, 2008, $8.2 million of total unrecognized compensation cost, net of estimated forfeitures, related to restricted stock grants with market conditions is expected to be recognized over a weighted average period of approximately 2.8 years.

        A summary of the restricted stock grants with market conditions activity for the quarter ended March 29, 2008 follows (shares in thousands):
       
Weighted Average
     
       
Grant Date
 
Aggregate
 
       
Fair Value
 
Intrinsic
 
   
Shares
 
Per Share
 
Value
 
Non-vested balance at December 31, 2007
   
-
 
$
-
       
Granted
   
384
   
24.78
       
Vested
   
-
   
-
       
Forfeited
   
(1
)
 
24.78
       
Non-vested balance at March 29, 2008
   
383
 
$
24.78
 
$
6,630
 

        The total grant date fair value of restricted stock grants with market conditions during the quarter ended March 29, 2008 was $8.9 million.
 
11

 
Employee Stock Purchase Program:

The Company maintains an Employee Stock Purchase Program (the “Program”). The Program is designed to qualify as an employee stock purchase plan under Section 423 of the Internal Revenue Code of 1986, as amended. It enables eligible employees to purchase shares of the Company’s common stock at a 5% discount to the fair market value. An aggregate of 1,000 shares of common stock has been reserved for sale to employees under the Program. Employees purchased 4 shares during the three-month period ended March 29, 2008. There was no Program activity during the three months ended March 31, 2007 as the Program was suspended by the Company from July 2006 to December 2007.

Note 4 - Available for Sale Debt and Marketable Equity Securities:

At March 29, 2008 and December 31, 2007, all of the Company’s investments in debt and marketable equity securities were classified as available for sale and, as a result, were reported at their estimated fair values on the condensed consolidated balance sheets. Refer to Note 20, “Fair Value Measurements.” The following is a summary of amortized cost and estimated fair value of the Company’s debt and marketable equity securities available for sale at March 29, 2008:
 
           
Estimated
 
       
Unrealized
 
Fair
 
   
Cost
 
Gain
 
(Loss)
 
Value
 
Securities issued by government agencies
 
$
26,237
 
$
25
 
$
-
 
$
26,262
 
Debt securities issued by various state and local municipalities and agencies
   
36,427
   
184
   
-
   
36,611
 
Other debt securities
   
10,069
   
16
   
(1,656
)
 
8,429
 
Available for sale debt securities
   
72,733
   
225
   
(1,656
)
 
71,302
 
                           
Marketable equity securities available for sale Hana Biosciences, Inc.
   
3,850
   
-
   
(1,300
)
 
2,550
 
                           
Total
 
$
76,583
 
$
225
 
$
(2,956
)
$
73,852
 

Of the $3.0 million of unrealized loss as of March 29, 2008, $1.7 million has been in an unrealized loss position for greater than one year. The Company believes that these losses are not other-than-temporary in accordance with FASB Staff Position Nos. FAS 115-1 / 124-1, “The Meaning of Other-Than-Temporary Impairment and Its Application to Certain Investments,” due to its assessment that all amounts due according to the contractual terms of the related debt security will be collected and its ability and intent to hold the related debt security for a reasonable period of time sufficient for a recovery of fair value up to (or beyond) the cost of the investment. The Company has classified a certain other debt security that matures in 2015 as a noncurrent asset on its condensed consolidated balance sheet as of March 29, 2008 due to its intent to hold the investment for a period of time greater than 12 months.
 
The Company recorded an unrealized loss of $0.1 million for the quarter ended March 29, 2008, which was included in other comprehensive income to reflect the change in estimated fair value of its investment in Hana Biosciences, Inc. (“Hana”). The Company evaluated the near-term prospects of Hana in relation to the severity and duration of the period that the investment has been in an unrealized loss position. The investment has been in an unrealized loss position for less than 6 months as of March 29, 2008. Based on that evaluation and the Company's ability and intent to hold those investments for a reasonable period of time sufficient for a forecasted recovery of fair value, the Company does not consider the investment to be other-than-temporarily impaired at March 29, 2008. The Company has classified its investment in Hana as a noncurrent asset on its condensed consolidated balance sheet as of March 29, 2008 due to its intent to hold the investment for a period of time greater than 12 months.

The following is a summary of amortized cost and estimated fair value of the Company’s investments in debt and marketable equity securities available for sale at December 31, 2007:
           
Estimated
 
       
Unrealized
 
Fair
 
   
Cost
 
Gain
 
(Loss)
 
Value
 
Securities issued by government agencies
 
$
46,177
 
$
24
 
$
-
 
$
46,201
 
Debt securities issued by various state and local municipalities and agencies
   
24,226
   
-
   
(3
)
 
24,223
 
Other debt securities
   
15,020
   
-
   
(1,029
)
 
13,991
 
Auction rate securities
   
5,000
   
-
   
-
   
5,000
 
Available for sale debt securities
   
90,423
   
24
   
(1,032
)
 
89,415
 
                           
Marketable equity securities available for sale Hana Biosciences, Inc.
   
3,850
   
-
   
(1,200
)
 
2,650
 
                           
Total
 
$
94,273
 
$
24
 
$
(2,232
)
$
92,065
 
 
12

 
Auction Rate Securities
 
Auction rate securities were classified as short-term available for sale debt securities as of December 31, 2007. Auction rate securities are variable rate bonds and preferred stock tied to short-term interest rates with maturities on the face of the securities in excess of 90 days. Auction rate securities have interest rate resets through a modified Dutch auction, at predetermined short-term intervals, usually every 7, 28 or 35 days. Interest paid during a given period is based upon the interest rate determined during the prior auction. Although these securities are issued and rated as long-term securities, they are priced and traded as short-term instruments because of the historical liquidity provided through the interest rate reset. All of the Company’s auction rate securities were tax-exempt or tax-advantaged as of December 31, 2007. All of the Company’s auction rate securities were tied to debt securities issued by various state and local municipalities and agencies and the auction rate securities are insured by insurance companies as of December 31, 2007. Given the negative liquidity conditions in the global credit markets, there were failed auctions and related impairments relating to auction rate securities in late 2007 and in January and February 2008, including those auction rate securities tied to various municipalities. The Company’s auction rate securities did not experience any failed auctions and the Company sold its remaining auction rate securities during the three months ended March 29, 2008.

The following is a summary of the contractual maturities of the Company’s available for sale debt securities at March 29, 2008:
   
March 29, 2008
 
       
Estimated Fair
 
   
Cost
 
Value
 
Less than one year
 
$
22,515
 
$
22,548
 
Due between 1-2 years
   
32,309
   
32,494
 
Due between 2-5 years
   
12,844
   
12,851
 
Due after 5 years
   
5,065
   
3,409
 
Total
 
$
72,733
 
$
71,302
 
 
Note 5 - Other Investments:

Balance at March 29, 2008
 
Carrying Value
 
IntelliPharmaCeutics Ltd.
 
$
2,500
 
Total other investments
 
$
2,500
 

       
Balance at December 31, 2007
 
Carrying Value
 
IntelliPharmaCeutics Ltd.
 
$
2,500
 
Total other investments
 
$
2,500
 

The Company assesses whether temporary or other-than-temporary losses on its investments have occurred due to declines in fair value or other market conditions. At March 29, 2008 and December 31, 2007, the Company believed the carrying values of its cost method investments was equal to their fair values.
 
In August 2007, the Company announced that it entered into a stock purchase agreement to acquire an equity interest in IntelliPharmaCeutics Ltd. (“IPC Ltd.”), a privately held Delaware company. The terms of the agreement included a $5.0 million private placement investment that represents a 4.2 percent equity interest in IntelliPharmaCeutics Corp. (“IPC Corp.”), the operating subsidiary of IPC Ltd. The Company recorded its investment in IPC Corp. at $2.5 million based on the Company’s assessment of the fair value of its investment and charged $2.5 million, which represents a non-refundable upfront license payment, to research and development expense in the third quarter of 2007. Because IPC Ltd. is privately-held and accounted for under the cost method, the Company monitors the investment on a periodic basis to evaluate whether any declines in value become other-than-temporary.
 
13

 
Note 6 - Accounts Receivable:
 
The Company recognizes revenue for product sales when title and risk of loss have transferred to its customers, when reliable estimates of rebates, chargebacks, returns and other adjustments can be made, and when collectibility is reasonably assured. This is generally at the time that products are received by the customers. Upon recognizing revenue from a sale, the Company records estimates for chargebacks, rebates and incentive programs, product returns, cash discounts and other sales reserves that reduce accounts receivable.
   
March 29,
 
December 31,
 
   
2008
 
2007
 
           
Gross trade accounts receivable
 
$
217,256
 
$
216,327
 
Chargebacks
   
(43,987
)
 
(46,006
)
Rebates and incentive programs
   
(32,959
)
 
(42,859
)
Returns
   
(40,493
)
 
(47,102
)
Cash discounts and other
   
(15,762
)
 
(16,158
)
Doubtful accounts
   
(20
)
 
(20
)
Accounts receivable, net
 
$
84,035
 
$
64,182
 

Allowance for doubtful accounts
     
   
For the three-month period ended
 
   
March 29, 2008
 
March 31, 2007
 
Balance at beginning of period
 
$
(20
)
$
(2,465
)
Additions – charge to expense
   
-
   
-
 
Adjustments and/or deductions
   
-
   
2,443
 
Balance at end of period
 
$
(20
)
$
(22
)

The following tables summarize the activity for the three months ended March 29, 2008 and March 31, 2007, respectively, in the accounts affected by the estimated provisions described below: 
   
For the three months ended March 29, 2008
 
Accounts receivable reserves
 
Beginning
balance
 
Provision
recorded
for current
period
sales
 
(Provision)
reversal
recorded
for prior
period sales
 
Credits
processed
 
Ending
balance
 
Chargebacks
 
$
(46,006
)
$
(107,639
)  
$
(539
)(1)
$
110,197
 
$
(43,987
)
Rebates and incentive programs
   
(42,859
)
 
(24,207
)  
 
(1,571
)
 
35,678
   
(32,959
)
Returns
   
(47,102
)
 
(4,904
)  
 
4,293
   
7,220
   
(40,493
)
Cash discounts and other
   
(16,158
)
 
(12,274
)  
 
349
   
12,321
   
(15,762
)
Total
 
$
(152,125
)
$
(149,024
)  
$
2,532
 
$
165,416
 
$
(133,201
)
                                                                  
Accrued liabilities (2)
 
$
(17,684
)
$
(7,361
)  
$
805
 
$
536
 
$
(23,704
)

   
For the three months ended March 31, 2007
 
Accounts receivable reserves
 
Beginning
balance
 
Provision
recorded
for current
period
sales
 
(Provision)
reversal
recorded
for prior
period sales
 
Credits
processed
 
Ending
balance
 
Chargebacks
 
$
(51,891
)
$
(88,364
)  
$
--
(1)
$
92,531
 
$
(47,724
)
Rebates and incentive programs
   
(85,888
)
 
(55,192
)  
 
2,699
   
50,889
   
(87,492
)
Returns
   
(42,905
)
 
(10,770
)  
 
(794
)
 
6,099
   
(48,370
)
Cash discounts and other
   
(18,038
)
 
(14,382
)  
 
211
   
6,652
   
(25,557
)
Total
 
$
(198,722
)
$
(168,708
)  
$
2,116
 
$
156,171
 
$
(209,143
)
                                                                                                          
Accrued liabilities (2)
 
$
(10,583
)
$
(4,644
)  
$
-
 
$
547
 
$
(14,680
)

(1)
Unless specific in nature, the amount of provision or reversal of reserves related to prior periods for chargebacks is not determinable on a product or customer specific basis; however, based upon historical analysis and analysis of activity in subsequent periods, the Company has determined that its chargeback estimates remain reasonable.
 
14

 
(2)
Includes amounts due to customers for which no underlying accounts receivable exists, including Medicaid rebates. The Company included additional amounts that were part of accrued expenses and other current liabilities on the condensed consolidated balance sheets as of December 31, 2006 ($171), March 31, 2007 ($332) and December 31, 2007 ($869) in the tables above that are similar to the previously disclosed amounts due to customers for which no underlying accounts receivable exists.

The Company sells its products directly to wholesalers, retail drug store chains, drug distributors, mail order pharmacies and other direct purchasers and customers that purchase its products indirectly through the wholesalers, including independent pharmacies, non-warehousing retail drug store chains, managed health care providers and other indirect purchasers. The Company has entered into agreements at negotiated contract prices with those health care providers that purchase products through the Company’s wholesale customers at those contract prices. Chargeback credits are issued to wholesalers for the difference between the Company’s invoice price to the wholesaler and the contract price through which the product is resold to health care providers. Approximately 72% and 55% of the Company’s net product sales were derived from the wholesale distribution channel for the three months ended March 29, 2008 and March 31, 2007, respectively. The information that the Company considers when establishing its chargeback reserves includes contract and non-contract sales trends, average historical contract pricing, actual price changes, processing time lags and customer inventory information from its three largest wholesale customers. The Company’s chargeback provision and related reserve vary with changes in product mix, changes in customer pricing and changes to estimated wholesaler inventory.

Customer rebates and incentive programs are generally provided to customers as an incentive for the customers to continue to carry the Company’s products or replace competing products in their distribution channels with those products sold by the Company. Rebate programs are based on a customer’s dollar purchases made during an applicable monthly, quarterly or annual period. The Company also provides indirect rebates, which are rebates paid to indirect customers that have purchased the Company’s products from a wholesaler under a contract with the Company. The incentive programs include stocking or trade show promotions where additional discounts may be given on a new product or certain existing products as an added incentive to stock the Company’s products. The Company may, from time to time, also provide price and/or volume incentives on new products that have multiple competitors and/or on existing products that confront new competition in order to attempt to secure or maintain a certain market share. The information that the Company considers when establishing its rebate and incentive program reserves are rebate agreements with and purchases by each customer, tracking and analysis of promotional offers, projected annual sales for customers with annual incentive programs, actual rebates and incentive payments made, processing time lags, and for indirect rebates, the level of inventory in the distribution channel that will be subject to indirect rebates. The Company does not provide incentives designed to increase shipments to its customers that it believes would result in out-of-the ordinary course of business inventory for them. The Company regularly reviews and monitors estimated or actual customer inventory information at its three largest wholesale customers for its key products to ascertain whether customer inventories are in excess of ordinary course of business levels.

Pursuant to a drug rebate agreement with the Centers for Medicare and Medicaid Services, TriCare and similar supplemental agreements with various states, the Company provides such states with a rebate on drugs dispensed under government programs. The Company determines its estimate of Medicaid rebate accrual primarily based on historical experience of claims submitted by the various states and any new information regarding changes in the Medicaid program that might impact the Company’s provision for Medicaid rebates. In determining the appropriate accrual amount the Company considers historical payment rates; processing lag for outstanding claims and payments; and levels of inventory in the distribution channel. The Company reviews the accrual and assumptions on a quarterly basis against actual claims data to help ensure that the estimates made are reliable.

The Company accepts returns of product according to the following criteria: (i) the product returns must be approved by authorized personnel in writing or by telephone with the lot number and expiration date accompanying any request and (ii) the Company generally will accept returns of products from any customer and will provide the customer with a credit memo for such returns if such products are returned within six months prior to, and until 12 months following, such products’ expiration date. The Company records a provision for product returns based on historical experience, including actual rate of expired and damaged returns, average remaining shelf-lives of products sold, which generally range from 12 to 36 months, and estimated return dates. Additionally the Company considers other factors when estimating its current period return provision, including levels of inventory in the distribution channel, significant market changes that may impact future expected returns, and actual product returns, and may record additional provisions for specific returns that it believes are not covered by the historical rates.

The Company offers cash discounts to its customers, generally 2% of the sales price, as an incentive for paying within invoice terms, which generally range from 30 to 90 days. The Company accounts for cash discounts by reducing accounts receivable by the full amount of the discounts that the Company expects its customers to take. In addition to the significant gross-to-net sales adjustments described above, the Company periodically makes other sales adjustments. The Company generally accounts for these other gross-to-net adjustments by establishing an accrual in the amount equal to its estimate of the adjustments attributable to the sale.

The Company may at its discretion provide price adjustments due to various competitive factors, through shelf-stock adjustments on customers’ existing inventory levels. There are circumstances under which the Company may not provide price adjustments to certain customers and consequently, as a matter of business strategy, may lose future sales volume to competitors rather than reduce its pricing.
 
15

 
As detailed above, the Company has the experience and access to relevant information that it believes are necessary to reasonably estimate the amounts of such deductions from gross revenues. Some of the assumptions used by the Company for certain of its estimates are based on information received from third parties, such as wholesale customer inventories and market data, or other market factors beyond the Company’s control. The estimates that are most critical to the establishment of these reserves, and therefore, would have the largest impact if these estimates were not accurate, are estimates related to contract sales volumes, average contract pricing, customer inventories and return volumes. The Company regularly reviews the information related to these estimates and adjusts its reserves accordingly, if and when actual experience differs from previous estimates. With the exception of the product returns allowance, the ending balances of accounts receivable reserves and allowances generally are processed during a two-month to four-month period.

Use of Estimates in Reserves
The Company believes that its reserves, allowances and accruals for items that are deducted from gross revenues are reasonable and appropriate based on current facts and circumstances. It is possible, however, that other parties applying reasonable judgment to the same facts and circumstances could develop different allowance and accrual amounts for items that are deducted from gross revenues. Additionally, changes in actual experience or changes in other qualitative factors could cause the Company’s allowances and accruals to fluctuate, particularly with newly launched or acquired products. The Company reviews the rates and amounts in its allowance and accrual estimates on a quarterly basis. If future rates and amounts are significantly greater than those reflected in its recorded reserves, the resulting adjustments to those reserves would decrease the Company’s reported net revenues; conversely, if actual product returns, rebates and chargebacks are significantly less than those reflected in its recorded reserves, then the resulting adjustments to those reserves would increase its reported net revenues. If the Company were to change its assumptions and estimates, its reserves would change, which would impact the net revenues that the Company reports. The Company regularly reviews the information related to these estimates and adjusts its reserves accordingly, if and when actual experience differs from previous estimates.

Major Customers
The amounts due from the Company’s four largest customers, McKesson Corporation, AmerisourceBergen Corporation, Cardinal Health Inc., and Walgreen Co., accounted for approximately 34%, 21%, 14% and 6%, respectively, of the gross accounts receivable balance at March 29, 2008 and approximately 31%, 21%, 17%, and 7%, respectively, of the gross accounts receivable balance at December 31, 2007.

Note 7 - Inventories:

   
March 29,
 
December 31,
 
   
2008
 
2007
 
Raw materials and supplies
 
$
19,246
 
$
22,815
 
Work-in-process
   
4,253
   
2,630
 
Finished goods
   
41,684
   
59,442
 
   
$
65,183
 
$
84,887
 

Inventory write-offs were $3.1 million and $4.6 million for the quarters ended March 29, 2008 and March 31, 2007, respectively. The Company capitalizes inventory costs associated with certain products prior to regulatory approval and product launch, based on management's judgment of reasonably certain future commercial use and net realizable value. The Company could be required to permanently write down previously capitalized costs related to pre-launch inventories upon a change in such judgment, or due to a denial or delay of approval by regulatory bodies, or a delay in commercialization, or other potential factors. As of March 29, 2008, the Company had inventories related to products that were not available to be marketed of $9.2 million, comprised of pre-launch inventories of $7.0 million (of which $5.6 million is for a specific partnered product anticipated to launch in the second quarter of 2008) and research and development inventories of $2.2 million. Should the launch anticipated for the second quarter of 2008 be delayed, inventory write-offs may occur to the extent the Company is unable to recover the full value of its inventory investment.
 
