-----BEGIN PRIVACY-ENHANCED MESSAGE----- Proc-Type: 2001,MIC-CLEAR Originator-Name: webmaster@www.sec.gov Originator-Key-Asymmetric: MFgwCgYEVQgBAQICAf8DSgAwRwJAW2sNKK9AVtBzYZmr6aGjlWyK3XmZv3dTINen TWSM7vrzLADbmYQaionwg5sDW3P6oaM5D3tdezXMm7z1T+B+twIDAQAB MIC-Info: RSA-MD5,RSA, MidFI3KVKlZLD15hM2+cmNDeKc/YXeYmfucYTXwVWjWA8iLksCRLhx+UmVKY9akq lm/PnX/n00BTPJNwFSkqTw== 0001104659-05-053989.txt : 20051109 0001104659-05-053989.hdr.sgml : 20051109 20051109143645 ACCESSION NUMBER: 0001104659-05-053989 CONFORMED SUBMISSION TYPE: 10-Q PUBLIC DOCUMENT COUNT: 7 CONFORMED PERIOD OF REPORT: 20050930 FILED AS OF DATE: 20051109 DATE AS OF CHANGE: 20051109 FILER: COMPANY DATA: COMPANY CONFORMED NAME: CEPHALON INC CENTRAL INDEX KEY: 0000873364 STANDARD INDUSTRIAL CLASSIFICATION: PHARMACEUTICAL PREPARATIONS [2834] IRS NUMBER: 232484489 STATE OF INCORPORATION: DE FISCAL YEAR END: 1231 FILING VALUES: FORM TYPE: 10-Q SEC ACT: 1934 Act SEC FILE NUMBER: 000-19119 FILM NUMBER: 051189371 BUSINESS ADDRESS: STREET 1: 41 MOORES ROAD CITY: FRAZER STATE: PA ZIP: 19355 BUSINESS PHONE: 6103440200 MAIL ADDRESS: STREET 1: 41 MOORES ROAD CITY: FRAZER STATE: PA ZIP: 19355 10-Q 1 a05-18061_110q.htm QUARTERLY REPORT PURSUANT TO SECTIONS 13 OR 15(D)

 

UNITED STATES
SECURITIES AND EXCHANGE COMMISSION

WASHINGTON, D.C.  20549

 


 

FORM 10-Q

 

(Mark One)

 

ý

QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(D) OF THE SECURITIES EXCHANGE ACT OF 1934

 

For the quarterly period ended September 30, 2005

 

OR

 

o

TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(D) OF THE SECURITIES EXCHANGE ACT OF 1934

 

For the transition period from                 to                   

 

Commission File Number 0-19119

 

CEPHALON, INC.

(Exact Name of Registrant as Specified in its Charter)

 

Delaware

 

23-2484489

(State or Other Jurisdiction of Incorporation or

 

(I.R.S. Employer Identification Number)

Organization)

 

 

 

 

 

41 Moores Road, Frazer, PA

 

19355

(Address of Principal Executive Offices)

 

(Zip Code)

 

(610) 344-0200

(Registrant’s Telephone Number, Including Area Code)

 

Not Applicable

(Former Name, Former Address and Former Fiscal Year, If Changed Since Last Report)

 

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  ý  No  o

 

Indicate by check mark whether the registrant is an accelerated filer (as defined in Rule 12b-2 of the Exchange Act).
Yes  
ý  No  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  ý

 

Indicate the number of shares outstanding of each of the registrant’s classes of common stock, as of the latest practicable date.

 

Class

 

Outstanding as of November 3, 2005

Common Stock, par value $.01

 

58,088,789 Shares

 

 



 

CEPHALON, INC. AND SUBSIDIARIES

 

INDEX

 

Cautionary Note Regarding Forward-Looking Statements

3

 

 

 

 

 

PART I – FINANCIAL INFORMATION

 

 

 

 

 

 

 

Item 1.

Consolidated Financial Statements

 

 

 

 

 

 

 

 

 

Consolidated Balance Sheets -
September 30, 2005 and December 31, 2004

4

 

 

 

 

 

 

 

 

Consolidated Statements of Operations -
Three and nine months ended September 30, 2005 and 2004

5

 

 

 

 

 

 

 

 

Consolidated Statements of Stockholders’ Equity -
September 30, 2005 and December 31, 2004

6

 

 

 

 

 

 

 

 

Consolidated Statements of Cash Flows -
Nine months ended September 30, 2005 and 2004

7

 

 

 

 

 

 

 

 

Notes to Consolidated Financial Statements

8

 

 

 

 

 

 

Item 2.

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

21

 

 

 

 

 

 

Item 3.

Quantitative and Qualitative Disclosure about Market Risk

48

 

 

 

 

 

 

Item 4.

Controls and Procedures

48

 

 

 

 

 

PART II – OTHER INFORMATION

 

 

 

 

 

 

 

Item 1.

Legal Proceedings

49

 

 

 

 

 

 

Item 2.

Unregistered Sales of Equity Securities and Use of Proceeds

49

 

 

 

 

 

 

Item 5.

Other Information

49

 

 

 

 

 

 

Item 6.

Exhibits

49

 

 

 

 

 

SIGNATURES

51

 

2



 

CAUTIONARY NOTE REGARDING FORWARD-LOOKING STATEMENTS

 

In addition to historical facts or statements of current condition, this report and the documents into which this report is and will be incorporated contain forward-looking statements within the meaning of Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, as amended. Forward-looking statements contained in this report constitute our expectations or forecasts of future events as of the date this report was filed with the SEC and are not statements of historical fact. You can identify these statements by the fact that they do not relate strictly to historical or current facts. Such statements may include words such as “anticipate,” “will,” “estimate,” “expect,” “project,” “intend,” “should,” “plan,” “believe,” “hope,” and other words and terms of similar meaning in connection with any discussion of, among other things, future operating or financial performance, strategic initiatives and business strategies, regulatory or competitive environments, our intellectual property and product development. In particular, these forward-looking statements include, among others, statements about:

 

                  our dependence on sales of PROVIGIL® (modafinil) tablets [C-IV], ACTIQ® (oral transmucosal fentanyl citrate) [C-II] and GABITRIL® (tiagabine hydrochloride) in the United States and the market prospects and future marketing efforts for these products and for our near-term product candidates, if approved;

                  any potential expansion of the authorized uses of our existing products or approval of our potential product candidates;

                  our anticipated scientific progress in our research programs and our development of potential pharmaceutical products including our ongoing or planned clinical trials, the timing and costs of such trials and the likelihood or timing of revenues from these products, if any;

                  the timing and unpredictability of regulatory approvals;

                  our ability to adequately protect our technology and enforce our intellectual property rights and the future expiration of patent and/or regulatory exclusivity on certain of our products;

                  our future cash flow, our ability to service or repay our existing debt and our ability to raise additional funds, if needed, in light of our current and projected level of operations; and

                  other statements regarding matters that are not historical facts or statement of current condition.

 

Any or all of our forward-looking statements in this report and in the documents we have referred you to may turn out to be wrong. They can be affected by inaccurate assumptions we might make or by known or unknown risks and uncertainties. Therefore, you should not place undue reliance on any such forward-looking statements. The factors that could cause actual results to differ from those expressed or implied by our forward-looking statements include, among others:

 

                  the acceptance of our products by physicians and patients in our current markets and new markets;

                  our ability to obtain regulatory approvals of our product candidates and to launch such products successfully;

                  scientific or regulatory setbacks with respect to research programs, clinical trials, manufacturing activities and/or our existing products;

                  unanticipated cash requirements to support current operations, expand our business or incur capital expenditures;

                  the inability to adequately protect our key intellectual property rights, including as a result of an adverse adjudication with respect to the PROVIGIL or ACTIQ patent litigation;

                  the loss of key management or scientific personnel;

                  the activities of our competitors in the industry, including the possibility of generic competition to PROVIGIL and ACTIQ;

                  market conditions in the biotechnology industry that make raising capital or consummating acquisitions difficult, expensive or both; and

                  enactment of new government regulations, court decisions, regulatory interpretations or other initiatives that are adverse to us or our interests.

 

We do not intend to update publicly any forward-looking statement, whether as a result of new information, future events or otherwise, except as required by law. We discuss in more detail the risks that we anticipate in the section above included in Part I, Item 2 of this report entitled “Certain Risks Related to our Business.” This discussion is permitted by the Private Securities Litigation Reform Act of 1995.

 

3



 

PART I – FINANCIAL INFORMATION

ITEM 1. CONSOLIDATED FINANCIAL STATEMENTS

 

CEPHALON, INC. AND SUBSIDIARIES

 

CONSOLIDATED BALANCE SHEETS

 

 

 

September 30,

 

December 31,

 

(In thousands, except share data)

 

2005

 

2004

 

 

 

(Unaudited)

 

 

 

ASSETS

 

 

 

 

 

 

 

 

 

 

 

CURRENT ASSETS:

 

 

 

 

 

Cash and cash equivalents

 

$

585,276

 

$

574,244

 

Investments

 

230,348

 

217,432

 

Receivables, net

 

160,362

 

208,225

 

Inventory, net

 

119,342

 

86,629

 

Deferred tax asset

 

50,835

 

47,118

 

Other current assets

 

43,224

 

39,915

 

Total current assets

 

1,189,387

 

1,173,563

 

 

 

 

 

 

 

PROPERTY AND EQUIPMENT, net

 

274,020

 

244,834

 

GOODWILL

 

369,534

 

372,534

 

INTANGIBLE ASSETS, net

 

512,991

 

449,402

 

DEBT ISSUANCE COSTS, net

 

41,282

 

25,401

 

DEFERRED TAX ASSET, net

 

286,077

 

163,620

 

OTHER ASSETS

 

17,677

 

22,549

 

 

 

$

2,690,968

 

$

2,451,903

 

 

 

 

 

 

 

LIABILITIES AND STOCKHOLDERS’ EQUITY

 

 

 

 

 

 

 

 

 

 

 

CURRENT LIABILITIES:

 

 

 

 

 

Current portion of long-term debt

 

$

3,465

 

$

5,114

 

Accounts payable

 

56,795

 

52,488

 

Accrued expenses

 

189,644

 

169,568

 

Current portion of deferred revenues

 

444

 

868

 

Total current liabilities

 

250,348

 

228,038

 

 

 

 

 

 

 

LONG-TERM DEBT

 

1,692,630

 

1,284,410

 

DEFERRED REVENUES

 

1,174

 

1,769

 

DEFERRED TAX LIABILITIES

 

103,879

 

94,100

 

OTHER LIABILITIES

 

55,602

 

13,542

 

Total liabilities

 

2,103,633

 

1,621,859

 

 

 

 

 

 

 

COMMITMENTS AND CONTINGENCIES

 

 

 

 

 

 

 

 

 

STOCKHOLDERS’ EQUITY:

 

 

 

 

 

Preferred stock, $.01 par value, 5,000,000 shares authorized, 2,500,000 shares issued, and none outstanding

 

 

 

Common stock, $.01 par value, 200,000,000 shares authorized, 58,079,125 and 57,973,050 shares issued, and 57,745,625 and 57,640,266 shares outstanding

 

581

 

580

 

Additional paid-in capital

 

1,151,933

 

1,172,499

 

Treasury stock, 333,500 and 332,784 shares outstanding, at cost

 

(14,892

)

(14,860

)

Accumulated deficit

 

(588,145

)

(395,118

)

Accumulated other comprehensive income

 

37,858

 

66,943

 

Total stockholders’ equity

 

587,335

 

830,044

 

 

 

$

2,690,968

 

$

2,451,903

 

 

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

 

4



 

CEPHALON, INC. AND SUBSIDIARIES

 

CONSOLIDATED STATEMENTS OF OPERATIONS

(Unaudited)

 

 

 

Three Months Ended
September 30,

 

Nine Months Ended
September 30,

 

(In thousands, except per share data)

 

2005

 

2004

 

2005

 

2004

 

 

 

 

 

 

 

 

 

 

 

REVENUES:

 

 

 

 

 

 

 

 

 

Sales

 

$

294,371

 

$

253,594

 

$

833,588

 

$

698,975

 

Other revenues

 

15,165

 

8,373

 

41,900

 

17,451

 

 

 

309,536

 

261,967

 

875,488

 

716,426

 

 

 

 

 

 

 

 

 

 

 

COSTS AND EXPENSES:

 

 

 

 

 

 

 

 

 

Cost of sales

 

37,629

 

33,782

 

114,093

 

89,599

 

Research and development

 

91,934

 

67,683

 

255,591

 

198,208

 

Selling, general and administrative

 

103,253

 

76,204

 

302,904

 

243,908

 

Depreciation and amortization

 

22,346

 

13,784

 

61,151

 

36,927

 

Impairment charge

 

 

 

 

30,071

 

Acquired in-process research and development

 

5,500

 

185,700

 

295,615

 

185,700

 

 

 

260,662

 

377,153

 

1,029,354

 

784,413

 

 

 

 

 

 

 

 

 

 

 

INCOME (LOSS) FROM OPERATIONS

 

48,874

 

(115,186

)

(153,866

)

(67,987

)

 

 

 

 

 

 

 

 

 

 

OTHER INCOME AND EXPENSE

 

 

 

 

 

 

 

 

 

Interest income

 

7,247

 

4,804

 

19,559

 

11,639

 

Interest expense

 

(7,494

)

(5,176

)

(19,311

)

(16,888

)

Debt exchange expense

 

 

(28,230

)

 

(28,230

)

Gain (charge) on early extinguishment of debt

 

2,085

 

(1,352

)

2,085

 

(2,313

)

Other income (expense), net

 

(38

)

(642

)

1,983

 

(2,444

)

 

 

1,800

 

(30,596

)

4,316

 

(38,236

)

 

 

 

 

 

 

 

 

 

 

INCOME (LOSS) BEFORE INCOME TAXES

 

50,674

 

(145,782

)

(149,550

)

(106,223

)

 

 

 

 

 

 

 

 

 

 

INCOME TAX EXPENSE

 

(21,331

)

(19,464

)

(43,477

)

(45,695

)

 

 

 

 

 

 

 

 

 

 

NET INCOME (LOSS)

 

$

29,343

 

$

(165,246

)

$

(193,027

)

$

(151,918

)

 

 

 

 

 

 

 

 

 

 

BASIC INCOME (LOSS) PER COMMON SHARE

 

$

0.51

 

$

(2.94

)

$

(3.33

)

$

(2.71

)

 

 

 

 

 

 

 

 

 

 

DILUTED INCOME (LOSS) PER COMMON SHARE

 

$

0.50

 

$

(2.94

)

$

(3.33

)

$

(2.71

)

 

 

 

 

 

 

 

 

 

 

WEIGHTED AVERAGE NUMBER OF COMMON SHARES OUTSTANDING

 

58,064

 

56,178

 

58,035

 

56,065

 

 

 

 

 

 

 

 

 

 

 

WEIGHTED AVERAGE NUMBER OF COMMON SHARES OUTSTANDING-ASSUMING DILUTION

 

59,398

 

56,178

 

58,035

 

56,065

 

 

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

 

5



 

CEPHALON, INC. AND SUBSIDIARIES

 

CONSOLIDATED STATEMENTS OF STOCKHOLDERS’ EQUITY

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Accumulated

 

 

 

 

 

 

 

 

 

 

 

Additional

 

 

 

 

 

 

 

Other

 

 

 

Comprehensive

 

 

 

Common Stock

 

Paid-in

 

Treasury Stock

 

Accumulated

 

Comprehensive

 

(In thousands, except share data)

 

Income (Loss)

 

Total

 

Shares

 

Amount

 

Capital

 

Shares

 

Amount

 

Deficit

 

Income

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

BALANCE, JANUARY 1, 2004

 

 

 

$

770,370

 

55,842,510

 

$

558

 

$

1,052,059

 

308,828

 

$

(13,692

)

$

(321,305

)

$

52,750

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Net Loss

 

$

(73,813

)

(73,813

)

 

 

 

 

 

 

 

 

 

 

(73,813

)

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Foreign currency translation gain

 

16,071

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Unrealized investment losses

 

(1,878

)

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Other comprehensive gain

 

14,193

 

14,193

 

 

 

 

 

 

 

 

 

 

 

 

 

14,193

 

Comprehensive loss

 

$

(59,620

)

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Issuance of common stock upon conversion of convertible notes

 

 

 

105,122

 

1,518,169

 

15

 

105,107

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Tax effect upon conversion of convertible notes

 

 

 

(10,100

)

 

 

 

 

(10,100

)

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Stock options exercised

 

 

 

12,051

 

535,446

 

6

 

12,045

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Tax benefit from the exercise of stock options

 

 

 

8,017

 

 

 

 

 

8,017

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Restricted stock award plan

 

 

 

5,372

 

76,925

 

1

 

5,371

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Treasury stock acquired

 

 

 

(1,168

)

 

 

 

 

 

 

23,956

 

(1,168

)

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

BALANCE, DECEMBER 31, 2004

 

 

 

830,044

 

57,973,050

 

580

 

1,172,499

 

332,784

 

(14,860

)

(395,118

)

66,943

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Net Loss

 

$

(193,027

)

(193,027

)

 

 

 

 

 

 

 

 

 

 

(193,027

)

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Foreign currency translation loss

 

(27,427

)

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Unrealized investment losses

 

(1,658

)

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Other comprehensive loss

 

(29,085

)

(29,085

)

 

 

 

 

 

 

 

 

 

 

 

 

(29,085

)

Comprehensive loss

 

$

(222,112

)

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Sale of warrants associated with convertible subordinated notes

 

 

 

217,071

 

 

 

 

 

217,071

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Purchase of convertible note hedge associated with convertible subordinated notes

 

 

 

(382,261

)

 

 

 

 

(382,261

)

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Tax benefit from the purchase of convertible note hedge

 

 

 

133,791

 

 

 

 

 

133,791

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Stock options exercised

 

 

 

2,247

 

106,075

 

1

 

2,246

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Tax benefit from the exercise of stock options, net of adjustment

 

 

 

956

 

 

 

 

 

956

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Restricted stock award plan

 

 

 

7,631

 

 

 

 

 

7,631

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Treasury stock acquired

 

 

 

(32

)

 

 

 

 

 

 

716

 

(32

)

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

BALANCE, SEPTEMBER 30, 2005
(Unaudited)

 

 

 

$

587,335

 

58,079,125

 

$

581

 

$

1,151,933

 

333,500

 

$

(14,892

)

$

(588,145

)

$

37,858

 

 

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

 

6



 

CEPHALON, INC. AND SUBSIDIARIES

 

CONSOLIDATED STATEMENTS OF CASH FLOWS

(Unaudited)

 

 

 

Nine Months Ended
September 30,

 

(In thousands)

 

2005

 

2004

 

 

 

 

 

 

 

CASH FLOWS FROM OPERATING ACTIVITIES:

 

 

 

 

 

Net Loss

 

$

(193,027

)

$

(151,918

)

Adjustments to reconcile net loss to net cash provided by operating activities:

 

 

 

 

 

Deferred income taxes

 

27,931

 

11,853

 

Tax benefit from equity compensation

 

3,956

 

3,109

 

Debt exchange expense

 

 

28,230

 

Tax effect on conversion of convertible notes

 

 

(11,288

)

Depreciation and amortization

 

70,966

 

39,327

 

Amortization of debt issuance costs

 

6,521

 

6,420

 

Stock-based compensation expense

 

7,631

 

3,793

 

Non-cash (gain) charge on early extinguishment of debt

 

(4,549

)

2,313

 

Pension curtailment

 

 

(4,214

)

Loss on disposals of property and equipment

 

949

 

430

 

Impairment charge

 

 

30,071

 

Acquired in-process research and development

 

130,615

 

185,700

 

Increase (decrease) in cash due to changes in assets and liabilities, net of effect from acquisition:

 

 

 

 

 

Receivables

 

43,347

 

(40,085

)

Inventory

 

(37,084

)

(4,504

)

Other assets

 

(6,963

)

18,122

 

Accounts payable, accrued expenses and deferred revenues

 

21,671

 

12,018

 

Other liabilities

 

(3,555

)

2,225

 

 

 

 

 

 

 

Net cash provided by operating activities

 

68,409

 

131,602

 

 

 

 

 

 

 

CASH FLOWS FROM INVESTING ACTIVITIES:

 

 

 

 

 

Purchases of property and equipment

 

(63,951

)

(27,283

)

Acquisition of CIMA, net of cash acquired

 

 

(482,521

)

Acquisition of Salmedix, net of cash acquired

 

(130,733

)

 

Acquisition of TRISENOX

 

(69,722

)

 

Acquisition of intangible assets

 

(2,652

)

(308

)

Sales and maturities of investments

 

90,361

 

76,653

 

Purchases of investments

 

(104,474

)

(169,741

)

 

 

 

 

 

 

Net cash used for investing activities

 

(281,171

)

(603,200

)

 

 

 

 

 

 

CASH FLOWS FROM FINANCING ACTIVITIES:

 

 

 

 

 

Proceeds from exercises of common stock options

 

2,247

 

8,794

 

Acquisition of treasury stock

 

(32

)

(14

)

Payments on and retirements of long-term debt

 

(501,958

)

(45,924

)

Net proceeds from issuance of convertible subordinated notes

 

891,949

 

 

Proceeds from sale of warrants

 

217,071

 

 

Purchase of convertible note hedge

 

(382,261

)

 

 

 

 

 

 

 

Net cash provided by (used for) financing activities

 

227,016

 

(37,144

)

 

 

 

 

 

 

EFFECT OF EXCHANGE RATE CHANGES ON CASH AND CASH EQUIVALENTS

 

(3,222

)

(965

)

 

 

 

 

 

 

NET INCREASE (DECREASE) IN CASH AND CASH EQUIVALENTS

 

11,032

 

(509,707

)

 

 

 

 

 

 

CASH AND CASH EQUIVALENTS, BEGINNING OF PERIOD

 

574,244

 

1,115,699

 

 

 

 

 

 

 

CASH AND CASH EQUIVALENTS, END OF PERIOD

 

$

585,276

 

$

605,992

 

 

 

 

 

 

 

Non-cash financing activities:

 

 

 

 

 

Tax benefit from the purchase of convertible note hedge

 

$

133,791

 

$

 

Conversion of convertible notes into common stock

 

 

78,250

 

 

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

 

7



 

CEPHALON, INC. AND SUBSIDIARIES

NOTES TO CONSOLIDATED FINANCIAL STATEMENTS

(Unaudited)

Amounts in thousands, except share data

 

1.              BASIS OF PRESENTATION

 

The accompanying unaudited consolidated financial statements have been prepared in accordance with accounting principles generally accepted in the United States of America for interim financial information and with the instructions to Form 10-Q and Article 10 of Regulation S-X.  Accordingly, they do not include all of the information and footnote disclosures required by accounting principles generally accepted in the United States of America for complete financial statements.  In the opinion of management, all adjustments (consisting only of normal recurring accruals) considered necessary for a fair presentation have been included.  These financial statements should be read in conjunction with the consolidated financial statements and notes thereto included in our Annual Report on Form 10-K, filed with the Securities and Exchange Commission, which includes audited financial statements as of December 31, 2004 and 2003 and for each of the three years in the period ended December 31, 2004.  The results of our operations for any interim period are not necessarily indicative of the results of our operations for any other interim period or for a full year.

 

Reclassifications

 

Certain reclassifications of prior year amounts have been made to conform with the current year presentation.

 

Recent Accounting Pronouncements

 

We are currently in the process of evaluating or adopting the following recent accounting pronouncements:

 

In November 2004, the Financial Accounting Standards Board (“FASB”) issued Statement of Financial Accounting Standards (“SFAS”) No. 151, “Inventory Costs” (“SFAS No. 151”), which requires abnormal amounts of idle capacity and spoilage costs to be excluded from the cost of inventory and expensed when incurred.  SFAS No. 151 is effective for fiscal years beginning after June 15, 2005.  We are currently evaluating the impact of SFAS No. 151, and we do not expect the adoption of this statement to have a material impact on the financial statements.

 

In December 2004, the FASB issued SFAS No. 123R, “Share-Based Payment” (“SFAS No. 123R”) a revision of SFAS No. 123 “Accounting for Stock-Based Compensation” (“SFAS No. 123”) that addresses the accounting for share-based payment transactions in which an enterprise receives employee services in exchange for (a) equity instruments of the enterprise or (b) liabilities that are based on the fair value of the enterprise’s equity instruments or that may be settled by the issuance of such equity instruments.  SFAS No. 123R requires that an entity measure the cost of equity based service awards based on the grant-date fair value of the award and recognize the cost of such awards over the period during which the employee is required to provide service in exchange for the award (the vesting period).  SFAS No. 123R requires that an entity measure the cost of liability-based service awards based on current fair value that is remeasured subsequently at each reporting date through the settlement date.  On April 14, 2005, the Securities Exchange Commission delayed the effective date of SFAS No. 123R to annual periods that begin after June 15, 2005.  We will adopt this new standard effective January 1, 2006, under the modified prospective transition method, which will require us to recognize share-based compensation expense in our statement of operations for any new grants and modifications made after the date of adoption, plus any remaining unrecognized SFAS No. 123 expense of previously issued awards. We have not yet fully quantified the impact this statement will have on our future financial results, but expect that it will be material.

 

In December 2004, the FASB issued Staff Position No. FAS 109-1, “Application of FASB Statement No. 109, Accounting for Income Taxes, to the Tax Deduction on Qualified Production Activities Provided by the American Jobs Creation Act of 2004” (“FSP No. 109-1”), and Staff Position No. FAS 109-2, “Accounting and Disclosure Guidance for the Foreign Earnings Repatriation Provision within the American Jobs Creation Act of 2004” (“FSP No. 109-2”). These staff positions provide accounting guidance on how companies should account for the effects of the American Jobs Creation Act of 2004 that was signed into law on October 22, 2004. FSP No. 109-1 states that the tax relief (special tax deduction for domestic manufacturing) from this legislation should be accounted for as a “special deduction” instead of a tax rate reduction. FSP No. 109-2 gives a company additional time to evaluate the effects of the legislation on any plan for reinvestment or repatriation of foreign earnings for purposes of applying FASB Statement No. 109. FSP No. 109-1 has no significant impact on our current financial statements.  We have considered repatriation of unremitted earnings and have found it would not be beneficial to ongoing operations at this time.  As a result, FSP No. 109-2 has no significant impact on our current financial statements.

 

8



 

In May 2005, the FASB issued SFAS No. 154, “Accounting Changes and Error Corrections,” which requires retrospective application to prior period financial statements of changes in accounting principle or corrections of errors, unless it is impracticable to determine either the period-specific effects or the cumulative effect of the change, or where there is other specific guidance.  This statement is effective for accounting changes and corrections of errors made in fiscal years beginning after December 15, 2005.  We have not recorded any changes in accounting principle or made any corrections of errors under the scope of SFAS No. 154.  We will continue to evaluate these types of activities each reporting period going forward.

 

In March 2005, the FASB issued FASB Interpretation No. 47, “Accounting for Conditional Asset Retirement Obligations” (FIN 47).  FIN 47 clarifies that the term “conditional asset retirement” refers to an entity’s legal obligation to perform an asset retirement activity in which the timing and method of settlement are conditional on a future event that may or may not be within the control of the entity.  FIN 47 clarifies that an entity must record a liability for a conditional asset retirement obligation if the fair value of the obligation can be reasonably estimated.   We do not expect the application of FIN 47, effective the end of fiscal years ending after December 15, 2005, to have a material effect on our financial position, results of operations or cash flows.

 

Stock-Based Compensation

 

We account for stock option plans and restricted stock award plans using the intrinsic value method prescribed in Accounting Principles Board Opinion No. 25, “Accounting for Stock Issued to Employees.”  Compensation cost for stock options, if any, is measured as the excess of the quoted market price of the stock at the date of grant over the amount an employee must pay to acquire the stock.  Restricted stock awards are recorded as compensation cost over the requisite vesting periods based on the market value on the date of grant.  We have opted to disclose only the provisions of SFAS No. 123 and SFAS No. 148, “Accounting for Stock-Based Compensation – Transition and Disclosure – An Amendment to FASB Statement No. 123” (“SFAS No. 148”) as they pertain to financial statement recognition of compensation expense attributable to option grants.  As such, no compensation cost has been recognized for our stock option plans.  If we had elected to recognize compensation cost based on the fair value of granted stock options as prescribed by SFAS No. 123 and SFAS No. 148, the pro forma income and income per share amounts would have been as follows:

 

 

 

For the three months
ended September 30,

 

For the nine months
ended September 30,

 

 

 

2005

 

2004

 

2005

 

2004

 

Net income (loss), as reported

 

$

29,343

 

$

(165,246

)

$

(193,027

)

$

(151,918

)

Add: Stock-based compensation expense included in net income, net of related tax effects

 

1,473

 

792

 

5,099

 

2,314

 

Deduct: Total stock-based employee compensation expense determined under fair value based method for all awards, net of related tax effects

 

(6,514

)

(8,517

)

(22,664

)

(23,312

)

Pro forma net income (loss)

 

$

24,302

 

$

(172,971

)

$

(210,592

)

$

(172,916

)

 

 

 

 

 

 

 

 

 

 

Earnings per share:

 

 

 

 

 

 

 

 

 

Basic income (loss) per share, as reported

 

$

0.51

 

$

(2.94

)

$

(3.33

)

$

(2.71

)

Basic income (loss) per share, pro forma

 

$

0.42

 

$

(3.08

)

$

(3.63

)

$

(3.08

)

 

 

 

 

 

 

 

 

 

 

Diluted income (loss) per share, as reported

 

$

0.50

 

$

(2.94

)

$

(3.33

)

$

(2.71

)

Diluted income (loss) per share, pro forma

 

$

0.42

 

$

(3.08

)

$

(3.63

)

$

(3.08

)

 

No change to our previously reported earnings per share for the three and nine months ended September 30, 2004 has resulted from our adoption of EITF No. 04-8, which was effective on December 15, 2004.  See Note 11.

 

2.              ACQUISITION OF CIMA LABS INC.

 

On August 12, 2004, we completed our acquisition of CIMA LABS INC. (“CIMA LABS”). Under the Agreement and Plan of Merger dated November 3, 2003, we acquired each outstanding share of CIMA LABS common stock for $34.00 per share in cash.  The total cash paid to CIMA LABS stockholders in the transaction was approximately $482.5 million, net of CIMA LABS’ existing cash on hand, or $409.4 million, net of its cash, cash equivalents and investments.  As a result of the acquisition, we obtained the rights to CIMA LABS’ fentanyl effervescent buccal tablets product candidate (formerly referred to as ORAVESCENT® fentanyl), for which we recently filed an NDA with the FDA for the treatment of

 

9



 

breakthrough cancer pain in opioid-tolerant patients.  Fentanyl effervescent buccal tablets utilize an enhanced absorption transmucosal drug delivery technology that we believe may facilitate the rapid onset of pain relief in such patients.  We are targeting approval of this product by the FDA in late 2006.

 

The total purchase price of $514.1 million consists of $500.1 million for all outstanding shares of CIMA LABS at $34.00 per share and $14.0 million in direct transaction costs. The acquisition was funded from Cephalon’s existing cash and short-term investments. In connection with the acquisition, CIMA LABS used $18.8 million of their own funds to purchase all outstanding employee stock options, whether or not vested or exercisable, for an amount equal to $34.00 less the exercise price for such option.

 

The following table summarizes the estimated fair values of assets acquired and liabilities assumed at the date of acquisition:

 

 

 

At August 12,
2004

 

Cash and cash equivalents

 

$

31,604

 

Available-for-sale investments

 

73,169

 

Receivables

 

8,821

 

Inventory

 

6,224

 

Deferred tax asset, net

 

20,985

 

Other current assets

 

555

 

Property, plant and equipment

 

82,474

 

Intangible assets

 

113,100

 

Acquired in-process research and development

 

185,700

 

Goodwill

 

68,843

 

Total assets acquired

 

591,475

 

Current liabilities

 

(32,783

)

Deferred tax liability

 

(44,567

)

Total liabilities assumed

 

(77,350

)

Net assets acquired

 

$

514,125

 

 

Of the $113.1 million of acquired intangible assets, $70.0 million was assigned to the DuraSolv® technology with an estimated useful life of 14 years, $32.7 million was assigned to the OraSolv® technology with a weighted average estimated useful life of approximately 6 years, and $10.4 million was assigned to the developed OraVescent® technology with an estimated useful life of 15 years. The $68.8 million of goodwill was originally assigned to our biopharmaceutical segment.  As disclosed in footnote 12, we have revised our segment reporting to include two segments, United States and Europe.  In accordance with SFAS No. 142, “Goodwill and Other Intangible Assets” (“SFAS No. 142”), goodwill is not amortized, but will be subject to a periodic assessment for impairment by applying a fair-value-based test. None of this goodwill is expected to be deductible for income tax purposes.

 

Our purchase price allocation was finalized during the first quarter of 2005. We allocated $185.7 million of the purchase price to in-process research and development projects. In-process research and development (“IPR&D”) represents the valuation of acquired, to-be-completed research projects. At the acquisition date, CIMA LABS’ ongoing research and development initiatives were primarily involved with the development and commencement of Phase 3 clinical trials of fentanyl effervescent buccal tablets for the treatment of breakthrough cancer pain in opioid-tolerant patients, and several other minor ongoing research and development projects.  At the acquisition date of August 12, 2004, CIMA LABS had spent approximately $5.6 million on the fentanyl effervescent buccal tablets IPR&D project.  As of the end of the third quarter of 2005, we have spent an additional $13.6 million on the project, and we expect to spend an additional $4.7 million through the remainder of 2005.  The estimated revenues for the in-process projects are expected to be recognized from 2006 through 2019.

 

The value assigned to purchased in-process technology was determined by estimating the costs to develop the acquired technology into commercially viable products, estimating the resulting net cash flows from the projects, and discounting the net cash flows to their present value. The revenue projections used to value IPR&D were, in some cases, reduced based on the probability of developing a new drug, and considered the relevant market sizes and growth factors, expected trends in technology, and the nature and expected timing of new product introductions by us and our competitors. The resulting net cash flows from such projects are based on management’s estimates of cost of sales, operating expenses, and income taxes from such projects. The rates utilized to discount the net cash flows to their present value were based on estimated cost of capital calculations. Due to the nature of the forecast and the risks associated with the projected growth and

 

10



 

profitability of the developmental projects, discount rates of 28 percent were considered appropriate for the IPR&D. These discount rates were commensurate with the projects’ stage of development and the uncertainties in the economic estimates described above.

 

If these projects are not successfully developed, the sales and profitability of the combined company may be adversely affected in future periods. Additionally, the value of other acquired intangible assets may become impaired. We believed that the foregoing assumptions used in the IPR&D analysis were reasonable at the time of the acquisition. No assurance can be given, however, that the underlying assumptions used to estimate expected project sales, development costs or profitability, or the events associated with such projects, will transpire as estimated. At the date of acquisition, the development of these projects had not yet reached technological feasibility, and the research and development in progress had no alternative future uses. Accordingly, these costs in the amount of $185.7 million were charged to expense in the third quarter of 2004.

 

The results of operations for CIMA LABS have been included in our consolidated statements since the acquisition date of August 12, 2004.

 

The following unaudited pro forma information shows the results of our operations for the three and nine months ended September 30, 2004 as though the acquisition had occurred as of the beginning of the period presented:

 

 

 

Three months ended

 

Nine months ended

 

 

 

September 30, 2004

 

September 30, 2004

 

Total Revenues

 

$

268,147

 

$

753,004

 

Net Loss

 

$

(180,406

)

$

(170,649

)

Basic and diluted net income per common share:

 

 

 

 

 

Basic loss per common share

 

$

(3.21

)

$

(3.04

)

Diluted loss per common share

 

$

(3.21

)

$

(3.04

)

 

The pro forma results have been prepared for comparative purposes only and are not necessarily indicative of the actual results of operations had the acquisition taken place as of the beginning of the periods presented, or the results that may occur in the future. Furthermore, the pro forma results do not give effect to all cost savings or incremental costs that may occur as a result of the integration and consolidation of the acquisition.

 

3.              ACQUISITION OF SALMEDIX, INC.

 

On June 14, 2005, we completed our acquisition of Salmedix, Inc. (“Salmedix”).  Under the Agreement and Plan of Merger dated May 12, 2005, we acquired all of the outstanding capital stock of Salmedix for $160.9 million in cash and future payments totaling up to $40 million upon achievement of certain regulatory milestones.  The acquisition was funded from our existing cash on hand and was accounted for as an asset acquisition, as Salmedix is a development stage company.  As a result of the acquisition, we obtained the rights to market TREANDA™ (bendamustine hydrochloride) for which we are enrolling patients in Phase 3 clinical trials in the United States and Canada for the treatment of indolent (slowly progressing) non-Hodgkin’s lymphoma (NHL), a type of hematologic malignancy.  Of the purchase price, $30.8 million has been allocated to the fair value of the tangible net assets and liabilities as of the acquisition date, with the remaining purchase price of $130.1 million allocated to IPR&D relating primarily to TREANDA.  We did not record a tax benefit for the IPR&D charge related to Salmedix since we did not acquire a tax basis in its assets and do not expect to realize a tax deduction.  We recognized a net deferred tax asset of $4.3 million relating to the U.S. federal and state net operating losses acquired from Salmedix, which we believe are more likely than not to be utilized.  The results of operations for Salmedix have been included in our consolidated financial statements as of the acquisition date.

