-----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, QrRVyhGImNv4mE/QtDNjX0Hyq3qJa2mpD1b6q6wvmoFPARX6q8vjrlWayAxQ/zy0 fpx8eKsQ3kw3i3a7bAXf5Q== 0000069499-02-000037.txt : 20021118 0000069499-02-000037.hdr.sgml : 20021118 20021114182425 ACCESSION NUMBER: 0000069499-02-000037 CONFORMED SUBMISSION TYPE: 10-Q PUBLIC DOCUMENT COUNT: 3 CONFORMED PERIOD OF REPORT: 20020930 FILED AS OF DATE: 20021114 FILER: COMPANY DATA: COMPANY CONFORMED NAME: MYLAN LABORATORIES INC CENTRAL INDEX KEY: 0000069499 STANDARD INDUSTRIAL CLASSIFICATION: PHARMACEUTICAL PREPARATIONS [2834] IRS NUMBER: 251211621 STATE OF INCORPORATION: PA FISCAL YEAR END: 0331 FILING VALUES: FORM TYPE: 10-Q SEC ACT: 1934 Act SEC FILE NUMBER: 001-09114 FILM NUMBER: 02827366 BUSINESS ADDRESS: STREET 1: 130 SEVENTH ST STREET 2: 1030 CENTURY BLDG CITY: PITTSBURGH STATE: PA ZIP: 15222 BUSINESS PHONE: 4122320100 MAIL ADDRESS: STREET 1: 1030 CENTURY BUILDING STREET 2: 130 SEVENTH STREET CITY: PITTSBURGH STATE: PA ZIP: 15222 FORMER COMPANY: FORMER CONFORMED NAME: FRM CORP DATE OF NAME CHANGE: 19711003 10-Q 1 secondqtr03.txt MYLAN LABORATORIES INC. 10Q SECOND QUARTER 2003 - -------------------------------------------------------------------------------- UNITED STATES SECURITIES AND EXCHANGE COMMISSION WASHINGTON, D.C. 20549 FORM 10 - Q - -------------------------------------------------------------------------------- [X] QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the quarterly period ended September 30, 2002 OR [ ] 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 1-9114 MYLAN LABORATORIES INC. (Exact Name of registrant as specified in its charter) Pennsylvania 25-1211621 (State of incorporation) (I.R.S. Employer Identification No.) 130 Seventh Street 1030 Century Building Pittsburgh, Pennsylvania 15222 (Address of principal executive offices) (Zip Code) (412) 232-0100 (Registrant's telephone number, including area code) Indicate by check mark whether the Registrant (1) has filed all reports required to be filed by Section 13 or 15(d) of the Securities Exchange Act of 1934 during the preceding twelve months (or for such shorter period that the Registrant was required to file such reports), and (2) has been subject to such filing requirements for the past 90 days. YES |X| NO ___ Indicate the number of shares outstanding of each of the issuer's classes of common stock, as of the latest practicable date. Outstanding at Class of Common Stock November 6, 2002 - --------------------- ---------------- $ 0.50 par value 122,486,736 MYLAN LABORATORIES INC. AND SUBSIDIARIES FORM 10-Q For the Quarterly Period Ended September 30, 2002 INDEX Page Number PART I. FINANCIAL INFORMATION Item 1: Financial Statements Condensed Consolidated Statements of Earnings - Three and Six Months Ended September 30, 2002 and 2001 2 Condensed Consolidated Balance Sheets - September 30, 2002, and March 31, 2002 3 Condensed Consolidated Statements of Cash Flows - Six Months Ended September 30, 2002 and 2001 4 Notes to Condensed Consolidated Financial Statements 5 Item 2: Management's Discussion and Analysis of Results of Operations and Financial Condition 15 Item 3: Quantitative and Qualitative Disclosures About Market Risk 34 Item 4: Controls and Procedures 35 PART II. OTHER INFORMATION Item 1: Legal Proceedings 35 Item 4: Submission of Matters to a Vote of Security Holders 40 Item 6: Exhibits and Reports on Form 8-K 40 SIGNATURES 41 CERTIFICATIONS MYLAN LABORATORIES INC. AND SUBSIDIARIES Condensed Consolidated Statements of Earnings (unaudited; in thousands, except per share amounts) Three Months Six Months ------------ ---------- Period Ended September 30, 2002 2001 2002 2001 ---- ---- ---- ---- Net revenues $319,539 $286,328 $595,012 $524,261 Cost of sales 152,807 122,551 280,678 238,625 -------- -------- -------- -------- Gross profit 166,732 163,777 314,334 285,636 -------- -------- -------- -------- Operating expenses: Research and development 20,169 16,463 37,012 33,246 Selling and marketing 16,538 14,254 33,425 29,396 General and administrative 25,030 33,822 44,251 59,417 -------- -------- -------- -------- Total operating expenses 61,737 64,539 114,688 122,059 -------- -------- -------- -------- Earnings from operations 104,995 99,238 199,646 163,577 Other income, net 1,613 1,446 3,601 16,245 -------- -------- -------- -------- Earnings before income taxes 106,608 100,684 203,247 179,822 Provision for income taxes 38,379 36,548 73,169 65,038 -------- -------- -------- -------- Net earnings $ 68,229 $ 64,136 $130,078 $114,784 ======== ======== ======== ======== Earnings per common share: Basic $ 0.54 $ 0.51 $ 1.04 $ 0.92 ======== ======== ======== ======== Diluted $ 0.54 $ 0.50 $ 1.03 $ 0.90 ======== ======== ======== ======== Weighted average common shares: Basic 125,362 125,372 125,657 125,202 ======== ======== ======== ======== Diluted 126,777 127,338 126,866 126,856 ======== ======== ======== ======== Cash dividends declared per common share: $ 0.04 $ 0.04 $ 0.08 $ 0.08 ======== ======== ======== ======== See Notes to Condensed Consolidated Financial Statements 2 MYLAN LABORATORIES INC. AND SUBSIDIARIES Condensed Consolidated Balance Sheets (unaudited; in thousands) September 30, March 31, 2002 2002 ---------- ---------- Assets Current assets: Cash and cash equivalents $ 215,294 $ 160,790 Marketable securities 467,540 456,266 Accounts receivable, net 180,580 145,491 Inventories 196,253 195,074 Deferred income tax benefit 109,655 92,642 Other current assets 9,875 11,819 ---------- ---------- Total current assets 1,179,197 1,062,082 Property, plant and equipment, net 169,405 166,531 Intangible assets, net 159,765 169,315 Goodwill, net 103,196 103,196 Investment in and advances to Somerset 19,562 22,720 Other assets 77,868 92,866 ---------- ---------- Total assets $1,708,993 $1,616,710 ========== ========== Liabilities and shareholders' equity Liabilities Current liabilities: Trade accounts payable $ 35,459 $ 36,534 Income taxes payable 74,305 63,826 Other current liabilities 88,541 72,758 ---------- ---------- Total current liabilities 198,305 173,118 Long-term obligations 21,166 23,883 Deferred income tax liability 20,396 17,470 ---------- ---------- Total liabilities 239,867 214,471 ---------- ---------- Shareholders' equity: Common stock 66,413 66,100 Additional paid-in capital 360,641 349,719 Retained earnings 1,200,806 1,080,736 Accumulated other comprehensive earnings 6,486 7,920 ---------- ---------- 1,634,346 1,504,475 Less: treasury stock at cost 165,220 102,236 ---------- ---------- Total shareholders' equity 1,469,126 1,402,239 ---------- ---------- Total liabilities and shareholders' equity $1,708,993 $1,616,710 ========== ========== See Notes to Condensed Consolidated Financial Statements 3 MYLAN LABORATORIES INC. AND SUBSIDIARIES Condensed Consolidated Statements of Cash Flows (unaudited; in thousands) Six Months Ended September 30, 2002 2001 ---- ---- Cash flows from operating activities: Net earnings $ 130,078 $ 114,784 Adjustments to reconcile net earnings to net cash provided from operating activities: Depreciation and amortization 19,648 23,459 Deferred income tax benefit (19,050) (18,297) Equity in loss of and cash received from Somerset 3,158 1,919 Loss(earnings)from limited liability partnerships 3,334 (11,998) Adjustments to estimated sales allowances 52,234 30,038 Other noncash items (7,250) 7,616 Changes in operating assets and liabilities: Accounts receivable (87,234) (10,503) Inventories 1,363 (21,214) Trade accounts payable (1,075) 3,455 Income taxes 16,215 36,153 Other operating assets and liabilities, net 13,898 29,192 ---------- ---------- Net cash provided from operating activities 125,319 184,604 ---------- ---------- Cash flows from investing activities: Proceeds from (purchase of): Capital assets (13,109) (6,621) Other and intangible assets (612) (3,369) Marketable securities (385,883) (324,840) Sale and maturity of marketable securities 384,019 126,813 ---------- ---------- Net cash used in investing activities (15,585) (208,017) ---------- ---------- Cash flows from financing activities: Payments on long-term obligations -- (2,000) Cash dividends paid (10,066) (10,002) Purchase of common stock (56,042) -- Proceeds from exercise of stock options 10,878 6,965 ---------- ---------- Net cash used in financing activities (55,230) (5,037) ---------- ---------- Net increase (decrease) in cash and cash equivalents 54,504 (28,450) Cash and cash equivalents - beginning of period 160,790 229,183 ---------- ---------- Cash and cash equivalents - end of period $ 215,294 $ 200,733 ========== ========== Cash paid during the period for: Interest $ -- $ 105 ========== ========== Income taxes $ 52,893 $ 47,180 ========== ========== See Notes to Condensed Consolidated Financial Statements 4 MYLAN LABORATORIES INC. AND SUBSIDIARIES Notes to Condensed Consolidated Financial Statements (unaudited; in thousands, except share and per share amounts) 1. General In the opinion of management, the accompanying unaudited condensed consolidated financial statements (interim financial statements) have been prepared in accordance with the rules and regulations of the Securities and Exchange Commission (SEC) for reporting on Form 10-Q; therefore, as permitted under these rules, certain footnotes or other financial information required by generally accepted accounting principles and included in audited financial statements have been condensed or omitted. The accompanying financial statements contain all adjustments (consisting of only normal recurring adjustments) necessary to present fairly our interim results of operations, financial position and cash flows for the periods presented. These interim financial statements should be read in conjunction with the consolidated financial statements and notes thereto in our Annual Report on Form 10-K for the fiscal year ended March 31, 2002. Certain prior year amounts were reclassified to conform to the current year presentation. Such reclassifications had no impact on reported net earnings, earnings per share or shareholders' equity. The interim results of operations for the three and six months ended September 30, 2002, are not necessarily indicative of the results to be expected for the full fiscal year. 2. Revenue Recognition and Accounts Receivable We recognize revenue for product sales upon shipment when title and risk of loss transfer to our customers and when provisions for estimates, including discounts, rebates, price adjustments, returns, chargebacks and other promotional adjustments are reasonably determinable. Accounts receivable are presented net of allowances relating to these provisions. Such allowances were $259,487 and $214,637 as of September 30, 2002, and March 31, 2002. Other current liabilities include $26,839 and $21,577 at September 30, 2002, and March 31, 2002, for certain rebates and other adjustments that are payable to indirect customers. We perform ongoing credit evaluations of our customers and generally do not require collateral. Approximately 83% and 64% of the accounts receivable balances represent amounts due from four customers at September 30, 2002, and March 31, 2002. 5 3. Recent Accounting Pronouncements Effective April 1, 2002, Mylan adopted Statement of Financial Accounting Standards (SFAS) 142, Goodwill and Other Intangible Assets. Goodwill and other indefinite lived intangible assets are no longer amortized. Intangible assets determined to have indefinite lives were tested for potential impairment and no impairments were indicated. The transitional assessment of goodwill for impairment as of April 1, 2002, was completed during the quarter ended September 30, 2002, with no indication of impairment. An independent valuation specialist assisted in the determination of the fair values used to test for impairment. Assuming the adoption of SFAS 142 had occurred on April 1, 2001, and goodwill and other indefinite lived assets were no longer amortized, net earnings for the three and six months ended September 30, 2001, would have increased by $1,801 and $3,602 and earnings per basic and diluted share would have increased by $.02 per share and $.03 per share, respectively. SFAS 143, Accounting for Asset Retirement Obligations, establishes standards of accounting for obligations associated with the retirement of tangible long-lived assets. The statement is effective for fiscal years beginning after June 15, 2002. We are currently evaluating the impact, if any, this statement will have on our financial position and results of operations. Effective April 1, 2002, Mylan adopted SFAS 144, Accounting for the Impairment or Disposal of Long-Lived Assets, which addresses financial accounting and reporting for the impairment and disposal of long-lived assets. The impact of adoption had no material effect on our financial position or results of operations. SFAS 146, Accounting for Costs Associated with Exit or Disposal Activities, requires a liability for costs associated with an exit or disposal activity be recognized when the liability is incurred rather than when a commitment to an exit plan is made. SFAS 146 is effective for exit or disposal activities that are initiated after December 31, 2002. We believe the adoption of this statement will not have a material effect on our financial position or results of operations. 6 4. Balance Sheet Components Selected balance sheet components consist of the following: September 30, March 31, 2002 2002 ---- ---- Inventories: Raw materials $ 88,638 $ 74,782 Work in process 26,696 31,056 Finished goods 80,919 89,236 -------- -------- $196,253 $195,074 ======== ======== Other current liabilities: Rebates $ 26,839 $ 21,577 Payroll and related 22,355 18,936 Royalties and product license fees 14,961 12,363 Cash dividends payable 5,010 5,067 Other 19,376 14,815 -------- -------- $ 88,541 $ 72,758 ======== ======== 5. Goodwill and Intangible Assets Goodwill by operating segment as of September 30, 2002, and April 1, 2002: Generic $ 20,100 Brand 83,096 --------- Total $ 103,196 ========= Intangible assets, excluding goodwill, consist of the following components: Weighted Average Life Original Accumulated Net Book (years) Cost Amortization Value ------- ------- ------------ ------- September 30, 2002 - ------------------ Amortized intangible assets: Patents and technologies 19 $ 117,435 $ 33,038 $ 84,397 Product rights and related intangibles 12 107,273 42,309 64,964 Other 20 13,875 4,723 9,152 --------- --------- --------- $ 238,583 $ 80,070 158,513 ========= ========= Unamortized intangible assets: Trademarks 1,252 --------- $ 159,765 March 31, 2002 ========= - -------------- Amortized intangible assets: Patents and technologies $ 119,663 $ 32,056 $ 87,607 Product rights and related intangibles 107,907 36,950 70,957 Other 24,380 14,881 9,499 --------- --------- --------- 251,950 83,887 168,063 Trademarks 1,800 548 1,252 --------- --------- --------- $ 253,750 $ 84,435 $ 169,315 ========= ========= ========= 7 As of June 30, 2002, we removed from the balance sheet certain intangible assets with an original cost of $13,368. Such assets were fully amortized at March 31, 2002, and have no ongoing benefit to our current operations. Amortization expense for the current three and six month periods was $4,714 and $9,431 and is expected to be $18,578 for the fiscal year. Expected amortization expense for fiscal years 2004 through 2007 is $18,369, $16,904, $13,355 and $13,143, respectively. 6. Earnings per Common Share Basic earnings per common share is computed by dividing net earnings by the weighted average number of common shares outstanding during the period. Diluted earnings per common share is computed by dividing net earnings by the weighted average number of common shares outstanding during the period adjusted for the dilutive effect of stock options outstanding. The effect of dilutive stock options on the weighted average number of common shares outstanding was 1,415,000 and 1,966,000 for the three months ended September 30, 2002 and 2001, and 1,209,000 and 1,654,000 for the six months ended September 30, 2002 and 2001. Antidilutive stock options of 344,000 and 38,000 were excluded from the diluted earnings per common share calculation for the three months ended September 30, 2002 and 2001, and 527,000 and 351,000 were excluded for the six months ended September 30, 2002 and 2001. 7. Comprehensive Earnings Comprehensive earnings consist of the following: Three Months Six Months ------------ ------------ Period Ended September 30, 2002 2001 2002 2001 ---- ----- ---- ----- Net earnings $ 68,229 $ 64,136 $ 130,078 $ 114,784 Other comprehensive (loss) earnings, net of tax: Net unrealized (loss) gain on marketable securities (393) (1,035) 1,733 2,348 Reclassification for gains included in net earnings (3,198) (67) (3,167) (201) --------- --------- --------- --------- (3,591) (1,102) (1,434) 2,147 --------- --------- --------- --------- Comprehensive earnings $ 64,638 $ 63,034 $ 128,644 $ 116,931 ========= ========= ========= ========= 8 Accumulated other comprehensive earnings, as reflected on the balance sheet, is comprised solely of the net unrealized gain on marketable securities, net of deferred income taxes. 8. Common Stock As of September 30, 2002, and March 31, 2002, there were 300,000,000 shares of common stock authorized with 132,825,870 and 132,200,528 shares issued. Treasury shares held as of September 30, 2002, and March 31, 2002, were 7,908,246 and 5,813,033. In May 2002, the Board of Directors approved a stock purchase program to purchase up to 10,000,000 shares of our outstanding common stock. During the six months ended September 30, 2002, we purchased 2,092,700 shares for $62,906. Subsequent to September 30, 2002, and through October 24, 2002, we purchased an additional 2,341,600 shares for $73,743. 9. Stock Option Plan In July 2002, Mylan shareholders approved the proposal to amend and restate the Mylan Laboratories Inc. 1997 Incentive Stock Option Plan (the Plan) to add an additional 5,000,000 shares for which options may be granted and to authorize the grant of options to non-employee directors. Under the Plan, as amended, up to 15,000,000 shares of the Company's common stock may be granted to officers, employees, non-employee directors and non-employee consultants and agents as either incentive stock options or nonqualified stock options. As of September 30, 2002, 5,727,860 shares were available for future grants. 10. Segment Reporting Segment net revenues represent revenues from unrelated third parties. For the Generic and Brand Segments, segment profit (loss) represents segment gross profit less direct research and development, selling and marketing and general and administrative expenses. Corporate/Other includes legal costs, administrative expenses and other income and expense. 9 The following table presents the results of operations for each of our operating segments: Three Months Six Months ------------ ---------- Period Ended September 30, 2002 2001(1) 2002 2001(1) ---- ---- ---- ---- Consolidated: Net revenues $ 319,539 $ 286,328 $ 595,012 $ 524,261 Pretax earnings 106,608 100,684 203,247 179,822 Generic: Net revenues 274,281 252,817 509,926 462,639 Segment profit 120,747 127,851 227,070 217,256 Brand: Net revenues 45,258 33,511 85,086 61,622 Segment profit (loss) 1,127 (5,666) 713 (16,614) Corporate/Other: Segment loss (15,266) (21,501) (24,536) (20,820) (1)Includes amortization of goodwill and certain other intangible assets not amortized in the current fiscal year due to the adoption of SFAS 142. Quarterly amortization recorded in fiscal 2001 for these intangibles, including goodwill, was $1,599 in Corporate/Other, $167 in Generic and $35 in Brand. 11. Related Parties A consulting agreement dated July 2000 with a firm, which was previously owned by a director of the Company, was terminated in its entirety through mutual consent upon the director becoming an employee of the Company in July 2002. 12. Contingencies Product Litigation While it is not possible to determine with any degree of certainty the ultimate outcome of the following legal proceedings, we believe that we have meritorious defenses with respect to the claims asserted against the Company, and we intend to vigorously defend our position. AN ADVERSE OUTCOME IN ANY OF THESE PROCEEDINGS COULD HAVE A MATERIAL ADVERSE EFFECT ON OUR FINANCIAL POSITION AND RESULTS OF OPERATIONS. Paclitaxel In June 2001, NAPRO Biotherapeutics Inc. (NAPRO) and Abbott Laboratories Inc. (Abbott) filed suit against the Company in the United States (US) District Court for the Western District of Pennsylvania. Plaintiffs allege that the Company's manufacture, 10 use, and sale of its paclitaxel product infringes certain patents owned by NAPRO and allegedly licensed to Abbott. Plaintiffs seek unspecified damages plus interest, a finding of willful infringement which could result in treble damages, injunctive relief, attorneys' fees, costs of litigation, and such equitable and other relief as the court deems just and proper. The Company began selling its paclitaxel product in July 2001. Verapamil ER In July 2001, Biovail Laboratories Inc. (Biovail) filed a demand for arbitration against the Company with the American Arbitration Association. In response to such demand, the Company filed its answer and counterclaims. The dispute relates to a supply agreement under which the Company supplied extended-release verapamil to Biovail. The Company terminated the agreement in March 2001. Biovail's allegations include breach of contract, breach of implied covenant of good faith and fair dealing and unfair competition. Biovail is seeking damages plus interest, to be determined at trial, but in an amount of not less than $10,000, plus unspecified punitive damages, attorneys' fees and costs of litigation and such other relief as the panel may deem just and proper. The Company's allegations as set forth in its counterclaims include breach of obligations of good faith and fair dealing, fraud and unjust enrichment. Zagam(R) The Company filed suit against Aventis Pharmaceuticals, Inc., successor in interest to Rhone-Poulenc Rorer Pharmaceuticals, Inc.; Rhone-Poulenc Rorer Pharmaceuticals, LTD.; Rorer Pharmaceutical Products, Inc.; Rhone-Poulenc Rorer, S.A., and their affiliates in the US Federal District Court for the Western District of Pennsylvania in May 2001. The complaint sets forth claims of breach of contract, rescission, breach of implied covenant of good faith and fair dealing and unjust enrichment. The defendants' answer includes a counterclaim, which alleges nonpayment of royalties and failure to mitigate. The defendants are seeking royalties allegedly owed by the Company, attorneys' fees and costs of litigation and such other relief as may be demonstrated at trial. Nifedipine In February 2001, Biovail filed suit against the Company and Pfizer Inc. (Pfizer) in the US District Court for the Eastern District of Virginia alleging antitrust violations with respect to agreements entered into between the Company and Pfizer regarding nifedipine. The Company filed a motion to transfer the case to the US District Court for the Northern District of West Virginia, which was granted. The Company's motion to dismiss Biovail's complaint was denied. 