16

 
Note 8 – Property, Plant and Equipment, net:

   
March 29,
 
December 31,
 
   
2008
 
2007
 
Land
 
$
1,882
 
$
1,882
 
Buildings
   
25,977
   
25,947
 
Machinery and equipment
   
50,039
   
49,302
 
Office equipment, furniture and fixtures
   
5,476
   
5,476
 
Computer software and hardware
   
30,104
   
28,989
 
Leasehold improvements
   
14,861
   
14,865
 
Construction in progress
   
10,590
   
8,205
 
     
138,929
   
134,666
 
Less accumulated depreciation and amortization
   
55,613
   
52,016
 
   
$
83,316
 
$
82,650
 

Depreciation and amortization expense related to property, plant and equipment was $3,858 and $3,541 for the three months ended March 29, 2008 and March 31, 2007, respectively.

Note 9 - Intangible Assets, net:

   
March 29,
 
December 31,
 
   
2008
 
2007
 
Trademark licensed from Bristol-Myers Squibb Company, net of accumulated amortization of $2,489 and $2,155
 
$
7,512
 
$
7,846
 
Teva Pharmaceutical Industries, Inc. Asset Purchase Agreement, net of accumulated amortization of $3,480 and $3,193
   
5,007
   
5,294
 
Ivax License Agreement, net of accumulated amortization of $5,630 and $5,068
   
2,370
   
2,932
 
Paddock Licensing Agreement, net of accumulated amortization of $1,500 and $1,250
   
4,500
   
4,750
 
Spectrum Development and Marketing Agreement, net of accumulated amortization of $0 and $0
   
5,000
   
5,000
 
Genpharm, Inc. Distribution Agreement, net of accumulated amortization of $7,041 and $6,860
   
3,792
   
3,973
 
Bristol-Myers Squibb Company Asset Purchase Agreement, net of accumulated amortization of $10,167 and $9,749
   
1,532
   
1,950
 
FSC Laboratories Agreement, net of accumulated amortization of $3,939 and $3,814
   
1,883
   
2,008
 
Intellectual property, net of accumulated amortization of $1,009 and $940
   
1,682
   
1,751
 
Other intangible assets, net of accumulated amortization of $4,883 and $4,693
   
365
   
555
 
   
$
33,643
 
$
36,059
 
 
The Company recorded amortization expense related to intangible assets of $2,416 and $3,806, respectively, for the three month periods ended March 29, 2008 and March 31, 2007, and such expense is included in cost of goods sold. During the three-month period ended March 31, 2007, the Company made a $600 milestone payment to Nortec Development, Inc. related to the commercialization of propranolol HCl ER that was recorded in “other intangible assets.” Amortization expense related to the intangible assets currently being amortized is expected to total approximately $9,934 for the remainder of 2008, $7,771 in 2009, $6,648 in 2010, $5,214 in 2011, $3,325 in 2012 and $751 thereafter.

The Company evaluates all intangible assets for impairment quarterly or whenever events or other changes in circumstances indicate that the carrying value of an asset may no longer be recoverable. As of March 29, 2008, the Company believes its net intangible assets are recoverable.

Note 10 - Income Taxes:
 
The Company reflects interest and penalties attributable to income taxes, to the extent they arise, as a component of its income tax provision or benefit as well as its outstanding income tax assets and liabilities.
 
The IRS is currently examining the Company’s 2003-2006 federal income tax returns. Prior periods have either been audited or are no longer subject to IRS audit. The Company is currently under audit in one state jurisdiction for the years 2003-2005. In most other state jurisdictions, the Company is no longer subject to examination by tax authorities for years prior to 2003.
 
Current deferred income tax assets at March 29, 2008 and December 31, 2007 consisted of temporary differences primarily related to accounts receivable reserves. Non-current deferred income tax assets at March 29, 2008 and December 31, 2007 consisted of the tax benefit related to purchased call options, acquired in-process research and development and timing differences primarily related to intangible assets and stock options.
 
17

 
The Company’s effective tax rates for continuing operations for the three months ended March 29, 2008 and March 31, 2007 were 36% and 35%, respectively.

Note 11 - Long-Term Debt:
 
Long-Term Debt
   
March 29,
 
December 31,
 
   
2008
 
2007
 
Senior subordinated convertible notes (a)
 
$
200,000
 
$
200,000
 
Less current portion
   
(200,000
)
 
(200,000
)
 
  $ -  
$
-
 

 
(a)
Senior subordinated convertible notes in the aggregate principal amount of $200,000. The notes bear interest at an annual rate of 2.875%, payable semi-annually on March 30 and September 30 of each year. The notes are convertible into common stock at an initial conversion price of $88.76 per share, upon the occurrence of certain events. Upon conversion, the Company has agreed to satisfy the conversion obligation in cash in amount equal to the principal amount of the notes converted. The notes mature on September 30, 2010, unless earlier converted, accelerated or repurchased.  The Company may not redeem the notes prior to their maturity date. On March 29, 2008, the senior subordinated convertible notes had a quoted market value of $176,750. See “Legal Proceedings” in Note 14, “Commitments, Contingencies and Other Matters” for discussion involving notices of default and acceleration the Company received from the Trustee of the Company’s 2.875% Senior Subordinated Convertible Notes due 2010 and the related litigation. Until the matter is resolved, the Company is recording the payment obligations as a current liability as of March 29, 2008 because the Court in the matter could (i) rule against the Company’s position and (ii) determine that the appropriate remedy would be the accelerated payment of the Notes. Accordingly, the Company cannot consider the possibility of accelerated payment to be remote.
 
Note 12 - Changes in Stockholders’ Equity:
Changes in the Company’s Common Stock, Additional Paid-In Capital and Accumulated Other Comprehensive Loss accounts during the three-month period ended March 29, 2008 were as follows:

               
Accumulated
 
           
Additional
 
Other
 
   
Common Stock
 
Paid-In
 
Comprehensive
 
   
Shares
 
Amount
 
Capital
 
Loss
 
Balance, December 31, 2007
   
36,461
 
$
364
 
$
274,963
 
$
(1,362
)
Unrealized loss on available for sale securities, net of tax
   
-
   
-
   
-
   
(318
)
Exercise of stock options
   
42
   
-
   
301
   
-
 
Tax benefit from exercise of stock options
   
-
   
-
   
194
   
-
 
Tax deficiency related to vesting of restricted stock
   
-
   
-
   
(529
)
 
-
 
Issuance of common stock under the Employee Stock Purchase Program
   
-
   
-
   
75
   
-
 
Forfeitures of restricted stock
   
(8
)
 
-
   
-
   
-
 
Issuances of restricted stock
   
709
   
8
   
(8
)
 
-
 
Compensatory arrangements
   
-
   
-
   
3,463
   
-
 
Other
   
-
   
-
   
(48
)
 
-
 
Balance, March 29, 2008
   
37,204
 
$
372
 
$
278,411
 
$
(1,680
)
 
18

 
   
Three months ended
 
   
March 29,
 
March 31,
 
   
2008
 
2007
 
Comprehensive Income:
         
Net income
 
$
2,586
 
$
41,514
 
Other comprehensive income:
             
Unrealized (loss) gain on available for sale securities, net of tax
   
(318
)
 
3,640
 
Comprehensive Income
 
$
2,268
 
$
45,154
 

In April 2004, the Board authorized the repurchase of up to $50.0 million of the Company’s common stock. Repurchases are made, subject to compliance with applicable securities laws, from time to time in the open market or in privately negotiated transactions, whenever it appears prudent to do so. Shares of common stock acquired through the repurchase program are available for reissuance for general corporate purposes. In 2007, the Company announced that its Board approved an expansion of its share repurchase program allowing for the repurchase of up to $75 million of the Company’s common stock, inclusive of the $17.8 million remaining from the April 2004 authorization. The authorized amount remaining for stock repurchases under the repurchase program was $43.6 million, as of March 29, 2008. The repurchase program has no expiration date. 

Note 13 - Earnings Per Share:
 
The following is a reconciliation of the amounts used to calculate basic and diluted earnings per share:
   
Three months ended
 
   
March 29, 2008
 
March 31, 2007
 
           
Income from continuing operations
 
$
2,526
 
$
41,514
 
               
Gain from discontinued operations
   
505
   
-
 
Provision for income taxes
   
445
   
-
 
Gain from discontinued operations
   
60
   
-
 
Net income
 
$
2,586
 
$
41,514
 
               
Basic:
             
Weighted average number of common shares outstanding
   
33,220
   
34,618
 
               
Income from continuing operations
 
$
0.08
 
$
1.20
 
Gain from discontinued operations
   
0.00
   
-
 
Net income per share of common stock
 
$
0.08
 
$
1.20
 
               
Assuming dilution:
             
Weighted average number of common shares outstanding
   
33,220
   
34,618
 
Effect of dilutive securities
   
367
   
379
 
Weighted average number of common and common
   equivalent shares outstanding
   
33,587
   
34,997
 
               
Income from continuing operations
 
$
0.08
 
$
1.19
 
Gain from discontinued operations
   
0.00
   
-
 
Net income per share of common stock
 
$
0.08
 
$
1.19
 

Outstanding options of 3,968 and 4,788 as of March 29, 2008 and March 31, 2007, respectively, were not included in the computation of diluted earnings per share because their exercise prices were greater than the average market price of the common stock during the respective periods and their inclusion would, therefore, have been anti-dilutive. In addition, outstanding warrants sold concurrently with the sale of the subordinated convertible notes in September 2003 and issued in conjunction with the acquisition of Kali in June 2004 were not included in the computation of diluted earnings per share as of March 29, 2008 and March 31, 2007. The warrants related to the notes are exercisable for an aggregate of 2,253 shares of common stock at an exercise price of $105.20 per share and the warrants related to the Kali acquisition are exercisable for an aggregate of 150 shares of common stock at an exercise price of $47.00 per share.
 
19

 
Note 14 - Commitments, Contingencies and Other Matters:
 
Legal Proceedings
 
Contractual Matters
 
On May 3, 2004, Pentech Pharmaceuticals, Inc. (“Pentech”) filed an action against the Company in the United States District Court for the Northern District of Illinois. This action alleges that the Company breached its contract with Pentech relating to the supply and marketing of paroxetine (PaxilÒ) and that the Company breached fiduciary duties allegedly owed to Pentech. The Company and Pentech are in dispute over the amount of gross profit share due to them. Discovery in this case has concluded. The Court denied cross motions for summary judgment relating to the construction of the contract, and denied Pentech’s motion for summary judgment against the Company’s fraudulent inducement counterclaim. The Company also filed a motion for summary judgment against Pentech’s breach of fiduciary duty claim, and that motion was granted. A trial date has not yet been set. The Company intends to defend vigorously this action.

Unless otherwise indicated in the details provided below, the Company cannot predict with certainty the outcome or the effects on the Company of the litigations described below. The outcome of these litigations could include substantial damages, the imposition of substantial fines, penalties, and injunctive or administrative remedies, however unless otherwise indicated, the Company at this time is not able to estimate the possible loss or range of loss, if any, associated with these legal proceedings.

Corporate Litigation
 
The Company and certain of its executive officers have been named as defendants in several purported stockholder class action lawsuits filed on behalf of purchasers of common stock of the Company between April 29, 2004 and July 5, 2006. The lawsuits followed the Company’s July 5, 2006 announcement regarding the restatement of certain of its financial statements and allege that the Company and certain members of its management engaged in violations of the Securities Exchange Act of 1934, as amended (the “Exchange Act”), by issuing false and misleading statements concerning the Company’s financial condition and results. The class actions have been consolidated and are pending in the United States District Court, District of New Jersey. The Court has appointed co-lead plaintiffs and co-lead counsel. Co-lead plaintiffs filed a Consolidated Amended Complaint on April 30, 2007, purporting to represent purchasers of common stock of the Company between July 23, 2001 and July 5, 2006. Defendants filed a motion to dismiss the Amended Complaint on June 29, 2007. The Company intends, and the members of management named as defendants have stated their intentions, to vigorously defend the lawsuits and any additional lawsuits that may hereafter be filed with respect to the restatement.
 
On August 14, 2006, individuals claiming to be stockholders of the Company filed a derivative action in the U.S. District Court for the Southern District of New York, purportedly on behalf of the Company, against the current and certain former directors and certain current and former officers of the Company and the Company as a nominal defendant. The plaintiffs in this action allege that, among other things, the named defendants breached their fiduciary duties to the Company based on substantially the same factual allegations as the class action lawsuits referenced above. The plaintiffs also alleged that certain of the defendants have been unjustly enriched based on their receipt of allegedly backdated options to purchase shares of common stock of the Company, and seek to require those defendants to disgorge any profits made in connection with their exercise of such options and additional attendant damages relating to allegedly backdated options during the period from January 1, 1996 to the present. The action has been transferred to the United States District Court, District of New Jersey. On June 29, 2007, the plaintiffs filed their amended complaint and in connection therewith, dropped their claims related to the alleged stock option backdating. Defendants have made a motion to dismiss the complaint, which motion has been fully briefed. The Company intends and each of the individuals named as defendants have stated their intentions to vigorously defend against the remaining allegations.

On September 1, 2006, the Company received a notice of default from the American Stock Transfer & Trust Company, as trustee (the “Trustee”) of the Company’s 2.875% Senior Subordinated Convertible Notes due 2010 (the “Notes”). The Trustee claims, in essence, that the Company’s failure to include financial statements in its Quarterly Report on Form 10-Q for the second quarter of 2006 constituted a default under Section 6.2 of the Indenture, dated as of September 30, 2003 (the “Indenture”), between the Company, as issuer, and the Trustee, relating to the Notes. The notice of default asserted that if the purported default continued unremedied for 30 days after the receipt of the notice, an “event of default” would occur under the Indenture. Under the Indenture, the occurrence of an event of default would give the Trustee or certain holders of the Notes the right to declare all unpaid principal and accrued interest on the Notes immediately due and payable. On October 2, 2006, the Company received a notice of acceleration from the Trustee purporting to accelerate payment of the Notes.
 
The Company believes that it has complied with its obligations under the Indenture relating to the Notes. Therefore, the Company believes that the above-mentioned notice of default and notice of acceleration are invalid and without merit. Under the Indenture, the Company is required only to provide the Trustee with copies of its annual and other reports (or copies of such portions of such reports as the SEC may by rules and regulations prescribe) that it is required to file with the SEC pursuant to Section 13 or 15(d) of the Exchange Act within 15 calendar days after it files such annual and other reports with the SEC. Moreover, the Company’s Indenture specifically contemplates providing the Trustee with portions of reports. On August 24, 2006 (within 15 days of filing with the SEC), the Company provided to the Trustee a copy of its Quarterly Report on Form 10-Q for the second quarter of 2006. The Company’s Form 10-Q did not include the Company’s financial statements for the second quarter of 2006 and related Management’s Discussion and Analysis due to the Company’s work to restate certain of its past financial statements, and, therefore, in accordance with SEC rules, the Company filed a Form 12b-25 Notification of Late Filing disclosing the omissions. The Company’s Form 12b-25 also was provided to the Trustee on August 24, 2006. Accordingly, the Company believes that it complied with the Indenture provision in question.
 
20

 
After the Company communicated its position to the Trustee, the Trustee filed a lawsuit, on October 19, 2006, on behalf of the holders of the Notes in the Supreme Court of the State of New York, County of New York, alleging a breach of the Indenture and of an alleged covenant of good faith and fair dealing. The lawsuit demands, among other things, that the Company pay the holders of the Notes either the principal, any accrued and unpaid interest and additional interest (as such term is defined in the Indenture), if any, or the difference between the fair market value of the Notes on October 2, 2006 and par, whichever the Trustee elects, or in the alternative, damages to be determined at trial, alleged by the Trustee to exceed $30.0 million. The Company filed a Notice of Removal to remove the lawsuit to the U.S. District Court for the Southern District of New York and has filed its answer to the complaint in that Court. On January 19, 2007, the Trustee filed a motion for summary judgment along with supporting documentation. On February 16, 2007, the Company filed its response to the Trustee’s motion for summary judgment and cross-moved for summary judgment in its favor. The Court has not yet ruled on the motions. Until the matter is resolved, the Company is recording the payment obligations as a current liability on the condensed consolidated balance sheets because the Court in the matter could (i) rule against the Company’s position and (ii) determine that the appropriate remedy would be the accelerated payment of the convertible notes.

Patent Related Matters

On July 15, 2003, the Company filed a lawsuit against Roxane Laboratories, Inc. (“Roxane”) in the United States District Court for the District of New Jersey. The Company alleged that Roxane had infringed the Company’s U.S. Patents numbered 6,593,318 and 6,593,320 and that the infringement was willful. Roxane has denied these allegations and has counterclaimed for declaratory judgments of non-infringement and invalidity of both patents. On September 8, 2006, the Court issued a claim construction ruling on certain claim terms in dispute between the parties. Based on that construction, the Court ruled in favor of the Company and dismissed Roxane’s motion for summary judgment of non-infringement. On November 8, 2006, the Court ruled that the claims at issue in these patents were invalid as non-enabled on summary judgment. On December 8, 2006, the Company appealed the ruling to the Federal Circuit Court of Appeals, highlighting the district court’s failure to apply its own claim construction and to consider the testimony of the Company’s experts before awarding summary judgment to Roxane. On October 26, 2007, the U.S. Circuit Court of Appeals for the Federal Circuit affirmed the New Jersey District Court's ruling of invalidity for non-enablement. In January 2008, the District Court conducted a hearing on Roxane’s application for attorneys’ fees under 35 U.S.C. section 285. Briefs in opposition for both sides were filed on March 10, 2008 and a motion hearing was set for April 7, 2008. On April 10, 2008, the District Court rejected Roxane’s request for attorneys’ fees.
 
On March 10, 2006, Apotex Inc. and Apotex Corp. (“Apotex”) filed a lawsuit against the Company in the United States District Court for New Jersey, seeking a declaratory judgment that four of the Company’s patents relating to megestrol acetate oral suspension are invalid, unenforceable and not infringed by an Apotex product that was launched in the third quarter of 2006. The Company has moved for a preliminary injunction against Apotex pending resolution of the litigation and has asserted counterclaims that the Apotex product infringes at least one claim of U.S. Patent 6,593,318. The Company was granted a stay and the action was terminated without prejudice on April 9, 2007 pending final resolution of the Roxane appeal. On February 6, 2008, a joint stipulation of dismissal and order with prejudice was signed by the Judge in the case with each party only liable for its own costs and attorneys’ fees.
 
On April 28, 2006, CIMA Labs, Inc. (“CIMA”) and Schwarz Pharma, Inc. (“Schwarz Pharma”) filed separate lawsuits against the Company in the United States District Court for the District of New Jersey (CIMA Labs, Inc. et al. v. Par Pharmaceutical Companies, Inc. et al., (Civil Action Nos. 06-CV-1970, 1999 (DRD)(ES)). CIMA and Schwarz Pharma each have alleged that the Company infringed U.S. Patent Nos. 6,024,981 (the “’981 patent”) and 6,221,392 (the “’392 patent”) by submitting a Paragraph IV certification to the FDA for approval of alprazolam orally disintegrating tablets. CIMA owns the ’981 and ’392 patents and Schwarz Pharma is CIMA’s exclusive licensee. The two lawsuits were consolidated on January 29, 2007. In response to the lawsuit, the Company has answered and counterclaimed denying CIMA’s and Schwarz Pharma’s infringement allegations, asserting that the ’981 and ’392 patents are not infringed and are invalid and/or unenforceable. The parties have exchanged written discovery. All 40 claims in the ’981 patent were rejected in a non-final office action in a reexamination proceeding at the United States Patent and Trademark Office (“PTO”) on February 24, 2006. The PTO again rejected all 40 claims in a second non-final office action dated February 24, 2007. The ‘392 patent is also the subject of a reexamination proceeding. The Company will continue to monitor these ongoing reexamination proceedings. CIMA has moved to stay this lawsuit pending the outcome of the reexamination proceedings and to consolidate this lawsuit with another lawsuit in the same district involving the same patents (CIMA Labs, Inc. et al. v. Actavis Group hf et al., (Civil Action No. 07-CV-0893 (DRD) (ES)). A hearing on these motions was held on May 30, 2007. The Company intends to vigorously defend this lawsuit and pursue its counterclaims.
 
