ý | QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 |
¨ | TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 |
Delaware | 94-3047598 |
(State or Other Jurisdiction of Incorporation or Organization) | (IRS Employer Identification No.) |
333 Lakeside Drive, Foster City, California | 94404 |
(Address of principal executive offices) | (Zip Code) |
PART I. | ||||
Item 1. | ||||
Item 2. | ||||
Item 3. | ||||
Item 4. | ||||
PART II. | ||||
Item 1. | ||||
Item 1A. | ||||
Item 2. | ||||
Item 3. | ||||
Item 4. | ||||
Item 5. | ||||
Item 6. | ||||
PART I. | FINANCIAL INFORMATION |
ITEM I. | CONSOLIDATED FINANCIAL STATEMENTS |
March 31, 2013 | December 31, 2012 | ||||||
(unaudited) | |||||||
Assets | |||||||
Current assets: | |||||||
Cash and cash equivalents | $ | 1,863,972 | $ | 1,803,694 | |||
Short-term marketable securities | 78,804 | 58,556 | |||||
Accounts receivable, net | 1,945,189 | 1,751,388 | |||||
Inventories | 1,799,618 | 1,744,982 | |||||
Deferred tax assets | 211,938 | 262,641 | |||||
Prepaid taxes | 411,117 | 348,420 | |||||
Prepaid expenses | 134,711 | 102,364 | |||||
Other current assets | 217,748 | 84,302 | |||||
Total current assets | 6,663,097 | 6,156,347 | |||||
Property, plant and equipment, net | 1,125,794 | 1,100,259 | |||||
Long-term portion of prepaid royalties | 179,207 | 175,790 | |||||
Long-term deferred tax assets | 139,663 | 131,107 | |||||
Long-term marketable securities | 688,254 | 719,836 | |||||
Intangible assets, net | 12,077,548 | 11,736,393 | |||||
Goodwill | 1,188,157 | 1,060,919 | |||||
Other long-term assets | 149,948 | 159,187 | |||||
Total assets | $ | 22,211,668 | $ | 21,239,838 | |||
Liabilities and Stockholders’ Equity | |||||||
Current liabilities: | |||||||
Accounts payable | $ | 1,356,372 | $ | 1,327,339 | |||
Accrued government rebates | 875,751 | 745,148 | |||||
Accrued compensation and employee benefits | 152,663 | 236,716 | |||||
Income taxes payable | 19,240 | 13,403 | |||||
Other accrued liabilities | 819,009 | 674,762 | |||||
Deferred revenues | 124,369 | 103,162 | |||||
Current portion of long-term debt and other obligations, net | 942,811 | 1,169,490 | |||||
Total current liabilities | 4,290,215 | 4,270,020 | |||||
Long-term deferred revenues | 32,204 | 20,532 | |||||
Long-term debt, net | 7,054,796 | 7,054,555 | |||||
Long-term income taxes payable | 110,250 | 115,822 | |||||
Long-term deferred tax liabilities | 118,403 | 10,190 | |||||
Other long-term obligations | 213,327 | 217,850 | |||||
Commitments and contingencies (Note 10) | |||||||
Stockholders’ equity: | |||||||
Preferred stock, par value $0.001 per share; 5,000 shares authorized; none outstanding | — | — | |||||
Common stock, par value $0.001 per share; 2,800,000 shares authorized; 1,524,383 and 1,519,163 shares issued and outstanding (1) | 760 | 760 | |||||
Additional paid-in capital | 5,829,126 | 5,649,850 | |||||
Accumulated other comprehensive income (loss) | 20,806 | (45,615 | ) | ||||
Retained earnings | 4,301,539 | 3,704,744 | |||||
Total Gilead stockholders’ equity | 10,152,231 | 9,309,739 | |||||
Noncontrolling interest | 240,242 | 241,130 | |||||
Total stockholders’ equity | 10,392,473 | 9,550,869 | |||||
Total liabilities and stockholders’ equity | $ | 22,211,668 | $ | 21,239,838 |
Three Months Ended | ||||||||
March 31, | ||||||||
2013 | 2012 | |||||||
Revenues: | ||||||||
Product sales | $ | 2,393,568 | $ | 2,208,342 | ||||
Royalty revenues | 134,407 | 71,105 | ||||||
Contract and other revenues | 3,660 | 3,002 | ||||||
Total revenues | 2,531,635 | 2,282,449 | ||||||
Costs and expenses: | ||||||||
Cost of goods sold | 634,448 | 580,931 | ||||||
Research and development | 497,632 | 458,211 | ||||||
Selling, general and administrative | 374,296 | 443,121 | ||||||
Total costs and expenses | 1,506,376 | 1,482,263 | ||||||
Income from operations | 1,025,259 | 800,186 | ||||||
Interest expense | (81,787 | ) | (97,270 | ) | ||||
Other income (expense), net | (3,324 | ) | (34,085 | ) | ||||
Income before provision for income taxes | 940,148 | 668,831 | ||||||
Provision for income taxes | 222,438 | 231,300 | ||||||
Net income | 717,710 | 437,531 | ||||||
Net loss attributable to noncontrolling interest | 4,476 | 4,425 | ||||||
Net income attributable to Gilead | $ | 722,186 | $ | 441,956 | ||||
Net income per share attributable to Gilead common stockholders—basic (1) | $ | 0.47 | $ | 0.29 | ||||
Shares used in per share calculation—basic (1) | 1,521,372 | 1,512,572 | ||||||
Net income per share attributable to Gilead common stockholders—diluted (1) | $ | 0.43 | $ | 0.28 | ||||
Shares used in per share calculation—diluted (1) | 1,665,060 | 1,554,776 |
Three Months Ended | ||||||||
March 31, | ||||||||
2013 | 2012 | |||||||
Net income | $ | 717,710 | $ | 437,531 | ||||
Other comprehensive income (loss): | ||||||||
Net foreign currency translation gain (loss), net of tax | (8,956 | ) | 4,897 | |||||
Available-for-sale securities: | ||||||||
Net unrealized gain (loss), net of tax impact of $(1,016) and $266 | 1,785 | (463 | ) | |||||
Reclassifications to net income, net of tax impact of $(9) and $(519) | (17 | ) | 30,600 | |||||
Net change | 1,768 | 30,137 | ||||||
Cash flow hedges: | ||||||||
Net unrealized gain (loss), net of tax impact of $(1,849) and $1,802 | 74,060 | (48,816 | ) | |||||
Reclassification to net income, net of tax impact of $(11) and $(400) | (451 | ) | (10,827 | ) | ||||
Net change | 73,609 | (59,643 | ) | |||||
Other comprehensive income (loss) | 66,421 | (24,609 | ) | |||||
Comprehensive income | 784,131 | 412,922 | ||||||
Comprehensive loss attributable to noncontrolling interest | 4,476 | 4,425 | ||||||
Comprehensive income attributable to Gilead | $ | 788,607 | $ | 417,347 |
Three Months Ended | ||||||||
March 31, | ||||||||
2013 | 2012 | |||||||
Operating Activities: | ||||||||
Net income | $ | 717,710 | $ | 437,531 | ||||
Adjustments to reconcile net income to net cash provided by operating activities: | ||||||||
Depreciation expense | 23,973 | 19,710 | ||||||
Amortization expense | 50,353 | 46,457 | ||||||
Stock-based compensation expense | 61,767 | 48,731 | ||||||
Excess tax benefits from stock-based compensation | (40,746 | ) | (23,304 | ) | ||||
Tax benefits from employee stock plans | 38,905 | 18,153 | ||||||
Deferred income taxes | 39,301 | 51,385 | ||||||
Other | 8,262 | 13,767 | ||||||
Changes in operating assets and liabilities: | ||||||||
Accounts receivable, net | (231,781 | ) | (196,531 | ) | ||||
Inventories | (57,109 | ) | (26,833 | ) | ||||
Prepaid expenses and other assets | (187,304 | ) | (75,176 | ) | ||||
Accounts payable | 30,792 | 107,652 | ||||||
Income taxes payable | 12,056 | (99,151 | ) | |||||
Accrued liabilities | 173,042 | 110,402 | ||||||
Deferred revenues | 32,880 | 20,176 | ||||||
Net cash provided by operating activities | 672,101 | 452,969 | ||||||
Investing Activities: | ||||||||
Purchases of marketable securities | (62,604 | ) | — | |||||
Proceeds from sales of marketable securities | 65,985 | 56,719 | ||||||
Proceeds from maturities of marketable securities | 6,862 | — | ||||||
Purchases of other investments | — | (25,000 | ) | |||||
Acquisitions, net of cash acquired | (378,645 | ) | (10,751,636 | ) | ||||
Capital expenditures | (38,854 | ) | (23,199 | ) | ||||
Net cash used in investing activities | (407,256 | ) | (10,743,116 | ) | ||||
Financing Activities: | ||||||||
Proceeds from debt financing, net of issuance costs | — | 2,144,733 | ||||||
Proceeds from convertible note hedges | 100,771 | — | ||||||
Proceeds from issuances of common stock | 86,049 | 132,530 | ||||||
Repurchases of common stock | (82,239 | ) | (20,770 | ) | ||||
Repayments of debt financing | (347,896 | ) | (350,000 | ) | ||||
Repayments of other long-term obligations | (20 | ) | (612 | ) | ||||
Excess tax benefits from stock-based compensation | 40,746 | 23,304 | ||||||
Contributions from (distributions to) noncontrolling interest | 3,588 | (73,595 | ) | |||||
Net cash provided by (used in) financing activities | (199,001 | ) | 1,855,590 | |||||
Effect of exchange rate changes on cash | (5,566 | ) | 2,722 | |||||
Net change in cash and cash equivalents | 60,278 | (8,431,835 | ) | |||||
Cash and cash equivalents at beginning of period | 1,803,694 | 9,883,777 | ||||||
Cash and cash equivalents at end of period | $ | 1,863,972 | $ | 1,451,942 | ||||
1. | SUMMARY OF SIGNIFICANT ACCOUNTING POLICIES |
Three Months Ended | ||||||||
March 31, | ||||||||
2013 | 2012 | |||||||
Numerator: | ||||||||
Net income attributable to Gilead | $ | 722,186 | $ | 441,956 | ||||
Denominator: | ||||||||
Weighted-average shares of common stock outstanding used in the calculation of basic net income per share attributable to Gilead common stockholders | 1,521,372 | 1,512,572 | ||||||
Effect of dilutive securities: | ||||||||
Stock options and equivalents | 36,812 | 29,746 | ||||||
Conversion spread related to the May 2013 Notes | 10,703 | 6,846 | ||||||
Conversion spread related to the May 2014 Notes | 25,554 | 3,010 | ||||||
Conversion spread related to the May 2016 Notes | 25,140 | 2,602 | ||||||
Warrants related to the Convertible Notes | 45,479 | — | ||||||
Weighted-average shares of common stock outstanding used in the calculation of diluted net income per share attributable to Gilead common stockholders | 1,665,060 | 1,554,776 |
2. | FAIR VALUE MEASUREMENTS |
• | Level 1 inputs which include quoted prices in active markets for identical assets or liabilities; |
• | Level 2 inputs which include observable inputs other than Level 1 inputs, such as quoted prices for similar assets or liabilities; quoted prices for identical or similar assets or liabilities in markets that are not active; or other inputs that are observable or can be corroborated by observable market data for substantially the full term of the asset or liability. For our marketable securities, we review trading activity and pricing as of the measurement date. When sufficient quoted pricing for identical securities is not available, we use market pricing and other observable market inputs for similar securities obtained from various third-party data providers. These inputs either represent quoted prices for similar assets in active markets or have been derived from observable market data; and |
• | Level 3 inputs which include unobservable inputs that are supported by little or no market activity and that are significant to the fair value of the underlying asset or liability. Level 3 assets and liabilities include those whose fair value measurements are determined using pricing models, discounted cash flow methodologies or similar valuation techniques and significant management judgment or estimation. |
March 31, 2013 | December 31, 2012 | |||||||||||||||||
Type of Borrowing | Description | Carrying Value | Fair Value | Carrying Value | Fair Value | |||||||||||||
Convertible Senior | May 2013 Notes | $ | 342,759 | $ | 825,330 | $ | 419,433 | $ | 815,297 | |||||||||
Convertible Senior | May 2014 Notes | 1,211,072 | 2,696,870 | 1,210,213 | 2,040,363 | |||||||||||||
Convertible Senior | May 2016 Notes | 1,156,632 | 2,704,726 | 1,157,692 | 2,110,938 | |||||||||||||
Senior Unsecured | April 2021 Notes | 993,138 | 1,133,650 | 992,923 | 1,146,990 | |||||||||||||
Senior Unsecured | December 2014 Notes | 749,473 | 771,398 | 749,394 | 772,650 | |||||||||||||
Senior Unsecured | December 2016 Notes | 699,152 | 749,784 | 699,095 | 748,902 | |||||||||||||
Senior Unsecured | December 2021 Notes | 1,247,501 | 1,405,125 | 1,247,428 | 1,420,725 | |||||||||||||
Senior Unsecured | December 2041 Notes | 997,828 | 1,208,000 | 997,810 | 1,252,090 |
March 31, 2013 | December 31, 2012 | ||||||||||||||||||||||||||||||
Level 1 | Level 2 | Level 3 | Total | Level 1 | Level 2 | Level 3 | Total | ||||||||||||||||||||||||
Assets: | |||||||||||||||||||||||||||||||
Debt securities: | |||||||||||||||||||||||||||||||
U.S. treasury securities | $ | 95,855 | $ | — | $ | — | $ | 95,855 | $ | 81,903 | $ | — | $ | — | $ | 81,903 | |||||||||||||||
Money market funds | 1,633,153 | — | — | 1,633,153 | 1,416,355 | — | — | 1,416,355 | |||||||||||||||||||||||
U.S. government agencies securities | — | 218,038 | — | 218,038 | — | 248,952 | — | 248,952 | |||||||||||||||||||||||
Municipal debt securities | — | 12,115 | — | 12,115 | — | 12,088 | — | 12,088 | |||||||||||||||||||||||
Corporate debt securities | — | 355,063 | — | 355,063 | — | 352,718 | — | 352,718 | |||||||||||||||||||||||
Residential mortgage and asset-backed securities | — | 85,987 | — | 85,987 | — | 82,732 | — | 82,732 | |||||||||||||||||||||||
Total debt securities | 1,729,008 | 671,203 | — | 2,400,211 | 1,498,258 | 696,490 | — | 2,194,748 | |||||||||||||||||||||||
Derivatives | — | 43,182 | — | 43,182 | — | 14,823 | — | 14,823 | |||||||||||||||||||||||
$ | 1,729,008 | $ | 714,385 | $ | — | $ | 2,443,393 | $ | 1,498,258 | $ | 711,313 | $ | — | $ | 2,209,571 | ||||||||||||||||
Liabilities: | |||||||||||||||||||||||||||||||
Contingent consideration | $ | — | $ | — | $ | 211,084 | $ | 211,084 | $ | — | $ | — | $ | 205,060 | $ | 205,060 | |||||||||||||||
Derivatives | — | 18,671 | — | 18,671 | — | 65,248 | — | 65,248 | |||||||||||||||||||||||
$ | — | $ | 18,671 | $ | 211,084 | $ | 229,755 | $ | — | $ | 65,248 | $ | 205,060 | $ | 270,308 |
Balance at December 31, 2012 | $ | 205,060 | ||
Additions from new acquisitions | — | |||
Net changes in valuation | 6,024 | |||
Balance at March 31, 2013 | $ | 211,084 |
3. | AVAILABLE-FOR-SALE SECURITIES |
March 31, 2013 | December 31, 2012 | |||||||||||||||||||||||||||||||
Amortized Cost | Gross Unrealized Gains | Gross Unrealized Losses | Estimated Fair Value | Amortized Cost | Gross Unrealized Gains | Gross Unrealized Losses | Estimated Fair Value | |||||||||||||||||||||||||
Debt securities: | ||||||||||||||||||||||||||||||||
U.S. treasury securities | $ | 95,661 | $ | 194 | $ | — | $ | 95,855 | $ | 81,752 | $ | 151 | $ | — | $ | 81,903 | ||||||||||||||||
Money market funds | 1,633,153 | — | — | 1,633,153 | 1,416,356 | — | — | 1,416,356 | ||||||||||||||||||||||||
U.S. government agencies securities | 217,680 | 358 | — | 218,038 | 248,595 | 386 | (29 | ) | 248,952 | |||||||||||||||||||||||
Municipal debt securities | 12,049 | 66 | — | 12,115 | 12,062 | 33 | (7 | ) | 12,088 | |||||||||||||||||||||||
Corporate debt securities | 353,468 | 1,630 | (35 | ) | 355,063 | 351,309 | 1,492 | (84 | ) | 352,717 | ||||||||||||||||||||||
Residential mortgage and asset-backed securities | 86,034 | 96 | (143 | ) | 85,987 | 82,717 | 156 | (141 | ) | 82,732 | ||||||||||||||||||||||
Total | $ | 2,398,045 | $ | 2,344 | $ | (178 | ) | $ | 2,400,211 | $ | 2,192,791 | $ | 2,218 | $ | (261 | ) | $ | 2,194,748 |
March 31, 2013 | December 31, 2012 | ||||||
Cash and cash equivalents | $ | 1,633,153 | $ | 1,416,356 | |||
Short-term marketable securities | 78,804 | 58,556 | |||||
Long-term marketable securities | 688,254 | 719,836 | |||||
Total | $ | 2,400,211 | $ | 2,194,748 |
March 31, 2013 | ||||||||
Amortized Cost | Fair Value | |||||||
Less than one year | $ | 1,711,889 | $ | 1,711,957 | ||||
Greater than one year but less than five years | 661,969 | 664,058 | ||||||
Greater than five years but less than ten years | 9,437 | 9,460 | ||||||
Greater than ten years | 14,750 | 14,736 | ||||||
Total | $ | 2,398,045 | $ | 2,400,211 |
Three Months Ended | ||||||||
March 31, | ||||||||
2013 | 2012 | |||||||
Gross realized gains on sales | $ | 182 | $ | 10,015 | ||||
Gross realized losses on sales | $ | (156 | ) | $ | (40,096 | ) |
Less Than 12 Months | 12 Months or Greater | Total | ||||||||||||||||||||||
Gross Unrealized Losses | Estimated Fair Value | Gross Unrealized Losses | Estimated Fair Value | Gross Unrealized Losses | Estimated Fair Value | |||||||||||||||||||
March 31, 2013 | ||||||||||||||||||||||||
Debt securities: | ||||||||||||||||||||||||
U.S. government agencies securities | $ | — | $ | — | $ | — | $ | — | $ | — | $ | — | ||||||||||||
Municipal debt securities | — | — | — | — | — | — | ||||||||||||||||||
Corporate debt securities | (35 | ) | 47,567 | — | — | (35 | ) | 47,567 | ||||||||||||||||
Residential mortgage and asset-backed securities | (143 | ) | 47,748 | — | — | (143 | ) | 47,748 | ||||||||||||||||
Total | $ | (178 | ) | $ | 95,315 | $ | — | $ | — | $ | (178 | ) | $ | 95,315 | ||||||||||
December 31, 2012 | ||||||||||||||||||||||||
Debt securities: | ||||||||||||||||||||||||
U.S. government agencies securities | $ | (29 | ) | $ | 26,306 | $ | — | $ | — | $ | (29 | ) | $ | 26,306 | ||||||||||
Municipal debt securities | (7 | ) | 3,993 | — | — | (7 | ) | 3,993 | ||||||||||||||||
Corporate debt securities | (84 | ) | 72,722 | — | — | (84 | ) | 72,722 | ||||||||||||||||
Residential mortgage and asset-backed securities | (141 | ) | 36,415 | — | — | (141 | ) | 36,415 | ||||||||||||||||
Total | $ | (261 | ) | $ | 139,436 | $ | — | $ | — | $ | (261 | ) | $ | 139,436 |
4. | DERIVATIVE FINANCIAL INSTRUMENTS |
March 31, 2013 | ||||||||||||
Asset Derivatives | Liability Derivatives | |||||||||||
Classification | Fair Value | Classification | Fair Value | |||||||||
Derivatives designated as hedges: | ||||||||||||
Foreign currency exchange contracts | Other current assets | $ | 33,048 | Other accrued liabilities | $ | 17,915 | ||||||
Foreign currency exchange contracts | Other long-term assets | 9,697 | Other long-term obligations | 106 | ||||||||
Total derivatives designated as hedges | 42,745 | 18,021 | ||||||||||
Derivatives not designated as hedges: | ||||||||||||
Foreign currency exchange contracts | Other current assets | 437 | Other accrued liabilities | 650 | ||||||||
Total derivatives not designated as hedges | 437 | 650 | ||||||||||
Total derivatives | $ | 43,182 | $ | 18,671 |
December 31, 2012 | ||||||||||||
Asset Derivatives | Liability Derivatives | |||||||||||
Classification | Fair Value | Classification | Fair Value | |||||||||
Derivatives designated as hedges: | ||||||||||||
Foreign currency exchange contracts | Other current assets | $ | 14,556 | Other accrued liabilities | $ | 54,597 | ||||||
Foreign currency exchange contracts | Other long-term assets | 142 | Other long-term obligations | 10,630 | ||||||||
Total derivatives designated as hedges | 14,698 | 65,227 | ||||||||||
Derivatives not designated as hedges: | ||||||||||||
Foreign currency exchange contracts | Other current assets | 125 | Other accrued liabilities | 21 | ||||||||
Total derivatives not designated as hedges | 125 | 21 | ||||||||||
Total derivatives | $ | 14,823 | $ | 65,248 |
Three Months Ended | ||||||||
March 31, | ||||||||
2013 | 2012 | |||||||
Derivatives designated as hedges: | ||||||||
Net gains (losses) recognized in OCI (effective portion) | $ | 70,860 | $ | (48,886 | ) | |||
Net gains reclassified from accumulated OCI into product sales (effective portion) | $ | 462 | $ | 11,227 | ||||
Losses recognized in other income (expense), net (ineffective portion and amounts excluded from effectiveness testing) | $ | (2,132 | ) | $ | (3,212 | ) | ||
Derivatives not designated as hedges: | ||||||||
Net gains (losses) recognized in other income (expense), net | $ | 32,620 | $ | (27,174 | ) |
March 31, 2013 | ||||||||||||||||||||||||
Offsetting of Derivative Assets/Liabilities | ||||||||||||||||||||||||
Gross Amounts Not Offset in the Consolidated Balance Sheet | ||||||||||||||||||||||||
Description | Gross Amounts of Recognized Assets/Liabilities | Gross Amounts Offset in the Consolidated Balance Sheet | Amounts of Assets/Liabilities Presented in the Consolidated Balance Sheet | Derivative Financial Instruments | Cash Collateral Received/Pledged | Net Amount (Legal Offset) | ||||||||||||||||||