 

4.              VIVITREX LICENSE AND COLLABORATION

 

In June 2005, we entered into a license and collaboration agreement with Alkermes, Inc. (“Alkermes”) to develop and commercialize VIVITREX® (naltrexone long-acting injection) in the United States.  Concurrent with the execution of this agreement, we entered into a supply agreement under which Alkermes will provide to us finished commercial supplies of VIVITREX.  VIVITREX is an investigational drug in development by Alkermes for the treatment of alcohol dependence.

 

Alkermes submitted an NDA for VIVITREX to the FDA on March 31, 2005, which has been granted priority review.  The Prescription Drug User Fee Act (“PDUFA”) action date currently is scheduled for December 30, 2005.  We made an initial payment of $160 million cash to Alkermes upon execution of the agreement, all of which has been recorded

 

11



 

as an IPR&D charge as the product has not yet received FDA approval.  We recognized a valuation allowance on the majority of the potential tax benefit related to the acquired product rights as we believe it is more likely than not that such potential tax benefit will not be realized.  We also have agreed to make an additional cash payment of $110 million to Alkermes if VIVITREX is approved by the FDA.  Alkermes also could receive up to an additional $220 million in milestone payments from us upon attainment of certain agreed-upon sales levels of VIVITREX.

 

Cephalon and Alkermes have formed a joint steering committee that will share responsibility for the commercialization, development and supply strategy for VIVITREX.  We will have primary responsibility for the commercialization of VIVITREX, while Alkermes will be responsible for obtaining marketing approval and manufacturing the product.  Until the later of December 31, 2007 or 18 months following FDA approval of the product, Alkermes is responsible for any cumulative losses up to $120 million and Cephalon is responsible for any cumulative losses in excess of $120 million.  Pre-tax profit, as adjusted for certain items, and losses incurred after the later of December 31, 2007 or 18 months following FDA approval will be split equally between the parties.  Cephalon will recognize all product sales following commercial launch.

 

5.              ACQUISITION OF TRISENOX

 

On July 18, 2005, we completed the acquisition of substantially all assets related to the TRISENOX® (arsenic trioxide) injection business from Cell Therapeutics, Inc. (“CTI”) and CTI Technologies, Inc., a wholly owned subsidiary of CTI, for $69.7 million in cash, funded from existing cash on hand.  The acquisition agreement provides for contingent future cash payments to CTI, totaling up to $100.0 million, upon the achievement of certain label expansion and sales milestones.  TRISENOX is indicated as a single agent for the treatment of patients with relapsed or refractory acute promyelocytic leukemia (APL), a life-threatening hematologic cancer.  CTI’s worldwide net sales of TRISENOX in 2004 totaled approximately $26.6 million.  The results of operations of TRISENOX have been included in the consolidated statements of operations since the acquisition date.

 

The acquisition of the assets related to the TRISENOX business has been accounted for as a business combination as we acquired all of the elements necessary to continue to conduct normal operations of the product.  At the date of acquisition, the fair value of assets and liabilities acquired equaled $114.0 million, consisting of $0.7 million of net working capital, $113.0 million of intangible assets, $0.5 million of acquired in-process research and development (which was expensed in the third quarter of 2005), net deferred tax assets of $15.6 million and deferred tax liabilities of $15.8 million.  We expect to finalize our purchase price allocation during the fourth quarter of 2005.

 

The fair value of acquired net assets exceeds the cost by $44.3 million. Because the acquisition agreement provides for contingent consideration up to $100 million, the $44.3 million excess of fair value of acquired net assets over cost has been recognized as a liability at the date of acquisition in accordance with SFAS 141.  When the contingencies are resolved, any amounts paid will reduce this liability.  Any excess of the contingent payments over this liability will be recognized as an additional cost of the TRISENOX acquisition.  Any excess of this liability over the contingent payments will reduce the recognized value of the acquired net assets on a pro rata basis.

 

All of the intangible assets acquired relate to the developed TRISENOX technology with estimated useful lives between eight and 13 years.

 

6.              INVENTORY, NET

 

Inventory consisted of the following:

 

 

 

September 30,

 

December 31,

 

 

 

2005

 

2004

 

Raw materials

 

$

56,541

 

$

31,511

 

Work-in-process

 

18,703

 

4,286

 

Finished goods

 

44,098

 

50,832

 

 

 

$

119,342

 

$

86,629

 

 

We capitalize inventory costs associated with marketed products and certain products prior to regulatory approval and product launch, based on management’s judgment of probable future commercial use and net realizable value. We could be required to expense previously capitalized costs related to pre-approval or pre-launch inventory upon a change in such judgment, due to a denial or delay of approval by regulatory bodies, a delay in commercialization, or other potential factors.

 

12



 

At September 30, 2005, we had $39.7 million of capitalized inventory costs for products that have not yet received regulatory approval.

 

7.              INTANGIBLE ASSETS, NET

 

Intangible assets consisted of the following:

 

 

 

 

 

September 30, 2005

 

December 31, 2004

 

 

 

Estimated

 

Gross

 

 

 

Net

 

Gross

 

 

 

Net

 

 

 

Useful

 

Carrying

 

Accumulated

 

Carrying

 

Carrying

 

Accumulated

 

Carrying

 

 

 

Lives

 

Amount

 

Amortization

 

Amount

 

Amount

 

Amortization

 

Amount

 

Developed Technology acquired from Group Lafon

 

10-15 years

 

$

132,000

 

$

37,000

 

$

95,000

 

$

132,000

 

$

29,600

 

$

102,400

 

Trademarks/tradenames acquired from Group Lafon

 

15 years

 

16,000

 

4,000

 

12,000

 

16,000

 

3,200

 

12,800

 

GABITRIL product rights

 

9-15 years

 

112,630

 

35,042

 

77,588

 

119,352

 

29,859

 

89,493

 

Novartis CNS product rights

 

10 years

 

41,641

 

19,779

 

21,862

 

41,641

 

16,656

 

24,985

 

ACTIQ marketing rights

 

10 years

 

75,465

 

29,446

 

46,019

 

75,465

 

23,707

 

51,758

 

Modafinil marketing rights

 

10 years

 

9,078

 

2,717

 

6,361

 

10,288

 

2,314

 

7,974

 

DuraSolv® technology

 

14 years

 

70,000

 

5,478

 

64,522

 

70,000

 

1,826

 

68,174

 

OraSolv® technology

 

6 years

 

32,700

 

5,899

 

26,801

 

32,700

 

1,966

 

30,734

 

OraVescent® technology

 

15 years

 

10,400

 

761

 

9,639

 

10,400

 

254

 

10,146

 

NAXY and MONO-NAXY product rights

 

5 years

 

39,104

 

5,867

 

33,237

 

44,343

 

176

 

44,167

 

TRISENOX product rights

 

8-13 years

 

113,070

 

2,251

 

110,819

 

 

 

 

Other product rights

 

5-14 years

 

22,635

 

13,492

 

9,143

 

22,283

 

15,512

 

6,771

 

 

 

 

 

$

674,723

 

$

161,732

 

$

512,991

 

$

574,472

 

$

125,070

 

$

449,402

 

 

Other intangible assets are amortized over their estimated useful economic life using the straight-line method.  Amortization expense was $15.5 million and $9.7 million for the three months ended September 30, 2005 and 2004, respectively, and $42.2 million and $26.5 million for the nine months ended September 30, 2005 and 2004, respectively.  Estimated amortization expense of intangible assets for each of the next five fiscal years is approximately $61.5 million in 2006, $60.2 million in 2007 and 2008, $60.1 million in 2009 and $49.8 million in 2010.

 

8.              LONG-TERM DEBT

 

Long-term debt consisted of the following:

 

 

 

September 30,

 

December 31,

 

 

 

2005

 

2004

 

2% convertible senior subordinated notes due June 1, 2015

 

$

920,000

 

$

 

2.5% convertible subordinated notes due December 2006

 

10,007

 

521,750

 

Change in fair value of hedged portion of 2.5% convertible subordinated notes

 

 

(1,772

)

Zero Coupon convertible subordinated notes first putable June 2008 (Old)

 

313

 

303

 

Zero Coupon convertible subordinated notes first putable June 2010 (Old)

 

99

 

102

 

Zero Coupon convertible subordinated notes first putable June 2008 (New)

 

374,890

 

374,697

 

Zero Coupon convertible subordinated notes first putable June 2010 (New)

 

375,027

 

374,898

 

Mortgage and building improvement loans

 

9,211

 

9,721

 

Capital lease obligations

 

2,454

 

3,270

 

Other

 

4,094

 

6,555

 

Total debt

 

1,696,095

 

1,289,524

 

Less current portion

 

(3,465

)

(5,114

)

Total long-term debt

 

$

1,692,630

 

$

1,284,410

 

 

13



 

2% Convertible Senior Subordinated Notes

 

In June and July 2005, we issued through a public offering $920 million of 2% convertible senior subordinated notes due June 1, 2015 (the “2% Notes”).  Interest on the notes is payable semi-annually in arrears on June 1 and December 1 of each year, commencing December 1, 2005.

 

The 2% Notes are subordinated to our existing and future senior indebtedness and senior to the Company’s existing and future subordinated indebtedness.  The 2% Notes are convertible prior to maturity, subject to certain conditions described below, into cash and shares of our common stock at an initial conversion price of $46.70 per share, subject to adjustment (equivalent to a conversion rate of approximately 21.4133 shares per $1,000 principal amount of 2% Notes).

 

The 2% Notes also contain a restricted convertibility feature that does not affect the conversion price of the 2% Notes but, instead, places restrictions on a holder’s ability to convert their 2% Notes into shares of our common stock (the “conversion shares”).  A holder may convert the 2% Notes prior to December 1, 2014 only if one or more of the following conditions are satisfied:

 

                  if, on the trading day prior to the date of surrender, the closing sale price of our common stock is more than 120% of the applicable conversion price per share (the “conversion price premium”);

                  if the average of the trading prices of the 2% Notes for any five consecutive trading day period is less than 100% of the average of the conversion values of the 2% Notes during that period; or

                  if we make certain significant distributions to our holders of common stock; we enter into specified corporate transactions; or our common stock ceases to be approved for listing on the Nasdaq National Market and is not listed for trading on a U.S. national securities exchange or any similar U.S. system of automated securities price dissemination.

 

Holders also may surrender their 2% Notes for conversion anytime after December 1, 2014 and on or prior to the close of business on the business day immediately preceding the maturity date, regardless if any of the foregoing conditions have been satisfied.  Upon the satisfaction of any of the foregoing conditions as of the last day of the reporting period, or during the twelve months prior to December 1, 2014, we would classify the then-aggregate principal balance of the 2% Notes as a current liability on our balance sheet and would write off to expense all remaining unamortized debt issuance charges.

 

Each $1,000 principal amount of the 2% Notes is convertible into cash and shares of our common stock, if any, based on an amount (the “Daily Conversion Value”), calculated for each of the twenty trading days immediately following the conversion date (the “Conversion Period”). The Daily Conversion Value for each trading day during the Conversion Period for each $1,000 aggregate principal amount of the 2% Notes is equal to one-twentieth of the product of the then applicable conversion rate multiplied by the volume weighted average price of our common stock on that day.

 

For each $1,000 aggregate principal amount of the 2% Notes surrendered for conversion, we will deliver the aggregate of the following for each trading day during the Conversion Period:

 

(1) if the Daily Conversion Value for each trading day for each $1,000 aggregate principal amount of the 2% Notes exceeds $50.00, (a) a cash payment of $50.00 and (b) the remaining Daily Conversion Value in shares of our common stock; or

 

(2) if the Daily Conversion Value for each trading day for each $1,000 aggregate principal amount of the 2% Notes is less than or equal to $50.00, a cash payment equal to the Daily Conversion Value.

 

If the 2% Notes are converted in connection with certain fundamental changes that occur prior to June 2015, we may be obligated to pay an additional (or “make whole”) premium with respect to the 2% Notes so converted.

 

The aggregate commissions and other debt issuance costs incurred with respect to the issuance of the 2% Notes are $28.1 million, which have been capitalized as debt issuance costs on our consolidated balance sheet and are being amortized until December 1, 2014, the first date that the 2% Notes are convertible at the option of the holder.

 

Convertible Note Hedge and Warrant Agreements

 

Concurrent with the sale of the 2% Notes, we purchased convertible note hedges from Deutsche Bank AG (DB) at a cost of $382.3 million.  We also sold to DB warrants to purchase an aggregate of 19,700,214 shares of our common stock and

 

14



 

received net proceeds from the sale of these warrants of $217.1 million.  Taken together, the convertible note hedge and warrant agreements have the effect of increasing the effective conversion price of the 2% Notes from our perspective to $67.92 per share.  At our option, the warrants may be settled in either net cash or net shares.  The convertible note hedge must be settled using net shares.  Under the convertible note hedge, DB will deliver to us the aggregate number of shares we are required to deliver to a holder of 2% Notes that presents such notes for conversion.  If the market price per share of our common stock is above $67.92 per share, we will be required to deliver either shares of our common stock or cash to DB representing the value of the warrants in excess of the strike price of the warrants.  In accordance with Emerging Issues Task Force Issue (“EITF”) No. 00-19, “Accounting for Derivative Financial Instruments Indexed to, and Potentially Settled In, a Company’s Own Stock” (“EITF No. 00-19”) and SFAS No. 150, “Accounting for Certain Financial Instruments with Characteristics of both Liabilities and Equity,” we recorded the convertible note hedges and warrants in additional paid in capital, and will not recognize subsequent changes in fair value. We also recognized a deferred tax asset of $133.8 million for the effect of the future tax benefits related to the convertible note hedge.

 

The warrants have a strike price of $67.92.  The warrants are exercisable only on the respective expiration dates (European style).  We issued and sold the warrants to DB in a transaction exempt from the registration requirements of the Securities Act of 1933, as amended, because the offer and sale did not involve a public offering.  There were no underwriting commissions or discounts in connection with the sale of the warrants.

 

2.5% Convertible Subordinated Notes

 

In July 2005, we completed a cash tender offer for our outstanding 2.5% Convertible Subordinated Notes Due December 2006 (“the 2.5% Notes”). As a result of the tender, we purchased approximately $512 million of the 2.5% Notes at a price of $975 for each $1,000 of principal amount of 2.5% Notes tendered, plus accrued and unpaid interest to the date of payment of $1.94 for each $1,000 of principal amount of 2.5% Notes tendered.  After completion of the tender offer, there remains outstanding approximately $10 million of the 2.5% Notes.  In July 2005, we also terminated the interest rate swap agreement associated with $200 million notional amount of the 2.5% Notes.

 

In the third quarter of 2005, we recognized a net gain of $2.1 million consisting of a gain on extinguishment of the 2.5% Notes of $7.4 million and a loss on the termination of the interest rate swap of $5.3 million.

 

3.875% Convertible Subordinated Notes

 

In March 2004 and August 2004, we repurchased for cash $10.0 million (at a price of 109.5% of the face amount) and $33.0 million (at a price of 104% of the face amount), respectively, of the 3.875% convertible subordinated notes in private transactions.  As a result, during the nine months ended September 30, 2004, $2.3 million was recognized in our financial statements as a charge on early extinguishment of debt.

 

9.              LEGAL PROCEEDINGS

 

We have filed a patent infringement lawsuit in U.S. District Court in New Jersey against Teva Pharmaceuticals USA, Inc., Mylan Pharmaceuticals, Inc., Ranbaxy Laboratories Limited and Barr Laboratories, Inc. based upon the ANDAs filed by each of these companies with the FDA seeking approval to market a generic form of modafinil.  The lawsuit claims infringement of our U.S. Patent No. RE37,516 (the “‘516 Patent”) which covers the pharmaceutical compositions and methods of treatment with the form of modafinil contained in PROVIGIL.  Each of the defendants has asserted defenses and/or counterclaims for non-infringement and/or patent invalidity. Mylan and Ranbaxy also have asserted counterclaims for patent unenforceability based on alleged inequitable conduct.  We have moved to dismiss the unenforceability counterclaims and a decision is pending.  Discovery in this lawsuit is complete, and all four defendants have filed motions for summary judgment of non-infringement and/or patent invalidity.  We have filed our oppositions to the motions, and the court has not yet set a date for a hearing on defendants’ summary judgment motions.  We do not anticipate a decision on these motions prior to the end of 2005.  We expect a trial to begin no earlier than the second quarter of 2006.  In early 2005, we also filed suit for infringement of the ‘516 Patent against Carlsbad Technology, Inc. in the U.S. District Court in New Jersey based upon the ANDA filed by Carlsbad with the FDA seeking to market a generic form of modafinil.  Carlsbad has asserted counterclaims for non-infringement of the ‘516 Patent and invalidity of the ‘516 Patent.  Carlsbad also has asserted a counterclaim for non-infringement of our U.S. Patent No. 4,927,855 (which we have not asserted against Carlsbad).  We have moved to dismiss all of Carlsbad’s counterclaims; Carlsbad has opposed the motion, and a decision is pending.  Discovery in this action has only recently commenced.    While we intend to vigorously defend the validity of these patents and prevent infringement, these efforts will be both expensive and time consuming and, ultimately, may not be successful.

 

15



 

In June 2005, Tenlec Pharma Limited was issued a product license by the Medicines and Healthcare products Regulatory Agency in the United Kingdom for its generic version of PROVIGIL that we believe will be marketed and sold jointly with Teva UK Limited.  Following the issuance of this license, we and our subsidiary, Cephalon (UK) Limited, filed a lawsuit against Teva and Tenlec claiming infringement of the European patents covering PROVIGIL, which do not expire until 2014.  Tenlec and Teva deny infringement and have claimed that the patents are invalid.  Notwithstanding this, in late July 2005, Teva and Tenlec provided undertakings to the Royal Court of Justice (High Court) in London agreeing that they will not market or sell a generic version of PROVIGIL in the United Kingdom, prior to a trial and court decision, currently anticipated in early 2006.  While we intend to vigorously defend the validity of these patents and prevent infringement, these efforts will be both expensive and time consuming and ultimately, may not be successful.

 

In January 2005, we filed a patent infringement lawsuit in U.S. District Court in Delaware against Barr Laboratories, Inc., claiming infringement of U.S. Patent No. 4,863,737, based on an ANDA filed by Barr seeking approval to market a generic form of ACTIQ.  Barr has asserted counterclaims for non-infringement and patent invalidity.  We have moved to dismiss those counterclaims, Barr has opposed our motion, and a decision is pending.  Fact discovery is substantially complete, and this lawsuit is currently in the expert discovery phase.  A Markman Hearing has been held and the court has issued a claim construction ruling.  We anticipate trial in this matter to occur during the first six months of 2006.  Neither the ANDA filing nor this lawsuit affects the terms of the existing license grant to Barr of certain intellectual property related to ACTIQ, and we do not expect any change in the anticipated date of Barr’s entry to the market.  However, depending on the timing and outcome of the trial, it is possible that Barr could enter the market prior to our current expectations.  At the same time, we continue to comply in good faith with the FTC Decision and Order requiring us to provide the ACTIQ manufacturing process and other information to Barr to assist its efforts to manufacture a licensed generic version of ACTIQ when Barr’s license becomes effective.  While we intend to vigorously defend the validity of the ACTIQ patents and prevent infringement by Barr until the license effective date, these efforts will be both expensive and time consuming and, ultimately, may not be successful.

 

In September 2004, we announced that we had received subpoenas from the U.S. Attorney’s Office in Philadelphia.  That same month, we received a voluntary request for information from the Office of the Connecticut Attorney General.  Both the subpoenas and the voluntary request for information appear to be focused on Cephalon’s sales and promotional practices with respect to ACTIQ, GABITRIL and PROVIGIL, including the extent of off-label prescribing of our products by physicians.  We are cooperating with the U.S. Attorney’s Office and the Office of the Connecticut Attorney General, and are providing documents and other information to both offices in response to these and additional requests.  These matters may involve the bringing of criminal charges and fines, and/or civil penalties.  We cannot predict or determine the outcome of these matters or reasonably estimate the amount or range of amounts of any fines or penalties that might result from an adverse outcome.  However, an adverse outcome could have a material adverse effect on our financial position, liquidity and results of operations.

 

We are a party to certain other litigation in the ordinary course of our business, including, among others, European patent oppositions, and matters alleging employment discrimination, product liability and breach of commercial contract. We are vigorously defending ourselves in all of the actions against us and do not believe these matters, even if adversely adjudicated or settled, would have a material adverse effect on our financial condition, results of operations or cash flows.

 

10.       COMPREHENSIVE INCOME (LOSS)

 

Our comprehensive income includes net income (loss), unrealized gains (losses) from foreign currency translation adjustments and unrealized investment losses.  Our total comprehensive income (loss) is as follows:

 

 

 

Three months ended
September 30,

 

Nine months ended
September 30,

 

 

 

2005

 

2004

 

2005

 

2004

 

Net income (loss)

 

$

29,343

 

$

(165,246

)

$

(193,027

)

$

(151,918

)

 

 

 

 

 

 

 

 

 

 

Foreign currency translation adjustments

 

(539

)

3,588

 

(27,427

)

(3,022

)

Unrealized investment (losses) gains

 

(1,037

)

227

 

(1,658

)

(1,187

)

Other comprehensive income (loss)

 

(1,576

)

3,815

 

(29,085

)

(4,209

)

 

 

 

 

 

 

 

 

 

 

Comprehensive income (loss)

 

$

27,767

 

$

(161,431

)

$

(222,112

)

$

(156,127

)

 

16



 

11.       EARNINGS PER SHARE (EPS)

 

We compute income per common share in accordance with SFAS No. 128, “Earnings Per Share.” Basic income per common share is computed based on the weighted average number of common shares outstanding during the period. Diluted income per common share is computed based on the weighted average shares outstanding and the dilutive impact of common stock equivalents outstanding during the period. The dilutive effect of employee stock options, restricted stock awards, the Zero Coupon Convertible Notes issued in December 2004 (the “New Zero Coupon Notes”) and the 2% Notes is measured using the treasury stock method. The dilutive effect of all other convertible notes including the remaining outstanding portions of the 2.5% Notes and the Old Zero Coupon Notes, is measured using the “if-converted” method.  Common stock equivalents are not included in periods where there is a loss, as they are anti-dilutive.

 

The following is a reconciliation of net income (loss) and weighted average common shares outstanding for purposes of calculating basic and diluted income (loss) per common share:

 

 

 

Three months ended
September 30,

 

Nine months ended
September 30,

 

 

 

2005

 

2004

 

2005

 

2004

 

Basic income (loss) per share computation:

 

 

 

 

 

 

 

 

 

Numerator:

 

 

 

 

 

 

 

 

 

Net income (loss) used for basic income per common share

 

$

29,343

 

$

(165,246

)

$

(193,027

)

$

(151,918

)

Net income used for basic income per participating security

 

 

 

 

 

Total net income (loss)

 

$

29,343

 

$

(165,246

)

$

(193,027

)

$

(151,918

)

Denominator:

 

 

 

 

 

 

 

 

 

Weighted average shares used for basic income (loss) per common share

 

58,064

 

56,178

 

58,035

 

56,065

 

Weighted average shares of participating securities

 

 

214

 

 

422

 

 

 

58,064

 

56,392

 

58,035

 

56,487

 

 

 

 

 

 

 

 

 

 

 

Basic income (loss) per common share:

 

$

0.51

 

$

(2.94

)

$

(3.33

)

$

(2.71

)

 

 

 

 

 

 

 

 

 

 

Diluted income (loss) per share computation:

 

 

 

 

 

 

 

 

 

Numerator:

 

 

 

 

 

 

 

 

 

Net income (loss) used for basic income per common share

 

$

29,343

 

$

(165,246

)

$

(193,027

)

$

(151,918

)

Interest on convertible subordinated notes (net of tax)

 

240

 

 

 

 

Net income (loss) used for diluted income per common share

 

$

29,583

 

$

(165,246

)

$

(193,027

)

$

(151,918

)

 

 

 

 

 

 

 

 

 

 

Denominator:

 

 

 

 

 

 

 

 

 

Weighted average shares used for basic income (loss) per common share

 

58,064

 

56,178

 

58,035

 

56,065

 

Effect of dilutive securities:

 

 

 

 

 

 

 

 

 

Employee stock options and restricted stock awards

 

509

 

 

 

 

Convertible subordinated notes

 

825

 

 

 

 

Weighted average shares used for diluted income (loss) per common share

 

59,398

 

56,178

 

58,035

 

56,065

 

 

 

 

 

 

 

 

 

 

 

Diluted income (loss) per common share:

 

$

0.50

 

$

(2.94

)

$

(3.33

)

$

(2.71

)

 

The following reconciliation shows the shares excluded from the calculation of diluted income (loss) per common share as the inclusion of such shares would be anti-dilutive:

 

17



 

 

 

Three months ended
September 30,

 

Nine months ended
September 30,

 

 

 

2005

 

2004

 

2005

 

2004

 

Weighted average shares excluded:

 

 

 

 

 

 

 

 

 

Employee stock options

 

8,486

 

7,728

 

8,820

 

2,305

 

Convertible notes

 

32,633

 

19,753

 

25,956

 

20,497

 

 

 

41,119

 

27,481

 

34,776

 

22,802

 

 

The 2% Notes and New Zero Coupon Notes each are considered to be instrument C securities as defined by EITF 90-19, “Convertible Bonds with Issuer Option to Settle for Cash upon Conversion”; therefore, these notes are included in the dilutive earnings per share calculation using the treasury stock method.  Under the treasury stock method, we must calculate the number of shares issuable under the terms of these notes based on the average market price of the stock during the period, and include that number in the total diluted shares figure for the period.  For example, using the treasury stock method, if the average price of our stock during the three months ended September 30, 2005 had been $65.00 or $80.00, the shares from the 2% Notes to be included in diluted EPS would have been 5.5 million and 8.2 million shares, respectively, and the shares from the New Zero Coupon Notes would have been 1.4 million and 3.6 million shares, respectively.  The total number of shares that could potentially be included in diluted EPS is 19.7 million and 12.9 million for the 2% Notes and the New Zero Coupon Notes, respectively.  Since the average share price of our stock during the three and nine months ended September 30, 2005 did not exceed the conversion prices of $46.70 for the 2% Notes and $56.50 and $59.50 for the New Zero Coupon Notes, there was no impact of these notes on diluted shares or diluted EPS during these periods.

 

We have entered into convertible note hedge and warrant agreements that, in combination, have the economic effect of reducing the dilutive impact of the 2% Notes and the New Zero Coupon Notes by increasing the effective conversion price for these notes, from our perspective, to $67.92 and $72.08, respectively.  SFAS No. 128, however, requires us to analyze separately the impact of the convertible note hedge and warrant agreements on diluted EPS.  As a result, the purchases of the convertible note hedges are excluded because their impact will always be anti-dilutive.  SFAS No. 128 further requires that the impact of the sale of the warrants be computed using the treasury stock method.  For example, using the treasury stock method, if the average price of our stock during the three months ended September 30, 2005 had been $65.00 or $80.00, the shares issuable pursuant to the warrants related to the 2% Notes to be included in diluted EPS would have been zero and 3.0 million shares, respectively, and the shares issuable pursuant to the warrants related to the New Zero Coupon Notes would have been zero and 1.0 million, respectively.  The total number of shares that could potentially be included under the warrants is 19.7 million for the 2% Notes and 12.9 million for the New Zero Coupon Notes.  Since the average share price of our stock during the three and nine months ended September 30, 2005 did not exceed the conversion prices of either the 2% Notes or New Zero Coupon Notes, there was no impact of the warrants on diluted shares or diluted EPS during these periods.

 

12.       SEGMENT AND SUBSIDIARY INFORMATION

 

Due to changes in our internal management and reporting structure in the second quarter of 2005, our chief operating decision maker now evaluates performance and makes decisions based on two segments, United States and Europe.  As a result of this change, we have revised our segment reporting to include inter-segment sales and pre-tax income for these two segments as required by SFAS No. 131 “Disclosure about Segments of an Enterprise and Related Information” (“SFAS No. 131”).  Prior to the second quarter of 2005, we disclosed financial information for the United States and Europe in order to satisfy the geographical requirements of SFAS No. 131 but did not present inter-segment sales and pre-tax income for these two segments.

 

Revenue and pre-tax income for the three and nine months ended September 30, 2005 and 2004, and long-lived assets as of September 30, 2005 and December 31, 2004 is provided below:

 

Revenues for the three months ended September 30:

 

18



 

 

 

2005

 

2004

 

 

 

United

 

 

 

 

 

United

 

 

 

 

 

 

 

States

 

Europe

 

Total

 

States

 

Europe

 

Total

 

PROVIGIL sales

 

$

126,387

 

$

8,103

 

$

134,490

 

$

92,631

 

$

9,347

 

$

101,978

 

ACTIQ sales

 

95,485

 

4,759

 

100,244

 

100,753

 

1,941

 

102,694

 

GABITRIL sales

 

15,178

 

1,333

 

16,511

 

23,046

 

1,577

 

24,623

 

Other sales

 

15,575

 

27,551

 

43,126

 

5,224

 

19,075

 

24,299

 

Other revenues

 

13,260

 

1,905

 

15,165

 

6,585

 

1,788

 

8,373

 

Total External Revenues

 

265,885

 

43,651

 

309,536

 

228,239

 

33,728

 

261,967

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Inter-Segment Sales

 

4,594

 

11,276

 

15,870

 

1,821

 

7,052

 

8,873

 

Elimination of Inter-Segment Sales

 

(4,594

)

(11,276

)

(15,870

)

(1,821

)

(7,052

)

(8,873

)

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Total Revenues

 

$

265,885

 

$

43,651

 

$

309,536

 

$

228,239

 

$

33,728

 

$

261,967

 

 

Revenues for the nine months ended September 30:

 

 

 

2005

 

2004

 

 

 

United

 

 

 

 

 

United

 

 

 

 

 

 

 

States

 

Europe

 

Total

 

States

 

Europe

 

Total

 

PROVIGIL sales

 

$

338,529

 

$

26,009

 

$

364,538

 

$

276,071

 

$

23,221

 

$

299,292

 

ACTIQ sales

 

282,105

 

11,904

 

294,009

 

253,130

 

5,350

 

258,480

 

GABITRIL sales

 

54,023

 

4,562

 

58,585

 

67,372

 

4,659

 

72,031

 

Other sales

 

36,319

 

80,137

 

116,456

 

5,224

 

63,948

 

69,172

 

Other revenues

 

36,176

 

5,724

 

41,900

 

12,212

 

5,239

 

17,451

 

Total External Revenues

 

747,152

 

128,336

 

875,488

 

614,009

 

102,417

 

716,426

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Inter-Segment Sales

 

9,064

 

56,405

 

65,469

 

8,454

 

25,302

 

33,756

 

Elimination of Inter-Segment Sales

 

(9,064

)

(56,405

)

(65,469

)

(8,454

)

(25,302

)

(33,756

)

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Total Revenues

 

$

747,152

 

$

128,336

 

$

875,488

 

$

614,009

 

$

102,417

 

$

716,426

 

 

 

 

Three months ended
September 30,

 

Nine months ended
September 30,

 

 

 

2005

 

2004

 

2005

 

2004

 

Pre-tax income (loss):

 

 

 

 

 

 

 

 

 

United States

 

$

46,761

 

$

(148,849

)

$

(159,788

)

$

(118,818

)

Europe

 

3,913

 

3,067

 

10,238

 

12,595

 

Total

 

$

50,674

 

$

(145,782

)

$

(149,550

)

$

(106,223

)

 

19



 

 

 

September 30,

 

December 31,

 

 

 

2005

 

2004

 

Long-lived assets:

 

 

 

 

 

United States

 

$

1,152,345

 

$

695,279

 

Europe

 

349,236

 

583,061

 

Total

 

$

1,501,581

 

$

1,278,340

 

 

We performed our annual test of impairment of goodwill as of July 1, 2005.  Under SFAS No. 142, as a result of our reorganization of our internal management and reporting structure, we allocated goodwill to each of our reporting units based on their relative fair value.  During the third quarter of 2005, $281.6 million of goodwill was allocated to our United States segment and $87.9 million was allocated to our Europe segment.  Following the completion of this allocation, we completed our annual test of impairment of goodwill and concluded that goodwill was not impaired.

 

13.       PENSIONS AND OTHER POSTRETIREMENT BENEFITS

 

We have a defined benefit pension plan and other postretirement benefit plans covering employees at our French subsidiaries.  These plans are noncontributory and are not funded; benefit payments are funded from operations.

 

A summary of the components of net periodic benefit costs is as follows:

 

 

 

Pension Benefits
For the three months
ended September 30,

 

Pension Benefits
For the nine months
ended September 30,

 

 

 

2005

 

2004

 

2005

 

2004

 

Service cost

 

$

123

 

$

113

 

$

380

 

$

346

 

Interest cost

 

76

 

82

 

240

 

250

 

Recognized actuarial gain

 

(63

)

(62

)

(196

)

(189

)

Change in benefit obligation

 

$

136

 

$

133

 

$

424

 

$

407

 

 

 

 

 

 

 

 

 

 

 

 

 

Other Benefits
For the three months
ended September 30,

 

Other Benefits
For the nine months
ended September 30,

 

 

 

2005

 

2004

 

2005

 

2004

 

Service cost

 

$

8

 

$

8

 

$

26

 

$

23

 

Interest cost

 

13

 

21

 

41

 

63

 

Amortization of prior improvements

 

(6

)

 

(19

)

 

Recognized actuarial gain

 

(1

)

(9

)

(4

)

(28

)

Recognized gain due to plan curtailment

 

 

 

 

(4,240

)

Change in benefit obligation

 

$

14

 

$

20

 

$

44

 

$

(4,182

)

 

In the first quarter of 2004, we cancelled postretirement health care benefits for employees at our French subsidiaries that had not yet retired.  This resulted in a gain of $4.2 million that has been recognized as an offset to net periodic benefits costs for the nine months ended September 30, 2004.

 

20



 

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

 

Management’s Discussion and Analysis of Financial Condition and Results of Operations (MD&A) is intended to provide information to assist you in better understanding and evaluating our financial condition and results of operations. We recommend that you read this MD&A in conjunction with our consolidated financial statements included in Item 1 of this Quarterly Report on Form 10-Q, as well as our Annual Report on Form 10-K for the year ended December 31, 2004.

 

EXECUTIVE SUMMARY

 

Cephalon is an international biopharmaceutical company dedicated to the discovery, development and marketing of innovative products to treat sleep disorders, neurological disorders, cancer and pain. In addition to conducting an active research and development program, we market four products in the United States and numerous products in various countries throughout Europe.  Through our wholly-owned subsidiary, CIMA LABS INC., we develop and manufacture orally disintegrating tablets using proprietary technologies.  Our three largest products in terms of product sales, PROVIGIL, ACTIQ and GABITRIL, comprised approximately 86% of our worldwide net sales for the nine months ended September 30, 2005.  We market four products in the United States through our approximately 525-person sales force.

 

Our corporate headquarters are in Frazer, Pennsylvania, and our research and development headquarters are in West Chester, Pennsylvania.  In addition, we have offices in Utah, Minnesota, France, the United Kingdom, Germany and Switzerland. We operate manufacturing facilities in France for the production of modafinil, which is the active drug substance in PROVIGIL, in Utah for the production of ACTIQ, and in Minnesota for the production of orally disintegrating versions of drugs for our partners.

 

Our future success is highly dependent on obtaining and maintaining patent protection for our products and technology.  With respect to PROVIGIL, we have filed patent infringement lawsuits against five generic companies based upon the ANDAs filed by these companies seeking FDA approval to market a generic version of modafinil.  We anticipate that the first trial will begin no earlier than the second quarter of 2006.  See “– Certain Risks Related to Our Business.”  For ACTIQ, the patents covering the previous formulation of the product expired in May 2005 and the patent covering the current formulation is set to expire as early as September 2006.  As a result of the License and Supply Agreement we entered into with Barr Laboratories, Inc. in July 2004, we could face generic competition from Barr prior to September 2006 if we receive FDA approval of fentanyl effervescent buccal tablets before this date.  See “Recent Acquisitions and Transactions - CIMA LABS INC.” below.  In December 2004, we announced that the FDA had acknowledged receipt of an ANDA filed by Barr seeking approval to market a generic form of ACTIQ.  In January 2005, we filed a patent infringement lawsuit against Barr to defend our patents until the license effective date.  Neither the ANDA filing nor this lawsuit modify the existing license grant to Barr, and we do not expect any change in the anticipated date of Barr’s entry to market.  However, depending on the timing and outcome of the trial, it is possible that Barr could enter the market prior to our current expectations.  The loss of patent protection on any of our existing U.S. products, whether by third-party challenge, invalidation, circumvention, license or patent expiration, would materially impact our results of operations.