11 The Company has been named as a defendant in five other putative class action suits alleging antitrust claims based on the settlement entered into by the Company with Pfizer regarding nifedipine. Two of the class actions have been dismissed in their entirety and the remaining actions have been dismissed in part. The plaintiffs in the remaining actions, as well as Biovail, are seeking unspecified compensatory and treble damages, attorneys' fees, costs of litigation, restitution, disgorgement and declaratory and injunctive relief. Buspirone The Company filed an ANDA seeking approval to market buspirone, a generic equivalent to Bristol-Myers Squibb's (BMS) BuSpar(R). The Company filed the appropriate certifications relating to the patents for this product that were then listed in the US Food and Drug Administration (FDA) publication entitled Approved Drug Products with Therapeutic Equivalence Evaluations, popularly known as the "Orange Book." In November 2000, a new patent claiming the administration of a metabolite of buspirone (which BMS claims also covers the administration of buspirone itself) was issued to BMS. The subsequent listing of this patent in the Orange Book prevented the FDA from granting final approval for the Company's buspirone ANDA. In November 2000, the Company filed suit against the FDA and BMS in the US District Court for the District of Columbia. The complaint asked the court to order the FDA to immediately grant final approval of the Company's ANDA for the 15mg buspirone product and require BMS to request withdrawal of the patent from the Orange Book. Upon the Company's posting of a bond in the amount of $25,000, the court entered an order granting the Company's motion for a preliminary injunction. Following a brief stay by the US Court of Appeals for the Federal Circuit (Federal Circuit), the FDA granted approval of the Company's ANDA with respect to the 15mg strength. Upon receiving FDA approval, the Company began marketing and selling the 15mg tablet in March 2001. The Company has also been selling the 30mg tablet since August 2001 and the 5mg and 10mg tablets since March 2002. BMS appealed the preliminary injunction order to both the Federal Circuit and the US Court of Appeals for the District of Columbia Circuit. The District of Columbia Court of Appeals denied BMS' application and stayed the Company's motion to dismiss pending the decision of the Federal Circuit. In October 2001, the Federal Circuit overturned the lower court ruling and held that the Company did not have a cognizable claim against BMS under the Declaratory Judgment Act to challenge the listing of BMS' patent, which the Federal Circuit viewed as an improper effort to enforce the Federal Food, Drug and Cosmetic Act. The Federal Circuit did not address the lower court's determination that the BMS patent does not claim buspirone or a method of administration of the drug. The Company filed a petition with the Federal Circuit asking that the court reconsider its holding. The 12 petition was denied in January 2002. A petition for review by the US Supreme Court was denied in October 2002. In January 2002, the Company filed a motion in the US District Court for the District of Columbia seeking a preliminary injunction which, if granted, would require that the FDA refuse to list the BMS patent should BMS submit it for re-listing in the Orange Book. The District of Columbia Court has entered an order staying further proceedings in this case pending appeal of the order entered in the US District Court for the Southern District of New York granting the Company's motion for summary judgment of non-infringement. The Company is involved in three other suits related to buspirone. In November 2000, the Company filed suit against BMS in the US District Court for the Northern District of West Virginia. The suit seeks a declaratory judgment of non-infringement and/or invalidity of the BMS patent listed in November 2000. In January 2001, BMS sued the Company for patent infringement in the US District Court for the District of Vermont and also in the US District Court for the Southern District of New York. In each of these cases, BMS asserts that the Company infringes BMS' patent and seeks to rescind approval of the Company's ANDA. BMS seeks to recover damages equal to lost profits plus interest, a finding of willful infringement which could result in treble damages, injunctive relief, attorneys' fees, costs of litigation, and such other relief as the court deems just and proper. The Company subsequently filed motions to dismiss the Vermont case and dismiss and transfer the New York case to the US District Court for the Northern District of West Virginia. The Judicial Panel on Multi-District Litigation ordered these cases, along with another patent case and numerous antitrust suits filed against BMS, be consolidated for pre-trial purposes in the US District Court for the Southern District of New York. The New York Court has granted the Company's motion for summary judgment that the BMS patent is not infringed or, alternatively, is invalid. BMS has appealed this decision to the Court of Appeals for the Federal Circuit. The New York Court also denied the BMS motion to dismiss the Company's antitrust counterclaims. Lorazepam and Clorazepate In January 1999, four companies who claim to have purchased lorazepam and/or clorazepate from the Company filed suit alleging that the Company engaged in restraint of trade, monopolization, attempted monopolization and conspiracy to monopolize arising out of certain agreements involving the supply of raw materials used to manufacture those two products. In July 2001, the US Court for the District of Columbia certified a litigation class consisting of direct purchasers. The plaintiffs seek to recover treble damages equal to three times the 13 overcharge they claim to have paid, plus injunctive relief, attorneys' fees, costs of litigation and such other relief as the court deems proper. In December 2001, four third-party reimbursers filed separate actions against the Company. These actions are pending in the US District Court for the District of Columbia. The Company is also defending a civil action in the State of California that was brought under state law on behalf of independent retail pharmacies who purchased lorazepam and/or clorazepate. The California action has not been certified as a class action. The plaintiffs in each of these actions seek unspecified monetary damages, equitable relief, attorneys' fees and costs of litigation. Average Wholesale Price litigation The Company, along with a number of other pharmaceutical manufacturers, has been named as a defendant in four lawsuits filed in the state courts of California in which the plaintiffs allege the defendants unlawfully, unfairly and fraudulently manipulated the reported average wholesale price of various products, allegedly to increase third party reimbursements to others for their products. None of these four cases has been certified as a class action, although all four cases seek class action and representative status. Plaintiffs seek equitable relief in the form of disgorgement and restitution, attorneys' fees and costs of litigation. While it is not possible to determine with any degree of certainty the ultimate outcome of these suits, we believe that we have meritorious defenses with respect to the claims asserted against the Company, and we intend to vigorously defend our position. AN ADVERSE OUTCOME IN ANY OF THESE SUITS COULD HAVE A MATERIAL ADVERSE EFFECT ON OUR FINANCIAL POSITION AND RESULTS OF OPERATIONS. Other Litigation The Company is involved in various other legal proceedings that are considered normal to its business. While it is not feasible to predict the ultimate outcome of such other proceedings, we believe that the ultimate outcome of such other proceedings will not have a material adverse effect on our financial position or results of operations. 14 ITEM 2. MANAGEMENT'S DISCUSSION AND ANALYSIS OF RESULTS OF OPERATIONS AND FINANCIAL CONDITION The following discussion addresses material changes in the Company's results of operations and financial condition for the periods presented. This discussion and analysis should be read in conjunction with the Consolidated Financial Statements, the related Notes to Consolidated Financial Statements and Management's Discussion and Analysis of Results of Operations and Financial Condition included in our Annual Report on Form 10-K for the fiscal year ended March 31, 2002, and the unaudited interim condensed consolidated financial statements and related notes included in Item 1 of this Report on Form 10-Q. Results of Operations - --------------------- Net earnings increased 6% or $4.1 million for the current quarter and 13% or $15.3 million for the current six months, compared to the same prior year periods. Earnings per diluted share increased 8% or $.04 per share for the current quarter and 14% or $.13 per share for the current six months. The increases in net earnings were primarily the result of increased net revenues and decreased operating expenses. The increases in net revenues for the current year were primarily attributable to new products, increased volume, relatively stable pricing for generic products and improved marketing conditions for brand products. Operating expenses in the current year decreased primarily due to lower general and administrative expenses. 15 Segment Results (in thousands) Three Months Six Months ------------ ---------- Period Ended September 30, 2002 2001(1) 2002 2001(1) ---- ------- ---- ------- Consolidated: Net revenues $ 319,539 $ 286,328 $ 595,012 $ 524,261 Gross profit 166,732 163,777 314,334 285,636 Research and development 20,169 16,463 37,012 33,246 Selling and marketing 16,538 14,254 33,425 29,396 General and administrative 25,030 33,822 44,251 59,417 Other income, net 1,613 1,446 3,601 16,245 Pretax earnings 106,608 100,684 203,247 179,822 Generic Segment: Net revenues 274,281 252,817 509,926 462,639 Gross profit 139,872 145,073 264,355 254,236 Research and development 10,873 7,393 20,887 16,682 Selling and marketing 2,551 3,224 5,299 6,302 General and administrative 5,701 6,605 11,099 13,996 Segment profit 120,747 127,851 227,070 217,256 Brand Segment: Net revenues 45,258 33,511 85,086 61,622 Gross profit 26,860 18,704 49,979 31,400 Research and development 9,296 9,070 16,125 16,564 Selling and marketing 13,987 11,030 28,126 23,094 General and administrative 2,450 4,270 5,015 8,357 Segment profit (loss) 1,127 (5,666) 713 (16,614) Corporate/Other: Segment loss (15,266) (21,501) (24,536) (20,820)
Segment net revenues represent revenues from unrelated third parties. For the Generic and Brand segments, segment profit (loss) represents segment gross profit less direct research and development, selling and marketing and general and administrative expenses. Corporate/Other includes legal costs, administrative expenses and other income and expense. 1 Includes amortization of goodwill and certain other intangible assets not amortized in the current fiscal year due to the adoption of SFAS 142. Quarterly amortization recorded in fiscal 2001 for these intangibles, including goodwill, was $1,599 in Corporate/Other, $167 in Generic and $35 in Brand. Quarter Ended September 30, 2002, compared to Quarter Ended September 30, 2001 Net Revenues and Gross Profit Net revenues for the current quarter increased 12% or $33.2 million compared to the prior year quarter. The Generic segment accounted for 65% or $21.5 million of the total increase in net revenues, while the Brand segment accounted for the remaining 35% or $11.7 million. New products launched subsequent to September 30, 2001, primarily generics, contributed $24.7 million. New generic products and increased net revenues on core generic products (excluding buspirone 15mg and 30mg) more than offset the decrease in net revenues experienced on buspirone. Excluding the impact of buspirone, Generic net revenues for the quarter increased 24% or $50.8 million over the prior year 16 quarter. The increase in core products' net revenues was primarily the result of relatively stable pricing, favorable product mix and increased volume. Buspirone net revenues decreased 80%, primarily due to the loss of marketing exclusivity and the competitive pressures resulting from new entrants into the marketplace. Brand net revenues for the current quarter increased 35% or $11.7 million. The increase was primarily due to improved pricing, product mix and increased volume, in part due to the curtailment of end-of-quarter promotions in the prior year. Gross profit increased 2% or $3.0 million. Generic gross profit decreased 4% or $5.2 million, primarily due to decreased gross profit on buspirone sales. The lower gross profit recognized on buspirone was partially offset by contributions from core products. Brand gross profit increased 44% or $8.2 million, primarily due to favorable pricing, product mix and increased volume, in part due to the curtailment of end-of-quarter promotions in the prior year. Operating Expenses Research and development (R&D) expenses for the current quarter increased 23% or $3.7 million compared to the same prior year quarter. The increase was primarily related to Generic expenses due to the timing and number of studies being conducted. We expect R&D expenses to continue to increase for both the Generic and Brand segments throughout fiscal 2003 as activities related to current projects progress. Selling and marketing expenses for the current quarter were up 16% or $2.3 million over the prior year quarter. The increase was primarily related to Brand advertising and promotional expenses, focused primarily on Digitek(R), Phenytek(TM) and, in part, Amnesteem(TM) (isotretinoin). General and administrative (G&A) expenses decreased 26% or $8.8 million over the prior year quarter. The decrease was primarily related to decreased Corporate expenses. Corporate expenses in the prior year quarter included $5.3 million related to increased retirement benefits for certain executive and management employees. Additionally, Corporate expenses for the prior year quarter included $1.6 million of goodwill amortization, which, due to the April 1, 2002, adoption of SFAS 142, is no longer amortized. The $1.8 million decrease in Brand expenses was primarily related to a $1.4 million decrease in relocation expenses. Bertek Pharmaceuticals Inc. (Bertek) completed its move to Raleigh, North Carolina, in fiscal 2002. Other Income, net Other income, net of non-operating expenses, increased 31% or $.8 million over the prior year quarter. The increase was primarily due to an increase in interest income due to higher cash balances and a $4.6 million increase in 17 realized gains on the sale of marketable securities in the current quarter, which was offset by a $4.6 million decrease in income from our pooled asset funds. The increase in the loss from our equity investment in Somerset Pharmaceuticals, Inc. (Somerset) was primarily attributable to increased R&D expenses. We expect to continue to recognize losses on our equity investment in Somerset throughout fiscal 2003 as its R&D activities continue. Six Months Ended September 30, 2002, compared to Six Months Ended September 30, 2001 Net Revenues and Gross Profit Net revenues for the current six months increased 13% or $70.8 million compared to the same prior year six months. The Generic segment accounted for 67% or $47.3 million of the total increase in net revenues, while the Brand segment accounted for the remaining 33% or $23.5 million. New products launched subsequent to September 30, 2001, primarily generics, contributed net revenues of $32.3 million. Generic net revenues increased principally due to increased sales of core products, which experienced relatively stable pricing, favorable product mix and increased volume. Excluding the impact of buspirone (15mg and 30mg), Generic net revenues for the current six months increased 27% or $105.0 million over the prior year six months. Buspirone net revenues for the current six months decreased 81%, primarily due to the loss of market exclusivity and the competitive pressures resulting from new entrants into the marketplace. The increase in Brand net revenues was due to both favorable pricing, product mix and increased volume, in part due to the prior year's curtailment of end-of-quarter promotions. Gross profit for the current six months increased 10% or $28.7 million. Generic gross profit increased 4% or $10.1 million, representing 35% of the total gross profit increase. Increased gross profit contributed from our core generic products was partially offset by decreased gross profit contributed from buspirone. Brand gross profit increased 59% or $18.6 million, primarily due to favorable pricing and product mix and in part to the prior year's curtailment of end-of-quarter promotions. Operating Expenses R&D expenses for the current six months increased 11% or $3.8 million. The increase was primarily related to expenses incurred by the Generic segment. Generic studies and related expenses were up $3.5 million primarily due to the timing and number of studies being conducted. We expect our R&D expenses to 18 continue to increase, for both the Generic and Brand segments, as activities related to current projects progress. Selling and marketing expenses increased 14% or $4.0 million. The increase was primarily attributable to increased brand advertising and promotional activities, focused primarily on Digitek(R), Phenytek(TM) and, in part, Amnesteem(TM) (isotretinoin). G&A expenses for the current six months decreased 26% or $15.2 million. The decrease in Corporate expenses was primarily related to a decrease in payroll related expenses and goodwill no longer amortized in the current year. The prior year six months included expense of $5.3 million for changes in retirement benefits for certain executive and management employees. Other Corporate expenses with significant decreases were legal and professional fees of $2.5 million and goodwill amortization expense of $3.2 million. Brand expenses for the prior year six month period included relocation expenses of $2.6 million for Bertek's move to Raleigh, North Carolina, which was completed in fiscal 2002. Other Income, net The 63% or $11.3 million decrease in other income, net of non-operating expenses, for the current six months was primarily attributable to decreased earnings on our limited partnership investments of $15.3 million, which were partially offset by realized gains of $4.6 million on the sale of certain marketable securities. The Somerset loss for the current six months increased $1.3 million compared to the prior year six months. The increase was primarily attributable to decreased sales revenues and increased R&D expenses. We expect to continue to recognize losses on our equity investment in Somerset throughout fiscal 2003 as its R&D activities continue. Liquidity and Capital Resources - ------------------------------- Our primary source of liquidity continues to be cash flow from operating activities, which was $125.3 million for the current six months. Working capital as of September 30, 2002, was $980.9 million, an increase of $91.9 million from March 31, 2002. Of our $1.7 billion of total assets at September 30, 2002, 40% or $682.8 million was held in cash, cash equivalents and marketable securities. Investments in marketable securities consist primarily of high-quality government and commercial paper that generally mature within one year. These investments are highly liquid and are available for operating needs. As these instruments mature, we generally reinvest the funds in instruments with similar characteristics. In May 2002, the Board of Directors (Board) approved a stock purchase program that authorized the purchase of up to 10.0 million shares of the 19 Company's outstanding common stock. Through October 24, 2002, we purchased approximately 4.4 million shares of common stock for $136.6 million. Capital expenditures during the six months ended September 30, 2002, were $13.1 million. These expenditures were primarily for machinery and equipment used in our manufacturing facilities. We expect such expenditures to continue at current year levels. Mylan has historically paid a quarterly cash dividend of $.04 per common share, which, for the six months ended September 30, 2002, totaled $10.1 million. However, our Board approved an increase in the quarterly cash dividend to $.05 per share, beginning with the dividend payable to shareholders of record on December 31, 2002, resulting in an expected increase in annual dividends of approximately $5.0 million. We maintain commercial insurance to protect against and manage the risks involved in conducting our business. The cost to obtain insurance coverage for such risks has significantly increased due to the environment within the commercial insurance industry. The recent renewals of our policies resulted in increased deductibles and decreased levels of coverage. We have evaluated and will continue to evaluate the types and levels of insurance coverage purchased. To the extent that a loss occurs, it could have a material adverse effect on our financial position and results of operations depending on the nature of the loss and the level of insurance coverage maintained. We are involved in various legal proceedings that are considered normal to our business (see Note 12 to Condensed Consolidated Financial Statements). While it is not feasible to predict the outcome of such proceedings, an adverse outcome in any of these proceedings could materially affect our financial position and cash flow. We are actively pursuing, and are currently involved in, joint development projects in an effort to broaden our scope of capabilities to market both generic and brand products. Many of these arrangements provide for payments by us upon the attainment of specified milestones. While these arrangements help to reduce our financial risk for unsuccessful projects, fulfillment of specified milestones or the occurrence of other obligations may result in fluctuations in cash flow from operating activities. To provide additional operating leverage, if necessary, we maintain a revolving line of credit of up to $50.0 million with a commercial bank. As of September 30, 2002, no funds have been advanced under this line of credit, which expires in March 2003. Additionally, we are continuously evaluating the potential acquisition of products, as well as companies, as a strategic part of our future growth. Consequently, we may utilize current cash reserves or incur additional indebtedness to finance these acquisitions, which could impact future liquidity. 20 Recent Accounting Pronouncements - -------------------------------- Effective April 1, 2002, Mylan adopted Statement of Financial Accounting Standards (SFAS) 142, Goodwill and Other Intangible Assets. Goodwill and other indefinite lived intangible assets are no longer amortized. Intangible assets determined to have indefinite lives were tested for potential impairment and no impairments were indicated. The transitional assessment of goodwill for impairment as of April 1, 2002, was completed during the quarter ended September 30, 2002, with no indication of impairment. An independent valuation specialist assisted in the determination of the fair values used to test for impairment. Assuming the adoption of SFAS 142 had occurred on April 1, 2001, and goodwill and other indefinite lived assets were no longer amortized, net earnings for the three and six months ended September 30, 2001, would have increased by $1.8 million and $3.6 million and earnings per basic and diluted share would have increased by $.02 per share and $.03 per share, respectively. SFAS 143, Accounting for Asset Retirement Obligations, establishes standards of accounting for obligations associated with the retirement of tangible long-lived assets. The statement is effective for fiscal years beginning after June 15, 2002. We are currently evaluating the impact, if any, this statement will have on our financial position and results of operations. Effective April 1, 2002, Mylan adopted SFAS 144, Accounting for the Impairment or Disposal of Long-Lived Assets, which addresses financial accounting and reporting for the impairment and disposal of long-lived assets. The impact of adoption had no material effect on our financial position or results of operations. SFAS 146, Accounting for Costs Associated with Exit or Disposal Activities, requires a liability for costs associated with an exit or disposal activity be recognized when the liability is incurred rather than when a commitment to an exit plan is made. SFAS 146 is effective for exit or disposal activities that are initiated after December 31, 2002. We believe the adoption of this statement will not have a material effect on our financial position or results of operations. Critical Accounting Policies - ---------------------------- The following discussion of critical accounting policies was condensed for presentation in this Report on Form 10-Q and should be read in conjunction with Management's Discussion and Analysis of Results of Operations and Financial Condition included in our Annual Report on Form 10-K for the fiscal year ended March 31, 2002. Our critical accounting policies are the determination of revenue provisions, useful lives and impairment of intangibles and the impact of existing legal matters. These critical accounting policies affect each of the operating segments. The application of these accounting policies involves the 21 exercise of judgment and the use of assumptions as to future uncertainties and, as a result, actual results could differ materially from these estimates. We are currently not aware of any reasonably likely event or circumstance that would result in different amounts being reported and that would have a material impact on our consolidated financial statements. Revenue Provisions Revenue is recognized for product sales upon shipment when title and risk of loss have transferred to the customer and when provisions for estimates, including discounts, rebates, price adjustments, returns, chargebacks and other promotional adjustments are reasonably determinable. These provisions are recognized as reductions to gross revenues, with the corresponding allowances recognized as reductions to accounts receivable or as components of other current liabilities. Accounts receivable are presented net of such allowances and totaled $259.5 million and $214.6 million at September 30, 2002, and March 31, 2002. Other accrued liabilities include $26.8 million and $21.6 million at September 30, 2002, and March 31, 2002, for certain rebates and other adjustments that are paid to indirect customers. The provision for chargebacks is the most significant and complex estimate used in the recognition of revenue. We are a party to arrangements with other parties establishing prices for products for which they independently select a wholesaler from which to purchase. Such parties are referred to as indirect customers. A chargeback represents the difference between our invoice price to the wholesaler and the indirect customer's contract price. The provision for estimated chargebacks is calculated primarily using historical chargeback experience and estimated wholesaler inventory levels. We continually monitor our assumptions, giving consideration to wholesaler buying patterns and current pricing trends, and make necessary adjustments when we believe that the actual chargeback credits may differ from those estimated. Useful Lives and Impairment of Intangibles As of September 30, 2002, and March 31, 2002, recorded goodwill, net of accumulated amortization, was $103.2 million. In addition to an annual impairment review, goodwill is reviewed for impairment when events or other changes in circumstances may indicate that the carrying amount of the goodwill may not be recoverable. SFAS 142 states that a potential impairment will be identified when the fair value, determined at least annually, of a reporting unit is less than the carrying value of its net assets. The determination of fair value in accordance with SFAS 142 generally requires the evaluation of the reporting unit's projected sales volumes, pricing structure and anticipated cost environment, which includes the reporting unit's product pipeline. During the quarter ended September 30, 2002, we performed this assessment, assisted by an independent valuation specialist, and determined there was no indication of goodwill impairment. If the key assumptions and projections utilized in the fair value 22 determinations, primarily our ability to receive new product approvals from the US Food and Drug Administration (FDA), do not properly reflect future activity, future valuations could be adversely impacted. The result could cause an impairment, which could materially affect our financial position and results of operations. As of September 30, 2002, and March 31, 2002, recorded intangible assets, excluding goodwill, net of accumulated amortization, were $159.8 million and $169.3 million. These intangible assets consist of both purchased and acquired product rights, as well as internally developed patents and technologies. Intangible assets are reviewed for impairment when certain events or other changes in circumstances may indicate that the carrying amount of the asset or asset group may not be recoverable. Impairment is determined when the undiscounted future cash flows, based on estimated sales volume, anticipated pricing and estimated product costs, are less than the carrying value of the intangible asset. If these estimates do not properly reflect future activity, our financial position and results of operations could be negatively impacted. Legal Matters The Company is involved in various legal proceedings, some of which involve claims for substantial amounts. An accrual for a loss contingency relating to any of these legal proceedings is made if it is probable that a liability was incurred at the date of the financial statements and the amount of loss can be reasonably estimated. After review, it was determined, at September 30, 2002, and March 31, 2002, that for each of the various legal proceedings in which we are involved, the conditions mentioned above were not met. However, if any of these legal proceedings would result in an adverse outcome for the Company, the impact could have a material adverse effect on our financial position and results of operations. Risk Factors - ------------ The following risk factors could have a material adverse effect on our business, financial position or results of operations. These risk factors may not include all of the important factors that could affect our business or our industry or that could cause our future financial results to differ materially from historic or expected results or cause the market price of our common stock to fluctuate or decline. Please refer to our other periodic reports filed with the Securities and Exchange Commission, including our Annual Report on Form 10-K for the fiscal year ended March 31, 2002. 