Derivative assets | $ | 43,182 | $ | — | $ | 43,182 | $ | (18,515 | ) | $ | — | $ | 24,667 | |||||||||||
Derivative liabilities | (18,671 | ) | — | (18,671 | ) | 18,515 | — | (156 | ) |
December 31, 2012 | ||||||||||||||||||||||||
Offsetting of Derivative Assets/Liabilities | ||||||||||||||||||||||||
Gross Amounts Not Offset in the Consolidated Balance Sheet | ||||||||||||||||||||||||
Description | Gross Amounts of Recognized Assets/Liabilities | Gross Amounts Offset in the Consolidated Balance Sheet | Amounts of Assets/Liabilities Presented in the Consolidated Balance Sheet | Derivative Financial Instruments | Cash Collateral Received/Pledged | Net Amount (Legal Offset) | ||||||||||||||||||
Derivative assets | $ | 14,823 | $ | — | $ | 14,823 | $ | (9,644 | ) | $ | — | $ | 5,179 | |||||||||||
Derivative liabilities | (65,248 | ) | — | (65,248 | ) | 9,644 | — | (55,604 | ) |
5. | ACQUISITION |
6. | INVENTORIES |
March 31, 2013 | December 31, 2012 | |||||||
Raw materials | $ | 693,139 | $ | 826,545 | ||||
Work in process | 529,157 | 358,525 | ||||||
Finished goods | 577,322 | 559,912 | ||||||
Total | $ | 1,799,618 | $ | 1,744,982 |
7. | INTANGIBLE ASSETS AND GOODWILL |
March 31, 2013 | December 31, 2012 | |||||||
Indefinite-lived intangible assets | $ | 11,348,900 | $ | 10,986,200 | ||||
Finite-lived intangible assets | 728,648 | 750,193 | ||||||
Total intangible assets | $ | 12,077,548 | $ | 11,736,393 |
March 31, 2013 | December 31, 2012 | |||||||
Indefinite-lived intangible asset - Sofosbuvir | $ | 10,720,000 | $ | 10,720,000 | ||||
Indefinite-lived intangible asset - Momelotinib (formerly CYT387) | 362,700 | — | ||||||
Indefinite-lived intangible assets - Other | 266,200 | 266,200 | ||||||
Total | $ | 11,348,900 | $ | 10,986,200 |
March 31, 2013 | December 31, 2012 | |||||||||||||||
Gross Carrying Amount | Accumulated Amortization | Gross Carrying Amount | Accumulated Amortization | |||||||||||||
Intangible asset - Ranexa | $ | 688,400 | $ | 147,552 | $ | 688,400 | $ | 133,119 | ||||||||
Intangible asset - Lexiscan | 262,800 | 101,902 | 262,800 | 95,466 | ||||||||||||
Other | 42,995 | 16,093 | 42,995 | 15,417 | ||||||||||||
Total | $ | 994,195 | $ | 265,547 | $ | 994,195 | $ | 244,002 |
Fiscal Year | Amount | ||
2013 (remaining nine months) | $ | 64,636 | |
2014 | 92,441 | ||
2015 | 97,673 | ||
2016 | 107,312 | ||
2017 | 116,137 | ||
2018 | 124,561 | ||
Total | $ | 602,760 |
Balance at December 31, 2012 | $ | 1,060,919 | |
Goodwill resulting from the acquisition of YM | 127,238 | ||
Balance at March 31, 2013 | $ | 1,188,157 |
8. | COLLABORATIVE ARRANGEMENTS |
9. | LONG-TERM OBLIGATIONS |
Type of Borrowing | Description | Issue Date | Due Date | Interest Rate | March 31, 2013 | December 31, 2012 | ||||||||||
Convertible Senior | May 2013 Notes | April 2006 | May 2013 | 0.625% | $ | 342,759 | $ | 419,433 | ||||||||
Convertible Senior | May 2014 Notes | July 2010 | May 2014 | 1.00% | 1,211,072 | 1,210,213 | ||||||||||
Convertible Senior | May 2016 Notes | July 2010 | May 2016 | 1.625% | 1,156,632 | 1,157,692 | ||||||||||
Senior Unsecured | April 2021 Notes | March 2011 | April 2021 | 4.50% | 993,138 | 992,923 | ||||||||||
Senior Unsecured | December 2014 Notes | December 2011 | December 2014 | 2.40% | 749,473 | 749,394 | ||||||||||
Senior Unsecured | December 2016 Notes | December 2011 | December 2016 | 3.05% | 699,152 | 699,095 | ||||||||||
Senior Unsecured | December 2021 Notes | December 2011 | December 2021 | 4.40% | 1,247,501 | 1,247,428 | ||||||||||
Senior Unsecured | December 2041 Notes | December 2011 | December 2041 | 5.65% | 997,828 | 997,810 | ||||||||||
Credit Facility | Five-Year Revolver | January 2012 | January 2017 | Variable | 600,000 | 750,000 | ||||||||||
Total debt, net | $ | 7,997,555 | $ | 8,223,988 | ||||||||||||
Less current portion | 942,759 | 1,169,433 | ||||||||||||||
Total long-term debt, net | $ | 7,054,796 | $ | 7,054,555 |
10. | COMMITMENTS AND CONTINGENCIES |
11. | STOCK-BASED COMPENSATION |
Three Months Ended | ||||||||
March 31, | ||||||||
2013 | 2012 | |||||||
Cost of goods sold | $ | 1,841 | $ | 2,101 | ||||
Research and development expenses | 26,875 | 118,622 | ||||||
Selling, general and administrative expenses | 33,051 | 121,945 | ||||||
Stock-based compensation expense included in total costs and expenses | 61,767 | 242,668 | ||||||
Income tax effect | (16,387 | ) | (13,064 | ) | ||||
Stock-based compensation expense, net of tax | $ | 45,380 | $ | 229,604 |
12. | STOCKHOLDERS’ EQUITY |
Foreign Currency Items | Unrealized Gains and Losses on Available-for-Sale Securities | Unrealized Gains and Losses on Cash Flow Hedges | Total | |||||||||||||
Balance at December 31, 2012 | $ | 30,084 | $ | (24,002 | ) | $ | (51,697 | ) | $ | (45,615 | ) | |||||
Other comprehensive income (loss) before reclassifications | (8,956 | ) | 1,785 | 74,060 | 66,889 | |||||||||||
Amounts reclassified from accumulated other comprehensive income | — | (17 | ) | (451 | ) | (468 | ) | |||||||||
Net current period other comprehensive income (loss) | (8,956 | ) | 1,768 | 73,609 | 66,421 | |||||||||||
Balance at March 31, 2013 | $ | 21,128 | $ | (22,234 | ) | $ | 21,912 | $ | 20,806 |
13. | SEGMENT INFORMATION |
Three Months Ended | ||||||||
March 31, | ||||||||
2013 | 2012 | |||||||
Antiviral products: | ||||||||
Atripla | $ | 877,073 | $ | 887,596 | ||||
Truvada | 700,242 | 758,263 | ||||||
Viread | 210,332 | 191,693 | ||||||
Complera/Eviplera | 148,189 | 52,180 | ||||||
Stribild | 92,148 | — | ||||||
Hepsera | 26,423 | 29,297 | ||||||
Emtriva | 6,671 | 6,777 | ||||||
Total antiviral products | 2,061,078 | 1,925,806 | ||||||
Letairis | 118,107 | 87,288 | ||||||
Ranexa | 96,286 | 83,201 | ||||||
AmBisome | 85,275 | 84,764 | ||||||
Other products | 32,822 | 27,283 | ||||||
Total product sales | $ | 2,393,568 | $ | 2,208,342 |
Three Months Ended | ||||||
March 31, | ||||||
2013 | 2012 | |||||
Cardinal Health, Inc. | 19 | % | 20 | % | ||
McKesson Corp. | 14 | % | 16 | % | ||
AmerisourceBergen Corp. | 11 | % | 11 | % |
14. | INCOME TAXES |
ITEM 2. | MANAGEMENT’S DISCUSSION AND ANALYSIS OF FINANCIAL CONDITION AND RESULTS OF OPERATIONS |
• | Initiated two Phase 3 clinical trials evaluating a single tablet regimen containing tenofovir alafenamide (TAF) for the treatment of HIV-1 infection in treatment-naïve adults; |
• | Announced Phase 2 study results evaluating a once-daily single tablet regimen containing TAF was similar to a regimen of Stribild; |
• | Reached an agreement with Teva Pharmaceuticals (Teva) to settle ongoing patent litigation under which Teva will be allowed to launch a generic version of Viread on December 15, 2017; and |
• | The scientific committee of the European Medicines Agency adopted a positive opinion on our marketing authorisation application for Stribild. |
• | Announced full clinical trial results of the Phase 2 ELECTRON study that confirmed all patients achieved a sustained virologic response (SVR) four weeks after stopping therapy; |
• | Initiated and provided an update on the Phase 3 ION-1 study evaluating a once-daily fixed-dose combination of sofosbuvir/ledipasvir with and without ribavirin (RBV) for 12 or 24 weeks in treatment naïve genotype 1 HCV patients. A planned review by the study's Data and Safety Monitoring Board of safety data concluded that the trial should continue without modification; |
• | Began screening and completed enrollment in the second Phase 3 ION-2 study evaluating sofosbuvir/ledipasvir with RBV for 12 weeks, and with and without RBV for 24 weeks, in treatment-experienced genotype 1 HCV patients; |
• | Enrolled patients in the Phase 2 LONESTAR study of sofosbuvir/ledipasvir with and without RBV for eight weeks and of sofosbuvir/ledipasvir for 12 weeks in genotype 1 treatment-naïve patients; |
• | Announced topline results from the Phase 3 FISSION study, evaluating therapy with either a 12-week course of sofosbuvir plus RBV or standard of care with 24 weeks of treatment with pegylated interferon (peg-IFN) plus RBV in genotype 2 or 3 HCV patients which met its primary efficacy endpoint of non-inferiority; and |
• | Announced topline results from the Phase 3 NEUTRINO and FUSION studies, evaluating 12- and 16-week courses of various therapies with sofosbuvir, RBV and peg-IFN in genotypes 1, 2, 3, 4, 5 and 6 HCV patients. The studies met their primary efficacy endpoints of superiority compared to a predefined historic control SVR rate. |
Three Months Ended | |||||||||||
March 31, | |||||||||||
2013 | 2012 | Change | |||||||||
Antiviral products: | |||||||||||
Atripla | $ | 877,073 | $ | 887,596 | (1 | )% | |||||
Truvada | 700,242 | 758,263 | (8 | )% | |||||||
Viread | 210,332 | 191,693 | 10 | % | |||||||
Complera/Eviplera | 148,189 | 52,180 | 184 | % | |||||||
Stribild | 92,148 | — | — | ||||||||
Hepsera | 26,423 | 29,297 | (10 | )% | |||||||
Emtriva | 6,671 | 6,777 | (2 | )% | |||||||
Total antiviral products | 2,061,078 | 1,925,806 | 7 | % | |||||||
Letairis | 118,107 | 87,288 | 35 | % | |||||||
Ranexa | 96,286 | 83,201 | 16 | % | |||||||
AmBisome | 85,275 | 84,764 | 1 | % | |||||||
Other | 32,822 | 27,283 | 20 | % | |||||||
Total product sales | $ | 2,393,568 | $ | 2,208,342 | 8 | % |
• | Atripla |
• | Truvada |
• | Complera/Eviplera |
• | Stribild |
Three Months Ended | |||||||||||
March 31, | |||||||||||
2013 | 2012 | Change | |||||||||
Royalty revenues | $ | 134,407 | $ | 71,105 | 89 | % |
Three Months Ended | |||||||||||
March 31, | |||||||||||
2013 | 2012 | Change | |||||||||
Total product sales | $ | 2,393,568 | $ | 2,208,342 | 8 | % | |||||
Cost of goods sold | $ | 634,448 | $ | 580,931 | 9 | % | |||||
Product gross margin | 73 | % | 74 | % |
Three Months Ended | |||||||||||
March 31, | |||||||||||
(In thousands, except percentages) | 2013 | 2012 | Change | ||||||||
Research and development | $ | 497,632 | $ | 458,211 | 9 | % |
Three Months Ended | |||||||||||
March 31, | |||||||||||
(In thousands, except percentages) | 2013 | 2012 | Change | ||||||||
Selling, general and administrative | $ | 374,296 | $ | 443,121 | (16 | )% |
March 31, 2013 | December 31, 2012 | ||||||
Cash, cash equivalents and marketable securities | $ | 2,631,030 | $ | 2,582,086 | |||
Working capital | $ | 2,372,882 | $ | 1,886,327 |
Three Months Ended | |||||||
March 31, | |||||||
2013 | 2012 | ||||||
Cash provided by (used in): | |||||||
Operating activities | $ | 672,101 | $ | 452,969 | |||
Investing activities | $ | (407,256 | ) | $ | (10,743,116 | ) | |
Financing activities | $ | (199,001 | ) | $ | 1,855,590 |
Type of Borrowing | Description | Issue Date | Due Date | Interest Rate | March 31, 2013 | December 31, 2012 | ||||||||||
Convertible Senior | May 2013 Notes | April 2006 | May 2013 | 0.625% | $ | 342,759 | $ | 419,433 | ||||||||
Convertible Senior | May 2014 Notes | July 2010 | May 2014 | 1.00% | 1,211,072 | 1,210,213 | ||||||||||
Convertible Senior | May 2016 Notes | July 2010 | May 2016 | 1.625% | 1,156,632 | 1,157,692 | ||||||||||
Senior Unsecured | April 2021 Notes | March 2011 | April 2021 | 4.50% | 993,138 | 992,923 | ||||||||||
Senior Unsecured | December 2014 Notes | December 2011 | December 2014 | 2.40% | 749,473 | 749,394 | ||||||||||
Senior Unsecured | December 2016 Notes | December 2011 | December 2016 | 3.05% | 699,152 | 699,095 | ||||||||||
Senior Unsecured | December 2021 Notes | December 2011 | December 2021 | 4.40% | 1,247,501 | 1,247,428 | ||||||||||
Senior Unsecured | December 2041 Notes | December 2011 | December 2041 | 5.65% | 997,828 | 997,810 | ||||||||||
Credit Facility | Five-Year Revolver | January 2012 | January 2017 | Variable | 600,000 | 750,000 | ||||||||||
Total debt, net | $ | 7,997,555 | $ | 8,223,988 | ||||||||||||
Less current portion | 942,759 | 1,169,433 | ||||||||||||||
Total long-term debt, net | $ | 7,054,796 | $ | 7,054,555 |
ITEM 3. | QUANTITATIVE AND QUALITATIVE DISCLOSURES ABOUT MARKET RISK |
ITEM 4. | CONTROLS AND PROCEDURES |
PART II. | OTHER INFORMATION |
ITEM 1. | LEGAL PROCEEDINGS |
ITEM 1A. | RISK FACTORS |
• | As our HIV products are used over a longer period of time in many patients and in combination with other products, and additional studies are conducted, new issues with respect to safety, resistance and interactions with other drugs may arise, which could cause us to provide additional warnings or contraindications on our labels, narrow our approved indications or halt sales of a product, each of which could reduce our revenues. |
• | As our HIV products mature, private insurers and government payers often reduce the amount they will reimburse patients for these products, which increases pressure on us to reduce prices. |
• | A large part of the market for our HIV products consists of patients who are already taking other HIV drugs. If we are not successful in encouraging physicians to change patients' regimens to include our HIV products, the sales of our HIV products will be limited. |
• | As generic HIV products are introduced into major markets, our ability to maintain pricing and market share may be affected. |
• | our minimum base rebate amount owed to Medicaid on products reimbursed by Medicaid increased by 8%, and the discounts or rebates we owe to ADAPs and other Public Health Service entities which reimburse or purchase our products also increased by 8%; |
• | we are required to extend rebates to patients receiving our products through Medicaid managed care organizations; |
• | we are required to provide a 50% discount on products sold to patients while they are in the Medicare Part D “donut hole;” and |
• | we, along with other pharmaceutical manufacturers of branded drug products, were required to pay a portion of a new industry fee (also known as the pharmaceutical excise tax) of $2.8 billion for 2012, calculated based on select government sales during the 2010 calendar year as a percentage of total industry government sales. |
• | we are unable to control the resources our corporate partners devote to our programs or products; |
• | disputes may arise with respect to the ownership of rights to technology developed with our corporate partners; |
• | disagreements with our corporate partners could cause delays in, or termination of, the research, development or commercialization of product candidates or result in litigation or arbitration; |
• | contracts with our corporate partners may fail to provide significant protection or may fail to be effectively enforced if one of these partners fails to perform; |
• | our corporate partners have considerable discretion in electing whether to pursue the development of any additional products and may pursue alternative technologies or products either on their own or in collaboration with our competitors; |
• | our corporate partners with marketing rights may choose to pursue competing technologies or to devote fewer resources to the marketing of our products than they do to products of their own development; and |
• | our distributors and our corporate partners may be unable to pay us, particularly in light of current economic conditions. |
• | not provide us with accurate or timely information regarding their inventories, patient data or safety complaints; |
• | not effectively sell or support Cayston or Letairis; |
• | not devote the resources necessary to sell Cayston or Letairis in the volumes and within the time frames that we expect; |
• | not be able to satisfy their financial obligations to us or others; or |
• | cease operations. |
• | obtain patents and licenses to patent rights; |
• | preserve trade secrets; |
• | defend against infringement and efforts to invalidate our patents; and |
• | operate without infringing on the property of others. |
March 31, 2013 | ||||||||
Greater than 120 days past due | Greater than 365 days past due | |||||||
Italy | $ | 99,239 | $ | 37,303 | ||||
Spain | 141,460 | 7,938 | ||||||
Portugal | 74,654 | 62,934 | ||||||
Greece | 33,178 | 5,957 | ||||||
Total | $ | 348,531 | $ | 114,132 |
ITEM 2. | UNREGISTERED SALES OF EQUITY SECURITIES AND USE OF PROCEEDS |
Total Number of Shares Purchased | Average Price Paid per Share | Total Number of Shares Purchased as Part of Publicly Announced Program | (1) | Maximum Fair Value of Shares that May Yet Be Purchased Under the Program | (1) | |||||||||
January 1 – January 31, 2013 | 1,843 | $ | 38.84 | 1,785 | $ | 3,860,776 | ||||||||
February 1 – February 28, 2013 | 1,291 | $ | 40.75 | 321 | $ | 3,847,868 | ||||||||
March 1 – March 31, 2013 | 199 | $ | 45.87 | — | $ | 3,847,868 | ||||||||
Total | 3,333 | (2) | $ | 40.00 | 2,106 | (2) |
(1) | In January 2011, we announced that our Board authorized a $5.00 billion stock repurchase program, which expires in January 2014. |
(2) | The difference between the total number of shares purchased and the total number of shares purchased as part of publicly announced programs is due to the equivalent value in shares of common stock withheld by us from employee restricted stock awards in order to satisfy our applicable tax withholding obligations. |
ITEM 3. | DEFAULTS UPON SENIOR SECURITIES |
ITEM 4. | MINE SAFETY DISCLOSURES |
ITEM 5. | OTHER INFORMATION |
Exhibit Footnote | Exhibit Number | Description of Document | ||
√(1) | 2.1 | Agreement and Plan of Merger among Registrant, Apex Merger Sub, Inc. and CV Therapeutics, Inc., dated as of March 12, 2009 | ||
†(2) | 2.5 | Agreement and Plan of Merger among Registrant, Merger Sub and Pharmasset, Inc., dated as of November 21, 2011 | ||
(3) | 3.1 | Amended and Restated Certificate of Incorporation of Registrant, as amended and restated on May 8, 2013 | ||
(4) | 3.2 | Amended and Restated Bylaws of Registrant, as amended and restated on May 12, 2011 | ||
4.1 | Reference is made to Exhibit 3.1 and Exhibit 3.2 | |||
(5) | 4.2 | Indenture related to the Convertible Senior Notes due 2013 (2013 Notes), between Registrant and Wells Fargo Bank, National Association, as trustee (including form of 0.625% Convertible Senior Note due 2013), dated April 25, 2006 | ||
(6) | 4.3 | Indenture related to the Convertible Senior Notes due 2014 (2014 Notes), between Registrant and Wells Fargo Bank, National Association, as trustee (including form of 1.00% Convertible Senior Note due 2014), dated July 30, 2010 | ||
(6) | 4.4 | Indenture related to the Convertible Senior Notes due 2016 (2016 Notes), between Registrant and Wells Fargo Bank, National Association, as trustee (including form of 1.625% Convertible Senior Note due 2016), dated July 30, 2010 | ||
(7) | 4.5 | Indenture related to Senior Notes, dated as of March 30, 2011, between Registrant and Wells Fargo, National Association, as Trustee | ||
(7) | 4.6 | First Supplemental Indenture related to Senior Notes, dated as of March 30, 2011, between Registrant and Wells Fargo, National Association, as Trustee (including form of Senior Notes) | ||
(8) | 4.7 | Second Supplemental Indenture related to Senior Notes, dated as of December 13, 2011, between Registrant and Wells Fargo, National Association, as Trustee (including Form of 2014 Note, Form of 2016 Note, Form of 2021 Note, Form of 2041 Note) | ||
(9) | 10.1 | Confirmation of OTC Convertible Note Hedge related to 2013 Notes, dated April 19, 2006, as amended and restated as of April 24, 2006, between Registrant and Bank of America, N.A. | ||
(9) | 10.2 | Confirmation of OTC Warrant Transaction, dated April 19, 2006, as amended and restated as of April 24, 2006, between Registrant and Bank of America, N.A. for warrants expiring in 2013 | ||