21

 
The Company entered into a licensing agreement with developer Paddock Laboratories, Inc. (“Paddock”) to market testosterone 1% gel, a generic version of Unimed Pharmaceuticals, Inc.’s (“Unimed”) product Androgel®. Pursuant to this agreement, the Company is responsible for management of any litigation and payment of all legal fees associated with this product. The product, if successfully brought to market, would be manufactured by Paddock and marketed by the Company. Paddock has filed an ANDA (that is pending with the FDA) for the testosterone 1% gel product. As a result of the filing of the ANDA, Unimed and Laboratories Besins Iscovesco (“Besins”), co-assignees of the patent-in-suit, filed a lawsuit against Paddock in the United States District Court for the Northern District of Georgia, alleging patent infringement on August 22, 2003. The Company has an economic interest in the outcome of this litigation by virtue of its licensing agreement with Paddock. Unimed and Besins sought an injunction to prevent Paddock from manufacturing the generic product. On November 18, 2003, Paddock answered the complaint and filed a counterclaim, seeking a declaration that the patent-in-suit is invalid and/or not infringed by Paddock’s product. On September 13, 2006, the Company acquired from Paddock all rights to the ANDA for testosterone 1% gel, a generic version of Unimed’s product Androgel® for $6 million. The lawsuit was resolved by settlement. The settlement and license agreement terminates all on-going litigation. The settlement and license agreement also permits the Company to launch the generic version of the product no earlier than August 31, 2015 and no later than February 28, 2016, assuring the Company’s ability to market a generic version of Androgel® well before the expiration of the patents at issue. On March 7, 2007, the Company was issued a Civil Investigative Demand seeking information and documents in connection with the court-approved settlement in 2006 of the patent infringement case, Unimed v. Paddock, in the U.S. District Court for Northern District of Georgia. The Bureau of Competition for the Federal Trade Commission (“FTC”) is investigating whether the settlement of the litigation constituted unfair methods of competition in a potential violation of Section 5 of the FTC Act. The Company believes it has complied with all applicable laws in connection with the court-approved settlement and it intends to co-operate with the FTC in this matter.
 
On October 4, 2006, Novartis Corporation, Novartis Pharmaceuticals Corporation, and Novartis International AG (collectively “Novartis”) filed a lawsuit against the Company in the United States District Court for the District of New Jersey. Novartis alleged that the Company and Kali infringed U.S. Patent No. 6,162,802 (the “’802 patent”) by submitting a Paragraph IV certification to the FDA for approval of amlodipine and benazepril hydrochloride combination capsules. The Company and its subsidiaries denied Novartis’ allegation, asserting that the ’802 patent is not infringed and is invalid. The parties are currently engaged in discovery regarding the claims with expert discovery due to the Court by June 13, 2008. The Company intends to defend vigorously this action and pursue its counterclaims against Novartis.

On December 19, 2006, Reliant Pharmaceuticals, Inc. (“Reliant”) filed a lawsuit against the Company in the United States District Court for the District of Delaware (Reliant Pharmaceuticals, Inc. v. Par Pharmaceutical Inc., (Civil Action Nos. 06-CV-774-JJF)). Reliant alleged, in its Complaint, that the Company infringed U.S. Patent No. 5,681,588 (the “’588 patent”) by submitting a Paragraph IV certification to the FDA for approval to market generic 325 mg Propafenone HCl SR capsules. On January 26, 2007, Reliant amended its complaint to add the additional allegation that the Company infringed the ‘588 patent by submitting a Paragraph IV certification to the FDA for approval to market generic 225 mg and 425 mg—in addition to the 325 mg—Propafenone HCl SR capsules. The Company has answered and counterclaimed denying Reliant’s infringement allegations, and asserting that the ’588 patent is invalid and unenforceable. A scheduling order has been entered under which a claim construction hearing was held on April 2, 2008 and under which all fact and expert discovery will be completed by May 30, 2008. The parties have begun discovery and Reliant has filed a motion to disqualify the Company’s counsel, a motion that was denied in September 2007 with ongoing written discovery on the issue. The Company intends to vigorously defend this lawsuit and pursue its counterclaims.
 
On May 9, 2007, Purdue Pharma Products L.P. (“Purdue”), Napp Pharmaceutical Group Ltd. (“Napp”), Biovail Laboratories International SRL (“Biovail”), and Ortho-McNeil, Inc. (“Ortho-McNeil”) filed a lawsuit against the Company in the United States District Court for the District of Delaware. The complaint alleges infringement of U.S. Patent No. 6,254,887 (the “’887 patent”) because the Company submitted a Paragraph IV certification to the FDA for approval of 200mg extended release tablets containing tramadol hydrochloride. On May 30, 2007, the Company filed its answer and counterclaim to the complaint seeking a declaration of noninfringement and invalidity of the '887 patent. A subsequent complaint was served on July 2, 2007 in the same District Court. The new complaint alleges that the Company's 100mg and 200mg extended release tablets containing tramadol hydrochloride infringe the ‘887 patent. The Company filed its answer and counterclaim on July 23, 2007 and will assert all available defenses in addition to seeking a declaration of noninfringement and invalidity of the '887 patent. On October 24, 2007, plaintiffs filed an amended complaint in the Delaware District Court in view of the Company's amendment of its ANDA to include the 300 mg strength of extended release tramadol. A scheduling order has been entered in the case requiring that fact discovery be completed by May 15, 2008; expert discovery completed by August 15, 2008; a Markman hearing be held July 2008; and a trial date set for November 10, 2008. The Company intends to defend this action vigorously and pursue its counterclaims against Purdue, Napp, Biovail and Ortho-McNeil.
 
On July 6, 2007, Sanofi-Aventis and Debiopharm, S.A. filed a lawsuit against the Company and its development partner, MN Pharmaceuticals ("MN"), in the United States District Court for the District of New Jersey. The complaint alleges infringement of U.S. Patent Nos. 5,338,874 and 5,716,988 because the Company and MN submitted a Paragraph IV certification to the FDA for approval of 50 mg/10 ml, 100 mg/20 ml, and 200 mg/40 ml oxaliplatin by injection. The Company and MN filed their answer and counterclaims on October 10, 2007. On January 14, 2008, following MN's amendment of its ANDA to include oxaliplatin injectable 5 mg/ml, 40 ml vial, Sanofi-Aventis filed a complaint asserting infringement of the '874 and the '998 patents. The Company and MN filed their answer and counterclaim on February 20, 2008. The Company and MN intend to defend these actions vigorously and pursue their counterclaims against Sanofi and Debiopharm.
 
22

 
On September 21, 2007, Sanofi-Aventis and Sanofi-Aventis U.S., LLC (“Sanofi-Aventis”) filed a lawsuit against the Company and its development partner, Actavis South Atlantic LLC ("Actavis"), in the United States District Court for the District of Delaware. The complaint alleges infringement of U.S. Patent Nos. 4,661,491 and 6,149,940 because the Company and Actavis submitted a Paragraph IV certification to the FDA for approval of 10 mg alfuzosin hydrochloride extended release tablets. The Company filed its answer and counterclaims on October 24, 2007. The Company filed its amended answer and counterclaims on November 19, 2007. On April 3, 2008, the Judge in Delaware ordered all actions in the case stayed pending the plaintiff’s motion for transfer and consolidation under the rules governing multi-district litigation. The Company intends to defend this action vigorously and pursue its counterclaims against Sanofi-Aventis.

On October 1, 2007, Elan Corporation, PLC (“Elan”) filed a lawsuit against the Company and its development partner, IntelliPharmaCeutics Corp., and IntelliPharmaCeutics Ltd. ("IPC") in the United States District Court for the District of Delaware. On October 5, 2007, Celgene Corporation (“Celgene”) and Novartis filed a lawsuit against IPC in the United States District Court for the District of New Jersey. The complaint in the Delaware case alleged infringement of U.S. Patent Nos. 6,228,398 and 6,730,325 because the Company submitted a Paragraph IV certification to the FDA for approval of 5, 10, 15, and 20 mg dexmethylphenidate hydrochloride extended release capsules. Elan filed an amended Complaint on October 15, 2007. The original complaint in the New Jersey case alleged infringement of U.S. Patent Nos. 6,228,398; 6,730,325; 5,908,850; 6,355,656; 6,528,530; 5,837,284; and 6,635,284 because the Company and IPC submitted a Paragraph IV certification to the FDA for approval of 5, 10, 15, and 20 mg dexmethylphenidate extended release capsules. The Company and IPC filed their answer and counterclaims in the Delaware case on November 19, 2007. Celgene and Novartis filed an amended complaint on October 15, 2007 and the Company and IPC filed their answer and counterclaims in the New Jersey case on November 20, 2007. The Company and IPC filed an amended answer in Delaware December 12, 2007, and Elan filed their answer and motion to consolidate the cases on January 2, 2008. On February 20, 2008, the judge in the Delaware litigation consolidated all 4 related cases pending in Delaware and entered a scheduling order providing for April 15, 2009 as the deadline for all discovery and August 17, 2009 as the date for a bench trial. A Rule 16 conference was held for the New Jersey litigation on March 4, 2008 setting a deadline of December 12, 2008 for all discovery. The Company intends to defend these actions vigorously and pursue its counterclaims against Elan, Celgene and Novartis.

On September 13, 2007, Santarus, Inc. (“Santarus”), and The Curators of the University of Missouri (“Missouri”) filed a lawsuit against the Company in the United States District Court for the District of Delaware. The complaint alleges infringement of U.S. Patent Nos. 6,699,885; 6,489,346; and 6,645,988 because the Company submitted a Paragraph IV certification to the FDA for approval of 20 mg and 40 mg omeprazole/sodium bicarbonate capsules. The Company filed its answer and counterclaims on October 17, 2007. A scheduling conference was held February 11, 2008, setting September 8, 2008 as the date for the claim construction hearing and July 13, 2009 as the first day of the bench trial. On March 4, 2008, the cases pertaining to the Company’s ANDAs for omeprazole capsules and omeprazole oral suspension (see below) were consolidated for all purposes. The Company intends to defend this action vigorously and pursue its counterclaims against Santarus and Missouri. 

On December 11, 2007, AstraZeneca Pharmaceuticals, LP, AstraZeneca UK Ltd., IPR Pharmaceuticals, Inc. and Shionogi Seiyaku Kabushiki Kaisha filed a lawsuit against the Company in the United States District Court for the District of Delaware. The complaint alleges patent infringement because the Company submitted a Paragraph IV certification to the FDA for approval of 5 mg, 10 mg, 20 mg and 40 mg rosuvastatin calcium tablets. The Company filed its answer and counterclaims on January 31, 2008. The Company intends to defend these actions vigorously and pursue its counterclaims against AstraZeneca Pharmaceuticals, LP, AstraZeneca UK Ltd., IPR Pharmaceuticals, Inc. and Shionogi Seiyaku Kabushiki Kaisha. 
 
On December 20, 2007, Santarus, Inc. (“Santarus”), and The Curators of the University of Missouri (“Missouri”) filed a lawsuit against the Company in the United States District Court for the District of Delaware. The complaint alleges infringement of U.S. Patent Nos. 6,699,885; 6,489,346; 6,780,882; and 6,645,988 because the Company submitted a Paragraph IV certification to the FDA for approval of 20 mg and 40 mg omeprazole/sodium bicarbonate powders for oral suspension. The Company filed its answer on January 10, 2008 and filed its amended answer and counterclaims on January 30, 2008. On March 4, 2008, the cases pertaining to the Company’s ANDAs for omeprazole capsules (see above) and omeprazole oral suspension were consolidated for all purposes. The Company intends to defend this action vigorously against Santarus and Missouri.
 
23

 
Industry Related Matters

On September 10, 2003, the Company and a number of other generic and brand pharmaceutical companies were sued by Rockland County in New York State (the suit has since been joined by additional New York counties) that has alleged violations of laws (including the Racketeer Influenced and Corrupt Organizations Act, common law fraud and obtaining funds by false statements) related to participation in the Medicaid program. The complaint seeks declaratory relief; actual, statutory and treble damages, with interest; punitive damages; an accounting and disgorgement of any illegal profits; a constructive trust and restitution; and attorneys’ and experts’ fees and costs. On August 4, 2004, the Company and a number of other generic and brand pharmaceutical companies were also sued by the City of New York, which has alleged violations of laws (including common law fraud and obtaining funds by false statements) related to participation in its Medicaid program. On June 15, 2005, a consolidated complaint was filed on behalf of a number of the New York counties and the City of New York. This case was transferred to the United States District Court for the District of Massachusetts for coordinated and consolidated pre-trial proceedings. The complaint filed by Erie County in New York was not included in the consolidated complaint and has been removed to federal district court. In addition, on September 25, 2003, the Office of the Attorney General of the Commonwealth of Massachusetts filed a complaint in the District of Massachusetts against the Company and 12 other leading generic pharmaceutical companies, alleging principally that the Company and such other companies violated, through their marketing and sales practices, state and federal laws, including allegations of common law fraud and violations of Massachusetts false statements statutes, by inflating generic pharmaceutical product prices paid for by the Massachusetts Medicaid program. The complaint seeks injunctive relief, treble damages, disgorgement of excessive profits, civil penalties, reimbursement of investigative and litigation costs (including experts’ fees) and attorneys’ fees. On January 29, 2004, the Company and the other defendants involved in the litigation brought by the Office of the Attorney General of the Commonwealth of Massachusetts filed a motion to dismiss, which was denied on August 15, 2005. The Commonwealth of Massachusetts subsequently filed an amended complaint, and the defendants, including the Company, have filed a motion to dismiss the amended complaint. In addition to Massachusetts, the Commonwealth of Kentucky, the State of Illinois and the State of Alabama have filed similar suits in their respective jurisdictions, all of which have been removed to federal district court. The lawsuit brought by the State of Alabama was remanded to the Alabama state court on August 11, 2005. Following the remand, on October 13, 2005, the Court denied the defendants’ motion to dismiss, but granted in part the defendants’ motion for a more definite statement, and further ruled that the State may amend its complaint within 90 days. On October 20, 2005, the State of Mississippi filed in the Chancery Court for Hinds County, Mississippi a complaint naming the Company (among other companies) as a defendant. The Company intends to defend vigorously these actions.

On April 27, 2006, the State of Hawaii filed a complaint naming the Company as a defendant that has alleged violations of laws related to participation in the Medicaid program. The Hawaii complaint pleads causes of action for (i) false claims; (ii) unfair or deceptive acts or practices; (iii) unfair competition; (iv) violation of the Deceptive Trade Practices Act; (v) non-disclosure; and (vi) unjust enrichment. The complaint seeks general and special damages; treble damages, or in the alternative, punitive damages; costs, pre-judgment and post-judgment interest, and attorneys’ fees; injunctive relief; and such other and further relief or equitable relief as the Court deems just and proper. The Company intends to defend this action vigorously.
 
On May 8, 2006, the County of Oswego filed a complaint against the Company and certain other pharmaceutical companies. This complaint pleads causes of action for (i) fraud; (ii) violation of New York Social Services Law § 366-b; (iii) violation of New York Social Services Law § 145-b; (iv) violation of New York General Business Law § 349; (v) unjust enrichment; and (vi) fraudulent concealment. The County of Schenectady filed a similar complaint on May 9, 2006. The Company intends to defend these actions vigorously.
 
With respect to the Erie action, on September 7, 2006, the New York Supreme Court for the County of Erie granted the defendants' joint motion to dismiss in part and denied it in part. The defendants then removed the Erie action for a second time to the United States District Court for the Western District of New York on October 11, 2006, and the case was subsequently transferred to the United States District Court for the District of Massachusetts for coordinated and consolidated pre-trial proceedings. A motion to remand to State Court is currently pending.
 
The County of Nassau, New York filed a Second Amended Complaint in its action against a number of other generic and brand pharmaceutical companies, naming the Company as a defendant on January 30, 2006. The case has been consolidated, for purposes of discovery and briefing, with the action filed by a number of other New York counties and the City of New York. The matters are presently in the United States District Court for the District of Massachusetts for coordinated and consolidated pre-trial proceedings. On March 3, 2006, the Company and the other defendants filed motions to dismiss the Second Amended Complaint filed by Nassau County and the consolidated complaint brought by the other counties and the City of New York. These motions were granted in part and denied in part on April 2, 2007. On June 8, 2007, the City of New York and various other New York counties, this time including Nassau County, filed a First Amended Consolidated Complaint. On June 22, 2007, the defendants filed a joint motion to dismiss the First Amended Consolidated Complaint. The Court granted the defendants' motion in part and denied it in part on July 30, 2007. On October 5, 2007, the City of New York and various other New York counties filed a Revised First Amended Consolidated Complaint, which the Company answered on October 26, 2007.
 
With respect to the Oswego and Schenectady matters, the cases have been transferred to the United States District Court for the District of Massachusetts for coordinated and consolidated pre-trial proceedings. On September 17, 2007, the United States District Court for the District of Massachusetts granted the motions filed by Erie, Oswego, and Schenectady Counties to remand their respective cases to New York state court. Each of these three matters was subsequently remanded to the New York Supreme Courts for the Counties of Erie, Oswego, and Schenectady, respectively. On November 28, 2007, the defendants filed a joint motion, with the State of New York Litigation Coordinating Panel, to coordinate the three actions. This motion is currently pending.
 
The Company's motion to dismiss the Commonwealth of Massachusetts' First Amended Complaint was denied on August 15, 2005. The Company answered the Commonwealth's First Amended Complaint on November 14, 2005.
 
24

 
With respect to the Alabama action, the Company filed an answer to the Second Amended Complaint on January 30, 2006. On October 11, 2006, the defendants for the second time removed the case to the United States District Court for the Middle District of Alabama. On November 2, 2006, the matter was again remanded to State court. Certain defendants, including the Company, filed motions in September 2006 to sever or for separate trials. The trial court denied these motions. On June 1, 2007, upon the petitions of certain defendants, including the Company, the Supreme Court of Alabama granted a writ of mandamus and ordered the trial court to sever the claims against all defendants.
 
With respect to the Illinois action, the United States District Court for the District of Massachusetts granted the State of Illinois' motion to remand on September 17, 2007. The case was remanded to the Circuit Court of Cook County, Illinois. On November 19, 2007, certain defendants, including the Company, filed a new joint motion to dismiss the First Amended Complaint. This motion is currently pending.
 
The court denied the defendants’ motions to dismiss in the action brought by the Commonwealth of Kentucky on June 23, 2006. The Company answered the First Amended Complaint on July 19, 2006. The Commonwealth of Kentucky filed a Second Amended Complaint on September 28, 2007. The Company answered the Second Amended Complaint on October 15, 2007.
 