23 OUR FUTURE REVENUE GROWTH AND PROFITABILITY ARE DEPENDENT UPON OUR ABILITY TO DEVELOP AND LICENSE OR OTHERWISE ACQUIRE AND INTRODUCE NEW PRODUCTS ON A TIMELY BASIS IN RELATION TO OUR COMPETITOR' PRODUCT INTRODUCTIONS, AND OUR FAILURE TO DO SO SUCCESSFULLY COULD HAVE A MATERIAL ADVERSE EFFECT ON OUR FINANCIAL POSITION AND RESULTS OF OPERATIONS AND COULD CAUSE THE MARKET VALUE OF OUR COMMON STOCK TO DECLINE. Our future revenues and profitability will depend, to a significant extent, upon our ability to successfully develop and license or otherwise acquire and commercialize new generic and patent or statutorily protected (usually brand) pharmaceutical products in a timely manner. Product development is inherently risky, especially for new drugs for which safety and efficacy have not been established and the market is not yet proven. The development process, particularly with regard to new drugs, also requires substantial time, effort and financial resources. We may not be successful in commercializing any of the products that we are developing on a timely basis, if at all, which could adversely affect our product introduction plans, financial position and results of operations and could cause the market value of our common stock to decline. FDA approval is required before any drug product, including generic drug products, can be marketed. The process of obtaining FDA approval to manufacture and market new and generic pharmaceutical products is rigorous, time-consuming, costly and largely unpredictable. We may be unable to obtain requisite FDA approvals on a timely basis for new generic or brand products that we may develop, license or otherwise acquire. The timing and cost of obtaining FDA approvals could adversely affect our product introduction plans, financial position and results of operations and could cause the market value of our common stock to decline. The Abbreviated New Drug Application (ANDA) process, through which we obtain FDA approval for our generic drugs, often results in the FDA granting final approval to a number of ANDAs for a given product at the time a patent claim for a corresponding brand product or other market exclusivity expires. This often forces us to face immediate competition when we introduce a generic product into the market. Additionally, the Waxman-Hatch Act provides for a period of 180 days of generic marketing exclusivity for each ANDA applicant that is first to file an ANDA containing a certification of invalidity, non-infringement or unenforceability related to a patent listed with respect to a reference drug product. A reference drug product refers to a drug product, usually brand, included in the FDA Publication entitled "Approved Drug Products with Therapeutic Equivalence Evaluations" and known in the industry as the "Orange Book." If the patent challenge of the first such ANDA applicant is successful, it generally results in higher market share, net revenues and gross margin for that applicant. Even if we obtain FDA approval for our generic drug products, if we are not the first ANDA applicant to challenge a listed patent for such a product, we may lose significant advantages to a competitor who filed its ANDA containing such a challenge. Such a situation could have a material 24 adverse effect on our ability to market that product profitably, our financial position and results of operations and the market value of our common stock could decline. OUR APPROVED PRODUCTS MAY NOT ACHIEVE EXPECTED LEVELS OF MARKET ACCEPTANCE, WHICH COULD HAVE A MATERIAL ADVERSE EFFECT ON OUR PROFITABILITY, FINANCIAL POSITION AND RESULTS OF OPERATIONS AND COULD CAUSE THE MARKET VALUE OF OUR COMMON STOCK TO DECLINE. Even if we are able to obtain regulatory approvals for our new pharmaceutical products, generic or brand, the success of those products is dependent upon market acceptance. Levels of market acceptance for our new products could be impacted by several factors, including: o the availability of alternative products from our competitors; o the price of our products relative to that of our competitors; o the timing of our market entry; o the ability of our customers to market our products effectively to the retail level; and o the acceptance of our products by government and private formularies. These factors are not within our control. Our new products may not achieve expected levels of market acceptance, which could have a material adverse effect on our profitability, financial position and results of operations and the market value of our common stock could decline. A RELATIVELY SMALL GROUP OF PRODUCTS MAY REPRESENT A SIGNIFICANT PORTION OF OUR NET REVENUES OR NET EARNINGS FROM TIME TO TIME. IF THE VOLUME OR PRICING OF ANY OF THE PRODUCTS DECLINES, IT COULD HAVE A MATERIAL ADVERSE EFFECT ON OUR BUSINESS, FINANCIAL POSITION AND RESULTS OF OPERATIONS AND COULD CAUSE THE MARKET VALUE OF OUR COMMON STOCK TO DECLINE. Sales of a limited number of our products often represent a significant portion of our net revenues and net earnings. If the sales or pricing of our largest selling products decline in the future, our business, financial position and results of operations could be materially adversely affected and the market value of our common stock could decline. WE FACE VIGOROUS COMPETITION FROM OTHER PHARMACEUTICAL MANUFACTURERS THAT THREATENS THE COMMERCIAL ACCEPTANCE AND PRICING OF OUR PRODUCTS, WHICH COULD HAVE A MATERIAL ADVERSE EFFECT ON OUR BUSINESS, FINANCIAL POSITION AND RESULTS OF OPERATIONS AND COULD CAUSE THE MARKET VALUE OF OUR COMMON STOCK TO DECLINE. Our competitors vary depending upon therapeutic and product categories. Our primary competitors include major manufacturers of brand name and generic 25 pharmaceuticals. Our competitors may be able to develop products and processes competitive with or superior to our own for many reasons, including that they may have: o proprietary processes or delivery systems; o larger research and development and marketing staffs; o larger production capabilities in a particular therapeutic area; o more experience in preclinical testing and human clinical trials; o more products; or o more experience in developing new drugs and financial resources, particularly with regards to brand manufacturers. Each of these factors and others could have a material adverse effect on our business, financial position and results of operations and could cause the market value of our common stock to decline. BECAUSE THE PHARMACEUTICAL INDUSTRY IS HEAVILY REGULATED, WE FACE SIGNIFICANT COSTS AND UNCERTAINTIES ASSOCIATED WITH OUR EFFORTS TO COMPLY WITH APPLICABLE REGULATIONS, AND SHOULD WE FAIL TO COMPLY WE COULD EXPERIENCE MATERIAL ADVERSE EFFECTS ON OUR BUSINESS, FINANCIAL POSITION AND RESULTS OF OPERATIONS AND THE MARKET VALUE OF OUR COMMON STOCK COULD DECLINE. The pharmaceutical industry is subject to regulation by various federal and state governmental authorities. For instance, we must comply with FDA requirements with respect to the manufacture, labeling, sale, distribution, marketing, advertising, promotion and development of pharmaceutical products. Failure to comply with FDA and other governmental regulations can result in fines, disgorgement, unanticipated compliance expenditures, recall or seizure of products, total or partial suspension of production and/or distribution, suspension of FDA's review of New Drug Applications (NDAs), which are filed for products with active ingredients or combinations of such ingredients not previously approved by the FDA, or ANDAs, enforcement actions, injunctions and criminal prosecution. Under certain circumstances, the FDA also has the authority to revoke previously granted drug approvals. Although we have internal regulatory compliance programs and policies and have had a favorable compliance history, if these programs were not to meet regulatory agency standards in the future or if our compliance were deemed deficient in any significant way, it could have a material adverse effect on our business, financial position and results of operations and could cause the market value of our common stock to decline. In addition to the new drug approval process, the FDA also regulates the facilities and operational procedures that we use to manufacture our products. We must register our facilities with the FDA. All products manufactured in those facilities must be made in a manner consistent with "current good manufacturing practices." Failure to do so could result in an enforcement action brought by the FDA, which periodically inspects our manufacturing facilities for compliance. FDA approval to manufacture a drug is site-specific. If the FDA would cause one of our manufacturing facilities to cease or limit production, 26 our business could be adversely affected. Delay and cost in obtaining FDA approval to manufacture at a different facility also could have a material adverse effect on our business, financial position and results of operations and could cause the market value of our common stock to decline. We also are subject to various other federal, state and local environmental protection laws and regulations, including those governing the discharge of materials into the environment. Although we have not incurred significant costs associated with complying with such environmental provisions in the past, if changes to such environmental provisions are made in the future that require significant changes in our operations or if we engage in the development and manufacturing of new products requiring new or different environmental controls, we may be required to expend significant funds. Such changes could have a material adverse effect on our business, financial position and results of operations and could cause the market value of our common stock to decline. WE EXPEND A SIGNIFICANT AMOUNT OF RESOURCES ON RESEARCH AND DEVELOPMENT EFFORTS THAT MAY NOT LEAD TO SUCCESSFUL PRODUCT INTRODUCTIONS.FAILURE TO SUCCESSFULLY INTRODUCE PRODUCTS INTO THE MARKET COULD HAVE A MATERIAL ADVERSE EFFECT ON OUR BUSINESS, FINANCIAL POSITION AND RESULTS OF OPERATIONS AND THE MARKET VALUE OF OUR COMMON STOCK COULD DECLINE. Much of our development effort is focused on technically difficult-to-formulate products and/or products that require advanced manufacturing technology. Research and development efforts are conducted primarily to enable us to manufacture and market FDA-approved pharmaceuticals in accordance with FDA regulations. Typically, research expenses related to the development of innovative compounds and the filing of NDAs are significantly greater than those expenses associated with ANDAs. As we continue to develop new products, our research expenses will likely increase. Because of the inherent risk associated with research and development efforts in our industry, particularly with respect to new drugs, our research and development expenditures may not result in the successful introduction of FDA approved new pharmaceutical products. Also, after submission, the FDA may request additional studies be conducted, and as a result, we may be unable to reasonably determine the total research and development costs to develop a particular product. To the extent that we expend significant resources on research and development efforts and are not able ultimately to introduce successful new products as a result of those efforts, our business, financial position and results of operations may be materially adversely affected and the market value of our common stock could decline. 27 A SIGNIFICANT PORTION OF OUR NET REVENUES ARE DERIVED FROM SALES TO A LIMITED NUMBER OF CUSTOMERS. ANY SIGNIFICANT REDUCTION OF BUSINESS WITH ANY OF THESE CUSTOMERS COULD HAVE A MATERIAL ADVERSE EFFECT ON OUR BUSINESS, FINANCIAL POSITION AND RESULTS OF OPERATIONS AND THE MARKET VALUE OF OUR COMMON STOCK COULD DECLINE. A significant portion of our net revenues are derived from sales to a limited number of customers. If we were to lose the business of, or experience a significant reduction in business with, any of these or our other major customers, or if any of them were to experience difficulty in paying us on a timely basis, our business, financial position and results of operations could be materially adversely affected and the market value of our common stock could decline. THE USE OF LEGAL, REGULATORY AND LEGISLATIVE STRATEGIES BY COMPETITORS, BOTH BRAND AND GENERIC, MAY INCREASE OUR COSTS ASSOCIATED WITH THE INTRODUCTION OR MARKETING OF OUR GENERIC PRODUCTS OR COULD DELAY OR PREVENT SUCH INTRODUCTION. THESE FACTORS COULD HAVE A MATERIAL ADVERSE EFFECT ON OUR BUSINESS, FINANCIAL POSITION AND RESULTS OF OPERATIONS AND COULD CAUSE THE MARKET VALUE OF OUR COMMON STOCK TO DECLINE. Our competitors often pursue strategies to prevent or delay competition from generic alternatives to brand products. These strategies include, but are not limited to: o seeking to establish regulatory and legal obstacles that would make it more difficult to demonstrate bioequivalence; o initiating legislative efforts in various states to limit the substitution of generic versions of brand pharmaceuticals; o filing suits for patent infringement that automatically delays FDA approval of many generic products; o introducing "second generation" products prior to the expiration of market exclusivity for the reference product, which often materially reduces the demand for the first generic product for which we seek FDA approval; o obtaining extensions of market exclusivity by conducting trials of brand drugs in pediatric populations; o persuading the FDA to withdraw the approval of brand name drugs, for which the patents are about to expire, thus allowing the brand name company to obtain new patented products serving as substitutes for the products withdrawn; o seeking to obtain new patents on drugs for which patent protection is about to expire; and o filing a citizen petition with the FDA, which often results in delays of our approvals. 28 Some companies have lobbied Congress for amendments to the Waxman-Hatch legislation that would give them additional advantages over generic competitors. For example, although the term of a company's drug patent can be extended to reflect a portion of the time an NDA is under regulatory review, some companies have proposed extending the patent term by a full year for each year spent in clinical trials, rather than the one-half year that is currently permitted. If proposals like these become effective, our entry into the market and our ability to generate revenues associated with these products may be delayed, which could have a material adverse effect on our business, financial position and results of operations and could cause the market value of our common stock to decline. THE USE OF LEGAL, REGULATORY AND LEGISLATIVE STRATEGIES BY COMPETITORS, BOTH BRAND AND GENERIC, MAY INCREASE OUR COSTS ASSOCIATED WITH THE INTRODUCTION OR MARKETING OF OUR GENERIC PRODUCTS OR COULD DELAY OR PREVENT SUCH INTRODUCTION. THESE FACTORS COULD HAVE A MATERIAL ADVERSE EFFECT ON OUR BUSINESS, FINANCIAL POSITION AND RESULTS OF OPERATIONS AND COULD CAUSE THE MARKET VALUE OF OUR COMMON STOCK TO DECLINE. The active ingredient(s), i.e., the chemical compound(s) which produces the desired therapeutic effect, and other materials and supplies that we use in our pharmaceutical manufacturing operations are generally available and purchased from many different foreign and domestic suppliers. In some cases, however, we have listed only one supplier in our applications with the FDA. Although we maintain safety stocks in inventory, and in some cases have received FDA approval to use alternative suppliers should the need arise, a prolonged interruption in the supply of a single-sourced active ingredient could cause our financial position and results of operations to be materially adversely affected and the market value of our common stock could decline. In addition, if any of our suppliers interrupt the supply of products that we use or experience quality deficiencies in products that they supply to us for a prolonged period, it could have a material adverse effect on our business, financial position and results of operations, and the market value of our common stock could decline. WE USE SEVERAL MANUFACTURING FACILITIES TO MANUFACTURE OUR PRODUCTS. HOWEVER, A SIGNIFICANT NUMBER OF OUR GENERIC PRODUCTS ARE PRODUCED AT ONE LOCATION. PRODUCTION AT THE FACILITY COULD BE INTERRUPTED, WHICH COULD HAVE A MATERIAL ADVERSE EFFECT ON OUR BUSINESS, FINANCIAL POSITION AND RESULTS OF OPERATIONS AND COULD CAUSE THE MARKET VALUE OF OUR COMMON STOCK TO DECLINE. Although we have other facilities, a significant amount of our generic products are produced at our largest manufacturing facility. A significant disruption at that facility, even on a short-term basis, could impair our ability to produce and ship products to the market on a timely basis, which could have a material adverse effect on our business, financial position and 29 results of operations and could cause the market value of our common stock to decline. WE MAY EXPERIENCE DECLINES IN THE SALES AND PRICES OF OUR PRODUCTS AS THE RESULT OF THE CONTINUING TREND TOWARD CONSOLIDATION OF CERTAIN CUSTOMER GROUPS SUCH AS THE WHOLESALE DRUG DISTRIBUTION AND RETAIL PHARMACY INDUSTRIES AND THE EMERGENCE OF LARGE BUYING GROUPS. ANY SUCH DECLINES COULD HAVE A MATERIAL ADVERSE EFFECT ON OUR BUSINESS, FINANCIAL POSITION AND RESULTS OF OPERATIONS AND COULD CAUSE THE MARKET VALUE OF OUR COMMON STOCK TO DECLINE. Drug wholesalers and retail drug chains have undergone, and are continuing to undergo, significant consolidation. This consolidation may result in these groups gaining additional purchasing leverage and consequently increasing the product pricing pressures facing our business. The emergence of large buying groups representing independent retail pharmacies and the prevalence and influence of managed care organizations and similar institutions potentially enable those groups to attempt to extract price discounts on our products. The result of these developments may have a material adverse effect on our business, financial position and results of operations and could cause the market value of our common stock to decline. WE MAY BE UNABLE TO PROTECT OUR INTELLECTUAL AND OTHER PROPRIETARY PROPERTY IN AN EFFECTIVE MANNER, WHICH COULD HAVE A MATERIAL ADVERSE EFFECT ON OUR BUSINESS, FINANCIAL POSITION AND RESULTS OF OPERATIONS AND COULD CAUSE THE MARKET VALUE OF OUR COMMON STOCK TO DECLINE. We own or license a number of patents in the US and in foreign countries covering certain products. We consider the overall protection of our patents, trademarks and license rights to be of material value and will act appropriately to prevent these rights from being infringed. Our patents on our brand products may not prevent other companies from developing functionally equivalent products or from challenging the validity or enforceability of our patents. If our patents are found to be non-infringed, invalid or not enforceable we could experience an adverse affect on our ability to commercially promote patented products. We could be required to enforce our patent or other intellectual property rights through litigation, which can be protracted and involve significant expense and an inherently uncertain outcome. Any negative outcome could have a material adverse effect on our business, financial position and results of operations and could cause the market value of our common stock to decline. 30 OUR COMPETITORS MAY ALLEGE THAT WE ARE INFRINGING THEIR INTELLECTUAL PROPERTY, FORCING US TO EXPEND SUBSTANTIAL RESOURCES IN RESULTING LITIGATION, THE OUTCOME OF WHICH IS UNCERTAIN. ANY UNFAVORABLE OUTCOME OF SUCH LITIGATION COULD HAVE A MATERIAL ADVERSE EFFECT ON OUR BUSINESS, FINANCIAL POSITION AND RESULTS OF OPERATIONS AND COULD CAUSE THE MARKET VALUE OF OUR COMMON STOCK TO DECLINE. Companies that produce brand pharmaceutical products routinely bring litigation against ANDA applicants who seek FDA approval to manufacture and market generic forms of their branded products. These companies allege patent infringement or other violations of intellectual property rights as the basis for filing suit against an ANDA applicant. Litigation often involves significant expense, or can delay or prevent introduction of our generic products. There may also be situations where the Company uses its business judgement and decides to market and sell products, notwithstanding the fact that allegations of patent infringement(s) by our competitors have not been finally resolved by the courts. An adverse decision in a case such as this or in other similar litigation could have a material adverse effect on our business, financial position and results of operations and could cause the market value of our common stock to decline. WE MAY EXPERIENCE REDUCTIONS IN THE LEVELS OF REIMBURSEMENT FOR PHARMACEUTICAL PRODUCTS BY GOVERNMENTAL AUTHORITIES, HMOS OR OTHER THIRD-PARTY PAYERS. ANY SUCH REDUCTIONS COULD HAVE A MATERIAL ADVERSE EFFECT ON OUR BUSINESS, FINANCIAL POSITION AND RESULTS OF OPERATIONS AND COULD CAUSE THE MARKET VALUE OF OUR COMMON STOCK TO DECLINE. Various governmental authorities and private health insurers and other organizations, such as HMOs, provide reimbursement to consumers for the cost of certain pharmaceutical products. Demand for our products depends in part on the extent to which such reimbursement is available. Third-party payers increasingly challenge the pricing of pharmaceutical products. This trend and other trends toward the growth of HMOs, managed healthcare and legislative healthcare reform create significant uncertainties regarding the future levels of reimbursement for pharmaceutical products. Further, any reimbursement may be reduced in the future, perhaps to the point that market demand for our products declines. Such a decline could have a material adverse effect on our business, financial position and results of operations and could cause the market value of our common stock to decline. WE ARE INVOLVED IN VARIOUS LEGAL PROCEEDINGS AND MAY EXPERIENCE UNFAVORABLE OUTCOMES OF SUCH PROCEEDINGS, WHICH COULD HAVE A MATERIAL ADVERSE EFFECT ON OUR BUSINESS, FINANCIAL POSITION AND RESULTS OF OPERATIONS AND COULD CAUSE THE MARKET VALUE OF OUR COMMON STOCK TO DECLINE. We are involved in various legal proceedings including, but not limited to, product liability, breach of contract and claims involving Medicaid and Medicare 31 reimbursements, some of which are described in our periodic reports and involve claims for substantial amounts of money or for other relief. If any of these legal proceedings were to result in an adverse outcome, the impact could have a material adverse effect on our business, financial position and results of operations and could cause the market value of our common stock to decline. OUR ACQUISITION STRATEGIES INVOLVE A NUMBER OF INHERENT RISKS. THESE RISKS COULD CAUSE A MATERIAL ADVERSE EFFECT ON OUR BUSINESS, FINANCIAL POSITION AND RESULTS OF OPERATIONS AND COULD CAUSE A DECLINE IN THE MARKET VALUE OF OUR COMMON STOCK. We continually seek to expand our product line through complementary or strategic acquisitions of other companies, products and assets, through joint ventures, licensing agreements or other arrangements. Acquisitions, joint ventures and other business combinations involve various inherent risks, such as assessing accurately the values, strengths, weaknesses, contingent and other liabilities, regulatory compliance and potential profitability of acquisition or other transaction candidates. Other inherent risks include the potential loss of key personnel of an acquired business, our inability to achieve identified financial and operating synergies anticipated to result from an acquisition or other transaction and unanticipated changes in business and economic conditions affecting an acquisition or other transaction. International acquisitions and other transactions could also be affected by export controls, exchange rate fluctuations, domestic and foreign political conditions and the deterioration in domestic and foreign economic conditions. We may be unable to realize synergies or other benefits expected to result from acquisitions, joint ventures and other transactions or investments we may undertake, or be unable to generate additional revenue to offset any unanticipated inability to realize these expected synergies or benefits. Realization of the anticipated benefits of acquisitions or other transactions could take longer than expected, and implementation difficulties, market factors and the deterioration in domestic and global economic conditions could alter the anticipated benefits of any such transactions. These factors could cause a material adverse effect on our business, financial position and results of operations and could cause a decline in the market value of our common stock. OUR FUTURE SUCCESS IS HIGHLY DEPENDENT ON OUR CONTINUED ABILITY TO ATTRACT AND RETAIN KEY PERSONNEL. ANY FAILURE TO ATTRACT AND RETAIN KEY PERSONNEL COULD HAVE A MATERIAL ADVERSE EFFECT ON OUR BUSINESS, FINANCIAL POSITION AND RESULTS OF OPERATIONS AND COULD CAUSE THE MARKET VALUE OF OUR COMMON STOCK TO DECLINE. Because our success is largely dependent on the scientific nature of our business, it is imperative that we attract and retain qualified personnel in order to develop new products and compete effectively. If we fail to attract and 32 retain key scientific, technical or management personnel, our business could be affected adversely. While we have employment agreements with certain key employees, we may not succeed in retaining all of these persons, which could have a material adverse effect on our business, financial position and results of operations and could cause the market value of our common stock to decline. WE MAY MAINTAIN INVESTMENTS IN MARKETABLE DEBT AND/OR EQUITY SECURITIES, OTHER INVESTMENTS, BOTH PUBLICLY AND PRIVATELY HELD, AND MAY MAINTAIN DEPOSIT BALANCES AT BANKS IN EXCESS OF FEDERALLY INSURED AMOUNTS. WE MAY