(10) | 10.3 | Confirmation of OTC Convertible Note Hedge related to 2014 Notes, dated July 26, 2010, between Registrant and Goldman, Sachs & Co. | ||
(10) | 10.4 | Confirmation of OTC Convertible Note Hedge related to 2014 Notes, dated July 26, 2010, between Registrant and JPMorgan Chase Bank, National Association | ||
(10) | 10.5 | Confirmation of OTC Convertible Note Hedge related to 2016 Notes, dated July 26, 2010, between Registrant and Goldman, Sachs & Co. | ||
(10) | 10.6 | Confirmation of OTC Convertible Note Hedge related to 2016 Notes, dated July 26, 2010, between Registrant and JPMorgan Chase Bank, National Association | ||
(10) | 10.7 | Confirmation of OTC Warrant Transaction, dated July 26, 2010, between Registrant and Goldman, Sachs & Co. for warrants expiring in 2014 | ||
(10) | 10.8 | Confirmation of OTC Warrant Transaction, dated July 26, 2010, between Registrant and JPMorgan Chase Bank, National Association for warrants expiring in 2014 | ||
(10) | 10.9 | Confirmation of OTC Warrant Transaction, dated July 26, 2010, between Registrant and Goldman, Sachs & Co. for warrants expiring in 2016 | ||
(10) | 10.10 | Confirmation of OTC Warrant Transaction, dated July 26, 2010, between Registrant and JPMorgan Chase Bank, National Association for warrants expiring in 2016 |
Exhibit Footnote | Exhibit Number | Description of Document | ||
(11) | 10.11 | Confirmation of OTC Additional Convertible Note Hedge related to 2014 Notes, dated August 5, 2010, between Registrant and Goldman, Sachs & Co. | ||
(11) | 10.12 | Confirmation of OTC Additional Convertible Note Hedge related to 2014 Notes, dated August 5, 2010, between Registrant and JPMorgan Chase Bank, National Association | ||
(11) | 10.13 | Confirmation of OTC Additional Convertible Note Hedge related to 2016 Notes, dated August 5, 2010, between Registrant and Goldman, Sachs & Co. | ||
(11) | 10.14 | Confirmation of OTC Additional Convertible Note Hedge related to 2016 Notes, dated August 5, 2010, between Registrant and JPMorgan Chase Bank, National Association | ||
(11) | 10.15 | Confirmation of OTC Additional Warrant Transaction, dated August 5, 2010, between Registrant and Goldman, Sachs & Co. for warrants expiring in 2014 | ||
(11) | 10.16 | Confirmation of OTC Additional Warrant Transaction, dated August 5, 2010, between Registrant and JPMorgan Chase Bank, National Association for warrants expiring in 2014 | ||
(11) | 10.17 | Confirmation of OTC Additional Warrant Transaction, dated August 5, 2010, between Registrant and Goldman, Sachs & Co. for warrants expiring in 2016 | ||
(11) | 10.18 | Confirmation of OTC Additional Warrant Transaction, dated August 5, 2010, between Registrant and JPMorgan Chase Bank, National Association for warrants expiring in 2016 | ||
(11) | 10.19 | Amendment to Confirmation of OTC Convertible Note Hedge related to 2014 Notes, dated August 30, 2010, between Registrant and Goldman, Sachs & Co. | ||
(11) | 10.20 | Amendment to Confirmation of OTC Convertible Note Hedge related to 2014 Notes, dated August 30, 2010, between Registrant and JPMorgan Chase Bank, National Association | ||
(11) | 10.21 | Amendment to Confirmation of OTC Convertible Note Hedge related to 2016 Notes, dated August 30, 2010, between Registrant and Goldman, Sachs & Co. | ||
(11) | 10.22 | Amendment to Confirmation of OTC Convertible Note Hedge related to 2016 Notes, dated August 30, 2010, between Registrant and JPMorgan Chase Bank, National Association | ||
(11) | 10.23 | Amendment to Confirmation of OTC Additional Convertible Note Hedge related to 2014 Notes, dated August 30, 2010, between Registrant and Goldman, Sachs & Co. | ||
(11) | 10.24 | Amendment to Confirmation of OTC Additional Convertible Note Hedge related to 2014 Notes, dated August 30, 2010, between Registrant and JPMorgan Chase Bank, National Association | ||
(11) | 10.25 | Amendment to Confirmation of OTC Additional Convertible Note Hedge related to 2016 Notes, dated August 30, 2010, between Registrant and Goldman, Sachs & Co. | ||
(11) | 10.26 | Amendment to Confirmation of OTC Additional Convertible Note Hedge related to 2016 Notes, dated August 30, 2010, between Registrant and JPMorgan Chase Bank, National Association | ||
(12) | 10.27 | 5-Year Revolving Credit Facility Credit Agreement among Registrant and Gilead Biopharmaceutics Ireland Corporation, as Borrowers, Bank of America, N.A., as Administrative Agent, Swing Line Lender and L/C Issuer, certain other lenders parties thereto, Barclays Capital, as Syndication Agent, and Goldman Sachs Bank USA, JPMorgan Chase Bank, N.A., Royal Bank of Canada and Wells Fargo Bank, N.A., as Co-Documentation Agents, dated as of January 12, 2012 | ||
(12) | 10.28 | Parent Guaranty Agreement (5-Year Revolving Credit Facility), dated as of January 12, 2012, by Registrant | ||
*(13) | 10.29 | Gilead Sciences, Inc. 1991 Stock Option Plan, as amended through January 29, 2003 | ||
*(14) | 10.30 | Form of option agreements used under the 1991 Stock Option Plan | ||
*(13) | 10.31 | Gilead Sciences, Inc. 1995 Non-Employee Directors' Stock Option Plan, as amended through January 30, 2002 | ||
Exhibit Footnote | Exhibit Number | Description of Document | ||
*(14) | 10.32 | Form of option agreement used under the Gilead Sciences, Inc. 1995 Non-Employee Directors' Stock Option Plan | ||
*(16) | 10.33 | Gilead Sciences, Inc. 2004 Equity Incentive Plan, as amended through May 6, 2009 | ||
*(17) | 10.34 | Form of employee stock option agreement used under 2004 Equity Incentive Plan (for grants prior to February 2008) | ||
*(18) | 10.35 | Form of employee stock option agreement used under 2004 Equity Incentive Plan (for grants made February 2008 through April 2009) | ||
*(19) | 10.36 | Form of employee stock option agreement used under 2004 Equity Incentive Plan (for grants commencing in May 2009) | ||
*(20) | 10.37 | Form of employee stock option agreement used under 2004 Equity Incentive Plan (for grants commencing in February 2010) | ||
*(21) | 10.38 | Form of employee stock option agreement used under 2004 Equity Incentive Plan (for 2011 and subsequent year grants) | ||
*(18) | 10.39 | Form of non-employee director stock option agreement used under 2004 Equity Incentive Plan (for grants prior to 2008) | ||
*(18) | 10.40 | Form of non-employee director option agreement used under 2004 Equity Incentive Plan (for initial grants made in 2008) | ||
*(18) | 10.41 | Form of non-employee director option agreement used under 2004 Equity Incentive Plan (for annual grants made in May 2008) | ||
*(19) | 10.42 | Form of non-employee director option agreement used under 2004 Equity Incentive Plan (for annual grants commencing in May 2009) | ||
*(22) | 10.43 | Form of restricted stock unit issuance agreement used under 2004 Equity Incentive Plan (for annual grants to non-employee directors commencing in May 2012) | ||
*(19) | 10.44 | Form of restricted stock award agreement used under 2004 Equity Incentive Plan (for annual grants to certain non-employee directors prior to May 2012) | ||
*(19) | 10.45 | Form of performance share award agreement used under the 2004 Equity Incentive Plan (for grants to certain executive officers made in 2009) | ||
*(20) | 10.46 | Form of performance share award agreement used under the 2004 Equity Incentive Plan (for grants to certain executive officers made in 2010) | ||
*(21) | 10.47 | Form of performance share award agreement used under the 2004 Equity Incentive Plan (for grants to certain executive officers made in 2011) | ||
*(23) | 10.48 | Form of performance share award agreement used under the 2004 Equity Incentive Plan (for grants to certain executive officers made in 2012) | ||
* | 10.49 | Form of performance share award agreement used under the 2004 Equity Incentive Plan (for TSR Goals in 2013) | ||
* | 10.50 | Form of performance share award agreement used under the 2004 Equity Incentive Plan (for Revenue Goals in 2013) | ||
*(24) | 10.51 | Form of restricted stock unit issuance agreement used under the 2004 Equity Incentive Plan (for grants to certain executive officers made prior to May 2009) | ||
*(19) | 10.52 | Form of restricted stock unit issuance agreement used under the 2004 Equity Incentive Plan (for grants to certain executive officers commencing in May 2009) | ||
*(25) | 10.53 | Form of restricted stock unit issuance agreement used under the 2004 Equity Incentive Plan (service-based vesting for certain executive officers commencing in November 2009) | ||
Exhibit Footnote | Exhibit Number | Description of Document | ||
*(21) | 10.54 | Form of restricted stock unit issuance agreement used under the 2004 Equity Incentive Plan (service-based vesting for certain executive officers commencing in 2011) | ||
*(20) | 10.55 | Gilead Sciences, Inc. Employee Stock Purchase Plan, amended and restated on November 3, 2009 | ||
*(26) | 10.56 | Gilead Sciences, Inc. International Employee Stock Purchase Plan, adopted November 3, 2009 | ||
*(27) | 10.57 | Gilead Sciences, Inc. Deferred Compensation Plan-Basic Plan Document | ||
*(27) | 10.58 | Gilead Sciences, Inc. Deferred Compensation Plan-Adoption Agreement | ||
*(27) | 10.59 | Addendum to the Gilead Sciences, Inc. Deferred Compensation Plan | ||
*(28) | 10.60 | Gilead Sciences, Inc. 2005 Deferred Compensation Plan, as amended and restated on October 23, 2008 | ||
*(23) | 10.61 | Gilead Sciences, Inc. Severance Plan, as amended on January 26, 2012 | ||
*(17) | 10.62 | Gilead Sciences, Inc. Corporate Bonus Plan | ||
*(4) | 10.63 | Amended and Restated Gilead Sciences, Inc. Code Section 162(m) Bonus Plan | ||
*(29) | 10.64 | 2013 Base Salaries for the Named Executive Officers | ||
*(30) | 10.65 | Offer Letter dated April 16, 2008 between Registrant and Robin Washington | ||
*(14) | 10.66 | Form of Indemnity Agreement entered into between Registrant and its directors and executive officers | ||
*(14) | 10.67 | Form of Employee Proprietary Information and Invention Agreement entered into between Registrant and certain of its officers and key employees | ||
*(20) | 10.68 | Form of Employee Proprietary Information and Invention Agreement entered into between Registrant and certain of its officers and key employees (revised in September 2006) | ||
(31) | 10.69 | Amended and Restated Collaboration Agreement by and among Registrant, Gilead Holdings, LLC, Bristol-Myers Squibb Company, E.R. Squibb & Sons, L.L.C., and Bristol-Myers Squibb & Gilead Sciences, LLC, dated September 28, 2006 | ||
(18) | 10.70 | Commercialization Agreement by and between Gilead Sciences Limited and Bristol-Myers Squibb Company, dated December 10, 2007 | ||
(32) | 10.71 | Amendment Agreement, dated October 25, 1993, between Registrant, the Institute of Organic Chemistry and Biochemistry (IOCB) and Rega Stichting v.z.w. (REGA), together with the following exhibits: the License Agreement, dated December 15, 1991, between Registrant, IOCB and REGA (the 1991 License Agreement), the License Agreement, dated October 15, 1992, between Registrant, IOCB and REGA (the October 1992 License Agreement) and the License Agreement, dated December 1, 1992, between Registrant, IOCB and REGA (the December 1992 License Agreement) | ||
(33) | 10.72 | Amendment Agreement between Registrant and IOCB/REGA, dated December 27, 2000 amending the 1991 License Agreement and the December 1992 License Agreement | ||
(31) | 10.73 | Sixth Amendment Agreement to the License Agreement, between IOCB/REGA and Registrant, dated August 18, 2006 amending the October 1992 License Agreement and the December 1992 License Agreement | ||
(31) | 10.74 | Development and License Agreement among Registrant and F. Hoffmann-La Roche Ltd and Hoffmann-La Roche Inc., dated September 27, 1996 | ||
(34) | 10.75 | First Amendment and Supplement dated November 15, 2005 to the Development and Licensing Agreement between Registrant, F. Hoffmann-La Roche Ltd and Hoffman-La Roche Inc. dated September 27, 1996 | ||
Exhibit Footnote | Exhibit Number | Description of Document | ||
(35) | 10.76 | Second Amendment dated December 22, 2011 to the Development and Licensing Agreement between Registrant, F. Hoffmann-La Roche Ltd and Hoffman-La Roche Inc. dated September 27, 1996 | ||
+ (36) | 10.77 | Third Amendment dated October 5, 2012 to the Development and Licensing Agreement between Registrant, F. Hoffmann-La Roche Ltd and Hoffman-La Roche Inc. dated September 27, 1996 | ||
(37) | 10.78 | Exclusive License Agreement between Registrant (as successor to Triangle Pharmaceuticals, Inc.), Glaxo Group Limited, The Wellcome Foundation Limited, Glaxo Wellcome Inc. and Emory University, dated May 6, 1999 | ||
(38) | 10.79 | Royalty Sale Agreement by and among Registrant, Emory University and Investors Trust & Custodial Services (Ireland) Limited, solely in its capacity as Trustee of Royalty Pharma, dated July 18, 2005 | ||
(38) | 10.80 | Amended and Restated License Agreement between Registrant, Emory University and Investors Trust & Custodial Services (Ireland) Limited, solely in its capacity as Trustee of Royalty Pharma, dated July 21, 2005 | ||
(39) | 10.81 | License Agreement between Japan Tobacco Inc. and Registrant, dated March 22, 2005 | ||
(40) | 10.82 | First Amendment to License Agreement between Japan Tobacco Inc. and Registrant, dated May 19, 2005 | ||
(40) | 10.83 | Second Amendment to License Agreement between Japan Tobacco Inc. and Registrant, dated May 17, 2010 | ||
(40) | 10.84 | Third Amendment to License Agreement between Japan Tobacco Inc. and Registrant, dated July 5, 2011 | ||
(40) | 10.85 | Fourth Amendment to License Agreement between Japan Tobacco Inc. and Registrant, dated July 5, 2011 | ||
(41) | 10.86 | License Agreement between Registrant (as successor to Myogen, Inc.) and Abbott Deutschland Holding GmbH dated October 8, 2001 | ||
+(42) | 10.87 | License Agreement between Registrant (as successor to Myogen, Inc.) and Glaxo Group Limited, dated March 3, 2006 | ||
(41) | 10.88 | License Agreement between Registrant (as successor to CV Therapeutics, Inc.) and Roche Palo Alto LLC (successor in interest by merger to Syntex (U.S.A.) Inc.), dated March 27, 1996 | ||
(43) | 10.89 | First Amendment to License Agreement between Registrant (as successor to CV Therapeutics, Inc.) and Roche Palo Alto LLC (successor in interest by merger to Syntex (U.S.A.) Inc.), dated July 3, 1997 | ||
(43) | 10.90 | Amendment No. 2 to License Agreement between Registrant (as successor to CV Therapeutics, Inc.) and Roche Palo Alto LLC (successor in interest by merger to Syntex (U.S.A.) Inc.), dated November 30. 1999 | ||
(44) | 10.91 | Amendment No. 4 to License Agreement with Registrant (as successor to CV Therapeutics, Inc.) and Roche Palo Alto LLC (successor in interest by merger to Syntex (U.S.A.) Inc.), dated June 20, 2006 | ||
(35) | 10.92 | Amendment No. 5 to License Agreement with Registrant (as successor to CV Therapeutics, Inc.) and Roche Palo Alto LLC (successor in interest by merger to Syntex (U.S.A.) Inc.), dated December 22, 2011 | ||
(45) | 10.93 | License and Collaboration Agreement by and among Registrant, Gilead Sciences Limited and Janssen R&D Ireland (formerly Tibotec Pharmaceuticals), dated July 16, 2009 | ||
(40) | 10.94 | Second Amendment to License and Collaboration Agreement by and among Registrant, Gilead Sciences Limited and Janssen R&D Ireland (formerly Tibotec Pharmaceuticals), dated July 1, 2011 | ||
Exhibit Footnote | Exhibit Number | Description of Document | ||
+ | 10.95 | Amended and Restated Second Amendment to License and Collaboration Agreement by and among Registrant, Gilead Sciences Limited and Janssen R&D Ireland (formerly Tibotec Pharmaceuticals), dated February 7, 2013 | ||
(46) | 10.96 | Master Clinical and Commercial Supply Agreement between Gilead World Markets, Limited, Registrant and Patheon Inc., dated January 1, 2003 | ||
(38) | 10.97 | Tenofovir Disoproxil Fumarate Manufacturing Supply Agreement by and between Gilead Sciences Limited and PharmaChem Technologies (Grand Bahama), Ltd., dated July 17, 2003 | ||
(47) | 10.98 | Addendum to Tenofovir Disoproxil Fumarate Manufacturing Supply Agreement by and between Gilead Sciences Limited and PharmaChem Technologies (Grand Bahama) Ltd., dated May 10, 2007 | ||
(28) | 10.99 | Addendum to Tenofovir Disoproxil Fumarate Manufacturing Supply Agreement by and between Gilead Sciences Limited and PharmaChem Technologies (Grand Bahama) Ltd., dated December 5, 2008 | ||
(21) | 10.100 | Addendum to Tenofovir Disoproxil Fumarate Manufacturing Supply Agreement by and between Gilead Sciences Limited and PharmaChem Technologies (Grand Bahama) Ltd., dated February 3. 2011 | ||
(34) | 10.101 | Restated and Amended Toll Manufacturing Agreement between Gilead Sciences Limited, Registrant and Nycomed GmbH (formerly ALTANA Pharma Oranienburg GmbH), dated November 7, 2005 | ||
+(9) | 10.102 | Emtricitabine Manufacturing Supply Agreement between Gilead Sciences Limited and Evonik Degussa GmbH (formerly known as Degussa AG), dated June 6, 2006 | ||
+(10) | 10.103 | Amendment No. 1 to Emtricitabine Manufacturing Supply Agreement between Gilead Sciences Limited and Evonik Degussa GmbH (formerly known as Degussa AG), dated April 30, 2010 | ||
(48) | 10.104 | Purchase and Sale Agreement and Joint Escrow Instructions between Electronics for Imaging, Inc. and Registrant, dated July 18, 2012 | ||
(59) | 10.105 | Amendment No. 1, dated October 30, 2012, to the Purchase and Sale Agreement and Joint Escrow Instructions between Electronics for Imaging, Inc. and Registrant, dated July 18, 2012 | ||
31.1 | Certification of Chief Executive Officer, as required by Rule 13a-14(a) or Rule 15d-14(a) of the Securities Exchange Act of 1934, as amended | |||
31.2 | Certification of Chief Financial Officer, as required by Rule 13a-14(a) or Rule 15d-14(a) of the Securities Exchange Act of 1934, as amended | |||
32.1** | Certifications of Chief Executive Officer and Chief Financial Officer, as required by Rule 13a-14(b) or Rule 15d-14(b) and Section 1350 of Chapter 63 of Title 18 of the United States Code (18 U.S.C. §1350) | |||
101*** | The following materials from Registrant's Quarterly Report on Form 10-Q for the quarter ended March 31, 2013, formatted in Extensible Business Reporting Language (XBRL) includes: (i) Consolidated Balance Sheets, (ii) Consolidated Statements of Income, (iii) Consolidated Statements of Comprehensive Income, (iv) Consolidated Statements of Cash Flows and (v) Notes to Consolidated Financial Statements. | |||
(1) | Filed as an exhibit to Registrant's Current Report on Form 8-K filed on March 12, 2009, and incorporated herein by reference. |
(2) | Filed as an exhibit to Registrant's Current Report on Form 8-K filed on November 25, 2011, and incorporated herein by reference. |
(3) | Filed as an exhibit to Registrant's Current Report on Form 8-K filed on May 8, 2013, and incorporated herein by reference. |
(4) | Filed as an exhibit to Registrant's Current Report on Form 8-K filed on May 17, 2011, and incorporated herein by reference. |
(5) | Filed as an exhibit to Registrant's Current Report on Form 8-K filed on April 25, 2006, and incorporated herein by reference. |
(6) | Filed as an exhibit to Registrant's Current Report on Form 8-K filed on August 2, 2010, and incorporated herein by reference. |
(7) | Filed as an exhibit to Registrant's Current Report on Form 8-K filed on April 1, 2011, and incorporated herein by reference. |