 

To mitigate the risk from current generic challenges to our key products, we are seeking FDA approval for five product candidates during 2006 and early 2007.  The following chart summarizes our progress with respect to these product opportunities, as well as our current expectations with respect to the timing of regulatory filings and possible launch dates, assuming FDA approval:

 

21



 

Product
Candidate

 

Expected
Indication

 

Anticipated
Filing Date

 

Target
Launch Date

 

Other

SPARLON™ (modafinil)*

 

ADHD in children and adolescents

 

Filed sNDA 4Q 2004

 

1Q 2006

 

Received approvable letter from FDA on October 20, 2005

 

 

 

 

 

 

 

 

 

NUVIGIL® (armodafinil)

 

Excessive sleepiness

 

Filed NDA 1Q 2005

 

Early 2006

 

Current PDUFA date: January 2006

 

 

 

 

 

 

 

 

 

VIVITREX® (naltrexone long acting injection)*

 

Alcohol dependence

 

Filed NDA 1Q 2005

 

1st Half 2006

 

Current PDUFA date: December 2005

 

 

 

 

 

 

 

 

 

fentanyl effervescent buccal tablets

 

Breakthrough cancer pain

 

Filed NDA 3Q 2005

 

Late 2006

 

Awaiting written FDA notification of filing acceptance

 

 

 

 

 

 

 

 

 

GABITRIL® (tiagabine hydrochloride)

 

Generalized Anxiety Disorder

 

1st Half 2006

 

1st Half 2007

 

Phase 3 clinical trials are ongoing

 


*

Cephalon is a party to a co-promotion agreement with McNeil Consumer & Specialty Pharmaceuticals with respect to SPARLON and a license and collaboration agreement with Alkermes, Inc. with respect to VIVITREX.

 

Even if we successfully achieve FDA approval for each of the product candidates described above, we will face significant challenges in successfully launching these products into highly competitive marketplaces.  In anticipation of these challenges, we recently decided to increase the size of our sales force and to align it by our four therapeutic franchises: central nervous system, pain, oncology and addiction.

 

As part of our business strategy, in the future we expect to continue to consider and, as appropriate, consummate acquisitions of other technologies, products and businesses and enter into collaborative arrangements.  Since March 31, 2005, we have acquired Salmedix, Inc., a privately held company in San Diego, entered into a license and collaboration agreement with Alkermes with respect to VIVITREX, acquired substantially all of the assets related to the TRISENOX injection business, a product indicated for patients with relapsed or refractory APL, and entered into a co-promotion agreement with McNeil Consumer & Specialty Pharmaceuticals with respect to SPARLON.

 

We also have significant research programs focused on developing therapeutics to treat oncological disorders.  In the cancer area, we have a program with a molecule, CEP-701, and are currently conducting Phase 2 clinical trials in patients suffering from acute myeloid leukemia (AML).  We are currently conducting Phase 3 clinical trials with TREANDA in patients suffering from indolent (slowly progressing) non-Hodgkin’s lymphoma (NHL), a type of hematologic malignancy. During the third quarter of 2005, we ceased clinical development of CEP-7055, one of the molecules in our VEGF inhibitor research program.  We are continuing the VEGF program and are pursuing other molecules that may have utility in the treatment of solid tumors, including CEP-11981, a preclinical drug candidate that we believe may have superior pharmaceutical properties to CEP-7055.  In the pharmaceutical industry, the development of new pharmaceutical products is highly uncertain because the majority of therapeutic candidates fail to show the human safety and efficacy necessary for regulatory approval and successful commercialization.  In addition, these efforts require substantial time, effort and financial resources.  Our success in developing product candidates, or new or improved formulations of existing products, will be a significant factor in our long-term success.

 

We have significant levels of indebtedness outstanding, the majority of which consists of convertible notes with stated conversion prices or restricted conversion prices higher than our stock price as of the date of this filing.

 

The rate of our future growth and our ability to generate sufficient cash flows from operations to service and repay our indebtedness ultimately will depend, in large part, on our ability to maintain patent protection on our existing products and successfully acquire or develop and successfully market and sell new products and new indications for our existing products.

 

22



 

Recent Acquisitions and Transactions

 

CIMA LABS INC.

 

On August 12, 2004, we completed our acquisition of CIMA LABS INC.  Under the Agreement and Plan of Merger dated November 3, 2003, we acquired each outstanding share of CIMA LABS common stock for $34.00 per share in cash.  The total cash paid to CIMA LABS stockholders in the transaction was approximately $482.5 million, net of CIMA LABS’ existing cash on hand, or $409.4 million, net of its cash, cash equivalents and investments.  As a result of the acquisition, we obtained the rights to CIMA LABS’ fentanyl effervescent buccal tablets, for which we filed an NDA with the FDA for the treatment of breakthrough cancer pain in opioid-tolerant patients.  Fentanyl effervescent buccal tablets utilize an enhanced absorption transmucosal drug delivery technology, known as ORAVESCENT, that we believe may facilitate the rapid onset of pain relief in such patients.  We are targeting approval of this product by the FDA in late 2006.

 

To secure Federal Trade Commission (FTC) clearance of the CIMA LABS acquisition, we entered into a license and supply agreement with Barr whereby we agreed to license to Barr our U.S. rights to any intellectual property related to ACTIQ. The license to ACTIQ will become effective upon the earliest to occur of (i) final FDA approval of fentanyl effervescent buccal tablets, (ii) September 5, 2006, if we have not received a pediatric extension of exclusivity for ACTIQ or (iii) February 3, 2007, if we have received a pediatric extension of exclusivity for ACTIQ.  As we currently expect to receive a pediatric extension of exclusivity for ACTIQ prior to September 2006, we anticipate that the Barr license will be effective upon fentanyl effervescent buccal tablets approval.  See also footnote 9 of the Consolidated Financial Statements included in Part I, Item 1 of this Report.  Under the agreement, Barr also may receive a license to the sugar-free formulation of ACTIQ under development; this license would become effective upon fentanyl effervescent buccal tablets approval by the FDA.

 

Under the license and supply agreement, we also agreed to transfer to Barr our technological know-how and intellectual property related to ACTIQ and to sell to Barr, for period of up to three years, a generic form of ACTIQ for resale in the United States if Barr is unable to manufacture an FDA-approved generic version of ACTIQ by the date the license takes effect.  In addition, we have agreed to forbear from asserting any remaining patent rights in ACTIQ against other parties beginning on the earlier of August 3, 2007 or six months following the effective date of Barr’s license.

 

Salmedix, Inc.

 

On June 14, 2005, we completed our acquisition of Salmedix, Inc.  Under the Agreement and Plan of Merger dated May 12, 2005, we acquired all of the outstanding capital stock of Salmedix for $160.9 million in cash and future payments totaling up to $40 million upon achievement of certain regulatory milestones.  The acquisition was funded from our existing cash on hand and was accounted for as an asset acquisition, as Salmedix is a development stage company.  As a result of the acquisition, we obtained the rights to market TREANDA™ (bendamustine hydrochloride) for which we currently are conducting Phase 3 clinical trials in the United States and Canada for the treatment of indolent (slowly progressing) non-Hodgkin’s lymphoma (NHL), a type of hematologic malignancy.  Of the purchase price, $30.8 million has been allocated to the fair value of the tangible net assets and liabilities as of the acquisition date, with the remaining purchase price of $130.1 million allocated to IPR&D relating primarily to TREANDA.  We did not record a tax benefit for the IPR&D charge related to Salmedix since we did not acquire a tax basis in its assets and do not expect to realize a tax deduction.  We recognized a net deferred tax asset of $4.3 million relating to the U.S. federal and state net operating losses acquired from Salmedix, which we believe are more likely than not to be utilized.  The results of operations for Salmedix have been included in our consolidated financial statements as of the acquisition date.

 

VIVITREX License and Collaboration

 

In June 2005, we entered into a license and collaboration agreement with Alkermes, Inc. to develop and commercialize VIVITREX® (naltrexone long-acting injection) in the United States.  Concurrent with the execution of this agreement, we entered into a supply agreement under which Alkermes will provide to us finished commercial supplies of VIVITREX.  VIVITREX is an investigational drug in development by Alkermes for the treatment of alcohol dependence.  Alkermes submitted an NDA for VIVITREX to the FDA on March 31, 2005, which has been granted priority review.  We made an initial payment of $160 million cash to Alkermes upon execution of the agreement, all of which has been recorded as an IPR&D charge as the product has not yet received FDA approval.  We recognized a valuation allowance on the majority of the potential tax benefit related to the acquired product rights as we believe it is more likely than not that such potential tax benefit will not be realized.  We also have agreed to make an additional cash payment of $110 million to Alkermes if VIVITREX is approved by the FDA.  Alkermes also could receive up to an additional $220 million in milestone payments from us upon attainment of certain agreed-upon sales levels of VIVITREX.

 

23



 

We have formed a joint steering committee with Alkermes that will share responsibility for the commercialization, development and supply strategy for VIVITREX.  We will have primary responsibility for the commercialization of VIVITREX, while Alkermes will be responsible for obtaining marketing approval and manufacturing the product.  Until the later of December 31, 2007 or 18 months following FDA approval of the product, Alkermes is responsible for any cumulative losses up to $120 million, and we are responsible for any cumulative losses in excess of $120 million.  Pre-tax profit, as adjusted for certain items, and losses incurred after the later of December 31, 2007 or 18 months following FDA approval will be split equally between the parties.  We will recognize product sales upon commercial launch.

 

TRISENOX Acquisition

 

On July 18, 2005, we completed the acquisition of substantially all assets related to the TRISENOX® (arsenic trioxide) injection business from Cell Therapeutics, Inc. (“CTI”) and CTI Technologies, Inc., a wholly owned subsidiary of CTI, for $69.7 million in cash, funded from existing cash on hand.  The acquisition agreement provides for contingent future cash payments to CTI, totaling up to $100.0 million, upon the achievement of certain label expansions and sales milestones.  TRISENOX is indicated as a single agent for the treatment of patients with relapsed or refractory acute promyelocytic leukemia (APL), a life-threatening hematologic cancer.  CTI’s worldwide net sales of TRISENOX in 2004 totaled approximately $26.6 million.  The results of operations of TRISENOX have been included in the consolidated statements of operations since the acquisition date.

 

Co-Promotion Agreement with McNeil

 

In August 2005, Cephalon and McNeil Consumer & Specialty Pharmaceuticals Division of McNeil-PPC, Inc.  entered into a co-promotion agreement with respect to SPARLON.  On October 21, 2005, we announced that the FDA issued an approvable letter for SPARLON for the treatment of attention-deficit/hyperactivity disorder (ADHD) in children and adolescents between the ages of six and 17.  We are working closely with the FDA to obtain final approval and expect to launch this product in the first quarter of 2006.

 

Under the co-promotion agreement, McNeil has agreed to have at least 300 McNeil sales representatives co-promote and detail SPARLON upon FDA approval in the United States primarily to pediatricians, psychiatrists and pediatric neurologists.  We will promote the product to psychiatrists, neurologists, primary care physicians, and other appropriate health care professionals.  The parties have formed a joint commercialization committee to oversee the promotion of SPARLON.  We retain all responsibility for the development, manufacture, distribution and sale of the product.  We will pay McNeil commission fees calculated as a percentage of annual net sales of SPARLON during the term of the agreement and, if specified sales levels are reached in the final year of the agreement, during the three calendar years following the expiration of the agreement.  Commission fees will be recognized as Sales and Marketing expenses in the same period that the related net sales are recognized.

 

McNeil may terminate prior to the end of the three-year term of the agreement if “Lost CONCERTA Market Exclusivity” occurs, subject to the following conditions:

 

                                          Except as set forth in the next bullet, McNeil may only terminate the co-promotion agreement effective on or after a date that is six months following the first commercial sale of SPARLON in the United States by providing us with at least 90 days’ advance written notice of termination; and

 

                                          If Lost CONCERTA Market Exclusivity occurs prior to the first commercial sale of SPARLON in the United States, McNeil may terminate the Agreement on or after a date that is the later of (a) the four-month anniversary of Lost CONCERTA Market Exclusivity and (b) April 30, 2006, by providing us with at least 90 days’ advance written notice of termination; provided that if the first commercial sale of the product occurs before the effective date of termination, then McNeil may only terminate the co-promotion agreement effective on or after a date that is at least six (6) months following the first commercial sale of SPARLON.

 

“Lost CONCERTA Market Exclusivity” will occur if a generic form of McNeil’s ADHD product CONCERTA (methylphenidate HCl) Extended-release Tablets is sold in the United States for at least 60 days during the term of the co-promotion agreement.  If McNeil exercises its option to terminate the co-promotion agreement because of the Lost CONCERTA Market Exclusivity, then we have the right to offer employment at that time to some or all of McNeil’s sales force covered by the co-promotion agreement.

 

24



 

RESULTS OF OPERATIONS

 

Three months ended September 30, 2005 compared to three months ended September 30, 2004:

 

 

 

2005

 

2004

 

% Increase (Decrease)

 

 

 

United

 

 

 

 

 

United

 

 

 

 

 

United

 

 

 

 

 

 

 

States

 

Europe

 

Total

 

States

 

Europe

 

Total

 

States

 

Europe

 

Total

 

Sales:

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

PROVIGIL

 

$

126,387

 

$

8,103

 

$

134,490

 

$

92,631

 

$

9,347

 

$

101,978

 

36

%

(13

)%

32

%

ACTIQ

 

95,485

 

4,759

 

100,244

 

100,753

 

1,941

 

102,694

 

(5

)%

145

%

(2

)%

GABITRIL

 

15,178

 

1,333

 

16,511

 

23,046

 

1,577

 

24,623

 

(34

)%

(15

)%

(33

)%

Other

 

15,575

 

27,551

 

43,126

 

5,224

 

19,075

 

24,299

 

198

%

44

%

77

%

Total Sales

 

252,625

 

41,746

 

294,371

 

221,654

 

31,940

 

253,594

 

14

%

31

%

16

%

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Other Revenues

 

13,260

 

1,905

 

15,165

 

6,585

 

1,788

 

8,373

 

101

%

7

%

81

%

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Total Revenues

 

$

265,885

 

$

43,651

 

$

309,536

 

$

228,239

 

$

33,728

 

$

261,967

 

16

%

29

%

18

%

 

Sales—In the United States, we sell our products to pharmaceutical wholesalers, the largest three of which accounted for 84% of our worldwide net sales for the three months ended September 30, 2005 and 85% of our worldwide net sales for the nine months ended September 30, 2005.  Decisions made by these wholesalers regarding the levels of inventory they hold (and thus the amount of product they purchase from us) can materially affect the level of our sales in any particular period and thus may not necessarily correlate to the number of prescriptions written for our products as reported by IMS Health.  We believe that speculative buying of product, particularly in anticipation of possible price increases, has been the historic practice of many pharmaceutical wholesalers.  For our part, we attempted to minimize these fluctuations in the past both by providing, from time to time, discounts to our customers to stock normal amounts of inventory (which we had historically defined as approximately one month’s supply at our current sales level) and by canceling orders if we believe a particular customer is speculatively buying inventory in anticipation of possible price increases.

 

Over the past year, our wholesaler customers, as well as others in the industry, have begun to modify their business models from arrangements where they derive profits from the management of various discounts and rebates, to arrangements where they charge a fee for their services.  In connection with this new wholesaler business model, we entered into wholesaler service agreements in the third quarter of 2005 with our major wholesaler customers.  These agreements obligate the wholesalers to provide us with periodic retail demand information and current inventory levels for our products held at their warehouse locations; additionally, the wholesalers have agreed to manage the variability of their purchases within specified limits based on product demand. In return, we will provide the wholesalers with additional discounts in exchange for their services.

 

As of September 30, 2005, we received information from our three largest U.S. wholesaler customers about the levels of inventory they held for our products.  Based on this information, which we have not independently verified, we believe that total inventory held at these wholesalers is approximately 2 to 3 weeks supply at our current sales levels.

 

For the three months ended September 30, 2005, total sales increased by 16% over the prior period.  The factors that contributed to the increase in sales are summarized as follows:

 

                  Sales of PROVIGIL increased 32% in the third quarter of 2005 as compared to 2004. Demand for PROVIGIL increased as evidenced by an increase in U.S. prescriptions for PROVIGIL of 11%, according to IMS Health. During the third quarter of 2005, sales of PROVIGIL also were impacted by domestic price increases of approximately 30% from period to period, offset by a decrease in the number of units of inventory held by U.S. wholesalers during the quarter as well as an increase in the adjustments recorded to gross sales.

 

                  Sales of ACTIQ decreased 2% as compared to the same period last year. Demand for ACTIQ in the U.S. increased as evidenced by an increase in U.S. prescriptions for ACTIQ of 9%, according to IMS Health. During the third quarter of 2005, sales of ACTIQ also were impacted by domestic price increases of approximately 27% from period to period.  These increases were more than offset by a decrease in the number of units of inventory held by U.S. wholesalers during the quarter as well as an increase in adjustments recorded to gross

 

25


 


 

sales, as shown in the table below.

 

                  Sales of GABITRIL decreased 33% as compared to the same period last year.  During the third quarter, U.S. prescriptions for GABITRIL decreased by 30% from period to period, according to IMS Health.  This was driven primarily by our decision to reduce our sales and marketing efforts following an update in February 2005 to the label information for GABITRIL.  During the third quarter of 2005, sales of GABITRIL also were impacted by domestic price increases of approximately 51% from period to period, offset by a decrease in the number of units held by U.S. wholesalers during the quarter and an increase in adjustments recorded to gross sales.

 

                  Other sales, which consist primarily of sales of other products and certain third party products, increased 77% as compared to the same period last year.  The most significant increases in this category are sales of SPASFON® (phloroglucinol), sales of NAXY® (clarithromycin), which we acquired in December 2004, sales of products manufactured and sold to pharmaceutical partners by CIMA LABS, which we acquired in August 2004 and sales of TRISENOX®, which we acquired in July 2005.

 

Analysis of gross sales to net sales—The following table presents the adjustments deducted from gross sales to arrive at a net sales figure:

 

 

 

For the three months
ended September 30,

 

 

 

 

 

 

 

2005

 

2004

 

Change

 

% Change

 

Gross sales

 

$

335,284

 

$

279,447

 

$

55,837

 

20

%

 

 

 

 

 

 

 

 

 

 

Adjustments to gross sales:

 

 

 

 

 

 

 

 

 

Prompt payment discounts

 

5,424

 

4,585

 

839

 

18

%

Wholesaler discount reserve

 

5,593

 

 

5,593

 

100

%

Returns

 

668

 

3,246

 

(2,578

)

(79

)%

Coupons

 

6,688

 

4,397

 

2,291

 

52

%

Medicaid discounts

 

15,276

 

10,726

 

4,550

 

42

%

Managed care and governmental agreements

 

7,264

 

2,899

 

4,365

 

151

%

 

 

40,913

 

25,853

 

15,060

 

 

 

 

 

 

 

 

 

 

 

 

 

Net sales

 

$

294,371

 

$

253,594

 

$

40,777

 

16

%

 

 

 

 

 

 

 

 

 

 

Adjustments to gross sales as a percentage of gross sales

 

12.2

%

9.3

%

 

 

 

 

 

Increases in the adjustments to gross sales as a percentage of gross sales from the quarter ended September 30, 2004 to the quarter ended September 30, 2005 primarily reflect the establishment of a wholesaler discount reserve in 2005 to provide for fees consistent with the terms of the wholesaler service agreements we recently executed, increased Medicaid discounts resulting from both increased usage and increased rebate percentages due to price increases, and additional rebates for certain governmental programs.

 

Other Revenues—The increase of 81% from period to period is primarily due to the inclusion of product development and licensing fees and royalties attributable to CIMA LABS of $10.3 million for the quarter ended September 30, 2005, compared to $5.4 million from the acquisition date of August 12, 2004 to September 30, 2004.

 

26



 

 

 

For the three months
ended September 30,

 

 

 

 

 

 

 

2005

 

2004

 

Change

 

% Change

 

Costs and expenses:

 

 

 

 

 

 

 

 

 

Cost of sales

 

$

37,629

 

$

33,782

 

$

3,847

 

11

%

Research and development

 

91,934

 

67,683

 

24,251

 

36

%

Selling, general and administrative

 

103,253

 

76,204

 

27,049

 

35

%

Depreciation and amortization

 

22,346

 

13,784

 

8,562

 

62

%

Acquired in-process research and development

 

5,500

 

185,700

 

(180,200

)

(97

)%

 

 

$

260,662

 

$

377,153

 

$

(116,491

)

(31

)%

 

Cost of Sales— Cost of sales as a percentage of net sales was approximately 13% for both the third quarter of 2005 and the third quarter of 2004.  Cost of sales as a percentage of net sales was impacted by the addition of CIMA LABS’ product sales beginning in the third quarter of 2004, for which the margin is lower than our other products.  This impact was offset by lower production costs per unit for ACTIQ during the third quarter of 2005 resulting from higher production levels and by the effect of price increases on our three major US products effective February 2005 and July 2005.

 

Research and Development Expenses—Research and development expenses increased $24.3 million, or 36%, in the third quarter of 2005 as compared to the third quarter of 2004.  Of this increase, $10.6 million is due to clinical research costs including expenditures associated with increased headcount necessary to support higher levels of clinical activities and expenditures associated with clinical studies to explore the utility of GABITRIL in generalized anxiety disorder and Phase 3 studies of fentanyl effervescent buccal tablets. These increases were partially offset by a decrease in clinical research costs due to the inclusion in 2004 of four double-blind studies in our NUVIGIL program, which were completed in January 2005. The remainder of the increase from period to period is largely due to an increase in headcount-related expenditures in other research and development areas.

 

Selling, General and Administrative Expenses—Selling, general and administrative expenses increased $27.0 million, or 35%, in the third quarter of 2005 as compared to the third quarter of 2004.  Selling, general and administrative expenses increased period to period primarily due to (1) sales and marketing costs in France to support NAXY® and MONO-NAXY®, which we acquired from Sanofi-Synthelabo France in December 2004, (2) expenditures associated with an increase in headcount, (3) the inclusion of a full quarter of CIMA LABS in 2005, which we acquired in August 2004 and (4) expansion of our field sales forces, additional product promotional expense and an increased number of medical education programs, offset somewhat by a reduction in GABITRIL marketing activity.

 

Depreciation and Amortization Expenses—Depreciation and amortization expenses increased by $8.6 million, or 62%, in the third quarter of 2005 as compared to the third quarter of 2004.  This increase is primarily the result of increased capital investments in software, building, leasehold and laboratory improvements at our West Chester and Frazer locations, increased spending on manufacturing equipment at our Salt Lake City location and the acquisition of property, plant and equipment associated with the CIMA LABS acquisition. Amortization expense increased due to the inclusion of amortization expense associated with the CIMA LABS (August 2004), NAXY® and MONO-NAXY® (December 2004) and TRISENOX® (July 2005) transactions.

 

Acquired In-Process Research and Development—The decrease in acquired in-process research and development expense in 2005 as compared to 2004 is due to the inclusion of in-process research and development charge in 2004 as a result of our acquisition of CIMA LABS.

 

 

 

For the three months
ended September 30,

 

 

 

 

 

 

 

2005

 

2004

 

Change

 

% Change

 

Other income and expense:

 

 

 

 

 

 

 

 

 

Interest income

 

$

7,247

 

$

4,804

 

$

2,443

 

51

%

Interest expense

 

(7,494

)

(5,176

)

(2,318

)

(45

)%

Debt exchange expense

 

 

(28,230

)

28,230

 

100

%

Gain (charge) on early extinguishment of debt

 

2,085

 

(1,352

)

3,437

 

254

%

Other income (expense), net

 

(38

)

(642

)

604

 

94

%

 

 

$

1,800

 

$

(30,596

)

$

32,396

 

106

%

 

27



 

Other Income and Expense—Total other income and expense, net, increased $32.4 million, or 106%, in the third quarter of 2005 from the third quarter of 2004 due to:

 

                  a $2.4 million increase in interest income in the third quarter of 2005 from the third quarter of 2004 due to higher investment returns partially offset by lower average investment balances;

 

                  a $2.3 million increase in interest expense due to higher average debt balances;

 

                  a $28.2 million decrease in debt exchange expense which was recognized in the third quarter of 2004 related to the exchange of $78.3 million of our 2.5% convertible subordinated notes;

 

                  a net gain (charge) on early extinguishment of debt in the third quarter of 2005 includes a $7.4 million gain on the repurchase of approximately $512 million of the 2.5% convertible subordinated notes and a net loss of $5.3 million on the termination of the interest rate swap agreement associated with $200 million notional amount of the 2.5% convertible subordinated notes in a private transaction; in the third quarter of 2004, the $1.4 million charge on early extinguishment of debt was a result of the repurchase of $33.0 million of our 3.875% convertible subordinated notes.

 

 

 

For the three months
ended September 30,

 

 

 

 

 

 

 

2005

 

2004

 

Change

 

% Change

 

 

 

 

 

 

 

 

 

 

 

Income tax expense

 

$

(21,331

)

$

(19,464

)

$

(1,867

)

(10

)%

 

Income Taxes—We recognized $21.3 million of income tax expense in the third quarter of 2005 and $19.5 million of income tax expense in the third quarter of 2004.  The effective tax rate in the third quarter of 2005 and 2004 is 42.1% and (13.4)%, respectively.  We recognized a valuation allowance on the majority of the potential tax benefit related to acquired in-process research and development expense during the third quarter of 2005 as we believe it is more likely than not that such potential tax benefit will not be realized.  No tax benefit was recorded for the $185.7 million charge for in-process research and development expense recognized in the third quarter of 2004.  We recognized a tax benefit and a reduction of additional paid in capital of $11.3 million for the $28.2 million debt exchange expense recognized upon conversion of $78.3 million of our 2.5% convertible subordinated notes in the third quarter of 2004.  We will continue to review and analyze the likelihood of realizing tax benefits relating to deferred tax assets as there is more certainty surrounding our future levels of profitability, particularly in light of potential product regulatory approvals in the fourth quarter of 2005 and early 2006 launches.

 

Nine months ended September 30, 2005 compared to nine months ended September 30, 2004:

 

 

 

2005

 

2004

 

% Increase (Decrease)

 

 

 

United

 

 

 

 

 

United

 

 

 

 

 

United

 

 

 

 

 

 

 

States

 

Europe

 

Total

 

States

 

Europe

 

Total

 

States

 

Europe

 

Total

 

Sales:

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

PROVIGIL

 

$

338,529

 

$

26,009

 

$

364,538

 

$

276,071

 

$

23,221

 

$

299,292

 

23

%

12

%

22

%

ACTIQ

 

282,105

 

11,904

 

294,009

 

253,130

 

5,350

 

258,480

 

11

%

123

%

14

%

GABITRIL

 

54,023

 

4,562

 

58,585

 

67,372

 

4,659

 

72,031

 

(20

)%

(2

)%

(19

)%

Other

 

36,319

 

80,137

 

116,456

 

5,224

 

63,948

 

69,172

 

595

%

25

%

68

%

Total Sales

 

710,976

 

122,612

 

833,588

 

601,797

 

97,178

 

698,975

 

18

%

26

%

19

%

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Other Revenues

 

36,176

 

5,724

 

41,900

 

12,212

 

5,239

 

17,451

 

196

%

9

%

140

%

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Total Revenues

 

$

747,152

 

$

128,336

 

$

875,488

 

$

614,009

 

$

102,417

 

$

716,426

 

22

%

25

%

22

%

 

For the nine months ended September 30, 2005, total sales increased by 19% over the prior period.  The factors that contributed to the increase in sales are summarized as follows:

 

                  Sales of PROVIGIL increased 22% as compared to the same period last year. Demand for PROVIGIL increased

 

28



 

as evidenced by an increase in U.S. prescriptions for PROVIGIL of 19%, according to IMS Health. For the nine months ended 2005, sales of PROVIGIL also were impacted by domestic price increases of approximately 20% from period to period, offset by a decrease in the number of units of inventory held by U.S. wholesalers and an increase in the adjustments recorded to gross sales.

 

                  Sales of ACTIQ increased 14% as compared to the same period last year. Demand for ACTIQ increased as evidenced by an increase in U.S. prescriptions for ACTIQ of 10%, according to IMS Health. For the nine months ended 2005, sales of ACTIQ also were impacted by an increase in domestic prices of approximately 18% from period to period, offset by a decrease in the number of units of inventory held by U.S. wholesalers as well as an increase in adjustments recorded to gross sales.

 

                  Sales of GABITRIL decreased 19% as compared to the same period last year.  U.S. prescriptions for GABITRIL decreased 10% according to IMS Health.  This decrease was driven primarily by our decision to reduce our sales and marketing efforts following an update in February 2005 to the label information for GABITRIL. For the nine months ended 2005, sales of GABITRIL also were impacted by domestic price increases of approximately 28% from period to period, offset by a decrease in the number of units held by U.S. wholesalers during the nine months ended September 30, 2005 as well as an increase in adjustments recorded to gross sales.

 

                  Other sales, which consist primarily of sales of other products and certain third party products, increased 68% as compared to the same period last year.  The most significant increases in this category are sales of SPASFON® (phloroglucinol), sales of NAXY® (clarithromycin), which we acquired in December 2004, sales of products manufactured and sold to pharmaceutical partners by CIMA LABS, which we acquired in August 2004 and sales of TRISENOX® which we acquired in July 2005.

 

Analysis of gross sales to net sales—The following table presents the adjustments from gross sales to arrive at a net sales figure:

 

 

 

For the nine months
ended September 30,

 

 

 

 

 

 

 

2005

 

2004

 

Change

 

% Change

 

Gross sales

 

$

955,429

 

$

769,966

 

$

185,463

 

24

%

 

 

 

 

 

 

 

 

 

 

Adjustments to gross sales:

 

 

 

 

 

 

 

 

 

Prompt payment discounts

 

15,839

 

13,192

 

2,647

 

20

%

Wholesaler discount reserve

 

18,139

 

 

18,139

 

100

%

Returns

 

10,634

 

9,336

 

1,298

 

14

%

Coupons

 

16,683

 

11,774

 

4,909

 

42

%

Medicaid discounts

 

43,156

 

28,948

 

14,208

 

49

%

Managed care and governmental agreements

 

17,390

 

7,741

 

9,649

 

125

%

 

 

121,841

 

70,991

 

50,850

 

 

 

 

 

 

 

 

 

 

 

 

 

Net sales

 

$

833,588

 

$

698,975

 

$

134,613

 

19

%

 

 

 

 

 

 

 

 

 

 

Adjustments to gross sales as a percentage of gross sales

 

12.8

%

9.2

%

 

 

 

 

 

Increases in the adjustments to gross sales as a percentage of gross sales from the nine months ended September 30, 2004 to the nine months ended September 30, 2005 primarily reflects the establishment of a wholesaler discount reserve to provide for fees consistent with the terms of the wholesaler service agreements recently executed with our wholesaler customers, increased Medicaid discounts resulting from both increased usage and increased discount percentages due to price increases, and additional rebates for certain governmental programs.  Additionally, we extended discounts totaling $2.2 million in the first quarter of 2005 to certain of our wholesalers in order to maintain inventory at estimated historic levels.

 

Other Revenues—The increase of 140% from period to period is primarily due to the inclusion of product

 

29



 

development and licensing fees and royalties attributable to CIMA LABS of $27.6 million for the nine months ended September 30, 2005, compared to $5.4 million from the acquisition date of August 12, 2004 to September 30, 2004.

 

 

 

For the nine months
ended September 30,

 

 

 

 

 

 

 

2005

 

2004

 

Change

 

% Change

 

Costs and expenses:

 

 

 

 

 

 

 

 

 

Cost of sales

 

$

114,093

 

$

89,599

 

$

24,494

 

27

%

Research and development

 

255,591

 

198,208

 

57,383

 

29

%

Selling, general and administrative

 

302,904

 

243,908

 

58,996

 

24

%

Depreciation and amortization

 

61,151

 

36,927

 

24,224

 

66

%

Impairment charge

 

 

30,071

 

(30,071

)

(100

)%

Acquired in-process research and development

 

295,615

 

185,700

 

109,915

 

59

%

 

 

$

1,029,354

 

$

784,413

 

$

244,941

 

31

%

 

Cost of Sales—Cost of sales as a percentage of net sales was approximately 14% for the nine months ended September 30, 2005 and 13% for the nine months ended September 30, 2004.  The increase is primarily due to the addition of CIMA LABS’ product sales for which the margin is lower than our other products and which was acquired in the third quarter of 2004.  This increase was partially offset by the effect of price increases on our three major US products effective February 2005 and July 2005.

 

Research and Development Expenses—Research and development expenses increased $57.4 million, or 29%, for the nine months ended September 30, 2005 as compared to the nine months ended September 30, 2004. Of this increase, $23.2 million is due to clinical research costs including expenditures associated with increased headcount necessary to support higher levels of clinical activities and expenditures associated with clinical studies to explore the utility of GABITRIL in generalized anxiety disorder and Phase 3 studies of fentanyl effervescent buccal tablets. These increases were partially offset by a decrease in clinical research costs due to the conclusion in 2005 of four double-blind studies in our NUVIGIL program. The remainder of the increase from period to period is largely due to an increase in headcount-related expenditures in other research and development areas and the inclusion of a full nine months of CIMA LABS, which was acquired in August 2004.

 

Selling, General and Administrative Expenses—Selling, general and administrative expenses increased $59.0 million, or 24%, for the nine months ended September 30, 2005 as compared to the nine months ended September 30, 2004.  Selling, general and administrative expenses increased period to period primarily due to (1) increased sales and marketing costs in France to support NAXY® and MONO-NAXY®, which were acquired from Sanofi-Synthelabo France in December 2004, (2) expenditures associated with an increase in headcount, (3) the inclusion of a full nine months of CIMA LABS, which was acquired in August 2004, and (4) the recognition of a gain of $4.2 million in the first quarter in 2004 as a result of retiree medical benefit changes for employees at Cephalon France for which there is no comparable amount in the first quarter of 2005, offset somewhat by a reduction in GABITRIL marketing activity.

 

Depreciation and Amortization Expenses—Depreciation and amortization expenses increased by $24.2 million, or 66%, for the nine months ended September 30, 2005 as compared to the nine months ended September 30, 2004.  This increase is primarily the result of increased capital investments in software, building, leasehold and laboratory improvements at our West Chester and Frazer locations, increased spending on manufacturing equipment at our Salt Lake City location and the acquisition of property, plant and equipment associated with the CIMA LABS acquisition. Amortization expense increased due to the amortization of technology, trademark and marketing rights acquired from CIMA LABS in the third quarter of 2004, the amortization of French marketing rights to NAXY® and MONO-NAXY® and the amortization of TRISENOX® technology acquired in July 2005.

 

Impairment Charge—During 2004, we recorded an impairment charge of $30.1 million for the write-off of our investment in MDS Proteomics Inc.

 

Acquired In-Process Research and Development—The increase in acquired in-process research and development expense in 2005 as compared to 2004 is due to our acquisition of Salmedix, Inc. and the license and collaboration agreement we entered into with Alkermes for VIVITREX.  We recorded $130.1 million for Salmedix and $160 million for VIVITREX in acquired in-process research and development expense in the second quarter of 2005.   In 2004, in connection with our acquisition of CIMA in August 2004, we allocated approximately $185.7 million of purchase price to in-process research and development projects.

 

30



 

 

 

For the nine months
ended September 30,

 

 

 

 

 

 

 

2005

 

2004

 

Change

 

% Change

 

Other income and expense:

 

 

 

 

 

 

 

 

 

Interest income

 

$

19,559

 

$

11,639

 

$

7,920

 

68

%

Interest expense

 

(19,311

)

(16,888

)

(2,423

)

(14

)%

Debt exchange expense

 

 

(28,230

)

28,230

 

100

%

Gain (charge) on early extinguishment of debt

 

2,085

 

(2,313

)

4,398

 

190

%

Other income (expense), net

 

1,983

 

(2,444

)

4,427

 

181

%

 

 

$

4,316

 

$

(38,236

)

$

42,552

 

111

%

 

Other Income and Expense—Total other income and expense, net, increased $42.6 million, or 111%, in the nine months ended September 30, 2005 from the nine months ended September 30, 2004 due to:

 

                  a $7.9 million increase in interest income in 2005 due to higher investment returns partially offset by lower average investment balances.  This increase was partially offset by a $2.4 million increase in interest expense due to higher average debt balances.

 

                  a $28.2 million decrease in debt exchange expense which was recognized in 2004 related to the exchange of $78.3 million of our 2.5% convertible subordinated notes.

 

                  a net gain (charge) on early extinguishment of debt of $2.1 million in 2005 compared to ($2.3) million in 2004.  The net gain in 2005 includes a $7.4 million gain on the repurchase of approximately $512 million of the 2.5% convertible subordinated notes and a net loss of $5.3 million on the termination of the interest rate swap agreement associated with $200 million notional amount of the 2.5% convertible subordinated notes.  The charge in 2004 relates to the repurchase of $10.0 million and $33.0 million of our 3.875% convertible subordinated notes in private transactions in March 2004 and August 2004, respectively.

 

                  a $4.4 million increase in other income period over period primarily due to gains recorded in foreign currency transactions.