With respect to the Mississippi action, the Special Masters assigned to the case recommended the denial of the defendants' motion to dismiss on September 22, 2006. On October 2, 2006, the defendants objected to the Special Masters' recommendation. The Court had not ruled on this objection at the time the case was removed to federal district court. Also, after removal, the matter was transferred to the United States District Court for the District of Massachusetts for coordinated and consolidated pre-trial proceedings, where the State's motion to remand is pending. The case was remanded to the Chancery Court of Hinds County, Mississippi. On December 13, 2007, the Court denied the defendants’ pending motion to dismiss. The defendants appealed the trial court's decision to the Supreme Court of Mississippi on January 3, 2008. This appeal is currently pending.
 
With respect to the Hawaii matter, the State's motion to remand the action was granted on November 30, 2006. On January 12, 2007, the defendants filed a joint motion to dismiss the State's First Amended Complaint. This motion was denied on April 11, 2007, and the Company answered the First Amended Complaint on April 23, 2007.
 
The State of Alaska filed an Amended Complaint on October 17, 2006, naming the Company and other pharmaceutical companies as defendants. The Alaska complaint pleads causes of action for (i) violation of the Alaska Unfair Trade Practices and Consumer Protection Act and (ii) unjust enrichment. The complaint seeks monetary damages; declarative relief; injunctive relief; compensatory, restitution, and/or disgorgement damages; civil penalties; punitive damages; costs, attorneys' fees, and prejudgment interest; and other relief deemed just and equitable by the Court. The defendants filed a joint motion to dismiss the State's Amended Complaint on January 5, 2007. This motion was denied on May 7, 2007. The Company intends to defend this action vigorously.
 
The State of South Carolina filed two related actions against the Company and other pharmaceutical companies on December 1, 2006. One of these Complaints seeks relief on behalf of the South Carolina Medicaid Agency and the other seeks relief on behalf of the South Carolina State Health Plan. Both South Carolina Complaints plead causes of action for (i) violation of the South Carolina Unfair Trade Practices Act; (ii) unjust enrichment; and (iii) injunctive relief. Both Complaints seek monetary damages and prejudgment interest; treble damages, attorneys' fees, and costs; civil penalties; disgorgement; injunctive relief; and other relief deemed just and equitable by the Court. On January 26, 2007, the Company moved to dismiss each Complaint or, in the alternative, for a more definite statement with respect to each Complaint. These motions are currently pending.
 
The State of Idaho filed a Complaint against the Company and various other pharmaceutical companies on January 26, 2007. The Idaho Complaint pleads causes of action for (i) violation of the Idaho Consumer Protection Act; and (ii) unjust enrichment. The State seeks declaratory and injunctive relief; monetary damages; civil penalties; disgorgement; attorneys' fees and costs; and other relief deemed just and equitable by the Court. On March 30, 2007, the defendants filed a joint motion to dismiss the State's Complaint. On August 31, 2007, the Court granted in part the defendants' joint motion to dismiss and denied it in part. On October 1, 2007, the Company answered the State's Complaint.
 
On April 5, 2007, the County of Orange, New York, filed a Complaint against the Company and various other pharmaceutical companies. The Orange County Complaint pleads causes of action for (i) violations of the Racketeer Influenced and Corrupt Practices Act; (ii) violation of various federal and state Medicaid laws; (iii) unfair trade practices; and (iv) common law claims for breach of contract, unjust enrichment, fraud, and fraudulent concealment. The County seeks actual, statutory, and treble damages, including interest; declaratory relief; disgorgement; restitution; attorneys' fees, experts' fees, and costs; and other relief deemed just and equitable by the Court. The Orange County action was transferred to the United States District Court for the District of Massachusetts for coordinated and consolidated pretrial proceedings. On September 6, 2007, that Court entered an order adding Orange County to the First Amended Consolidated Complaint filed by the City of New York and various other New York counties.
 
On September 21, 2007, the State of Utah filed a Complaint against the Company and various other pharmaceutical companies. The Utah Complaint pleads causes of action for (i) violations of the Utah False Claims Act and (ii) common law fraudulent misrepresentation. The State seeks actual, statutory, and treble damages, including prejudgment interest; restitution; attorneys' fees, experts' fees, and costs; and other relief deemed just and equitable by the Court. On November 20, 2007, the Judicial Panel on Multidistrict Litigation issued an order conditionally transferring the case to the United States District Court for the District of Massachusetts for coordinated and consolidated pretrial proceedings. The State then filed a motion to remand the case to state court, on December 7, 2007, and a motion to vacate the conditional transfer order, on December 12, 2007. These motions are currently pending.
 
25

 
On October 9, 2007, the State of Iowa filed a Complaint against the Company and various other pharmaceutical companies. The Iowa Complaint pleads causes of action for (i) violations of the Iowa Consumer Fraud Act, (ii) common law fraudulent misrepresentation, (iii) common law unjust enrichment and (iv) reporting of false best price information in violation of 42 USC Sec 1396R-8. The State seeks (i) a declaration that the Company committed the alleged violations, (ii) injunctive relief against the continuation of the alleged violations, (iii) actual, statutory damages, including prejudgment interest for the claim of unjust enrichment, (iv) actual, statutory damages, including prejudgment interest for the claim of fraudulent misrepresentation, (v) actual and punitive damages for alleged fraud, and (vi) an accounting of alleged illegal profits and a disgorgement of same, restitution, attorneys' fees, experts' fees, and costs and other relief deemed just and equitable by the Court. The Iowa action has been transferred to the United States District Court for the District of Massachusetts for coordinated and consolidated pretrial proceedings.
 
In March 2008, the Company received a letter request from the Attorney General of the State of Michigan. The request seeks documents and information relating to nominal price transactions. The Company is responding to the request and will cooperate with the inquiry.
 
Other

The Company is, from time to time, a party to certain other litigations, including product liability litigations. The Company believes that these litigations are part of the ordinary course of its business and that their ultimate resolution will not have a material adverse effect on its financial condition, results of operations or liquidity. The Company intends to defend or, in cases where the Company is plaintiff, to prosecute these litigations vigorously.
 
Note 15 – Investment in Joint Venture:
 
On April 15, 2002, Rhodes Technology (“Rhodes”) and the Company created a joint venture, SVC Pharma (“SVC”), to research, develop, commercialize and market pharmaceutical preparations for human therapy. The parties agreed to capitalize the joint venture with equal contributions and all profits or losses are to be shared equally between Rhodes and the Company. The Company accounts for this investment under the equity method of accounting in accordance with APB No. 18, the Equity Method of Accounting for Investments in Common Stock. As of March 29, 2008, the Company’s net investment in SVC totaled approximately $6,433. The investment in SVC is reviewed for impairment each reporting period. Any impairment deemed to be “other-than temporary” will be recognized in the appropriate period and the basis will be adjusted. As of March 29, 2008, the Company believes its investment in SVC was not impaired. Should the anticipated launch of the product being developed by SVC be affected due to a denial or delay of approval by regulatory bodies, a delay in commercialization, or other potential risk factors, investment impairment charges may occur to the extent the Company is unable to recover the full value of its investment.

Note 16 – Discontinued Operations - Related Party Transaction:
 
In January 2006, the Company announced the divestiture of FineTech, effective December 31, 2005. The Company transferred the business for no proceeds to Dr. Arie Gutman, president and chief executive officer of FineTech. Dr. Gutman also resigned from the Company’s Board of Directors. The results of FineTech operations have been classified as discontinued for all periods presented because the Company had no continuing involvement in FineTech. In January 2008, Dr. Gutman sold FineTech to a third party. Under the terms of the divestiture, the Company recorded a receivable of $505 on the condensed consolidated balance sheet as of March 29, 2008 to reflect the Company’s share of the net proceeds of the sale transaction. The $505 has been classified as discontinued operations on the condensed consolidated statement of operations for the three months ended March 29, 2008.

Note 17 - Segment Information:
 
Starting in the third quarter of 2005, the Company operates in two reportable business segments: generic pharmaceuticals and branded pharmaceuticals. In 2007, the Company began operating the brand pharmaceutical segment under the name Strativa Pharmaceuticals. Strativa products are marketed under brand names through marketing programs that are designed to generate physician and consumer loyalty. These branded products generally are patent protected, which provides a period of market exclusivity during which they are sold with little or no competition. Generic pharmaceutical products are the chemical and therapeutic equivalents of reference brand drugs. The Drug Price Competition and Patent Term Restoration Act of 1984 provides that generic drugs may enter the market upon the approval of an ANDA and the expiration, invalidation or circumvention of any patents on corresponding brand drugs, or the expiration of any other market exclusivity periods related to the brand drugs.
 
The business segments of the Company were determined based on management’s reporting and decision-making requirements in accordance with SFAS No. 131, “Disclosures about Segments of an Enterprise and Related Information.” The Company believes that its generic products represent a single operating segment because the demand for these products is mainly driven by consumers seeking a lower cost alternative to brand name drugs. The Company’s generic drugs are developed using similar methodologies, for the same purpose (e.g., seeking bioequivalence with a brand name drug nearing the end of its market exclusivity period for any reason discussed above). The Company’s generic products are produced using similar processes and standards mandated by the FDA, and the Company’s generic products are sold to similar customers. Based on the economic characteristics, production processes and customers of the Company’s generic products, the Company has determined that its generic pharmaceuticals are a single reportable business segment. The Company’s chief operating decision maker does not review the generic segment in any more granularity, such as at the therapeutic or other classes or categories. Certain of the Company’s expenses, such as the direct sales force and other sales and marketing expenses and specific research and development expenses, are charged directly to either of the two segments. Other expenses, such as general and administrative expenses and non-specific research and development expenses are allocated between the two segments based on assumptions determined by the Company’s management.
 
26

 
 The financial data for the two business segments are as follows:
   
Three months ended
 
   
March 29,
 
March 31,
 
   
2008
 
2007
 
Revenues:
         
Generic
 
$
129,884
 
$
214,736
 
Strativa
   
25,044
   
19,474
 
Total revenues
 
$
154,928
 
$
234,210
 
               
Gross margin:
             
Generic
 
$
30,132
 
$
73,483
 
Strativa
   
19,389
   
14,206
 
Total gross margin
 
$
49,521
 
$
87,689
 
               
Operating income:
             
Generic
 
$
1,679
 
$
43,850
 
Strativa
   
963
   
17,821
 
Total operating income
 
$
2,642
 
$
61,671
 
Other expense, net
   
-
   
(19
)
Equity in loss of joint venture
   
(20
)
 
(148
)
Realized gain on sale of marketable securities
   
-
   
1,397
 
Interest income
   
3,014
   
2,684
 
Interest expense
   
(1,667
)
 
(1,718
)
Provision for income taxes
   
1,443
   
22,353
 
Income from continuing operations
 
$
2,526
 
$
41,514
 

The Company’s chief operating decision maker does not review the Company’s assets, depreciation or amortization by business segment at this time as they are not material to its branded operations. Therefore, such allocations by segment are not provided.
 
Total revenues of the Company’s top selling products were as follows:
Product
 
For the three months ended
March 29, 2008
     
For the three months
ended March 31, 2007
 
Generic
             
Metoprolol succinate ER (Toprol-XL®)
 
$
43,298
 
$
12,342
 
Fluticasone (Flonase®)
   
17,762
   
49,930
 
Cabergoline (Dostinex®)
   
7,982
   
11,395
 
Meclizine Hydrochloride (Anitvert®)
   
6,513
   
1,855
 
Various amoxicillin products (Amoxil®)
   
5,588
   
19,711
 
Propranolol HCl ER (Inderal LA®)
   
5,455
   
31,252
 
Ibuprofen Rx (Advil®, Nuprin®, Motrin®)
   
3,279
   
4,288
 
Methimazole (Tapazole®)
   
3,019
   
2,810
 
Hydralazine Hydrochloride (Apresoline®)
   
2,586
   
2,646
 
Megestrol oral suspension (Megace®)
   
2,065
   
806
 
Ranitidine HCl Syrup (Zantac®)
   
1,863
   
4,151
 
Lovastatin (Mevacor®)
   
1,340
   
3,774
 
Glyburide & Metformin HCl (Glucovance®)
   
(31
)
 
4,449
 
Tramadol HCl and acetaminophen tablets (Ultracet®)
   
(92
)
 
5,687
 
Polyethylene glycol (Miralax®)
   
(189
)
 
4,293
 
Other product related revenues (2)
   
1,048
   
9,121
 
Other (1)
   
28,398
   
46,226
 
Total Generic Revenues
 
$
129,884
 
$
214,736
 
               
Strativa
             
Megace® ES
 
$
22,401
 
$
16,974
 
Other product related revenues (2)
   
2,643
   
2,500
 
Total Strativa Revenues
 
$
25,044
 
$
19,474
 
 
27

 
(1)  
The further detailing of revenues of the Company’s other approximately 60 generic products is impracticable due to the low volume of revenues associated with each of these generic products. No single product in the other category is in excess of 3% of total generic revenues for three month periods ended March 29, 2008 or March 31, 2007.

(2)  
Other product related revenues represents licensing and royalty related revenues from profit sharing agreements related to products such as ondansetron ODT, the generic version of Zofran ODT®, nifedipine ER, the generic version of Procardia®, doxycycline monohydrate, the generic version of Adoxa®, and quinapril, the generic version of Accupril®. Other product related revenues included in the Strativa business relate to a co-promotion arrangement with Solvay.

During the first quarter of 2008, the Company recognized a gain on the sale of product rights of $1,000 related to the sale of two ANDAs related to two generic products. In November 2007, the Company entered into an agreement to provide certain information and other deliverables related to Megace® ES to enable the formal technology transfer to a third party that is seeking to commercialize Megace® ES outside of the U.S. The Company recorded $625 in the quarter ended March 29, 2008 in Strativa’s operating results when the Company’s obligations were fulfilled related to this agreement.

Note 18 - Research and Development Agreements:

In January 2008, the Company entered into an exclusive license agreement with Alfacell Corporation (“Alfacell”).  Under the agreement, the Company received the exclusive U.S. commercialization rights to Alfacell’s ONCONASE® (ranpirnase).  In exchange for the U.S. commercialization rights, the Company made an initial payment to Alfacell of $5 million and will make a subsequent payment of up to $30 million upon (and subject to) Alfacell’s receipt of FDA approval for the product.  If ONCONASE® receives FDA approval, the Company will commercialize the product in the United States and pay Alfacell royalties on net sales of the product, and Alfacell will be eligible to receive additional milestone payments if net sales reach certain threshold amounts in any given calendar year.  In addition, Alfacell may be eligible to receive milestone payments upon the achievement of certain development and regulatory milestones with respect to future indications for ONCONASE®.  Under a separate supply agreement between Alfacell and the Company, Alfacell will supply commercial quantities of ONCONASE® to the Company.  

Note 19 - Subsequent Events:

On April 21, 2008, Strativa announced that its development partner, BioAlliance, reported preliminary, top-line results for a Phase III study of Loramyc® (miconazole Lauriad®) mucoadhesive buccal tablets, in the treatment of oropharyngeal candidiasis (OPC). Top line data show that Loramyc® achieved its primary endpoint of noninferiority to Mycelex® Troche (clotrimazole) in the complete resolution of signs and symptoms of OPC (complete clinical cure). The randomized, double-blind, double-dummy study was conducted in 577 HIV-positive patients in 40 sites in the United States, Canada, and South Africa. All secondary endpoints were also met. Loramyc®, which is approved in Europe and currently being marketed in France, is an antifungal delivered in a mucoadhesive buccal tablet designed to enable local once-daily dosing of the active ingredient at the site of infection.

On May 7, 2008 the Company announced an amendment to its agreement with Spectrum Pharmaceuticals and paid $20 million pursuant to which the Company will increase its share of the profits from 38% to 95% for the commercialization of the authorized generic versions of GlaxoSmithKline's (“GSK”) Imitrex® Injection.  Based on a settlement agreement between Spectrum Pharmaceuticals and GSK, the Company will be permitted to sell generic versions of certain sumatriptan injection products with an expected launch date no later than November 2008. 
 
Note 20 - Fair Value Measurements
 
As described in Note 2 “Recent Accounting Pronouncements,” the Company adopted SFAS 157 with respect to financial assets and liabilities as of January 1, 2008. SFAS 157 defines fair value as the 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. SFAS 157 requires that assets and liabilities carried at fair value be classified and disclosed in one of the following three categories:
 
Level 1:
quoted market prices in active markets for identical assets and liabilities. Active market means a market in which transactions for assets or liabilities occur with “sufficient frequency” and volume to provide pricing information on an ongoing unadjusted basis. The Company’s Level 1 assets include a short-term investment in a time deposit and the Company’s investment in Hana Biosciences, Inc that is traded in an active exchange market.
Level 2:
observable inputs other than Level 1 prices, such as quoted prices for similar assets or liabilities; or other inputs that are observable or can be corroborated by observable market data for substantially the full term of the assets or liabilities. The Company’s Level 2 assets primarily include debt securities including governmental agency and municipal securities, and corporate bonds with quoted prices that are traded less frequently than exchange-traded instruments, whose value is determined using a pricing model with inputs that are observable in the market or can be derived principally from or corroborated by observable market data.
Level 3:
unobservable inputs that are not corroborated by market data.

The fair value of the Company’s financial assets and liabilities measured at fair value on a recurring basis were as follows:
 
   
Estimated Fair Value at March 29, 2008
 
Level 1
 
Level 2
 
Level 3
 
Securities issued by government agencies (Note 4)
 
$
26,262
 
$
-
 
$
26,262
 
$
-
 
Debt securities issued by various state and local municipalities and agencies (Note 4)
   
36,611
   
-
   
36,611
   
-
 
Other debt securities (Note 4)
   
8,429
   
5,020
   
3,409
   
-
 
Marketable equity securities available for sale Hana Biosciences, Inc. (Note 4)
   
2,550
   
2,550
   
-
   
-
 
Total investments in debt and marketable equity securities
 
$
73,852
 
$
7,570
 
$
66,282
 
$
-
 

The Company’s Level 2 assets are valued at the quoted market price from broker or dealer quotations.
 
28

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

Certain statements in this Report constitute “forward-looking statements” within the meaning of the Private Securities Litigation Reform Act of 1995, including those concerning management’s expectations with respect to future financial performance, trends and future events, particularly relating to sales of current products and the introduction of new manufactured and distributed products. Such statements involve known and unknown risks, uncertainties and contingencies, many of which are beyond the control of the Company, which could cause actual results and outcomes to differ materially from those expressed herein. These statements are often, but not always, made using words such as “estimates,” “plans,” “projects,” “anticipates,” “continuing,” “ongoing,” “expects,” “intends,” “believes,” “forecasts” or similar words and phrases. Factors that might affect such forward-looking statements set forth in this Report include: (i) increased competition from new and existing competitors, and pricing practices from such competitors (particularly upon completion of exclusivity periods), (ii) pricing pressures resulting from the continued consolidation by the Company’s distribution channels, (iii) the amount of funds available for internal research and development and research and development joint ventures, (iv) research and development project delays and unanticipated costs in obtaining regulatory approvals, (v) continuation of distribution rights under significant agreements, (vi) the continued ability of distributed product suppliers to meet future demand, (vii) the costs, delays involved in and outcome of any threatened or pending litigations, including patent and infringement claims, (viii) unanticipated costs, delays and liabilities in integrating acquisitions, (ix) obtaining or losing 180-day marketing exclusivity periods on products, and future new product launches, and (x) general industry and economic conditions. To the extent that any statements made in this Report contain information that is not historical, such statements are essentially forward-looking and are subject to certain risks and uncertainties, including the risks described above as well as the risks and uncertainties discussed from time to time in other of the Company's filings with the SEC, including its Annual Reports on Form 10-K and Current Reports on Form 8-K. Any forward-looking statements included in this Quarterly Report on Form 10-Q are made as of the date hereof only, based on information available to the Company as of the date hereof, and, subject to any applicable law to the contrary, the Company assumes no obligation to publicly update any forward-looking statements, whether as a result of new information, future events or otherwise.