(8) | Filed as an exhibit to Registrant's Current Report on Form 8-K filed on December 13, 2011, and incorporated herein by reference. |
(9) | Filed as an exhibit to Registrant's Quarterly Report on Form 10-Q for the quarter ended June 30, 2006, and incorporated herein by reference. |
(10) | Filed as an exhibit to Registrant's Quarterly Report on Form 10-Q for the quarter ended June 30, 2010, and incorporated herein by reference. |
(11) | Filed as an exhibit to Registrant's Quarterly Report on Form 10-Q for the quarter ended September 30, 2010, and incorporated herein by reference. |
(12) | Filed as an exhibit to Registrant's Current Report on Form 8-K filed on January 17, 2012, and incorporated herein by reference. |
(13) | Filed as an exhibit to Registrant's Registration Statement on Form S-8 (No. 333-102912) filed on January 31, 2003, and incorporated herein by reference. |
(14) | Filed as an exhibit to Registrant's Registration Statement on Form S-1 (No. 33-55680), as amended, and incorporated herein by reference. |
(15) | Filed as an exhibit to Registrant's Annual Report on Form 10-K/A for the fiscal year ended December 31, 1998, and incorporated herein by reference. |
(16) | Filed as an exhibit to Registrant's Current Report on Form 8-K filed on May 11, 2009, and incorporated herein by reference. |
(17) | Filed as an exhibit to Registrant's Current Report on Form 8-K/A filed on February 22, 2006, and incorporated herein by reference. |
(18) | Filed as an exhibit to Registrant's Annual Report on Form 10-K for the fiscal year ended December 31, 2007, and incorporated herein by reference. |
(19) | Filed as an exhibit to Registrant's Quarterly Report on Form 10-Q for the quarter ended June 30, 2009, and incorporated herein by reference. |
(20) | Filed as an exhibit to Registrant's Annual Report on Form 10-K for the fiscal year ended December 31, 2009, and incorporated herein by reference. |
(21) | Filed as an exhibit to Registrant's Quarterly Report on Form 10-Q for the quarter ended March 31, 2011, and incorporated herein by reference. |
(22) | Filed as an exhibit to Registrant's Quarterly Report on Form 10-Q for the quarter ended June 30, 2012, and incorporated herein by reference. |
(23) | Filed as an exhibit to Registrant's Quarterly Report on Form 10-Q for the quarter ended March 31, 2012, and incorporated herein by reference. |
(24) | Filed as an exhibit to Registrant's Current Report on Form 8-K first filed on December 19, 2007, and incorporated herein by reference. |
(25) | Filed as an exhibit to Registrant's Quarterly Report on Form 10-Q for the quarter ended March 31, 2010, and incorporated herein by reference. |
(26) | Filed as an exhibit to Registrant's Registration Statement on Form S-8 (No. 333-163871) filed on December 21, 2009, and incorporated herein by reference. |
(27) | Filed as an exhibit to Registrant's Annual Report on Form 10-K for the fiscal year ended December 31, 2001, and incorporated herein by reference. |
(28) | Filed as an exhibit to Registrant's Annual Report on Form 10-K for the fiscal year ended December 31, 2008, and incorporated herein by reference. |
(29) | Information is included in Registrant's Current Report on Form 8-K filed on February 4, 2013, and incorporated herein by reference. |
(30) | Filed as an exhibit to Registrant's Quarterly Report on Form 10-Q for the quarter ended June 30, 2008, and incorporated herein by reference. |
(31) | Filed as an exhibit to Registrant's Quarterly Report on Form 10-Q for the quarter ended September 30, 2006, and incorporated herein by reference. |
(32) | Filed as an exhibit to Registrant's Annual Report on Form 10-K for the fiscal year ended March 31, 1994, and incorporated herein by reference. |
(33) | Filed as an exhibit to Registrant's Annual Report on Form 10-K for the fiscal year ended December 31, 2000, and incorporated herein by reference. |
(34) | Filed as an exhibit to Registrant's Annual Report on Form 10-K for the fiscal year ended December 31, 2005, and incorporated herein by reference. |
(35) | Filed as an exhibit to Registrant's Annual Report on Form 10-K for the fiscal year ended December 31, 2011, and incorporated herein by reference |
(36) | Filed as an exhibit to Registrant's Annual Report on Form 10-K for the fiscal year ended December 31, 2012, and incorporated herein by reference |
(37) | Filed as an exhibit to Triangle Pharmaceuticals, Inc.'s Quarterly Report on Form 10-Q/A filed on November 3, 1999, and incorporated herein by reference. |
(38) | Filed as an exhibit to Registrant's Quarterly Report on Form 10-Q for the quarter ended September 30, 2005, and incorporated herein by reference. |
(39) | Filed as an exhibit to Registrant's Quarterly Report on Form 10-Q for the quarter ended March 31, 2005, and incorporated herein by reference. |
(40) | Filed as an exhibit to Registrant's Quarterly Report on Form 10-Q for the quarter ended September 30, 2011, and incorporated herein by reference. |
(41) | Filed as an exhibit to Myogen, Inc.'s Registration Statement on Form S-1 (No. 333-108301), as amended, originally filed on August 28, 2003, and incorporated herein by reference. |
(42) | Filed as an exhibit to Myogen, Inc.'s Quarterly Report on Form 10-Q filed on May 9, 2006, and incorporated herein by reference. |
(43) | Filed as an exhibit to CV Therapeutics, Inc.'s Registration Statement on Form S-3 (No. 333-59318), as amended, originally filed on April 20, 2001, and incorporated herein by reference. |
(44) | Filed as an exhibit to CV Therapeutics, Inc.'s Quarterly Report on Form 10-Q for the quarter ended June 30, 2006, and incorporated herein by reference. |
(45) | Filed as an exhibit to Registrant's Quarterly Report on Form 10-Q for the quarter ended September 30, 2009, and incorporated herein by reference. |
(46) | Filed as an exhibit to Registrant's Annual Report on Form 10-K for the fiscal year ended December 31, 2003, and incorporated herein by reference. |
(47) | Filed as an exhibit to Registrant's Current Report on Form 8-K filed on August 7, 2007, and incorporated herein by reference. |
(48) | Filed as an exhibit to Registrant's Quarterly Report on Form 10-Q for the quarter ended September 30, 2012, and incorporated herein by reference. |
(49) | Filed as an exhibit to Registrant's Annual Report on Form 10-K for the fiscal year ended December 31, 2012, and incorporated herein by reference. |
√ | The Agreement and Plan of Merger (the Merger Agreement) contains representations and warranties of Registrant, Apex Merger Sub, Inc. and CV Therapeutics, Inc. made solely to each other as of specific dates. Those representations and warranties were made solely for purposes of the Merger Agreement and may be subject to important qualifications and limitations agreed to by Registrant, Apex Merger Sub, Inc. and CV Therapeutics, Inc. Moreover, some of those representations and warranties may not be accurate or complete as of any specified date, may be subject to a standard of materiality provided for in the Merger Agreement and have been used for the purpose of allocating risk among Registrant, Apex Merger Sub, Inc. and CV Therapeutics, Inc. rather than establishing matters as facts. |
† | The Agreement and Plan of Merger (the Pharmasset Merger Agreement) contains representations and warranties of Registrant, Merger Sub and Pharmasset, Inc. made solely to each other as of specific dates. Those representations and warranties were made solely for purposes of the Pharmasset Merger Agreement and may be subject to important |
* | Management contract or compensatory plan or arrangement. |
** | This certification accompanies the Form 10-Q to which it relates, is not deemed filed with the Securities and Exchange Commission and is not to be incorporated by reference into any filing of Registrant under the Securities Act of 1933, as amended, or the Securities Exchange Act of 1934, as amended (whether made before or after the date of the Form 10-Q), irrespective of any general incorporation language contained in such filing. |
*** | XBRL information is filed herewith. |
+ | Certain confidential portions of this Exhibit were omitted by means of marking such portions with an asterisk (the Mark). This Exhibit has been filed separately with the Secretary of the SEC without the Mark pursuant to Registrant's Application Requesting Confidential Treatment under Rule 24b-2 under the Securities Exchange Act of 1934, as amended. |
GILEAD SCIENCES, INC. | ||
(Registrant) | ||
Date: | May 8, 2013 | /s/ JOHN C. MARTIN |
John C. Martin, Ph.D. Chairman and Chief Executive Officer (Principal Executive Officer) | ||
Date: | May 8, 2013 | /s/ ROBIN L. WASHINGTON |
Robin L. Washington Senior Vice President and Chief Financial Officer (Principal Financial and Accounting Officer) |
Exhibit Footnote | Exhibit Number | Description of Document | ||
√(1) | 2.1 | Agreement and Plan of Merger among Registrant, Apex Merger Sub, Inc. and CV Therapeutics, Inc., dated as of March 12, 2009 | ||
†(2) | 2.5 | Agreement and Plan of Merger among Registrant, Merger Sub and Pharmasset, Inc., dated as of November 21, 2011 | ||
(3) | 3.1 | Amended and Restated Certificate of Incorporation of Registrant, as amended and restated on May 8, 2013 | ||
(4) | 3.2 | Amended and Restated Bylaws of Registrant, as amended and restated on May 12, 2011 | ||
4.1 | Reference is made to Exhibit 3.1 and Exhibit 3.2 | |||
(5) | 4.2 | Indenture related to the Convertible Senior Notes due 2013 (2013 Notes), between Registrant and Wells Fargo Bank, National Association, as trustee (including form of 0.625% Convertible Senior Note due 2013), dated April 25, 2006 | ||
(6) | 4.3 | Indenture related to the Convertible Senior Notes due 2014 (2014 Notes), between Registrant and Wells Fargo Bank, National Association, as trustee (including form of 1.00% Convertible Senior Note due 2014), dated July 30, 2010 | ||
(6) | 4.4 | Indenture related to the Convertible Senior Notes due 2016 (2016 Notes), between Registrant and Wells Fargo Bank, National Association, as trustee (including form of 1.625% Convertible Senior Note due 2016), dated July 30, 2010 | ||
(7) | 4.5 | Indenture related to Senior Notes, dated as of March 30, 2011, between Registrant and Wells Fargo, National Association, as Trustee | ||
(7) | 4.6 | First Supplemental Indenture related to Senior Notes, dated as of March 30, 2011, between Registrant and Wells Fargo, National Association, as Trustee (including form of Senior Notes) | ||
(8) | 4.7 | Second Supplemental Indenture related to Senior Notes, dated as of December 13, 2011, between Registrant and Wells Fargo, National Association, as Trustee (including Form of 2014 Note, Form of 2016 Note, Form of 2021 Note, Form of 2041 Note) | ||
(9) | 10.1 | Confirmation of OTC Convertible Note Hedge related to 2013 Notes, dated April 19, 2006, as amended and restated as of April 24, 2006, between Registrant and Bank of America, N.A. | ||
(9) | 10.2 | Confirmation of OTC Warrant Transaction, dated April 19, 2006, as amended and restated as of April 24, 2006, between Registrant and Bank of America, N.A. for warrants expiring in 2013 | ||
(10) | 10.3 | Confirmation of OTC Convertible Note Hedge related to 2014 Notes, dated July 26, 2010, between Registrant and Goldman, Sachs & Co. | ||
(10) | 10.4 | Confirmation of OTC Convertible Note Hedge related to 2014 Notes, dated July 26, 2010, between Registrant and JPMorgan Chase Bank, National Association | ||
(10) | 10.5 | Confirmation of OTC Convertible Note Hedge related to 2016 Notes, dated July 26, 2010, between Registrant and Goldman, Sachs & Co. | ||
(10) | 10.6 | Confirmation of OTC Convertible Note Hedge related to 2016 Notes, dated July 26, 2010, between Registrant and JPMorgan Chase Bank, National Association | ||
(10) | 10.7 | Confirmation of OTC Warrant Transaction, dated July 26, 2010, between Registrant and Goldman, Sachs & Co. for warrants expiring in 2014 | ||
(10) | 10.8 | Confirmation of OTC Warrant Transaction, dated July 26, 2010, between Registrant and JPMorgan Chase Bank, National Association for warrants expiring in 2014 | ||
(10) | 10.9 | Confirmation of OTC Warrant Transaction, dated July 26, 2010, between Registrant and Goldman, Sachs & Co. for warrants expiring in 2016 | ||
(10) | 10.10 | Confirmation of OTC Warrant Transaction, dated July 26, 2010, between Registrant and JPMorgan Chase Bank, National Association for warrants expiring in 2016 |
Exhibit Footnote | Exhibit Number | Description of Document | ||
(11) | 10.11 | Confirmation of OTC Additional Convertible Note Hedge related to 2014 Notes, dated August 5, 2010, between Registrant and Goldman, Sachs & Co. | ||
(11) | 10.12 | Confirmation of OTC Additional Convertible Note Hedge related to 2014 Notes, dated August 5, 2010, between Registrant and JPMorgan Chase Bank, National Association | ||
(11) | 10.13 | Confirmation of OTC Additional Convertible Note Hedge related to 2016 Notes, dated August 5, 2010, between Registrant and Goldman, Sachs & Co. | ||
(11) | 10.14 | Confirmation of OTC Additional Convertible Note Hedge related to 2016 Notes, dated August 5, 2010, between Registrant and JPMorgan Chase Bank, National Association | ||
(11) | 10.15 | Confirmation of OTC Additional Warrant Transaction, dated August 5, 2010, between Registrant and Goldman, Sachs & Co. for warrants expiring in 2014 | ||
(11) | 10.16 | Confirmation of OTC Additional Warrant Transaction, dated August 5, 2010, between Registrant and JPMorgan Chase Bank, National Association for warrants expiring in 2014 | ||
(11) | 10.17 | Confirmation of OTC Additional Warrant Transaction, dated August 5, 2010, between Registrant and Goldman, Sachs & Co. for warrants expiring in 2016 | ||
(11) | 10.18 | Confirmation of OTC Additional Warrant Transaction, dated August 5, 2010, between Registrant and JPMorgan Chase Bank, National Association for warrants expiring in 2016 | ||
(11) | 10.19 | Amendment to Confirmation of OTC Convertible Note Hedge related to 2014 Notes, dated August 30, 2010, between Registrant and Goldman, Sachs & Co. | ||
(11) | 10.20 | Amendment to Confirmation of OTC Convertible Note Hedge related to 2014 Notes, dated August 30, 2010, between Registrant and JPMorgan Chase Bank, National Association | ||
(11) | 10.21 | Amendment to Confirmation of OTC Convertible Note Hedge related to 2016 Notes, dated August 30, 2010, between Registrant and Goldman, Sachs & Co. | ||
(11) | 10.22 | Amendment to Confirmation of OTC Convertible Note Hedge related to 2016 Notes, dated August 30, 2010, between Registrant and JPMorgan Chase Bank, National Association | ||
(11) | 10.23 | Amendment to Confirmation of OTC Additional Convertible Note Hedge related to 2014 Notes, dated August 30, 2010, between Registrant and Goldman, Sachs & Co. | ||
(11) | 10.24 | Amendment to Confirmation of OTC Additional Convertible Note Hedge related to 2014 Notes, dated August 30, 2010, between Registrant and JPMorgan Chase Bank, National Association | ||
(11) | 10.25 | Amendment to Confirmation of OTC Additional Convertible Note Hedge related to 2016 Notes, dated August 30, 2010, between Registrant and Goldman, Sachs & Co. | ||
(11) | 10.26 | Amendment to Confirmation of OTC Additional Convertible Note Hedge related to 2016 Notes, dated August 30, 2010, between Registrant and JPMorgan Chase Bank, National Association | ||
(12) | 10.27 | 5-Year Revolving Credit Facility Credit Agreement among Registrant and Gilead Biopharmaceutics Ireland Corporation, as Borrowers, Bank of America, N.A., as Administrative Agent, Swing Line Lender and L/C Issuer, certain other lenders parties thereto, Barclays Capital, as Syndication Agent, and Goldman Sachs Bank USA, JPMorgan Chase Bank, N.A., Royal Bank of Canada and Wells Fargo Bank, N.A., as Co-Documentation Agents, dated as of January 12, 2012 | ||
(12) | 10.28 | Parent Guaranty Agreement (5-Year Revolving Credit Facility), dated as of January 12, 2012, by Registrant | ||
*(13) | 10.29 | Gilead Sciences, Inc. 1991 Stock Option Plan, as amended through January 29, 2003 | ||
*(14) | 10.30 | Form of option agreements used under the 1991 Stock Option Plan | ||
*(13) | 10.31 | Gilead Sciences, Inc. 1995 Non-Employee Directors' Stock Option Plan, as amended through January 30, 2002 | ||
Exhibit Footnote | Exhibit Number | Description of Document | ||
*(14) | 10.32 | Form of option agreement used under the Gilead Sciences, Inc. 1995 Non-Employee Directors' Stock Option Plan | ||
*(16) | 10.33 | Gilead Sciences, Inc. 2004 Equity Incentive Plan, as amended through May 6, 2009 | ||
*(17) | 10.34 | Form of employee stock option agreement used under 2004 Equity Incentive Plan (for grants prior to February 2008) | ||
*(18) | 10.35 | Form of employee stock option agreement used under 2004 Equity Incentive Plan (for grants made February 2008 through April 2009) | ||
*(19) | 10.36 | Form of employee stock option agreement used under 2004 Equity Incentive Plan (for grants commencing in May 2009) | ||
*(20) | 10.37 | Form of employee stock option agreement used under 2004 Equity Incentive Plan (for grants commencing in February 2010) | ||
*(21) | 10.38 | Form of employee stock option agreement used under 2004 Equity Incentive Plan (for 2011 and subsequent year grants) | ||
*(18) | 10.39 | Form of non-employee director stock option agreement used under 2004 Equity Incentive Plan (for grants prior to 2008) | ||
*(18) | 10.40 | Form of non-employee director option agreement used under 2004 Equity Incentive Plan (for initial grants made in 2008) | ||
*(18) | 10.41 | Form of non-employee director option agreement used under 2004 Equity Incentive Plan (for annual grants made in May 2008) | ||
*(19) | 10.42 | Form of non-employee director option agreement used under 2004 Equity Incentive Plan (for annual grants commencing in May 2009) | ||
*(22) | 10.43 | Form of restricted stock unit issuance agreement used under 2004 Equity Incentive Plan (for annual grants to non-employee directors commencing in May 2012) | ||
*(19) | 10.44 | Form of restricted stock award agreement used under 2004 Equity Incentive Plan (for annual grants to certain non-employee directors prior to May 2012) | ||
*(19) | 10.45 | Form of performance share award agreement used under the 2004 Equity Incentive Plan (for grants to certain executive officers made in 2009) | ||
*(20) | 10.46 | Form of performance share award agreement used under the 2004 Equity Incentive Plan (for grants to certain executive officers made in 2010) | ||
*(21) | 10.47 | Form of performance share award agreement used under the 2004 Equity Incentive Plan (for grants to certain executive officers made in 2011) | ||
*(23) | 10.48 | Form of performance share award agreement used under the 2004 Equity Incentive Plan (for grants to certain executive officers made in 2012) | ||
* | 10.49 | Form of performance share award agreement used under the 2004 Equity Incentive Plan (for TSR Goals in 2013) | ||
* | 10.50 | Form of performance share award agreement used under the 2004 Equity Incentive Plan (for Revenue Goals in 2013) | ||
*(24) | 10.51 | Form of restricted stock unit issuance agreement used under the 2004 Equity Incentive Plan (for grants to certain executive officers made prior to May 2009) | ||
*(19) | 10.52 | Form of restricted stock unit issuance agreement used under the 2004 Equity Incentive Plan (for grants to certain executive officers commencing in May 2009) | ||
*(25) | 10.53 | Form of restricted stock unit issuance agreement used under the 2004 Equity Incentive Plan (service-based vesting for certain executive officers commencing in November 2009) | ||