EXPERIENCE DECLINES IN THE MARKET VALUE OF THESE SECURITIES, AND/OR LOSSES OF PRINCIPAL INVESTED OR AN UNINSURED LOSS OF DEPOSITED FUNDS. SIGNIFICANT DECLINES OR LOSSES COULD HAVE A MATERIAL ADVERSE EFFECT ON OUR BUSINESS, FINANCIAL POSITION AND RESULTS OF OPERATIONS AND COULD CAUSE THE MARKET VALUE OF OUR COMMON STOCK TO DECLINE. To the extent that we maintain investments in marketable debt securities, marketable equity securities, and/or investments in other securities, both publicly and privately held, we are subject to many risks. Such risks include market risk associated with declines in the market values of such securities, interest rate risk and the risk of default. As a result of such risks, we could experience a substantial loss, or may even lose all, of the basis or principal we have invested in such securities. Any such declines or losses could have a material adverse effect on our business, financial position and results of operations and could cause the market value of our common stock to decline. THERE ARE INHERENT UNCERTAINTIES INVOLVED IN ESTIMATES, JUDGMENTS AND ASSUMPTIONS USED IN THE PREPARATION OF FINANCIAL STATEMENTS IN ACCORDANCE WITH GAAP. ANY CHANGES IN ESTIMATES, JUDGMENTS AND ASSUMPTIONS USED COULD HAVE A MATERIAL ADVERSE EFFECT ON OUR BUSINESS, FINANCIAL POSITION AND RESULTS OF OPERATIONS AND COULD CAUSE THE MARKET VALUE OF OUR COMMON STOCK TO DECLINE. The consolidated and condensed consolidated financial statements included in the periodic reports we file with the Securities and Exchange Commission are prepared in accordance with generally accepted accounting principles in the United States of America, or GAAP. The preparation of financial statements in accordance with GAAP involves making estimates, judgments and assumptions that affect reported amounts of assets (including intangible assets), liabilities, revenues, expenses and income. This includes, but is not limited to, estimates, judgments and assumptions used in the adoption of the provisions of SFAS 142, Goodwill and Other Intangible Assets and SFAS 144, Accounting for the Impairment or Disposal of Long-Lived Assets. Estimates, judgments and assumptions are inherently subject to change in the future, and any such changes could result in corresponding changes to the amounts of assets (including goodwill and other intangible assets), liabilities, revenues, expenses and income. Any such changes 33 could have a material adverse effect on our financial position and results of operations and could cause the market value of our common stock to decline. Forward-Looking Statements - -------------------------- This Report on Form 10-Q may contain "forward-looking statements." Such forward-looking statements may include, without limitation, statements about our market opportunities, strategies, competition and expected activities and expenditures. These statements can be identified by the use of words such as "may," "will," "could," "should," "would," "project," "believe," "anticipate," "expect," "plan," "estimate," "forecast," "potential," "intend," "continue" and variations of these words or comparable words. We believe that it is important to communicate our future expectations to our investors. However, there may be events in the future that we are not able to accurately predict or control and that may cause our actual results to differ materially from the expectations expressed or implied by these forward-looking statements. Investors are cautioned that all forward-looking statements involve risks and uncertainties, and actual results may differ materially from those discussed as a result of various factors, including, but not limited to, those factors described in this Report on Form 10-Q, as well as in other documents that we filed with the Securities and Exchange Commission. We undertake no obligation to update any forward-looking statements. ITEM 3. QUANTITATIVE AND QUALITATIVE DISCLOSURES ABOUT MARKET RISK We are subject to market risk primarily from changes in the market values of investments in marketable debt and equity securities, including marketable securities owned indirectly through certain pooled asset funds that are classified as other assets on our balance sheet. Additional investments are made in overnight deposits, money market funds and marketable securities with maturities of less than three months. These instruments are classified as cash equivalents for financial reporting purposes and have minimal or no interest rate risk due to their short-term nature. The majority of our investments are managed by professional portfolio managers. The following table summarizes the investments which subject the Company to market risk: September 30, March 31, (in thousands) 2002 2002 ---- ---- Debt securities $ 440,368 $ 435,499 Equity securities 27,172 20,767 Pooled asset funds 11,224 26,144 --------- --------- $ 478,764 $ 482,410 ========= ========= 34 Pooled Asset Funds Pooled asset funds consist of investments in limited liability partnerships. The assets of these funds are typically actively traded and are exposed to market fluctuations. During the quarter ended September 30, 2002, we received a distribution of $11.6 million from a certain fund in the form of common shares of a publicly traded company. These shares are classified as marketable equity securities. Unlike investments in marketable debt and equity securities, the changes in the market values of these investments are recognized as other income or loss in the Consolidated Statements of Earnings. A 20% change in the market value of the pooled asset funds would result in a $2.2 million change in other assets and a corresponding change to other income or expense. ITEM 4. CONTROLS AND PROCEDURES Our disclosure controls and procedures are designed to ensure that information required to be disclosed in this Report on Form 10-Q is recorded, processed, summarized and reported within the time period specified. Our management, including the Chief Executive Officer and Chief Financial Officer, has evaluated the effectiveness of our disclosure controls and procedures (as defined in Rule 13a-14(c) under the Securities Exchange Act) within ninety days prior to the filing of this Report and has concluded that such disclosure controls and procedures are effective. There were no significant changes in our internal controls or in other factors that could significantly affect these controls subsequent to the last day they were evaluated by management, including our Chief Executive Officer and Chief Financial Officer. PART II. OTHER INFORMATION - -------------------------- ITEM 1. LEGAL PROCEEDINGS Product Litigation While it is not possible to determine with any degree of certainty the ultimate outcome of the following legal proceedings, we believe that we have meritorious defenses with respect to the claims asserted against the Company, and we intend to vigorously defend our position. AN ADVERSE OUTCOME IN ANY OF THESE PROCEEDINGS COULD HAVE A MATERIAL ADVERSE EFFECT ON OUR FINANCIAL POSITION AND RESULTS OF OPERATIONS. 35 Paclitaxel In June 2001, NAPRO Biotherapeutics Inc. (NAPRO) and Abbott Laboratories Inc. (Abbott) filed suit against the Company in the United States (US) District Court for the Western District of Pennsylvania. Plaintiffs allege that the Company's manufacture, use, and sale of its paclitaxel product infringes certain patents owned by NAPRO and allegedly licensed to Abbott. Plaintiffs seek unspecified damages plus interest, a finding of willful infringement which could result in treble damages, injunctive relief, attorneys' fees, costs of litigation, and such equitable and other relief as the court deems just and proper. The Company began selling its paclitaxel product in July 2001. Verapamil ER In July 2001, Biovail Laboratories Inc. (Biovail) filed a demand for arbitration against the Company with the American Arbitration Association. In response to such demand, the Company filed its answer and counterclaims. The dispute relates to a supply agreement under which the Company supplied extended-release verapamil to Biovail. The Company terminated the agreement in March 2001. Biovail's allegations include breach of contract, breach of implied covenant of good faith and fair dealing and unfair competition. Biovail is seeking damages plus interest, to be determined at trial, but in an amount of not less than $10.0 million, plus unspecified punitive damages, attorneys' fees and costs of litigation and such other relief as the panel may deem just and proper. The Company's allegations as set forth in its counterclaims include breach of obligations of good faith and fair dealing, fraud and unjust enrichment. Zagam(R) The Company filed suit against Aventis Pharmaceuticals, Inc., successor in interest to Rhone-Poulenc Rorer Pharmaceuticals, Inc.; Rhone-Poulenc Rorer Pharmaceuticals, LTD.; Rorer Pharmaceutical Products, Inc.; Rhone-Poulenc Rorer, S.A., and their affiliates in the US Federal District Court for the Western District of Pennsylvania in May 2001. The complaint sets forth claims of breach of contract, rescission, breach of implied covenant of good faith and fair dealing and unjust enrichment. The defendants' answer includes a counterclaim, which alleges nonpayment of royalties and failure to mitigate. The defendants are seeking royalties allegedly owed by the Company, attorneys' fees and costs of litigation and such other relief as may be demonstrated at trial. Nifedipine In February 2001, Biovail filed suit against the Company and Pfizer Inc. (Pfizer) in the US District Court for the Eastern District of Virginia alleging 36 antitrust violations with respect to agreements entered into between the Company and Pfizer regarding nifedipine. The Company filed a motion to transfer the case to the US District Court for the Northern District of West Virginia, which was granted. The Company's motion to dismiss Biovail's complaint was denied. The Company has been named as a defendant in five other putative class action suits alleging antitrust claims based on the settlement entered into by the Company with Pfizer regarding nifedipine. Two of the class actions have been dismissed in their entirety and the remaining actions have been dismissed in part. The plaintiffs in the remaining actions, as well as Biovail, are seeking unspecified compensatory and treble damages, attorneys' fees, costs of litigation, restitution, disgorgement and declaratory and injunctive relief. Buspirone The Company filed an ANDA seeking approval to market buspirone, a generic equivalent to Bristol-Myers Squibb's (BMS) BuSpar(R). The Company filed the appropriate certifications relating to the patents for this product that were then listed in the US Food and Drug Administration (FDA) publication entitled Approved Drug Products with Therapeutic Equivalence Evaluations, popularly known as the "Orange Book." In November 2000, a new patent claiming the administration of a metabolite of buspirone (which BMS claims also covers the administration of buspirone itself) was issued to BMS. The subsequent listing of this patent in the Orange Book prevented the FDA from granting final approval for the Company's buspirone ANDA. In November 2000, the Company filed suit against the FDA and BMS in the US District Court for the District of Columbia. The complaint asked the court to order the FDA to immediately grant final approval of the Company's ANDA for the 15mg buspirone product and require BMS to request withdrawal of the patent from the Orange Book. Upon the Company's posting of a bond in the amount of $25.0 million, the court entered an order granting the Company's motion for a preliminary injunction. Following a brief stay by the US Court of Appeals for the Federal Circuit (Federal Circuit), the FDA granted approval of the Company's ANDA with respect to the 15mg strength. Upon receiving FDA approval, the Company began marketing and selling the 15mg tablet in March 2001. The Company has also been selling the 30mg tablet since August 2001 and the 5mg and 10mg tablets since March 2002. BMS appealed the preliminary injunction order to both the Federal Circuit and the US Court of Appeals for the District of Columbia Circuit. The District of Columbia Court of Appeals denied BMS' application and stayed the Company's motion to dismiss pending the decision of the Federal Circuit. In October 2001, the Federal Circuit overturned the lower court ruling and held that the Company did not have a cognizable claim against BMS under the Declaratory Judgment Act to challenge the listing of BMS' patent, which the Federal Circuit viewed as an improper effort to enforce the Federal Food, Drug and Cosmetic Act. The Federal Circuit did not address the lower court's determination that the BMS patent does not claim buspirone or a method of 37 administration of the drug. The Company filed a petition with the Federal Circuit asking that the court reconsider its holding. The petition was denied in January 2002. A petition for review by the US Supreme Court was denied in October 2002. In January 2002, the Company filed a motion in the US District Court for the District of Columbia seeking a preliminary injunction which, if granted, would require that the FDA refuse to list the BMS patent should BMS submit it for re-listing in the Orange Book. The District of Columbia Court has entered an order staying further proceedings in this case pending appeal of the order entered in the US District Court for the Southern District of New York granting the Company's motion for summary judgment of non-infringement. The Company is involved in three other suits related to buspirone. In November 2000, the Company filed suit against BMS in the US District Court for the Northern District of West Virginia. The suit seeks a declaratory judgment of non-infringement and/or invalidity of the BMS patent listed in November 2000. In January 2001, BMS sued the Company for patent infringement in the US District Court for the District of Vermont and also in the US District Court for the Southern District of New York. In each of these cases, BMS asserts that the Company infringes BMS' patent and seeks to rescind approval of the Company's ANDA. BMS seeks to recover damages equal to lost profits plus interest, a finding of willful infringement which could result in treble damages, injunctive relief, attorneys' fees, costs of litigation, and such other relief as the court deems just and proper. The Company subsequently filed motions to dismiss the Vermont case and dismiss and transfer the New York case to the US District Court for the Northern District of West Virginia. The Judicial Panel on Multi-District Litigation ordered these cases, along with another patent case and numerous antitrust suits filed against BMS, be consolidated for pre-trial purposes in the US District Court for the Southern District of New York. The New York Court has granted the Company's motion for summary judgment that the BMS patent is not infringed or, alternatively, is invalid. BMS has appealed this decision to the Court of Appeals for the Federal Circuit. The New York Court also denied the BMS motion to dismiss the Company's antitrust counterclaims. Lorazepam and Clorazepate In January 1999, four companies who claim to have purchased lorazepam and/or clorazepate from the Company filed suit alleging that the Company engaged in restraint of trade, monopolization, attempted monopolization and conspiracy to monopolize arising out of certain agreements involving the supply of raw materials used to manufacture those two products. In July 2001, the US Court for the District of Columbia certified a litigation class consisting of direct purchasers. The plaintiffs seek to recover treble damages equal to three times 38 the overcharge they claim to have paid, plus injunctive relief, attorneys' fees, costs of litigation and such other relief as the court deems proper. In December 2001, four third-party reimbursers filed separate actions against the Company. These actions are pending in the US District Court for the District of Columbia. The Company is also defending a civil action in the State of California that was brought under state law on behalf of independent retail pharmacies who purchased lorazepam and/or clorazepate. The California action has not been certified as a class action. The plaintiffs in each of these actions seek unspecified monetary damages, equitable relief, attorneys' fees and costs of litigation. Average Wholesale Price Litigation The Company, along with a number of other pharmaceutical manufacturers, has been named as a defendant in four lawsuits filed in the state courts of California in which the plaintiffs allege the defendants unlawfully, unfairly and fraudulently manipulated the reported average wholesale price of various products, allegedly to increase third party reimbursements to others for their products. None of these four cases has been certified as a class action, although all four cases seek class action and representative status. Plaintiffs seek equitable relief in the form of disgorgement and restitution, attorneys' fees and costs of litigation. While it is not possible to determine with any degree of certainty the ultimate outcome of these suits, we believe that we have meritorious defenses with respect to the claims asserted against the Company, and we intend to vigorously defend our position. AN ADVERSE OUTCOME IN ANY OF THESE SUITS COULD HAVE A MATERIAL ADVERSE EFFECT ON OUR FINANCIAL POSITION AND RESULTS OF OPERATIONS. Other Litigation The Company is involved in various other legal proceedings that are considered normal to its business. While it is not feasible to predict the ultimate outcome of such other proceedings, we believe that the ultimate outcome of such other proceedings will not have a material adverse effect on our results of operations or financial position. 39 ITEM 4. SUBMISSION OF MATTERS TO A VOTE OF SECURITY HOLDERS The following provides a summary of votes cast for the proposals on which our shareholders voted at our Annual Meeting of Shareholders held on July 26, 2002. Proposal No. 1 - Election of Eleven Directors. Nominee For Withheld ------- --- -------- Milan Puskar 106,711,820 3,730,913 Robert J. Coury 106,852,059 3,590,674 Wendy Cameron 107,097,191 3,345,542 Leslie B. Daniels(1) 106,592,768 3,849,965 Laurence S. DeLynn 106,393,165 4,049,568 John C. Gaisford, M.D. 106,462,193 3,980,540 Douglas J. Leech 106,247,714 4,195,019 Patricia A. Sunseri 106,833,630 3,609,103 C.B. Todd 106,834,762 3,607,971 Randall L. Vanderveen, Ph.D. 107,119,522 3,323,211 Stuart A. Williams, Esq. 106,444,594 3,998,139 (1) Resigned effective September 1, 2002. Proposal No. 2 - Approval of proposed amendment and restatement of the Mylan Laboratories Inc. 1997 Incentive Stock Option Plan. For Against Abstain --- ------- ------- 102,097,178 7,783,463 562,079 Proposal No. 3 - Approval of the appointment of Deloitte & Touche LLP as independent auditors. For Against --- ------- 104,483,610 5,485,278 ITEM 6. EXHIBITS AND REPORTS ON FORM 8-K a. Exhibits 3.1 Amended and Restated Articles of Incorporation of the registrant, filed as Exhibit 4.2 to the Form S-8 on December 23, 1997, (registration number 333-43081) and incorporated herein by reference. 40 3.2 By-laws of the registrant, as amended to date, filed herewith. 10.1 Mylan Laboratories Inc. 1997 Incentive Stock Option Plan, as amended to date, filed herewith. b. Reports on Form 8-K On July 22, 2002, we filed a Report on Form 8-K announcing changes in senior management. SIGNATURES Pursuant to the requirements of the Securities Exchange Act of 1934, the registrant has duly caused this Report on Form 10-Q for the quarterly period ended September 30, 2002, to be signed on its behalf by the undersigned thereunto duly authorized as of November 14, 2002. Mylan Laboratories Inc. (Registrant) /s/ Robert J. Coury ------------------------------ Robert J. Coury Vice-Chairman of the Board and Chief Executive Officer (Principal executive officer) /s/ Edward J. Borkowski ------------------------------- Edward J. Borkowski Chief Financial Officer (Principal financial officer) /s/ Gary E. Sphar ------------------------------- Gary E. Sphar Vice President, Corporate Controller (Principal accounting officer) 41 Sarbanes-Oxley Section 302 Certification I, Robert J. Coury, certify that: 1. I have reviewed this quarterly report on Form 10-Q of Mylan Laboratories Inc.; 2. Based on my knowledge, this quarterly report does not contain any untrue statement of a material fact or omit to state a material fact necessary to make the statements made, in light of the circumstances under which such statements were made, not misleading with respect to the period covered by this quarterly report; 3. Based on my knowledge, the financial statements, and other financial information included in this quarterly report, fairly present in all material respects the financial condition, results of operations and cash flows of the registrant as of, and for, the period[s] presented in this quarterly report; 4. The registrant's other certifying officers and I are responsible for establishing and maintaining disclosure controls and procedures (as defined in Exchange Act Rules 13a-14 and 15d-14) for the registrant and we have: a) designed such disclosure controls and procedures to ensure that material information relating to the registrant, including its consolidated subsidiaries, is made known to us by others within those entities, particularly during the period in which this quarterly report is being prepared; b) evaluated the effectiveness of the registrant's disclosure controls and procedures as of a date within 90 days prior to the filing date of this quarterly report (the "Evaluation Date"); and c) presented in this quarterly report our conclusions about the effectiveness of the disclosure controls and procedures based on our evaluation as of the Evaluation Date; 5. The registrant's other certifying officers and I have disclosed, based on our most recent evaluation, to the registrant's auditors and the audit committee of registrant's board of directors (or persons performing the equivalent function): a) all significant deficiencies in the design or operation of internal controls which could adversely affect the registrant's ability to record, process, summarize and report financial data and have identified for the registrant's auditors any material weaknesses in internal controls; and b) any fraud, whether or not material, that involves management or other employees who have a significant role in the registrant's internal controls; and 6. The registrant's other certifying officers and I have indicated in this quarterly report whether or not there were significant changes in internal controls or in other factors that could significantly affect internal controls subsequent to the date of our most recent evaluation, including any corrective actions with regard to significant deficiencies and material weaknesses. Date: November 14, 2002 /s/ Robert J. Coury ------------------------ Robert J. Coury Chief Executive Officer, Mylan Laboratories Inc. Sarbanes-Oxley Section 302 Certification I, Edward J. Borkowski, certify that: 1. I have reviewed this quarterly report on Form 10-Q of Mylan Laboratories Inc.; 2. Based on my knowledge, this quarterly report does not contain any untrue statement of a material fact or omit to state a material fact necessary to make the statements made, in light of the circumstances under which such statements were made, not misleading with respect to the period covered by this quarterly report; 3. Based on my knowledge, the financial statements, and other financial information included in this quarterly report, fairly present in all material respects the financial condition, results of operations and cash flows of the registrant as of, and for, the period[s] presented in this quarterly report; 4. The registrant's other certifying officers and I are responsible for establishing and maintaining disclosure controls and procedures (as defined in Exchange Act Rules 13a-14 and 15d-14) for the registrant and we have: a) designed such disclosure controls and procedures to ensure that material information relating to the registrant, including its consolidated subsidiaries, is made known to us by others within those entities, particularly during the period in which this quarterly report is being prepared; b) evaluated the effectiveness of the registrant's disclosure controls and procedures as of a date within 90 days prior to the filing date of this quarterly report (the "Evaluation Date"); and c) presented in this quarterly report our conclusions about the effectiveness of the disclosure controls and procedures based on our evaluation as of the Evaluation Date; 5. The registrant's other certifying officers and I have disclosed, based on our most recent evaluation, to the registrant's auditors and the audit committee of registrant's board of directors (or persons performing the equivalent function): a) all significant deficiencies in the design or operation of internal controls which could adversely affect the registrant's ability to record, process, summarize and report financial data and have identified for the registrant's auditors any material weaknesses in internal controls; and b) any fraud, whether or not material, that involves management or other employees who have a significant role in the registrant's internal controls; and 6. The registrant's other certifying officers and I have indicated in this quarterly report whether or not there were significant changes in internal controls or in other factors that could significantly affect internal controls subsequent to the date of our most recent evaluation, including any corrective actions with regard to significant deficiencies and material weaknesses. Date: November 14, 2002 /s/ Edward J. Borkowski ------------------------ Edward J. Borkowski Chief Financial Officer, Mylan Laboratories Inc. Sarbanes-Oxley Section 906 Certification Each of the undersigned hereby certifies, pursuant to 18 U.S.C. Section 1350 as adopted pursuant to Section 906 of the Sarbanes-Oxley Act of 2002, that, based on my knowledge, this Report on Form 10-Q for the quarter ended September 30, 2002, fully complies with the requirements of Section 13(a) or 15(d) of the Securities Exchange Act of 1934, as amended, and the information contained in such report fairly presents, in all material respects, the financial condition and results of operations of Mylan Laboratories Inc. Date: November 14, 2002 /s/ Robert J. Coury ----------------------- Robert J. Coury Chief Executive Officer /s/ Edward J. Borkowski ----------------------- Edward J. Borkowski Chief Financial Officer EX-10 3 optionplan2.htm Mylan Laboratories Inc. 1997 Incentive Stock Option Plan Amendment