 

 

 

For the nine months
ended September 30,

 

 

 

 

 

 

 

2005

 

2004

 

Change

 

% Change

 

 

 

 

 

 

 

 

 

 

 

Income tax expense

 

$

(43,477

)

$

(45,695

)

$

2,218

 

5

%

 

Income Taxes—We recognized $43.5 million of income tax expense in the nine months ended September 30, 2005 and $45.7 million of income tax expense in the nine months ended September 30, 2004.  The effective tax rate for the nine months ended 2005 and 2004 is (29.1)% and (43.0)%, respectively.  The 2005 effective tax rate includes a benefit of $5.0 million on the $160.0 million of IPR&D charged to expense in 2005 relating to the VIVITREX collaboration.  We recognized a valuation allowance on the majority of the potential tax benefit related to the acquired VIVITREX product rights as we believe it is more likely than not that such potential tax benefit will not be realized.  We did not record a tax benefit for the IPR&D charge related to Salmedix since we did not acquire a tax basis in its assets and do not expect to realize a tax deduction.  We recognized a net deferred tax asset of $4.3 million relating to the U.S. federal and state net operating losses acquired from Salmedix, which we believe are more likely than not to be utilized.  We recognized a valuation allowance on the majority of the potential tax benefit associated with $5.0 million of IPR&D expense in connection with a license agreement entered into during the quarter as we believe it is more likely than not that such potential tax benefit will not be realized.  No tax benefit was recorded for the $185.7 million charge for in-process research and development expense recognized in 2004.  We recognized a tax benefit and a reduction of additional paid in capital of $11.3 million for the $28.2 million debt exchange expense recognized upon conversion of $78.3 million of our 2.5% convertible subordinated notes in 2004.  We did not record a tax benefit on the impairment charge of $30.1 million recognized in 2004 since the realization of this deduction for tax purposes was not yet assured as of September 30, 2004.  We will continue to review and analyze the likelihood of realizing tax benefits relating to deferred tax assets as there is more certainty surrounding our future levels of

 

31



 

profitability, particularly in light of potential product regulatory approvals in the fourth quarter of 2005 and early 2006 launches.

 

LIQUIDITY AND CAPITAL RESOURCES

 

Cash, cash equivalents and investments at September 30, 2005 were $815.6 million, representing 30% of total assets, up from $791.7 million, or 32% of total assets, at December 31, 2004. During 2005, we have received net proceeds of $726.8 million received from the sale of 2% convertible senior subordinated notes and the related sale of warrants and purchase of a convertible note hedge.  The receipt of the proceeds were more than offset by (1) our acquisition of Salmedix in June 2005 for $130.7 million, net of cash acquired, (2) our acquisition of VIVITREX product rights in June 2005 for $160 million, (3) our acquisition of TRISENOX in July 2005 for $69.7 million and (4) the completion of our tender offer to purchase our 2.5% Notes for $499.0 million.

 

Working capital, which is calculated as current assets less current liabilities, was $939.0 million at September 30, 2005 compared to $945.5 million at December 31, 2004.

 

Net Cash Provided by Operating Activities

 

Net cash provided by operating activities was $68.4 million for the nine months ended September 30, 2005 as compared to net cash provided by operating activities of $131.6 million for 2004. The change is primarily a result of a payment of $160 million cash in June 2005 to Alkermes, Inc. under the license and collaboration agreement related to VIVITREX, offset by income from our operations.  The payment to Alkermes has been recorded as an IPR&D charge as the product has not yet received FDA approval.

 

Net Cash Used for Investing Activities

 

Net cash used for investing activities was $281.2 million for the nine months ended September 30, 2005 as compared to $603.2 million for 2004. A large portion of the cash used for investing activities during 2004 was due to the acquisition of CIMA in August 2004 for $482.5 million, net of cash acquired and the increase of purchases of available-for-sale investments in order to benefit from rising interest rates on longer term investments.  During 2005, our primary uses of cash for investing activities have been related to our acquisition of Salmedix in June 2005 for $130.7 million, net of cash, and our acquisition of TRISENOX for $69.7 million.  In addition, we are currently investing funds to make facilities improvements at our new corporate headquarters in Frazer, Pennsylvania and at our West Chester, Salt Lake City and France locations to accommodate our growth, and we are purchasing manufacturing equipment at our Salt Lake City location for the production of ACTIQ and other products, including fentanyl effervescent buccal tablets, if approved, for the U.S. and European markets.

 

Net Cash Provided by (Used for) Financing Activities

 

Net cash provided by financing activities was $227.0 million for the nine months ended September 30, 2005 as compared to net cash used for financing activities of $37.1 million in the same period in 2004. We received net proceeds in 2005 of $892.0 million from the sale of 2% convertible senior subordinated notes. Concurrent with the sale of the 2% notes, we purchased a convertible note hedge for $382.3 million and sold warrants to purchase an aggregate of 19,700,214 shares of our common stock for net proceeds of $217.1 million.  In July 2005, we completed a tender offer to purchase our outstanding 2.5% convertible subordinated notes for $499.0 million in cash. During 2004, we repurchased $43.0 million of the 3.875% convertible subordinated notes.

 

Outlook

 

We expect to use our remaining cash, cash equivalents and investments for working capital and general corporate purposes, including the acquisition of businesses, products, product rights, or technologies, the payment of contractual obligations, including scheduled interest payments on our convertible notes and regulatory or sales milestones that may become due to Cell Therapeutics, Alkermes, or the former stockholders of Salmedix, and/or the purchase, redemption or retirement of our convertible notes.  However, in 2006, we expect that sales of our currently marketed products, together with sales of our near-term product candidates, assuming approval in the anticipated time frames, should allow us to generate positive cash flow from operations.  At this time, we cannot accurately predict the effect of certain developments on the rate of sales growth in 2007 and beyond, such as the degree of market acceptance, patent protection and exclusivity of our products, the impact of competition, the effectiveness of our sales and marketing efforts and the outcome of our current efforts to develop, receive approval for and successfully launch our near-term product candidates.

 

32



 

Based on our current level of operations, projected sales of our existing products and estimated sales from our product candidates, if approved, combined with other revenues and interest income, we also believe that we will be able to service our existing debt and meet our capital expenditure and working capital requirements in the near term. However, we cannot be sure that our anticipated revenue growth will be realized or that we will continue to generate significant positive cash flow from operations. We may need to obtain additional funding for future significant strategic transactions, to repay our outstanding indebtedness or for our future operational needs, and we cannot be certain that funding will be available on terms acceptable to us, or at all.

 

Marketed Products

 

Continued sales growth of PROVIGIL beyond the December 2005 expiration of orphan drug exclusivity depends, in part, on our maintaining protection in the United States and abroad of the modafinil particle-size patent through its expiration beginning in 2014.  See footnote 9 to the Consolidated Financial Statements included in Part I, Item 1 of this Report.  We currently expect that we will complete clinical studies of PROVIGIL in pediatric patients prior to December 2005, which should cause the FDA to grant us a six-month extension of our current exclusivity (to June 2006) and of the particle-size patent.  Future growth of modafinil-based product sales in 2006 and beyond also will depend on our ability to achieve FDA approval of NUVIGIL and final FDA approval of SPARLON.

 

Our sales of ACTIQ depend on our existing patent protection for the approved compressed powder formulation, which expires in the U.S. in September 2006.  The patent covering the previous formulation of ACTIQ expired in May 2005.  See “Certain Risks Related to our Business” below.  If we complete clinical studies in pediatric patients that are agreeable to the FDA, the FDA could grant us six months of exclusivity beyond the September 2006 compressed powder patent expiration.  However, even with this additional exclusivity, Barr’s license to the ACTIQ patents could become effective as early as the launch of fentanyl effervescent buccal tablets (expected in late 2006), and in no event later than February 3, 2007.  The entry of Barr with a generic form of ACTIQ beginning in late 2006 or early 2007 likely will significantly and negatively impact future ACTIQ sales.

 

Clinical Studies

 

                                                Over the past few years, we have incurred significant expenditures related to conducting clinical studies to develop new pharmaceutical products and exploring the utility of our existing products in treating disorders beyond those currently approved in their respective labels.  For 2006, we expect to continue to incur significant levels of research and development expenditures, though the aggregate amount of such expenditures will likely be less than that incurred in 2005.  We expect to continue the following significant clinical programs, among others, in 2006: a Phase 3 program evaluating GABITRIL for the treatment of generalized anxiety disorder; a Phase 3 program evaluating TREANDA for the treatment of NHL; and a Phase 2 program evaluating CEP-701 for the treatment of AML.  During the third quarter of 2005, we ceased clinical development of CEP-7055, one of the molecules in our VEGF inhibitor research program.  We are continuing the VEGF program and are pursuing other molecules that may have utility in the treatment of solid tumors, including CEP-11981, a preclinical drug candidate that we believe may have superior pharmaceutical properties to CEP-7055.  We may seek to mitigate the risk in our research and development programs by seeking sources of funding for a portion of these expenses through collaborative arrangements with third parties. However, we intend to retain a portion of the commercial rights to these programs and, as a result, we still expect to spend significant funds on our share of the cost of these programs, including the costs of research, preclinical development, clinical research and manufacturing.

 

Manufacturing, Selling and Marketing Efforts

 

In 2006, we expect to incur significant expenditures associated with manufacturing, selling and marketing our products.  The aggregate amount of our sales and marketing expenses in 2006 will likely be significantly higher than that incurred in 2005, primarily as a result of higher expenses associated with an increase in the size of our sales force and planned product launches for SPARLON, NUVIGIL, and fentanyl effervescent buccal tablets, if approved.  In 2006, we expect to continue in-process capital expenditure projects at our research and development facilities in France and West Chester, PA and at our Salt Lake City manufacturing facility.

 

Indebtedness

 

We have significant indebtedness outstanding, consisting principally of indebtedness on convertible subordinated notes.  The following table summarizes the principal terms of our most significant convertible subordinated notes outstanding as of September 30, 2005:

 

33



 

Security

 

Outstanding (in
millions)

 

Conversion
Price

 

Other

 

 

 

 

 

 

 

2.0% Convertible Senior Subordinated Notes due June 2015 (the “2% Notes”)

 

$

920.0

 

$

46.70

*

Generally not redeemable by the holder prior to December 2014

 

 

 

 

 

 

 

2.5% Convertible Subordinated Notes due December 2006 (the “2.5% Notes”)

 

$

10.0

 

$

81.00

 

Redeemable on or after December 20, 2004 at our option at a redemption price of 100% of the principal amount redeemed.

 

 

 

 

 

 

 

Zero Coupon Convertible Notes due June 2033, first putable June 15, 2008 (the “2008 Zero Coupon Notes”)

 

$

374.8

 

$

59.50

*

Redeemable on June 15, 2008 at either option of holder or us at a redemption price of 100.25% of the principal amount redeemed.

 

 

 

 

 

 

 

Zero Coupon Convertible Notes due June 2033, first putable June 15, 2010 (the “2010 Zero Coupon Notes”)

 

$

374.9

 

$

56.50

*

Redeemable on June 15, 2010 at either option of holder or us at a redemption price of 100.25% of the principal amount redeemed.

 


*                 Stated conversion prices as per the terms of the notes. However, each convertible note contains certain terms restricting a holder’s ability to convert the notes, including that a holder may only convert if the closing price of our stock on the day prior to conversion is higher than $56.04, $71.40 or $67.80 with respect to the 2% Notes, the 2008 Zero Coupon Notes or the 2010 Zero Coupon Notes, respectively. If the restrictions on conversion are satisfied, we would classify the then-aggregate outstanding principal balance of such affected notes as a current liability on our balance sheet and, if such notes are presented for conversion, we would be required to pay to the holder the principal balance of such notes in cash. For a more complete description of these notes, including the associated convertible note hedge strategies, see Note 8 to our consolidated financial statements included in this Form 10-Q and Notes 1 and 11 to our consolidated financial statements included in Item 8 of our Form 10-K for the fiscal year ended December 31, 2004.

 

The annual interest payments on our convertible notes outstanding as of the date of this report are $18.7 million, payable at various dates throughout the year.  In the future, we may agree to exchanges of the notes for shares of our common stock or debt, or may determine to use a portion of our existing cash on hand to purchase, redeem or retire all or a portion of the outstanding convertible notes.  In January 2003, we entered into an interest rate swap agreement with a financial institution relating to our 2.5% Notes in the aggregate notional amount of $200.0 million.  Following our purchase of $512 million of the outstanding 2.5% Notes, we terminated this agreement in July 2005 resulting in a loss of $5.3 million.

 

Acquisition Strategy

 

As part of our business strategy, we plan to consider and, as appropriate, make acquisitions of other businesses, products, product rights or technologies. Our cash reserves and other liquid assets may be inadequate to consummate such acquisitions and it may be necessary for us to raise substantial additional funds in the future to complete future transactions. In addition, as a result of our acquisition efforts, we are likely to experience significant charges to earnings for merger and related expenses (whether or not our efforts are successful) that may include transaction costs, closure costs or acquired in-process research and development charges.

 

Other

 

We may experience significant fluctuations in quarterly results based primarily on the level and timing of:

 

                                          product sales and cost of product sales;

                                          inventory stocking or destocking practices of our wholesalers and large retail chain customers;

                                          achievement and timing of research and development milestones;

                                          collaboration revenues;

                                          cost and timing of clinical trials;

                                          marketing and other expenses; and

                                          manufacturing or supply disruptions.

 

34



 

CRITICAL ACCOUNTING POLICIES AND ESTIMATES

 

Our consolidated financial statements have been prepared in accordance with accounting principles generally accepted in the United States of America. Preparation of these statements requires management to make judgments and estimates. Some accounting policies have a significant impact on amounts reported in these financial statements. A summary of significant accounting policies and a description of accounting policies that are considered critical may be found in Item 8 of our Annual Report on Form 10-K for the year ended December 31, 2004 in the “Critical Accounting Policies and Estimates” section and the “Recent Accounting Pronouncements” section.

 

Gross to Net Sales Adjustments—We record product sales net of the following significant categories of gross to net sales adjustments:  prompt payment discounts, returns, coupons, Medicaid discounts and managed care and governmental contracts.  In addition to these adjustments, in the first quarter of 2005 we also began recording an adjustment to product sales for wholesaler discount reserves. Calculating each of these items involves significant estimates and judgments and requires us to use information from external sources.

 

Wholesaler discount reserves—In the third quarter of 2005, we entered into standard wholesaler service agreements with a number of our wholesaler customers that provide our wholesalers with the opportunity to earn up to 2% in additional discounts in exchange for the performance of certain services.  These agreements are effective from January 1, 2005.  We have therefore recorded a provision equal to 2% of sales for the nine months ended September 30, 2005.  In addition, at our discretion, we may provide additional discounts to wholesalers such as the discounts of $2.2 million that were provided and recorded during the first quarter of 2005.  Actual discounts provided could therefore exceed historical experience and our estimates of expected discounts.  If these discounts were to increase by 1.0% of sales for the nine months ended September 30, 2005, then an additional provision of $9.6 million would result.

 

The following table summarizes activity in each of the above categories for the year ended December 31, 2004 and the nine months ended, September 30, 2005 (in thousands):

 

35



 

 

 

Prompt

 

 

 

 

 

 

 

 

 

Managed Care

 

 

 

 

 

Payment

 

Wholesaler

 

 

 

 

 

Medicaid

 

& Gov’t

 

 

 

 

 

Discounts

 

Discounts

 

Returns *

 

Coupons

 

Discounts

 

Contracts

 

Total

 

Balance at
January 1, 2004

 

$

(1,108

)

$

 

$

(7,121

)

$

(2,175

)

$

(10,038

)

$

(1,692

)

$

(22,134

)

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Provision:

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Current period

 

(18,443

)

 

(12,822

)

(16,521

)

(41,027

)

(12,263

)

(101,076

)

Prior periods

 

 

 

1,575

 

 

(247

)

(285

)

1,043

 

Total

 

(18,443

)

 

(11,247

)

(16,521

)

(41,274

)

(12,548

)

(100,033

)

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Actual:

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Current period

 

15,497

 

 

 

13,538

 

25,321

 

8,118

 

62,474

 

Prior periods

 

1,155

 

 

6,641

 

993

 

7,916

 

1,713

 

18,418

 

Total

 

16,652

 

 

6,641

 

14,531

 

33,237

 

9,831

 

80,892

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Balance at December 31, 2004

 

$

(2,899

)

$

 

$

(11,727

)

$

(4,165

)

$

(18,075

)

$

(4,409

)

$

(41,275

)

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Provision:

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Current period

 

(15,839

)

(18,139

)

(7,913

)

(16,683

)

(42,565

)

(17,446

)

(118,585

)

Prior periods

 

 

 

(2,721

)

 

(591

)

56

 

(3,256

)

Total

 

(15,839

)

(18,139

)

(10,634

)

(16,683

)

(43,156

)

(17,390

)

(121,841

)

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Actual:

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Current period **

 

13,798

 

21,387

 

(1,572

)

13,633

 

24,970

 

13,774

 

85,990

 

Prior periods

 

2,899

 

 

4,556

 

4,150

 

14,568

 

3,170

 

29,343

 

Total

 

16,697

 

21,387

 

2,984

 

17,783

 

39,538

 

16,944

 

115,333

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Balance at September 30, 2005

 

$

(2,041

)

$

3,248

 

$

(19,377

)

$

(3,065

)

$

(21,693

)

$

(4,855

)

$

(47,783

)

 


*                 Given our returned goods policy, we assume that all returns in a current year relate to prior period sales.

**          Includes beginning reserve balances related to TRISENOX, which was acquired in the third quarter of 2005.

 

Valuation of Goodwill—We evaluate the recoverability and measure the possible impairment of our goodwill under SFAS No. 142, “Goodwill and Other Intangible Assets.” The impairment test is a two-step process that begins with the estimation of the fair value of each reporting unit. The first step screens for potential impairment, and the second step measures the amount of the impairment, if any. Our estimate of fair value considers publicly available information regarding the market capitalization of our company, as well as (i) publicly available information regarding comparable publicly-traded companies in the pharmaceutical industry, (ii) the financial projections and future prospects of our reporting units, including our growth opportunities and likely operational improvements, and (iii) comparable sales prices, if available. As part of the first step to assess potential impairment, we compare our estimate of fair value for each of the reporting units to the book value of our reporting unit’s net assets. If the book value of our reporting unit’s net assets were greater than our estimate of fair value of the reporting unit, we would then proceed to the second step to measure the impairment, if any. The second step measures the amount of impairment by comparing the implied fair value of the reporting unit’s goodwill with its carrying value. The implied fair value is determined by allocating the fair value of the reporting unit to all of the assets and liabilities of that unit as if the reporting unit had been acquired in a business combination, and the fair value of the reporting unit was the purchase price paid to acquire the reporting unit. The excess of the fair value of the reporting unit over the amounts assigned to its assets and liabilities is the implied fair value of goodwill. If the carrying amount of the reporting unit goodwill is greater than its implied fair value, an impairment loss will be recognized in the amount of the excess.

 

We performed our annual test of impairment of goodwill as of July 1, 2005.  Under SFAS No. 142, as a result of our reorganization of our internal management and reporting structure, we allocated goodwill to each of our reporting units based on their relative fair value.  During the third quarter of 2005, $288.6 million of goodwill was allocated by reporting unit to

 

36



 

our United States segment and $80.9 million was allocated to our Europe segment.  Following the completion of this allocation, we completed our annual test of impairment of goodwill and concluded that it was not appropriate to record an impairment charge.

 

Income Taxes—We provide for income taxes in accordance with SFAS No. 109, “Accounting for Income Taxes,” which requires the recognition of deferred tax assets and liabilities for the expected tax consequences of temporary differences between the tax and financial reporting bases of assets and liabilities.

 

Prior to 2002, we had a history of losses from our operations, which generated significant international, federal and state net operating loss carryforwards. We record a valuation allowance against deferred tax assets if we believe that we are not likely to realize future tax benefits.  Based on our profitability for the year ended December 31, 2002 and projected future results, in the fourth quarter of 2002, we concluded that it was likely that we would be able to realize a significant portion of the deferred tax assets, and therefore, we reversed a significant portion of the valuation allowance.  As a result, beginning in 2003, we began providing for income taxes at a rate equal to our estimated annual combined federal, state and foreign statutory effective rates. Subsequent adjustments to our estimates of our ability to recover the deferred tax assets or other changes in circumstances or estimates could cause our provision for income taxes to vary from period to period.

 

At September 30, 2005, we retained a valuation allowance of $127.6 million against a total deferred tax asset balance of $464.5 million.  We believe that this reserve is appropriate given the significant risks which face the company. We will continue to review and analyze the likelihood of realizing tax benefits related to deferred tax assets as there is more certainty surrounding our future levels of profitability, particularly in light of potential product regulatory approvals in the fourth quarter of 2005 and early 2006 launches.  In addition, we will continue to assess the challenges of generics to our key products. Without favorable outcomes of these events, it is not likely that we will be able to utilize the deferred tax assets that currently have a valuation allowance against them.

 

CERTAIN RISKS RELATED TO OUR BUSINESS

 

You should carefully consider the risks described below, in addition to the other information contained in this report, before making an investment decision. Our business, financial condition or results of operations could be harmed by any of these risks. The risks and uncertainties described below are not the only ones we face. Additional risks not presently known to us or other factors not perceived by us to present significant risks to our business at this time also may impair our business operations.

 

A significant portion of our revenues is derived from U.S. sales of our three largest products, and our future success will depend on the continued acceptance and growth of these products.

 

For the nine months ended September 30, 2005, approximately 86% of our worldwide net sales were derived from sales of PROVIGIL, ACTIQ and GABITRIL.  With respect to PROVIGIL and ACTIQ, we have commenced litigation against a number of generic companies related to the patents covering these products.  A finding that these companies do not infringe our patents or that our patents are invalid will likely lead to generic competition to one or both of these products in 2006, which would significantly and negatively impact our sales of these products.  In the case of ACTIQ, even if we prevail in the litigation, Barr’s license to the ACTIQ patents could become effective as early as September 2006.  Notwithstanding the patent infringement litigation, we also cannot be certain that these products, as well as GABITRIL, will continue to be accepted in their markets. Specifically, the following factors, among others, could affect the level of market acceptance of PROVIGIL, ACTIQ and GABITRIL:

 

                  a change in the perception of the healthcare community of their safety and efficacy, both in an absolute sense and relative to that of competing products;

                  the level and effectiveness of our sales and marketing efforts;

                  any unfavorable publicity regarding these products or similar products;

                  the price of the product relative to other competing drugs or treatments;

                  any changes in government and other third-party payer reimbursement policies and practices; and

                  regulatory developments affecting the manufacture, marketing or use of these products.

 

Any adverse developments with respect to the sale or use of PROVIGIL, ACTIQ and GABITRIL could significantly reduce our product revenues and have a material adverse effect on our ability to generate net income and positive net cash flow from operations.

 

37



 

We may be unsuccessful in our efforts to obtain regulatory approval for new products or for new formulations or indications for our existing products, which would significantly hamper future sales and earnings growth.

 

Our prospects, particularly with respect to the growth of our future sales and earnings, depend substantially on our ability to obtain FDA approval for our near-term product candidates:  NUVIGIL, SPARLON, fentanyl effervescent buccal tablets for use in treating breakthrough cancer pain, VIVITREX and GABITRIL for GAD.  We do not know whether we or, in the case of VIVITREX, our partner will succeed in obtaining regulatory approval to market any of these products or what level of market acceptance these products may achieve.  It is possible that a generic version of PROVIGIL could affect market acceptance of NUVIGIL and SPARLON and that a generic version of ACTIQ could negatively impact sales of fentanyl effervescent buccal tablets.  We also have not yet completed Phase 3 studies of GABITRIL for use in treating GAD.  If the results of some of these additional studies are negative or adverse, this could undermine physician and patient comfort with the current product, limit its commercial success, and diminish its acceptance. Even if the results of these studies are positive, the impact on sales of GABITRIL may be minimal unless we are able to obtain regulatory approval to expand the authorized uses of this product. FDA regulations limit our ability to communicate the results of additional clinical studies to patients and physicians without first obtaining regulatory approval for any expanded uses.

 

We may not be able to maintain adequate protection for our intellectual property or market exclusivity for certain of our products and, therefore, competitors may develop competing products, which could result in a decrease in sales and market share, cause us to reduce prices to compete successfully and limit our commercial success.

 

We place considerable importance on obtaining patent protection for new technologies, products and processes. To that end, we file applications for patents covering the compositions or uses of our drug candidates or our proprietary processes. The patent positions of pharmaceutical and biotechnology companies can be highly uncertain and involve complex legal, scientific and factual questions.  Accordingly, the patents and patent applications relating to our products, product candidates and technologies may be challenged, invalidated or circumvented by third parties and might not protect us against competitors with similar products or technology. Patent disputes in our industry are frequent and can preclude commercialization of products. If we ultimately engage in and lose any such disputes, we could be subject to competition or significant liabilities, we could be required to enter into third party licenses or we could be required to cease using the technology or product in dispute. In addition, even if such licenses are available, the terms of any license requested by a third party could be unacceptable to us.

 

PROVIGIL

 

The U.S. composition of matter patent for modafinil expired in 2001.  We own U.S. and foreign patent rights that expire between 2014 and 2015 and cover pharmaceutical compositions and uses of modafinil, specifically, certain particle sizes of modafinil contained in the pharmaceutical composition.  Ultimately, these patents might be found invalid as the result of a challenge by a third party, or a potential competitor could develop a competing product or product formulation that avoids infringement of these patents.  As of the date of this report, the FDA has accepted five ANDAs for pharmaceutical products containing modafinil and containing a Paragraph IV certification in which the ANDA applicant certified that the U.S. particle-size modafinil patent covering PROVIGIL either is invalid or will not be infringed by the ANDA product. We have filed a patent infringement lawsuit in the U.S. District Court in New Jersey against Teva Pharmaceuticals USA, Inc., Mylan Pharmaceuticals, Inc., Ranbaxy Laboratories Limited and Barr Laboratories, Inc. based upon the ANDAs filed by each of these companies with the FDA seeking approval to market a generic form of modafinil.  The lawsuit claims infringement of our U.S. Patent No. RE37,516 (“the ‘516 Patent”) which covers the pharmaceutical compositions and methods of treatment with the form of modafinil contained in PROVIGIL.  Each of the defendants has asserted defenses and/or counterclaims for non-infringement and/or patent invalidity. Mylan and Ranbaxy also have asserted counterclaims for patent unenforceability based on alleged inequitable conduct.  We have moved to dismiss the unenforceability counterclaims and a decision is pending.  Discovery in this lawsuit is complete, and all four defendants have filed motions for summary judgment of non-infringement and/or patent invalidity.  We have filed our oppositions to the motions, and the court has not yet set a date for a hearing on the defendants’ summary judgment motions.  We do not anticipate a decision on these motions prior to the end of 2005.  We expect a trial to begin no earlier than the second quarter of 2006.  In early 2005, we also filed suit for infringement of the ‘516 Patent against Carlsbad Technology, Inc. in the U.S. District Court in New Jersey based upon the ANDA filed by Carlsbad with the FDA seeking to market a generic form of modafinil.  Carlsbad has asserted counterclaims for non-infringement of the ‘516 Patent and invalidity of the ‘516 Patent.  Carlsbad also has asserted a counterclaim for non-infringement of our U.S. Patent No. 4,927,855 (which we have not asserted against Carlsbad).  We have moved to dismiss all of Carlsbad’s counterclaims; Carlsbad has opposed the motion, and a decision is pending.  Discovery in this action has only recently commenced.    While we intend to vigorously defend the validity of these patents and prevent infringement, these

 

38



 

efforts will be both expensive and time consuming and, ultimately, may not be successful.  The loss of patent protection for PROVIGIL would significantly and negatively impact future PROVIGIL sales.

 

Barr, Mylan and Ranbaxy have each announced the receipt of tentative FDA approval for their respective generic versions of PROVIGIL.  Under the provisions of the Hatch-Waxman Act, we are entitled to a 30-month stay of final FDA approval of these generic versions of PROVIGIL.  This stay precludes these companies from selling a modafinil-based product until the earlier to occur of the conclusion of the lawsuit or June 2006.  However, if the court finds our particle-size patent is invalid or not infringed, these companies could begin selling their modafinil-based products upon the expiration of our FDA orphan drug exclusivity, currently in December 2005, which would significantly and negatively impact revenues from PROVIGIL. We do not know whether the ANDAs filed by Teva and Carlsbad have been, or will be, tentatively approved by the FDA.

 

If we complete clinical studies of PROVIGIL in pediatric patients that are acceptable to the FDA, the FDA could grant us a six-month extension of our orphan drug exclusivity (to June 2006) and six months of exclusivity beyond the 2014 expiration of the particle-size patent term.

 

In June 2005, Tenlec Pharma Limited was issued a product license by the Medicines and Healthcare products Regulatory Agency in the United Kingdom for its generic version of PROVIGIL, which, we understand, will be marketed and sold jointly with Teva UK Limited.  Following the issuance of this license, we and our subsidiary, Cephalon (UK) Limited, filed a lawsuit against Teva and Tenlec claiming infringement of the European patents covering PROVIGIL, which do not expire until 2014.  Tenlec and Teva deny infringement and have claimed that the patents are invalid.  Notwithstanding this, in late July 2005, Teva and Tenlec provided undertakings to the Royal Court of Justice (High Court) in London agreeing that they will not market or sell a generic version of PROVIGIL in the United Kingdom, prior to a trial and court decision, currently anticipated in early 2006. While we intend to vigorously defend the validity of these patents and prevent infringement, these efforts will be both expensive and time consuming and ultimately, may not be successful.

 

ACTIQ

 

With respect to ACTIQ, we hold an exclusive license to U.S. patents covering the currently approved compressed powder pharmaceutical composition and methods for administering fentanyl via this composition that are set to expire in September 2006. Corresponding patents in foreign countries are set to expire between 2009 and 2010. Our patent protection with respect to the ACTIQ formulation we sold prior to June 2003 expired in May 2005. If we complete an additional clinical study in pediatric patients that is agreeable to the FDA, the FDA could grant us six months of exclusivity beyond the September 2006 compressed powder patent expiration.  However, even with this additional exclusivity, Barr’s license to the ACTIQ patents under the license and supply agreement could become effective as early as the launch of ORAVESCENT fentanyl (expected in late 2006), and in no event later than February 3, 2007.  In December 2004, we announced that FDA had acknowledged receipt of an ANDA filed by Barr seeking approval for a generic form of ACTIQ and in January 2005, we filed a patent infringement lawsuit against Barr to defend our patents until the license effective date.  Barr has asserted counterclaims for non-infringement and patent invalidity.  We have moved to dismiss those counterclaims, Barr has opposed our motion, and a decision is pending.  Fact discovery is substantially complete, and this lawsuit is currently in the expert discovery phase.  A Markman Hearing has been held and the court has issued a claim construction ruling.  We anticipate trial in this matter to occur during the first six months of 2006.  Neither the ANDA filing nor this lawsuit affects the terms of the existing license grant to Barr of certain intellectual property related to ACTIQ, and we do not expect any change in the anticipated date of Barr’s entry to the market.  However, depending on the timing and outcome of the trial, it is possible that Barr could enter the market prior to our current expectations.  At the same time, we continue to comply in good faith with the FTC Decision and Order requiring us to provide the ACTIQ manufacturing process and other information to Barr to assist its efforts to manufacture a licensed generic version of ACTIQ when Barr’s license becomes effective.  While we intend to vigorously defend the validity of the ACTIQ patents and prevent infringement by Barr until the license effective date, these efforts will be both expensive and time consuming and, ultimately, may not be successful.  The entry of Barr with a generic form of ACTIQ likely will significantly and negatively impact future ACTIQ sales.

 

GABITRIL

 

With respect to GABITRIL, we hold an exclusive sublicense to four U.S. composition-of-matter patents covering the currently approved product: a patent claiming tiagabine, the active drug substance contained in GABITRIL; a patent claiming crystalline tiagabine hydrochloride monohydrate and its use as an anti-epileptic agent; a patent claiming the pharmaceutical formulation; and a patent claiming anhydrous crystalline tiagabine hydrochloride and processes for its preparation.  These patents currently are set to expire in 2011, 2012, 2016 and 2017, respectively.  Supplemental Protection Certificates based upon corresponding foreign patents covering this product are set to expire in 2011.  Ultimately, these patents might be found invalid as the result of a challenge by a third party, or a potential competitor could develop a

 

39



 

competing product or product formulation that avoids infringement of these patents.

 

We also rely on trade secrets, know-how and continuing technological advancements to support our competitive position. Although we have entered into confidentiality and invention rights agreements with our employees, consultants, advisors and collaborators, these parties could fail to honor such agreements or we could be unable to effectively protect our rights to our unpatented trade secrets and know-how. Moreover, others could independently develop substantially equivalent proprietary information and techniques or otherwise gain access to our trade secrets and know-how. In addition, many of our scientific and management personnel have been recruited from other biotechnology and pharmaceutical companies where they were conducting research in areas similar to those that we now pursue. As a result, we could be subject to allegations of trade secret violations and other claims.

 

In April 2005, we received notice from SUN Pharmaceutical Industries Limited that it had filed an ANDA with the FDA seeking approval to market a generic form of GABITRIL.  The ANDA as filed does not include a Paragraph IV certification with respect to the patent claiming tiagabine and, as such, SUN is not seeking to market a generic form of GABITRIL until the expiration of this patent in 2011.  Instead, the ANDA alleges (1) non-infringement of a patent claiming crystalline tiagabine hydrochloride monohydrate and its use as an anti-epileptic agent and a patent claiming the pharmaceutical formulation of the product and (2) non-infringement and invalidity of our patent claiming anhydrous crystalline tiagabine hydrochloride and its processes for preparation.

 

Our activities and products are subject to significant government regulations and approvals, which are often costly and could result in adverse consequences to our business if we fail to comply.

 

We currently have a number of products that have been approved for sale in the United States, foreign countries or both. All of our approved products are subject to extensive continuing regulations relating to, among other things, testing, manufacturing, quality control, labeling, and promotion. The failure to comply with any rules and regulations of the FDA or any foreign medical authority, or the post-approval discovery of previously unknown problems relating to our products, could result in, among other things:

 

                                          fines, recalls or seizures of products;

                                          total or partial suspension of manufacturing or commercial activities;

                                          non-approval of product license applications;

                                          restrictions on our ability to enter into strategic relationships; and

                                          criminal prosecution.

 

In September 2004, we announced that we had received subpoenas from the U.S. Attorney’s Office in Philadelphia.  That same month, we received a voluntary request for information from the Office of the Connecticut Attorney General.  Both the subpoenas and the voluntary request for information appear to be focused on Cephalon’s sales and promotional practices with respect to ACTIQ, GABITRIL and PROVIGIL, including the extent of off-label prescribing of our products by physicians.  We are cooperating with the U.S. Attorney’s Office and the Office of the Connecticut Attorney General; and are providing documents and other information to both offices in response to these and additional requests.  These matters may involve the bringing of criminal charges and fines, and/or civil penalties.  We cannot predict or determine the outcome of these matters or reasonably estimate the amount or range of amounts of any fines or penalties that might result from an adverse outcome.  However, an adverse outcome could have a material adverse effect on our financial position, liquidity and results of operations.

 

It is both costly and time-consuming for us to comply with these inquiries and regulations. Additionally, incidents of adverse drug reactions, unintended side effects or misuse relating to our products could result in additional regulatory controls or restrictions, or even lead to withdrawal of a product from the market.

 

With respect to our product candidates and for new therapeutic indications for our existing products, we conduct research, preclinical testing and clinical trials, each of which requires us to comply with extensive government regulations. We cannot market these product candidates or these new indications in the United States or other countries without receiving approval from the FDA or the appropriate foreign medical authority. The approval process is highly uncertain and requires substantial time, effort and financial resources. Ultimately, we may never obtain approval in a timely manner, or at all. Without these required approvals, our ability to substantially grow revenues in the future could be adversely affected.

 

In addition, because PROVIGIL and ACTIQ contain active ingredients that are controlled substances, we are subject to regulation by the Drug Enforcement Administration (DEA) and analogous foreign organizations relating to the

 

40



 

manufacture, shipment, sale and use of the applicable products. These regulations also are imposed on prescribing physicians and other third parties, making the storage, transport and use of such products relatively complicated and expensive. With the increased concern for safety by the FDA and the DEA with respect to products containing controlled substances and the heightened level of media attention given to this issue, it is possible that these regulatory agencies could impose additional restrictions on marketing or even withdraw regulatory approval for such products. In addition, adverse publicity may bring about a rejection of the product by the medical community. If the DEA, FDA or a foreign medical authority withdrew the approval of, or placed additional significant restrictions on the marketing of any of our products, our product sales and ability to promote our products could be substantially affected.

 

We rely on third parties for the timely supply of specified raw materials, equipment, contract manufacturing, formulation or packaging services, product distribution services, customer service activities and product returns processing.  Although we actively manage these third party relationships to ensure continuity and quality, some events beyond our control could result in the complete or partial failure of these goods and services.  Any such failure could have a material adverse effect on our financial condition and result of operations.

 

Manufacturing, supply and distribution problems may create supply disruptions that could result in a reduction of product sales revenue and an increase in costs of sales, and damage commercial prospects for our products.

 

The manufacture, supply and distribution of pharmaceutical products, both inside and outside the United States, is highly regulated and complex. We, and the third parties we rely upon for the manufacturing and distribution of our products, must comply with all applicable regulatory requirements of the FDA and foreign authorities, including current Good Manufacturing Practice regulations. In addition, we must comply with all applicable regulatory requirements of the DEA and analogous foreign authorities for certain of our products that contain controlled substances. The facilities used to manufacture, store and distribute our products also are subject to inspection by regulatory authorities at any time to determine compliance with regulations.  These regulations are complex, and any failure to comply with them could lead to remedial action, civil and criminal penalties and delays in production or distribution of material.