Exhibit Footnote | Exhibit Number | Description of Document | ||
*(21) | 10.54 | Form of restricted stock unit issuance agreement used under the 2004 Equity Incentive Plan (service-based vesting for certain executive officers commencing in 2011) | ||
*(20) | 10.55 | Gilead Sciences, Inc. Employee Stock Purchase Plan, amended and restated on November 3, 2009 | ||
*(26) | 10.56 | Gilead Sciences, Inc. International Employee Stock Purchase Plan, adopted November 3, 2009 | ||
*(27) | 10.57 | Gilead Sciences, Inc. Deferred Compensation Plan-Basic Plan Document | ||
*(27) | 10.58 | Gilead Sciences, Inc. Deferred Compensation Plan-Adoption Agreement | ||
*(27) | 10.59 | Addendum to the Gilead Sciences, Inc. Deferred Compensation Plan | ||
*(28) | 10.60 | Gilead Sciences, Inc. 2005 Deferred Compensation Plan, as amended and restated on October 23, 2008 | ||
*(23) | 10.61 | Gilead Sciences, Inc. Severance Plan, as amended on January 26, 2012 | ||
*(17) | 10.62 | Gilead Sciences, Inc. Corporate Bonus Plan | ||
*(4) | 10.63 | Amended and Restated Gilead Sciences, Inc. Code Section 162(m) Bonus Plan | ||
*(29) | 10.64 | 2013 Base Salaries for the Named Executive Officers | ||
*(30) | 10.65 | Offer Letter dated April 16, 2008 between Registrant and Robin Washington | ||
*(14) | 10.66 | Form of Indemnity Agreement entered into between Registrant and its directors and executive officers | ||
*(14) | 10.67 | Form of Employee Proprietary Information and Invention Agreement entered into between Registrant and certain of its officers and key employees | ||
*(20) | 10.68 | Form of Employee Proprietary Information and Invention Agreement entered into between Registrant and certain of its officers and key employees (revised in September 2006) | ||
(31) | 10.69 | Amended and Restated Collaboration Agreement by and among Registrant, Gilead Holdings, LLC, Bristol-Myers Squibb Company, E.R. Squibb & Sons, L.L.C., and Bristol-Myers Squibb & Gilead Sciences, LLC, dated September 28, 2006 | ||
(18) | 10.70 | Commercialization Agreement by and between Gilead Sciences Limited and Bristol-Myers Squibb Company, dated December 10, 2007 | ||
(32) | 10.71 | Amendment Agreement, dated October 25, 1993, between Registrant, the Institute of Organic Chemistry and Biochemistry (IOCB) and Rega Stichting v.z.w. (REGA), together with the following exhibits: the License Agreement, dated December 15, 1991, between Registrant, IOCB and REGA (the 1991 License Agreement), the License Agreement, dated October 15, 1992, between Registrant, IOCB and REGA (the October 1992 License Agreement) and the License Agreement, dated December 1, 1992, between Registrant, IOCB and REGA (the December 1992 License Agreement) | ||
(33) | 10.72 | Amendment Agreement between Registrant and IOCB/REGA, dated December 27, 2000 amending the 1991 License Agreement and the December 1992 License Agreement | ||
(31) | 10.73 | Sixth Amendment Agreement to the License Agreement, between IOCB/REGA and Registrant, dated August 18, 2006 amending the October 1992 License Agreement and the December 1992 License Agreement | ||
(31) | 10.74 | Development and License Agreement among Registrant and F. Hoffmann-La Roche Ltd and Hoffmann-La Roche Inc., dated September 27, 1996 | ||
(34) | 10.75 | First Amendment and Supplement dated November 15, 2005 to the Development and Licensing Agreement between Registrant, F. Hoffmann-La Roche Ltd and Hoffman-La Roche Inc. dated September 27, 1996 | ||
Exhibit Footnote | Exhibit Number | Description of Document | ||
(35) | 10.76 | Second Amendment dated December 22, 2011 to the Development and Licensing Agreement between Registrant, F. Hoffmann-La Roche Ltd and Hoffman-La Roche Inc. dated September 27, 1996 | ||
+ (36) | 10.77 | Third Amendment dated October 5, 2012 to the Development and Licensing Agreement between Registrant, F. Hoffmann-La Roche Ltd and Hoffman-La Roche Inc. dated September 27, 1996 | ||
(37) | 10.78 | Exclusive License Agreement between Registrant (as successor to Triangle Pharmaceuticals, Inc.), Glaxo Group Limited, The Wellcome Foundation Limited, Glaxo Wellcome Inc. and Emory University, dated May 6, 1999 | ||
(38) | 10.79 | Royalty Sale Agreement by and among Registrant, Emory University and Investors Trust & Custodial Services (Ireland) Limited, solely in its capacity as Trustee of Royalty Pharma, dated July 18, 2005 | ||
(38) | 10.80 | Amended and Restated License Agreement between Registrant, Emory University and Investors Trust & Custodial Services (Ireland) Limited, solely in its capacity as Trustee of Royalty Pharma, dated July 21, 2005 | ||
(39) | 10.81 | License Agreement between Japan Tobacco Inc. and Registrant, dated March 22, 2005 | ||
(40) | 10.82 | First Amendment to License Agreement between Japan Tobacco Inc. and Registrant, dated May 19, 2005 | ||
(40) | 10.83 | Second Amendment to License Agreement between Japan Tobacco Inc. and Registrant, dated May 17, 2010 | ||
(40) | 10.84 | Third Amendment to License Agreement between Japan Tobacco Inc. and Registrant, dated July 5, 2011 | ||
(40) | 10.85 | Fourth Amendment to License Agreement between Japan Tobacco Inc. and Registrant, dated July 5, 2011 | ||
(41) | 10.86 | License Agreement between Registrant (as successor to Myogen, Inc.) and Abbott Deutschland Holding GmbH dated October 8, 2001 | ||
+(42) | 10.87 | License Agreement between Registrant (as successor to Myogen, Inc.) and Glaxo Group Limited, dated March 3, 2006 | ||
(41) | 10.88 | License Agreement between Registrant (as successor to CV Therapeutics, Inc.) and Roche Palo Alto LLC (successor in interest by merger to Syntex (U.S.A.) Inc.), dated March 27, 1996 | ||
(43) | 10.89 | First Amendment to License Agreement between Registrant (as successor to CV Therapeutics, Inc.) and Roche Palo Alto LLC (successor in interest by merger to Syntex (U.S.A.) Inc.), dated July 3, 1997 | ||
(43) | 10.90 | Amendment No. 2 to License Agreement between Registrant (as successor to CV Therapeutics, Inc.) and Roche Palo Alto LLC (successor in interest by merger to Syntex (U.S.A.) Inc.), dated November 30. 1999 | ||
(44) | 10.91 | Amendment No. 4 to License Agreement with Registrant (as successor to CV Therapeutics, Inc.) and Roche Palo Alto LLC (successor in interest by merger to Syntex (U.S.A.) Inc.), dated June 20, 2006 | ||
(35) | 10.92 | Amendment No. 5 to License Agreement with Registrant (as successor to CV Therapeutics, Inc.) and Roche Palo Alto LLC (successor in interest by merger to Syntex (U.S.A.) Inc.), dated December 22, 2011 | ||
(45) | 10.93 | License and Collaboration Agreement by and among Registrant, Gilead Sciences Limited and Janssen R&D Ireland (formerly Tibotec Pharmaceuticals), dated July 16, 2009 | ||
(40) | 10.94 | Second Amendment to License and Collaboration Agreement by and among Registrant, Gilead Sciences Limited and Janssen R&D Ireland (formerly Tibotec Pharmaceuticals), dated July 1, 2011 | ||
Exhibit Footnote | Exhibit Number | Description of Document | ||
+ | 10.95 | Amended and Restated Second Amendment to License and Collaboration Agreement by and among Registrant, Gilead Sciences Limited and Janssen R&D Ireland (formerly Tibotec Pharmaceuticals), dated February 7, 2013 | ||
(46) | 10.96 | Master Clinical and Commercial Supply Agreement between Gilead World Markets, Limited, Registrant and Patheon Inc., dated January 1, 2003 | ||
(38) | 10.97 | Tenofovir Disoproxil Fumarate Manufacturing Supply Agreement by and between Gilead Sciences Limited and PharmaChem Technologies (Grand Bahama), Ltd., dated July 17, 2003 | ||
(47) | 10.98 | Addendum to Tenofovir Disoproxil Fumarate Manufacturing Supply Agreement by and between Gilead Sciences Limited and PharmaChem Technologies (Grand Bahama) Ltd., dated May 10, 2007 | ||
(28) | 10.99 | Addendum to Tenofovir Disoproxil Fumarate Manufacturing Supply Agreement by and between Gilead Sciences Limited and PharmaChem Technologies (Grand Bahama) Ltd., dated December 5, 2008 | ||
(21) | 10.100 | Addendum to Tenofovir Disoproxil Fumarate Manufacturing Supply Agreement by and between Gilead Sciences Limited and PharmaChem Technologies (Grand Bahama) Ltd., dated February 3. 2011 | ||
(34) | 10.101 | Restated and Amended Toll Manufacturing Agreement between Gilead Sciences Limited, Registrant and Nycomed GmbH (formerly ALTANA Pharma Oranienburg GmbH), dated November 7, 2005 | ||
+(9) | 10.102 | Emtricitabine Manufacturing Supply Agreement between Gilead Sciences Limited and Evonik Degussa GmbH (formerly known as Degussa AG), dated June 6, 2006 | ||
+(10) | 10.103 | Amendment No. 1 to Emtricitabine Manufacturing Supply Agreement between Gilead Sciences Limited and Evonik Degussa GmbH (formerly known as Degussa AG), dated April 30, 2010 | ||
(48) | 10.104 | Purchase and Sale Agreement and Joint Escrow Instructions between Electronics for Imaging, Inc. and Registrant, dated July 18, 2012 | ||
(49) | 10.105 | Amendment No. 1, dated October 30, 2012, to the Purchase and Sale Agreement and Joint Escrow Instructions between Electronics for Imaging, Inc. and Registrant, dated July 18, 2012 | ||
31.1 | Certification of Chief Executive Officer, as required by Rule 13a-14(a) or Rule 15d-14(a) of the Securities Exchange Act of 1934, as amended | |||
31.2 | Certification of Chief Financial Officer, as required by Rule 13a-14(a) or Rule 15d-14(a) of the Securities Exchange Act of 1934, as amended | |||
32.1** | Certifications of Chief Executive Officer and Chief Financial Officer, as required by Rule 13a-14(b) or Rule 15d-14(b) and Section 1350 of Chapter 63 of Title 18 of the United States Code (18 U.S.C. §1350) | |||
101*** | The following materials from Registrant's Quarterly Report on Form 10-Q for the quarter ended March 31, 2013, formatted in Extensible Business Reporting Language (XBRL) includes: (i) Consolidated Balance Sheets, (ii) Consolidated Statements of Income, (iii) Consolidated Statements of Comprehensive Income, (iv) Consolidated Statements of Cash Flows and (v) Notes to Consolidated Financial Statements. |
(1) | Filed as an exhibit to Registrant's Current Report on Form 8-K filed on March 12, 2009, and incorporated herein by reference. |
(2) | Filed as an exhibit to Registrant's Current Report on Form 8-K filed on November 25, 2011, and incorporated herein by reference. |
(3) | Filed as an exhibit to Registrant's Current Report on Form 8-K filed on May 8, 2013, and incorporated herein by reference. |
(4) | Filed as an exhibit to Registrant's Current Report on Form 8-K filed on May 17, 2011, and incorporated herein by reference. |
(5) | Filed as an exhibit to Registrant's Current Report on Form 8-K filed on April 25, 2006, and incorporated herein by reference. |
(6) | Filed as an exhibit to Registrant's Current Report on Form 8-K filed on August 2, 2010, and incorporated herein by reference. |
(7) | Filed as an exhibit to Registrant's Current Report on Form 8-K filed on April 1, 2011, and incorporated herein by reference. |
(8) | Filed as an exhibit to Registrant's Current Report on Form 8-K filed on December 13, 2011, and incorporated herein by reference. |
(9) | Filed as an exhibit to Registrant's Quarterly Report on Form 10-Q for the quarter ended June 30, 2006, and incorporated herein by reference. |
(10) | Filed as an exhibit to Registrant's Quarterly Report on Form 10-Q for the quarter ended June 30, 2010, and incorporated herein by reference. |
(11) | Filed as an exhibit to Registrant's Quarterly Report on Form 10-Q for the quarter ended September 30, 2010, and incorporated herein by reference. |
(12) | Filed as an exhibit to Registrant's Current Report on Form 8-K filed on January 17, 2012, and incorporated herein by reference. |
(13) | Filed as an exhibit to Registrant's Registration Statement on Form S-8 (No. 333-102912) filed on January 31, 2003, and incorporated herein by reference. |
(14) | Filed as an exhibit to Registrant's Registration Statement on Form S-1 (No. 33-55680), as amended, and incorporated herein by reference. |
(15) | Filed as an exhibit to Registrant's Annual Report on Form 10-K/A for the fiscal year ended December 31, 1998, and incorporated herein by reference. |
(16) | Filed as an exhibit to Registrant's Current Report on Form 8-K filed on May 11, 2009, and incorporated herein by reference. |
(17) | Filed as an exhibit to Registrant's Current Report on Form 8-K/A filed on February 22, 2006, and incorporated herein by reference. |
(18) | Filed as an exhibit to Registrant's Annual Report on Form 10-K for the fiscal year ended December 31, 2007, and incorporated herein by reference. |
(19) | Filed as an exhibit to Registrant's Quarterly Report on Form 10-Q for the quarter ended June 30, 2009, and incorporated herein by reference. |
(20) | Filed as an exhibit to Registrant's Annual Report on Form 10-K for the fiscal year ended December 31, 2009, and incorporated herein by reference. |
(21) | Filed as an exhibit to Registrant's Quarterly Report on Form 10-Q for the quarter ended March 31, 2011, and incorporated herein by reference. |
(22) | Filed as an exhibit to Registrant's Quarterly Report on Form 10-Q for the quarter ended June 30, 2012, and incorporated herein by reference. |
(23) | Filed as an exhibit to Registrant's Quarterly Report on Form 10-Q for the quarter ended March 31, 2012, and incorporated herein by reference. |
(24) | Filed as an exhibit to Registrant's Current Report on Form 8-K first filed on December 19, 2007, and incorporated herein by reference. |
(25) | Filed as an exhibit to Registrant's Quarterly Report on Form 10-Q for the quarter ended March 31, 2010, and incorporated herein by reference. |
(26) | Filed as an exhibit to Registrant's Registration Statement on Form S-8 (No. 333-163871) filed on December 21, 2009, and incorporated herein by reference. |
(27) | Filed as an exhibit to Registrant's Annual Report on Form 10-K for the fiscal year ended December 31, 2001, and incorporated herein by reference. |
(28) | Filed as an exhibit to Registrant's Annual Report on Form 10-K for the fiscal year ended December 31, 2008, and incorporated herein by reference. |
(29) | Information is included in Registrant's Current Report on Form 8-K filed on February 4, 2013, and incorporated herein by reference. |
(30) | Filed as an exhibit to Registrant's Quarterly Report on Form 10-Q for the quarter ended June 30, 2008, and incorporated herein by reference. |
(31) | Filed as an exhibit to Registrant's Quarterly Report on Form 10-Q for the quarter ended September 30, 2006, and incorporated herein by reference. |
(32) | Filed as an exhibit to Registrant's Annual Report on Form 10-K for the fiscal year ended March 31, 1994, and incorporated herein by reference. |
(33) | Filed as an exhibit to Registrant's Annual Report on Form 10-K for the fiscal year ended December 31, 2000, and incorporated herein by reference. |
(34) | Filed as an exhibit to Registrant's Annual Report on Form 10-K for the fiscal year ended December 31, 2005, and incorporated herein by reference. |
(35) | Filed as an exhibit to Registrant's Annual Report on Form 10-K for the fiscal year ended December 31, 2011, and incorporated herein by reference |
(36) | Filed as an exhibit to Registrant's Annual Report on Form 10-K for the fiscal year ended December 31, 2012, and incorporated herein by reference |
(37) | Filed as an exhibit to Triangle Pharmaceuticals, Inc.'s Quarterly Report on Form 10-Q/A filed on November 3, 1999, and incorporated herein by reference. |
(38) | Filed as an exhibit to Registrant's Quarterly Report on Form 10-Q for the quarter ended September 30, 2005, and incorporated herein by reference. |
(39) | Filed as an exhibit to Registrant's Quarterly Report on Form 10-Q for the quarter ended March 31, 2005, and incorporated herein by reference. |
(40) | Filed as an exhibit to Registrant's Quarterly Report on Form 10-Q for the quarter ended September 30, 2011, and incorporated herein by reference. |
(41) | Filed as an exhibit to Myogen, Inc.'s Registration Statement on Form S-1 (No. 333-108301), as amended, originally filed on August 28, 2003, and incorporated herein by reference. |
(42) | Filed as an exhibit to Myogen, Inc.'s Quarterly Report on Form 10-Q filed on May 9, 2006, and incorporated herein by reference. |
(43) | Filed as an exhibit to CV Therapeutics, Inc.'s Registration Statement on Form S-3 (No. 333-59318), as amended, originally filed on April 20, 2001, and incorporated herein by reference. |
(44) | Filed as an exhibit to CV Therapeutics, Inc.'s Quarterly Report on Form 10-Q for the quarter ended June 30, 2006, and incorporated herein by reference. |
(45) | Filed as an exhibit to Registrant's Quarterly Report on Form 10-Q for the quarter ended September 30, 2009, and incorporated herein by reference. |
(46) | Filed as an exhibit to Registrant's Annual Report on Form 10-K for the fiscal year ended December 31, 2003, and incorporated herein by reference. |
(47) | Filed as an exhibit to Registrant's Current Report on Form 8-K filed on August 7, 2007, and incorporated herein by reference. |
(48) | Filed as an exhibit to Registrant's Quarterly Report on Form 10-Q for the quarter ended September 30, 2012, and incorporated herein by reference. |
(49) | Filed as an exhibit to Registrant's Annual Report on Form 10-K for the fiscal year ended December 31, 2012, and incorporated herein by reference. |
√ | The Agreement and Plan of Merger (the Merger Agreement) contains representations and warranties of Registrant, Apex Merger Sub, Inc. and CV Therapeutics, Inc. made solely to each other as of specific dates. Those representations and warranties were made solely for purposes of the Merger Agreement and may be subject to important qualifications and limitations agreed to by Registrant, Apex Merger Sub, Inc. and CV Therapeutics, Inc. Moreover, some of those representations and warranties may not be accurate or complete as of any specified date, may be subject to a standard of materiality provided for in the Merger Agreement and have been used for the purpose of allocating risk among Registrant, Apex Merger Sub, Inc. and CV Therapeutics, Inc. rather than establishing matters as facts. |
† | The Agreement and Plan of Merger (the Pharmasset Merger Agreement) contains representations and warranties of Registrant, Merger Sub and Pharmasset, Inc. made solely to each other as of specific dates. Those representations and warranties were made solely for purposes of the Pharmasset Merger Agreement and may be subject to important |
* | Management contract or compensatory plan or arrangement. |
** | This certification accompanies the Form 10-Q to which it relates, is not deemed filed with the Securities and Exchange Commission and is not to be incorporated by reference into any filing of Registrant under the Securities Act of 1933, as amended, or the Securities Exchange Act of 1934, as amended (whether made before or after the date of the Form 10-Q), irrespective of any general incorporation language contained in such filing. |
*** | XBRL information is filed herewith. |
+ | Certain confidential portions of this Exhibit were omitted by means of marking such portions with an asterisk (the Mark). This Exhibit has been filed separately with the Secretary of the SEC without the Mark pursuant to Registrant's Application Requesting Confidential Treatment under Rule 24b-2 under the Securities Exchange Act of 1934, as amended. |
Participant | [FIRST NAME MIDDLE NAME LAST NAME] |
Award Date: | [GRANT DATE] |