MYLAN LABORATORIES INC.

1997 INCENTIVE STOCK OPTION PLAN

(AS AMENDED AND RESTATED EFFECTIVE JUNE 23, 2002 AND APPROVED BY

THE SHAREHOLDERS ON JULY 26, 2002)

MYLAN LABORATORIES INC.

1997 INCENTIVE STOCK OPTION PLAN

1 PLAN NAME
  This Plan shall be known as the "MYLAN LABORATORIES INC. 1997 Incentive Stock Option Plan" (the "Plan").

2 EFFECTIVE DATE
  The effective date of the Plan shall be January 23, 1997; provided, however, that if the shareholders of MYLAN LABORATORIES INC. (the “Corporation”) do not approve the Plan by January 22, 1998, no Options (as defined in paragraph 3) granted under the Plan shall constitute Incentive Stock Options (as defined in paragraph 5(c)(ii)(A)). Certain provisions of this Plan have been amended from time to time. Generally Options (as defined in paragraph 3) granted under this Plan are governed by the provisions of the Plan in effect at the date of the grant of such Option. This Amended and Restated version of the Plan incorporates all Plan amendments adopted through June 23, 2002 and also incorporates a total reservation Fifteen Million (15,000,000) shares. The amendments and the increase in the number of shares available under the Plan were approved by the shareholders on July 26, 2002.

3 PURPOSE
  The purpose of this Plan is to provide a means whereby the Corporation may, through the grant of options to purchase Class A Common Stock, par value $.50 per share (“Common Stock”) of the Corporation (“Options”) to employees (including officers and directors who are also employees) and nonemployee directors (including nonemployee directors who are also officers), consultants, agents and advisors, attract, retain and motivate these persons to exert their best efforts on behalf of the Corporation and its subsidiaries. Collectively, these persons are called “key employees.”

4 NUMBER OF SHARES AVAILABLE UNDER PLAN
(a) Options may be granted by the Corporation from time to time to key employees of the Corporation and its subsidiaries to purchase an aggregate of Fifteen Million (15,000,000) shares of Common Stock of the Corporation and Fifteen Million (15,000,000) shares of Common Stock shall be reserved for Options granted under the Plan (subject to adjustment as provided in paragraph 6(j)).

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(b) Shares issued upon exercise of Options granted under the Plan may be authorized and unissued shares or shares held by the Corporation in its treasury.

(c) If any Option granted under the Plan shall terminate, expire or be canceled as to any shares, new Options may thereafter be granted under the Plan covering those shares, subject to the limitations imposed under paragraph 5(a)(vi).

5 ADMINISTRATION
(a) Except as further provided in this paragraph 5(a), the Plan shall be administered by a Stock Option Committee (“Committee”) consisting of at least two members of the Board of Directors of the Corporation who shall be appointed by, and serve at the pleasure of, the Board of Directors. The composition of the Committee shall be controlled by the following provisions of this paragraph 5(a).

    (i) Each member of the Committee must be a “non-employee director” within the meaning of Rule 16b-3, as that Rule may be amended from time to time (“Rule 16b-3”), under the Securities Exchange Act of 1934, as amended, when the Committee is acting to grant Options to those key employees who are also directors or officers. Those actions which require a Committee of non-employee directors include:

      (A) Selecting the directors or officers to whom Options may be granted;

      (B) Deciding or determining the timing, price, number or other terms and conditions of, or shares subject to, each Option made to a key employee who is also a director or officer; and

      (C) Interpreting the Plan or Option agreements with regard to Options granted to a director or officer.

    (ii) Each member of the Committee must be an “outside director” within the meaning of Regulation 1.162-27(e)(3), as that Regulation may be amended from time to time (“Regulation”), under the Internal Revenue Code of 1986, as amended (“Code”), when the Committee is acting to grant Options to those key employees who have the following employment status with the Corporation:

      (A) The chief executive officer of the corporation or the individual acting in that capacity;

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      (B) One of the four highest compensated officers (other than the chief executive officer) of the Corporation; or

      (C) In the judgment of the Board of Directors, is deemed reasonably likely to become an employee described in clause (A) or (B) of this paragraph 5(a)(ii) within the exercise period of any contemplated option.