The financial data contained in this section is in thousands or as otherwise noted.

The following discussion should be read in conjunction with the Company’s Condensed Consolidated Financial Statements and related Notes to Condensed Consolidated Financial Statements contained elsewhere in this Form 10-Q.

OVERVIEW
 
Critical to the growth of the Company is its introduction of new manufactured and distributed products at selling prices that generate adequate gross margins. The Company, through its internal generic development program and various strategic alliances and relationships, seeks to introduce new products that have less competition and to broaden its product list. The Company plans to continue to invest in its generic internal research and development efforts, brand marketing strategy and its strategic alliances and relationships throughout 2008 and beyond. Also, the Company will continue seeking additional products for sale through new and existing distribution agreements or acquisitions of complementary products and businesses, additional first-to-file opportunities and unique dosage forms to differentiate its products in the marketplace. The Company pays a percentage of the gross profits or sales to its strategic partners on sales of products covered by its distribution agreements. Generally, products that the Company develops internally, and to which it is not required to split any profits with strategic partners, contribute higher gross margins than products covered by distribution agreements.

GENERIC BUSINESS

In November 2008, the Company expects to launch authorized generic versions of Imitrex® (sumatriptan) injection 4mg and 6mg starter kits and 4mg and 6mg prefilled syringe cartridges pursuant to a supply and distribution agreement with GlaxoSmithKline plc (“GSK”).  On May 7, 2008 the Company announced an amendment to its agreement with Spectrum Pharmaceuticals and paid $20 million pursuant to which the Company will increase its share of the profits from 38% to 95% for the commercialization of the authorized generic versions of GSK's Imitrex® Injection.  New product launches in 2007 included propranolol HCl extended release (“ER”) capsules, a product resulting from the Company’s strategic partnership with Nortec Development Associates, Inc., ranitidine HCl syrup, pursuant to a supply and distribution agreement with GSK and the launch of metoprolol succinate ER 25 mg in the fourth quarter of 2006 and additional strengths (50mg, 100mg, and 200mg) in the third quarter 2007, pursuant to a supply and distribution agreement with AstraZeneca (“AZ”).
 
In addition, the Company’s investment in its generic first-to-file development strategy is expected to yield approximately eleven new product launches during 2009 and 2010 based on one or more of the following: expiry of the 30-month stay period; patent expiry date; expiry of regulatory exclusivity; and date certain due to settlement agreement. However, such dates may change due to several circumstances, extended litigation, outstanding citizens petitions, other regulatory requirements set forth by the FDA, and stays of litigation. These launches will be significant mileposts for the Company as many of these products are first-to-file opportunities with significant gross margins. In addition, the Company has a growing pipeline and a strong track record of first-to-file drugs. Looking ahead, the Company will strive to average six to ten first-to-file applications per year with a goal of more than half of its products coming from internal development.
 
29

 
STRATIVA
 
For Strativa, the Company will continue to accelerate its brand growth through products primarily focused on supportive care. The Company also intends to continue to grow Megace® ES and leverage its existing infrastructure as the Company prepares to expand its branded drug portfolio. The Company anticipates the following three potential new product filings in 2008 for Strativa, thus contributing to its goal of generating annualized brand total revenues in excess of $250 million by the end of 2010.

In July 2005, the Company received FDA approval for its first New Drug Application (“NDA”), filed pursuant to Section 505(b)(2) of the Federal Food, Drug and Cosmetic Act, and immediately began marketing megestrol acetate oral suspension NanoCrystal® Dispersion (“Megace® ES”). Megace® ES is indicated for the treatment of anorexia, cachexia or any unexplained significant weight loss in patients with a diagnosis of AIDS and is utilizing the Megace® brand name that the Company has licensed from Bristol-Myers Squibb Company (“BMS”).
 
In September 2006, the Company entered into an extended-reach agreement with Solvay Pharmaceuticals, Inc. (“Solvay”) that provides for the Company’s branded sales force to co-promote Androgel®, as well as future versions of the product or other products that are mutually agreed upon, for a period of six years. As compensation for its marketing and sales efforts, the Company will receive up to $10 million annually, paid quarterly, for the six-year period. The Company has progressed on its business plan during 2007 by acquiring the rights to additional branded products currently in Phase III clinical trials.
 
In July 2007, the Company also acquired an exclusive licensing agreement under which the Company will receive commercialization rights in the U.S. to BioAlliance Pharma's Loramyc® (miconazole Lauriad®), an antifungal therapy for the treatment of oropharyngeal candidiasis, an opportunistic infection commonly found in immunocompromised patients, including those with HIV and cancer.
 
In August 2007, the Company also acquired the North American commercial rights to ZensanaTM (ondansetron HCl) Oral Spray from Hana Biosciences, Inc. (“Hana”). Ondansetron is used to prevent nausea and vomiting after chemotherapy, radiation and surgery, and following successful development and approval, ZensanaTM could be among the first in its class of 5-HT3 antagonist anti-emetic therapies to be available in an oral spray form. The Company also announced that it has entered into an agreement with NovaDel, to collaborate in the reformulation of ZensanaTM. Following completion of reformulation efforts already under way, the Company will reconfirm the product's pharmacokinetic profile and resubmit the NDA to the FDA.
 
In January 2008, the Company announced that it entered into an exclusive licensing agreement with Alfacell Corporation (“Alfacell”) to acquire the commercialization rights in the United States and its territories for ONCONASE® (ranpirnase). ONCONASE® is in Phase III development for the treatment of inoperable malignant mesothelioma, a rare cancer affecting the lungs usually associated with exposure to asbestos. ONCONASE® was previously granted orphan drug status as well as fast-track development status by the FDA for the treatment of malignant mesothelioma.

OTHER CONSIDERATIONS
 
In addition to the substantial costs of product development, the Company may incur significant legal costs in bringing certain products to market. Litigation concerning patents and proprietary rights is often protracted and expensive. Pharmaceutical companies with patented brand products are increasingly suing companies that produce generic forms of their patented brand name products for alleged patent infringement or other violations of intellectual property rights, which could delay or prevent the entry of such generic products into the market. Generally, a generic drug may not be marketed until the applicable patent(s) on the brand name drug expires. When an ANDA is filed with the FDA for approval of a generic drug, the filing person may certify either that the patent listed by the FDA as covering the branded product is about to expire, in which case the ANDA will not become effective until the expiration of such patent, or that the patent listed as covering the branded drug is invalid or will not be infringed by the manufacture, sale or use of the new drug for which the ANDA is filed. In either case, there is a risk that a branded pharmaceutical company may sue the filing person for alleged patent infringement or other violations of intellectual property rights. Because a substantial portion of the Company’s current business involves the marketing and development of generic versions of brand products, the threat of litigation, the outcome of which is inherently uncertain, is always present. Such litigation is often costly and time-consuming, and could result in a substantial delay in, or prevent, the introduction and/or marketing of products, which could have a material adverse effect on the Company’s business, financial condition, prospects and results of operations.
 
30

 
Sales and gross margins of the Company’s products depend principally on the: (i) introduction of other generic drug manufacturers’ products in direct competition with the Company’s significant products; (ii) ability of generic competitors to quickly enter the market after patent or exclusivity period expirations, or during exclusivity periods with authorized generic products, diminishing the amount and duration of significant profits to the Company from any one product; (iii) pricing practices of competitors and the removal of competing products from the market; (iv) continuation of existing distribution agreements; (v) introduction of new distributed products; (vi) consolidation among distribution outlets through mergers, acquisitions and the formation of buying groups; (vii) willingness of generic drug customers, including wholesale and retail customers, to switch among generic pharmaceutical manufacturers; (viii) approval of ANDAs, introduction of new manufactured products, and future new product launches, (ix) granting of potential marketing exclusivity periods; (x) extent of market penetration for the existing product line; (xi) level, quality and amount of customer service; and (xii) market acceptance of the Company’s recently introduced branded product and the successful development to commercialization of the Company's in-licensed branded product pipeline.

Net sales and gross margins derived from generic pharmaceutical products often follow a pattern based on regulatory and competitive factors that are believed by the Company’s management to be unique to the generic pharmaceutical industry. As the patent(s) for a brand name product and the related exclusivity period(s) expire, the first generic manufacturer to receive regulatory approval from the FDA for a generic equivalent of the product is often able to capture a substantial share of the market. At that time, however, the branded company may license an authorized generic product to a competing generic company. As additional generic manufacturers receive regulatory approvals for competing products, the market share and the price of that product have typically declined, often significantly, depending on several factors, including the number of competitors, the price of the brand product and the pricing strategy of the new competitors.

RESULTS OF OPERATIONS
 
The following table shows the revenues, gross margin, and operating income by segment for the three months ended March 29, 2008 and March 31, 2007:
 
   
Three months ended
 
   
March 29,
 
March 31,
 
   
2008
 
2007
 
Revenues:
             
Generic
 
$
129,884
 
$
214,736
 
Strativa
   
25,044
   
19,474
 
Total revenues
 
$
154,928
 
$
234,210
 
               
Gross margin:
             
Generic
 
$
30,132
 
$
73,483
 
Strativa
   
19,389
   
14,206
 
Total gross margin
 
$
49,521
 
$
87,689
 
               
Operating income:
             
Generic
 
$
1,679
 
$
43,850
 
Strativa
   
963
   
17,821
 
Total operating income
 
$
2,642
 
$
61,671
 
 
Revenues
Total revenues for the three months ended March 29, 2008 were $154,928, decreasing $79,282, or 33.9%, from total revenues of $234,210 for the three months ended March 31, 2007. Revenues for generic products for the three months ended March 29, 2008 were $129,884, decreasing $84,852, or 39.5%, from generic revenues of $214,736 for the three months ended March 31, 2007. Lower generic revenues in 2008 were primarily due to competitive pressure, including for fluticasone, which decreased $32,168, propranolol, which decreased $25,797, various amoxicillin products, which decreased $14,123, tramadol HCl and acetaminophen tablets, which decreased $5,779, glyburide/metformin, which decreased $4,480, cabergoline, which decreased $3,413, ranitidine HCl syrup, which decreased $2,288, and lower royalties driven by ondansetron tablets which launched during the fourth quarter of 2006. Partially offsetting these decreases were increased sales of metoprolol resulting from the launch of additional strengths in the third quarter of 2007 (increase of $30,956). Net sales of distributed products were approximately $87,040 or 56% of the Company’s total product revenues in the first quarter of 2008, and $118,830, or 51% of the Company’s total revenues in the first quarter of 2007. The Company is substantially dependent upon distributed products for its overall sales and any inability by its suppliers to meet demand could adversely affect the Company’s future sales.
 
Revenues for the Strativa segment were $25,044 for the three months ended March 29, 2008, increasing $5,570, or 28.6%, from Strativa revenues of $19,474 for the three months ended March 31, 2007, due to increased net sales of Megace® ES.

Generic drug pricing at the wholesale level can create significant differences between the invoice price and the Company’s net selling price. Wholesale customers purchase product from the Company at invoice price, then resell the product to specific healthcare providers on the basis of prices negotiated between the Company and the providers, and the wholesaler submits a chargeback credit to the Company for the difference. The Company records estimates for these chargebacks, sales returns, rebates and incentive programs, and other sales allowances, for all its customers at the time of sale, as reductions to gross revenues, with corresponding adjustments to its accounts receivable reserves and allowances.
 
31

 
The Company’s gross revenues before deductions for chargebacks, rebates and incentive programs (including rebates paid under federal and state government Medicaid drug reimbursement programs), sales returns and other sales allowances were $307,976 for the three months ended March 29, 2008 compared to $405,446 for the three months ended March 31, 2007. Deductions from gross revenues were $153,048 for the three months ended March 29, 2008 compared to $171,236 for the three months ended March 31, 2007. These deductions are discussed in the Notes to condensed consolidated financial statements – Note 6 – “Accounts Receivable.” The total gross-to-net sales adjustments as a percentage of gross sales increased to 49.7% for the three months ended March 29, 2008 compared to 42.2% for the three months ended March 31, 2007, primarily due to increased pricing pressure for key products and lower royalty income in 2008, tempered by improved returns experience and a trend toward customer net pricing programs. Among the top selling products that did not have sales in the corresponding prior year three month period were metoprolol succinate ER 50 mg, 100 mg, and 200 mg.

As detailed above, the Company has the experience and the access to relevant information that it believes are necessary to reasonably estimate the amounts of such deductions from gross revenues. Some of the assumptions used by the Company for certain of its estimates are based on information received from third parties, such as wholesale customer inventory data and market data, or other market factors beyond the Company’s control. The estimates that are most critical to the establishment of these reserves, and therefore would have the largest impact if these estimates were not accurate, are estimates related to expected contract sales volumes, average contract pricing, customer inventories and return levels. The Company regularly reviews the information related to these estimates and adjusts its reserves accordingly, if and when actual experience differs from previous estimates. With the exception of the product returns allowance, the ending balances of account receivable reserves and allowances generally are eliminated during a two- to four-month period, on average.

The Company recognizes revenue for product sales when title and risk of loss have transferred to its customers and when collectibility is reasonably assured. This is generally at the time that products are received by the customers. Upon recognizing revenue from a sale, the Company records estimates for chargebacks, rebates and incentives, returns, cash discounts and other sales reserves that reduce accounts receivable.

The following tables summarize the activity for the three months ended March 29, 2008 and March 31, 2007 in the accounts affected by the estimated provisions described below:   

   
For the three months ended March 29, 2008
 
 
Beginning
balance
 
Provision
recorded
for current
period
sales
 
(Provision)
reversal
recorded
for prior
period sales
 
Credits
processed
 
Ending
balance
 
Accounts receivable reserves
                               
Chargebacks
 
$
(46,006
$
(107,639
$
(539
)(1) 
$
110,197
  
$
(43,987
)
Rebates and incentive programs
   
(42,859
)
 
(24,207
)
 
(1,571
)
 
35,678
   
(32,959
)
Returns
   
(47,102
)
 
(4,904
)
 
4,293
   
7,220
   
(40,493
)
Cash discounts and other
   
(16,158
)
 
(12,274
)
 
349
   
12,321
   
(15,762
)
Total
 
$
(152,125
)
$
(149,024
)
$
2,532
 
$
165,416
 
$
(133,201
)
                                                
Accrued liabilities (2)
 
$
(17,684
)
$
(7,361
)
$
805
 
$
536
 
$
(23,704
)
 
32

 
   
For the three months ended March 31, 2007
 
 
Beginning
Balance
 
Provision
recorded
for current
period
sales
 
(Provision)
reversal
recorded
for prior
period sales
 
Credits
Processed
 
Ending
balance
 
Accounts receivable reserves
                               
Chargebacks
 
$
(51,891
$
(88,364
$
-
(1) 
$
92,531
  
$
(47,724
)
Rebates and incentive programs
   
(85,888
)
 
(55,192
)
 
2,699
   
50,889
   
(87,492
)
Returns
   
(42,905
)
 
(10,770
)
 
(794
)
 
6,099
   
(48,370
)
Cash discounts and other
   
(18,038
)
 
(14,382
)
 
211
   
6,652
   
(25,557
)
Total
 
$
(198,722
)
$
(168,708
)
$
2,116
 
$
156,171
 
$
(209,143
)
                                                
Accrued liabilities (2)
 
$
(10,583
)
$
(4,644
)
$
-
 
$
547
 
$
(14,680
)

(1)
Unless specific in nature, the amount of provision or reversal of reserves related to prior periods for chargebacks is not determinable on a product or customer specific basis; however, based upon historical analysis and analysis of activity in subsequent periods, the Company has determined that its chargeback estimates remain reasonable.

(2)
Includes amounts due to customers for which no underlying accounts receivable exists, including Medicaid rebates. The Company included additional amounts that were part of accrued expenses and other current liabilities on the condensed consolidated balance sheets as of December 31, 2006 ($171), March 31, 2007 ($332) and December 31, 2007 ($869) in the tables above that are similar to the previously disclosed amounts due to customers for which no underlying accounts receivable exists.

Use of Estimates in Reserves

The Company believes that its reserves, allowances and accruals for items that are deducted from gross revenues are reasonable and appropriate based on current facts and circumstances. It is possible, however, that other parties applying reasonable judgment to the same facts and circumstances could develop different allowance and accrual amounts for items that are deducted from gross revenues. Additionally, changes in actual experience or changes in other qualitative factors could cause the Company’s allowances and accruals to fluctuate, particularly with newly launched or acquired products. The Company reviews the rates and amounts in its allowance and accrual estimates on a quarterly basis. If future estimated rates and amounts are significantly greater than those reflected in its recorded reserves, the resulting adjustments to those reserves would decrease the Company’s reported net revenues; conversely, if actual product returns, rebates and chargebacks are significantly less than those reflected in its recorded reserves, the resulting adjustments to those reserves would increase its reported net revenues. If the Company were to change its assumptions and estimates, its reserves would change, which would impact the net revenues that the Company reports. The Company regularly reviews the information related to these estimates and adjusts its reserves accordingly, if and when actual experience differs from previous estimates.

Gross Margin

The Company’s gross margin of $49,521 (32.0% of total revenues) for the three months ended March 29, 2008 decreased $38,168 from $87,689 (37.4% of total revenues) for the three months ended March 31, 2007. This decrease in gross margin is attributed to the decreased sales of existing products resulting from competitive pressure and lower royalty income. The generic products gross margin of $30,132 (23.2% of generic revenues) for the three months ended March 29, 2008 decreased $43,351 from $73,483 (34.2% of generic revenues) for the three months ended March 31, 2007 primarily due to lower sales of fluticasone, propranolol, various amoxicillin products, tramadol HCl and acetaminophen tablets, glyburide/metformin, cabergoline and ranitidine syrup and lower royalties primarily from ondansetron tablets. Partially offsetting these decreases were increased sales of metoprolol resulting from the launch of additional strengths during the third quarter of 2007. Strativa gross margin of $19,389 (77.4% of Strativa revenues) for the three months ended March 29, 2008 increased by $5,183 from $14,206 (72.9% of Strativa revenues) for the three months ended March 31, 2007 due to higher net sales of Megace® ES. The Company’s gross margin percentage decreased from 37.4% to 32.0% driven primarily by the increased sales of lower margin metoprolol, lower royalty income and lower sales of higher margin products such as propranolol which launched in February of 2007, tempered by increased net sales of Megace® ES.
 
33

 
Operating Expenses

 Research and Development
 
The Company’s research and development expenses of $17,158 (11.1% of total revenues) for the three months ended March 29, 2008 increased $3,119, or 22.2%, from $14,039 (6.0% of total revenues) for the three months ended March 31, 2007. The increase in expense is primarily attributable to costs incurred in support of the Company’s strategy related to expansion of its Strativa segment, principally through in-licensing compounds in late-stage development. These increases are partially offset by lower costs of $1,903 related to PAR 101, which was divested in the first quarter of 2007.
 
In January 2008, the Company entered into an exclusive licensing agreement with Alfacell Corporation to acquire the commercialization rights to ONCONASE® (ranpirnase) in the United States and its territories. ONCONASE® is in Phase III clinical development for the treatment of inoperable malignant mesothelioma, a rare cancer affecting the lungs usually associated with exposure to asbestos. Under the terms of the agreement, the Company made an initial payment of $5 million in cash to Alfacell, which was included in research and development expense.
 