Designated Number of Performance Shares: | The actual number of shares of Common Stock that may become issuable pursuant to the Performance Shares awarded under this Agreement shall be determined in accordance with the applicable performance-vesting and service-vesting provisions of this Agreement. For purposes of the applicable calculations to be made under those vesting provisions, the total designated number of Performance Shares to be utilized is [SHARES] shares (the “Performance Shares”). |
Vesting Schedule: | Vesting Requirements. The Performance Shares shall be subject to the performance-vesting requirements set forth in attached Schedule I and the service-vesting requirements set forth in Paragraph 3 of this Agreement. Change in Control Vesting. The Performance Shares and the underlying shares of Common Stock may also vest on an accelerated basis in accordance with the applicable provisions of Paragraph 5 of this Agreement should a Change in Control occur after the start but prior to the completion of the Performance Period applicable to the Performance Shares. |
Issuance Date: | The shares of Common Stock which actually vest and become issuable pursuant to the Performance Shares subject to this Award shall be issued in accordance with the provisions of this Agreement applicable to the particular circumstances under which such vesting occurs. |
GILEAD SCIENCES, INC. | |
By: | |
Title: |
Participant | [FIRST NAME MIDDLE NAME LAST NAME] |
Award Date: | [GRANT DATE] |
Designated Number of Performance Shares: | The actual number of shares of Common Stock that may become issuable pursuant to the Performance Shares awarded under this Agreement shall be determined in accordance with the performance-vesting and service-vesting provisions of attached Schedule I. For purposes of the applicable calculations under Schedule I, the total designated number of Performance Shares to be utilized is [SHARES] shares (the” Performance Shares”). |
The Performance Shares shall be divided into three separate Tranches, and one third of the total number of Performance Shares shall be allocated to each such Tranche. |
Vesting Schedule: | Normal Vesting. Each Tranche of Performance Shares shall be subject to the performance-vesting and service-vesting requirements set forth for that particular Tranche in attached Schedule I. Change in Control Vesting. The shares of Common Stock underlying each Tranche of Performance Shares may also vest on an accelerated basis in accordance with the applicable provisions of Paragraph 4 of this Agreement should a Change in Control occur after the start but prior to the completion of the Performance Period or Service Period applicable to that particular Tranche. |
Issuance Date: | The shares of Common Stock which actually vest and become issuable pursuant to each Tranche of Performance Shares shall be issued in accordance with the provisions of this Agreement applicable to the particular circumstances under which such vesting occurs. |
GILEAD SCIENCES, INC. | |
By: | |
Title: |
SECTION 40. | Additional Representations, Warranties and Covenants of Gilead. |
JANSSEN R&D IRELAND | |
By: | /s/ Margaret Dunlea Name: Margaret Dunlea Title: Managing Director Janssen R&D Ireland |
GILEAD SCIENCES, INC. | |
By: | /s/ John F. Milligan Name: John F. Milligan, Ph.D. Title: President and Chief Operating Officer |
GILEAD SCIENCES LIMITED | |
By: | /s/ John F. Milligan Name: John F. Milligan, Ph.D. Title: Director |
I. | Annex I: Calculation of Actual Percentages |
II. | Annex L: Annual Adjustments to Account for Actual Yield |
III. | Annex M: Payment Terms for TMC278 Invoices |
IV. | Annex N: Post-Conversion Supply Price |
V. | Annex Q: Additional Financial Reporting |
VI. | Annex R: Discount Rules and Related Matters |
VII. | Annex W: In-License Agreement Compliance |
VIII. | Annex Y: Limited Region A, Region B and Region C Pricing and Discounts |
IX. | Annex Z: Territory Combination Product Supply to Janssen |
X. | Annex AA: Selling Party and Country List for Region A, Region B and Region C |
XI. | Annex BB: Invoice and Payment Terms for Territory Combination Product in Janssen Countries |
XII. | Annex CC: Exchange Rates and Currency Conversion True-Up Principles |
XIII. | Annex DD: Calendar Year End Invoice Adjustment for Janssen Countries |
XIV. | Annex EE: Letter Agreement Regarding Marketing Authorization for Combination Product. |
I. | Annex I: Calculation of Actual Percentages |
A. | Territory-Wide Percentages. |
100% - Actual Percentage of Janssen for such Calendar Year |
B. | Regional Percentages |
B.1. | Expanded Existing Region |
[*] |
[*] |
100% - Regional Actual Percentage of Janssen for such Calendar Year |
B.2. | Limited Region A, Region B and Region C. |
II. | Annex L: Annual Adjustments to Account for Actual Yield |
1. | At the end of each Calendar Year, Gilead shall determine [*], Gilead shall use reasonable efforts to provide such determinations to Janssen by February 15 after the end of the applicable Calendar Year and shall provide such determinations no later than March 1 after the end of such Calendar Year. |
2. | For each Calendar Year, no later than thirty (30) days after the applicable notification is provided pursuant to Paragraph 1 of this Annex L, (a) [*]. |
3. | For clarification, there shall be [*]. |
III. | Annex M: Payment Terms for TMC278 Invoices |
A. | Gilead Countries in the Expanded Existing Region |
A.1. | Determination of the Annual Forecast Payment Term |
1) | On a country-by-country basis, for each Gilead Country [*] (each a “Default Payment Term”). Gilead shall promptly notify Janssen of the Default Payment Term for each applicable country, once calculated. |
2) | On a country-by-country basis, for each Gilead Country [*] (each a “TPD Default Payment Term”). |
A.2. | Deviation from Annual Forecast Payment Term. |
A.3. | Payment Terms |
a) | TMC278 Invoices. |
B. | Limited Region A Gilead Countries |
C. | Region B and Region C Gilead Countries |
D. | Region A, Region B and Region C Janssen Countries |
A. | The Gilead Countries in the Expanded Existing Region |
B. | Janssen Countries |
C. | Gilead Countries in Limited Region A, Region B and Region C |
C.1. | Post-Conversion Supply Price |
C.2. | Regional TMC278 Annual True-Up |
A. | Generally. |
B. | Pricing Principles Outside the Expanded Existing Region. |
1. | The Selling Party shall have discretion as to the price that it offers to sell the Territory Combination Product unless otherwise specifically provided in this Annex Y. Except as otherwise agreed by the Parties in writing, with respect to any Price Approval Country, the Selling Party shall be responsible for managing the negotiation with the applicable authority(ies) in each such country in the Territory to obtain and maintain pricing approval. |
2. | Upon request of one Party, the other Party shall make available to such requesting Party, solely to the extent allowed by Applicable Law, such information Controlled by such other Party and its Affiliates as is required in order to obtain pricing and reimbursement approvals for the Territory Combination Product. |
3. | The following shall apply to Price Approval Countries in Limited Region A or Region B. If, following the Launch of the Territory Combination Product in a given Price Approval Country, [*] |
4. | As between the Parties (and their respective Affiliates), the Selling Party (and its Affiliates) (or its Third Party Distributor) shall have sole responsibility for conducting pricing and discounting negotiations (and all other contracting matters) with respect to the Territory Combination Product with Customers in the applicable country in the Territory in accordance with this Annex Y. |
5. | Gilead and Janssen shall each retain sole discretion with respect to price-setting and discounts for its respective Single Agent Products and Double Agent Product. Notwithstanding the foregoing, [*] |
C. | Disputes. |
Region A | |
Country | Selling Party |
Albania | Gilead |
Argentina | Janssen |
Bahrain | Janssen |
Bosnia-Herzegovina | Gilead |
Chile | Gilead |
Colombia | Gilead |
Costa Rica | Gilead |
Hong Kong | Janssen |
Israel | Janssen |
Japan | Janssen |
Kosovo | Gilead |
Kuwait | Janssen |
Lebanon | Janssen |
Macau | Janssen |
Malaysia | Janssen |
Mexico | Janssen |
Montenegro | Gilead |
Oman | Janssen |
Qatar | Janssen |
Russia | Janssen |
Saudi Arabia | Janssen |
Serbia | Gilead |
Singapore | Janssen |
South Korea | Janssen |
Taiwan | Janssen |
United Arab Emirates | Janssen |
Uruguay | Gilead |
Venezuela | Gilead |
Region B | |
Country | Selling Party |
Algeria | Janssen |
Azerbaijan | Janssen |
Belarus | Janssen |
Cayman Islands | Gilead |
Curacao | Gilead |
China (Mainland) | Janssen |
Egypt | Janssen |
Iran | Janssen |
Iraq | Janssen |
Jordan | Janssen |
Libya | Janssen |
Morocco | Janssen |
Panama | Gilead |
Paraguay | Gilead |
Peru | Gilead |
Philippines | Janssen |
Sint Maarten | Gilead |
Tunisia | Janssen |
Ukraine | Janssen |
Region C | |
Country | Selling Party |
Afghanistan | Janssen |
Angola | Janssen |
Anguilla | Gilead |
Antigua and Barbuda | Gilead |
Armenia | Janssen |
Aruba | Gilead |
Bahamas | Gilead |
Bangladesh | Janssen |
Barbados | Gilead |
Belize | Gilead |
Benin | Janssen |
Bhutan | Janssen |
Bolivia | Gilead |
Botswana | Janssen |
British Virgin Islands | Gilead |
Burkina Faso | Janssen |
Burundi | Janssen |
Cambodia | Janssen |
Cameroon | Janssen |
Cape Verde | Janssen |
Central African Republic | Janssen |
Chad | Janssen |
Comoros | Janssen |
Congo | Janssen |
Congo, Dem. Rep. of the | Janssen |
Cote d'Ivoire | Janssen |
Cuba | Gilead |
Djibouti | Janssen |
Dominica | Gilead |
Dominican Republic | Gilead |
Ecuador | Gilead |
El Salvador | Gilead |
Equatorial Guinea | Janssen |
Eritrea | Janssen |
Ethiopia | Janssen |
Fiji | Janssen |
Gabon | Janssen |
Gambia | Janssen |
Georgia | Janssen |
Ghana | Janssen |
Grenada | Gilead |
Guatemala | Gilead |
Guinea | Janssen |
Guinea-Bissau | Janssen |
Guyana | Gilead |
Haiti | Gilead |
Honduras | Gilead |
India | Janssen |
Indonesia | Janssen |
Jamaica | Gilead |
Kazakhstan | Janssen |
Kenya | Janssen |
Kiribati | Janssen |
Korea, Dem. People's Rep of | Janssen |
Kyrgyzstan | Janssen |
Lao, People's Dem. Rep. | Janssen |
Lesotho | Janssen |
Liberia | Janssen |
Madagascar | Janssen |
Malawi | Janssen |
Maldives | Janssen |
Mali | Janssen |
Mauritania | Janssen |
Mauritius | Janssen |
Moldova, Rep. of | Janssen |
Mongolia | Janssen |
Montserrat | Gilead |
Mozambique | Janssen |
Myanmar | Janssen |
Namibia | Janssen |
Nauru | Janssen |
Nepal | Janssen |
Nicaragua | Gilead |
Niger | Janssen |
Nigeria | Janssen |
Pakistan | Janssen |
Palau | Janssen |
Papua New Guinea | Janssen |
Rwanda | Janssen |
Saint Kitts and Nevis | Gilead |
Saint Lucia | Gilead |
Saint Vincent and the Grenadines | Gilead |
Samoa | Janssen |
Sao Tome and Principe | Janssen |
Senegal | Janssen |
Seychelles | Janssen |
Sierra Leone | Janssen |
Solomon Islands | Janssen |
Somalia | Janssen |
South Africa | Janssen |
South Sudan | Janssen |
Sri Lanka | Janssen |
Sudan | Janssen |
Suriname | Gilead |
Swaziland | Janssen |
Syria | Janssen |
Tajikistan | Janssen |
Tanzania, U. Rep. of | Janssen |
Thailand | Janssen |
Timor-Leste | Janssen |
Togo | Janssen |
Tonga | Janssen |
Trinidad and Tobago | Gilead |
Turkmenistan | Janssen |
Turks and Caicos | Gilead |
Tuvalu | Janssen |
Uganda | Janssen |
Uzbekistan | Janssen |
Vanuatu | Janssen |
Vietnam | Janssen |
Yemen | Janssen |
Zambia | Janssen |
Zimbabwe | Janssen |
XI. | Annex BB: Invoice and Payment Terms for Territory Combination Product in Janssen Countries |
A. | Janssen Country Combination Product Invoicing |
A.1. | Invoicing and Payment in Region A Janssen Countries |
A. | Janssen Country Combination Product Interim Supply Price |
B.1. | Region B and Region C Janssen Countries |
C. | Janssen Country Combination Product Annual True-Up |
C.1. | Region A Janssen Countries Excluding [*] |
C.2. | Region B and Region C Janssen Countries |
A. | Estimated Net Selling Price and TCP Interim Supply Price Currency Conversions |
B. | Regional TMC278 Annual True-Up and TCP Annual True-Up |
XIV. | Annex EE: Letter Agreement Regarding Marketing Authorization for Combination Product. |
Argentina |
Bahrain |
Hong Kong |
Israel |
Japan |
Kuwait |
Lebanon |
Macau |
Malaysia |
Mexico |
Oman |
Qatar |
Saudi Arabia |
Singapore |
South Korea |
Taiwan |
United Arab Emirates |
Algeria |
Azerbaijan |
Belarus |
Egypt |
Iran |
Iraq |
Jordan |
Libya |
Morocco |
Philippines |
Tunisia |
Ukraine |
Afghanistan |
Angola |
Armenia |
Bangladesh |
Benin |
Bhutan |
Botswana |
Burkina Faso |
Burundi |
Cambodia |
Cameroon |
Cape Verde |
Central African Republic |
Chad |
Comoros |
Congo |
Congo, Dem. Rep. of the |
Cote d'lvoire |
Djibouti |
Equatorial Guinea |
Eritrea |
Ethiopia |
Fiji |
Gabon |
Gambia |
Georgia |
Ghana |
Guinea |
Guinea-Bissau |
India |
Indonesia |
Kazakhstan |
Kenya |
Kiribati |
Korea, Denim. People's Rep. of |
Kyrgyzstan |
Lao, People's Dem. Rep. |
Lesotho |
Liberia |
Madagascar |
Malawi |
Maldives |
Mali |
Mauritania |
Mauritius |
Moldova, Rep. of |
Mongolia |
Mozambique |
Myanmar |
Namibia |
Nauru |
Nepal |
Niger |
Nigeria |
Pakistan |
Palau |
Papua New Guinea |
Rwanda |
Samoa |
Sao Tome and Principe |
Senegal |
Seychelles |
Sierra Leone |
Solomon Islands |
Somalia |
South Africa |
South Sudan |
Sri Lanka |
Sudan |
Swaziland |
Syria |
Tajikistan |
Tanzania, U. Rep. of |
Thailand |
Timor-Leste |
Togo |
Tonga |
Turkmenistan |
Tuvalu |
Uganda |
Uzbekistan |
Vanuatu |
Vietnam |
Yemen |
Zambia |
Zimbabwe |
Provision | Term |
1 Defined Terms | Capitalized terms used and not defined in this TDA have the respective meanings assigned to them in the Collaboration Agreement. For clarity, this TDA shall be deemed part of the Collaboration Agreement. Unless otherwise indicated, all section cross-references in this TDA are to the Sections of this TDA and not the Collaboration Agreement. “Contract Manufacturer” or “CMO” shall mean any Third Party contract manufacturer with which (a) Gilead or its Affiliates contracts for the Manufacture of Territory Combination Product to fulfill its obligations hereunder, or (b) Tibotec or its Affiliates contracts for the labeling, packaging, handling or storage of Territory Combination Product. “Gilead Manufacturer” shall mean a Person that Manufactures Territory Combination Product supplied hereunder by or on behalf of Gilead and its Affiliates, whether it be Gilead, an Affiliate of Gilead or a Contract Manufacturer of Gilead (or an Affiliate of Gilead). “Supply Committee” shall have the meaning set forth in the TMC278 Supply Agreement. “Territory Combination Product Specifications” shall mean the specifications for Major Market Combination Product and Branded Region B/C Combination Product, as applicable, in each case as provided by Gilead to Tibotec promptly following NDA approval in the United States, as amended from time to time in accordance with this TDA. “Tibotec Packager” shall mean a Person that packages or labels Territory Combination Product supplied hereunder by or on behalf of Tibotec and its Affiliates, whether it be Tibotec, an Affiliate of Tibotec or a Contract Manufacturer of Tibotec (or an Affiliate of Tibotec). |
2 Supply of Territory Combination Product; Minimum Shelf Life | 2.1 Generally. Subject to the terms and conditions of the Collaboration Agreement, during the term of this TDA, Gilead shall sell to Tibotec, and Tibotec shall purchase exclusively from Gilead, pursuant to Firm Orders properly submitted to Gilead hereunder, all of Tibotec's requirements of Territory Combination Product in unlabeled bottles of Major Market Combination Product or Branded Region B/C Combination Product, as applicable, for use solely as permitted under the Collaboration Agreement. The Supply Committee shall determine the commencement date for Manufacture and sale to Tibotec under this TDA of Branded Region B/C Combination Product, including any required Manufacture of validation batches required by Applicable Law; provided that the Parties understand and agree that Gilead shall require [*] 2.1 Minimum Shelf Life. 2.2.1 [*] 2.2.2 [*] and for clarity Section 10.6(b) of the Collaboration Agreement shall apply. |
3 Forecasts and Orders | 3.1 Generally. On or before the first day of each month (the “Forecast Date”) during the term of this TDA, commencing as of the date specified in Section 3.2 or 3.3 of this TDA as applicable, Tibotec shall submit to Gilead, a forecast of the quantity of Major Market Combination Product and Branded Region B/C Combination Product that Tibotec expects to order [*] following the applicable Forecast Date (each, a “Forecast”). Each forecast shall be prepared in good faith consultation with Gilead. In addition, Tibotec shall, prior to the end of each Calendar Year during the Term, provide Gilead with Tibotec's good faith estimate of its annual requirements for Major Market Combination Product and Branded Region B/C Combination Product for [*] following the Calendar Year in which such estimate is given; provided, however, that, in the case of [*] 3.2 Major Market Combination Product. Commencing [*] before the anticipated Launch in the first (1st) Tibotec Country where Tibotec will be selling the Major Market Combination Product, Tibotec shall submit to Gilead a Forecast of the quantity of Major Market Combination Product that Tibotec expects to order for [*] following the applicable Forecast Date. The quantity of the Major Market Combination Product set forth in a given Forecast for [*] shall be binding. Except as provided in the foregoing sentence, Forecasts shall be considered non-binding. 3.3 Branded Region B/C Combination Product. Commencing [*] before the anticipated Launch in the first Tibotec Country where Tibotec will be selling the Branded Region B/C Combination Product, Tibotec shall submit to Gilead a Forecast of the quantity of Branded Region B/C Combination Product that Tibotec expects to order for [*] following the applicable Forecast Date. Branded Region B/C Combination Product set forth in a given Forecast for [*] shall be binding. Except as provided in the foregoing sentence, Forecasts shall be considered non-binding. 3.4 Orders and Non-Binding Period. 3.4.1 Firm Orders. Tibotec shall notify Gilead, in the form of a purchase order or other form agreed by the Parties (each a “Firm Order”), of the Units of each of Major Market Combination Product and Branded Region B/C Combination Product to be Delivered to satisfy Tibotec's requirements at least [*] prior to the date on which such Territory Combination Product is to be Delivered. Each Firm Order shall (a) be consistent with the quantity set forth in the applicable binding portion of the Forecast; (b) be denominated in Units, unless otherwise mutually agreed by the Parties and (c) specify the Delivery date and any reasonable delivery instructions set forth in the Firm Order. Each Firm Order for Branded Region B/C Combination Product shall be [*] and, provided, further, that Tibotec acknowledges and agrees that production yield rates for Branded Region B/C Combination Product may inherently vary and that as a result Delivered lot sizes may inherently vary from the estimated lot size and the Parties' obligations as to such inherent variation are detailed in Section 6.1.2 of this TDA. 3.4.2 Non-Binding Forecasts [*] and by Supply Committee Determination. Notwithstanding Section 3.4.1, any Forecasts provided by Tibotec for [*] shall be deemed non-binding and the quantities of such Combination Product to be Delivered to Tibotec and timing of any such deliveries shall be determined by the Supply Committee and such determination of quantities and timing by the Supply Committee shall be binding on both Parties. 3.5 Russia. Tibotec shall place separate forecasts and Firm Orders for Major Market Combination Product that will be Distributed in Russia in accordance with Section 3.2 and 3.4. 3.6 Japan. Tibotec shall place separate forecasts and Firm Orders for Major Market Combination Product that will be Distributed in Japan in accordance with Section 3.2 and 3.4; provided, however, that such forecasts shall be [*] 3.7 Acceptance of Firm Orders. Within [*] of initial receipt of a Firm Order from Tibotec, Gilead shall notify Tibotec whether it accepts or rejects such Firm Order. Gilead shall accept any such Firm Order from Tibotec to the extent that such Firm Order complies with the requirements above. 3.8 Supply Committee. The roles and responsibilities of the Supply Committee shall include the supply of Major Market Combination Product and Branded Region B/C Combination Product, including issues related to supply for Japan and Russia and those responsibilities that are set forth in Section 2.2(c) of the TMC278 Supply Agreement but as applied to the Territory Combination Product rather than TMC278. 3.9 Distribution Limitation. Tibotec shall not Distribute (a) in Russia or Japan any Territory Combination Product ordered and Delivered for a country other than Russia or Japan, respectively, or (b) outside of Russia or Japan any Territory Combination Product ordered and Delivered for Russia or Japan, respectively. |