    (iii) An Officer or director who also has an employment status described in clause (A), (B) or (C) of paragraph 5(a)(ii), shall also be limited to a maximum number of Options under the Plan as provided under paragraph 5(a)(vi).

    (iv) Those actions which require a Committee of outside directors include the same actions as is described in the immediately preceding paragraph except that the employment relationships described in clauses (A), (B) and (C) of paragraph 5(a)(ii) shall be substituted for the references to director or officer. In addition, the provisions of paragraph 5(a)(vi) shall apply.

    (v) If an individual who is being considered for a grant of Options is an officer or director and also has an employment status described in clause (A), (B) or (C) of paragraph 5(a)(ii), the members of the Committee shall consist of whichever of the following director categories is the more restrictive: non-employee directors as defined in Section 5(a)(i), or of outside directors as defined in Section 5(a)(ii).

    (vi) In addition to any other limitation, the Committee shall not award to any Optionee options in any calendar year to purchase more than three hundred thousand (300,000) shares of Common Stock. Further, any Options awarded to such an employee which are thereafter canceled shall continue to count against the yearly maximum number of Options which may be awarded to that employee, and any Option of such an employee which is later repriced shall be deemed to be the cancellation of the original Option and the grant of a new Option for purposes determining the number of Options awarded to that employee.

(b) The Committee shall act in accord with the following:

    (i) A majority of the members of the Committee shall constitute a quorum, and the action of a majority of the members present at a meeting at which a quorum is present or authorized in writing by all members, shall be the action of the Committee.

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    (ii) A member participating in a meeting by telephone or similar communications equipment shall be deemed present for this purpose of establishing a quorum if the member or members who are present in person can hear him and he can hear them.

(c) The Committee shall have the power:

    (i) to determine and designate in its absolute discretion from time to time those employees of the Corporation, its subsidiaries, independent agents, consultants and attorneys who by reason of the nature of their duties, their present and potential contributions to the success of the Corporation and other factors, who are eligible to participate in the Plan and to whom Options are to be granted; provided, however, no Option shall be granted after January 23, 2007, the tenth (10th) anniversary of the original adoption date of the Plan:
    (ii) to grant options:

      (A) which qualify as Incentive Stock Options within the meaning of Code Section 422 (“Incentive Stock Option”); provided that only employees of the Corporation may be granted Incentive Stock Options: and

      (B) which do not qualify under Code Section 422 (“Nonqualified Stock Option”); provided that only Nonqualified Stock Options may be granted to persons who are not employees, but who are otherwise eligible for grant of options: and

    (iii) to determine the number of shares for each Option, subject to paragraph 5(a)(vi);

    (iv) to determine the time or times and the manner when each Option shall be exercisable and the duration of the exercise period.

(d) The Committee may interpret the Plan, prescribe, amend and rescind any rules and regulations necessary or appropriate for the administration of the Plan and make other determinations and take other action as it deems necessary or advisable. Without limiting the generality of the foregoing sentence the Committee may, in its discretion, treat all or any portion of any period during which an Optionee is on military or an approved leave of absence from the Corporation as a period of employment of the Optionee by the Corporation, as the case may be, for the purpose of accrual of rights under

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an Option. An interpretation, determination or other action made or taken by the Committee shall be final, binding and conclusive.

(e) In addition to other rights that they may have as Directors or as members of the Committee, the members of the Committee shall be indemnified by the Corporation against the reasonable expenses, including attorney’s fees actually and reasonably incurred in connection with the defense of any action, suit or proceeding, or in connection with any appeal therein, to which they or any of them may be a party by reason of any action taken or failure to act under or in connection with the Plan or any Option granted thereunder, and against all amounts paid by them in settlement thereof or paid by them in satisfaction of a judgment in any such action, suit or proceeding, except in relation to matters as to which it shall be adjudged in the action, suit or proceeding that the Committee member’s action or failure to act constituted self-dealing, willful misconduct or recklessness; provided that within sixty (60) days after institution of any action, suit or proceeding a Committee member shall in writing offer the Corporation the opportunity, at its own expense, to handle and defend the same.

6 TERMS AND CONDITIONS

(a) Each Option granted under the Plan shall be evidenced by an agreement between the Company and the Optionee.

(b) The Agreement shall be in a form approved by the Committee and executed by the Optionee and a member of the Committee, or an officer of the Company to whom the Committee has delegated such authority.

(c) The Option shall be subject to the following expressed terms and conditions and to such other terms and conditions as the Committee may deem appropriate, including those imposed by Section 8 following amendment of the Plan requiring shareholder approval:

    (i) Each Option agreement shall specify the period for which the Option hereunder is granted (which in no event shall exceed ten (10) years from the date of the grant of the Option) and shall provide that the Option shall expire at the end of that period.

    (ii) The Option price per share shall be determined by the Committee at the time any Option is granted, and shall not be less than the fair market value (but in no event less than the par value if any) of the Common Stock of the Corporation on the date the Option is granted, as determined by the Committee.

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    (iii) The aggregate fair market value (determined at the time the Option is granted) of the stock with respect to which Incentive Stock Options are exercisable for the first time by an Optionee during any calendar year (under all plans of the Corporation and its subsidiaries and parents) shall not exceed $100,000.

    (iv) Subject in each case to the provisions of paragraphs (i), (ii), (iii) and (v) of this Section 6(c), any Option meeting the requirements of Code Section 422 may be exercised, to the extent exercisable by its terms, at the time or times as may be determined by the Committee at the time of grant; subject, however, to the following limitations:

      (A) No portion of an Option granted to an employee of the Corporation or its subsidiaries shall be exercisable unless the Optionee has been employed by the Corporation or its subsidiaries until the second anniversary of the date of the grant of the Option;

      (B) Between the second anniversary and the third anniversary of the date of the grant of the Option, if the Optionee is still employed by the Corporation or its subsidiaries, the Optionee may exercise up to twenty-five percent (25%) of the Option;

      (C) Between the third anniversary and the fourth anniversary of the date of the grant of the Option, if the Optionee is still employed by the Corporation or its subsidiaries, the Optionee may exercise cumulatively up to fifty percent (50%) of the Option; and

      (D) On and after the fourth anniversary of the date of the grant of the Option (but in no event longer than the period provided in paragraph 6(c)(i)), if the Optionee is still employed by the Corporation or its subsidiaries, the Optionee may exercise cumulatively up to one hundred percent (100%) of the Option.

    (v) The Committee, in its sole discretion, however, may reduce or eliminate the limitations set forth in paragraph 6(c)(iv) (A), (B), (C) and (D) for Options granted to any employee having at least two years of continuous service with the Corporation or its subsidiaries.

    The provisions of this paragraph 6(c) shall apply to options granted on and after July 26, 2000.

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  (d) (i) Options, to the extent that the Options have vested on the date of any termination of the employment of the Optionee by the Corporation, shall be exercisable at any time, or from time to time, but in no event later than the expiration date specified in paragraph 6(c)(i), so long as the employment of the Optionee by the Corporation has not been voluntarily terminated by the Optionee and so long as that employment was not terminated by the Corporation for cause. Options held by Optionees who voluntarily terminate employment or whose employment is terminated for cause shall in any event expire on the Optionee’s last day of employment.

  The provisions of this paragraph 6(d)(i) shall apply to options granted on and after January 26, 2000 but shall not apply to options granted on or after July 26, 2000.

    (ii) Notwithstanding the limitations on vesting set forth above, if an Optionee’s employment is terminated due to death, Permanent Disability (as defined in paragraph 6(f)(i)(B)), or Retirement (as defined in paragraph 6(f)(v)), one hundred percent (100%) of the Optionee’s Option may be exercised in accordance with the provisions of paragraph 6(f). Vesting provisions substantially similar to those set forth above may be imposed upon any Option granted to a nonemployee Optionee (or to an employee who is granted a Nonqualified Stock Option) at the sole and absolute discretion of the Committee.

  The provisions of this paragraph 6(d) shall apply to options granted on or after July 26, 2000.

(e) The purchase price of Common Stock as to which an Option shall be exercised and any employment taxes arising therefrom shall be paid to the Corporation at the time of exercise in cash or, at the discretion of the Committee, in stock of the Corporation; payment in stock of the Corporation shall include the right of an Optionee to elect to receive the shares of Common Stock issuable upon exercise of an Option reduced by that number of shares of Common Stock necessary to satisfy the purchase price and/or the minimum statutory withholding requirements for employment taxes (hereinafter “Net Exercise”).

  (f) (i) If an Optionee who is an employee of the Corporation or its subsidiaries shall die:

      (A) while an employee of the Corporation or its subsidiaries or

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      (B) within three (3) months after termination of the Optionee’s employment with the Corporation or its subsidiaries because the Optionee is permanently and totally disabled (within the meaning of Code Section 22(e)(3)) (“Permanent Disability”),

  any Option of the Optionee may be exercised by the person or persons to whom the Optionee’s rights under the Option pass by will or applicable law or if no person has the right, by the Optionee’s executors or administrators, at any time or from time to time, within one (1) year after the date of the death, or in the instances to which paragraph (f)(i)(B) of this Section 6 applies, one (1) year after the date of termination of employment, but in no event later than the expiration date specified in paragraph (c)(i) of this Section 6.

    (ii) If an Optionee’s employment by the Corporation or its subsidiaries shall terminate because of Permanent Disability, the Optionee may exercise any Option of the Optionee at any time, or from time to time, within one (1) year of the date of the termination of employment, but in no event later than the expiration date specified in paragraph (c)(i) of this Section 6.

    (iii) Unless a date of re-employment is identified at the time of a termination of employment that is the result of a reduction in force, the Optionee may exercise any Option to the extent that the Optionee may be entitled to do so, at any time, or from time to time, within three (3) months of the effective date of the reduction in force, but in no event later than the expiration date specified in paragraph (c)(i) of this Section 6.

    (iv) If an Optionee’s employment by the Corporation or its subsidiaries shall terminate because of Retirement, any Option of the Optionee may be exercised by the Optionee at any time, or from time to time, during the balance of the ten (10) year exercise period as set forth in paragraph (c)(1) of this Section 6, but in no event later than the expiration date specified in paragraph (c)(i) of this Section 6. If such an Optionee dies after Retirement but before such Optionee’s Options have either been exercised or otherwise expired, such Options may be exercised by the person to whom such options pass by will or applicable law or, if no person has that right, by the Optionee’s executors or administrators at any time, or from time to time, during the balance of the (10) year exercise period set forth in paragraph (c)(i) of this Section 6, but in no event later than the expiration date specified in paragraph (c)(i) of this Section 6. In the event that such Optionee’s Options were granted as Incentive Stock Options and they

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      are not exercised within three (3) months after the termination of employment, such Options shall thereafter be deemed and become Nonqualified Stock Options.

    (v) Retirement for purposes of exercising any Option(s) granted hereunder is defined as:

      (A) the Optionee has reached age 55 and has accumulated at least ten (10) years of continuous service with the Company; or

      (B) the Committee, in its sole discretion, has determined that the Optionee has retired regardless of age and service with the Company.

    (vi) Except as provided by subparagraphs (i) through (iv) of this paragraph (f) of Section 6, if an Optionee’s employment shall cease by reason of a voluntary or involuntary termination, either with or without cause, any Option of the Optionee shall terminate immediately.

    The provisions of this paragraph 6(f) shall apply to options granted on or after July 26, 2000.

(g) Each Nonqualified Stock Option shall be for a term of 10 years, subject to earlier termination as provided in paragraph 6(f), unless the Nonqualified Stock Option Agreement expressly provides for a different term, not in excess of ten (10) years, and/or expressly provides that the provisions of any or all of paragraph 6(f) shall not apply to cause the Nonqualified Stock Option to terminate earlier. A Nonqualified Stock Option shall not be exercisable after the expiration of its term. Except as otherwise provided in the Nonqualified Stock Option Agreement, if an Optionee is not an employee of the Corporation or its subsidiaries when the Optionee is granted an Option, that Option shall terminate one (1) year after the date of the Optionee’s death, but in no event later than the expiration date specified in paragraph (c)(i) of this Section 6. If such an Optionee dies, any Option of the Optionee may be exercised by the person to whom the Optionee’s rights under the Option pass by will or applicable law or if no person has that right, by the Optionee’s executors or administrators, at any time, or from time to time within one (1) year after the date of the death, but in no event later than the expiration date specified in paragraph (c)(i) of this Section 6.

The provisions of this paragraph 6(g) shall apply to options granted on or after July 26, 2000.

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(h) Options granted under the Plan shall be transferrable by will or by the laws of descent and distribution. In addition, Nonqualified Stock Options granted under the Plan can be transferred during the lifetime of the Optionee only if all of the following conditions are satisfied:

    (i) the Stock Option Committee has approved the proposed transfer in writing;

    (ii) the proposed transfer is to be made without consideration;

    (iii) the proposed transferee is a member or members of the Optionee’s immediate family (i.e., a child, or children, a grandchild or grandchildren, or the Optionee’s spouse) and/or to a trust established for the benefit of an immediate family member or members, or a family limited partnership which includes the Optionee and/or members of the Optionee’s immediate family, or a trust established for the benefit of the Optionee, and/or an immediate family member or members and a charity exempt from taxation under Code 501(c)(3); and

    (iv) after transfer, each option transferred by the Optionee shall remain subject to the provisions of the Plan under which it was granted.

(i) Each Option agreement shall provide that upon demand by the Committee, the Optionee (or any person acting under paragraph 6(f)) shall deliver a written representation to the Committee at the time of any exercise of an Option that the shares to be acquired upon the exercise are to be acquired for investment and not for resale or with a view to the distribution thereof. Upon demand, delivery of the representation prior to the delivery of any shares to be issued upon exercise of an Option and prior to the expiration of the Option period shall be a condition precedent to the right of the Optionee or other person to purchase any shares.

(j) In the event of any change in the Common Stock of the Corporation by reason of any stock dividend, recapitalization, reorganization, merger, consolidation, split-up, combination, or exchange of shares, or rights offering to purchase Common Stock at a price substantially below fair market value, or any similar change affecting the Common Stock, the number and kind of shares which thereafter may be optioned and sold under the Plan and the number and kind of shares subject to option in outstanding Option agreements and the purchase price per share thereof shall be appropriately adjusted consistent with the change in a manner as the Committee may deem equitable to prevent substantial dilution or enlargement of the rights granted to, or available for, participants in the Plan.

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(k) Each Option agreement which provides for the grant of an Incentive Stock Option to an employee shall contain terms and provisions as the Committee may determine to be necessary or desirable in order to qualify the Option as an Incentive Stock Option within the meaning of Code Section 422, or successor thereto and to meet the requirement of Rule 16b-3.

(l) No Optionee shall have any rights as a shareholder with respect to any shares subject to an Option prior to the date of issuance to the Optionee of a certificate or certificates for the shares.

(m) The Plan and any Option granted under the Plan shall not confer upon any Optionee any right with respect to continuance of employment by the Corporation or any subsidiary of the Corporation, nor shall they interfere in any way with the right of the Corporation to terminate the Optionee’s employment at any time.

7 COMPLIANCE WITH OTHER LAWS AND REGULATIONS

(a) The Plan, the grant and exercise of Options thereunder, and the obligation of the Corporation to sell and deliver shares under Options, shall be subject to all applicable Federal and state laws, rules and regulations and to required approvals of any government or regulatory agency.

(b) The Corporation shall not be required to issue or deliver any certificates for shares of Common Stock prior to the completion of any registration or qualification of the shares under any Federal or state law, or any ruling or regulation of any government body which the Corporation shall, in its sole discretion, determine to be necessary or advisable.

8 AMENDMENT AND DISCONTINUANCE

(a) The Board of Directors of the Corporation may from time to time amend, suspend or discontinue the Plan; provided, however, that subject to the provisions of paragraph 6(c)(i) or the approval of the Corporation’s shareholders no action of the Board of Directors or of the Committee may:

(i) extend the period during which Options may be granted as provided in paragraph 6(c)(i);

(ii) increase the number of shares reserved for Options pursuant to Section 4;

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(iii) permit the granting of any Option at an Option price less than that determined in accordance with paragraph 6(c)(ii);

(iv) permit the granting of Options which expire beyond the period provided for in paragraph 6(c)(i);

(v) materially increase the benefits accruing to participants in the Plan;

(vi) (vi) materially modify the requirements for eligibility for participation in the Plan; or

(vii) otherwise cause Rule 16b-3 or the requirements for Incentive Stock Options to become inapplicable.

(b) Without the written consent of an Optionee, no amendment or suspension of the Plan shall diminish or impair any Option previously granted to the Optionee under the Plan.

(c) Notwithstanding any other provision of the Plan, if an amendment to the Plan requires the approval of the Corporation’s shareholders, every Option granted after that amendment and before approval of the shareholders (and the Optionee’s or other person’s rights in every share issued upon an exercise of an Option granted during that time) shall be conditional and contingent upon the approval of the Corporation’s shareholders. Further, those Options (and shares issued under those options) shall not be subject to sale or transfer unless and until shareholder approval is obtained. The Committee shall implement procedures for compliance with these restrictions when applicable.

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 EX-3 4 bylaws2.htm Mylan Laboratories Inc. Second Amendment and Restated Bylaws

MYLAN LABORATORIES INC.

a Pennsylvania corporation

Second Amended and Restated Bylaws

ARTICLE I

Shareholders

        Section 1.01. Annual Shareholders Meetings. The annual meeting of the shareholders of Mylan Laboratories Inc. (the “Corporation”) shall be held on the last Friday of July in each year if not a legal holiday, and if a legal holiday, then on the next succeeding day which is not a legal holiday, at 11:00 a.m., at the principal executive office of the Corporation, or at such other date, time and place as may be fixed by the Board of Directors (the “Board”).

        Section 1.02. Special Shareholders Meetings. Special meetings of the shareholders may be called at any time by the Chairman of the Board or by two-thirds of the Board. Special shareholders meetings shall be held at such time and such place as designated by the Chairman of the Board or his designee. No business may be transacted at any special meeting of the shareholders other than that stated in the notice of meeting.

        Section 1.03. Organization. The Chairman of the Board shall preside and the Secretary, or in his absence any Assistant Secretary, shall act as secretary, at all meetings of the shareholders. In the event that the Chairman of the Board is absent, the Vice Chairman of the Board shall preside at such meeting. In the absence of the Vice Chairman of the Board, the Chairman of the Board shall designate another member of the Board, or an officer of the Corporation, to preside over such meeting. If the Chairman of

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the Board fails to designate such person, a member of the Board or an officer of the Corporation shall be selected by a majority of the Board in attendance at such meeting, and that officer shall preside over the meeting. In the absence of the Secretary and any Assistant Secretary, the person presiding over the meeting shall designate any person to act as secretary of the meeting.