Although there can be no such assurance, research and development expenses for 2008, including payments to be made to unaffiliated companies and milestone payments are expected to decrease by approximately 20% to 25% from 2007.
 
Selling, General and Administrative Expenses
 
Total selling, general and administrative (“SG&A”) expenses of $31,346 for the three months ended March 29, 2008 decreased $1,211 or 3.7% from $32,557 for the three months ended March 31, 2007. The decrease in expense is driven by lower expenses related to sales and marketing of Megace® ES ($2,225), lower finance and accounting costs ($1,056), and lower stock –based compensation related employment costs. These savings were tempered by increased legal fees ($2,570) related to ongoing litigation.
 
Although there can be no such assurance, SG&A expenses, excluding the impact of Strativa spending for potential pre-launch activities, in 2008 are expected to decrease by 10% to 12% from fiscal year 2007 and may also fluctuate due to legal costs associated with the Company’s product litigations related to the success of its first-to-file generic strategy. 

Settlements, net

In August 2003, the Company and Perrigo Pharmaceuticals Company entered into a product development manufacturing and supply agreement to commercialize various products. In March 2007, the parties terminated the agreement. The terms of the settlement resulted in a net gain for the Company in the amount of $378 for the three months ended March 31, 2007.

In September 1999, the Company entered into an agreement to develop, manufacture and market the pharmaceutical formulation naturbinol with Resolution Chemicals Limited (“Resolution”). In February 2007, the parties agreed to terminate this agreement. The terms of the settlement resulted in a net gain for the Company in the amount of $200 for the three months ended March 31, 2007.

Gain on Sale of Product Rights and other
 
During the first quarter of 2008, the Company recognized a gain on the sale of product rights of $1,000 related to the sale of two ANDAs. In November 2007, the Company entered into an agreement to provide certain information and other deliverables related to Megace® ES to enable the formal technology transfer to a third party that is seeking to commercialize Megace® ES outside of the U.S. The Company recorded $625 in the quarter ended March 29, 2008 when the Company’s obligations were fulfilled related to this agreement.

In May 2005 the Company and Optimer entered into a joint development and collaboration agreement to commercialize Difimicin (PAR 101), an investigational drug to treat Clostridium difficle-associated diarrhea. On February 27, 2007 in exchange for $20,000 the Company returned the marketing rights to Optimer and recorded a corresponding gain on the sale of product rights.

Realized Gain on Sale of Marketable Securities
 
In February 2007, the Company sold approximately 1.1 million shares of its investment in Optimer stock for approximately $6.8 million and recognized a pre-tax gain of approximately $1.4 million for the three month period ended March 31, 2007.
 
34

 
Equity in Loss of Joint Venture

Equity in loss of joint venture was $20 and $148 for the three months ended March 29, 2008 and March 31, 2007, respectively. The amounts represent the Company’s share of loss in the joint venture created with Rhodes Technology (“Rhodes”) which primarily relates to research and development costs incurred by the joint venture to develop ANDAs. Should the anticipated launch of product being developed by SVC be affected due to a denial or delay of approval by regulatory bodies, a delay in commercialization, or other potential risk factors, investment impairment charges may occur to the extent the Company is unable to recover the full value of its investment.

Interest Income

Interest income was $3,014 and $2,684 for the three months ended March 29, 2008 and March 31, 2007, respectively. Interest income principally includes interest income derived primarily from money market and other short-term investments.

Interest Expense

Interest expense was $1,667 and $1,718 for the three months ended March 29, 2008 and March 31, 2007, respectively. Interest expense principally includes interest payable on the Company’s convertible notes.

Income Taxes
 
The Company recorded a provision for income taxes of $1,443 and $22,353 for the three months ended March 29, 2008 and March 31, 2007, respectively. The Company’s effective tax rates for continuing operations for the three months ended March 29, 2008 and March 31, 2007 were 36% and 35%, respectively.

Discontinued Operations
 
In January 2006, the Company announced the divestiture of FineTech, effective December 31, 2005. The Company transferred the business for no proceeds to Dr. Arie Gutman, president and chief executive officer of FineTech. Dr. Gutman also resigned from the Company’s Board of Directors. The results of FineTech operations have been classified as discontinued for all periods presented because the Company had no continuing involvement in FineTech. In January 2008, Dr. Gutman sold FineTech to a third party. Under the terms of the divestiture, the Company recorded a receivable of $505 on the condensed consolidated balance sheet as of March 29, 2008 to reflect the Company’s share of the net proceeds of the sale transaction and classified the $505 as discontinued operations on the condensed consolidated statement of operations for the three months ended March 29, 2008.

FINANCIAL CONDITION

Liquidity and Capital Resources

Cash and cash equivalents of $231,193 at March 29, 2008 increased $31,061 from $200,132 at December 31, 2007. Cash provided by operations was $18,479 for the three months ended March 29, 2008 driven by net income from continuing operations of $2,526 and adjusted primarily for depreciation and amortization of $6,274 and share-based compensation of $3,463. Net accounts receivable increased by $19,853 driven primarily by timing of customer collections while inventories declined $19,704 driven by lower demand for certain products due to increased competitive pressures and seasonality, which the Company had planned for and due to timing of receipts of certain purchased finished goods. Payables due to distribution agreement partners increased $8,774 due mainly to higher sales of partnered products. Cash flows provided by investing activities of $13,076 were driven by net proceeds of $17,690 from the conversion of available for sale securities to shorter term investments that are classified as cash equivalents in response to market conditions that made investments in available for sale securities riskier than in prior periods, tempered by capital expenditures of $4,023. Cash used in financing activities of $494 was primarily due to the purchase of treasury stock related to shares surrendered to the Company to satisfy tax withholding obligations in connection with the vesting of restricted stock issued to employees.   

The Company’s working capital, current assets minus current liabilities, of $218,033 at March 29, 2008 increased $7,519 from $210,514 at December 31, 2007. The working capital ratio, which is calculated by dividing current assets by current liabilities, was 1.69x at March 29, 2008 compared to 1.67x at December 31, 2007. The Company believes that its working capital ratio indicates the ability to meet its ongoing and foreseeable obligations for the next 12 fiscal months.

In 2004, the Board authorized the repurchase of up to $50,000 of the Company’s common stock. Repurchases are made, subject to compliance with applicable securities laws, from time to time in the open market or in privately negotiated transactions. Shares of common stock acquired through the repurchase program are available for general corporate purposes. In 2007, the Company announced that its Board approved an expansion of its share repurchase program allowing for the repurchase of up to $75,000 of the Company’s common stock, inclusive of the $17,800 remaining from the April 2004 authorization. The Company repurchased 1,643 shares of its common stock for approximately $31,400 pursuant to the expanded program in the fourth quarter of 2007. The authorized amount remaining for stock repurchases under the repurchase program was approximately $43,600, as of March 29, 2008.
 
35

 
In addition to its cash and cash equivalents, the Company had $67,893 of available for sale debt securities classified as current assets on the condensed consolidated balance sheet as of March 29, 2008. These available for sale debt securities were all available for immediate sale. The Company intends to continue to use its current liquidity to support the expansion of its business, increasing its generic research and development activities, entering into product license arrangements, potentially acquiring other complementary businesses and products and for general corporate purposes.

As of March 29, 2008, the Company had payables due to distribution agreement partners of $45,253 related primarily to amounts due under profit sharing agreements, particularly including an amount owed to Pentech with respect to paroxetine. The Company is expected to pay substantially all of these amounts, with the exception of the payable due to Pentech, which is being disputed in current litigation with Pentech, out of its working capital during the first two months of the second quarter of 2008. In 2004, Pentech filed a legal action against the Company alleging that the Company breached its contract with Pentech. The Company and Pentech are in dispute over the amount of gross profit share.  
 
There have been no material changes to contractual obligations table presented as of December 31, 2007 in the Company’s Form 10-K.

In addition to its internal research and development costs, the Company, from time to time, enters into agreements with third parties for the development of new products and technologies. To date, the Company has entered into agreements and advanced funds and has commitments or contingent liabilities with several non-affiliated companies for products in various stages of development. These contingent payments or commitments are generally dependent on the third party achieving certain milestones or the timing of third-party research and development or legal expenses. Due to the uncertainty of the timing and/or realization of such contingent commitments, these obligations were not included in the contractual obligations table presented as of December 31, 2007 in the Company’s Form 10-K. Payments made pursuant to these agreements are either capitalized or expensed in accordance with the Company’s accounting policies. The total amount that ultimately could be due under agreements with contingencies is approximately $64,000 as of March 29, 2008.

The Company expects to continue to fund its operations, including its research and development activities, capital projects, in-licensing product activity and obligations under its existing distribution and development arrangements discussed herein, out of its working capital. Implementation of the Company’s business plan may require additional debt and/or equity financing; there can be no assurance that the Company will be able to obtain any such additional financing when needed on terms acceptable or favorable to it.

Financing

At March 29, 2008, the Company’s total outstanding short and long-term debt, including the current portion, was $200,000. The amount consisted of senior subordinated convertible notes that the Company sold in 2003 pursuant to Rule 144A under the Securities Act of 1933, as amended.  The notes bear interest at an annual rate of 2.875%, payable semi-annually on March 30 and September 30 of each year. The notes are convertible into shares of common stock of the Company at an initial conversion price of $88.76 per share, only upon the occurrence of certain events. Upon redemption, the Company has agreed to satisfy the conversion obligation in cash in an amount equal to the principal amount of the notes converted. The notes mature on September 30, 2010, unless earlier converted, accelerated or repurchased.  The Company may not redeem the notes prior to the maturity date. The Trustee under the Indenture governing the Notes has alleged that the Company has defaulted in the performance of its obligations under the Indenture and has instituted a lawsuit in connection therewith. Accordingly, until the matter is resolved, the Company is recording the payment obligations under the Notes as a current liability on the Company’s condensed consolidated balance sheet as of March 29, 2008. Refer to Notes to condensed consolidated financial statements – Note 14 – “Commitments, Contingencies and Other Matters.”

Critical Accounting Policies and Use of Estimates
 
The Company’s critical accounting policies are set forth in its Annual Report on Form 10-K for the fiscal year ended December 31, 2007. There has been no change, update or revision to the Company’s critical accounting policies subsequent to the filing of the Company’s Form 10-K for the fiscal year ended December 31, 2007.
 
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Inventories:
 
Inventories are stated at the lower of cost (first-in, first-out basis) or market value. The Company establishes reserves for its inventory to reflect situations in which the cost of the inventory is not expected to be recovered. In evaluating whether inventory is stated at the lower of cost or market, management considers such factors as the amount of inventory on hand, estimated time required to sell such inventory, remaining shelf life and current expected market conditions, including level of competition. The Company records provisions for inventory to cost of goods sold.
 
The Company capitalizes costs associated with certain products prior to regulatory approval and product launch (“pre-launch inventories”) when it is reasonably certain that the pre-launch inventories will be saleable, based on management’s judgment of future commercial use and net realizable value. The Company could be required to expense previously capitalized costs related to pre-launch inventories upon a change in such judgment, due to a denial or delay of approval by regulatory bodies, a delay in commercialization, or other potential risk factors. If these risks were to materialize and the launch of such product were significantly delayed, the Company may have to write-off all or a portion of such pre-launch inventories and such amounts could be material. As of March 29, 2008, the Company had inventories related to products that were not available to be marketed of $9.2 million, comprised of research and development inventories of $2.2 million, and pre-launch inventories of $7.0 million, of which $5.6 million is for a specific partnered product anticipated to launch in the second quarter of 2008. Should the launch be delayed inventory write-offs may occur to the extent the Company is unable to recover the full value of its inventory investment.

Recent Accounting Pronouncements Adopted as of January 1, 2008
 
In June 2007, the FASB ratified Emerging Issue Task Force Issue No. 07-3 (“EITF 07-3”), Accounting for Non-Refundable Advance Payments for Goods or Services to Be Used in Future Research and Development Activities, which requires nonrefundable advance payments for goods and services that will be used or rendered for future research and development activities to be deferred and capitalized. These amounts will be recognized as expense in the period that the related goods are delivered or the related services are performed or when an entity does not expect the goods to be delivered or services to be rendered. EITF 07-3 is effective for the fiscal years beginning after December 31, 2007, including interim periods within those fiscal years. The Company’s adoption of the provisions of EITF 07-3, beginning January 1, 2008 did not have a material impact on its condensed consolidated financial statements.

In February 2007, the FASB issued SFAS No. 159 The Fair Value Option for Financial Assets and Financial Liabilities — Including an Amendment of FASB Statement No. 115 (“SFAS 159”), which becomes effective for fiscal periods beginning after November 15, 2007.  Under SFAS 159, companies may elect to measure specified financial assets and liabilities at fair value that are not otherwise measured at fair value, with changes in fair value recognized in earnings each subsequent reporting period.  This election, called the “fair value option”, will enable some companies to reduce volatility in reported earnings caused by measuring related assets and liabilities differently.  SFAS 159 also establishes presentation and disclosure requirements designed to draw a comparison between the different measurement attributes a company elects for similar types of assets and liabilities. The Company did not elect the “fair value option” for any of its eligible financial assets or liabilities and therefore the Company’s adoption of SFAS 159 did not have a material impact on its condensed consolidated financial statements.
 
In September 2006, the FASB issued SFAS No. 157 Fair Value Measurements (“SFAS 157”).  SFAS 157 establishes a common definition for fair value to be applied to GAAP guidance requiring use of fair value, establishes a framework for measuring fair value, and expands disclosure about such fair value measurements.  SFAS 157 applies to fair value measurements that are already required or permitted by other accounting standards, except for measurements of share-based payments and measurements that are similar to, but not intended to be, fair value. The FASB has previously concluded in those accounting pronouncements that fair value is the relevant measurement attribute. Accordingly, this Statement does not require any new fair value measurements. SFAS 157 is effective for fiscal years beginning after November 15, 2007.  In November 2007, FASB granted a one year deferral for the implementation of SFAS 157 for non-financial assets and liabilities. The Company’s adoption of SFAS 157 with respect to financial assets and liabilities did not have a material impact on its condensed consolidated financial statements.

 
     Available for sale debt securities   
 
The primary objectives for the Company’s investment portfolio are liquidity and safety of principal. Investments are made with the intention to achieve the best available rate of return on traditionally low risk investments. The Company’s investment policy limits investments to certain types of instruments issued by institutions with investment-grade credit ratings, the U.S. government and U.S. governmental agencies. The Company is subject to market risk primarily from changes in the fair values of its investments in debt securities including governmental agency and municipal securities, and corporate bonds. These instruments are classified as available for sale securities for financial reporting purposes. A ten percent increase in interest rates would cause the fair value of the Company’s investments in available for sale debt securities to decline by approximately $0.3 million. Additional investments are made in overnight deposits and money market funds. These instruments are classified as cash and cash equivalents for financial reporting purposes, generally also have lower interest rate risk relative to its investments in debt securities and changes in interest rates generally have little or no impact on their fair values. For cash, cash equivalents and available for sale debt securities, a ten percent decrease in interest rates would decrease interest income by approximately $1.0 million. The Company does not have any financial obligations exposed to variability in interest rates.
 
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The following table summarizes the available for sale securities that subject the Company to market risk at March 29, 2008 and December 31, 2007:
 
   
March 29,
 2008
 
December 31,
2007
 
Securities issued by government agencies
 
$
26,262
 
$
46,201
 
Debt securities issued by various state and local municipalities and agencies
   
36,611
   
24,223
 
Other debt securities
   
8,429
   
13,991
 
Marketable equity securities available for sale
   
2,550
   
2,650
 
Auction rate securities
   
-
   
5,000
 
Total
 
$
73,852
 
$
92,065
 
 
Marketable equity securities available for sale
 
In addition to the investments described above, the Company is also subject to market risk in respect to its investment in Hana. In August 2007, the Company made an equity investment in Hana for $5.0 million at a contractually agreed premium to the prevailing market price. Of this amount, $1.2 million was charged to research and development expense in the third quarter of 2007. The Company has classified its investment in Hana as a noncurrent asset on its consolidated balance sheet as of March 29, 2008 due to its contractual obligations with Hana and its ability and intent to hold the investment for a reasonable period of time (not anticipated to be less than 12 months) sufficient for a recovery of fair value up to (or beyond) the cost of the investment. The Company recorded an unrealized loss of $1.3 million as of March 29, 2008, which is included in other comprehensive income to reflect the estimated fair value of its investment in Hana. A 10% adverse change in the market price of Hana common stock would impact the fair value of the investment by approximately $0.3 million.


Disclosure Controls and Procedures
 
The Company maintains disclosure controls and procedures that are designed to ensure that information required to be disclosed in the Company’s filings with the SEC is recorded, processed, summarized and reported within the time period specified in the SEC’s rules and forms, and that such information is accumulated and communicated to management, including the Company’s Chief Executive Officer (CEO) and Chief Financial Officer (CFO), as appropriate, to allow timely decisions regarding required disclosure based on the definition of “disclosure controls and procedures” as defined in Rule 13a-15(e) promulgated under the Securities Exchange Act of 1934, as amended (the “Exchange Act”). In designing and evaluating disclosure controls and procedures, the Company has 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 is required to apply judgment in evaluating its controls and procedures. An evaluation was performed under the supervision and with the participation of Company management, including the CEO and the CFO, to assess the effectiveness of the design and operation of its disclosure controls and procedures (as defined under the Exchange Act) as of March 29, 2008. Based on that evaluation, the Company’s management, including its CEO and the CFO, concluded that the Company’s disclosure controls and procedures were not effective as of March 29, 2008 because it has not yet been concluded that the material weakness in the Company’s internal control over financial reporting related to the recording of proper income tax benefits from discontinued operations reported as of December 31, 2007 in the Company’s Form 10-K has been remediated.

Changes in Internal Control over Financial Reporting
 
There have been no significant changes in the Company's internal control over financial reporting identified during the quarter ended March 29, 2008, except for the implementation of measures described below under “Remediation of Material Weakness”.

Remediation of Material Weakness
 
The Company has taken the following steps to remediate the weakness mentioned above: 1) replaced members of senior management and managers responsible for the oversight of income tax matters, 2) formalized a policy and procedure for the communication and review of non-routine tax matters by senior management, and 3) as appropriate the Company will engage external tax advisors for advice with respect to non-routine tax matters.
 
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The Company anticipates that these actions will remediate the material weakness. The effectiveness of its remediation efforts will not be known until the Company can test those controls in connection with the management tests of internal controls over financial reporting that the Company will perform as of December 31, 2008.


 
Contractual Matters
 
On May 3, 2004, Pentech Pharmaceuticals, Inc. (“Pentech”) filed an action against the Company in the United States District Court for the Northern District of Illinois. This action alleges that the Company breached its contract with Pentech relating to the supply and marketing of paroxetine (PaxilÒ) and that the Company breached fiduciary duties allegedly owed to Pentech. The Company and Pentech are in dispute over the amount of gross profit share due to them. Discovery in this case has concluded. The Court denied cross motions for summary judgment relating to the construction of the contract, and denied Pentech’s motion for summary judgment against the Company’s fraudulent inducement counterclaim. The Company also filed a motion for summary judgment against Pentech’s breach of fiduciary duty claim, and that motion was granted. A trial date has not yet been set. The Company intends to defend vigorously this action.