4 Deviations from Firm Orders | 4.1 [*] notify Tibotec of the quantities of Major Market Combination Product or Branded Region B/C Combination Product, as applicable, that Gilead expects to be able to Deliver by the delivery date specified in the applicable Firm Order. 4.2 Reduced Order Quantity. In the event that Tibotec places a Firm Order that is less than the binding Forecast for such period, [*] |
5 Non-Conforming Product | 5.1 Notice of Nonconformity. Tibotec shall notify Gilead in writing of any claim that any Territory Combination Product supplied under this TDA is not in conformance with the warranties set forth herein (“Nonconforming”) [*] Tibotec shall promptly provide Gilead with a sample of such Nonconforming Territory Combination Product, if available, and all relevant reports, data, and laboratory test results indicating that such Territory Combination Product is Nonconforming. Tibotec shall [*] If Gilead and Tibotec disagree as to whether Units of Territory Combination Product are Nonconforming, Gilead and Tibotec shall designate an independent testing laboratory reasonably acceptable to both Parties to make a determination, which determination shall be binding on the Parties, absent manifest error. Gilead shall [*] 5.2 [*] Nonconforming Territory Combination Product. If the independent testing laboratory (as set forth above) determines that the Territory Combination Product was Nonconforming or the Parties agree that the Territory Combination Product was Nonconforming, then [*] 5.3 Destruction of Nonconforming Territory Combination Product. Tibotec shall arrange for the destruction, return or other disposal, at Gilead's election, of any Nonconforming Territory Combination Product in compliance with Gilead's instructions and Applicable Law. [*] |
6 Territory Combination Product Shortage; Failure to Supply | 6.1 Inadequate Delivered Quantity of Territory Combination Product. 6.1.1 Tibotec shall notify Gilead in writing of any failure to Deliver Major Market Combination Product or a shortage in quantity in any shipment of Major Market Combination Product (as compared with the amount specified for Delivery in the applicable Firm Order given by Tibotec (as set forth above)) [*] days after Delivery (or scheduled Delivery) thereof. In the event Gilead disagrees with any claim of shortage by Tibotec, each Party shall designate a representative to be present at the inventorying of the at-issue Major Market Combination Product, the results of which shall be binding on the Parties, absent manifest error (and Gilead shall invoice Tibotec solely based on such binding inventory). Gilead shall use its Commercially Reasonable Efforts to promptly Deliver any shortage amount (as agreed upon by the Parties or determined by the inventory) of Major Market Combination Product as promptly as possible. [*] 6.1.2 For Firm Orders of Branded Region B/C Combination Product, Gilead's obligation to Deliver shall be deemed fulfilled if Gilead delivers [*] 6.2 Shortage of Territory Combination Product. If Gilead is unable to supply the full quantities of Territory Combination Product set forth in the Firm Orders from Tibotec and its Affiliates together with the amounts of Territory Combination Product needed by Gilead and its Affiliates, then Gilead shall allocate the available supply of Territory Combination Product [*] 6.3 Notification and Cure. If Gilead fails to supply Territory Combination Product for which it has received a Firm Order in accordance with this TDA, [*] then the matter shall be referred to the Executives for resolution pursuant to Section 2.4 of the Collaboration Agreement; provided that subsection 2.4(b) thereof shall not apply to such resolution. 6.4 Other Remedies. Subject to the express limitations set forth herein, the remedies set forth in this Section 6 for a material breach by Gilead shall be in addition to any other remedies Tibotec may have under this TDA, the Collaboration Agreement, or at law. |
7 Territory Combination Product Packaging by Gilead | 7.1 Labeling. Gilead shall supply Tibotec with Units of unlabeled bottles of Territory Combination Product. 7.2 Packaging. Each shipment shall be packed, sealed, and shipped in accordance with Gilead's customary packaging practices and GMP. |
8 Packaging, Labeling and Storage Technology Transfer; Packaging and Labeling Requirements | 8.1 Gilead shall assist Tibotec in establishing proper procedures with respect to packaging, labeling and storage of Territory Combination Product. 8.2 Gilead shall provide Tibotec with the core secondary packaging and packaging insert artwork with respect to the Territory Combination Product (“Core Materials” ) for use by Tibotec in packaging and labeling Territory Combination Product. Tibotec shall use the Core Materials to package and label the Territory Combination Product, but shall modify the Core Materials as required by Applicable Law and shall provide any necessary translations. Gilead shall have the right, but not the obligation, to review and approve in advance the Core Materials, as so modified, for any country for which Tibotec is the Selling Party. |
9 Territory Combination Product Delivery | 9.1 Delivery shall be [*] 9.2 The shipment shall be labeled with a traceable batch number. The bill of lading shall list the gross weight and net weight of the shipment. Concurrent with each shipment of Territory Combination Product, Gilead shall provide Tibotec with an electronic copy of the certificate of analysis confirming that such batch meets the applicable Specifications. In addition, upon delivery to Tibotec's carrier, Gilead shall provide Tibotec with notice that the shipment has been delivered, including the quantity of Territory Combination Product delivered. If Tibotec requests, Gilead shall provide a written certificate of compliance for a batch or batches of Territory Combination Product delivered to Tibotec. |
10 Safety Stock | 10.1 Safety Stocks. [*] |
11 Quality Control | 11.1 Warranty on Territory Combination Product. Gilead represents and warrants that, at the time of Delivery, the Territory Combination Product supplied hereunder, other than as a result of any defect or condition of the Supplied TMC278 included therein, including any breach of any warranty with respect to the Supplied TMC278 made by Tibotec in the TMC278 Supply Agreement (a) shall have been Manufactured in accordance with GMP and Applicable Law, and (b) shall conform to the Territory Combination Product Specifications for Major Market Combination Product or Branded Region B/C Combination Product, as applicable, and the applicable certificate of analysis. 11.2 Changes to Territory Combination Product Specifications. 11.2.1 Changes to Territory Combination Product Specifications that are an Additional Requirement, shall be governed by Section 8.4 of the Collaboration Agreement. All other changes to the Territory Combination Product Specifications for Major Market Combination Product or Branded Region B/C Combination Product shall be subject to the provisions in this TDA. 11.2.2 If Gilead wishes to amend the Territory Combination Product Specifications, Gilead shall provide written notice thereof to the Tibotec. [*] Prior to delivery of Territory Combination Product to Tibotec pursuant to this TDA and solely to the extent not provided in the Product Specifications, Gilead shall establish and provide to Tibotec the specifications for bottle size and shape with respect to the supplied Territory Combination Product. Any changes to such bottle size and shape specifications shall be treated in accordance with the process for changing the Product Specifications. 11.3 Territory Combination Product Manufacturing-Related Changes. Manufacturing-related changes that are an Additional Requirement shall be governed by Section 8.4 of the Collaboration Agreement. Subject to the requirements above, other manufacturing-related changes with respect to Territory Combination Product, [*] Any Manufacturing-Related Changes made with respect to Territory Combination Product shall, in each case, comply with GMP and Applicable Law. In the event of any such change, Gilead shall (i) be responsible to ensure that all Territory Combination Product Manufactured under the changed Manufacturing process by or on behalf of Gilead or its Affiliates meets the applicable Territory Combination Product Specifications, and (ii) provide Tibotec in a timely manner with all information reasonably needed to make corresponding amendments to the applicable regulatory filings in the Territory maintained by Tibotec with respect to the Territory Combination Product (including amending Approvals in the Territory), to the extent necessary. 11.4 Quality Agreements. 11.4.1 Between Gilead and its CMOs. During the term of this TDA, Gilead shall have quality agreements in place with each of its Contract Manufacturers that Manufacture Territory Combination Product for supply hereunder. Such quality agreements shall, at a minimum, have terms governing GMP compliance as are customary in the pharmaceutical industry. 11.4.2 Between Gilead and Tibotec. Prior to the shipment of any Territory Combination Product hereunder, the Parties shall enter into an agreement which sets out the policies, procedures, and standards by which the Parties shall coordinate and implement the operational and quality assurance activities and regulatory compliance objectives contemplated under this TDA with respect to the Territory Combination Product and the subsequent labeling, packaging and storage of such Territory Combination Product by Tibotec (the “Quality Agreement”). Any amendment to the Quality Agreement shall require the written agreement of the Parties. 11.4.3 Between Tibotec and its CMOs. During the term of this TDA, Tibotec shall have quality agreements in place with each of its CMOs that package, label or handle Territory Combination Product purchased hereunder. Such quality agreements shall, at a minimum, have terms governing GMP compliance as are customary in the pharmaceutical industry. |
12 Combination Product Inspections | 12.1 [*] Inspections. During the term of this TDA and no more than [*] (a) Tibotec and/or its agents may inspect, during regular business hours, [*] to ascertain compliance with GMP, Applicable Law, the Territory Combination Product Specifications and the terms of this TDA in the Manufacture, handling and shipping of Territory Combination Product; and (b) Gilead and/or its agents may inspect, during regular business hours, [*] to ascertain compliance with GMP, Applicable Law, the Territory Combination Product Specifications and the terms of this TDA. Any such inspection of a Contract Manufacturer, a Gilead Manufacturer or a Tibotec Packager shall be coordinated with inspections thereof conducted by or on behalf of the other Party or its Affiliates, and may be conditioned on the execution of a customary confidentiality agreement between the inspecting Party (or its agent) and such Contract Manufacturer, Gilead Manufacturer or Tibotec Packager. As part of any inspection conducted pursuant to this Section, the inspecting Party and/or its agents may inspect, as applicable, [*] (such activities, an “Inspection”). 12.2 “For Cause” Inspection. 12.2.1 Tibotec may conduct an Inspection of the relevant facilities of any Gilead Manufacturer that supplies Territory Combination Product hereunder, if such an Inspection is a reasonable response to a Regulatory Authority audit notice or inquiry regarding any Territory Combination Product, an unresolved deviation in the Manufacture of the Territory Combination Product, or customer complaints or adverse events regarding the Territory Combination Product. Tibotec and Gilead shall coordinate in good faith as to the timing of any Inspection of a Contract Manufacturer conducted pursuant to this Section and Gilead or its designee shall be present at any such Inspection. 12.2.2 Gilead may conduct an Inspection of the relevant facilities of any Tibotec Packager, if such an Inspection is a reasonable response to a Regulatory Authority audit notice or inquiry regarding any Territory Combination Product, an unresolved deviation in the packaging, labeling or storage of the Territory Combination Product, or customer complaints or adverse events regarding the Territory Combination Product. Tibotec and Gilead shall coordinate in good faith as to the timing of any Inspection of a Contract Manufacturer conducted pursuant to this Section and Tibotec or its designee shall be present at any such Inspection. 12.3 Remedial Efforts. Following any Inspection conducted (as described above), the Parties shall meet to discuss the inspecting Party's findings, and [*] |
13 Payments | 13.1 Territory Combination Product. Subject to the terms and conditions of this TDA and the Collaboration Agreement, for Territory Combination Product Delivered by Gilead to Tibotec hereunder, Gilead shall issue to Tibotec an invoice upon shipment of the Territory Combination Product as provided in Annex BB of the Collaboration Agreement. Each such invoice shall state the quantity of Major Market Combination Product and Branded Region B/C Combination Product covered by such invoice and specify all amounts due in United States Dollars. Subject to the terms and conditions of this TDA and the Collaboration Agreement, Tibotec shall pay each such invoice in accordance with the payment terms set forth in Annex BB of the Collaboration Agreement. 13.2 Expenses. Any expenses and/or losses hereunder which are deemed in this TDA to be included in the Manufacturing Fee shall be calculated and invoiced in accordance with Section 10.2 of the Collaboration Agreement. Unless otherwise agreed by the Parties (including in the preceding sentence and in Section 10 of the Collaboration Agreement), (a) each Party promptly shall invoice the other Party for any amounts due under this TDA and (b) each Party shall pay any valid invoice provided by the other Party pursuant to this TDA within [*] after receipt of such invoice. |
14 Tibotec Representations, Warranties and Covenants | 14.1 Warranty on Distributed Territory Combination Product. Tibotec represents and warrants that, at the time of distribution or sale of Territory Combination Product supplied hereunder to Third Parties, that such Territory Combination Product shall not be expired or otherwise unfit for sale as a result of Tibotec's packaging, labeling, handling or storage of such Territory Combination Product and such Territory Combination Product shall be in conformance with the Territory Combination Product Specifications and Applicable Law with respect to packaging and labeling. 14.2 Permits. Tibotec shall obtain and maintain, all necessary permits for the packaging, labeling, receipt, storage, handling and distribution of Territory Combination Product at the facility(ies) where Territory Combination Product supplied hereunder is packaged, labeled and/or stored by or on behalf of Tibotec or its Affiliates. 14.3 Manufacturing and Storage Records. Tibotec shall maintain complete and accurate records relating to the receipt, handling, storage, use, packaging, labeling and disposal by or on behalf of Tibotec or its Affiliates of the Territory Combination Product supplied hereunder and standard operating procedures for the foregoing in accordance with Applicable Law and GMP and shall provide a written account of any discrepancies. Gilead shall have the right to review such records upon the reasonable request of Gilead. 14.4 Packaging and Labeling Specifications. Tibotec shall label and package the Territory Combination Product in accordance with GMP and Applicable Law for the country or region in which such Territory Combination Product will be sold, released or distributed. If any Territory Combination Product intended for release, sale or distribution by Tibotec fails to comply with the labeling and packaging requirements in accordance with the Territory Combination Product Specifications or Applicable Law for the country or region in which such Territory Combination Product will be sold, released or distributed, then Tibotec shall not release, sell or distribute such Territory Combination Product. 14.5 Tibotec Packagers. Tibotec shall, or shall cause the Tibotec Packagers to, maintain the facilities, equipment and machinery used in connection with the labeling and packaging of Territory Combination Product in a state of repair and operating efficiency that enables it to meet the applicable Territory Combination Product Specifications. Tibotec shall, or shall cause such Tibotec Packagers to, validate the equipment and the labeling and packaging process and any other appropriate steps performed at such facilities and validate/calibrate all instruments used in testing such equipment and machinery, in each case to the extent used in connection with the labeling or packaging of Territory Combination Product and as required by GMP and Applicable Law. 14.6 Handling and Storage. Tibotec shall at all times handle, store and transport Territory Combination Product in accordance with Applicable Law, GMP and GDP and in a manner and with a level of care consistent with Tibotec's handling, storage and transport of similar pharmaceutical products. |
15 Consequences of Termination | 15.1 Consequences of Termination. In the event the Collaboration Agreement terminates or upon Tibotec ceasing to Distribute Territory Collaboration Product and/or there ceasing to be any Tibotec Countries, the following provisions shall apply: 15.1.1 Prior Orders. [*] 15.1.2 Territory Combination Product. Upon termination of the Collaboration Agreement by Tibotec for a Material Breach by Gilead, [*] |