 

We predominately depend upon single sources for the manufacture of both the active drug substances contained in our products and for finished commercial supplies. For example:

 

                  modafinil: Our manufacturing facility in France is a primary source of the active drug substance modafinil. With respect to finished commercial supplies of PROVIGIL, we currently have two qualified manufacturers, DSM Pharmaceuticals Inc., in Greenville, North Carolina, and Patheon, Inc., in Ontario, Canada.  With respect to SPARLON, we expect to have two qualified manufacturers of finished commercial supplies following final FDA approval of the product.

 

                  ACTIQ: Our U.S. facility in Salt Lake City, Utah, is the sole source for the worldwide manufacture and supply of finished commercial supplies of ACTIQ.

 

                  GABITRIL: Abbott Laboratories manufactures finished commercial supplies of GABITRIL for the U.S. market (through at least December 2008) and Sanofi-Synthelabo manufactured GABITRIL for non-U.S. markets through the end of the third quarter of 2005.  We have identified a third party manufacturer for the future worldwide production of the active drug substance tiagabine and finished commercial supplies of GABITRIL.  We are in the process of qualifying this manufacturer with appropriate U.S. and European regulatory authorities.

 

                  Other Products: Certain of our products are manufactured at our facilities in France, with the remaining products manufactured by single source third parties. Our subsidiary, CIMA LABS, also manufactures products at its Minnesota facilities for certain of its pharmaceutical company partners.

 

The process of changing or adding a manufacturer or changing a formulation requires prior FDA and/or European medical authority approval and is very time-consuming. If we are unable to manage this process effectively or if an unforeseen event occurs at any facility, we could face supply disruptions that would result in significant costs and delays, undermine goodwill established with physicians and patients, damage commercial prospects for our products and adversely affect operating results.

 

With respect to VIVITREX, Alkermes is obligated to provide to us finished commercial supplies of the product under the terms of a supply agreement.  While Alkermes has manufactured VIVITREX in small quantities for use in clinical trials, we cannot be sure that they will be able to successfully manufacture VIVITREX at a commercial scale in a timely or

 

41



 

economical manner, or at all, if the product is approved by the FDA. If Alkermes is unable to successfully increase its manufacturing scale or capacity, the commercial launch of VIVITREX could be delayed or there could be a shortage in supply of the product, either of which could harm the commercial prospects for the product. In addition, Alkermes is responsible for the entire supply chain for VIVITREX, including the sourcing of raw materials and active pharmaceutical agents from third parties. Alkermes has no previous experience in managing a complex, cGMP supply chain and issues with its supply sources could impair its ability to supply VIVITREX under the supply agreement and have a material adverse effect on our commercial prospects for VIVITREX.

 

As our products are used commercially, unintended side effects, adverse reactions or incidents of misuse may occur that could result in additional regulatory controls, adverse publicity and reduced sales of our products.

 

During research and development, the use of pharmaceutical products, such as ours, is limited principally to clinical trial patients under controlled conditions and under the care of expert physicians. The widespread commercial use of our products could identify undesirable or unintended side effects that have not been evident in our clinical trials or the relatively limited commercial use to date.  For example, in February 2005, working with the FDA, we updated our prescribing information for GABITRIL to include a bolded warning describing the risk of new onset seizures in non-induced patients without epilepsy.  In addition, in patients who take multiple medications, drug interactions could occur that can be difficult to predict. Additionally, incidents of product misuse, product diversion or theft may occur, particularly with respect to products such as ACTIQ and PROVIGIL, which contain controlled substances. These events, among others, could result in adverse publicity that harms the commercial prospects of our products or lead to additional regulatory controls that could limit the circumstances under which the product is prescribed or even lead to the withdrawal of the product from the market. In particular, ACTIQ has been approved under regulations concerning drugs with certain safety profiles, under which the FDA has established special restrictions to ensure safe use. Any violation of these special restrictions could lead to the imposition of further restrictions or withdrawal of the product from the market.

 

We face significant product liability risks, which may have a negative effect on our financial performance.

 

The administration of drugs to humans, whether in clinical trials or commercially, can result in product liability claims whether or not the drugs are actually at fault for causing an injury. Furthermore, our products may cause, or may appear to have caused, adverse side effects (including death) or potentially dangerous drug interactions that we may not learn about or understand fully until the drug has been administered to patients for some time. As our products are used more widely and in patients with varying medical conditions, the likelihood of an adverse drug reaction, unintended side effect or incidence of misuse may increase. Product liability claims can be expensive to defend and may result in large judgments or settlements against us, which could have a negative effect on our financial performance. The cost of product liability insurance has increased in recent years, and the availability of coverage has decreased. Nevertheless, we maintain product liability insurance in amounts we believe to be commercially reasonable. However, any claims could easily exceed our current coverage limits. Even if a product liability claim is not successful, the adverse publicity and time and expense of defending such a claim may interfere with our business.

 

Our product sales and related financial results will fluctuate, and these fluctuations may cause our stock price to fall, especially if investors do not anticipate them.

 

A number of analysts and investors who follow our stock have developed models to attempt to forecast future product sales and expenses, and have established earnings expectations based upon those models. These models, in turn, are based in part on estimates of projected revenue and earnings that we disclose publicly. Forecasting future revenues is difficult, especially when we only have a few years of commercial history and when the level of market acceptance of our products is changing rapidly.  Forecasting is further complicated by the difficulties in estimating both existing inventory levels for our products at pharmaceutical wholesalers and retail pharmacies and the timing of their purchases to replenish these stocks. As a result, it is likely that our product sales will fluctuate significantly, which may not meet with market expectations and which also may adversely affect our stock price. There are a number of other factors that could cause our financial results to fluctuate unexpectedly, including:

 

                  cost of product sales;

                  achievement and timing of research and development milestones;

                  collaboration revenues;

                  cost and timing of clinical trials and regulatory approvals;

                  marketing and other expenses;

                  manufacturing or supply disruptions; and

 

42



 

                  costs associated with the operations of recently-acquired businesses and technologies.

 

We may be unable to repay our substantial indebtedness and other obligations.

 

As of September 30, 2005, we had $1,696.1 million of indebtedness outstanding, including $1,680 million outstanding under convertible notes with stated conversion prices or restricted conversion prices higher than our stock price as of the date of this filing.  There are no restrictions on our use of our existing cash, cash equivalents and investments, and we cannot be sure that these funds will be available or sufficient in the future to enable us to repay our indebtedness. In the future, these factors, among other things, could make it difficult for us to service, repay or refinance our indebtedness or to obtain additional financing, or limit our flexibility and make us more vulnerable in the event of a downturn in our business. Unless we are able to generate cash flow from operations that, together with our available cash on hand, is sufficient to repay our indebtedness, we will be required to raise additional funds. Because the financing markets may be unwilling to provide funding to us or may only be willing to provide funding on terms that we would consider unacceptable, we may not have cash available or be able to obtain funding to permit us to meet our repayment obligations, thus adversely affecting the market price for our securities.

 

Our research and development and marketing efforts are often dependent on corporate collaborators and other third parties who may not devote sufficient time, resources and attention to our programs, which may limit our efforts to develop and market potential products.

 

To maximize our growth opportunities, we have entered into a number of collaboration agreements with third parties.  For example, in the United States, we are party to an agreement with McNeil Consumer & Specialty Pharmaceuticals Division of McNeil-PPC, Inc. under which McNeil will co-promote our proprietary pediatric formulation of modafinil for ADHD for up to three years following the commercial launch of the product, if approved by FDA.  Our ability to successfully commercialize the product will depend to a significant degree on the efforts of our partner.  If McNeil fails to live up to its obligations under the co-promotion agreement or determines to terminate the agreement prior to the end of its term, the launch and subsequent marketing of the product could be materially and negatively impacted.  Additionally, if McNeil elects to terminate the agreement early as provided for by the agreement, we may be unsuccessful in our efforts to hire the McNeil sales representatives, as permitted under the agreement, or in our efforts to promote the product on our own.

 

In certain countries outside the United States, we have entered into agreements with a number of partners with respect to the development, manufacturing and marketing of our products.   In some cases, our collaboration agreements call for our partners to control:

 

                  the supply of bulk or formulated drugs for use in clinical trials or for commercial use;

                  the design and execution of clinical studies;

                  the process of obtaining regulatory approval to market the product; and/or

                  marketing and selling of an approved product.

 

In each of these areas, our partners may not support fully our research and commercial interests because our program may compete for time, attention and resources with the internal programs of our corporate collaborators. As such, our program may not move forward as effectively, or advance as rapidly, as it might if we had retained complete control of all research, development, regulatory and commercialization decisions. We also rely on some of these collaborators and other third parties for the production of compounds and the manufacture and supply of pharmaceutical products. Additionally, we may find it necessary from time to time to seek new or additional partners to assist us in commercializing our products, though we ultimately might not be successful in establishing any such new or additional relationships.

 

The efforts of government entities and third party payers to contain or reduce the costs of health care may adversely affect our sales and limit the commercial success of our products.

 

In certain foreign markets, pricing or profitability of pharmaceutical products is subject to various forms of direct and indirect governmental control, including the control over the amount of reimbursements provided to the patient who is prescribed specific pharmaceutical products. For example, we are aware of governmental efforts in France to limit or eliminate reimbursement for some of our products, particularly FONZYLANE, which could impact revenues from our French operations.

 

In the United States, there have been, and we expect there will continue to be, various proposals to implement similar controls. The commercial success of our products could be limited if federal or state governments adopt any such proposals. In addition, in the United States and elsewhere, sales of pharmaceutical products depend in part on the availability

 

43



 

of reimbursement to the consumer from third party payers, such as government and private insurance plans. These third party payers are increasingly utilizing their significant purchasing power to challenge the prices charged for pharmaceutical products and seek to limit reimbursement levels offered to consumers for such products.  Moreover, many governments and private insurance plans have instituted reimbursement schemes that favor the substitution of generic pharmaceuticals for more expensive brand-name pharmaceuticals.  In the U.S. in particular, generic substitution statutes have been enacted in virtually all states and permit or require the dispensing pharmacist to substitute a less expensive generic drug instead of an original branded drug.  These third party payers could focus their cost control efforts on our products, especially with respect to prices of and reimbursement levels for products prescribed outside their labeled indications. In these cases, their efforts could negatively impact our product sales and profitability.

 

We experience intense competition in our fields of interest, which may adversely affect our business.

 

Large and small companies, academic institutions, governmental agencies and other public and private research organizations conduct research, seek patent protection and establish collaborative arrangements for product development in competition with us. Products developed by any of these entities may compete directly with those we develop or sell.  In addition, our two largest products, PROVIGIL and ACTIQ, could face competition in 2006 from companies seeking to market generic forms of these products.

 

The conditions that our products treat, and some of the other disorders for which we are conducting additional studies, are currently treated with many drugs, several of which have been available for a number of years or are available in inexpensive generic forms. With respect to PROVIGIL, and, if approved, NUVIGIL, there are several other products used for the treatment of excessive sleepiness or narcolepsy in the United States, including methylphenidate products such as RITALIN® by Novartis, and in our other territories, many of which have been available for a number of years and are available in inexpensive generic forms. If we are successful in obtaining final FDA approval of SPARLON, we will face well established and intense competition from stimulants such as RITALIN® by Novartis, STRATERRA® by Eli Lilly, and CONCERTA® by McNeil, as well as from amphetamines such as DEXEDRINE® by GlaxoSmithKline and ADDERALL® by Shire.  With respect to ACTIQ, we face competition from numerous short- and long-acting opioid products, including three products—Johnson & Johnson’s DURAGESIC® and Purdue Pharmaceutical’s OXYCONTIN® and MS-CONTIN®—that dominate the market. In addition, we are aware of numerous other companies developing other technologies for rapidly delivering opioids to treat breakthrough pain, including transmucosal, transdermal, nasal spray and inhaled delivery systems, among others, that will compete against ACTIQ and, if approved, fentanyl effervescent buccal tablets.  With respect to GABITRIL, there are several products, including NEURONTIN® (gabapentin) by Pfizer, used as adjunctive therapy for the partial seizure market. Some are well-established therapies that have been on the market for several years while others have recently entered the partial seizure marketplace. In addition, several treatments for partial seizures are available in inexpensive generic forms. If we are successful in our efforts to expand the label of GABITRIL to include anxiety disorders, we will face significant competition from well-established Selective Serotonin Reuptake Inhibitor (SSRI) products such as Paxil®, Effexor XR® and Lexapro®.  For all of our products, we need to demonstrate to physicians, patients and third party payers that the cost of our products is reasonable and appropriate in the light of their safety and efficacy, the price of competing products and the related health care benefits to the patient.

 

Many of our competitors have substantially greater capital resources, research and development staffs and facilities than we have, and substantially greater experience in conducting clinical trials, obtaining regulatory approvals and manufacturing and marketing pharmaceutical products. These entities represent significant competition for us. In addition, competitors who are developing products for the treatment of neurological or oncological disorders might succeed in developing technologies and products that are more effective than any that we develop or sell or that would render our technology and products obsolete or noncompetitive. Competition and innovation from these or other sources, including advances in current treatment methods, could potentially affect sales of our products negatively or make our products obsolete. Furthermore, we may be at a competitive marketing disadvantage against companies that have broader product lines and whose sales personnel are able to offer more complementary products than we can. Any failure to maintain our competitive position could adversely affect our business and results of operations.

 

We plan to consider and, as appropriate, make acquisitions of technologies, products and businesses, which may subject us to a number of risks and/or result in us experiencing significant charges to earnings that may adversely affect our stock price, operating results and financial condition.

 

As part of our efforts to acquire businesses or to enter into other significant transactions, we conduct business, legal and financial due diligence with the goal of identifying and evaluating material risks involved in the transaction. Despite our efforts, we ultimately may be unsuccessful in ascertaining or evaluating all such risks and, as a result, we might not realize the intended advantages of the acquisition.  If we fail to realize the expected benefits from acquisitions we may consummate

 

44



 

in the future, whether as a result of unidentified risks, integration difficulties, regulatory setbacks or other events, our business, results of operations and financial condition could be adversely affected.  For example, in connection with our recent acquisitions of Salmedix and TRISENOX and the license and collaboration agreement with Alkermes, we estimated the values of these transactions by making certain assumptions about, among other things, likelihood of regulatory approval for unapproved products and the market potential for each of TREANDA, TRISENOX and VIVITREX.  Ultimately, our assumptions may prove to be incorrect, which could cause us to fail to realize the anticipated benefits of these transactions.

 

In addition, we have experienced, and will likely continue to experience, significant charges to earnings related to our efforts to consummate acquisitions.  For transactions that ultimately are not consummated, these charges may include fees and expenses for investment bankers, attorneys, accountants and other advisers in connection with our efforts.  Even if our efforts are successful, we may incur as part of a transaction substantial charges for closure costs associated with the elimination of duplicate operations and facilities and acquired in-process research and development charges.  In either case, the incurrence of these charges could adversely affect our results of operations for particular quarterly or annual periods.

 

We may be unable to successfully consolidate and integrate the operations of businesses we acquire, which may adversely affect our stock price, operating results and financial condition.

 

We must consolidate and integrate the operations of an acquired business with our business.  During the past year, we have completed the acquisitions of CIMA LABS and Salmedix, Inc., have purchased assets related to TRISENOX, have entered into license agreements with Sanofi-Synthelabo for NAXY and with Alkermes for VIVITREX, and executed a co-promotion agreement with McNeil for our proprietary pediatric formulation of modafinil for ADHD.  Integration efforts often take a significant amount of time, place a significant strain on our managerial, operational and financial resources and could prove to be more difficult and expensive than we predicted.  The diversion of our management’s attention and any delays or difficulties encountered in connection with these recent acquisitions, any future acquisitions we may consummate, could result in the disruption of our ongoing business or inconsistencies in standards, controls, procedures and policies that could negatively affect our ability to maintain relationships with customers, suppliers, employees and others with whom we have business dealings.

 

The results and timing of our research and development activities, including future clinical trials, are difficult to predict, subject to potential future setbacks and, ultimately, may not result in viable pharmaceutical products, which may adversely affect our business.

 

In order to sustain our business, we focus substantial resources on the search for new pharmaceutical products. These activities include engaging in discovery research and process development, conducting preclinical and clinical studies and seeking regulatory approval in the United States and abroad. In all of these areas, we have relatively limited resources and compete against larger, multinational pharmaceutical companies. Moreover, even if we undertake these activities in an effective and efficient manner, regulatory approval for the sale of new pharmaceutical products remains highly uncertain because the majority of compounds discovered do not enter clinical studies and the majority of therapeutic candidates fail to show the human safety and efficacy necessary for regulatory approval and successful commercialization.

 

In the pharmaceutical business, the research and development process can take up to 12 years, or even longer, from discovery to commercial product launch. During each stage of this process, there is a substantial risk of failure.  Preclinical testing and clinical trials must demonstrate that a product candidate is safe and efficacious. The results from preclinical testing and early clinical trials may not be predictive of results obtained in subsequent clinical trials, and these clinical trials may not demonstrate the safety and efficacy necessary to obtain regulatory approval for any product candidates. A number of companies in the biotechnology and pharmaceutical industries have suffered significant setbacks in advanced clinical trials, even after obtaining promising results in earlier trials. For ethical reasons, certain clinical trials are conducted with patients having the most advanced stages of disease and who have failed treatment with alternative therapies. During the course of treatment, these patients often die or suffer other adverse medical effects for reasons that may not be related to the pharmaceutical agent being tested. Such events can have a negative impact on the statistical analysis of clinical trial results.

 

The completion of clinical trials of our product candidates may be delayed by many factors, including the rate of enrollment of patients. Neither we nor our collaborators can control the rate at which patients present themselves for enrollment, and the rate of patient enrollment may not be consistent with our expectations or sufficient to enable clinical trials of our product candidates to be completed in a timely manner or at all. In addition, we may not be permitted by regulatory authorities to undertake additional clinical trials for one or more of our product candidates. Even if such trials are conducted, our product candidates may not prove to be safe and efficacious or receive regulatory approvals. Any significant delays in, or termination of, clinical trials of our product candidates could impact our ability to generate product sales from these product candidates in the future.

 

45



 

The price of our common stock has been and may continue to be highly volatile, which may make it difficult for stockholders to sell our common stock when desired or at attractive prices.

 

The market price of our common stock is highly volatile, and we expect it to continue to be volatile for the foreseeable future. For example, from January 1, 2004 through September 30, 2005 our common stock traded at a high price of $60.98 and a low price of $37.35. Negative announcements, including, among others:

 

                  adverse regulatory decisions;

                  disappointing clinical trial results;

                  disputes and other developments concerning patent or other proprietary rights with respect to our products; or

                  sales or operating results that fall below the market’s expectations

 

could trigger significant declines in the price of our common stock. In addition, external events, such as news concerning economic conditions, our competitors or our customers, changes in government regulations impacting the biotechnology or pharmaceutical industries or the movement of capital into or out of our industry, also are likely to affect the price of our common stock, regardless of our operating performance.

 

Our internal controls over financial reporting may not be considered effective, which could result in possible regulatory sanctions and a decline in our stock price.

 

Section 404 of the Sarbanes-Oxley Act of 2002 requires us to furnish annually a report on our internal controls over financial reporting.  The internal control report must contain an assessment by our management of the effectiveness of our internal control over financial reporting (including the disclosure of any material weakness) and a statement that our independent auditors have attested to and reported on management’s evaluation of such internal controls.  The Sarbanes-Oxley Act requires, among other things, that we maintain effective disclosure controls and procedures and internal controls over financial reporting.  In order for management to evaluate our internal controls, we must regularly review and document our internal control processes and procedures and test such controls.  Ultimately, we or our independent auditors could conclude that our internal control over financial reporting may not be effective if, among others things:

 

                                          any material weakness in our internal controls over financial reporting exist; or

                                          we fail to remediate assessed deficiencies.

 

In 2006, we are planning to implement a new worldwide financial reporting system that will require changes to certain aspects of our existing system of internal control over financial reporting.  Due to the number of controls to be examined, both with respect to the new reporting system and our other internal controls over financial reporting, the complexity of these projects, and the subjectivity involved in determining the effectiveness of controls, we cannot be certain that, in the future, all of our controls will continue to be considered effective by management or, if considered effective by our management, that our auditors will agree with such assessment.

 

If, in the future, we are unable to assert that our internal control over financial reporting is effective, or if our auditors are unable to attest that our management’s report is fairly stated or they are unable to express an opinion on our management’s evaluation, we could be subject to regulatory sanctions or lose investor confidence in the accuracy and completeness of our financial reports, either of which could have an adverse effect on the market price for our securities.

 

A portion of our revenues and expenses is subject to exchange rate fluctuations in the normal course of business, which could adversely affect our reported results of operations.

 

Historically, a portion of our revenues and expenses has been earned and incurred, respectively, in currencies other than the U.S. dollar. For the nine months ended September 30, 2005, approximately 15% of our revenues were denominated in currencies other than the U.S. dollar. We translate revenues earned and expenses incurred into U.S. dollars at the average exchange rate applicable during the relevant period. A weakening of the U.S. dollar would, therefore, increase both our revenues and expenses. Fluctuations in the rate of exchange between the U.S. dollar and the euro and other currencies may affect period-to-period comparisons of our operating results. Historically, we have not hedged our exposure to these fluctuations in exchange rates.

 

46



 

Our customer base is highly concentrated.

 

Our principal customers are wholesale drug distributors. These customers comprise a significant part of the distribution network for pharmaceutical products in the United States. Three large wholesale distributors, Cardinal Health, Inc., McKesson Corporation and AmerisourceBergen Corporation, control a significant share of this network. These three wholesaler customers, in the aggregate, accounted for 85% of our worldwide net sales for the nine months ended September 30, 2005. Fluctuations in the buying patterns of these customers, which may result from seasonality, wholesaler buying decisions or other factors outside of our control, could significantly affect the level of our net sales on a period to period basis.  Because of this, the amounts purchased by these customers during any quarterly or annual period may not correlate to the level of underlying demand evidenced by the number of prescriptions written for such products, as reported by IMS Health Incorporated.  Furthermore, the loss or bankruptcy of any of these customers could materially and adversely affect our results of operations and financial condition.

 

We are involved, or may become involved in the future, in legal proceedings that, if adversely adjudicated or settled, could materially impact our financial condition.

 

As a biopharmaceutical company, we are or may become a party to litigation in the ordinary course of our business, including, among others, matters alleging employment discrimination, product liability, patent or other intellectual property rights infringement, patent invalidity or breach of commercial contract. In general, litigation claims can be expensive and time consuming to bring or defend against and could result in settlements or damages that could significantly impact results of operations and financial condition. We currently are vigorously defending ourselves against certain litigation matters in addition to those key patent litigation matters specifically described above.  While we currently do not believe that the settlement or adverse adjudication of these other litigation matters would materially impact our results of operations or financial condition, the final resolution of these matters and the impact, if any, on our results of operations, financial condition or cash flows is unknown but could be material.

 

Our dependence on key executives and scientists could impact the development and management of our business.

 

We are highly dependent upon our ability to attract and retain qualified scientific, technical and managerial personnel. There is intense competition for qualified personnel in the pharmaceutical and biotechnology industries, and we cannot be sure that we will be able to continue to attract and retain the qualified personnel necessary for the development and management of our business. Although we do not believe the loss of one individual would materially harm our business, our business might be harmed by the loss of the services of multiple existing personnel, as well as the failure to recruit additional key scientific, technical and managerial personnel in a timely manner. Much of the know-how we have developed resides in our scientific and technical personnel and is not readily transferable to other personnel. While we have employment agreements with our key executives, we do not ordinarily enter into employment agreements with our other key scientific, technical and managerial employees. We do not maintain “key man” life insurance on any of our employees.

 

We may be required to incur significant costs to comply with environmental laws and regulations, and our related compliance may limit any future profitability.

 

Our research and development activities involve the controlled use of hazardous, infectious and radioactive materials that could be hazardous to human health and safety or the environment. We store these materials, and various wastes resulting from their use, at our facilities pending ultimate use and disposal. We are subject to a variety of federal, state and local laws and regulations governing the use, generation, manufacture, storage, handling and disposal of these materials and wastes, and we may be required to incur significant costs to comply with related existing and future environmental laws and regulations.

 

While we believe that our safety procedures for handling and disposing of these materials comply with foreign, federal, state and local laws and regulations, we cannot completely eliminate the risk of accidental injury or contamination from these materials. In the event of an accident, we could be held liable for any resulting damages, which could include fines and remedial costs. These damages could require payment by us of significant amounts over a number of years, which could adversely affect our results of operations and financial condition.

 

Anti-takeover provisions may delay or prevent changes in control of our management or deter a third party from acquiring us, limiting our stockholders’ ability to profit from such a transaction.

 

Our board of directors has the authority to issue up to 5,000,000 shares of preferred stock, $0.01 par value, of which 1,000,000 have been reserved for issuance in connection with our stockholder rights plan, and to determine the price, rights, preferences and privileges of those shares without any further vote or action by our stockholders. Our stockholder rights plan could have the effect of making it more difficult for a third party to acquire a majority of our outstanding voting stock.

 

47



 

We are subject to the anti-takeover provisions of Section 203 of the Delaware General Corporation Law, which prohibits us from engaging in a “business combination” with an “interested stockholder” for a period of three years after the date of the transaction in which the person becomes an interested stockholder, unless the business combination is approved in a prescribed manner. The application of Section 203 could have the effect of delaying or preventing a change of control of Cephalon. Section 203, the rights plan, and certain provisions of our certificate of incorporation, our bylaws and Delaware corporate law, may have the effect of deterring hostile takeovers, or delaying or preventing changes in control of our management, including transactions in which stockholders might otherwise receive a premium for their shares over then-current market prices.

 

ITEM 3.  QUANTITATIVE AND QUALITATIVE DISCLOSURE ABOUT MARKET RISK

 

We are exposed to foreign currency exchange risk related to operations conducted by our European subsidiaries that have transactions, assets, and liabilities denominated in foreign currencies that are translated into U.S. dollars for consolidated financial reporting purposes.  Historically, we have not hedged any of these foreign currency exchange risks.  For the nine months ended September 30, 2005, an average 10% weakening of the U.S. dollar relative to the currencies in which our European subsidiaries operate would have resulted in an increase of $12.8 million in reported total revenues and a corresponding percentage increase in reported expenses.  This sensitivity analysis of the effect of changes in foreign currency exchange rates does not assume any changes in the level of operations of our European subsidiaries.

 

In January 2003, we entered into an interest rate swap agreement with a financial institution, relating to our $600.0 million 2.5% convertible subordinated notes, in the aggregate notional amount of $200.0 million. We terminated this agreement in July 2005, following our repurchase for cash of all but $10 million of the outstanding aggregate principal balance of the 2.5% convertible notes.

 

As of September 30, 2005, our exposure to market risk for a change in interest rates relates to our investment portfolio, since all of our outstanding debt is fixed rate. Our investments are classified as short-term and as “available for sale.” We do not believe that short-term fluctuations in interest rates would materially affect the value of our securities.

 

ITEM 4.  CONTROLS AND PROCEDURES

 

(a)                                  Evaluation of Disclosure Controls and Procedures

 

Our management, with the participation of our Chief Executive Officer and Chief Financial Officer, evaluated the effectiveness of our disclosure controls and procedures as of the end of the period covered by this report. Based on that evaluation, the Chief Executive Officer and Chief Financial Officer concluded that our disclosure controls and procedures as of the end of the period covered by this report have been designed and are functioning effectively to provide reasonable assurance that the information required to be disclosed by us in reports filed under the Securities Exchange Act of 1934 is recorded, processed, summarized and reported within the time periods specified in the SEC’s rules and forms. We believe that a controls system, no matter how well designed and operated, cannot provide absolute assurance that the objectives of the controls system are met, and no evaluation of controls can provide absolute assurance that all control issues and instances of fraud, if any, within a company have been detected.

 

(b)                                  Change in Internal Control over Financial Reporting

 

There have been no changes in our internal control over financial reporting during our most recent fiscal quarter that have materially affected, or are reasonably likely to materially affect, our internal control over financial reporting.

 

48



 

PART II – OTHER INFORMATION

 

ITEM 1.                             LEGAL PROCEEDINGS

 

The information required by this Item is incorporated by reference to footnote 9 of the Consolidated Financial Statements included in Part I, Item 1 of this Report.

 

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

 

Tender Offer for Convertible Notes:

 

                                                In July 2005, we completed a tender offer in which we offered to purchase all of our outstanding 2.5% Notes for $975.00 for each $1,000 principal amount of Notes, plus accrued and unpaid interest up to, but not including, the date of payment for the 2.5% Notes accepted for payment.  The following table reflects the 2.5% Notes tendered in the tender offer.

 

Period

 

Total Principal
Amount of
Notes
Tendered

 

Average Price Per
$1,000 Principal
Amount of the
Notes Tendered

 

Total Principal
Amount of Notes
Purchased as Part of
Publicly Announced
Plans or Programs
(1)

 

Approximate
Dollar Value of
Notes that May Yet
Be Purchased
Under the Plans or
Programs

 

July 1—31, 2005

 

$

511,743,000

 

$

976.94

 

$

511,743,000

 

 

August 1—31, 2005

 

 

 

 

 

September 1—30, 2005

 

 

 

 

 

Total

 

$

511,743,000

 

$

976.94

 

$

511,743,000

 

 

 


(1)               On June 10, 2005, we announced an offer to purchase all of our outstanding 2.5% Notes.  The offer expired on July 11, 2005.

 

ITEM 5.                             OTHER INFORMATION

 

Ratios of Earnings to Fixed Charges

 

Our deficiency of earnings available to cover fixed charges for the years ended December 31, 2000, 2001 and 2004 and for the nine months ended September 30, 2005 was $102.8 million, $61.1 million, $28.2 million and $149.6 million, respectively.  Since earnings were insufficient to cover fixed charges for the years ended December 31, 2000, 2001 and 2004 and the nine months ended September 30, 2005, we are unable to provide ratios of earnings to fixed charges for each respective period.

 

Our ratio of earnings to fixed charges for the years ended December 31, 2002 and 2003 was 2.57x and 5.18x, respectively.

 

ITEM 6.                             EXHIBITS

 

Exhibits:

 

Exhibit
No.

 

Description

10.1*

 

Co-Promotion Agreement by and between Cephalon, Inc. and McNeil Consumer & Specialty Pharmaceuticals, a division of McNeil-PPC, Inc. dated August 31, 2005. (1)

10.2*

 

Termination Agreement dated July 18, 2005 by and between Cephalon, Inc. and Credit Suisse First Boston International.

31.1*

 

Certification of Frank Baldino, Jr., Chairman and Chief Executive Officer of the Company, as required pursuant to Section 302 of the Sarbanes-Oxley Act of 2002.

31.2*

 

Certification of J. Kevin Buchi, Senior Vice President and Chief Financial Officer of the Company, as required pursuant to Section 302 of the Sarbanes-Oxley Act of 2002.

32.1#

 

Certification of Frank Baldino, Jr., Chairman and Chief Executive Officer of the Company, as

 

 

required pursuant to Section 906 of the Sarbanes-Oxley Act of 2002.

32.2#

 

Certification of J. Kevin Buchi, Senior Vice President and Chief Financial Officer of the Company, as required pursuant to Section 906 of the Sarbanes-Oxley Act of 2002.

 

49



 


*

Filed herewith.

#

This exhibit shall not be deemed “filed” for purposes of Section 18 of the Securities Exchange Act of 1934, as

amended, or otherwise subject to the liability of that section. Further, this exhibit shall not be deemed to be incorporated by reference in any document filed under the Securities Act of 1933, as amended, or the Securities Exchange Act of 1934, as amended.

(1)

Portions of the Exhibit have been omitted and have been filed separately pursuant to an application for confidential

treatment filed with the Securities and Exchange Commission pursuant to Rule 24b-2 under the Securities Exchange Act of 1934, as amended.

 

50



 

SIGNATURES

 

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

 

 

 

CEPHALON, INC.

 

(Registrant)

 

 

 

 

November 9, 2005

By

 

/s/ FRANK BALDINO, JR.

 

 

 

 

Frank Baldino, Jr., Ph.D.

 

 

 

Chairman and Chief Executive Officer

 

 

 

(Principal executive officer)

 

 

 

 

 

 

 

 

 

By

 

/s/ J. KEVIN BUCHI

 

 

 

 

J. Kevin Buchi

 

 

 

Senior Vice President and Chief Financial Officer

 

 

 

(Principal financial and accounting officer)

 

51


 

EX-10.1 2 a05-18061_1ex10d1.htm MATERIAL CONTRACTS

EXHIBIT 10.1

 

CO-PROMOTION AGREEMENT

 

dated as of August 31, 2005

 

by and between

 

CEPHALON, INC.

 

and

 

McNEIL CONSUMER & SPECIALTY
PHARMACEUTICALS, a Division of
McNEIL-PPC, INC.

 



 

TABLE OF CONTENTS

 

ARTICLE 1

DEFINITIONS

 

 

 

 

ARTICLE 2

RIGHTS AND OBLIGATIONS

 

 

 

 

2.1

Grant of Rights

 

 

 

 

2.2

McNeil Duties and Obligations

 

 

 

 

2.3

Cephalon Duties and Obligations

 

 

 

 

2.4

Ownership

 

 

 

 

ARTICLE 3

JOINT COMMERCIAL COMMITTEE

 

 

 

 

3.1

Members; Officers

 

 

 

 

3.2

Quorum; Voting; Decisions

 

 

 

 

3.3

Minutes

 

 

 

 

3.4

Expenses

 

 

 

 

3.5

Responsibilities

 

 

 

 

3.6

Meetings

 

 

 

 

3.7

Dispute Resolution

 

 

 

 

ARTICLE 4

CO-PROMOTION AND DETAILING

 

 

 

 

4.1

Marketing Activities and Expenses for the Product

 

 

 

 

4.2

McNeil Sales Representative Requirements

 

 

 

 

4.3

McNeil Sales Representatives

 

 

 

 

4.4

Cephalon Benefit Plans

 

 

 

 

4.5

McNeil Salaries and Wages

 

 

 

 

4.6

Cephalon Sales Meetings

 

 

 

 

4.7

Non-Compete and Non Solicitation

 

 

 

 

4.8

Reports and Audit Rights

 

 

 

 

ARTICLE 5

FINANCIAL PROVISIONS

 

 

 

 

5.1

Payments

 

 

 

 

5.2

Net Sales Reports

 

 

 

 

5.3

GAAP

 

 

 

 

5.4

Manner of Payments

 

 

 

 

5.5

Interest on Late Payments

 

 

 

 

5.6

Financial Records; Audits

 

 

i



 

ARTICLE 6

PROMOTIONAL MATERIALS

 

 

 

 

6.1

Ownership of Promotional Materials

 

 

 

 

6.2

Content, Quantity Compliance with Laws and Distribution of Promotional Materials

 

 

 

 

6.3

Payment for Promotional Materials

 

 

 

 

6.4

Review of Promotional Materials in the Territory

 

 

 

 

6.5

Discontinued Use

 

 

 

 

6.6

Use of McNeil Name

 

 

 

 

ARTICLE 7

INFORMATION CONCERNING THE PRODUCT

 

 

 

 

7.1

Statements Consistent with Labeling

 

 

 

 

7.2

Medical Inquiries

 

 

 

 

7.3

Standard Operating Procedures

 

 

 

 

7.4

Exchange of Drug Safety Information

 

 

 

 

7.5

Recalls Or Other Corrective Action

 

 

 

 

7.6

Events Affecting Integrity or Reputation

 

 

 

 

ARTICLE 8

ORDERS; SUPPLY AND RETURNS; REGULATORY

 

 

 

 

8.1

Orders and Terms of Sale

 

 

 

 

8.2

Misdirected Orders

 

 

 

 

8.3

Product Returns

 

 

 

 

8.4

Regulatory

 

 

 

 

ARTICLE 9

CONFIDENTIAL INFORMATION

 

 

 

 

9.1

Confidential Information

 

 

 

 

9.2

Permitted Disclosure and Use

 

 

 

 

9.3

Public Announcements

 

 

 

 

9.4

Confidentiality of this Agreement

 

 

 

 

9.5

Survival

 

 

 

 

ARTICLE 10

REPRESENTATIONS AND WARRANTIES; COVENANTS

 

 

 

 

10.1

Mutual Representations and Warranties

 

 

 

 

10.2

Additional Cephalon Representations, Warranties and Covenants

 

 

 

 

10.3

Covenants

 

 

 

 

ARTICLE 11

INDEMNIFICATION

 

 

 

 

11.1

Indemnification by Cephalon

 

 

 

 

11.2

Indemnification by McNeil

 

 

ii



 

11.3

Procedure for Indemnification

 

 

 

 

11.4

Assumption of Defense

 

 

 

 

11.5

Insurance

 

 

 

 

11.6

Waivers

 

 

 

 

ARTICLE 12

TERM AND TERMINATION

 

 

 

 

12.1

Term

 

 

 

 

12.2

Termination for Breach

 

 

 

 

12.3

Termination for Bankruptcy

 

 

 

 

12.4

McNeil Termination for Other Reason

 

 

 

 

12.5

Effects of Expiration or Termination of this Agreement

 

 

 

 

ARTICLE 13

MISCELLANEOUS

 

 

 

 

13.1

Relationship of the Parties

 

 

 

 

13.2

Registration and Filing of this Agreement

 

 

 

 

13.3

Force Majeure

 

 

 

 

13.4

Governing Law

 

 

 

 

13.5

Dispute Resolution; Arbitration

 

 

 

 

13.6

Assignment

 

 

 

 

13.7

Notices

 

 

 

 

13.8

Severability

 

 

 

 

13.9

Headings

 

 

 

 

13.10

Waiver

 

 

 

 

13.11

Entire Agreement

 

 

 

 

13.12

No License

 

 

 

 

13.13

Third Party Beneficiaries

 

 

 

 

13.14

Counterparts

 

 

iii



 

CO-PROMOTION AGREEMENT

 

This CO-PROMOTION AGREEMENT (“Agreement”) dated as of August 31, 2005 (the “Effective Date”), is made by and between McNEIL CONSUMER & SPECIALTY PHARMACEUTICALS, a division of McNEIL-PPC, Inc., a New Jersey corporation having its principal office at 7050 Camp Hill Road, Fort Washington, Pennsylvania 19034 (“McNeil”) and CEPHALON, INC., a Delaware corporation having its principal office at 41 Moores Road, Frazer, Pennsylvania 19355 (“Cephalon”).  McNeil and Cephalon may be referred to as a “Party” or together as the “Parties”.