Corporate Litigation
 
The Company and certain of its executive officers have been named as defendants in several purported stockholder class action lawsuits filed on behalf of purchasers of common stock of the Company between April 29, 2004 and July 5, 2006. The lawsuits followed the Company’s July 5, 2006 announcement regarding the restatement of certain of its financial statements and allege that the Company and certain members of its management engaged in violations of the Securities Exchange Act of 1934, as amended (the “Exchange Act”), by issuing false and misleading statements concerning the Company’s financial condition and results. The class actions have been consolidated and are pending in the United States District Court, District of New Jersey. The Court has appointed co-lead plaintiffs and co-lead counsel. Co-lead plaintiffs filed a Consolidated Amended Complaint on April 30, 2007, purporting to represent purchasers of common stock of the Company between July 23, 2001 and July 5, 2006. Defendants filed a motion to dismiss the Amended Complaint on June 29, 2007. The Company intends, and the members of management named as defendants have stated their intentions, to vigorously defend the lawsuits and any additional lawsuits that may hereafter be filed with respect to the restatement.
 
On August 14, 2006, individuals claiming to be stockholders of the Company filed a derivative action in the U.S. District Court for the Southern District of New York, purportedly on behalf of the Company, against the current and certain former directors and certain current and former officers of the Company and the Company as a nominal defendant. The plaintiffs in this action allege that, among other things, the named defendants breached their fiduciary duties to the Company based on substantially the same factual allegations as the class action lawsuits referenced above. The plaintiffs also alleged that certain of the defendants have been unjustly enriched based on their receipt of allegedly backdated options to purchase shares of common stock of the Company, and seek to require those defendants to disgorge any profits made in connection with their exercise of such options and additional attendant damages relating to allegedly backdated options during the period from January 1, 1996 to the present. The action has been transferred to the United States District Court, District of New Jersey. On June 29, 2007, the plaintiffs filed their amended complaint and in connection therewith, dropped their claims related to the alleged stock option backdating. Defendants have made a motion to dismiss the complaint, which motion has been fully briefed. The Company intends and each of the individuals named as defendants have stated their intentions to vigorously defend against the remaining allegations.

On September 1, 2006, the Company received a notice of default from the American Stock Transfer & Trust Company, as trustee (the “Trustee”) of the Company’s 2.875% Senior Subordinated Convertible Notes due 2010 (the “Notes”). The Trustee claims, in essence, that the Company’s failure to include financial statements in its Quarterly Report on Form 10-Q for the second quarter of 2006 constituted a default under Section 6.2 of the Indenture, dated as of September 30, 2003 (the “Indenture”), between the Company, as issuer, and the Trustee, relating to the Notes. The notice of default asserted that if the purported default continued unremedied for 30 days after the receipt of the notice, an “event of default” would occur under the Indenture. Under the Indenture, the occurrence of an event of default would give the Trustee or certain holders of the Notes the right to declare all unpaid principal and accrued interest on the Notes immediately due and payable. On October 2, 2006, the Company received a notice of acceleration from the Trustee purporting to accelerate payment of the Notes.
 
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The Company believes that it has complied with its obligations under the Indenture relating to the Notes. Therefore, the Company believes that the above-mentioned notice of default and notice of acceleration are invalid and without merit. Under the Indenture, the Company is required only to provide the Trustee with copies of its annual and other reports (or copies of such portions of such reports as the SEC may by rules and regulations prescribe) that it is required to file with the SEC pursuant to Section 13 or 15(d) of the Exchange Act within 15 calendar days after it files such annual and other reports with the SEC. Moreover, the Company’s Indenture specifically contemplates providing the Trustee with portions of reports. On August 24, 2006 (within 15 days of filing with the SEC), the Company provided to the Trustee a copy of its Quarterly Report on Form 10-Q for the second quarter of 2006. The Company’s Form 10-Q did not include the Company’s financial statements for the second quarter of 2006 and related Management’s Discussion and Analysis due to the Company’s work to restate certain of its past financial statements, and, therefore, in accordance with SEC rules, the Company filed a Form 12b-25 Notification of Late Filing disclosing the omissions. The Company’s Form 12b-25 also was provided to the Trustee on August 24, 2006. Accordingly, the Company believes that it complied with the Indenture provision in question.
 
After the Company communicated its position to the Trustee, the Trustee filed a lawsuit, on October 19, 2006, on behalf of the holders of the Notes in the Supreme Court of the State of New York, County of New York, alleging a breach of the Indenture and of an alleged covenant of good faith and fair dealing. The lawsuit demands, among other things, that the Company pay the holders of the Notes either the principal, any accrued and unpaid interest and additional interest (as such term is defined in the Indenture), if any, or the difference between the fair market value of the Notes on October 2, 2006 and par, whichever the Trustee elects, or in the alternative, damages to be determined at trial, alleged by the Trustee to exceed $30.0 million. The Company filed a Notice of Removal to remove the lawsuit to the U.S. District Court for the Southern District of New York and has filed its answer to the complaint in that Court. On January 19, 2007, the Trustee filed a motion for summary judgment along with supporting documentation. On February 16, 2007, the Company filed its response to the Trustee’s motion for summary judgment and cross-moved for summary judgment in its favor. The Court has not yet ruled on the motions. Until the matter is resolved, the Company is recording the payment obligations as a current liability on the condensed consolidated balance sheets because the Court in the matter could (i) rule against the Company’s position and (ii) determine that the appropriate remedy would be the accelerated payment of the convertible notes.

Patent Related Matters

On July 15, 2003, the Company filed a lawsuit against Roxane Laboratories, Inc. (“Roxane”) in the United States District Court for the District of New Jersey. The Company alleged that Roxane had infringed the Company’s U.S. Patents numbered 6,593,318 and 6,593,320 and that the infringement was willful. Roxane has denied these allegations and has counterclaimed for declaratory judgments of non-infringement and invalidity of both patents. On September 8, 2006, the Court issued a claim construction ruling on certain claim terms in dispute between the parties. Based on that construction, the Court ruled in favor of the Company and dismissed Roxane’s motion for summary judgment of non-infringement. On November 8, 2006, the Court ruled that the claims at issue in these patents were invalid as non-enabled on summary judgment. On December 8, 2006, the Company appealed the ruling to the Federal Circuit Court of Appeals, highlighting the district court’s failure to apply its own claim construction and to consider the testimony of the Company’s experts before awarding summary judgment to Roxane. On October 26, 2007, the U.S. Circuit Court of Appeals for the Federal Circuit affirmed the New Jersey District Court's ruling of invalidity for non-enablement. In January 2008, the District Court conducted a hearing on Roxane’s application for attorneys’ fees under 35 U.S.C. section 285. Briefs in opposition for both sides were filed on March 10, 2008 and a motion hearing was set for April 7, 2008. On April 10, 2008, the District Court rejected Roxane’s request for attorneys’ fees.
 
On March 10, 2006, Apotex Inc. and Apotex Corp. (“Apotex”) filed a lawsuit against the Company in the United States District Court for New Jersey, seeking a declaratory judgment that four of the Company’s patents relating to megestrol acetate oral suspension are invalid, unenforceable and not infringed by an Apotex product that was launched in the third quarter of 2006. The Company has moved for a preliminary injunction against Apotex pending resolution of the litigation and has asserted counterclaims that the Apotex product infringes at least one claim of U.S. Patent 6,593,318. The Company was granted a stay and the action was terminated without prejudice on April 9, 2007 pending final resolution of the Roxane appeal. On February 6, 2008, a joint stipulation of dismissal and order with prejudice was signed by the Judge in the case with each party only liable for its own costs and attorneys’ fees.
 
On April 28, 2006, CIMA Labs, Inc. (“CIMA”) and Schwarz Pharma, Inc. (“Schwarz Pharma”) filed separate lawsuits against the Company in the United States District Court for the District of New Jersey (CIMA Labs, Inc. et al. v. Par Pharmaceutical Companies, Inc. et al., (Civil Action Nos. 06-CV-1970, 1999 (DRD)(ES)). CIMA and Schwarz Pharma each have alleged that the Company infringed U.S. Patent Nos. 6,024,981 (the “’981 patent”) and 6,221,392 (the “’392 patent”) by submitting a Paragraph IV certification to the FDA for approval of alprazolam orally disintegrating tablets. CIMA owns the ’981 and ’392 patents and Schwarz Pharma is CIMA’s exclusive licensee. The two lawsuits were consolidated on January 29, 2007. In response to the lawsuit, the Company has answered and counterclaimed denying CIMA’s and Schwarz Pharma’s infringement allegations, asserting that the ’981 and ’392 patents are not infringed and are invalid and/or unenforceable. The parties have exchanged written discovery. All 40 claims in the ’981 patent were rejected in a non-final office action in a reexamination proceeding at the United States Patent and Trademark Office (“PTO”) on February 24, 2006. The PTO again rejected all 40 claims in a second non-final office action dated February 24, 2007. The ‘392 patent is also the subject of a reexamination proceeding. The Company will continue to monitor these ongoing reexamination proceedings. CIMA has moved to stay this lawsuit pending the outcome of the reexamination proceedings and to consolidate this lawsuit with another lawsuit in the same district involving the same patents (CIMA Labs, Inc. et al. v. Actavis Group hf et al., (Civil Action No. 07-CV-0893 (DRD) (ES)). A hearing on these motions was held on May 30, 2007. The Company intends to vigorously defend this lawsuit and pursue its counterclaims.
 
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The Company entered into a licensing agreement with developer Paddock Laboratories, Inc. (“Paddock”) to market testosterone 1% gel, a generic version of Unimed Pharmaceuticals, Inc.’s (“Unimed”) product Androgel®. Pursuant to this agreement, the Company is responsible for management of any litigation and payment of all legal fees associated with this product. The product, if successfully brought to market, would be manufactured by Paddock and marketed by the Company. Paddock has filed an ANDA (that is pending with the FDA) for the testosterone 1% gel product. As a result of the filing of the ANDA, Unimed and Laboratories Besins Iscovesco (“Besins”), co-assignees of the patent-in-suit, filed a lawsuit against Paddock in the United States District Court for the Northern District of Georgia, alleging patent infringement on August 22, 2003. The Company has an economic interest in the outcome of this litigation by virtue of its licensing agreement with Paddock. Unimed and Besins sought an injunction to prevent Paddock from manufacturing the generic product. On November 18, 2003, Paddock answered the complaint and filed a counterclaim, seeking a declaration that the patent-in-suit is invalid and/or not infringed by Paddock’s product. On September 13, 2006, the Company acquired from Paddock all rights to the ANDA for testosterone 1% gel, a generic version of Unimed’s product Androgel® for $6 million. The lawsuit was resolved by settlement. The settlement and license agreement terminates all on-going litigation. The settlement and license agreement also permits the Company to launch the generic version of the product no earlier than August 31, 2015 and no later than February 28, 2016, assuring the Company’s ability to market a generic version of Androgel® well before the expiration of the patents at issue. On March 7, 2007, the Company was issued a Civil Investigative Demand seeking information and documents in connection with the court-approved settlement in 2006 of the patent infringement case, Unimed v. Paddock, in the U.S. District Court for Northern District of Georgia. The Bureau of Competition for the Federal Trade Commission (“FTC”) is investigating whether the settlement of the litigation constituted unfair methods of competition in a potential violation of Section 5 of the FTC Act. The Company believes it has complied with all applicable laws in connection with the court-approved settlement and it intends to co-operate with the FTC in this matter.
 
On October 4, 2006, Novartis Corporation, Novartis Pharmaceuticals Corporation, and Novartis International AG (collectively “Novartis”) filed a lawsuit against the Company in the United States District Court for the District of New Jersey. Novartis alleged that the Company and Kali infringed U.S. Patent No. 6,162,802 (the “’802 patent”) by submitting a Paragraph IV certification to the FDA for approval of amlodipine and benazepril hydrochloride combination capsules. The Company and its subsidiaries denied Novartis’ allegation, asserting that the ’802 patent is not infringed and is invalid. The parties are currently engaged in discovery regarding the claims with expert discovery due to the Court by June 13, 2008. The Company intends to defend vigorously this action and pursue its counterclaims against Novartis.

On December 19, 2006, Reliant Pharmaceuticals, Inc. (“Reliant”) filed a lawsuit against the Company in the United States District Court for the District of Delaware (Reliant Pharmaceuticals, Inc. v. Par Pharmaceutical Inc., (Civil Action Nos. 06-CV-774-JJF)). Reliant alleged, in its Complaint, that the Company infringed U.S. Patent No. 5,681,588 (the “’588 patent”) by submitting a Paragraph IV certification to the FDA for approval to market generic 325 mg Propafenone HCl SR capsules. On January 26, 2007, Reliant amended its complaint to add the additional allegation that the Company infringed the ‘588 patent by submitting a Paragraph IV certification to the FDA for approval to market generic 225 mg and 425 mg—in addition to the 325 mg—Propafenone HCl SR capsules. The Company has answered and counterclaimed denying Reliant’s infringement allegations, and asserting that the ’588 patent is invalid and unenforceable. A scheduling order has been entered under which a claim construction hearing was held on April 2, 2008 and under which all fact and expert discovery will be completed by May 30, 2008. The parties have begun discovery and Reliant has filed a motion to disqualify the Company’s counsel, a motion that was denied in September 2007 with ongoing written discovery on the issue. The Company intends to vigorously defend this lawsuit and pursue its counterclaims.
 
On May 9, 2007, Purdue Pharma Products L.P. (“Purdue”), Napp Pharmaceutical Group Ltd. (“Napp”), Biovail Laboratories International SRL (“Biovail”), and Ortho-McNeil, Inc. (“Ortho-McNeil”) filed a lawsuit against the Company in the United States District Court for the District of Delaware. The complaint alleges infringement of U.S. Patent No. 6,254,887 (the “’887 patent”) because the Company submitted a Paragraph IV certification to the FDA for approval of 200mg extended release tablets containing tramadol hydrochloride. On May 30, 2007, the Company filed its answer and counterclaim to the complaint seeking a declaration of noninfringement and invalidity of the '887 patent. A subsequent complaint was served on July 2, 2007 in the same District Court. The new complaint alleges that the Company's 100mg and 200mg extended release tablets containing tramadol hydrochloride infringe the ‘887 patent. The Company filed its answer and counterclaim on July 23, 2007 and will assert all available defenses in addition to seeking a declaration of noninfringement and invalidity of the '887 patent. On October 24, 2007, plaintiffs filed an amended complaint in the Delaware District Court in view of the Company's amendment of its ANDA to include the 300 mg strength of extended release tramadol. A scheduling order has been entered in the case requiring that fact discovery be completed by May 15, 2008; expert discovery completed by August 15, 2008; a Markman hearing be held July 2008; and a trial date set for November 10, 2008. The Company intends to defend this action vigorously and pursue its counterclaims against Purdue, Napp, Biovail and Ortho-McNeil.
 
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On July 6, 2007, Sanofi-Aventis and Debiopharm, S.A. filed a lawsuit against the Company and its development partner, MN Pharmaceuticals ("MN"), in the United States District Court for the District of New Jersey. The complaint alleges infringement of U.S. Patent Nos. 5,338,874 and 5,716,988 because the Company and MN submitted a Paragraph IV certification to the FDA for approval of 50 mg/10 ml, 100 mg/20 ml, and 200 mg/40 ml oxaliplatin by injection. The Company and MN filed their answer and counterclaims on October 10, 2007. On January 14, 2008, following MN's amendment of its ANDA to include oxaliplatin injectable 5 mg/ml, 40 ml vial, Sanofi-Aventis filed a complaint asserting infringement of the '874 and the '998 patents. The Company and MN filed their answer and counterclaim on February 20, 2008. The Company and MN intend to defend these actions vigorously and pursue their counterclaims against Sanofi and Debiopharm.
 
On September 21, 2007, Sanofi-Aventis and Sanofi-Aventis U.S., LLC (“Sanofi-Aventis”) filed a lawsuit against the Company and its development partner, Actavis South Atlantic LLC ("Actavis"), in the United States District Court for the District of Delaware. The complaint alleges infringement of U.S. Patent Nos. 4,661,491 and 6,149,940 because the Company and Actavis submitted a Paragraph IV certification to the FDA for approval of 10 mg alfuzosin hydrochloride extended release tablets. The Company filed its answer and counterclaims on October 24, 2007. The Company filed its amended answer and counterclaims on November 19, 2007. On April 3, 2008, the Judge in Delaware ordered all actions in the case stayed pending the plaintiff’s motion for transfer and consolidation under the rules governing multi-district litigation. The Company intends to defend this action vigorously and pursue its counterclaims against Sanofi-Aventis.

On October 1, 2007, Elan Corporation, PLC (“Elan”) filed a lawsuit against the Company and its development partner, IntelliPharmaCeutics Corp., and IntelliPharmaCeutics Ltd. ("IPC") in the United States District Court for the District of Delaware. On October 5, 2007, Celgene Corporation (“Celgene”) and Novartis filed a lawsuit against IPC in the United States District Court for the District of New Jersey. The complaint in the Delaware case alleged infringement of U.S. Patent Nos. 6,228,398 and 6,730,325 because the Company submitted a Paragraph IV certification to the FDA for approval of 5, 10, 15, and 20 mg dexmethylphenidate hydrochloride extended release capsules. Elan filed an amended Complaint on October 15, 2007. The original complaint in the New Jersey case alleged infringement of U.S. Patent Nos. 6,228,398; 6,730,325; 5,908,850; 6,355,656; 6,528,530; 5,837,284; and 6,635,284 because the Company and IPC submitted a Paragraph IV certification to the FDA for approval of 5, 10, 15, and 20 mg dexmethylphenidate extended release capsules. The Company and IPC filed their answer and counterclaims in the Delaware case on November 19, 2007. Celgene and Novartis filed an amended complaint on October 15, 2007 and the Company and IPC filed their answer and counterclaims in the New Jersey case on November 20, 2007. The Company and IPC filed an amended answer in Delaware December 12, 2007, and Elan filed their answer and motion to consolidate the cases on January 2, 2008. On February 20, 2008, the judge in the Delaware litigation consolidated all 4 related cases pending in Delaware and entered a scheduling order providing for April 15, 2009 as the deadline for all discovery and August 17, 2009 as the date for a bench trial. A Rule 16 conference was held for the New Jersey litigation on March 4, 2008 setting a deadline of December 12, 2008 for all discovery. The Company intends to defend these actions vigorously and pursue its counterclaims against Elan, Celgene and Novartis.

On September 13, 2007, Santarus, Inc. (“Santarus”), and The Curators of the University of Missouri (“Missouri”) filed a lawsuit against the Company in the United States District Court for the District of Delaware. The complaint alleges infringement of U.S. Patent Nos. 6,699,885; 6,489,346; and 6,645,988 because the Company submitted a Paragraph IV certification to the FDA for approval of 20 mg and 40 mg omeprazole/sodium bicarbonate capsules. The Company filed its answer and counterclaims on October 17, 2007. A scheduling conference was held February 11, 2008, setting September 8, 2008 as the date for the claim construction hearing and July 13, 2009 as the first day of the bench trial. On March 4, 2008, the cases pertaining to the Company’s ANDAs for omeprazole capsules and omeprazole oral suspension (see below) were consolidated for all purposes. The Company intends to defend this action vigorously and pursue its counterclaims against Santarus and Missouri. 

On December 11, 2007, AstraZeneca Pharmaceuticals, LP, AstraZeneca UK Ltd., IPR Pharmaceuticals, Inc. and Shionogi Seiyaku Kabushiki Kaisha filed a lawsuit against the Company in the United States District Court for the District of Delaware. The complaint alleges patent infringement because the Company submitted a Paragraph IV certification to the FDA for approval of 5 mg, 10 mg, 20 mg and 40 mg rosuvastatin calcium tablets. The Company filed its answer and counterclaims on January 31, 2008. The Company intends to defend these actions vigorously and pursue its counterclaims against AstraZeneca Pharmaceuticals, LP, AstraZeneca UK Ltd., IPR Pharmaceuticals, Inc. and Shionogi Seiyaku Kabushiki Kaisha. 
 