16 Survival | The following provisions of this TDA shall survive the expiry or termination of the Collaboration Agreement (which expiration or termination shall automatically terminate this TDA): Sections 1, 3.9, 9 (with respect to any Territory Combination Product Delivered following termination of this TDA), 11.1, 11.4.3, 14.3 (to the extent such records are required for a period of three (3) years following termination), 15, 16, 17 and 18. In addition to any other Sections which may survive pursuant to this Section 16, the provisions of Sections 2.2, 3.8, 5 (provided that there shall be no obligation to replace Nonconforming Territory Combination Product), 6 (provided that there shall be no obligation to [*]), 8.2 (solely with respect to Tibotec's packaging and labeling obligations), 13 and 14 shall survive, in each case solely with regard to the Territory Combination Product Delivered by Gilead. |
17 Subcontracting | Subject to the terms and conditions of this TDA, Gilead may subcontract the Manufacture of Territory Combination Product to one or more Contract Manufacturers. Gilead shall have the right to select such Contract Manufacturers in its sole discretion. In the event that Gilead delegates any of its obligations under this TDA to a subcontractor, Gilead shall remain primarily (and not secondarily or derivatively) liable for the full and timely performance by such subcontractor of all its obligations under this TDA. Notwithstanding anything to the contrary contained herein, if Gilead engages a subcontractor to fulfill any of Gilead's obligations hereunder, Gilead shall cause such subcontractor to comply with the provisions of this TDA. |
18 Incorporation with Collaboration Agreement; Interpretation | This TDA is incorporated into and subject to the terms of the Collaboration Agreement. If there is any inconsistency between the provisions of this TDA and the provisions of the Collaboration Agreement, the provisions of the Collaboration Agreement shall control. If there is any inconsistency between the provisions of this TDA and the Quality Agreement, or any purchase order, confirmation, or other document passing between the Parties relating to supply of Territory Combination Product by Gilead to Tibotec or the subsequent packaging, handling or storage of the Territory Combination Product by Tibotec hereunder, the provisions of this TDA shall control except that the Quality Agreement controls with respect to procedures for verifying compliance with quality requirements. |
/s/ JOHN C. MARTIN |
John C. Martin, Ph.D. Chairman and Chief Executive Officer |
/S/ ROBIN L. WASHINGTON |
Robin L. Washington Senior Vice President and Chief Financial Officer |
/s/ JOHN C. MARTIN | /s/ ROBIN L. WASHINGTON | |
John C. Martin, Ph.D. Chairman and Chief Executive Officer | Robin L. Washington Senior Vice President and Chief Financial Officer |
Intangible Assets and Goodwill Schedule of Finite Lived Intangible Assets (Details) (USD $)
In Thousands, unless otherwise specified |
Mar. 31, 2013
|
Dec. 31, 2012
|
---|---|---|
Ranexa [Member]
|
||
Finite Lived Intangible Assets [Line Items] | ||
Finite-Lived Intangible Assets, Accumulated Amortization | $ 147,552 | $ 133,119 |
Finite-Lived Intangible Assets, Gross Carrying Amount | 688,400 | 688,400 |
Lexiscan [Member]
|
||
Finite Lived Intangible Assets [Line Items] | ||
Finite-Lived Intangible Assets, Accumulated Amortization | 101,902 | 95,466 |
Finite-Lived Intangible Assets, Gross Carrying Amount | 262,800 | 262,800 |
Other [Member]
|
||
Finite Lived Intangible Assets [Line Items] | ||
Finite-Lived Intangible Assets, Accumulated Amortization | 16,093 | 15,417 |
Finite-Lived Intangible Assets, Gross Carrying Amount | 42,995 | 42,995 |
Total Member
|
||
Finite Lived Intangible Assets [Line Items] | ||
Finite-Lived Intangible Assets, Accumulated Amortization | 265,547 | 244,002 |
Finite-Lived Intangible Assets, Gross Carrying Amount | $ 994,195 | $ 994,195 |
Derivative Financial Instruments Derivative financial instruments Narrative (Details) (USD $)
In Billions, unless otherwise specified |
Mar. 31, 2013
|
Dec. 31, 2012
|
---|---|---|
Derivative Instruments and Hedging Activities Disclosure [Abstract] | ||
Notional Amount of Foreign Currency Derivatives | $ 3.47 | $ 3.39 |
Intangible Assets and Goodwill Schedule of Future Amortization Expense (Details) (USD $)
In Thousands, unless otherwise specified |
Mar. 31, 2013
|
---|---|
Goodwill and Intangible Assets Disclosure [Abstract] | |
2013 (remaining nine months) | $ 64,636 |
2014 | 92,441 |
2015 | 97,673 |
2016 | 107,312 |
2017 | 116,137 |
2018 | 124,561 |
Total | $ 602,760 |
Derivative Financial Instruments Summary of the effect of foreign currency exchange contracts on consolidated statements of income (Details) (USD $)
In Thousands, unless otherwise specified |
3 Months Ended | |
---|---|---|
Mar. 31, 2013
|
Mar. 31, 2012
|
|
Derivative Instruments and Hedging Activities Disclosure [Abstract] | ||
Net Gains (Losses) Recognized in OCI (effective portion) | $ 70,860 | $ (48,886) |
Net Gains Reclassified from Accumulated OCI into Product Sales (effective portion) | 462 | 11,227 |
Losses Recognized in Other Income (Expense), Net (ineffective portion and amounts excluded from effectiveness testing) | (2,132) | (3,212) |
Net Gains (Losses) Recognized in Other Income (Expense), Net | $ 32,620 | $ (27,174) |
Intangible Assets and Goodwill Intangible Assets and Goodwill (Narrative) (Details) (USD $)
In Millions, unless otherwise specified |
3 Months Ended | ||
---|---|---|---|
Mar. 31, 2013
|
Mar. 31, 2012
|
Feb. 08, 2013
|
|
Goodwill and Intangible Assets Disclosure [Abstract] | |||
Fair Value of Acquired Assets and Assumed Liabilities | $ 487.6 | ||
Acquired Indefinite-Lived Intangible Asset | 362.7 | ||
Amortization of Intangible Assets | 21.5 | 15.8 | |
Finite-Lived Intangible Asset, Useful Life | 11 years | ||
Goodwill Resulting from the Acquisition of YM | $ 127.2 |
Available-for-Sale Securities Available-for-sale securities (Tables)
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Mar. 31, 2013
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Investments, Debt and Equity Securities [Abstract] | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Summary of Available-for-Sale Securities at Estimated Fair Value [Table Text Block] | The following table is a summary of available-for-sale debt securities recorded in cash and cash equivalents or marketable securities in our Consolidated Balance Sheets (in thousands):
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Summary of the Classification of Available-for-Sale Securities [Table Text Block] | The following table summarizes the classification of the available-for-sale debt securities on our Consolidated Balance Sheets (in thousands):
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Summary of Available-for-Sale Securities by Contractual Maturity [Table Text Block] | The following table summarizes our portfolio of available-for-sale debt securities by contractual maturity (in thousands):
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Summary of Gross Realized Gains (Losses) Related to Sales of Marketable Securities [Table Text Block] | The following table summarizes the gross realized gains and losses related to sales of marketable securities (in thousands):
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Summary of Available-for-Sale Securities in a Continuous Loss Position Deemed not to be Other-than-Temporarily Impaired [Table Text Block] | The following table summarizes our available-for-sale debt securities that were in a continuous unrealized loss position, but were not deemed to be other-than-temporarily impaired (in thousands):
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Inventories Schedule of inventories (Details) (USD $)
In Thousands, unless otherwise specified |
Mar. 31, 2013
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Dec. 31, 2012
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Inventory Disclosure [Abstract] | ||
Raw Materials | $ 693,139 | $ 826,545 |
Work in Process | 529,157 | 358,525 |
Finished Goods | 577,322 | 559,912 |
Total | $ 1,799,618 | $ 1,744,982 |
Available-for-Sale Securities Summary of Gross Realized Gains and Losses Related to Sales of Marketable Securities (Details) (USD $)
In Thousands, unless otherwise specified |
3 Months Ended | |
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Mar. 31, 2013
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Mar. 31, 2012
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Investments, Debt and Equity Securities [Abstract] | ||
Gross Realized Gains on Sales | $ 182 | $ 10,015 |
Gross Realized Losses on Sales | $ (156) | $ (40,096) |
Fair value measurements Contingent Consideration Rollforward (Details) (USD $)
In Thousands, unless otherwise specified |
3 Months Ended |
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Mar. 31, 2013
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Fair Value, Liabilities Measured on Recurring Basis, Unobservable Input Reconciliation, Calculation [Roll Forward] | |
Balance, December 31, 2012 | $ 205,060 |
Additions from new acquisitions | 0 |
Net changes in valuation | 6,024 |
Balance, March 31, 2013 | $ 211,084 |
Intangible Assets and Goodwill Schedule of Carrying Amount of Intangible Assets (Details) (USD $)
In Thousands, unless otherwise specified |
Mar. 31, 2013
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Dec. 31, 2012
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Goodwill and Intangible Assets Disclosure [Abstract] | ||
Indefinite-Lived Intangible Assets | $ 11,348,900 | $ 10,986,200 |
Finite-Lived Intangible Assets | 728,648 | 750,193 |
Total Intangible Assets | $ 12,077,548 | $ 11,736,393 |
Segment information Segment information narrative (Details)
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3 Months Ended |
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Mar. 31, 2013
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Segment Reporting Information, Revenue for Reportable Segment [Abstract] | |
Major Customers Percentage Of Total Revenues Minimum | 10.00% |
Fair value measurements
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Mar. 31, 2013
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Fair Value, Assets and Liabilities Measured on Recurring Basis [Abstract] | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Fair Value Disclosures [Text Block] | FAIR VALUE MEASUREMENTS We determine the fair value of financial and non-financial assets and liabilities using the fair value hierarchy, which establishes three levels of inputs that may be used to measure fair value, as follows:
Our financial instruments consist principally of cash and cash equivalents, marketable securities, accounts receivable, foreign currency exchange forward and option contracts, accounts payable and short-term and long-term debt. Cash and cash equivalents, marketable securities and foreign currency exchange contracts that hedge accounts receivable and forecasted sales are reported at their respective fair values on our Consolidated Balance Sheets. Short-term and long-term debt are reported at their amortized cost on our Consolidated Balance Sheets. The remaining financial instruments are reported on our Consolidated Balances Sheets at amounts that approximate current fair values. The fair values of our Convertible Notes and senior unsecured notes were determined using Level 2 inputs based on their quoted market values. The following table summarizes the carrying values and fair values of the Convertible Notes and senior unsecured notes (in thousands):
The following table summarizes, for assets or liabilities recorded at fair value, the respective fair value and the classification by level of input within the fair value hierarchy defined above (in thousands):
Level 2 Inputs We estimate the fair values of our government related debt, corporate debt, residential mortgage and asset-backed securities by taking into consideration valuations obtained from third-party pricing services. The pricing services utilize industry standard valuation models, including both income- and market-based approaches, for which all significant inputs are observable, either directly or indirectly, to estimate fair value. These inputs include reported trades of and broker/dealer quotes on the same or similar securities; issuer credit spreads; benchmark securities; prepayment/default projections based on historical data; and other observable inputs. Substantially all of our foreign currency derivatives contracts have maturities primarily over an 18 month time horizon and all are with counterparties that have a minimum credit rating of A- or equivalent by Standard & Poor's, Moody's Investors Service, Inc. or Fitch, Inc. We estimate the fair values of these contracts by taking into consideration valuations obtained from a third-party valuation service that utilizes an income-based industry standard valuation model for which all significant inputs are observable, either directly or indirectly. These inputs include foreign currency rates, London Interbank Offered Rates (LIBOR) and swap rates. These inputs, where applicable, are at commonly quoted intervals. Level 3 Inputs For the three months ended March 31, 2013, we held no assets measured using Level 3 inputs. For the three months ended March 31, 2012, assets measured at fair value using Level 3 inputs were comprised of auction rate securities and Greek bonds within our available-for-sale investment portfolio. Our policy is to recognize transfers into or out of Level 3 classification as of the actual date of the event or change in circumstances that caused the transfer. Auction Rate Securities As of March 31, 2013, we did not hold any auction rate securities. During the third quarter of 2012, we sold our remaining portfolio of auction rate securities and as a result of the sale, we received total proceeds of $37.3 million which resulted in a $3.8 million loss that was recognized in other income (expense), net on our Consolidated Statement of Income. The underlying assets of our auction rate securities consisted of student loans. Although auction rate securities would typically be measured using Level 2 inputs, the failure of auctions and the lack of market activity and liquidity experienced since the beginning of 2008 required that these securities be measured using Level 3 inputs. The fair value of our auction rate securities was determined using a discounted cash flow model that considered projected cash flows for the issuing trusts, underlying collateral and expected yields. Projected cash flows were estimated based on the underlying loan principal, bonds outstanding and payout formulas. The weighted-average life over which the cash flows were projected considered the collateral composition of the securities and related historical and projected prepayments. Greek Government Bonds As of March 31, 2013, we did not hold any Greek government bonds. During the first quarter of 2012, the Greek government restructured its sovereign debt which impacted all holders of Greek bonds. As a result, we recorded a $40.1 million loss related to the debt restructuring as part of other income (expense), net on our Consolidated Statement of Income and exchanged the Greek government-issued bonds for new securities, which we liquidated during the first quarter of 2012. We estimated the fair value of the Greek zero-coupon bonds using Level 3 inputs due to the then current lack of market activity and liquidity. The discount rates used in our fair value model for these bonds were based on credit default swap rates. Contingent Consideration Liabilities In connection with certain acquisitions, we may be required to pay future consideration that is contingent upon the achievement of specified development, regulatory approval or sales-based milestone events. We estimate the fair value of the contingent consideration liabilities on the acquisition date and each reporting period thereafter using a probability-weighted income approach, which reflects the probability and timing of future payments. This fair value measurement is based on significant Level 3 inputs such as the anticipated timelines and probability of achieving development, regulatory approval or sales-based milestone events and projected revenues. The resulting probability-weighted cash flows are discounted using credit-risk adjusted interest rates. Each reporting period thereafter, we revalue these obligations by performing a review of the assumptions listed above and record increases or decreases in the fair value of these contingent consideration obligations in research and development (R&D) expenses within our Consolidated Statements of Income until such time that the related product candidate receives marketing approval. In the absence of any significant changes in key assumptions, the quarterly determination of fair values of these contingent consideration obligations would primarily reflect the passage of time. Significant judgment is employed in determining Level 3 inputs and fair value measurements as of the acquisition date and for each subsequent period. Updates to assumptions could have a significant impact on our results of operations in any given period and actual results may differ from estimates. For example, significant increases in the probability of achieving a milestone or projected revenues would result in a significantly higher fair value measurement while significant decreases in the estimated probability of achieving a milestone or projected revenues would result in a significantly lower fair value measurement. Significant increases in the discount rate or in the anticipated timelines would result in a significantly lower fair value measurement while significant decreases in the discount rate or anticipated timelines would result in a significantly higher fair value measurement. The potential contingent consideration payments required upon achievement of development or regulatory approval-based milestones related to our CGI Pharmaceuticals, Inc. and Calistoga Pharmaceuticals, Inc. acquisitions range from no payment if none of the milestones are achieved to an estimated maximum of $254.0 million (undiscounted), of which we had accrued $163.9 million as of March 31, 2013 and $159.3 million as of December 31, 2012. The remainder of the contingent consideration liabilities accrual as of March 31, 2013 and December 31, 2012 relates to potential future payments resulting from the acquisition of Arresto Biosciences, Inc. for royalty obligations on future sales once specified sales-based milestones are achieved. The following table provides a rollforward of our contingent consideration liabilities, which are recorded as part of other long-term obligations in our Consolidated Balance Sheets (in thousands):
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Stock-Based Compensation Stock-Based Compensation (Narrative) (Details) (USD $)
In Millions, unless otherwise specified |
3 Months Ended |
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Mar. 31, 2012
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Research and Development Expenses [Member]
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Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | |
Accelerated Stock-Based Compensation Expense | $ 100.1 |
Selling, General and Administrative Expenses [Member]
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Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | |
Accelerated Stock-Based Compensation Expense | $ 93.8 |