         Section 1.04. Business of Shareholders Meetings.
        (a) At any annual meeting of the shareholders, only such business will be conducted or considered as is properly brought before the meeting. To be properly brought before an annual shareholders meeting, business must be (i) specified in the notice of meeting (or any supplement thereto) given by or at the direction of the Board, (ii) brought before the meeting by the person presiding over the meeting, or (iii) otherwise properly requested to be brought before the meeting by a shareholder of the Corporation in accordance with Section 1.04(b) of these Bylaws.
        (b) For business to be properly requested by a shareholder to be brought before an annual shareholders meeting, the shareholder must (i) be a shareholder of the Corporation of record at the time of the giving of the notice for such annual meeting, (ii) be entitled to vote at such annual meeting, and (iii) be in compliance with the notice procedures set forth in this Section 1.04(b) of the Bylaws. To be timely, a shareholder’s notice must be received by the Secretary not less than sixty (60) calendar days prior to the annual shareholders meeting; provided, however, that in the event a public announcement of the date of the annual shareholders meeting is not made at least seventy-five (75) calendar days prior to the date of the annual shareholders meeting, notice by the shareholder to be timely must be received by the Secretary not later than the close of

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business on the tenth (10th) calendar day following the day on which a public announcement is first made of the date of the annual shareholders meeting. A shareholder’s notice to the Secretary must set forth as to each matter the shareholder proposes to bring before the annual shareholders meeting a description in reasonable detail of the business desired to be brought before the annual shareholders meeting and the reasons for conducting such business at the annual meeting; the name and address, as they appear on the Corporation’s books, of the shareholder proposing such business and the beneficial owner, if any, on whose behalf the proposal is made; the class and number of shares of the Corporation that are owned beneficially and of record by the shareholder proposing such business and the beneficial owner, if any, on whose behalf the proposal is made; and any material interest of such shareholder proposing such business and the beneficial owner, if any, on whose behalf the proposal is made. A shareholder must also submit a supporting statement indicating the reasons for bringing such proposal. A shareholder must also comply with all applicable requirements of the Securities Exchange Act of 1934, as amended (“Exchange Act”), and the rules and regulations (the “Regulations”) promulgated thereunder with respect to the matters set forth in this Section 1.04 of the Bylaws. For purposes of these Bylaws, the term “public announcement” means a posting on the Corporation’s website, disclosure in a press release reported by the Dow Jones News Service, Associated Press, or comparable national news service or in a document publicly filed by the Corporation with the Securities and Exchange Commission pursuant to Sections 13, 14, or 15(d) of the Exchange Act or furnished to shareholders. Nothing in this Section 1.04 of the Bylaws

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will be deemed to affect any rights of shareholders to request inclusion of proposal in the Corporation’s proxy statement pursuant to Rule 14a-8 under the Exchange Act.

        (c) The determination of whether any business sought to be brought before any annual or special meeting of the shareholders is properly brought before such meeting in accordance with these Bylaws will be made by the person presiding over such meeting, be it the Chairman of the Board, the Vice Chairman of the Board, a Board member or an officer of the Corporation appointed by the Chairman of the Board or selected to preside by the Board pursuant to Section 1.03 of these Bylaws. If the person presiding over the meeting determines that any business is not properly brought before such meeting, he will so declare to the meeting and any such business will not be conducted or considered.

        Section 1.05. Order of Business. The order and conduct of business at shareholders meetings shall be determined by the person presiding over the shareholders meeting. The person presiding over such meeting shall have the power to adjourn the meeting to another place, date and time.

ARTICLE II

Directors

        Section 2.01. Number, Election and Term of Office. The number of Directors which shall constitute the full Board shall be such number, not less than three, as shall be fixed by the Board or the shareholders; provided, however, that if all the shares of the Corporation shall be owned beneficially and of record by either one or two shareholders, the number of Directors may be less than three but not less than the number of shareholders. The shareholders shall elect a full Board at each annual meeting of shareholders. Each Director shall serve until the next annual shareholders meeting, and

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thereafter until his successor has been selected and qualified, or until his death, resignation or removal. The Board shall elect from among its members a Chairman of the Board who shall appoint a Vice Chairman of the Board.

        Section 2.02. Filling Vacancies. Any vacancy caused by the death, resignation or removal of a Director shall be filled by appointment thereto by the Chairman of the Board, or in his absence, by the Vice Chairman of the Board, and such Director so appointed shall serve for the unexpired term of the Director causing such vacancy.

Section 2.03. Nominations of Directors: Election.
        (a) Only persons who are nominated in accordance with the following procedures will be eligible for election at a meeting of shareholders as Directors of the Corporation.

        (b) Nominations of persons for election as Directors of the Corporation may be made only at an annual meeting of shareholders by or at the direction of the Board or by any shareholder who (i) is a shareholder of record at the time of giving of notice provided for in this Section 2.03 of the Bylaws, (ii) is entitled to vote for the election of Directors at such meeting, and (iii) is in compliance with the notice procedures set forth in this Section 2.03(c) of these Bylaws.

        (c) To be timely, a shareholder’s notice must be received by the Secretary not less than sixty (60) calendar days prior to the annual shareholders meeting; provided, however, that in the event a public announcement of the date of the annual shareholders meeting is not made at least seventy-five (75) calendar days prior to the date of the annual shareholders meeting, notice by the shareholder to be timely must be received by the Secretary not later than the close of business on the tenth (10th) calendar day following the day on which a public announcement is first made of the date of the annual

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shareholders meeting. To be in proper written form, such shareholder’s notice must set forth or include the name and address, as they appear on the Corporation’s books, of the shareholder giving the notice and of the beneficial owner, if any, on whose behalf the nomination is made; a representation that the shareholder giving the notice is a holder of record of stock of the Corporation entitled to vote at such annual meeting and intends to appear in person or by proxy at the annual meeting to nominate the person or persons specified in the notice; the class and number of shares of stock of the Corporation owned beneficially and of record by the shareholder giving the notice and by the beneficial owner, if any, on whose behalf the nomination is made; a description of all arrangements or understandings between or among any of the shareholder giving the notice, the beneficial owner on whose behalf the notice is given, each nominee, and any other person or persons (naming such person or persons) pursuant to which the nomination or nominations are to be made by the shareholder giving the notice; such other information regarding each nominee proposed by the shareholder giving the notice as would be required to be included in a proxy statement filed pursuant to the proxy rules of the Securities and Exchange Commission had the nominee been nominated, or intended to be nominated, by the Board; and the signed consent of each nominee to serve as a Director of the Corporation if so elected. At the request of the Board, any person nominated by the Board for election as a Director must furnish to the Secretary that information required to be set forth in a shareholder’s notice of nomination which pertains to the nominee. The person presiding over any annual meeting will, if the facts warrant, determine that a nomination was not made in accordance with the procedures prescribed by this Section 2.03 of the Bylaws, and if he should so determine, he will so declare to

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the meeting and the defective nomination will be disregarded. A shareholder must also comply with all applicable requirements of the Exchange Act and the Regulations with respect to the matters set forth in this Section 2.03 of the Bylaws.

        Section 2.04. Annual Meeting of the Board. The annual meeting of the Board shall be held immediately after the annual meeting of the shareholders and shall be the annual organizational meeting of the Directors-elect, at which meeting the new Board shall be organized, Committees of the Board shall be established, and the officers of the Corporation for the ensuing year shall be elected by the Board of Directors or appointed by the Chief Executive Officer consistent with these Bylaws.

        Section 2.05. Regular Board Meetings: Notice. Regular meetings of the Board shall be held at such places and times as shall be determined by resolution of the Board at its annual meeting. Notice of such regular meetings of the Board shall not be required to be given, except that whenever the time or place of such regular meetings shall be changed, notice of such action shall be given promptly by telephone or otherwise to each Director not participating in such action.

        Section 2.06. Special Board Meetings: Notice. Special meetings of the Board may be called at any time by the Chairman of the Board or by two-thirds of the Directors, to be held at such place and times as shall be specified in the notice or waiver of notice thereof. Notice of every special meeting of the Board, stating the place, day and hour thereof, shall be given by telephone or otherwise to each Director at least twenty-four (24) hours before the time at which the meeting is to be held, unless such notice is waived pursuant to Section 7.05 of the Bylaws.

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        Section 2.07. Action by Consent in Writing. Any action required or permitted to be taken at any meeting of the Board may be taken without a meeting if all members of the Board shall consent thereto in writing, and the writing or writings shall be filed with the minutes of the proceedings of the Board.

        Section 2.08. Organization. The Chairman of the Board shall preside at each meeting of the Board and the Secretary, or in his absence any Assistant Secretary, shall act as secretary at all meetings of the Board. In the event that the Chairman of the Board is absent, the Vice Chairman of the Board shall preside at such meeting. In the absence of the Vice Chairman of the Board, a Director shall be designated by the Chairman of the Board to preside over such meeting. If the Chairman of the Board fails to designate such person, a majority of the Board in attendance at such meeting shall select a Director to preside over such meeting. In the absence of the Secretary or any Assistant Secretary, the person presiding over the meeting shall designate any person to act as secretary of the meeting.

        Section 2.09. Board Meetings by Telephone. One or more of the Directors may participate in any regular or special meeting of the Board by telephone conference or similar communications equipment by means of which all persons participating in the meeting are able to hear each other.

        Section 2.10. Resignations. Any Director may resign at any time by delivering his letter of resignation to the Chairman of the Board with a copy to the Secretary. Any such resignation shall take effect at the time specified therein, or, if the time when it shall become effective shall not be specified therein, then it shall take effect immediately upon

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its receipt by the Chairman of the Board, and unless otherwise specified therein, the acceptance of such resignation shall not be necessary to make it effective.

        Section 2.11. Qualification of Directors. It shall be a qualification for membership on the Board that a Director not be a member of the board of directors or an officer or employee of a competitor (or an affiliate of a competitor) of the Corporation.

        Section 2.12. Limitation of Director Liability. A Director of the Corporation shall not be personally liable for monetary damages as such for any action taken, or any failure to take any action, unless the Director has breached or failed to perform the duties of his office under Subchapter B of Chapter 17 of the Business Corporation Law of Pennsylvania (“BCL”), including Section 1712 thereof (relating to standard of care and justifiable reliance) and the breach or failure to perform constitutes self-dealing, willful misconduct or recklessness; provided, however, that the limitation of liability provided in this Section 2.12 shall not apply to the responsibility or liability of a director pursuant to any criminal statute or the liability of a director for payment of taxes pursuant to local, state or federal law. Neither the amendment nor the repeal of this Section 2.12 shall eliminate or reduce the effect of this Section 2.12 with respect to any matter occurring, or any cause of action, suit or claim that, but for this Section 2.12, would accrue or arise, prior to such amendment or repeal. If Subchapter B of Chapter 17 of the BCL is amended to authorize corporate action further eliminating or limiting the personal liability of directors, then the liability of a Director of the Corporation shall be eliminated or limited to the fullest extent permitted by Subchapter B of Chapter 17, or any successor thereto under the BCL, as amended from time to time.

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ARTICLE III

Committees

        Section 3.01. Executive Committee: How Constituted and Powers. The Board may elect such Directors then in office, to constitute an Executive Committee (herein called the “Executive Committee”), provided, however, that both the Chairman of the Board and the Vice Chairman of the Board shall be members of said Committee. The Executive Committee shall keep proper minutes and records of its proceedings, and all actions of the Executive Committee shall be reported to the Board at its meeting next succeeding such activity. During the intervals between the meetings of the Board of Directors, the Executive Committee shall have, and may exercise, all powers and rights of the Board unless otherwise limited by a resolution of the Board.

        Section 3.02. Organization. The Chairman of the Board shall act as chairman at all meetings of the Executive Committee and shall designate a person to act as secretary thereof. In the event that the Chairman of the Board is absent, the Vice Chairman shall act as chairman at all meetings of the Executive Committee and shall designate a person to act as secretary thereof. If neither the Chairman of the Board, nor the Vice Chairman of the Board is present at such meeting, the chairman of such meeting shall be selected by a majority of the members of the Executive Committee in attendance at such meeting and that chairman shall designate a person to act as secretary thereof.

        Section 3.03. Other Committees. The Board shall form an Audit Committee, a Compensation Committee, a Finance Committee, a Governance and Nominating Committee and such other committees as it may determine, which shall in each case consist of Directors elected by the Board. Committees shall keep proper minutes and

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records of their proceedings and may exercise such powers as the Board may by resolution determine and specify in their respective charters and such other resolutions as the Board may adopt.

        Section 3.04. Procedures. A majority of all the members of any Committee of the Board may fix its rules of procedure, determine its action and fix the time and place of its meetings and specify what notice thereof, if any, shall be given, unless the Board shall otherwise by resolution provide.

        Section 3.05. Action by Consent in Writing. Any action required or permitted to be taken at any meeting of any Committee may be taken without a meeting if all members of the Committee shall consent thereto in writing and the writing or writings shall be filed with the minutes of proceedings of the Committee.

        Section 3.06. Meetings by Telephone. One or more members of a Committee may participate in any Committee meeting by telephone conference or similar communications equipment by means of which all persons participating in the meeting are able to hear each other.

        Section 3.07. Resignations; Removal; Vacancies. Any member of a Committee of the Board may resign therefrom at any time by delivering a letter of resignation to the Chairman of the Board with a copy to the Secretary. Any such resignation shall take effect at the time specified therein, or, if the time when it shall become effective shall not be specified therein, then it shall take effect immediately upon its receipt by the Chairman of the Board; and, unless otherwise specified therein, the acceptance of such resignation shall not be necessary to make it effective. The Board may remove a member of any Committee of the Board. Any vacancy in a Committee of the Board shall be filled

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by the vote of the Board and shall be effective upon delivery of a written designation of such appointment to the Secretary.

ARTICLE IV

Officers

        Section 4.01. Officers. The Corporation may have such officers as determined by the Board, subject to the requirements of the BCL or other applicable law, and pursuant to these Bylaws. Any two or more offices may be held by the same person, except that any officer holding the position of Chief Executive Officer, Chief Operating Officer, President or Chief Financial Officer, or any position equivalent to such position, cannot hold the office of the Secretary. The Board shall elect the Chief Executive Officer and the Board may elect, or delegate authority to the Chief Executive Officer to appoint, a President, a Chief Financial Officer, a Chief Legal Officer, a Chief Science Officer, and any other officers of the Corporation as the Board or the Chief Executive Officer may desire. Each officer elected by the Board, or appointed by the Chief Executive Officer, shall hold office until the next succeeding annual meeting of the Board and thereafter until his successor shall have been selected and shall qualify, or until his death, resignation or removal.

        Section 4.02. Removal. The Board may remove, either with or without cause, at any time, any officer elected by the Board; provided, however, that the removal shall be without prejudice to the contract rights, if any, of the person so removed. The Board may delegate to the Chief Executive Officer the right to remove, either with or without cause, at any time, any officer the Chief Executive Officer has appointed; provided, however,

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that the removal shall be without prejudice to the contract rights, if any, of the person so removed.

        Section 4.03. Resignations. Any officer may resign at any time by delivering a letter of resignation to the Chairman of the Board, or to the Chief Executive Officer if such officer was appointed by the Chief Executive Officer, with a copy to the Secretary. Any such resignation shall take effect at the time specified therein, or, if the time when it shall become effective shall not be specified therein, then it shall take effect immediately upon its receipt by the Chairman of the Board, or the Chief Executive Officer, as the case may be; and, unless otherwise specified therein, the acceptance of such resignation shall not be necessary to make it effective.

        Section 4.04. Vacancies. A vacancy caused by the death, resignation or removal of any officer elected by the Board shall be filled by an election by the Board, and such officer so elected by the Board shall serve for the unexpired portion of the term of the officer causing such vacancy. The Board may delegate to the Chief Executive Officer the right to fill any vacancy caused by the death, resignation or removal of an officer appointed by the Chief Executive Officer.

        Section 4.05. Chief Executive Officer The Chief Executive Officer shall have such powers and perform such duties as from time to time may be assigned to him by the Board including, but not limited to, those powers and duties that may be conferred upon the Chief Executive Officer under these Bylaws or any resolution adopted by the Board pursuant to these Bylaws. The Chief Executive Officer shall make a report of the state of the business of the Corporation at each annual meeting of the shareholders and from time to time the Chief Executive Officer shall report to the shareholders and to the Board those

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corporate matters, which, in the Chief Executive Officer’s judgment, are required to be brought to their attention. The Chief Executive Officer shall have general and active supervision and control of the over-all business and affairs of the Corporation. Unless otherwise directed by the Board, the Chief Executive Officer shall be the officer authorized to execute documents or take actions on behalf of the Corporation in its capacity as a shareholder or equity owner of any other entity. The Chief Executive Officer may sign, execute and deliver in the name of the Corporation all contracts or other instruments requiring execution by the Corporation, except in cases where the signing, execution or delivery thereof shall be expressly delegated by the Board or by a duly authorized Committee of the Board to some other officer or agent of the Corporation or where any of them shall be required by law to be signed, executed or delivered by a person other than the Chief Executive Officer. The Chief Executive Officer may appoint from time to time such agents as may be deemed advisable for the prompt and orderly transaction of the business of the Corporation, prescribe their duties and the terms of their engagements, fix their compensation and dismiss such agents so appointed.

         Section 4.06. President. The President shall have such powers and perform such duties as from time to time may be assigned to him by the Board or by the Chief Executive Officer.

        Section 4.07. Chief Operating Officer. The Chief Operating Officer shall have such powers and perform such duties as from time to time may be assigned to him by the Board, by the Chief Executive Officer or by the President. The Chief Operating Officer shall be charged with the supervision of the day-to-day operations of the Corporation.

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        Section 4.08. Chief Financial Officer. The Chief Financial Officer shall have such powers and perform such duties as from time to time may be assigned to him by the Board, by the Chief Executive Officer or by the President. The Chief Financial Officer shall keep and maintain, or cause to be kept and maintained, adequate and correct books and records of the Corporation, using appropriate accounting principles; have supervision over and be responsible for the financial affairs of the Corporation; cause to be kept at the principal executive office of the Corporation and preserved for review as required by law or regulation all financial records of the Corporation; be responsible for the establishment of adequate internal control over the transactions and books of account of the Corporation; and be responsible for rendering to the proper officers and the Board upon request, and to the shareholders and other parties as required by law or regulation, financial statements of the Corporation.

        Section 4.09. Chief Legal Officer. The Chief Legal Officer shall have such powers and perform such duties as from time to time may be assigned to him by the Board, by the Chief Executive Officer or by the President. The Chief Legal Officer shall be the primary legal officer of the Corporation and shall have general and active supervision and direction over the legal affairs of the Corporation.

        Section 4.10. Chief Science Officer. The Chief Science Officer shall have such powers and perform such duties as from time to time may be assigned to him by the Board, by the Chief Executive Officer or by the President. The Chief Science Officer shall be the person responsible for the implementation of the scientific direction of the corporation and shall have general and active supervision over scientific matters related to the Corporation.

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        Section 4.11. Vice Presidents. Each of the Vice Presidents (including each of the Executive Vice Presidents and Senior Vice Presidents) shall have such powers and perform such duties as from time to time may be assigned to him by the Chief Executive Officer or his designee.