 

RECITALS

 

WHEREAS, Cephalon is awaiting Marketing Authorization (as hereinafter defined) to market and sell the Product (as hereinafter defined) in the Territory (as hereinafter defined);

 

WHEREAS, McNeil is interested in Co-Promoting (as hereinafter defined) and Detailing (as hereinafter defined) the Product in the Territory; and

 

WHEREAS, Cephalon desires to appoint McNeil as an independent party for the purposes of exclusively (together with Cephalon) Co-Promoting and Detailing the Product in the Territory and McNeil desires to be so appointed by Cephalon.

 

NOW, THEREFORE, in consideration of the foregoing premises and the representations, covenants and agreements contained herein, McNeil and Cephalon, intending to be legally bound, hereby agree as follows:

 

ARTICLE 1
DEFINITIONS

 

For purposes of this Agreement, the following initially capitalized terms, whether used in the singular or plural, shall have the following meanings:

 

1.1           ADD”  means attention deficit disorder.

 

1.2           ADHD” means attention deficit hyperactivity disorder.

 

1.3           Adverse Drug Experience” means any of: an “adverse drug experience,” a “life-threatening adverse drug experience,” a “serious adverse drug experience,” or an “unexpected adverse drug experience,” as those terms are defined at either 21 C.F.R. § 312.32 or 21 C.F.R. § 314.80.

 

1.4           Affiliate” means, with respect to a Party, any Person, whether de jure or de facto, which directly or indirectly controls, is controlled by, or is under common control with such Person for so long as such control exists, where “control” means the decision-making authority as to such Person and, further, where such control shall be presumed to exist where a Person owns more than fifty percent (50%) of the equity having the power to vote on or direct the affairs of the entity.

 



 

1.5           Agreement Year” means the period commencing on the first day of the first month following the First Commercial Sale and ending twelve (12) consecutive calendar months later, and each successive twelve (12) consecutive calendar months period; provided, however, that the first Agreement Year shall include the period beginning on the date of the First Commercial Sale and prior to the first day of the first Agreement Year if such first day does not occur on the first day of a month.

 

1.6           Annual Net Sales” means the Net Sales during a particular Agreement Year.

 

1.7           Anti-Kickback Statute” means the Medicare and Medicaid Anti-Kickback Statute set forth at 42 U.S.C.
§1320a-7b(b).

 

1.8           Applicable Commercial Practices Policies” means the portions as identified by a Party of the Commercial Practices Policies of such Party applicable to the marketing, sale, promotion and detailing of pharmaceutical products, as amended or supplemented from time to time.  Copies of Cephalon’s Applicable Commercial Practices Policies and McNeil’s Applicable Commercial Practices Policies are attached to this Agreement as Schedule 1.8 and may be updated in writing by one Party to the other Party from time to time.

 

1.9           Base Sunset Commission Fees” shall have the meaning set forth in Section 5.1.3.

 

1.10         Calendar Quarter” means each of the three month periods ending March 31, June 30, September 30 and December 31; provided, however, that the first calendar quarter for the first Calendar Year shall extend from the date of the First Commercial Sale to the end of the first complete calendar quarter thereafter.

 

1.11         Call” means (a) with respect to a McNeil Sales Representative, a personal visit by a McNeil Sales Representative to a member of the Target Audience during which such McNeil Sales Representative Details the Product, and (b) with respect to a Cephalon Sales Representative, a personal visit by a Cephalon Sales Representative to a physician with authority to prescribe a pharmaceutical product or issue hospital orders for a pharmaceutical product in the United States during which such Cephalon Sales Representative Details the Product.

 

1.12         Cephalon’s Medical Education Grants Committee” or “CMEGC” means the committee formed by Cephalon to address issues related to medical education grants or any successor committee thereto.

 

1.13         Cephalon Sales Representative” means a field based sales representative engaged or employed by Cephalon and deployed by Cephalon to Co-Promote and Detail the Product.

 

1.14         Claims” means all charges, complaints, actions, suits, proceedings, hearings, investigations, claims and demands.

 

1.15         Commission Fees” shall have the meaning set forth in Section 5.1.1.

 

 

2



 

1.16         CONCERTA®” means the finished product of McNeil’s ADHD formulation of methylphenidate HCl in all package sizes and dosage forms, including all improvements, line extensions and formulations thereto.

 

1.17         Confidential Information” means all secret, confidential or proprietary information or data, whether provided in written, oral, graphic, video, computer or other form, provided by one Party (the “Disclosing Party”) to the other Party (the “Receiving Party”) pursuant to this Agreement or generated pursuant to this Agreement, including but not limited to, information relating to the Disclosing Party’s existing or proposed research, development efforts, patent applications, business or products, the terms of this Agreement and any other materials that have not been made available by the Disclosing Party to the general public.  Notwithstanding the foregoing sentence, Confidential Information shall not include any information or materials that:

 

1.17.1      were already known to the Receiving Party (other than under an obligation of confidentiality), at the time of disclosure by the Disclosing Party to the extent such Receiving Party has documentary evidence to that effect;

 

1.17.2      were generally available to the public or otherwise part of the public domain at the time of its disclosure to the Receiving Party;

 

1.17.3      became generally available to the public or otherwise part of the public domain after its disclosure or development, as the case may be, and other than through any act or omission of a Party in breach of such Party’s confidentiality obligations under this Agreement;

 

1.17.4      were disclosed to a Party under an obligation of confidentiality that has subsequently expired;

 

1.17.5      were disclosed to a Party, other than under an obligation of confidentiality, by a Third Party who had no obligation to the Disclosing Party not to disclose such information to others; or

 

1.17.6      were independently discovered or developed by or on behalf of the Receiving Party without the use of the Confidential Information belonging to the other Party and the Receiving Party has documentary evidence to that effect.

 

1.18         Co-Promotion” means those promotional activities undertaken by a pharmaceutical company’s sales force in concert with at least one other pharmaceutical company’s sales force to implement the marketing and sales plans with respect to a particular prescription pharmaceutical product under a single trademark.  When used as a verb, “Co-Promote” shall mean to engage in such activities.

 

1.19         Continuing Product Employee” shall have the meaning set forth in Section 10.3.5.

 

1.20         Detail” or “Detailing” means, with respect to the Product, the communication by a Sales Representative during a Call (a) involving face-to-face contact, (b) describing in a fair

 

 

3



 

and balanced manner, the FDA-approved indicated uses, and other relevant characteristics of the Product, (c) using the Promotional Materials in an effort to educate the prescriber concerning the Product and its FDA-approved indicated uses and (d) made at the Target Audience member’s office.  For the avoidance of doubt, discussions at conventions shall not constitute “Details” or “Detailing”.

 

1.21         Designated Senior Officer” means the senior officer designated by a Party to have final decision-making authority over certain disputes which, unless otherwise notified, shall be the President or Chief Executive officer of the Party; provided that the Designated Senior Officer of Cephalon shall not be the Chair of the JCC.

 

1.22         Detail Requirements” shall have the meaning set forth in Section 2.2.

 

1.23         Disputed Matters” shall have the meaning set forth in Section 3.7.

 

1.24         FDA” means the United States Food and Drug Administration and any successor agency thereto.

 

1.25         FD&C Act” means the United States Federal Food, Drug, and Cosmetic Act, as amended, and the regulations promulgated thereunder from time to time.

 

1.26         First Commercial Sale” means the first shipment of commercial quantities of the Product sold to a Third Party by Cephalon or its sublicensees in the Territory after receipt of Marketing Authorization for the Product in the Territory.  Sales for test marketing, sampling and promotional uses, clinical trial purposes or compassionate or similar uses shall not be considered to constitute a First Commercial Sale.

 

1.27         First Position Detail” means a Detail for the Product in the first (or only) position.

 

1.28         Governmental Authority” means any court, tribunal, arbitrator, agency, legislative body, commission, official or other instrumentality of (a) any government of any country, (b) a federal, state, province, county, city or other political subdivision thereof or (c) any supranational body.

 

1.29         Incentive Compensation” means the total sales performance incentive compensation for a product or all products, as applicable, available to be earned by a Sales Representative pursuant to the terms of the then current incentive compensation plan for such Sales Representative.

 

1.30         Joint Commercial Committee” or “JCC” shall have the meaning set forth in Section 3.1.

 

1.31         Laws” means all laws, statutes, rules, regulations, ordinances and other pronouncements having the binding effect of law of any Governmental Authority.

 

1.32         Losses” means any and all damages, awards, deficiencies, settlement amounts, defaults, assessments, fines, dues, penalties, costs, fees, liabilities, obligations, taxes, liens, losses

 

 

4



 

and expenses (including without limitation court costs, interest and reasonable fees of attorneys, accountants and other experts) incurred by or awarded to Third Parties and required to be paid to Third Parties with respect to a Claim by reason of any judgment, order, decree, stipulation or injunction, or any settlement entered into in accordance with the provisions of this Agreement, together with all documented reasonable out-of-pocket costs and expenses incurred in complying with any judgments, orders, decrees, stipulations and injunctions that arise from or relate to a Claim of a Third Party (including, without limitation, court costs, interest and reasonable fees of attorneys, accountants and other experts).

 

1.33         Lost CONCERTA® Market Exclusivity” shall occur if a drug product, that contains the same active ingredient as CONCERTA® (inactive ingredients may vary), is approved by the FDA in the Territory and designated by the FDA as “A/B Rated,” or the bioequivalent of, CONCERTA® and obtains sales in the Territory for sixty (60) days, which generic drug product sales are evidenced by independent market data (where available), such as that published by IMS.

 

1.34         Marketing Authorization” means, with respect to the Territory, the regulatory authorization required to market and sell the Product in the Territory as granted by the FDA.

 

1.35         Marketing Budget” means the annual marketing budget for the Product prepared by Cephalon and distributed by Cephalon to the JCC at least thirty (30) days prior to the beginning of any Agreement Year.  A copy of the Marketing Budget for the First Agreement Year is attached to this Agreement as Schedule 1.35.

 

1.36         McNeil ADHD Sales Force” means those McNeil sales representatives whose primary responsibility is the detailing and selling of CONCERTA® on the Effective Date.

 

1.37         McNeil Medical Science Liaisons” means independent contractors of McNeil who provide medical and scientific information to meet the needs of the medical community.

 

1.38         McNeil Sales Representative” means a field based sales representative engaged or employed by McNeil to conduct, among other sales responsibilities, Detailing and other promotional efforts with respect to products of McNeil including CONCERTA® for so long as McNeil continues to Detail CONCERTA®, and the Product.

 

1.39         McNeil Termination Date” shall have the meaning set forth in Section 10.3.3.

 

1.40         Net Sales” means the aggregate amount invoiced on account of sales of the Product by Cephalon or any of its Affiliates or their sublicensees to a Third Party in the Territory (but not including sales between Cephalon and its Affiliates where the Product is intended for resale) less the following relating to such sales: (a) trade, quantity and cash discounts or rebates actually allowed and taken, which are not already reflected in the amount invoiced; (b) any adjustments or allowances on account of price adjustments, billing errors, rejected goods, damaged goods and returns; (c) credits, volume rebates, charge-back and prime vendor rebates, fees, reimbursements or similar payments granted or given to wholesalers and other distributors, buying groups, health care insurance carriers, pharmacy benefit management companies, health maintenance organizations or other institutions or health care organizations, which are not

 

 

5



 

already reflected in the amount invoiced; (d) any tax, tariff, customs duty, excise or other duty or other governmental charge (other than a tax on income) levied on the sale, transportation or delivery of the Product and borne by the seller thereof, itemized on the applicable invoice and remitted to the applicable taxing authority; (e) payments or rebates paid in connection with sales of the Product to any governmental or regulatory authority in respect of any state or federal Medicare, Medicaid or similar programs, which are not already reflected in the amount invoiced; and (f) any invoiced charge for freight, insurance or other transportation costs charged to the customer.  For purposes of this definition, the Product shall be considered “sold” when so recorded in Cephalon’s financial statements audited in accordance with generally accepted accounting principles, consistently applied.

 

1.41         PDMA” means the Prescription Drug Marketing Act of 1987, as amended, and the regulations promulgated thereunder from time to time.

 

1.42         Person” means any natural person, corporation, general partnership, limited partnership, joint venture, proprietorship or other business organization.

 

1.43         PhRMA Code” means the PhRMA Code on Interactions with Health Care Professionals, as amended.

 

1.44         Plans” means the strategic and tactical plans developed by Cephalon related to the marketing, promotion, sampling and sale of the Product in the Territory, which may be amended by Cephalon from time to time during the Term.

 

1.45         PRC” means the committee formed by Cephalon to review Promotional Materials, which committee shall incorporate at least one representative of McNeil as a member with respect to the review of Promotional Materials.

 

1.46         Primary Detail Equivalents” or “PDEs” means a numerical amount that scores the value of Details performed by Sales Representatives as follows:  [**] for each First Position Detail and [**] for each Second Position Detail.

 

1.47         Product” means the finished product of Cephalon’s ADHD formulation of modafinil in all package sizes and dosage forms, including all improvements, line extensions and new approved indications (including, without limitation, ADD).

 

1.48         Promotion” means those promotional activities undertaken by a pharmaceutical company’s sales force to implement the marketing and sales plans with respect to a particular prescription product under a single trademark.  When used as a verb, “Promote” shall mean to engage in such activities.

 

1.49         Promotional Materials” means all written, printed, video or graphic advertising, promotional, training and communication materials (other than Product labeling) for marketing, advertising, promotion and sale of the Product for use in the Territory by (a) Sales Representatives or (b) advertisements or direct mail pieces.

 


**Portions of the Exhibit have been omitted and have been filed separately pursuant to an application for confidential treatment filed with the Securities and Exchange Commission pursuant to Rule 24b-2 under the Securities Exchange Act of 1934, as amended.

 

6



 

1.50         Sales Representative” means a McNeil Sales Representative or a Cephalon Sales Representative.  Sales Representatives means McNeil Sales Representatives and Cephalon Sales Representatives.

 

1.51         Second Position Detail” means a Detail for the Product in the second position.

 

1.52         Target Audience” means for the Product the current prescribing audience for CONCERTA®, including but not limited to the specialties set forth on Schedule 1.52, with authority to prescribe a pharmaceutical product or issue hospital orders for a pharmaceutical product in the United States.

 

1.53         Term” means the period of time from the Effective Date through the third anniversary of the First Commercial Sale, provided that the First Commercial Sale occurs on or prior to [**], and provided further that if the First Commercial Sale does not occur on or prior to [**], “Term” means the period from the Effective Date through [**], unless terminated earlier pursuant to the terms of this Agreement.

 

1.54         Termination Date” shall have the meaning set forth in Section 10.3.2.

 

1.55         Territory” means the United States, its territories and possessions.

 

1.56         Third Party” means a Person who is not a Party or an Affiliate of a Party.

 

1.57         Upside Sunset Commission Fees” shall have the meaning set forth in Section 5.1.4.

 

ARTICLE 2
RIGHTS AND OBLIGATIONS

 

2.1           Grant of Rights.  Subject to the terms of this Agreement, Cephalon grants to McNeil, on an exclusive basis together with Cephalon, the non-sublicensable right to Co-Promote and Detail the Product to the Target Audience in the Territory during the Term.  For the avoidance of doubt, the Parties acknowledge that, in addition to the Target Audience, Cephalon retains the right to Co-Promote and Detail the Product to all other health care professionals (including, without limitation, primary care physicians, neurologists and psychiatrists) to whom the Product may be Detailed in compliance with all applicable Laws. Cephalon shall not enter into any other co-promotion or similar arrangement with a Third Party regarding the Detailing of the Product in the Territory during the Term.

 

2.2           McNeil Duties and Obligations.

 

2.2.1        On and as of the First Commercial Sale and thereafter during the Term, McNeil shall use its commercially reasonable efforts to Co-Promote and Detail the Product within the Territory in accordance with the terms of this Agreement, the Plans as directed by the Joint Commercial Committee, the PhRMA Code, the Applicable Commercial Practices Policies and all applicable Laws, including, without limitation, the FD&C Act, the Anti-Kickback Statute and the PDMA.  McNeil shall cause the McNeil Sales Representatives to conduct the total Details required (the “Detail Requirements”) to be performed by the McNeil Sales

 


**Portions of the Exhibit have been omitted and have been filed separately pursuant to an application for confidential treatment filed with the Securities and Exchange Commission pursuant to Rule 24b-2 under the Securities Exchange Act of 1934, as amended.

 

7



 

Representatives during the Term as set forth on Schedule 2.2.1.  Notwithstanding anything to the contrary contained in this Agreement, if the FDA or any Federal health authority imposes or requires additional or modified restrictions or safety measures in relation to the use of the Product or with respect to its labeling, including, without limitation, warnings, contraindications or special precautions, which would place the safety profile of the Product at a materially competitive disadvantage when objectively compared with other products in the ADHD market, then the Parties will promptly negotiate in good faith to determine whether a reduction in, or elimination of, the Parties’ Detail Requirements and the Parties’ other obligations under this Agreement is appropriate.

 

2.2.2        Except as otherwise agreed, McNeil shall be responsible for providing its own management, equipment, automobiles, offices and fixtures, working facilities, and such other facilities and services as may be required for the McNeil Sales Representatives at its own expense.

 

2.2.3        McNeil shall not make any representation or statement, written or otherwise, concerning prices, terms of delivery, terms of payment or conditions of sale for the Product except and to the extent that the same is authorized by Cephalon.  McNeil shall have no right or authority to make any price guarantees, offer or agree to any discounts and/or accept any orders on Cephalon’s behalf.

 

2.2.4        McNeil shall be responsible for planning and conducting all training for the McNeil Sales Representatives, subject to timely (i) receipt of all training materials from Cephalon and (ii) training of McNeil’s trainers by Cephalon.  Subject to the timely provision by Cephalon of applicable training and accompanying training materials, McNeil shall be responsible for causing each McNeil Sales Representative to attend and successfully complete a training program with respect to the Promotional Materials regarding the Product provided by Cephalon prior to such McNeil Sales Representative Co-Promoting and Detailing the Product in the Territory.

 

2.2.5        McNeil shall cause at least [**] McNeil Medical Science Liaisons to [**] with respect to the Product.  The McNeil Medical Science Liaisons shall ensure the appropriate dissemination of information, scientific knowledge and services in a timely and ethical manner.  A member of McNeil’s regulatory and/or medical departments agrees to meet with one or more members of Cephalon’s regulatory and/or medical departments on a quarterly basis to discuss the prior and future activities by the McNeil Medical Science Liaisons related to the Product during the Term.  Continuing medical education activities relating to the Product shall be determined and conducted independently by the CMEGC in the sole discretion of Cephalon.

 

2.2.6        Promptly after the First Commercial Sale and to the extent that it is legally permitted to do so, McNeil shall use its commercially reasonable efforts to provide Cephalon with an electronic file listing of physician targets, including hospitals, physicians and other prescribers; number of Calls and type of Details (listed by First Position Details and Second Position Details) completed by prescriber on a weekly basis; and such other information as Cephalon may reasonably request.  In addition, McNeil shall provide to Cephalon within [**] an electronic file containing monthly call data including number of Calls and types of Details at an individual prescriber level.  McNeil shall provide to Cephalon, [**], reports of actual aggregate

 


**Portions of the Exhibit have been omitted and have been filed separately pursuant to an application for confidential treatment filed with the Securities and Exchange Commission pursuant to Rule 24b-2 under the Securities Exchange Act of 1934, as amended.

 

8



 

Incentive Compensation received by the McNeil Sales Representatives with respect to the Product in form and format agreed to by the Parties.

 

2.3           Cephalon Duties and Obligations.

 

2.3.1        Cephalon shall be responsible for timely conducting all training for McNeil’s training managers who will provide the training required pursuant to Section 2.2.4. Cephalon’s training managers shall attend all training programs required pursuant to Section 2.2.4 solely to the extent that such training programs relate to the Product; provided that Cephalon shall fund all travel, lodging and other out-of-pocket costs associated with its training managers attending such training programs.

 

2.3.2        Cephalon shall be responsible for planning and conducting all training for the Cephalon Sales Representatives.  Cephalon shall be responsible for causing each Cephalon Sales Representative to attend and successfully complete a training program with respect to medical and technical information regarding the Product prior to such Cephalon Sales Representative Co-Promoting and Detailing the Product in the Territory.

 

2.3.3        On and as of the First Commercial Sale and thereafter during the Term Cephalon will use commercially reasonable efforts to ensure that at least [**] Cephalon Sales Representatives Co-Promote and Detail the Product within the Territory in accordance with the terms of this Agreement, the Plans as directed by the Joint Commercial Committee, the PhRMA Code, the Applicable Commercial Practices Policies and all applicable Laws, including without limitation, the FD&C Act, the Anti-Kickback Statute and the PDMA.  Cephalon shall cause the Cephalon Sales Representative to conduct the Detail Requirements to be performed by the Cephalon Sales Representatives during the Term as set forth on Schedule 2.2.1.

 

2.3.4        Unless otherwise mutually agreed to by the Parties pursuant to Section 3.5.9, Cephalon shall be responsible for initiating and funding all advisory boards and speaker training programs, market research, clinical studies and collaborative research trials, if any, with respect to the Product.

 

2.3.5        Cephalon shall use its commercially reasonable efforts to spend not less than [**] percent ([**]%) of the total aggregate amounts set forth in the Marketing Budget and agrees, in any event, not to spend less than $[**] in brand marketing expenses in support of the Product during the First Agreement Year.

 

2.4           Ownership.  McNeil shall not represent to any Third Party that is has any proprietary or property right or interest in the Product, except for such rights granted to McNeil under this Agreement.

 

ARTICLE 3
JOINT COMMERCIAL COMMITTEE

 

3.1           Members; Officers.  Within ten (10) days after the Effective Date, the Parties shall establish a commercialization committee (the “Joint Commercial Committee” or “JCC”), and Cephalon and McNeil shall designate an equal number of representatives, up to a maximum

 


**Portions of the Exhibit have been omitted and have been filed separately pursuant to an application for confidential treatment filed with the Securities and Exchange Commission pursuant to Rule 24b-2 under the Securities Exchange Act of 1934, as amended.

 

9



 

total of [**] members on the JCC.  The Chair of the JCC shall be selected by Cephalon from among Cephalon’s JCC members.  Each of Cephalon and McNeil may replace any or all of its representatives on the JCC at any time upon written notice to the other.  Such representatives shall include individuals who have experience and expertise in pharmaceutical product marketing, sales and regulatory matters.  At least [**] percent ([**]%) of the JCC members from each of the Parties shall hold positions of reasonable seniority in their respective organizations, as reasonably determined by the Party designating its own JCC members.  A Party may designate a substitute to temporarily attend and perform the functions of such Party’s designee at any meeting of the JCC.  Cephalon and McNeil each may, upon prior written notice to the other Party, invite non-member representatives of such Party to attend meetings of the JCC.  The Chair shall prepare the agenda for each meeting of the JCC (which agenda shall be distributed to the JCC members at least five (5) days, or such shorter period if five (5) days is not practical as may be mutually agreed upon by the Parties from time to time, prior to any scheduled meeting) and shall appoint a secretary of the JCC for such meeting, who shall be a representative of McNeil.

 

3.2           Quorum; Voting; Decisions.  At each JCC meeting, the presence in person of at least one (1) member designated by each of Cephalon and McNeil shall constitute a quorum.  All decisions of the JCC shall be made by majority vote; provided, that, any member designated by either Cephalon or McNeil shall have the right to cast the votes of any of such Party’s member of the JCC who are absent from the meeting.  Alternatively, the JCC may act by written consent signed by all members designated by each of Cephalon and McNeil.  Whenever any action by the JCC is called for hereunder during a time period in which the JCC is not scheduled to meet, the Chair shall cause the JCC to take the action in the requested time period by calling a special meeting or by circulating a written consent.

 

3.3           Minutes.  The JCC shall keep minutes of its meetings that record, in reasonable detail, all decisions and all actions recommended or taken.  Drafts of the minutes shall be prepared and circulated to the members of the JCC within a reasonable time after the meeting, and McNeil shall be responsible for the preparation and circulation of draft minutes.  The draft minutes shall be approved, disapproved and revised as necessary at the next JCC meeting.  Upon approval, final minutes of each meeting shall be circulated to the members of the JCC by the Chair.

 

3.4           Expenses.  Each Party shall bear all expenses of their respective JCC representatives related to their participation on the JCC and attendance at JCC meetings.

 

3.5           Responsibilities.  The JCC shall perform the following functions with the objective of maximizing Net Sales and profitability of the Product, subject to applicable Laws and the Applicable Commercial Practices Policies:

 

3.5.1        Discuss the manner in which McNeil Sales Representatives and Cephalon Sales Representatives will Promote and Detail the Product in the ADHD marketplace based on the available information and data regarding the safety and efficacy of the Product;

 

3.5.2        Coordinate the Co-Promotion and Detailing activities related to the Product of the Cephalon Sales Representatives and McNeil Sales Representatives in the Territory;

 


**Portions of the Exhibit have been omitted and have been filed separately pursuant to an application for confidential treatment filed with the Securities and Exchange Commission pursuant to Rule 24b-2 under the Securities Exchange Act of 1934, as amended.

 

10



 

3.5.3        Discuss the state of the markets for the Product in the Territory and opportunities and issues concerning the Co-Promotion and Detailing of the Product in the Territory;

 

3.5.4        Discuss marketing support for the Product;

 

3.5.5        Discuss the pricing of the Product in a manner whereby Cephalon agrees to consider in good faith any McNeil suggestions with respect to such matters, but Cephalon retains sole discretion with respect to all final pricing decisions relating to the Product;

 

3.5.6        Discuss issues raised by Sales Representatives relating to Co-Promotion and Detailing of the Product in the Territory;

 

3.5.7        Discuss incentive compensation programs for the Sales Representatives;

 

3.5.8        Discuss the Plans and the Marketing Budget in a manner whereby Cephalon agrees to consider in good faith any McNeil suggestions with respect to such matters, but, subject to Sections 2.3.5, 3.7, 6.4 and 6.6, Cephalon retains final decision-making authority with respect to the Plans and the Marketing Budget;

 

3.5.9        Discuss [**]; and

 

3.5.10      Having such other responsibilities as may be mutually agreed upon by the Parties from time to time; provided that the JCC shall not have responsibility for (a) any aspect of the marketing, sale or promotion of CONCERTA®, or (b) with respect to the Product, any interactions with customers concerning rebating or discounting of any type or, subject to Section 3.5.5, other terms or conditions of sale or the development or implementation of strategies for the managed care market.

 

3.6           Meetings.  Unless otherwise agreed to by the Parties, the JCC shall meet at least [**] during every Calendar Quarter, and more frequently as Cephalon and McNeil mutually deem appropriate, on such dates, and at such places and times, as such Parties shall agree; provided that the Parties shall endeavor to have the first meeting of the JCC within thirty (30) days after the establishment of the JCC.  Meetings of the JCC that are held in person shall alternate between the United States offices of Cephalon and McNeil, or such other nearby place as the Party hosting the meeting may reasonably designate.  The first meeting of the JCC shall be held at Cephalon’s offices.  The members of the JCC also may convene or be polled or consulted from time to time by means of telecommunications, video conferences, electronic mail or correspondence, as deemed necessary or appropriate.

 

3.7           Dispute Resolution.  The JCC members shall use reasonable efforts to reach agreement on any and all matters.  In the event that, despite such reasonable efforts, agreement on a particular matter cannot be reached by the JCC within thirty (30) days after the JCC first meets to consider such matter (each such matter, a “Disputed Matter”), then the Chair of the JCC shall refer such Disputed Matter to the Designated Senior Officers of Cephalon and McNeil, who shall promptly initiate discussions in good faith to resolve such Disputed Matter.  If such Disputed Matter is not resolved by such Designated Senior Officers within thirty (30) days of the

 


**Portions of the Exhibit have been omitted and have been filed separately pursuant to an application for confidential treatment filed with the Securities and Exchange Commission pursuant to Rule 24b-2 under the Securities Exchange Act of 1934, as amended.

 

11



 

date that the matter was referred to such Designated Senior Officers, then the Designated Senior Officer of Cephalon shall have the right to make the final decision on any Disputed Matter relating directly to the Promotion and sale of the Product, but such Designated Senior Officer shall only exercise such right in good faith after full consideration of the positions of both Parties.  Notwithstanding the foregoing, (a) neither Party shall have final decision-making authority regarding the interpretation, or alleged breaches, of this Agreement, including a determination as to whether McNeil or Cephalon has fulfilled its obligations under this Agreement, (b) no decision or action requiring the consent or approval of one Party or both Parties pursuant to the terms of this Agreement shall be taken without the consent or approval of such Party or Parties, (c) the dispute resolution procedure set forth in this Section 3.7 shall not in any way limit either Party’s right to exercise any right of termination it may have under this Agreement and (d) McNeil shall not be required to implement any Plans or other marketing plans, or use any materials or engage in any activity which, in any case, references CONCERTA® or which McNeil reasonably believes to be in violation of any Laws or the Applicable Commercial Practices Policies of McNeil.

 

ARTICLE 4
CO-PROMOTION AND DETAILING

 

4.1           Marketing Activities and Expenses for the Product.  Except for the responsibilities set forth in Section 2.2, the Parties acknowledge and agree that McNeil will have no other duties and obligations with respect to the Product, and McNeil will not, without the prior written consent of Cephalon, initiate any advisory boards, speaker training programs or any other programs as part of its services herein where compensation is paid to a healthcare provider, provide any grants, or conduct any market research, in each case, solely with respect to the Product.

 

4.2           McNeil Sales Representative Requirements.

 

4.2.1        McNeil represents and warrants to Cephalon that during the Term, McNeil will not knowingly hire or employ an Ineligible Person to Co-Promote and Detail the Product as provided in this Agreement.  For the purposes of this Section 4.2, an “Ineligible Person” means an individual who (x) is currently excluded, debarred, suspended or otherwise ineligible to participate in a federal health care program or in federal procurement or nonprocurement programs, or (y) has been convicted of a criminal offense that falls within the ambit of 42 U.S.C. §1320a-7(a), but has not yet been excluded, debarred, suspended or otherwise declared ineligible.  If McNeil has actual notice that one of the McNeil Sales Representatives has become or is likely to become an Ineligible Person, McNeil will remove such person from any responsibility associated with any Co-Promotion or Detailing of the Product in the Territory or this Agreement.  Subject to applicable Laws, McNeil will promptly provide Cephalon with any data required by Cephalon for the purposes of complying with disclosure, reporting or compliance obligations under federal and state laws relating to reporting obligations for Ineligible Persons.

 

4.2.2        McNeil will use commercially reasonable efforts to ensure that during the Term (a) there are at least three hundred (300) McNeil Sales Representatives, (b) each of the McNeil Sales Representatives shall have received training and education of a quality substantially similar to

 

 

12



 

that required and provided to the McNeil ADHD Sales Force and (c) the McNeil Sales Representatives, as a whole, shall have on average at least [**] years experience conducting sales responsibilities for ADHD products.

 

4.3           McNeil Sales Representatives.  For the avoidance of doubt, McNeil Sales Representatives will not be, and will not be considered or deemed to be, employees of Cephalon for any purpose.  Cephalon will not have any responsibility for the hiring, termination, compensation, benefits or other conditions of employment of the employees of McNeil for any reason.

 

4.4           Cephalon Benefit Plans.  Subject to Article 10, McNeil Sales Representatives are not eligible to participate in any benefit programs offered by Cephalon to its employees, or in any pension plans, profit sharing plans, insurance plans or any other employee benefit plans offered from time to time by Cephalon to its employees.  McNeil acknowledges and agrees that Cephalon does not, and will not, maintain or procure any workers’ compensation or unemployment compensation insurance for or on behalf of the McNeil’s employees, including, without limitation, McNeil Sales Representatives.

 

4.5           McNeil Salaries and Wages.  Subject to Article 10, McNeil acknowledges and agrees that it will be solely responsible for paying all salaries, wages, benefits and other compensation which its employees, including without limitation the McNeil Sales Representatives, may be entitled to receive in connection with providing services under this Agreement.  The Parties acknowledge and McNeil agrees that at all times during the Term, the percentage of the Incentive Compensation available to be earned by McNeil Sales Representatives with respect to the Product will be [**] of Incentive Compensation available to be earned by McNeil Sales Representatives with respect to [**].  The Parties acknowledge and agree that the percentage of Incentive Compensation available to be earned by each McNeil Sales Representatives with respect to the Product shall be at least [**] percent ([**]%) of the total Incentive Compensation available to be earned by such McNeil Sales Representatives.  The Parties also acknowledge and agree that the actual percentage of Incentive Compensation earned in the aggregate by the McNeil Sales Representatives with respect to the Product shall be at least [**] percent ([**]%) of the total Incentive Compensation earned by such McNeil Sales Representatives.  In addition, at all times during the Term, Incentive Compensation available to be earned by McNeil Sales Representatives as a percentage of total compensation available to be earned by such McNeil Sales Representatives shall not be less than an amount equal to [**] percent ([**]%); provided, however, that Cephalon acknowledges and agrees that McNeil may at any time in its sole discretion [**] to the extent arising out of [**] where such [**] are applied proportionately to [**].

 

4.6           Cephalon Sales Meetings.  McNeil Sales Representatives will be invited to attend and participate in all portions of Cephalon sales meetings that pertain to the Product and shall be required to attend the launch sales meeting prior to the First Commercial Sale, which meeting shall be no more than [**] days in duration.  Costs and expenses of the sales meetings shall be borne by Cephalon and costs and expenses of lodging and transportation attributable to individual attendees of McNeil at such sales meetings shall be borne by McNeil.

 


**Portions of the Exhibit have been omitted and have been filed separately pursuant to an application for confidential treatment filed with the Securities and Exchange Commission pursuant to Rule 24b-2 under the Securities Exchange Act of 1934, as amended.

 

13



 

4.7           Non-Compete and Non Solicitation.

 

4.7.1        McNeil acknowledges and agrees that during the Term, it will not, without the prior written consent of Cephalon, market, sell, offer for sale or import in the Territory any pharmaceutical product that has been approved by the FDA and is indicated in the treatment of ADHD, except for the Product and CONCERTA®.

 

4.7.2        Cephalon acknowledges and agrees that during the Term, it will not, without the prior written consent of McNeil, market, sell, offer for sale or import in the Territory any pharmaceutical product that has been approved by the FDA and is indicated in the treatment of ADHD, except for the Product.

 

4.7.3        During the Term, McNeil shall not, directly or indirectly, solicit for employment any Cephalon Sales Representative or Cephalon representative on the JCC, provided that a general solicitation of employment shall not constitute a violation of this Section 4.7.3.

 

4.7.4        Except as otherwise permitted by Sections 10.3.3 and 10.3.4, during the Term, Cephalon shall not directly or indirectly solicit for employment any McNeil Sales Representative or McNeil representative on the JCC, provided that a general solicitation of employment shall not constitute a violation of this Section 4.7.4.

 

4.8           Reports and Audit Rights.

 

4.8.1        McNeil will use its commercially reasonable efforts to keep accurate records in accordance with its customary practices of the number of Calls and type of Details completed solely with respect to the Product and aggregate Incentive Compensation received by the McNeil Sales Representatives during the period for which such Incentive Compensation is paid.  McNeil shall keep such records regarding such McNeil Sales Representatives during the Term and for a period of one (1) year thereafter.