42

 
On December 20, 2007, Santarus, Inc. (“Santarus”), and The Curators of the University of Missouri (“Missouri”) filed a lawsuit against the Company in the United States District Court for the District of Delaware. The complaint alleges infringement of U.S. Patent Nos. 6,699,885; 6,489,346; 6,780,882; and 6,645,988 because the Company submitted a Paragraph IV certification to the FDA for approval of 20 mg and 40 mg omeprazole/sodium bicarbonate powders for oral suspension. The Company filed its answer on January 10, 2008 and filed its amended answer and counterclaims on January 30, 2008. On March 4, 2008, the cases pertaining to the Company’s ANDAs for omeprazole capsules (see above) and omeprazole oral suspension were consolidated for all purposes. The Company intends to defend this action vigorously against Santarus and Missouri.

Industry Related Matters

On September 10, 2003, the Company and a number of other generic and brand pharmaceutical companies were sued by Rockland County in New York State (the suit has since been joined by additional New York counties) that has alleged violations of laws (including the Racketeer Influenced and Corrupt Organizations Act, common law fraud and obtaining funds by false statements) related to participation in the Medicaid program. The complaint seeks declaratory relief; actual, statutory and treble damages, with interest; punitive damages; an accounting and disgorgement of any illegal profits; a constructive trust and restitution; and attorneys’ and experts’ fees and costs. On August 4, 2004, the Company and a number of other generic and brand pharmaceutical companies were also sued by the City of New York, which has alleged violations of laws (including common law fraud and obtaining funds by false statements) related to participation in its Medicaid program. On June 15, 2005, a consolidated complaint was filed on behalf of a number of the New York counties and the City of New York. This case was transferred to the United States District Court for the District of Massachusetts for coordinated and consolidated pre-trial proceedings. The complaint filed by Erie County in New York was not included in the consolidated complaint and has been removed to federal district court. In addition, on September 25, 2003, the Office of the Attorney General of the Commonwealth of Massachusetts filed a complaint in the District of Massachusetts against the Company and 12 other leading generic pharmaceutical companies, alleging principally that the Company and such other companies violated, through their marketing and sales practices, state and federal laws, including allegations of common law fraud and violations of Massachusetts false statements statutes, by inflating generic pharmaceutical product prices paid for by the Massachusetts Medicaid program. The complaint seeks injunctive relief, treble damages, disgorgement of excessive profits, civil penalties, reimbursement of investigative and litigation costs (including experts’ fees) and attorneys’ fees. On January 29, 2004, the Company and the other defendants involved in the litigation brought by the Office of the Attorney General of the Commonwealth of Massachusetts filed a motion to dismiss, which was denied on August 15, 2005. The Commonwealth of Massachusetts subsequently filed an amended complaint, and the defendants, including the Company, have filed a motion to dismiss the amended complaint. In addition to Massachusetts, the Commonwealth of Kentucky, the State of Illinois and the State of Alabama have filed similar suits in their respective jurisdictions, all of which have been removed to federal district court. The lawsuit brought by the State of Alabama was remanded to the Alabama state court on August 11, 2005. Following the remand, on October 13, 2005, the Court denied the defendants’ motion to dismiss, but granted in part the defendants’ motion for a more definite statement, and further ruled that the State may amend its complaint within 90 days. On October 20, 2005, the State of Mississippi filed in the Chancery Court for Hinds County, Mississippi a complaint naming the Company (among other companies) as a defendant. The Company intends to defend vigorously these actions.

On April 27, 2006, the State of Hawaii filed a complaint naming the Company as a defendant that has alleged violations of laws related to participation in the Medicaid program. The Hawaii complaint pleads causes of action for (i) false claims; (ii) unfair or deceptive acts or practices; (iii) unfair competition; (iv) violation of the Deceptive Trade Practices Act; (v) non-disclosure; and (vi) unjust enrichment. The complaint seeks general and special damages; treble damages, or in the alternative, punitive damages; costs, pre-judgment and post-judgment interest, and attorneys’ fees; injunctive relief; and such other and further relief or equitable relief as the Court deems just and proper. The Company intends to defend this action vigorously.
 
On May 8, 2006, the County of Oswego filed a complaint against the Company and certain other pharmaceutical companies. This complaint pleads causes of action for (i) fraud; (ii) violation of New York Social Services Law § 366-b; (iii) violation of New York Social Services Law § 145-b; (iv) violation of New York General Business Law § 349; (v) unjust enrichment; and (vi) fraudulent concealment. The County of Schenectady filed a similar complaint on May 9, 2006. The Company intends to defend these actions vigorously.
 
With respect to the Erie action, on September 7, 2006, the New York Supreme Court for the County of Erie granted the defendants' joint motion to dismiss in part and denied it in part. The defendants then removed the Erie action for a second time to the United States District Court for the Western District of New York on October 11, 2006, and the case was subsequently transferred to the United States District Court for the District of Massachusetts for coordinated and consolidated pre-trial proceedings. A motion to remand to State Court is currently pending.
 
The County of Nassau, New York filed a Second Amended Complaint in its action against a number of other generic and brand pharmaceutical companies, naming the Company as a defendant on January 30, 2006. The case has been consolidated, for purposes of discovery and briefing, with the action filed by a number of other New York counties and the City of New York. The matters are presently in the United States District Court for the District of Massachusetts for coordinated and consolidated pre-trial proceedings. On March 3, 2006, the Company and the other defendants filed motions to dismiss the Second Amended Complaint filed by Nassau County and the consolidated complaint brought by the other counties and the City of New York. These motions were granted in part and denied in part on April 2, 2007. On June 8, 2007, the City of New York and various other New York counties, this time including Nassau County, filed a First Amended Consolidated Complaint. On June 22, 2007, the defendants filed a joint motion to dismiss the First Amended Consolidated Complaint. The Court granted the defendants' motion in part and denied it in part on July 30, 2007. On October 5, 2007, the City of New York and various other New York counties filed a Revised First Amended Consolidated Complaint, which the Company answered on October 26, 2007.
 
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With respect to the Oswego and Schenectady matters, the cases have been transferred to the United States District Court for the District of Massachusetts for coordinated and consolidated pre-trial proceedings. On September 17, 2007, the United States District Court for the District of Massachusetts granted the motions filed by Erie, Oswego, and Schenectady Counties to remand their respective cases to New York state court. Each of these three matters was subsequently remanded to the New York Supreme Courts for the Counties of Erie, Oswego, and Schenectady, respectively. On November 28, 2007, the defendants filed a joint motion, with the State of New York Litigation Coordinating Panel, to coordinate the three actions. This motion is currently pending.
 
The Company's motion to dismiss the Commonwealth of Massachusetts' First Amended Complaint was denied on August 15, 2005. The Company answered the Commonwealth's First Amended Complaint on November 14, 2005.
 
With respect to the Alabama action, the Company filed an answer to the Second Amended Complaint on January 30, 2006. On October 11, 2006, the defendants for the second time removed the case to the United States District Court for the Middle District of Alabama. On November 2, 2006, the matter was again remanded to State court. Certain defendants, including the Company, filed motions in September 2006 to sever or for separate trials. The trial court denied these motions. On June 1, 2007, upon the petitions of certain defendants, including the Company, the Supreme Court of Alabama granted a writ of mandamus and ordered the trial court to sever the claims against all defendants.
 
With respect to the Illinois action, the United States District Court for the District of Massachusetts granted the State of Illinois' motion to remand on September 17, 2007. The case was remanded to the Circuit Court of Cook County, Illinois. On November 19, 2007, certain defendants, including the Company, filed a new joint motion to dismiss the First Amended Complaint. This motion is currently pending.
 
The court denied the defendants’ motions to dismiss in the action brought by the Commonwealth of Kentucky on June 23, 2006. The Company answered the First Amended Complaint on July 19, 2006. The Commonwealth of Kentucky filed a Second Amended Complaint on September 28, 2007. The Company answered the Second Amended Complaint on October 15, 2007.
 
With respect to the Mississippi action, the Special Masters assigned to the case recommended the denial of the defendants' motion to dismiss on September 22, 2006. On October 2, 2006, the defendants objected to the Special Masters' recommendation. The Court had not ruled on this objection at the time the case was removed to federal district court. Also, after removal, the matter was transferred to the United States District Court for the District of Massachusetts for coordinated and consolidated pre-trial proceedings, where the State's motion to remand is pending. The case was remanded to the Chancery Court of Hinds County, Mississippi. On December 13, 2007, the Court denied the defendants’ pending motion to dismiss. The defendants appealed the trial court's decision to the Supreme Court of Mississippi on January 3, 2008. This appeal is currently pending.
 
With respect to the Hawaii matter, the State's motion to remand the action was granted on November 30, 2006. On January 12, 2007, the defendants filed a joint motion to dismiss the State's First Amended Complaint. This motion was denied on April 11, 2007, and the Company answered the First Amended Complaint on April 23, 2007.
 
The State of Alaska filed an Amended Complaint on October 17, 2006, naming the Company and other pharmaceutical companies as defendants. The Alaska complaint pleads causes of action for (i) violation of the Alaska Unfair Trade Practices and Consumer Protection Act and (ii) unjust enrichment. The complaint seeks monetary damages; declarative relief; injunctive relief; compensatory, restitution, and/or disgorgement damages; civil penalties; punitive damages; costs, attorneys' fees, and prejudgment interest; and other relief deemed just and equitable by the Court. The defendants filed a joint motion to dismiss the State's Amended Complaint on January 5, 2007. This motion was denied on May 7, 2007. The Company intends to defend this action vigorously.
 
The State of South Carolina filed two related actions against the Company and other pharmaceutical companies on December 1, 2006. One of these Complaints seeks relief on behalf of the South Carolina Medicaid Agency and the other seeks relief on behalf of the South Carolina State Health Plan. Both South Carolina Complaints plead causes of action for (i) violation of the South Carolina Unfair Trade Practices Act; (ii) unjust enrichment; and (iii) injunctive relief. Both Complaints seek monetary damages and prejudgment interest; treble damages, attorneys' fees, and costs; civil penalties; disgorgement; injunctive relief; and other relief deemed just and equitable by the Court. On January 26, 2007, the Company moved to dismiss each Complaint or, in the alternative, for a more definite statement with respect to each Complaint. These motions are currently pending.
 
44

 
The State of Idaho filed a Complaint against the Company and various other pharmaceutical companies on January 26, 2007. The Idaho Complaint pleads causes of action for (i) violation of the Idaho Consumer Protection Act; and (ii) unjust enrichment. The State seeks declaratory and injunctive relief; monetary damages; civil penalties; disgorgement; attorneys' fees and costs; and other relief deemed just and equitable by the Court. On March 30, 2007, the defendants filed a joint motion to dismiss the State's Complaint. On August 31, 2007, the Court granted in part the defendants' joint motion to dismiss and denied it in part. On October 1, 2007, the Company answered the State's Complaint.
 
On April 5, 2007, the County of Orange, New York, filed a Complaint against the Company and various other pharmaceutical companies. The Orange County Complaint pleads causes of action for (i) violations of the Racketeer Influenced and Corrupt Practices Act; (ii) violation of various federal and state Medicaid laws; (iii) unfair trade practices; and (iv) common law claims for breach of contract, unjust enrichment, fraud, and fraudulent concealment. The County seeks actual, statutory, and treble damages, including interest; declaratory relief; disgorgement; restitution; attorneys' fees, experts' fees, and costs; and other relief deemed just and equitable by the Court. The Orange County action was transferred to the United States District Court for the District of Massachusetts for coordinated and consolidated pretrial proceedings. On September 6, 2007, that Court entered an order adding Orange County to the First Amended Consolidated Complaint filed by the City of New York and various other New York counties.
 
On September 21, 2007, the State of Utah filed a Complaint against the Company and various other pharmaceutical companies. The Utah Complaint pleads causes of action for (i) violations of the Utah False Claims Act and (ii) common law fraudulent misrepresentation. The State seeks actual, statutory, and treble damages, including prejudgment interest; restitution; attorneys' fees, experts' fees, and costs; and other relief deemed just and equitable by the Court. On November 20, 2007, the Judicial Panel on Multidistrict Litigation issued an order conditionally transferring the case to the United States District Court for the District of Massachusetts for coordinated and consolidated pretrial proceedings. The State then filed a motion to remand the case to state court, on December 7, 2007, and a motion to vacate the conditional transfer order, on December 12, 2007. These motions are currently pending.
 
On October 9, 2007, the State of Iowa filed a Complaint against the Company and various other pharmaceutical companies. The Iowa Complaint pleads causes of action for (i) violations of the Iowa Consumer Fraud Act, (ii) common law fraudulent misrepresentation, (iii) common law unjust enrichment and (iv) reporting of false best price information in violation of 42 USC Sec 1396R-8. The State seeks (i) a declaration that the Company committed the alleged violations, (ii) injunctive relief against the continuation of the alleged violations, (iii) actual, statutory damages, including prejudgment interest for the claim of unjust enrichment, (iv) actual, statutory damages, including prejudgment interest for the claim of fraudulent misrepresentation, (v) actual and punitive damages for alleged fraud, and (vi) an accounting of alleged illegal profits and a disgorgement of same, restitution, attorneys' fees, experts' fees, and costs and other relief deemed just and equitable by the Court. The Iowa action has been transferred to the United States District Court for the District of Massachusetts for coordinated and consolidated pretrial proceedings.

In March 2008, the Company received a letter request from the Attorney General of the State of Michigan. The request seeks documents and information relating to nominal price transactions. The Company is responding to the request and will cooperate with the inquiry.
 
Other

The Company is, from time to time, a party to certain other litigations, including product liability litigations. The Company believes that these litigations are part of the ordinary course of its business and that their ultimate resolution will not have a material adverse effect on its financial condition, results of operations or liquidity. The Company intends to defend or, in cases where the Company is plaintiff, to prosecute these litigations vigorously.

 
There are no material changes from the risk factors set forth in Part I, Item 1A, “Risk Factors,” of the Company’s 2007 Annual Report on Form 10-K. Please refer to that section for disclosures regarding certain risks and uncertainties related to the Company’s business and operations.

45


 
Issuer Purchases of Equity Securities(1)
 
Quarter Ending March 29, 2008
 
 
 
Period
 
Total Number
of Shares of
Common
Stock
Purchased (2)
 
Average
Price Paid
per Share of
Common
Stock
 
Total Number of Shares
of Common Stock
Purchased as Part of
Publicly Announced
Plans or Programs
 
Maximum Number of
Shares of Common
Stock that May Yet Be
Purchased Under the
Plans or Programs (3)
 
January 1, 2008 through January 26, 2008
   
23,546
     
N/A
     
-
     
-
 
January 27, 2008 through February 23, 2008
   
401
   
N/A
 
 
-
   
-
 
February 24, 2008 through March 29, 2008
   
29,411
   
N/A
   
-
   
2,517,860
 
Total
   
53,358
   
N/A
   
-
       
 
(1)
In April 2004, the Board authorized the repurchase of up to $50.0 million of the Company’s common stock. Repurchases are made, subject to compliance with applicable securities laws, from time to time in the open market or in privately negotiated transactions, whenever it appears prudent to do so. Shares of common stock acquired through the repurchase program are available for reissuance for general corporate purposes. On September 28, 2007, the Company announced that its Board approved an expansion of its share repurchase program allowing for the repurchase of up to $75 million of the Company’s common stock, inclusive of the $17.8 million remaining from the April 2004 authorization. The authorized amount remaining for stock repurchases under the repurchase program was $43.6 million, as of March 29, 2008. The repurchase program has no expiration date. 
 
(2)
The total number of shares purchased represents 53,358 shares surrendered to the registrant to satisfy tax withholding obligations in connection with the vesting of restricted stock issued to employees and issuance of stock in connection with restricted stock units issued to employees.
 
(3)
Based on the closing price of the Company’s common stock on the New York Stock Exchange of $17.30 at March 28, 2008.


10.1
Employment Agreement, dated as of March 4, 2008, by and between the Company, Par Pharmaceutical, Inc. and Patrick G. LePore (filed herewith).
   
10.2
Employment Agreement, dated as of March 4, 2008, by and between the Company, Par Pharmaceutical, Inc. and Gerard A. Martino (filed herewith).
   
10.3
Employment Agreement, dated as of March 4, 2008, by and between the Company, Par Pharmaceutical, Inc. and Thomas J. Haughey (filed herewith).
   
10.4
Employment Agreement, dated as of March 3, 2008, by and between the Company, Par Pharmaceutical, Inc. and Veronica Lubatkin (filed herewith).
   
10.5
Employment Agreement, dated as of March 5, 2008, by and between the Company, Par Pharmaceutical, Inc. and Paul V. Campanelli (filed herewith).
   
10.6
Employment Agreement, dated as of March 6, 2008, by and between the Company, Par Pharmaceutical, Inc. and John MacPhee (filed herewith).
   
31.1
Certification of the Principal Executive Officer (filed herewith).
   
31.2
Certification of the Principal Financial Officer (filed herewith).
   
32.1
Certification by the Chief Executive Officer pursuant to 18 U.S.C. Section 1350, as adopted pursuant to Section 906 of the Sarbanes-Oxley Act of 2002 (attached hereto).
   
32.2
Certification by the Chief Financial Officer pursuant to 18 U.S.C. Section 1350, as adopted pursuant to Section 906 of the Sarbanes-Oxley Act of 2002 (attached hereto).

46



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

 
PAR PHARMACEUTICAL COMPANIES, INC.
 
 
(Registrant)
 
     
Date: May 8, 2008
/s/ Patrick G. LePore
 
 
Patrick G. LePore
 
 
Chairman, President and Chief Executive Officer
 
     
Date: May 8, 2008
/s/ Veronica A. Lubatkin
 
 
Veronica A. Lubatkin
 
 
Executive Vice President and Chief Financial Officer
 

47


EXHIBIT INDEX

Exhibit Number
 
Description
     
10.1
 
Employment Agreement, dated as of March 4, 2008, by and between the Company, Par Pharmaceutical, Inc. and Patrick G. LePore (filed herewith).
     
10.2
 
Employment Agreement, dated as of March 4, 2008, by and between the Company, Par Pharmaceutical, Inc. and Gerard A. Martino (filed herewith).
     
10.3
 
Employment Agreement, dated as of March 4, 2008, by and between the Company, Par Pharmaceutical, Inc. and Thomas J. Haughey (filed herewith).
     
10.4
 
Employment Agreement, dated as of March 3, 2008, by and between the Company, Par Pharmaceutical, Inc. and Veronica Lubatkin (filed herewith).
     
10.5
 
Employment Agreement, dated as of March 5, 2008, by and between the Company, Par Pharmaceutical, Inc. and Paul V. Campanelli (filed herewith).
     
10.6
 
Employment Agreement, dated as of March 6, 2008, by and between the Company, Par Pharmaceutical, Inc. and John MacPhee (filed herewith).
     
31.1
 
Certification of the Principal Executive Officer (filed herewith).
     
31.2
 
Certification of the Principal Financial Officer (filed herewith).
     
32.1
 
Certification by the Chief Executive Officer pursuant to 18 U.S.C. Section 1350, as adopted pursuant to Section 906 of the Sarbanes-Oxley Act of 2002 (attached hereto).
     
32.2
 
Certification by the Chief Financial Officer pursuant to 18 U.S.C. Section 1350, as adopted pursuant to Section 906 of the Sarbanes-Oxley Act of 2002 (attached hereto).
 
48