        Section 4.12. The Secretary and Assistant Secretaries.
        (a) The Secretary shall record all the proceedings of the meetings of the shareholders and the Board in one or more minute books kept for that purpose; see that all notices shall be duly given in accordance with the provisions of these Bylaws or as required by law; be custodian of the seal of the Corporation, and shall see that such seal, or, if authorized by the Board, a facsimile thereof, shall be affixed to any documents the execution of which on behalf of the Corporation shall be duly authorized and may attest such seal when so affixed; have charge, directly or through the transfer agent or transfer agents and registrar or registrars duly appointed, of the issue, transfer and registration of certificates for stock of the Corporation and of the records thereof; upon request, exhibit or cause to be exhibited at all reasonable times to the Board, at the place where they shall be kept, such records of the issue, transfer and registration of the certificates for stock of the Corporation; and in general, perform all duties incident to the office of Secretary and such duties as from time to time may be assigned to him by the Board or the Chief Executive Officer.

        (b) At the request of the Secretary, or in his absence or inability to act, the Assistant Secretary, or if there be more than one, any of the Assistant Secretaries, shall perform the duties of the Secretary, and, when so acting, shall have the powers of, and be subject to all the restrictions upon, the Secretary. Each of the Assistant Secretaries shall

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perform such duties as from time to time may be assigned to him by the Board, the Chief Executive Officer or the Secretary.

         Section 4.13. The Treasurer and Assistant Treasurers.
        (a) The Treasurer shall have charge and custody of, and be responsible for, all funds, corporate securities and investments, notes and valuable effects of the Corporation; receive and give receipt for money due and payable to the Corporation from any sources whatsoever; deposit all such money to the credit of the Corporation in such banks, trust companies or other depositories as shall be selected in accordance with the provisions of Section 6.02 hereof, cause such funds to be disbursed by checks or drafts on the authorized depositories of the Corporation signed as provided in Section 6.01 hereof; and be responsible for the accuracy of the amounts of, and cause to be preserved proper vouchers for all moneys so disbursed; render to the Chief Executive Officer, the Chief Financial Officer, or the Board, whenever they, respectively, shall request the Treasurer so to do, an account of the financial condition of the Corporation and of all the Treasurer’s transactions as such officer; upon request, exhibit or cause to be exhibited at all reasonable times, at the place where they shall be kept, the Treasurer’s cash books and other records to the Board, the Chief Executive Officer or the Chief Financial Officer; and have such powers and perform such duties as from time to time may be assigned to him by the Board, the Chief Executive Officer or the Chief Financial Officer.

        (b) At the request of the Treasurer, or in his absence or inability to act, the Assistant Treasurer, or if there be more than one, any of the Assistant Treasurers, shall perform the duties of Treasurer, and, so acting, shall have all the powers of, and be subject to all of the restrictions upon, the Treasurer. Each Assistant Treasurer shall

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perform such duties as from time to time may be assigned to him by the Board, the Chief Executive Officer, the Chief Financial Officer and the Treasurer.

         Section 4.14. The Controller and Assistant Controllers.
        (a) The Controller shall keep or cause to be kept correct records of the business and transactions of the Corporation and shall, upon request, at all reasonable times exhibit or cause to be exhibited such records to the Board at the place where such records shall be kept. The Controller shall have such powers and perform such duties as from time to time may be assigned to him by the Board, the Chief Executive Officer or the Chief Financial Officer.

        (b) At the request of the Controller, or in case of his absence or inability to act, the Assistant Controller, or, if there be more than one, any of the Assistant Controllers, shall perform the duties of the Controller, and, when so acting, shall have all the powers of, and be subject to all the restrictions upon, the Controller. Each of the Assistant Controllers shall perform such duties as from time to time may be assigned to him by the Board, the Chief Executive Officer, the Chief Financial Officer or the Controller.

ARTICLE V

Shares of Capital Stock

        Section 5.01. Share Certificates. Every owner of stock of the Corporation shall be entitled to have a certificate registered in such owner’s name in such form as the Board shall prescribe, certifying the number of shares of stock of the Corporation owned by such owner. The certificates representing shares of stock shall be numbered in the order in which they shall be issued and shall be signed in the name of the Corporation by the Chief Executive Officer, the President or such other officer, duly authorized, and by the

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Secretary or an Assistant Secretary. Any or all of the signatures on any such certificate may be facsimiles. In case any officer or officers or transfer agent or registrar of the Corporation who shall have signed, or whose facsimile signature or signatures shall have been placed upon any such certificate shall cease to be such officer or officers or transfer agent or registrar before such certificate shall have been issued, such certificate may be issued by the Corporation with the same effect as though the person or persons who shall have signed such certificate, or whose facsimile signature or signatures shall have been placed thereupon, were such officer or officers or transfer agent or registrar at the date of issue. Records shall be kept of the amount of the stock of the Corporation issued and outstanding, the manner in which and the time when such stock was paid for, the respective names, alphabetically arranged, and the addresses of the persons, firms or corporations owning of record the stock represented by certificates for stock of the Corporation, the number, class and series of shares represented by such certificates, respectively, the time when each became an owner of record thereof, and the respective dates of such certificates, and in case of cancellation, the respective dates of cancellation. Every certificate surrendered to the Corporation for exchange or transfer shall be canceled and a new certificate or certificates shall not be issued in exchange for any existing certificate until such existing certificate shall have been so canceled except in cases provided for in Section 5.02 hereof.

        Section 5.02. Lost, Stolen, Destroyed or Mutilated Certificates. New certificates for shares of stock may be issued to replace certificates lost, stolen, destroyed or mutilated upon such conditions as the Board may from time to time determine. If the registered owner of any stock of the Corporation notifies the Corporation of any loss,

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theft, destruction or mutilation of the certificate therefor the Corporation may, in its discretion, require the registered owner of the lost, stolen or destroyed certificate or his legal representatives to give the Corporation a bond in such sum, limited or unlimited, and in such form and with such surety or sureties, as the Corporation shall in its uncontrolled discretion determine, to indemnify the Corporation against any claim that may be made against it on account of the alleged loss, theft or destruction of any such certificate, or the issuance of such new certificate. The Corporation may, however, in its discretion refuse to issue any such new certificate except pursuant to legal proceedings under the laws of the Commonwealth of Pennsylvania.

        Section 5.03. Regulations Relating to Shares. The Board shall have power and authority to make all such rules and regulations not inconsistent with these Bylaws as it may deem expedient, concerning the issue, transfer and registration of certificates representing shares of stock of the Corporation.

        Section 5.04. Holders of Record. The Corporation shall be entitled to treat the holder of record of any share or shares of stock as the holder and owner in fact thereof and, accordingly, shall not be bound to recognize any equitable or other claim to or interest in such shares on the part of any other person, whether or not it shall have express or other notice thereof, except as otherwise expressly provided by the laws of Commonwealth of Pennsylvania.

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ARTICLE VI

Execution of Instruments;

Deposit and Withdrawal of Corporate Funds

        Section 6.01. Execution of Instruments Generally. The authority to sign any contracts and other instruments requiring execution by the Corporation may be conferred by the Board upon an authorized officer of the Corporation or upon any other person or persons designated by the Board. Any person having authority to sign on behalf of the Corporation may delegate, from time to time, by instrument in writing, all or any part of such authority to any other person or persons so authorized by the Board.

        Section 6.02. General and Special Bank Accounts. The Board may from time to time authorize the opening and keeping of general and special bank accounts with such banks, trust companies or other depositories as the Board may select, or as may be selected by any officer or officers or agent or agents of the Corporation to whom power in that respect shall have been delegated by the Board. The Board may make such special rules and regulations with respect to such bank accounts, not inconsistent with the provisions of these Bylaws, as it may deem expedient.

ARTICLE VII

General Provisions

        Section 7.01. Offices. The principal executive office of the Corporation shall be located at such place within or without the Commonwealth of Pennsylvania as the Board from time to time designates. The registered office of the Corporation shall be located at 1030 Century Building, 130 Seventh Street, Pittsburgh, Pennsylvania 15222 or at such other place within the Commonwealth of Pennsylvania as the Board from time to time designates.

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         Section 7.02. Corporate Seal. The Board shall prescribe the form of a suitable corporate seal, which shall contain the full name of the Corporation and the year and state of incorporation.

         Section 7.03. Fiscal Year. The fiscal year of the Corporation shall commence on the first day of April and end on the thirty-first day of March in each year.

        Section 7.04. Financial Reports to Shareholders. The Board shall cause the preparation of financial statements reflecting the financial condition and results of operations of the Corporation as of and for the period ending upon the close of each fiscal year, and shall engage independent certified public accountants to audit such financial statements. The Board shall cause such financial statements and reports of auditors to be furnished to the shareholders, and shall cause such other financial statements, if any, as it deems advisable to be furnished to the shareholders.

        Section 7.05. Waiver of Notices. Whenever notice shall be required to be given by these Bylaws or by the Articles of Incorporation of the Corporation or by the BCL, a written waiver thereof, signed by the person or persons entitled to said notice, whether before or after the time stated therein, shall be deemed equivalent to notice.

        Section 7.06. Facsimile Signatures. In addition to the provisions for use of facsimile signatures elsewhere specifically authorized in these Bylaws, facsimile signatures of any officer or officers of the Corporation may be used whenever and as authorized by the Board or a Committee thereof.

        Section 7.07. Reliance Upon Books, Reports and Records. Each Director, each member of any Committee designated by the Board, and each officer of the Corporation shall, in the performance of his duties, be fully protected in relying in good faith upon the

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books of account or other records of the Corporation, including reports made to the Corporation by any of its officers, by an independent certified public accountant, by independent legal counsel, or by an appraiser.

         Section 7.08. Gender. Any words in the masculine gender in these Bylaws shall be deemed to include the feminine gender.

ARTICLE VIII

Indemnification of Officers and Directors

        Section 8.01. Right to Indemnification. Each person who was or is made a party or is threatened to be made a party to or is otherwise involved in any action, suit or proceeding, whether civil, criminal, administrative or investigative (hereinafter a “proceeding”), whether brought by or in the name of the Corporation or otherwise, by reason of the fact that he is or was a Director or an officer of the Corporation or is or was serving at the request of the Corporation as a Director, officer, employee or agent of another corporation or of a partnership, joint venture, trust or other enterprise, including service with respect to an employee benefit plan (hereinafter an “indemnitee”), whether the basis of such proceeding is alleged action in an official capacity as a Director, officer, employee or agent or in any other capacity while serving as a Director, officer, employee or agent, shall be indemnified and held harmless by the Corporation to the fullest extent authorized by law, including, but not limited to the BCL, as the same exists or may hereafter be amended (but, in the case of such amendment, only to the extent that such amendment permits the Corporation to provide broader indemnification rights than such law permitted the Corporation to provide prior to such amendment), against all expense, liability and loss (including attorneys’ fees, judgments, fines, ERISA excise taxes or

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penalties and amounts paid in settlement) reasonably incurred or suffered by such indemnitee in connection therewith; provided, however, that the Corporation shall indemnify any such indemnitee in connection with a proceeding (or part thereof) initiated by such indemnitee only if such proceeding (or part thereof) was authorized by the Board. For purposes of Section 8.01, 8.02 and 8.03, persons holding the following titles shall be considered officers of the Company: Chief Executive Officer, President, Chief Operating Officer, Chief Legal Officer, Chief Science Officer, and all persons holding the title of Executive Vice President, Senior Vice President or Vice President.

        Section 8.02. Right to Payment of Expenses. The right to indemnification conferred in Section 8.01 shall include the right to be paid by the Corporation the expenses (including attorneys’ fees) incurred in defending any such proceeding prior to its final disposition (hereinafter a “payment of expenses”). The rights to indemnification and to the payment of expenses conferred in Sections 8.01 and 8.02 shall be contract rights and such rights shall continue as to an indemnitee who has ceased to be a Director, officer, employee or agent and shall inure to the benefit of the indemnitee’s heirs, executors and administrators.

        Section 8.03. Right of Indemnitee to Bring Suit. If a claim under Section 8.01 or 8.02 of this Article is not paid in full by the Corporation within sixty (60) days after a written claim has been received by the Corporation, except in the case of a claim for a payment of expenses, in which case the applicable period shall be twenty (20) days, the indemnitee may at any time thereafter bring suit against the Corporation to recover the unpaid amount of the claim. If successful in whole or in part in any such suit, the

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indemnitee also shall be entitled to be paid the expense of prosecuting or defending such suit, including attorney’s fees.

        Section 8.04. Non-Exclusivity of Rights. The rights to indemnification and to the payment of expenses shall not be exclusive of any other right which any person may have or hereafter acquire under any statute, the Corporation’s Articles of Incorporation, Bylaws, any agreement, any vote of shareholders or disinterested directors or otherwise.

        Section 8.05. Insurance. The Corporation may maintain insurance, at its expense, to protect itself and any Director, officer, employee or agent of the Corporation or another corporation, partnership, joint venture, trust or other enterprise against any expense, liability or loss, whether or not the Corporation would have the power to indemnify such person against such expense, liability or loss under the BCL.

        Section 8.06. Indemnification of Other Officers, Employees, Assistants and Agents. The Corporation may, to the extent authorized from time to time by the Board, grant rights to indemnification and to the payment of expenses to any officer not otherwise covered by this Article, to an employee, an assistant or an agent of the Corporation to the fullest extent of the provisions of this Article with respect to the indemnification and payment of expenses of Directors and officers of the Corporation.

        Section 8.07. Other Enterprises, Fines, Serving at Corporation’s Request. For purposes of this Article, references to “other enterprises” shall include employee benefit plans; references to “fines” shall include any excise tax assessed on a person with respect to any employee benefit plan; and references to “serving at the request of the Corporation” shall include any service as a Director, officer, employee or agent of the Corporation which imposes duties on, or involves services by, such Director, officer,

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employee, or agent with respect to any employee benefit plan, its participants, or beneficiaries.

        Section 8.08. Effect of Amendment. Any amendment, repeal or modification of any provision of this Article by the shareholders or the Directors shall not adversely affect any right or protection of a Director or officer existing at the time of such amendment, repeal or modification.

        Section 8.09. Savings Clause. If this Article or any portion hereof shall be invalidated on any ground by any court of competent jurisdiction, then the Corporation shall nevertheless indemnify each indemnitee as to costs, charges and expenses (including attorneys’ fees), judgments, fines and amounts paid in settlement with respect to any action, suit or proceeding, whether civil, criminal, administrative or investigative, to the fullest extent permitted by any applicable portion of this Article that shall not have been invalidated and to the fullest extent permitted by applicable law.

ARTICLE IX

Amendments

         Section 9.01. Amendments. These Amended and Restated Bylaws may be amended, altered and repealed, and new Bylaws may be adopted, by the shareholders or the Board at any regular or special meeting.

ARTICLE X

Inapplicable Subchapters of Business Corporation Law of Pennsylvania

        Section 10.01. Subchapter E. The provisions of Subchapter E to Chapter 25 of the BCL (successor to Section 910 of the BCL) shall not be applicable to this Corporation.

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        Section 10.02. Subchapter G. The provisions of Subchapter G to Chapter 25 of the BCL, as approved April 27, 1990, shall not be applicable to this Corporation.

        Section 10.03. Subchapter H. The provision of Subchapter H to Chapter 25 of the BCL, as approved April 27, 1990, shall not be applicable to this Corporation.

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TABLE OF CONTENTS

ARTICLE I
Shareholders   1
  Section 1.01. Annual Shareholders Meetings   1
  Section 1.02. Special Shareholders Meetings   1
  Section 1.03. Organization   1
  Section 1.04. Business of Shareholders Meetings   2
  Section 1.05. Order of Business   4
ARTICLE II
Directors   4
  Section 2.01. Number, Election and Term of Office   4
  Section 2.02. Filling Vacancies   5
  Section 2.03. Nominations of Directors: Election   5
  Section 2.04. Annual Meeting of the Board   7
  Section 2.05. Regular Board Meetings: Notice   7
  Section 2.06. Special Board Meetings: Notice:   7
  Section 2.07. Action by Consent in Writing   8
  Section 2.08. Organization   8
  Section 2.09. Board Meetings by Telephone   8
  Section 2.10. Resignations   8
  Section 2.11. Qualification of Directors   9
  Section 2.12. Limitation of Director Liability   9
ARTICLE III
Committees   10
  Section 3.01. Executive Committee: How Constituted and Powers   10
  Section 3.02. Organization   10
  Section 3.03. Other Committees   10
  Section 3.04. Procedures   11
  Section 3.05. Action by Consent in Writing   11
  Section 3.06. Meetings by Telephone   11
  Section 3.07. Resignations; Removal; Vacancies   11
ARTICLE IV
Officers   12
  Section 4.01. Officers   12
  Section 4.02. Removal   12
  Section 4.03. Resignations   13
  Section 4.04. Vacancies   13
  Section 4.05. Chief Executive Officer   13
  Section 4.06. President   14
  Section 4.07. Chief Operating Officer   14
  Section 4.08. Chief Financial Officer   15
  Section 4.09. Chief Legal Officer   15
  Section 4.10. Chief Science Officer   15
i
  Section 4.11. Vice Presidents   16
  Section 4.12. The Secretary and Assistant Secretaries   16
  Section 4.13. The Treasurer and Assistant Treasurers   17
  Section 4.14. The Controller and Assistant Controllers   18
ARTICLE V
Shares of Capital Stock   18
  Section 5.01. Share Certificates   18
  Section 5.02. Lost, Stolen, Destroyed or Mutilated Certificates   19
  Section 5.03. Regulations Relating to Shares   20
  Section 5.04. Holders of Record   20
ARTICLE VI
Execution of Instruments   21
Deposit and Withdrawal of Corporate Funds   21
  Section 6.01. Execution of Instruments Generally   21
  Section 6.02. General and Special Bank Accounts   21
ARTICLE VII
General Provisions   21
  Section 7.01. Offices   21
  Section 7.02. Corporate Seal   22
  Section 7.04. Financial Reports to Shareholders   22
  Section 7.05. Waiver of Notices   22
  Section 7.06. Facsimile Signatures   22
  Section 7.07. Reliance Upon Books, Reports and Records   22
  Section 7.08. Gender   23
ARTICLE VIII
Indemnification of Officers and Directors   23
  Section 8.01. Right to Indemnification   23
  Section 8.02. Right to Payment of Expenses   24
  Section 8.03. Right of Indemnitee to Bring Suit   24
  Section 8.04. Non-Exclusivity of Rights   25
  Section 8.05. Insurance   25
  Section 8.06. Indemnification of Employees, Assistants and Agents   25
  Section 8.07. Other Enterprises, Fines, Serving at Corporation's Request   25
  Section 8.08. Effect of Amendment   26
  Section 8.09. Savings Clause   26
ARTICLE IX
Amendments   26
  Section 9.01. Amendments   26
ARTICLE X
Inapplicable Subchapters of Business Corporation Law of Pennsylvania   26
  Section 10.01. Subchapter E   26
  Section 10.02. Subchapter G   27
  Section 10.03. Subchapter H   27
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