 

4.8.2        Upon the request of Cephalon upon ten (10) days’ prior notice during normal business hours during the Term and for six (6) months thereafter, McNeil will permit an independent third party selected and engaged by Cephalon who undertakes appropriate confidentiality obligations to McNeil and reasonably acceptable to McNeil to inspect, audit and examine only those McNeil records setting out the number of Calls and type of Details completed by the McNeil Sales Representatives and the aggregate Incentive Compensation paid to the McNeil Sales Representatives; provided, however that such audit may not be performed on behalf of Cephalon more than once per Agreement Year and that Cephalon shall not be permitted to audit the same period of time more than once.  Such third party shall be instructed not to reveal to Cephalon the details of its review, except for (a) such information as is required to be disclosed under this Agreement and (b) such information presented in a summary fashion as is necessary to report such third party’s conclusions to Cephalon, and all such information shall be deemed Confidential Information of McNeil.  Any and all audits undertaken by Cephalon pursuant to this Section 4.8.2 will be performed at the sole and exclusive expense of Cephalon.

 

4.8.3        Upon the request of McNeil upon ten (10) days’ prior notice during normal business hours during the Term and for six (6) months thereafter, Cephalon will permit an independent third party selected and engaged by McNeil who undertakes appropriate

 

 

14



 

confidentiality obligations to Cephalon and reasonably acceptable to Cephalon to inspect, audit and examine only those Cephalon records setting out the number of Calls and type of Details completed by the Cephalon Sales Representatives; provided, however that such audit may not be performed on behalf of McNeil more than once per Agreement Year and that McNeil shall not be permitted to audit the same period of time more than once.  Such third party shall be instructed not to reveal to McNeil the details of its review, except for (a) such information as is required to be disclosed under this Agreement and (b) such information presented in a summary fashion as is necessary to report such third party’s conclusions to McNeil, and all such information shall be deemed Confidential Information of Cephalon.  Any and all audits undertaken by McNeil pursuant to this Section 4.8.3 will be performed at the sole and exclusive expense of McNeil.

 

ARTICLE 5
FINANCIAL PROVISIONS

 

5.1           Payments.

 

5.1.1        As reimbursement for McNeil’s Detailing and Co-Promotional activities pursuant to this Agreement, Cephalon shall pay to McNeil within thirty (30) days after the end of each Calendar Quarter commencing with the Calendar Quarter in which the First Commercial Sale occurs the following commission fees (“Commission Fees”) calculated as a percentage of the Annual Net Sales during the Term:

 

Annual Net Sales

 

Commission Fees

 

$

[**]

 

[**]

%

 

5.1.2        In addition to the Commission Fees, Cephalon shall pay to McNeil the following one- time sales milestones within thirty (30) days after the achievement of each such milestone if such milestones are reached during the Term:

 

Milestone Event

 

Milestone Payment

 

$

[**]

 

$

[**]

 

 

5.1.3        Following the expiration of the Term, provided that the Annual Net Sales during the last Calendar Year of the Term were at least $[**], Cephalon shall pay to McNeil within thirty (30) days after the end of each Calendar Quarter the following commission fees (the “Base Sunset Commission Fees”) based upon the Annual Net Sales of the Product in the Territory during each of such years:

 

Period

 

Base Sunset Commission Fees

 

[**]

 

[**]

%

 


**Portions of the Exhibit have been omitted and have been filed separately pursuant to an application for confidential treatment filed with the Securities and Exchange Commission pursuant to Rule 24b-2 under the Securities Exchange Act of 1934, as amended.

 

15



 

5.1.4        If, following the expiration of the Term, provided that the Annual Net Sales during the last Calendar Year of the Term were at least $[**], then in lieu of any payment under Section 5.1.3 Cephalon shall pay to McNeil within thirty (30) days after the end of each Calendar Quarter the following commission fees (the “Upside Sunset Commission Fees”) based upon the Annual Net Sales of the Product in the Territory during each of such years:

 

Period

 

Upside Sunset Commission Fees

 

[**]

 

[**]

%

 

5.1.5        If during the period that Cephalon is paying McNeil either Base Sunset Commission Fees or the Upside Sunset Commission Fee, McNeil promotes, markets or sells a product for ADHD other than CONCERTA®, then Cephalon’s obligation to pay such fees shall immediately terminate.

 

5.2           Net Sales Reports.  Within thirty (30) days after the end of each Calendar Quarter after the First Commercial Sale and each calendar quarter during which Base Sunset Fees, Upside Sunset Fees or any other amounts may be payable by Cephalon to McNeil, Cephalon shall submit to McNeil a written report setting forth Net Sales in the Territory with respect to such Calendar Quarter or calendar quarter, as the case may be (each a “Net Sales Report”). In addition, Cephalon shall provide actual gross sales recorded in the Territory from time to time, and, in any event at least on a monthly basis and in such detail and format as Cephalon otherwise prepares.

 

5.3           GAAP.  All financial terms and standards defined or used in this Agreement for sales or activities occurring in the Territory shall be governed by and determined in accordance with United States generally accepted accounting principles, consistently applied.

 

5.4           Manner of Payments.  All sums due to McNeil under this Agreement shall be payable in United States Dollars by bank wire transfer in immediately available funds to such bank account(s) as McNeil shall designate.  Cephalon shall notify McNeil as to the date and amount of any such wire transfer to McNeil at least two (2) business days prior to such transfer.

 

5.5           Interest on Late Payments.  If Cephalon shall fail to make a timely payment pursuant to this Agreement, any such payment that is not paid on or before the date such payment is due under this Agreement shall bear interest, to the extent permitted by applicable Law, at [**], effective for the first date on which payment was delinquent and calculated on the number of days such payment is overdue or, if such rate is not regularly published, as published in such source as the Parties agree.

 


**Portions of the Exhibit have been omitted and have been filed separately pursuant to an application for confidential treatment filed with the Securities and Exchange Commission pursuant to Rule 24b-2 under the Securities Exchange Act of 1934, as amended.

 

16



 

5.6           Financial Records; Audits.  Cephalon shall keep, and shall cause its Affiliates and sublicensees to keep, such accurate and complete records of Net Sales in the Territory as are necessary to determine the amounts due to McNeil under this Agreement during the Term and the period during which Base Sunset Fees, Upside Sunset Fees or any other amounts may be payable by Cephalon to McNeil and for a period of one (1) year thereafter.  During normal business hours and with not less than [**] advance written notice to Cephalon, such records shall be made available for inspection, review and audit, at the request and expense of McNeil, by an independent certified public accountant appointed by McNeil and reasonably acceptable to Cephalon for the sole purpose of verifying the accuracy of Cephalon’s accounting reports and payments made or to be made pursuant to this Agreement; provided, however that such audits may not be performed by McNeil more than once per Calendar Year and that McNeil shall not be permitted to audit the same period of time more than once.  Such accountants shall be instructed not to reveal to McNeil the details of its review, except for (a) such information as is required to be disclosed under this Agreement and (b) such information presented in a summary fashion as is necessary to report the accountants’ conclusions to McNeil, and all such information shall be deemed Confidential Information of Cephalon.  All costs and expenses incurred in connection with performing any such audit shall be paid by McNeil unless the audit discloses at least a [**] percent ([**]%) shortfall in the amounts due to McNeil, in which case Cephalon will bear the full cost of the audit for such Calendar Year.  McNeil will be entitled to recover any shortfall in payments due to it as determined by such audit, plus interest thereon calculated in accordance with Section 5.5.

 

ARTICLE 6
PROMOTIONAL MATERIALS

 

6.1           Ownership of Promotional Materials.  Cephalon will own all right, title and interest in and to all Promotional Materials during and after the Term, including, without limitation, any related copyrights and trademarks related to the Product.  Subject to Section 6.6 and the approval of the JCC, Promotional Materials used during the Term shall bear the names and logos of both Cephalon and McNeil giving equal positioning to both names and logos.  Notwithstanding anything in this Agreement to the contrary, if the Parties are unable to agree on any matters related to the use of the Promotional Materials and the Promotional Materials include the McNeil name or logo, then Cephalon shall, during any period when a dispute or disagreement relating to the Promotional Materials is ongoing, include only the Cephalon name and logo in the Promotional Materials and both Cephalon and McNeil shall use such Promotional Materials; provided that McNeil shall not be required to use such Promotional Materials if such Promotional Materials reference CONCERTA® or McNeil reasonably believes that such Promotional Materials violate any Law or conflict with McNeil’s Applicable Commercial Practices Policies.

 

6.2           Content, Quantity Compliance with Laws and Distribution of Promotional Materials.  The determination of the content of the Promotional Materials related to the Product shall be the responsibility of Cephalon; provided, however, that the Promotional Materials may not reference CONCERTA®.  All Promotional Materials shall comply with all applicable Laws.  The quantity and method of distribution of the Promotional Materials in the Territory for the McNeil Sales Representatives shall be equivalent to that for the Cephalon Sales Representatives.

 


**Portions of the Exhibit have been omitted and have been filed separately pursuant to an application for confidential treatment filed with the Securities and Exchange Commission pursuant to Rule 24b-2 under the Securities Exchange Act of 1934, as amended.

 

17



 

6.3           Payment for Promotional Materials.  Cephalon shall make available to McNeil all Promotional Materials and McNeil will purchase such Promotional Materials at Cephalon’s cost.  McNeil shall distribute such Promotional Materials at McNeil’s cost.  McNeil will store and subsequently distribute such Promotional Materials to the McNeil Sales Representatives, at its own cost, which will, in no event exceed an amount equal to $[**] per Agreement Year. Each Party will be responsible for managing the Promotional Materials usage and inventory levels with respect to its own Sales Representatives.  Subject to Section 6.6, all copyright, trademark and other intellectual property rights included in the Promotional Materials will inure to the benefit of Cephalon and will remain owned by and vested in Cephalon upon termination of this Agreement for any reason. Each Party will ensure that its Sales Representatives and other employees and contractors utilize and handle all Promotional Materials in compliance with the terms and conditions of this Agreement.  Unless and until Promotional Materials are approved by Cephalon for publication or other general dissemination, McNeil shall maintain them as Confidential Information.

 

6.4           Review of Promotional Materials in the Territory.  Cephalon shall provide to McNeil copies of all Promotional Materials in the Territory that Cephalon desires to be used by either Party in connection with this Agreement or Detailing activities related to the Product during the Term.  If the Promotional Materials reference CONCERTA® or McNeil believes that the Promotional Materials violate any Law or conflict with McNeil’s Applicable Commercial Practices Policies, McNeil shall promptly refer such matter to the PRC.  McNeil may appoint up to [**] representatives to attend meetings of the PRC relating to the Product.  Cephalon agrees to provide to McNeil sufficient advance notice, which shall be not less than five (5) business days’ notice of any PRC meeting and to include with such notice the Promotional Materials being discussed at such PRC meeting. While the PRC shall consider in good faith any suggestions from the McNeil representative(s), subject to the last proviso hereof, any and all final decisions of the PRC shall be decided in the sole discretion of Cephalon; provided, however, that if such matter is not resolved by the PRC to McNeil’s satisfaction within ten (10) business days after such referral, McNeil shall not be required to use any such Promotional Materials if such Promotional Materials reference CONCERTA® or McNeil reasonably believes that such Promotional Materials violate any Law or conflict with McNeil’s Applicable Commercial Practices Policies and such non-use by McNeil shall not itself give rise to a breach of Section 12.2 by either Party under this Agreement.

 

6.5           Discontinued Use.  Promptly after the termination or expiration of this Agreement, McNeil shall (a) immediately cease use of all Promotional Materials relating to the Product and (b) use its commercially reasonable efforts to return, or otherwise dispose of in accordance with instructions from Cephalon, all Promotional Materials relating to the Product that remain in McNeil’s or its Affiliates’ possession or control; provided however that McNeil shall be entitled to retain one copy of such Promotional Materials in its legal records.

 

6.6           Use of McNeil Name.  McNeil will own all right, title and interest in and to the McNeil name and logo during and after the Term. McNeil hereby agrees to permit Cephalon to use the McNeil name and logo in the Territory during the Term solely on Promotional Materials that have been approved in writing by McNeil.  McNeil shall review and notify Cephalon of McNeil’s approval or reasons for non-approval of the use of the McNeil name and logo in such

 


**Portions of the Exhibit have been omitted and have been filed separately pursuant to an application for confidential treatment filed with the Securities and Exchange Commission pursuant to Rule 24b-2 under the Securities Exchange Act of 1934, as amended.

 

18



 

Promotional Materials within five (5) days of receipt of such Promotional Materials from Cephalon.  All rights not expressly granted in the McNeil name and logo are reserved by McNeil and Cephalon acknowledges that nothing in this Agreement shall give it any right, title or interest in the McNeil name and logo other than the permission granted herein.

 

ARTICLE 7
INFORMATION CONCERNING THE PRODUCT

 

7.1           Statements Consistent with Labeling.  Neither Party shall make, nor permit its Sales Representatives to make, any promotional statement, representation or warranty, oral or written, concerning Products inconsistent with, or contrary to, the approved Product labeling or Promotional Materials.  Each Party shall ensure that its Sales Representatives Detail the Product in a fair and balanced manner in the Territory and consistent with the requirements of the FD&C Act, including, but not limited to, the regulations at 21 C.F.R. § 202 in the Territory.

 

7.2           Medical Inquiries.  Cephalon shall identify to McNeil the Person or Persons to whom McNeil and its Affiliates shall refer all medical questions or inquiries from members of the medical and paramedical professions and consumers regarding the Product in the Territory that McNeil and its Affiliates cannot readily answer by reference to the Product literature.  McNeil shall use its commercially reasonable efforts to refer, and to cause its Affiliates to refer, all such medical questions or inquiries to such identified Person or Persons.

 

7.3           Standard Operating Procedures.  Prior to the McNeil Sales Representatives being deployed to Co-Promote the Product, Cephalon shall provide to McNeil for its review and approval, such approval not to be unreasonably withheld or denied, a set of Cephalon’s standard operating procedures for responding promptly to medical questions or inquiries and product complaints in the Territory from members of the medical and paramedical professions and consumers relating to the Product.  McNeil shall cause the McNeil Sales Representatives to comply with any Cephalon standard operating procedures regarding how to respond to medical questions or inquiries and Product complaints in the Territory.  In addition, Cephalon shall train the McNeil Sales Representatives on how to respond to such questions or inquiries sufficiently in advance of receipt of such inquiries by the McNeil Sales Representatives and such training shall be consistent with applicable Laws.

 

7.4           Exchange of Drug Safety Information.  Cephalon shall have the sole responsibility for investigating and reporting to Governmental Authorities all Adverse Drug Experiences for the Product in accordance with Law.  McNeil shall have the responsibility for promptly forwarding to Cephalon, as reasonably instructed by Cephalon, any and all reports received by McNeil of Adverse Drug Experience of the Product, which reports shall be investigated by Cephalon.  Cephalon shall ensure that, in the Co-Promotion and Detailing of the Product, it will record, investigate, summarize, notify, report and review all Adverse Drug Experiences in accordance with Law.  Each Party shall require that such Affiliates (a) adhere to all requirements of applicable Laws which relate to the reporting and investigation of Adverse Drug Experiences by such Party, and (b) keep the Parties informed of such events, in each case with respect to the Product.

 

 

19



 

7.5           Recalls Or Other Corrective Action.  Cephalon shall promptly notify McNeil of any material actions to be taken by Cephalon with respect to any recall or market withdrawal or other corrective action related to the Product in the Territory, which decision to recall, withdraw or take any other corrective action relating to the Product in the Territory shall be made by Cephalon in its sole discretion and at Cephalon’s sole cost and expense.

 

7.6           Events Affecting Integrity or Reputation.  During the Term, the Parties shall notify each other immediately of any circumstances of which they are aware and which could impair the integrity and reputation of the Product or if a Party is threatened by the unlawful activity of any Third Party in relation to the Product, which circumstances shall include, by way of illustration, deliberate tampering with or contamination of the Product by any Third Party as a means of extorting payment from the Parties or another Third Party.  In any such circumstances, the Parties shall use commercially reasonable efforts to limit any damage to the Parties and/or to the Product with the understanding that the health and welfare of patients is of foremost importance.  The Parties shall promptly call a meeting to discuss and resolve such circumstances.

 

ARTICLE 8
ORDERS; SUPPLY AND RETURNS; REGULATORY

 

8.1           Orders and Terms of Sale.  Cephalon shall have the sole right in the Territory to (a) receive, accept and fill orders for the Product, (b) control pricing, invoicing, order processing and collection of accounts receivable for the sales of the Product and (c) record the sales of the Product in its books of account.

 

8.2           Misdirected Orders.  If, for any reason, McNeil receives orders for the Product, McNeil shall forward such orders to Cephalon (or if directed by Cephalon to Cephalon’s wholesalers) as soon as practical.

 

8.3           Product Returns.  Except as provided below, if any quantities of the Product are returned to McNeil, McNeil shall promptly notify Cephalon and ship them to the facility and in a manner designated by Cephalon, with any reasonable or authorized shipping or other documented direct cost to be paid by Cephalon upon receipt of an invoice from McNeil, or at Cephalon’s request, McNeil shall destroy the Product, the cost of such destruction to be borne by Cephalon.  McNeil, at its option, may advise the customer who made the return that the Product should have been returned to Cephalon, but shall take no other steps in respect of any return without the consent of Cephalon, such consent not to be unreasonably withheld, refused, conditioned or delayed.  In the event the Product is returned as a result of McNeil’s breach of this Agreement, or otherwise as a result of McNeil’s gross negligence, then any costs associated with such destruction shall be the sole responsibility of McNeil.

 

8.4           Regulatory.

 

8.4.1        Approvals.  Cephalon shall have exclusive authority to obtain, maintain and seek revisions of Marketing Authorization for the Product.  Cephalon shall be solely responsible for communications with the FDA regarding the Product, including but not limited to, reporting on Adverse Drug Experiences and complaints, provided that McNeil may communicate with FDA with respect to the Product where McNeil’s failure to so communicate

 

 

20



 

would violate applicable Law and provided further that McNeil shall use reasonable efforts to share in advance any such communications with Cephalon.  It shall be the obligation of Cephalon to ensure that the incidence, severity and/or nature of Adverse Drug Experiences are accurately reflected in the package inserts for the Product to the extent required under, and in accordance with, applicable Laws.

 

8.4.2        Provision of Reports to McNeil.  Cephalon shall provide McNeil with copies of: (a) the periodic Adverse Drug Experience reports submitted to any Governmental Authorities in the Territory regarding Product, within ten (10) days of submission to any Governmental Authorities in the Territory; and (b) all annual reports submitted by Cephalon to Governmental Authorities in the Territory redacted to include information only regarding the Product.

 

8.4.3        Actions by Governmental Authorities.  Cephalon shall promptly notify McNeil of any inspections, proposed regulatory actions, investigations or requests, and any corrective actions initiated by Cephalon with any Governmental Authorities in the Territory, in each case relating to the Product, and Cephalon shall provide McNeil with copies of all relevant documentation relating to the foregoing.

 

ARTICLE 9
CONFIDENTIAL INFORMATION

 

9.1           Confidential Information.  Each of Cephalon and McNeil shall keep all Confidential Information received from the other Party with the same degree of care it maintains the confidentiality of its own Confidential Information.  Neither Party shall use such Confidential Information for any purpose other than in performance of this Agreement or disclose the same to any other Person other than to such of its agents who have a need to know such Confidential Information to implement the terms of this Agreement or enforce its rights under this Agreement.  A Receiving Party shall advise any agent who receives such Confidential Information of the confidential nature thereof and of the obligations contained in this Agreement relating thereto, and the Receiving Party shall ensure that all such agents comply with such obligations as if they had been a Party hereto.  Upon termination of this Agreement, the Receiving Party shall use its commercially reasonable efforts to return or destroy, at the Receiving Party’s option, all documents, tapes or other media containing Confidential Information of the Disclosing Party that remain in the Receiving Party’s or its agents’ possession, except that the Receiving Party may keep one copy of the Confidential Information in the legal department files of the Receiving Party, solely for archival purposes.  Such archival copy shall be deemed to be the property of the Disclosing Party, and shall continue to be subject to the provisions of this Article 9.  Notwithstanding anything to the contrary in this Agreement, the Receiving Party shall have the right to disclose any Confidential Information provided hereunder if, in the reasonable opinion of the Receiving Party’s legal counsel, such disclosure is necessary to comply with the terms of this Agreement, or the requirements of any Law.  Where possible, the Receiving Party shall notify the Disclosing Party of the Receiving Party’s intent to make such disclosure of Confidential Information pursuant to the provision of the preceding sentence sufficiently prior to making such disclosure so as to allow the Disclosing Party adequate time to take whatever action the Disclosing Party may deem to be appropriate to protect the confidentiality of the information.

 

 

21



 

9.2           Permitted Disclosure and Use.  Notwithstanding Section 9.1, a Party may disclose Confidential Information belonging to the other Party only to the extent such disclosure is reasonably necessary to: (a) enforce the provisions of this Agreement; or (b) comply with Laws.  If a Party deems it necessary to disclose Confidential Information of the other Party pursuant to this Section 9.2, such Party shall give reasonable advance notice of such disclosure to the other Party to permit such other Party sufficient opportunity to object to such disclosure or to take measures to ensure confidential treatment of such information.

 

9.3           Public Announcements.  Except as may be expressly required by applicable Laws, neither Party will make any public announcement of any information regarding this Agreement or the Product under this Agreement without the prior written approval of the other Party.  Once any written statement is approved for disclosure by the Parties or information is otherwise made public in accordance with the preceding sentence, either Party may make a subsequent public disclosure of the contents of such statement solely to the extent such disclosure is required by applicable Laws following advance written notice to the other Party.

 

9.4           Confidentiality of this Agreement.  The terms of this Agreement shall be Confidential Information of each Party and, as such, shall be subject to the provisions of this Article 9.

 

9.5           Survival.  The obligations and prohibitions contained in this Article 9 shall survive the expiration or termination of this Agreement for a period of [**].

 

ARTICLE 10
REPRESENTATIONS AND WARRANTIES; COVENANTS

 

10.1         Mutual Representations and Warranties.  McNeil and Cephalon each represents and warrants to the other as of the Effective Date that:

 

10.1.1      Such Party (a) is a company duly organized, validly existing, and in good standing under the Laws of the jurisdiction of its incorporation; (b) is duly qualified as a corporation and in good standing under the Laws of each jurisdiction where its ownership or lease of property or the conduct of its business requires such qualification, where the failure to be so qualified would have a material adverse effect on its financial condition or its ability to perform its obligations hereunder; (c) has the requisite corporate power and authority and the legal right to conduct its business as now conducted and hereafter contemplated to be conducted; (d) has or will obtain all necessary licenses, permits, consents, or approvals from or by, and has made or will make all necessary notices to, all Governmental Authorities having jurisdiction over such Party, to the extent required for the ownership and operation of its business, where the failure to obtain such licenses, permits, consents or approvals, or to make such notices, would have a material adverse effect on its financial condition or its ability to perform its obligations hereunder; and (e) is in compliance with its charter documents;

 

10.1.2      The execution, delivery and performance of this Agreement by such Party and all instruments and documents to be delivered by such Party hereunder (a) are within the corporate power of such Party; (b) have been duly authorized by all necessary or proper corporate action; (c) do not conflict with any provision of the charter documents of such Party;

 


**Portions of the Exhibit have been omitted and have been filed separately pursuant to an application for confidential treatment filed with the Securities and Exchange Commission pursuant to Rule 24b-2 under the Securities Exchange Act of 1934, as amended.

 

22



 

(d) will not, to the best of such Party’s knowledge, violate any law or regulation or any order or decree of any court of governmental instrumentality; and (e) will not violate or conflict with any terms of any indenture, mortgage, deed of trust, lease, license, agreement, or other instrument to which such Party is a party, or by which such Party or any of its property is bound, which violation would have a material adverse effect on its financial condition or on its ability to perform its obligations hereunder; and

 

10.1.3      This Agreement has been duly executed and delivered by such Party and constitutes a legal, valid and binding obligation of such Party, enforceable against such Party in accordance with its terms, except as such enforceability may be limited by applicable insolvency and other Laws affecting creditors’ rights generally, or by the availability of equitable remedies.

 

10.2         Additional Cephalon Representations, Warranties and Covenants.

 

Cephalon represents, warrants and covenants to McNeil as follows:

 

10.2.1      that as of the Effective Date the manufacture, use, importation, offer for sale or sale of the Product, and the creation, use and dissemination of Promotional Materials as contemplated hereunder does not infringe, and will not infringe, any Third Party intellectual property right in the Territory;

 

10.2.2      that with respect to all regulatory filings to obtain the Marketing Authorization, the data and information in Cephalon’s submissions are and shall be free from fraud or material falsity, that the Marketing Authorization has not been and will not be obtained either through bribery or the payment of illegal gratuities, that the data and information in Cephalon’s submissions (and provided to McNeil in connection with its evaluation of the Product) are and shall be accurate and reliable for purposes of supporting approval of the submissions, and that the Marketing Authorization shall be obtained without illegal or unethical behavior of any kind;

 

10.2.3      that Cephalon solely owns all right, title and interest in the Product, the Cephalon patents and the Cephalon trademark with respect to the Product and has not granted any right to a Third Party that is in conflict with the rights granted hereunder;

 

10.2.4      that Cephalon has not received written notice from a Third Party claiming that a patent owned by such Third Party would be infringed by the manufacture, use, sale, offer for sale or import of the Product in the Territory, and no Third Party has threatened in writing to make any such claim;

 

10.2.5      that regulatory filings seeking Marketing Authorization have been accepted by the FDA;

 

10.2.6      that the Product labeling and the related Promotional Materials and training materials provided to McNeil by Cephalon shall conform to the FDA approved labeling for the Product and will comply with all applicable Laws; and

 

 

23



 

10.2.7      that Cephalon shall manufacture the Product in accordance with the provisions of the FD&C Act and the FDA’s Current Good Manufacturing Practices and regulations promulgated thereunder, relating to the manufacture of pharmaceutical products.

 

10.3         Covenants.

 

10.3.1      Each Party hereby covenants and agrees during the Term that it shall carry out the Co-Promotion and Detailing of the Product and its other obligations or activities hereunder in accordance with (a) the terms of this Agreement and (b) all applicable Laws.

 

10.3.2      If Lost CONCERTA® Market Exclusivity occurs during the Term, then the Parties shall meet immediately thereafter but in no event later than [**] following Lost CONCERTA® Market Exclusivity, and one of the following consequences shall apply: (a) within [**] after Lost CONCERTA® Market Exclusivity, the Parties may mutually agree to terminate this Agreement on a date that is at least [**] following the date of such mutual agreement (the “Termination Date”), in which case the consequences set forth in Sections 10.3.4(a) and 10.3.5 shall apply or (b) if the Parties do not mutually agree to so terminate this Agreement pursuant to Section 10.3.2(a), then unless and until McNeil terminates this Agreement pursuant to Section 10.3.3, the Parties shall continue this Agreement and [**] percent ([**]%) of the Details by the McNeil Sales Representatives shall be First Position Details until the effective date of the termination or expiration of this Agreement, provided that, notwithstanding anything to the contrary set forth in Section 10.3.2(b), there shall be no decrease in the number of total Details or total PDEs in the first Agreement Year as set forth on Schedule 2.2.1.  If McNeil terminates this Agreement pursuant to Section 10.3.3, then the consequences set forth in Sections 10.3.4(b) and 10.3.5 shall apply.

 

10.3.3      If Lost CONCERTA® Market Exclusivity occurs during the Term and the Parties do not terminate this Agreement pursuant to Section 10.3.2(a), then McNeil may, at its option, at any time following Lost CONCERTA® Market Exclusivity, terminate this Agreement in accordance with the provisions of this Section 10.3.3.  Except as set forth in the next sentence, McNeil may only terminate this Agreement pursuant to this Section 10.3.3 effective on or after a date that is six (6) months following the First Commercial Sale by providing to Cephalon at least ninety (90) days’ advance written notice of termination prior to the effective date of termination, in which case the consequences set forth in Sections 10.3.4(b) and 10.3.5 shall apply.  If Lost CONCERTA® Market Exclusivity occurs prior to the First Commercial Sale, McNeil may terminate this Agreement at its option by providing at least ninety (90) days’ advance written notice of termination to Cephalon where such termination will become effective on or after a date that is the later of (a) the four-month anniversary of Lost CONCERTA® Market Exclusivity and (b) April 30, 2006; provided that if the First Commercial Sale occurs before such effective date of termination, McNeil may only terminate this Agreement pursuant to this Section 10.3.3 where such termination will become effective on or after a date that is at least six (6) months following the First Commercial Sale.  The applicable effective date of termination of the Agreement under this Section 10.3.3 shall be referred to as the “McNeil Termination Date.”

 


**Portions of the Exhibit have been omitted and have been filed separately pursuant to an application for confidential treatment filed with the Securities and Exchange Commission pursuant to Rule 24b-2 under the Securities Exchange Act of 1934, as amended.

 

24



 

10.3.4

 

(a) If the Parties mutually agree to terminate this Agreement pursuant to Section 10.3.2(a), then Cephalon shall within [**] of receipt of notice of termination make offers of employment to all of the McNeil Sales Representatives.  The term of any such offers shall be at least substantially comparable to the then terms of employment of the McNeil Sales Representatives as to job description, base salary and incentive compensation.  Such offers shall include an agreement by Cephalon that if any McNeil Sales Representative accepts employment with Cephalon, and Cephalon within [**] following such acceptance, severs employment with such Sales Representative, Cephalon will pay such Sales Representative severance that is at least equal to the severance which such Sales Representatives would have been entitled to receive in the event that McNeil had terminated such employment based on combined service with McNeil and with Cephalon.  McNeil shall fully cooperate to assist Cephalon in its efforts to hire the McNeil Sales Representatives. McNeil and McNeil’s Affiliates will not offer positions of employment to any of the McNeil Sales Representatives prior to the Termination Date. In addition, for a period of [**] following the Termination Date, McNeil and McNeil’s Affiliates will not offer positions of employment to any of the McNeil Sales Representatives who have accepted positions of employment with Cephalon.  If Lost CONCERTA® Market Exclusivity occurs after the First Commercial Sale of the Product, and at least [**] percent ([**]%) of the McNeil Sales Representatives accept positions with Cephalon within thirty (30) days following receipt of Cephalon’s offer of employment, Cephalon shall pay to McNeil within sixty (60) days after the end of each Calendar Quarter during the [**] following the Termination Date a [**] percent ([**]%) commission fee calculated as a percentage of the Annual Net Sales during such [**] year period.

 

(b)  If McNeil voluntarily terminates this Agreement pursuant to Section 10.3.3, then Cephalon may, within [**] of receipt of notice of termination make offers of employment to such McNeil Sales Representatives as it deems appropriate, in its sole discretion.  The term of any such offers shall be at least substantially comparable to the then terms of employment of the McNeil Sales Representatives as to job description, base salary and incentive compensation.  Such offers shall include an agreement by Cephalon that if any McNeil Sales Representative accepts employment with Cephalon, and Cephalon within [**] following such acceptance, severs employment with such Sales Representative, Cephalon will pay such Sales Representative severance that is at least equal to the severance which such Sales Representatives would have been entitled to receive in the event that McNeil had terminated such employment based on combined service with McNeil and with Cephalon.  McNeil shall fully cooperate to assist Cephalon in its efforts to hire the McNeil Sales Representatives. McNeil and McNeil’s Affiliates will not offer positions of employment to any of the McNeil Sales Representatives prior to the McNeil Termination Date; provided that in the event that Cephalon has notified any McNeil Sales Representative that Cephalon will not be offering such McNeil Sales Representative an offer of employment, McNeil and its Affiliates may thereafter offer positions of employment to any such McNeil Sales Representative. In addition, for a period of [**] following the McNeil Termination Date, McNeil and McNeil’s Affiliates will not offer positions of employment to any of the McNeil Sales Representatives who have accepted positions of employment with Cephalon.

 

10.3.5      Each McNeil Sales Representative who accepts an employment offer with Cephalon (each a “Continuing Product Employee”) shall be covered under the employee benefit

 


**Portions of the Exhibit have been omitted and have been filed separately pursuant to an application for confidential treatment filed with the Securities and Exchange Commission pursuant to Rule 24b-2 under the Securities Exchange Act of 1934, as amended.

 

25



 

plans of Cephalon available to other employees of Cephalon who are employed in similar categories of employment.  Cephalon shall offer each McNeil Sales Representative the opportunity, as of the Termination Date or the McNeil Termination Date, as the case may be, to participate in all of Cephalon’s employee benefit plans for which each such person would be eligible under the guidelines for such plans.  Within the 30 day period after the date of this Agreement, Cephalon shall provide to McNeil summaries of the material terms and conditions of and guidelines for employee benefit plans (including, but not limited to, medical and dental insurance plans, life insurance plan, 401(k) savings plan, short-term and long-term disability plans, vacation plan and severance or termination plan).  For vesting and eligibility purposes under all of Cephalon’s employee benefit plans, all Continuing Product Employees shall be given full credit for all service with McNeil, McNeil’s Affiliates or McNeil’s former Affiliates.  In addition to such recognition of all such prior service for purposes of vesting and eligibility, all Continuing Product Employees shall be given credit for such prior service for purposes of (i) accrual of severance benefits and (ii) accrual of vacation benefits.  Schedule 10.3.5 hereto lists all periods of service of each McNeil Sales Representative with McNeil, McNeil’s Affiliates or McNeil’s former Affiliates, and Cephalon shall be entitled to rely on such Schedule 10.3.5 for the purposes of determining periods of prior service under this Section.  Cephalon agrees that in complying with the benefit requirements set forth in this Article 10, no pre-existing medical condition of any Continuing Product Employee or his or her eligible dependents shall cause Cephalon to deny, delay or otherwise alter coverage under Cephalon benefit plans to any such person.  At the commencement of employment with Cephalon, each Continuing Product Employee shall be entitled to vacation in accordance with the current Cephalon vacation policy.  The Continuing Product Employee shall be given credit for years of service at McNeil, McNeil’s Affiliates or McNeil’s former Affiliates in determining the amount of vacation he/she is entitled to under the current Cephalon vacation policy.  McNeil agrees to pay each Continuing Product Employee for all accrued and unused vacation through the Termination Date or the McNeil Termination Date, as the case may be, and each Continuing Product Employee shall have the right to take such vacation with Cephalon, without pay.

 

ARTICLE 11
INDEMNIFICATION

 

11.1         Indemnification by Cephalon.  Cephalon shall defend, indemnify and hold harmless McNeil and its Affiliates and each of their officers, directors, shareholders, employees, successors and assigns from and against all Claims of Third Parties, and all associated Losses, to the extent arising out of (a) Cephalon’s gross negligence or willful misconduct in performing any of its obligations under this Agreement, (b) a breach of, or inaccuracy in, any of the representations, warranties, covenants or agreements made by Cephalon under this Agreement, or (c) the distribution, manufacture, importation, promotion, marketing, use or sale of the Product, including without limitation, Claims involving any actual or alleged infringement of any intellectual property rights or misappropriation of any trade secrets of any Third Party and product liability Claims; provided, however, that in all cases referred to in this Section 11.1, Cephalon shall not be liable to indemnify McNeil for any Losses of McNeil to the extent that such Losses of McNeil were caused by (x) the gross negligence or willful misconduct of McNeil or (y) any breach by McNeil of its representations, warranties, covenants or agreements hereunder.

 

 

26



 

11.2         Indemnification by McNeil.  McNeil shall defend, indemnify and hold harmless Cephalon and its Affiliates and each of their officers, directors, shareholders, employees, successors and assigns from and against all Claims of Third Parties, and all associated Losses, to the extent arising out of (a) McNeil’s gross negligence or willful misconduct in performing any of its obligations under this Agreement, or (b) a breach of, or inaccuracy in, any of the representations, warranties, covenants or agreements made by McNeil under this Agreement; provided, however, that in all cases referred to in this Section 11.2, McNeil shall not be liable to indemnify Cephalon for any Losses of Cephalon to the extent that such Losses of Cephalon were caused by (x) the gross negligence or willful misconduct of Cephalon or (y) any breach by Cephalon of its representations, warranties, covenants or agreements hereunder.

 

11.3         Procedure for Indemnification.

 

11.3.1      Notice.  Each Party will promptly notify the other Party in writing if it receives a Claim by any Third Party (a “Third Party Claim”) for which indemnification may be sought by that Party and will give such information with respect thereto as the other Party shall reasonably request.  If any proceeding (including any governmental investigation) is instituted involving any Party for which such Party may seek an indemnity under Section 11.1 or 11.2, as the case may be (the “Indemnified Party”), the Indemnified Party shall promptly notify the other Party (the “Indemnifying Party”) in writing and, to the extent consistent with Applicable Laws, the Indemnifying Party and Indemnified Party shall meet to discuss how to respond to any Third Party Claims that are the subject matter of such proceeding.

 

11.3.2      Defense of Claim.  The Indemnifying Party may, to the extent permitted by applicable Law, elect to control the defense of a Third Party Claim; provided that (i) the Indemnifying Party gives notice to the Indemnified Party of its intention to do so within thirty (30) days after the receipt of the written notice from the Indemnified Party of the indemnifiable Third Party Claim, (ii) the Indemnifying Party expressly agrees the Indemnifying Party shall be responsible for satisfying and discharging any award made to the Third Party as a result of such proceedings or settlement amount agreed with the Third Party in respect of the Third Party Claim, (iii) the Indemnifying Party can demonstrate that it has adequate insurance or other financial means to satisfy the Third Party Claim and (iv) only monetary damages, and not, injunctive relief, are sought by such Third Party Claim (collectively, the “Litigation Condition”).  Subject to compliance with the Litigation Condition, the Indemnifying Party shall retain counsel reasonably acceptable to the Indemnified Party (such acceptance not to be unreasonably withheld, refused, conditioned or delayed) to represent the Indemnified Party and shall pay the fees and expenses of such counsel related to such proceeding.  In any such proceeding, the Indemnified Party shall have the right to retain its own counsel, but, to the extent the Litigation Condition is satisfied, the fees and expenses of such counsel shall be at the expense of the Indemnified Party, and otherwise such fees and expenses shall be at the expense of the Indemnifying Party.  The Indemnified Party shall, if requested by the Indemnifying Party, cooperate in all reasonable respects in the defense of such claim that is being managed and/or controlled by the Indemnifying Party.  The Indemnifying Party shall not, without the written consent of the Indemnified Party (which consent shall not be unreasonably withheld, refused, conditioned or delayed), effect any settlement of any pending or threatened proceeding in which the Indemnified Party is, or based on the same set of facts could have been, a party and

 

 

27



 

indemnity could have been sought hereunder by the Indemnified Party, unless such settlement includes an unconditional release of the Indemnified Party from all liability on claims that are the subject matter of such proceeding and does not include any injunctive relief against the Indemnified Party.  If the Litigation Condition is not met, then neither Party shall have the right to control the defense of such Third Party Claim and the Parties shall reasonably cooperate in and be consulted on the material aspects of such defense at the Indemnifying Party’s expense.

 

11.4         Assumption of Defense.  An Indemnified Party shall be entitled to assume the defense of any Third Party Claim with respect to the Indemnified Party, upon written notice to the Indemnifying Party pursuant to this Section 11.4, in which case the Indemnifying Party shall be relieved of liability under Section 11.1 or 11.2, as applicable, solely for such Third Party Claim and related Losses.

 

11.5         Insurance.

 

11.5.1      During the Term and for a period of [**] after the termination or expiration of this Agreement, Cephalon shall obtain and/or maintain at its sole cost and expense, liability insurance (including product liability insurance, workers compensation, general liability, automobile liability, and advertising liability insurance), which may be through self-insured arrangements, in amounts which are reasonable and customary in the U.S. pharmaceutical industry for companies of comparable size and activities at the respective place of business of Cephalon.  Such liability insurance or self-insured arrangements shall insure against bodily injury, physical injury or property damage arising out of the manufacture, sale, storage, promotion, distribution, or marketing of the Product.  Cephalon shall provide written proof of the existence of such insurance to McNeil upon request.

 

11.5.2      During the Term, McNeil will obtain and maintain workers compensation, general liability, automobile liability, and advertising liability insurance (including any self-insured arrangements) in amounts which are reasonable and customary in the U.S. pharmaceutical industry for companies of comparable size and activities at the respective place of business of McNeil.

 

11.6         WaiversEACH PARTY HERETO WAIVES ANY CLAIM TO PUNITIVE, EXEMPLARY OR MULTIPLIED DAMAGES FROM THE OTHER PARTY. EACH PARTY HERETO WAIVES ANY CLAIM OF CONSEQUENTIAL DAMAGES FROM THE OTHER PARTYTHE FOREGOING SENTENCE SHALL NOT LIMIT THE OBLIGATIONS OF EITHER PARTY TO INDEMNIFY THE OTHER PARTY FROM AND AGAINST THIRD PARTY CLAIMS UNDER THIS ARTICLE 11.

 

ARTICLE 12
TERM AND TERMINATION

 

12.1         Term.  Unless otherwise mutually agreed to by the Parties, this Agreement shall commence on the Effective Date and shall continue for the Term, unless terminated sooner as permitted hereunder.  The Term may be extended for additional one (1) year periods upon mutual written agreement of the Parties.

 


**Portions of the Exhibit have been omitted and have been filed separately pursuant to an application for confidential treatment filed with the Securities and Exchange Commission pursuant to Rule 24b-2 under the Securities Exchange Act of 1934, as amended.

 

28



 

12.2         Termination for Breach.  Either Party may, without prejudice to any other remedies available to it at law or in equity, terminate this Agreement in the event that the other Party (as used in this subsection, the “Breaching Party”) shall have breached or defaulted in the performance of any of its material obligations.  The Breaching Party shall, if such breach can be cured, have sixty (60) days after written notice thereof was provided to the Breaching Party by the non-breaching Party to remedy such default (or, if such default cannot be cured within such 60-day period, the Breaching Party must commence and diligently continue actions to cure such default during such 60-day period).  Any such termination shall become effective at the end of such 60-day period unless the Breaching Party has cured any such breach or default prior to the expiration of such 60-day period (or, if such default is capable of being cured but cannot be cured within such 60-day period, the Breaching Party has commenced and diligently continued actions to cure such default provided always that, in such instance, such cure must have occurred within one hundred twenty (120) days after written notice thereof was provided to the Breaching Party by the non-breaching Party to remedy such default). Notwithstanding the foregoing, breaches related to the failure to timely pay amounts due hereunder, must be cured by the Breaching Party within ten (10) days after written notice thereof was provided to the Breaching Party by the non-breaching Party to remedy such default, and if such default is not timely remedied, the Breaching Party may at any time thereafter while such default remains, at its election, terminate this Agreement.

 

12.3         Termination for Bankruptcy.  Either Party shall have the right to terminate this Agreement effective upon written notice to the other Party in the event the non-notifying party becomes insolvent or makes an assignment for the benefit of creditors, or in the event bankruptcy or insolvency proceedings are instituted against the non-notifying party or on the non-notifying party’s behalf.

 

12.4         McNeil Termination for Other Reason.  McNeil shall have the right to terminate this Agreement upon written notice to Cephalon in the event that the FDA determines that the Product is unreasonably unsafe, dangerous, or ineffective or the Product is withdrawn from the market in the Territory.

 

12.5         Effects of Expiration or Termination of this Agreement.  Upon the expiration or termination of this Agreement, the following shall occur:

 

12.5.1      Return of Materials.  McNeil shall promptly transfer to Cephalon, at Cephalon’s cost, copies of all data, reports, records and materials for the Territory in its possession or control that relate to the Product and return to Cephalon, or destroy at Cephalon’s request, all relevant records and materials in McNeil’s possession or control containing Confidential Information of Cephalon (provided that McNeil may keep one copy of such Confidential Information of Cephalon for archival purposes only).

 

12.5.2      Return of McNeil Confidential Information.  Cephalon shall promptly return to McNeil, at McNeil’s cost, or destroy at McNeil’s request all relevant records and materials in Cephalon’s possession or control containing Confidential Information of McNeil (provided that Cephalon may keep one copy of such Confidential Information of McNeil for archival purposes only).

 

 

29



 

12.5.3      Termination of Rights.  All rights granted by Cephalon to McNeil with respect to the Product under this Agreement shall be terminated.

 

12.5.4      Accrued Rights; Surviving Obligations.  Termination, relinquishment or expiration of this Agreement for any reason shall be without prejudice to any rights that shall have accrued to the benefit of any Party prior to such termination, relinquishment or expiration.  Such termination, relinquishment or expiration shall not relieve any Party from obligations which are expressly or by implication intended to survive termination, relinquishment or expiration of this Agreement and shall not affect or prejudice any provision of this Agreement which is expressly or by implication provided to come into effect on, or continue in effect after, such termination, relinquishment or expiration.

 

ARTICLE 13
MISCELLANEOUS

 

13.1         Relationship of the Parties.  Each Party shall bear its own costs incurred in the performance of its obligations hereunder without charge or expense to the other except as expressly provided in this Agreement.  Subject to Article 10, neither Party shall have any responsibility for the hiring, termination or compensation of the other Party’s employees or for any employee benefits of such employee.  No employee or representative of a Party shall have any authority to bind or obligate the other Party to this Agreement for any sum or in any manner whatsoever, or to create or impose any contractual or other liability on the other Party without said Party’s approval.  For all purposes, and notwithstanding any other provision of this Agreement to the contrary, McNeil’s legal relationship under this Agreement to Cephalon shall be that of independent contractor.  This Agreement is not a partnership agreement and nothing in this Agreement shall be construed to establish a relationship of co-partners or joint venturers between the Parties.

 

13.2         Registration and Filing of this Agreement.  To the extent, if any, that either Party concludes in good faith that it or the other Party is required to file or register this Agreement or a notification thereof with any Governmental Authority, including without limitation the U.S. Securities and Exchange Commission, in accordance with Law, such Party shall inform the other Party thereof.  Should both Parties jointly agree that either Party is required to submit or obtain any such filing, registration or notification, the Parties shall reasonably cooperate with one another, and all out-of-pocket expenses incurred by the Parties in connection with such filing, registration or notification shall be borne by the Party making such filing, registration or notification.  In such filing, registration or notification, the Parties shall request confidential treatment of sensitive provisions of this Agreement, to the extent permitted by Law.  The Parties shall promptly inform each other as to the activities or inquiries of any such Governmental Authority relating to this Agreement, and shall reasonably cooperate to respond to any request for further information therefrom on a timely basis.

 

13.3         Force Majeure.  The occurrence of an event which materially interferes with the ability of a Party to perform its obligations or duties hereunder (other than the obligation to pay money to the other Party hereunder) which is not within the reasonable control of the Party affected or any of its Affiliates, not due to malfeasance by such Party or its Affiliates, and which could not with the exercise of due diligence have been avoided (each, a “Force Majeure Event”),

 

 

30



 

including, but not limited to, an injunction, order or action by a Governmental Authority, fire, accident, labor difficulty, strike, riot, civil commotion, act of God, inability to obtain raw materials, delay or errors by shipping companies or change in law, shall not excuse such Party from the performance of its obligations or duties under this Agreement, but shall merely suspend such performance during the continuation of the Force Majeure Event.  The Party prevented from performing its obligations or duties because of a Force Majeure Event shall promptly notify the other Party of the occurrence and particulars of such Force Majeure Event and shall provide the other Party, from time to time, with its best estimate of the duration of such Force Majeure Event and with notice of the termination thereof.  The Party so affected shall use its commercially reasonable efforts to avoid or remove such causes of nonperformance as soon as is reasonably practicable.  Upon termination of the Force Majeure Event, the performance of any suspended obligation or duty shall promptly recommence.  The Party subject to the Force Majeure Event shall not be liable to the other Party for any direct, indirect, consequential, incidental, special, punitive, exemplary or other damages arising out of or relating to the suspension or termination of any of its obligations or duties under this Agreement by reason of the occurrence of a Force Majeure Event, provided such Party complies in all material respects with its obligations under this Section 13.3.

 

13.4         Governing Law.  This Agreement shall be construed, and the respective rights of the Parties determined, according to the substantive law of the State of Delaware notwithstanding the provisions governing conflict of laws under such Delaware law to the contrary.

 

13.5         Dispute Resolution; Arbitration.

 

13.5.1      Any dispute, claim or controversy arising from or related in any way to this Agreement or the interpretation, application, breach, termination or validity thereof, including any claim of inducement of this Agreement by fraud or otherwise, other than Disputed Matters relating directly to the Promotion and sale of the Product which shall be resolved in accordance with Section 3.7, will be submitted for resolution to arbitration pursuant to the rules then pertaining of the International Institute for Conflict Prevention and Resolution for Non-Administered Arbitration (available at http://www.cpradr.org), or successor (“CPR”), except where those rules conflict with these provisions, in which case these provisions control.  The arbitration will be held in Philadelphia, Pennsylvania.

 

13.5.2      The panel shall consist of three arbitrators chosen from the CPR Panels of Distinguished Neutrals (or, by agreement, from another provider of arbitrators) each of whom is a lawyer with at least fifteen (15) years experience with a law firm or corporate law department of over twenty-five (25) lawyers or who was a judge of a court of general jurisdiction.  In the event the aggregate damages sought by the claimant are stated to be less than $5 million, and the aggregate damages sought by the counterclaimant are stated to be less than $5 million, and neither side seeks equitable relief, then a single arbitrator shall be chosen, having the same qualifications and experience specified above. Each arbitrator shall be impartial and independent of the parties and shall abide by the Code of Ethics for Arbitrators in Commercial Disputes (available at http://www.adr.org/EthicsAndStandards).

 

13.5.3      The parties agree to cooperate (a) to attempt to select the arbitrator(s) by agreement within 45 days of initiation of the arbitration, including jointly interviewing the final

 

 

31



 

candidates, (b) to meet with the arbitrator(s) within forty-five (45) days of selection and (c) to agree at that meeting or before upon procedures for discovery and as to the conduct of the hearing which will result in the hearing being concluded within no more than nine (9) months after selection of the arbitrator(s) and in the award being rendered within sixty (60) days of the conclusion of the hearings, or of any post-hearing briefing, which briefing will be completed by both sides within forty-five (45) days after the conclusion of the hearings.

 

13.5.4      In the event the parties cannot agree upon selection of the arbitrator(s), the CPR will select arbitrator(s) as follows: CPR shall provide the parties with a list of no less than twenty-five (25) proposed arbitrators (fifteen (15) if a single arbitrator is to be selected) having the credentials referenced above.  Within twenty-five (25) days of receiving such list, the parties shall rank at least sixty-five percent (65%) of the proposed arbitrators on the initial CPR list, after exercising cause challenges.  The parties may then interview the five candidates (three if a single arbitrator is to be selected) with the highest combined rankings for no more than one hour each and, following the interviews, may exercise one peremptory challenge each.  The panel will consist of the remaining three candidates (or one, if one arbitrator is to be selected) with the highest combined rankings.  In the event these procedures fail to result in selection of the required number of arbitrators, CPR shall select the appropriate number of arbitrators from among the members of the various CPR Panels of Distinguished Neutrals, allowing each side challenges for cause and three peremptory challenges each.

 

13.5.5      In the event the parties cannot agree upon procedures for discovery and conduct of the hearing meeting the schedule set forth in Section 13.5.3, then the arbitrator(s) shall set dates for the hearing, any post-hearing briefing, and the issuance of the award in accord with the Section 13.5.3 schedule.  The arbitrator(s) shall provide for discovery according to those time limits, giving recognition to the understanding of the parties that they contemplate reasonable discovery, including document demands and depositions, but that such discovery be limited so that the Section 13.5.3 schedule may be met without difficulty. In no event will the arbitrator(s), absent agreement of the parties, allow more than a total of ten days for the hearing or permit either side to obtain more than a total of forty (40) hours of deposition testimony from all witnesses, including both fact and expert witnesses, or serve more than twenty (20) individual requests for documents, including subparts, or twenty (20) individual requests for admission or interrogatories, including subparts.  Multiple hearing days will be scheduled consecutively to the greatest extent possible.

 

13.5.6      The arbitrator(s) must render their award by application of the substantive law of Delaware and are not free to apply “amiable compositeur” or “natural justice and equity.”  The arbitrator(s) shall render a written opinion setting forth findings of fact and conclusions of law with the reasons therefore stated.  A transcript of the evidence adduced at the hearing shall be made and shall, upon request, be made available to either party.  The arbitrator(s) shall have power to exclude evidence on grounds of hearsay, prejudice beyond its probative value, redundancy, or irrelevance and no award shall be overturned by reason of such ruling on evidence.  To the extent possible, the arbitration hearings and award will be maintained in confidence.

 

13.5.7      In the event the panel’s award exceeds $5 million in monetary damages or includes or consists of equitable relief, or rejects a claim in excess of that amount or for that

 

 

32



 

relief, then the losing party may obtain review of the arbitrators’ award or decision by a single appellate arbitrator (the “Appeal Arbitrator”) selected from the CPR Panels of Distinguished Neutrals by agreement or, failing agreement within seven (7) working days, pursuant to the selection procedures specified in Section 13.5.4. If CPR cannot provide such services, the parties will together select another provider of arbitration services that can.  No Appeal Arbitrator shall be selected unless he or she can commit to rendering a decision within forty-five days following oral argument as provided in Section 13.5.8.  Any such review must be initiated within thirty (30) days following the rendering of the award referenced in Section 13.5.6.

 

13.5.8      The Appeal Arbitrator will make the same review of the arbitration panel’s ruling and its bases that the U.S. Court of Appeals of the Circuit where the arbitration hearings are held would make of findings of fact and conclusions of law rendered by a district court after a bench trial and then modify, vacate or affirm the arbitration panel’s award or decision accordingly, or remand to the panel for further proceedings.  The Appeal Arbitrator will consider only the arbitration panel’s findings of fact and conclusions of law, pertinent portions of the hearing transcript and evidentiary record as submitted by the parties, opening and reply briefs of the party pursuing the review, and the answering brief of the opposing party, plus a total of no more than four (4) hours of oral argument evenly divided between the parties.  The party seeking review must submit its opening brief and any reply brief within seventy-five (75) and one hundred thirty (130) days, respectively, following the date of the award under review, whereas the opposing party must submit its responsive brief within one hundred ten (110) days of that date.  Oral argument shall take place within five (5) months after the date of the award under review, and the Appeal Arbitrator shall render a decision within forty-five (45) days following oral argument.  That decision will be final and not subject to further review, except pursuant to the Federal Arbitration Act.

 

13.5.9      The parties consent to the jurisdiction of the Federal District Court for the district in which the arbitration is held for the enforcement of these provisions and the entry of judgment on any award rendered hereunder (including after review by the Appeal Arbitrator where such an appeal is pursued). Should such court for any reason lack jurisdiction, any court with jurisdiction shall act in the same fashion.

 

13.5.10    Each party has the right before or, if the arbitrator(s) cannot hear the matter within an acceptable period, during the arbitration to seek and obtain from the appropriate court provisional remedies such as attachment, preliminary injunction, replevin, etc. to avoid irreparable harm, maintain the status quo, or preserve the subject matter of the arbitration.

 

13.5.11    EACH PARTY HERETO WAIVES ITS RIGHT TO TRIAL OF ANY ISSUE BY JURY.

 

13.5.12    EACH PARTY HERETO WAIVES ANY CLAIM FOR ATTORNEYS’ FEES AND COSTS AND PREJUDGMENT INTEREST FROM THE OTHER.

 

 

33



 

13.6         Assignment.  This Agreement may not be assigned by either Party without the prior consent of the other Party; provided, however that either Party may assign this Agreement, in whole or in part, to any of its Affiliates if such Party remains liable for the performance of this Agreement by such Affiliate; and provided further that either Party may assign this Agreement to a successor to all or substantially all of the assets of such Party whether by merger, sale of stock, sale of assets or other similar transaction.  This Agreement shall be binding upon, and subject to the terms of the foregoing sentence, inure to the benefit of the Parties hereto, their permitted successors, legal representatives and assigns.

 

13.7         Notices.  All demands, notices, consents, approvals, reports, requests and other communications hereunder must be in writing and will be deemed to have been duly given only if delivered personally, by facsimile with confirmation of receipt, by mail (first class, postage prepaid), or by overnight delivery using a globally-recognized carrier, to the Parties at the following addresses:

 

McNeil:

McNeil Consumer & Specialty

 

Pharmaceuticals, a Division of

 

McNeil-PPC, Inc.

 

7050 Camp Hill Road

 

Fort Washington, Pennsylvania 19034

 

Facsimile: 215-273-4124

 

Attn: President

 

 

 

With a copy to:

 

Office of General Counsel

 

 

Johnson & Johnson

 

 

One Johnson & Johnson Plaza

 

 

New Brunswick, New Jersey 08933

 

 

Attn: Thomas J. Spellman III, Esq.

 

 

Facsimile: 732-524-2788

 

 

 

Cephalon:

Cephalon, Inc.

 

41 Moores Road

 

Frazer, Pennsylvania 19355

 

Attn: Company Secretary

 

Facsimile: 610-738-6258

 

 

 

With a copy to:

 

Dechert LLP

 

 

4000 Bell Atlantic Tower

 

 

1717 Arch Street

 

 

Philadelphia, Pennsylvania 19103

 

 

Attn: James A. Lebovitz, Esq.

 

 

Facsimile: 215-655-2510

 

or to such other address as the addressee shall have last furnished in writing in accord with this provision to the addressor.  All notices shall be deemed effective upon receipt by the addressee.

 

 

34



 

13.8         Severability.  In the event of the invalidity of any provisions of this Agreement or if this Agreement contains any gaps, the Parties agree that such invalidity or gap shall not affect the validity of the remaining provisions of this Agreement.  Nothing in this Agreement shall be interpreted so as to require either Party to violate any applicable Law.

 

13.9         Headings.  The headings used in this Agreement have been inserted for convenience of reference only and do not define or limit the provisions hereof.

 

13.10       Waiver.  Any term or condition of this Agreement may be waived at any time by the Party that is entitled to the benefit thereof, but no such waiver shall be effective unless set forth in a written instrument duly executed by or on behalf of the Party waiving such term or condition.  No waiver by any Party of any term or condition of this Agreement, in any one or more instances, shall be deemed to be or construed as a waiver of the same or any other term or condition of this Agreement on any future occasion.  Except as expressly set forth in this Agreement, all rights and remedies available to a Party, whether under this Agreement or afforded by law or otherwise, will be cumulative and not in the alternative to any other rights or remedies that may be available to such Party.

 

13.11       Entire Agreement.  This Agreement (including the exhibits and schedules hereto) constitutes the entire agreement between the Parties hereto with respect to the within subject matter and supersedes all previous agreements and understandings between the Parties, whether written or oral.  This Agreement may be altered, amended or changed only by a writing making specific reference to this Agreement and signed by duly authorized representatives of McNeil and Cephalon.

 

13.12       No License.  Nothing in this Agreement shall be deemed to constitute the grant of any license or other right in either Party, to or in respect of any Product, patent, trademark, Confidential Information, trade secret or other data or any other intellectual property of the other Party, except as expressly set forth herein.

 

13.13       Third Party Beneficiaries.  None of the provisions of this Agreement shall be for the benefit of or enforceable by any Third Party, including without limitation any creditor of either Party hereto.  No such Third Party shall obtain any right under any provision of this Agreement or shall by reasons of any such provision make any Claim in respect of any debt, liability or obligation (or otherwise) against either Party hereto.

 

13.14       Counterparts.  This Agreement may be executed in any two counterparts, each of which, when executed, shall be deemed to be an original and both of which together shall constitute one and the same document.

 

[Signature Page Follows]

 

 

35



 

IN WITNESS WHEREOF, McNeil and Cephalon, by their duly authorized officers, have executed this Agreement as of the Effective Date.

 

 

McNEIL-PPC, INC.

 

 

 

 

 

BY AND THROUGH ITS DIVISION,

 

 

McNEIL CONSUMER & SPECIALTY

 

 

PHARMACEUTICALS

 

 

 

CEPHALON, INC.

 

 

 

 

 

 

By:

/s/ Colin Watts

 

By:

/s/ J. Kevin Buchi

 

 

     Name: Colin Watts

 

 

Name: J. Kevin Buchi

 

     Title: President

 

 

Title: Sr. Vice President & CFO

 

 

36



 

SCHEDULE 1.8

 

Applicable Commercial Practices Policies

 

[**]

 

 


**Portions of the Exhibit have been omitted and have been filed separately pursuant to an application for confidential treatment filed with the Securities and Exchange Commission pursuant to Rule 24b-2 under the Securities Exchange Act of 1934, as amended.

 



 

SCHEDULE 1.35

 

Marketing Budget for

First Agreement Year

 

[**]

 

 


**Portions of the Exhibit have been omitted and have been filed separately pursuant to an application for confidential treatment filed with the Securities and Exchange Commission pursuant to Rule 24b-2 under the Securities Exchange Act of 1934, as amended.

 



 

SCHEDULE 1.52

 

Target Audience

 

[**]

[**]

Pediatricians

Psychiatrists

Pediatric Neurologists

[**]

[**]

 


**Portions of the Exhibit have been omitted and have been filed separately pursuant to an application for confidential treatment filed with the Securities and Exchange Commission pursuant to Rule 24b-2 under the Securities Exchange Act of 1934, as amended.

 



 

SCHEDULE 2.2.1

 

Detail Requirements for the Product

 

McNeil Minimum Number of Total Details and PDEs for the Product:

 

Agreement Year

 

Total Details(1)(2)

 

Total PDEs(1)(2)

 

First

 

[**]

(3)

[**]

(3)

Second

 

[**]

(4)

[**]

 

Third

 

[**]

(4)

[**]

 

 


(1)  At least [**] percent ([**]%) of the Total Details and Total PDEs for any Agreement Year shall be completed during each month of such Agreement Year.

 

(2)  Subject to Article 10.

 

(3)  In the first [**] months of the First Agreement Year, all Details shall be First Position Details.  In months [**] of the First Agreement Year, all Details may be either First Position Details or Second Position Details.  In months [**] of the First Agreement Year, all Details shall be First Position Details.

 

(4)  At least [**] of these Details shall be First Position Details and the balance, if any, shall be Second Position Details.

 

Cephalon Minimum Number of PDEs for the Product:

 

 

Agreement Year

 

Total PDEs

 

First

 

[**]

 

Second

 

[**]

 

Third

 

[**]

 

 

 


**Portions of the Exhibit have been omitted and have been filed separately pursuant to an application for confidential treatment filed with the Securities and Exchange Commission pursuant to Rule 24b-2 under the Securities Exchange Act of 1934, as amended.

 



 

SCHEDULE 10.3.5

 

Service Periods for McNeil Sales Representatives

 

[**]

 

Accrued Vacation for McNeil Sales Representatives

 

[**]

 

 


**Portions of the Exhibit have been omitted and have been filed separately pursuant to an application for confidential treatment filed with the Securities and Exchange Commission pursuant to Rule 24b-2 under the Securities Exchange Act of 1934, as amended.

 


EX-10.2 3 a05-18061_1ex10d2.htm MATERIAL CONTRACTS

EXHIBIT 10.2

 

Credit Suisse First Boston International

One Cabot Square

London E 14 4OJ

 

TERMINATION AGREEMENT

 

Date:

July 18, 2005

 

 

To:

Cephalon, Inc.

Attn:

J. Kevin Buchi

 

 

From:

Credit Suisse First Boston International

 

External ID: 8181764

 

TERMINATION AGREEMENT dated as of July 18, 2005 between Cephalon, Inc. (“Counterparty”) and Credit Suisse First Boston International (“CSFBi’).

 

WHEREAS, Counterparty and Credit Suisse First Boston International entered into a transaction (the “Transaction”) certain terms of which are set forth below:

 

Trade Date:

 

January 22, 2003

 

 

 

Termination Date:

 

December 15, 2006

 

 

 

Reference Bonds:

 

$600,000,000, 2.5% Convertible Subordinated Notes Due December 15, 2006, issued by Cephalon, Inc., Cusip# 156708AD1 and 156708AE9

 

 

 

Notional Amount:

 

$200,000,000

 

WHEREAS, the Transaction is evidenced by a Confirmation dated January 22, 2003 (the “Confirmation”) between Counterparty.

 

WHEREAS, subject to the term and provisions hereof, Credit Suisse First Boston International and Counterparty wish to cancel the Transaction.

 

NOW, THEREFORE, in consideration of the mutual premises herein, Credit Suisse First Boston International and Counterparty have agreed as follows:

 

1.                                       The Transaction shall be terminated and cancelled with effect from and including 18 July 2005 (the ‘Cancellation Date’) and all rights, duties, claims and obligations of Credit Suisse First Boston International and Counterparty thereunder shall be released and discharged with effect from and including the Cancellation Date without prejudice to any such rights, duties, claims and obligations which arose prior to the Cancellation Date.

 

2.                                       In consideration of the cancellation of the Transaction as outlined above, Counterparty shall pay to Credit Suisse First Boston International the sum of USD 5,400,000.00 for value 21 July 2005.

 

3.                                       This Cancellation Agreement may be executed in two or more counterparts, each of which shall be deemed to be an original and all of which shall be deemed to be one and the same instrument.

 

4.                                       This Cancellation Agreement shall be governed by, and construed in accordance with, the laws of the State of New York, without reference to choice of law doctrine and each party hereby submits to the jurisdiction of the Courts of the State of New York.

 



 

5.                                       Credit Suisse First Boston International and Counterparty each represents to the other that it has entered into this Cancellation Agreement in reliance upon such tax, accounting, regulatory, legal, and financial advice as it deems necessary and not upon any view expressed by the other.

 

6.                                       Account Details:

 

Credit Suisse First Boston International:

 

Bank of New York, NYC

 

 

ABA 021 000 018

 

 

Acct # 890-0360-968

 

 

Acct name CSFB Intl

 

 

 

Payments to Party B:

 

To be advised

 

7.                                       Office:

 

Credit Suisse First Boston International is acting through its London Office for the purposes of this Transaction.

 

Credit Suisse First Boston International is authorised and regulated by The Financial Services Authority and has entered into this cancelled transaction as principal. The time at which the above cancelled transaction was executed will be notified to Party B on request.

 

 

 

Yours Faithfully,

 

 

 

CREDIT SUISSE FIRST BOSTON
INTERNATIONAL

 

 

 

By its agent: Credit Suisse First Boston LLC

 

By:

/s/ Ricardo Harewood

 

 

Name: Ricardo Harewood

 

Title: Vice President, Operations

 

 

 

 

Confirmed as of the date first written above:

 

CEPHALON, INC.

 

 

 

By:

/s/ J. Kevin Buchi

 

 

Name: J. Kevin Buchi

 

Title: Sr. Vice President & CFO

 

 


EX-31.1 4 a05-18061_1ex31d1.htm 302 CERTIFICATION

EXHIBIT 31.1

 

CERTIFICATIONS

 

I, Frank Baldino, Jr., certify that:

 

1.               I have reviewed this quarterly report on Form 10-Q of Cephalon, Inc.;

 

2.               Based on my knowledge, this report does not contain any untrue statement of a material fact or omit to state a material fact necessary to make the statements made, in light of the circumstances under which such statements were made, not misleading with respect to the period covered by this report;

 

3.               Based on my knowledge, the financial statements, and other financial information included in this report, fairly present in all material respects the financial condition, results of operations and cash flows of the registrant as of, and for, the periods presented in this report;

 

4.               The registrant’s other certifying officer(s) and I are responsible for establishing and maintaining disclosure controls and procedures (as defined in Exchange Act Rules 13a-15(e) and 15d-15(e)) and internal control over financial reporting (as defined in Exchange Act Rules 13a-15(f) and 15d-15(f)) for the registrant and have:

 

(a)  Designed such disclosure controls and procedures, or caused such disclosure controls and procedures to be designed under our supervision, to ensure that material information relating to the registrant, including its consolidated subsidiaries, is made known to us by others within those entities, particularly during the period in which this report is being prepared;

 

(b)  Designed such internal control over financial reporting, or caused such internal control over financial reporting to be designed under our supervision, to provide reasonable assurance regarding the reliability of financial reporting and the preparation of financial statements for external purposes in accordance with generally accepted accounting principles;

 

(c)  Evaluated the effectiveness of the registrant’s disclosure controls and procedures and presented in this report our conclusions about the effectiveness of the disclosure controls and procedures, as of the end of the period covered by this report based on such evaluation; and

 

(d)  Disclosed in this report any change in the registrant’s internal control over financial reporting that occurred during the registrant’s most recent fiscal quarter (the registrant’s fourth fiscal quarter in the case of an annual report) that has materially affected, or is reasonably likely to materially affect, the registrant’s internal control over financial reporting; and

 

5.               The registrant’s other certifying officer(s) and I have disclosed, based on our most recent evaluation of internal control over financial reporting, to the registrant’s auditors and the audit committee of the registrant’s board of directors (or persons performing the equivalent functions):

 

(a)  All significant deficiencies and material weaknesses in the design or operation of internal control over financial reporting which are reasonably likely to adversely affect the registrant’s ability to record, process, summarize and report financial information; and

 

(b)  Any fraud, whether or not material, that involves management or other employees who have a significant role in the registrant’s internal control over financial reporting.

 

Date:     November 9, 2005

 

 

 

 

/s/ FRANK BALDINO, JR.

 

 

Frank Baldino, Jr., Ph.D.

 

Chairman and Chief Executive Officer

 

(Principal executive officer)

 


EX-31.2 5 a05-18061_1ex31d2.htm 302 CERTIFICATION

EXHIBIT 31.2

 

CERTIFICATIONS

 

I, J. Kevin Buchi, certify that:

 

1.               I have reviewed this quarterly report on Form 10-Q of Cephalon, Inc.;

 

2.               Based on my knowledge, this report does not contain any untrue statement of a material fact or omit to state a material fact necessary to make the statements made, in light of the circumstances under which such statements were made, not misleading with respect to the period covered by this report;

 

3.               Based on my knowledge, the financial statements, and other financial information included in this report, fairly present in all material respects the financial condition, results of operations and cash flows of the registrant as of, and for, the periods presented in this report;

 

4.               The registrant’s other certifying officer(s) and I are responsible for establishing and maintaining disclosure controls and procedures (as defined in Exchange Act Rules 13a-15(e) and 15d-15(e)) and internal control over financial reporting (as defined in Exchange Act Rules 13a-15(f) and 15d-15(f)) for the registrant and have:

 

(a)  Designed such disclosure controls and procedures, or caused such disclosure controls and procedures to be designed under our supervision, to ensure that material information relating to the registrant, including its consolidated subsidiaries, is made known to us by others within those entities, particularly during the period in which this report is being prepared;

 

(b)  Designed such internal control over financial reporting, or caused such internal control over financial reporting to be designed under our supervision, to provide reasonable assurance regarding the reliability of financial reporting and the preparation of financial statements for external purposes in accordance with generally accepted accounting principles;

 

(c)  Evaluated the effectiveness of the registrant’s disclosure controls and procedures and presented in this report our conclusions about the effectiveness of the disclosure controls and procedures, as of the end of the period covered by this report based on such evaluation; and

 

(d)  Disclosed in this report any change in the registrant’s internal control over financial reporting that occurred during the registrant’s most recent fiscal quarter (the registrant’s fourth fiscal quarter in the case of an annual report) that has materially affected, or is reasonably likely to materially affect, the registrant’s internal control over financial reporting; and

 

5.               The registrant’s other certifying officer(s) and I have disclosed, based on our most recent evaluation of internal control over financial reporting, to the registrant’s auditors and the audit committee of the registrant’s board of directors (or persons performing the equivalent functions):

 

(a)  All significant deficiencies and material weaknesses in the design or operation of internal control over financial reporting which are reasonably likely to adversely affect the registrant’s ability to record, process, summarize and report financial information; and

 

(b)  Any fraud, whether or not material, that involves management or other employees who have a significant role in the registrant’s internal control over financial reporting.

 

Date:     November 9, 2005

 

 

 

 

/s/ J. KEVIN BUCHI

 

 

J. Kevin Buchi

 

Senior Vice President and Chief Financial Officer

 

(Principal financial officer)

 


EX-32.1 6 a05-18061_1ex32d1.htm 906 CERTIFICATION

Exhibit 32.1

 

CERTIFICATION PURSUANT TO
18 U.S.C. SECTION 1350,
AS ADOPTED PURSUANT TO
SECTION 906 OF THE SARBANES-OXLEY ACT OF 2002

 

In connection with the Quarterly Report of Cephalon, Inc. (the “Company”) on Form 10-Q for the quarterly period ended September 30, 2005 as filed with the Securities and Exchange Commission on the date hereof (the “Report”), I, Frank Baldino, Jr., Chairman and Chief Executive Officer of the Company, certify, pursuant to 18 U.S.C. § 1350, as adopted pursuant to § 906 of the Sarbanes-Oxley Act of 2002, based on my knowledge, that:

 

(1)                                  The Report fully complies with the requirements of section 13(a) or 15(d) of the Securities Exchange Act of 1934; and

 

(2)                                  The information contained in the Report fairly presents, in all material respects, the financial condition and result of operations of the Company.

 

 

/s/ FRANK BALDINO, JR.

 

Frank Baldino, Jr., Ph.D.

Chairman and Chief Executive Officer

 

November 9, 2005

 


EX-32.2 7 a05-18061_1ex32d2.htm 906 CERTIFICATION

Exhibit 32.2

 

CERTIFICATION PURSUANT TO
18 U.S.C. SECTION 1350,
AS ADOPTED PURSUANT TO
SECTION 906 OF THE SARBANES-OXLEY ACT OF 2002

 

In connection with the Quarterly Report of Cephalon, Inc. (the “Company”) on Form 10-Q for the quarterly period ended September 30, 2005 as filed with the Securities and Exchange Commission on the date hereof (the “Report”), I, J. Kevin Buchi, Sr. Vice President and Chief Financial Officer of the Company, certify, pursuant to 18 U.S.C. § 1350, as adopted pursuant to § 906 of the Sarbanes-Oxley Act of 2002, based on my knowledge, that:

 

(1)                                  The Report fully complies with the requirements of section 13(a) or 15(d) of the Securities Exchange Act of 1934; and

 

(2)                                  The information contained in the Report fairly presents, in all material respects, the financial condition and result of operations of the Company.

 

 

/s/ J. KEVIN BUCHI

 

J. Kevin Buchi

Senior Vice President and Chief Financial Officer

November 9, 2005

 


-----END PRIVACY-ENHANCED MESSAGE-----